Date: Sun, 28 Nov 1999 21:59:42 -0500
From: Richard Wolfson GEN11-28DrPusztai
Here are comments by Dr. Arpad Pusztai, the Scottish scientists who was hassled after he went public about his research about rats showing internal damage after eating genetically engineered potatoes. Dr. Pusztai's research was published in Lancet, though there was tremendous pressure against him. Here is the report
A commentary by Arpad Pusztai, made available on the internet by Thorkild
C. Bøg-Hansen, Senior Associate Professor, University of Copenhagen,
Denmark. November 23, 1999
To remind you what happened around our Lancet article.
According to my contract with the Rowett, my former employer, I have to send my papers to the Director, Dr Peter Morgan, for "scrutiny" as Queen's Council advised me. What this means is that because of Pillip James' [the Rowett's previous Director] carelessly drafted letters of 16 & 19 February 99, I am no longer required to submit my drafts of scientific papers for his approval before I can submit them to any scientific journal for publication.
However, I am still under a legal obligation to show the Director any paper for his "examination" but not for editing and changing them. This I have to do sometimes between submission and actual publication. This was precisely what happened with the Lancet paper whose galley proofs were sent to Dr Morgan at the end of September when we thought that the paper would in fact be published by 1 October. For a number of technical reasons the paper was in fact published on 15 October that gave two weeks for the "rubbishing brigade" to do their job. Dr Morgan advised me in his letter that
The results, the threats to the Lancet Editor and our villification by the RS and other top establishment figures in the newspapers, BBC and in letters to the Editor in the Lancet are now well-known and I am not going to deal with them here.
Although most of the attacks on us were very personal and the language sometimes touching the level of the gutter, I am not willing to join in such a debate debasing science. However, I shall want to summarize the scientific, quasi-scientific and misinformed criticisms on our paper, which appeared mainly in letters to Editor in the Lancet and also some magazine/newspaper articles. I shall also try to summarize our responses to these which appeared mainly in the 13 November issue of the Lancet.
Even before our article appeared in the Lancet on 15 October, Prof. Pickett, one of the six referees of our paper who apparently opposed its publication, broke the over 200 year gentleman's-convention of refereeing and gave interviews to the press in which he stated his opposition to the paper in a few not-so-gentlemanly sentences. However, his main "scientific message" was that our results were uninterpretable because we "changed horses in mid-stream", meaning that we changed the diets of the rats from GM-potatoes to controls diets. We have but two interpretations of this criticism: either Prof. Pickett did not read the paper he was supposed to have refereed or he deliberately misinformed the reporter. In either case, he was not the right person to referee our paper.
Sir Aaron Klug, the President of the RS criticised our paper and said that it would not have been accepted by the RS for publication because we did not have low-protein control diets in our experiment. Apart from the fact that the RS does not publish peer-reviewed scientific papers, his comments suggested that he may not have read our paper in which it is clearly said that all diets (including control diets) contained the same amount of protein and were iso-energetic.
In the Lancet letters mainly two peoples' comments were scientifically worthy of reply.
In the invited commentary letter Kuiper et al (13 October) addressed two main issues: The first one concerned the specific criticisms of our paper and secondly they dealt with the issue whether there are adequate methods for the testing of the safety of GM-foods and whether this is necessary at all.
Concerning the specific criticisms of our paper and our replies could be summarized as follows:
- Clearly, in a short research letter this was not permitted by the journal. However, Kuiper et al have a copy of the two Rowett internal reports in the public domain which were released by the Rowett on the internet against my expressed wishes (and not by me as Kuiper et al say) with the results of extensive analyses. He could have checked up on these showing that the two GM-potato lines were not substantially equivalent in composition with the parent line or with each other. All the same, and most importantly, the GM-line 71 used for the Lancet experiment had the same protein content as the parent line and therefore all diets (including the controls) were iso-proteinic and iso-energetic.
- It is true that 6% protein is just over half of the protein content of the optimal rat diet. However, in a short-term (10 day) experiment the rats can cope with that and in any case the control diets had the same low protein content and the results were therefore comparable. In contrast, Kuiper et al say that low protein diets impair rat metabolism and therefore invalidate our results. Unfortunately, as their reference shows this conclusion is more likely to be valid only for rats kept on protein-free diet and food restriction. Starvation is an emotive and meaningless term in respect of our experiment because despite the low protein content of the diet the rats were in fact growing, albeit less slowly than on optimal diets.
- All our diets, including control diets contained the same poorly digestible raw potato starch. Moreover, some of the changes in gut parameters also occured in rats fed diets containing boiled GM-potatoes when compared to non-GM boiled potato diets and these contained no poorly digestible raw potato starches.
- Our study was not a toxicological but a nutritional study. Kuiper et al confuse these two different types of evaluation experiments. In our experiments there were six rats per group. This was more than adequate in comparison with the four or five rats per group usually used in nutritional experiments and described in top nutritional journals. I have published at least 40 such papers of nutritional evaluation of rat diets in the past 20 or so years. In any case, toxicological LD50-type experiments are only permitted in exceptional cases in the UK.
- True, this potato was created at Durham at my request but our work was stopped before we could test these.
The general comments of Kuiper et al which refer to the adequacy of the testing of GM-food:
- Although they hold up as an example of [this] some work carried out in Kuiper's lab that was published as a book Chapter (and not peer-reviewed!) this was somewhat disingenious on their part because the work (Bt toxin from GM-tomatoes) was not carried out with the gene product isolated from the GM-plant as it should have been but was done with an E. coli recombinant. As these two are quite different, conclusions drawn from recombinant work cannot be accepted as valid. Incidentally, all biotech companies do the same according to their submitted evidence to the regulatory authorities.
All the same, we wholeheartedly endorse Kuiper's views that ALL GM-PRODUCTS SHOULD BE FULLY TESTED FOR THEIR BIOLOGICAL EFFECTS ON ANIMALS AND THEN HUMAN VOLUNTEERS! However, such studies have so far only been carried out by us at the Rowett on GM-potatoes and GM-peas and only with rats but their results have been published!
- This is a really strange statement because no such studies, except one on round up-ready-soya in 1996, can be found in the scientific literature. In fact, what is in the literature (even in the above Monsanto paper) shows that GM-soya is compositionally different from non-GM-soya. I am afraid, as scientists we need more published evidence before we can accept the GM-foods already on the market are adequately tested.
- This is a baffling statement. What is the difference between the need to test the first and second generation of GM-food? Why is it that it is only the second generation of GM-food that needs to undergo "extensive toxicological and nutritional (for the first time that this is demanded by someone high up in the EU authorities) testing"?
We do not argue against this because it is a great advance on Kuiper et al's previous stance but we need to stress that this statement should equally apply to the first generation! We have no objections to the incorporation into the testing procedures his proposed more sophisticated analytical testing methods (microarray technology, mRNA fingerprinting, proteomics, etc) but find their logic somewhat inconsequentional when they say that "depending on these studies, further toxicological and nutritional studies may be needed".
This means in plain language that they first propose to carry out the analytical testing for some toxicant or allergen in the GM-crop but without knowing if they are there at all. How can you find something that you do not know what to look for and whether it is there. Surely, one does not want to waste time and precious resources by performing a lot of sophisticated analytical tests when in fact the GM-food may not show any signs of harming animals or humans. It is more logical that after some crude analyses (protein, starch oil) needed for formulating diets for animal testing, nutritional and toxicological evaluations are carried out first and if these indicate problems with the GM-food, we ought to find what is the cause(s) for them.
However, considering everything Kuiper et al's commentary is a good step forward in the safety testing of GM-food. Now we only want to establish who is doing the testing, where is it going to be done and who is going to pay for it? It is gratifying to know that someone like Kuiper to whom funds for such testing have already been allocated by the EU is a passionate advocate for the biological testing of at least the second generation of GM-crops. Hopefully, and particularly if the first generation is also included in his testing programme, the EU consumers will reap the benefits, and if all these studies will be as transparently presented to the scientific community (and consumers!) as promised by him in the last sentence of his Lancet commentary.
Allan Mowat in his letter to the Lancet (15 November) also makes a number of points which, together with our replies, are dealt with in the following:
- He is right, the values found with these potato diets are below of that found in well-fed normal rats. However, Mowat does not appreciate that as the potato lectin is antimitogenic it causes a reduction in crypt size and this is re-inforced by the low protein content of all the diets. It is the more remarkable therefore that even in the presence of such factors the GM-potato diet dramatically and significantly increases crypt depth to about 90 um. In any case, we have something like well over ten years of experience in carrying out these measurements on our rats kept on a great variety of different diets and therefore we are in a unique situation to make authorative statements on comparative and absolute values of crypt depth.
- We did not give IEL counts in the gut of rats fed on GNA-spiked potato diets for the simple reason that in our previous studies no lymphocyte infiltration was observed even with a 1000-fold excess of GNA in the diet. Moreover, as published by us even a 1000-fold excess of PHA, kidney bean lectin, caused no significant IEL increase in the gut.
- First, there is no villus damage! Second, it is true that mitotic counts are not given in the paper but these will be included in a second paper which is in preparation. However, we can confirm that only the GM-potato diets increased mitotic counts and no such increase was observed with the parent potato diets, with or without spiking with GNA.
There was a similar comment made by FitzGerald et al about the need for the measurement of mitotic counts in the same issue of the Lancet.
Our answer is of course the same as above.
Peter Lachmann's criticisms in the same issue of the Lancet were hostile but as they touched on scientific issues we decided to deal with them:
Points no. 1 & 2 have already been answered above.
- Yes, they were.
- This just shows that Lachmann does not understand the issue. All GM-foodstuffs so far accepted have been passed on the basis that they were substantially equivalent to their non-GM counterparts.
Thus, we do NOT have to prove pathological differences but only that the differences are significant. It is up to the companies and the regulatory authorities to show whether the changes are pathological. In any case, with Lachmann's background in medicine he ought to have appreciated that stimulation of gut growth in the young is at the expense of body growth (which is potentially harmful) as intestinal turnover uses up somewhere between 30-40% of the dietary intake of proteins. In the colon it is potentially even more serious because crypt cell proliferation in the colon may aid the development of tumours, and you cannot have anything more pathological than that.
- We did not have to correct for data dredging because we did do no such thing. The statistical methods of multivariate analysis of significance, one-way ANOVA, paired t-tests and Tukey's tests are all described in our Table 1. These analyses have been seen and approved by independent statisticians, including one of the referees of our paper. We are more likely to accept the advice of these independent people than that of Lachmann with his partizan views and of rather unproven statistical expertise.
In our final analysis, most of the comments by Kuiper et al and Mowat had legitimate scientific basis and were not personal. This is something that cannot be said of most of the others. We think that overall the Lancet initiative was helpful for both science and consumers by moving away from personal attacks and misinformation to a valid scientific debate on the safety testing of GM-foodstuffs. Let us hope that some of the conclusions will pass into practice and be accepted by the EU and all the regulatory authorities whose job was in the first place to start up this process but did not do so.
for the Lancet report go to: http://www.ncbi.nlm.nih.gov/htbin-post/Entrez/query?uid=10533866&form=6&db=m&Dopt=b
** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed for research and educational purposes only. **
Date: Sun, 28 Nov 1999 21:59:49 -0500
From: Richard Wolfson GEN11-28
By Andrew Pollack, The New York Times, November 26, 1999
For generations, tribesmen in the Amazon rain forest have used secretions from the skin of a frog to make poison blow darts. Now Abbott Laboratories is developing a painkiller modeled on the active chemical in the frog secretion that seems as effective as morphine but without damaging side effects. This, according to the story, does not sit well with the government of Ecuador and local environmental groups. With the American drug company standing to make millions of dollars if the new drug is successful, they say the country that is the source of the frog and the indigenous people who discovered the secretions should get a share of the proceeds. ...
Earlier this month, the U.S. Patent Office overturned a patent held by an American entrepreneur on a plant from the Amazon rain forest.
Once considered the common heritage of mankind, wild animals, plants and crops were taken without asking or freely exchanged. Now wildlife is increasingly viewed as a "genetic resource," the raw material of the biotechnology era, just as oil and iron were in the industrial age. ...
Developing countries object that widespread patenting will make them dependent on Western companies for seeds and drugs. They also say patents ignore the contributions by indigenous peoples, who often are the true discoverers of useful plants and animals, or of farmers who improve crops over the generations. ...
Farmers in India last year protested the patenting of a form of basmati rice by Ricetec, a Texas company with annual sales of about $10 million. Ricetec obtained a basmati seed, believed to be from Pakistan, free of charge from an Agriculture Department seed bank. Through crossbreeding, it developed a form of the long-grained, fragrant rice suitable for growing in America. In India, the world's largest producer of basmati rice, farmers accused the company of usurping the nation's heritage, threatening its exports and piggybacking on the work of generations of farmers who developed the crop. said Vandana Shiva, an activist on these issues in India, was quoted as saying, "It's a hijacking of prior innovation."
Date: Sun, 28 Nov 1999 21:59:49 -0500
From: Richard Wolfson GEN11-28
The USA Food and Drug Administration (FDA) has announced that they will be holding public hearings and soliciting public comments concerning the government's genetically engineered food policy. Americans, please let the government know what you think by submitting comments before January 13, 2000!
Send Written comments by going to http://www.foodsafetynow.org or http://www.centerforfoodsafety.org (click on Take Action Now!)
By Catherine Lazaroff http://ens.lycos.com/ens/jun99/1999L-06-17-05.html
WASHINGTON, DC, June 17, 1999 (ENS) - While public opinion about genetically modified organisms (GMOs) in the U.S. and Europe appears to differ radically, experts from both sides of the Atlantic agree that scientific advances in biotechnology are rapidly outpacing the laws meant to regulate the business.
At a news conference in Washington, D.C., on Wednesday, experts from the U.S. and the European Union (EU) spoke out in favor of a cautious approach to the development of new GMO products.
Biotechnological advances in agriculture are moving into the mainstream in the U.S. Genetically modified crops such as soybeans, corn and tomatoes can be easily found on American grocery shelves, though they are not always labeled as such.
In Europe however, consumers and policy makers have strongly resisted the influx of GM crops. Responding to citizen protests and media attention, several supermarket chains in Great Britain have banned all foods containing GM ingredients. Protesters have destroyed experimental GM crops throughout Europe, and even the Prince of Wales has spoken publicly against GM crops.
In May, the British Medical Association (BMA) put out a statement on the impact of genetic modification on agriculture, food safety and human health. "It is an interim statement because we believe that the advances in scientific knowledge, and the governmental responses to advances, and public responses to advances, are so rapid that it is not possible to make a definitive statement," said Sir William Asscher, chairman of the BMA’s board of science and education and director of the United Kingdom Coordinating Committee on Cancer Research.
Speaking at the news conference, Asscher said the BMA concluded, "There are too many fingers in the pie of regulating genetically modified foods in Britain. "What the BMA asked for was time to find out the effects of GMOs and time to get the regulatory system in place so as to be able to reassure on the basis of scientific knowledge and appropriate regulation rather than on prejudice and commercial pressure."
Tassos Haniotis, agriculture counselor for the European Commission, said a similar situation exists in Europe at large. "The situation in Europe is ever evolving," said Haniotis. "The Commission is caught up very often in an environment where one has a feeling that we’re always shooting at a moving target" in regard to GMOs.
In the U.S., Haniotis said, "The regulatory framework has been adjusted and adapted to facilitate the needs of the biotech industry." Yet, "on both sides of the Atlantic, the advances in science clearly outpace by far the adjustments that are done in the regulatory frameworks."
Haniotis sees different perceptions of acceptable risks and different regulatory frameworks as creating much of the friction between the U.S. and the European Union over GMOs. "We’re talking about the acceptable level of risk to consumers, and this is clearly set at a different level in Europe than what it is in the US. And this is set at a different level not overall but in food," he said.
"We don’t have a wide debate about the medical applications of biotechnology in Europe," said Haniotis. "This is because the costs and the benefits are weighed in a completely different manner than how they are weighed in agriculture."
The push in the U.S. to bring GM crops on the market may be moving too fast for either science or regulation to keep pace. Recent reports show that some GM crops thought to be harmless can damage non-target species. A modified corn crop designed to produce an insect toxin targeted at corn borers, agricultural pests, also kills harmless monarch butterflies exposed to the corn pollen.
Dr. David Andow, an entomologist at the University of Minnesota, says when the developers of the corn were asked whether it would injure other members of the same insect group, lepidoptera, they argued that no threatened or endangered lepidoptera eat corn. No one stopped to think that the corn pollen, which would naturally blow beyond corn fields, would also contain the toxin, Andow notes.
The same toxin has now been added to modified trees for the forest industry, Andow says. Poplar trees carrying the Bt toxin are "fairly far along in testing," he says, and experiments have begun using pine trees.
The effect of GM crops on nontarget species is one of the largely unexplored dangers of biotechnology. Humans may also be affected by these crops. Recently, organic corn chips from the U.S. that were imported to the EU were found to contain the Bt toxin, possibly indicating transference of the toxin from nearby GM corn fields.
"We are allowing interventions into the food supply in a variety of ways, but not giving enough information to consumers to allow them to make choices," said Dr. Paul Billings, chief medical officer and deputy director of the Veterans Health Administration and a board member of the Council for Responsible Genetics.
"There is an enormous inconsistency in how U.S. agencies are dealing with different aspects of biotechnology," said Dr. Billings. "I think that we should treat genetically engineered food like we do drugs. We ought to collect safety information and impact information in a scientific way. We ought to give informed consent to consumers through a labeling vehicle."
"With genetically modified foods, exposure is involuntary," agrees Asscher. "And when you are talking about involuntary exposure to possible hazards, the safety has to be really established to far more than a voluntary exposure as in the case of a medicine."
The British Medical Association has recommended mandatory labeling of all products containing GMOs, and the prohibition of any mixing of GM and non-GM crops at farms.
All the speakers at Wednesday’s press conference urged biotechnology companies to slow their rate of creating and introducing new GMOs, and recommended that more testing be done by independent scientists, rather than industry employees.
Because science is not infallible, the speakers also recommended additional caution on the part of policy makers. "It is clear to me everywhere in the world that scientists do not make policy decisions," says Haniotis. "If we treat science as something that provides absolute truth and perfect answers, then I think we are stretching to its limits its role which is essential in the policy making process."
"Once the genie is out of the bottle, it is not possible to put it back," warned Asscher. Unlike new medicines, which can be withdrawn from the market, recovering a GMO which has been released into the environment will not be as easy, he said. "With genetic modification, it may not be possible to reverse the environmental effects."
** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed for research and educational purposes only. **
Date: Mon, 29 Nov 1999 12:45:47 -0500
From: Richard Wolfson GEN11-29 Biotech News
Deutsche Bank advises against Biotech
Biotech Firms Top Blacklist
Grain Giant asks Farmers to Segregate
Demand for Non-Biotech Corn
Heinz GE-Free in Europe
GE Website for children
US Ambassador to EU Threatens Trade War
Super Opium Poppy
Honda Building U.S. Plant for GE-Free soybeans
UK Monsanto Executives Want to Pull Out of GE
Japanese Brewers Shunning GM corn
Reprinted with permission from the December 1999 issue of Alive: Canadian Journal of Health and Nutrition, 7436 Fraser Park Drive, Burnaby, BC V5J 5B9
Europe's biggest bank, Deutsche Bank, has advised several thousand of the world's largest investors not to invest in biotechnology. The report to its investors warns that farmers who plant biotech crops could lose money and that the market value of biotech companies could collapse. The report concludes: "GM organisms are dead" because consumers are suspicious about their impact on human health and the environment. The full report is accessible at: http://www.biotech-info.net/Deutsche.html
A survey of socially responsible investors by the Ethical Investment Trust shows that concern about investing in businesses carrying out biotech research has gone from being a minor issue two years ago to investors' second biggest concern. Arms manufacturing was ranked the least ethical investment, followed by biotech research.
U.S. grain giant Archer Daniels Midland Co. called on American farmers to segregate genetically modified and conventional crops. The British Retail Consortium, representing food outlets in UK, welcomed the move by ADM saying: "It will help British food retailers in their efforts to source non-GM ingredients." Grain merchants have already begun paying farmers higher prices for non-GE soy and corn.
Because of the controversy over biotech crops, the American Corn Growers Association (ACGA) is asking farmers to plant non-genetically engineered corn. According to Gary Goldberg, CEO of the association, "GMOs have become the albatross around the neck of farmers on issues of trade, labeling, testing, certification, segregation, market availability and agribusiness concentration. Until all these issues are answered, it is best for production agriculture to examine alternatives to planting GMOs."
In responding to public outcry against genetically engineered ingredients, the Pittsburgh-based food giant Heinz eliminated all genetically modified ingredients from beans, soups and other products sold in Europe.
Richard Morningstar, the new U.S. ambassador to the European Union, threatened a billion-dollar trade war over moves by European governments to refuse genetically engineered food imports. The warning fuels claims that the U.S. dominated biotech industry is using its ties with the American government to bully countries who do not want genetically modified foods.
Scientists in Australia have genetically engineered poppy plants capable of producing twice the opium. Australia produces about 25 percent of the world's legal opium. Senior police sources fear drug gangs, who have already stolen more than 50,000 poppy heads this year, could target seeds from the new super poppy.
Honda Trading Corp of Japan is building a plant in Ohio (USA) for sorting non-genetically modified soybeans. The plant will have a capacity of 20,000 tonnes of soybeans per year. Soybeans from the plant will be sold to manufacturers of GE-free soy products, such as in Japan where GE foods need be labeled.
According to the Independent (UK, September 5, 1999), top executives of Monsanto are pressuring the company to pull out of genetically modified crop trials in Britain. Senior managers are deeply concerned about continuing public resistance to GE crops.
Japan's third-largest beer maker Sapporo Breweries announced it will stop using genetically modified corn to make beer. A few days earlier, industry leader Kirin Brewery Co took the same action.
For further information on biotechnology and its hazards, see the website: http://www.concentric.net/~Rwolfson/home.html
** NOTICE: In accordance with Title 17 U.S.C. Section 107, this material is distributed for research and educational purposes only. **
Date: Tue, 30 Nov 1999 11:12:37 -0500
From: Richard Wolfson GEN11-30
Ottawa Citizen, November 29, 1999 Page A3
FREDERICTON McCain Foods has waded into the explosive debate over so-called "Frankenstein foods" by refusing to accept genetically engineered potatoes for processing.
Starting next year, the Florenceville, N.B.,-based company will no longer buy genetically altered potatoes grown by farmers in New Brunswick and the rest of the country.
McCain's chairman said the decision was made after months of pressure from consumers who fear genetic tampering could damage the environment and human health.
Story is also on CBC website
says the ban will begin next year. FULL STORY: http://cbc.ca/cgi-bin/templates/view.cgi?/news/1999/11/28/potato991128
Date: Tue, 30 Nov 1999 11:12:37 -0500
From: Richard Wolfson GEN11-30
TORONTO, November 29 /CNW/ via NewsEdge Corporation
Today Greenpeace Canada stepped up its campaign to pressure Canada's food distributors, including President's Choice and Betty Crocker, to remove genetically engineered (GE) ingredients such as potatoes from their products. This followed the weekend announcement from food giant McCain's that it will refuse to accept genetically engineered potatoes, citing consumer concerns.
McCain's chairman today said that `We've got too many people worried about eating the product. Greenpeace campaigner, Michael Khoo, applauded McCain's President's Choice and Betty Crocker should McCain's has shown that it can be done. It's up to the others to follow said Khoo
Greenpeace will be encouraging supporters to pressure the companies through their customer service lines (President's Choice-416-218-7777, Betty Crocker-9O5-212-4059, Lipton-1-800-565-7273) Canadian consumers are saying no to GE foods that put them, and the environment, at risk. Public opinion polls show that over 80% of Canadians added Khoo.
/For further information: Michael Khoo or Holly Penfound: 416-597-8408, cell: 416-569-8408; French release available on request from: Johanne Fillion or Nadine Bachand: 514-933-0021, cell: 514-898-3587/
Date: Tue, 30 Nov 1999 11:12:37 -0500
From: Richard Wolfson GEN11-30
By Pauline Tam, Ottawa Citizen, Tuesday, Nov 30, P. A1
Biotech giant Monsanto Company struck a private deal with senior federal food regulators that resulted in the swift approval of two new kinds of genetically modified potatoes, according to an internal Health Canada document obtained by the Citizen.
The undated memo, addressed to a senior aide for Health Minister Allan Rock, outlines a deal brokered in March that paved the way for Monsanto to begin selling its new potato seeds less than two months later.
Until the deal was negotiated, the potatoes had been held up in the regulatory system because Monsanto refused to provide key scientific information to regulators assessing the products' health and environmental effects, the memo shows.
"Monsanto objected to these requests believing that their data adequately supports their conclusions that these products present 'no significant environmental, feed or food safety risk.' "
The seeds, marketed by the NatureMark unit of Monsanto and sold under the brand names New Leaf Y and New Leaf Plus, are genetically engineered to repel two separate potato viruses.
They are also designed to resist the Colorado Potato Beetle, a common pest.
While the seeds have been approved for sale, they do not yet exist in large enough quantities for commercial farming.
Details of the deal and how it was made point to evidence of high-level industry interference in a regulatory process that the government has defended as impartial and rigorous, said Michele Brill-Edwards, a former Health Canada drug regulator and critic of the system.
"What you're seeing is a high-level example of a very dirty game that practically nobody knows about. These kinds of meetings go on all the time and it's almost never captured because people are careful not to let this kind of thing be known."
She added it is highly unusual for briefing notes of such meetings to be prepared for top ministerial aides.
The memo was written by George Paterson, former director general of Health Canada's Food Directorate, and addressed to John Dossetor, a senior policy advisor to Mr. Rock.
Mr. Dossetor did not respond to requests from the Citizen for comment. While it's unclear who requested the memo or whether Mr. Dossetor received it, a Health Canada spokeswoman said there are occasions when ministers' aides are briefed on meetings between regulators and biotech companies.
"This just informs them of what happened at that meeting and it's for their information," said Lynn Lesage.
The revelations come at a time when consumer sensitivity about genetically modified foods is high, and the credibility of the country's food-safety system is being called into question.
This week, New Brunswick-based McCain Foods announced it would stop buying genetically altered potatoes from Canadian farmers in response to consumer fears about such products.
The move comes just weeks after 200 scientists from Health Canada's Health Protection Branch signed a petition that, among other things, raised alarm at the acute shortage of scientists for evaluations and risk assessments of genetically modified foods. Public-health critics also attacked the regulatory system for relying on data supplied by industry rather than original research.
According to the memo, released under the Access to Information Act to Ottawa-based researcher Ken Rubin, the deal was made after two high-level meetings in February and March.
The meetings were attended by Ron Doering, president of the Canadian Food Inspection Agency (CFIA), officials from Agriculture and Agrifood Canada, deputy ministers from New Brunswick and Prince Edward Island, and groups representing potato growers from four provinces. On the second occasion, representatives from Monsanto were also present.
The resulting deal set deadlines over a six-week period during which Monsanto agreed to provide regulators with the missing information. The data were needed to complete a routine government assessment of the potatoes' impact on human health and the environment.
In exchange for Monsanto's co-operation, Health Canada and the CFIA "agreed to a 30-day turnaround for reviewing the information provided" on the potatoes.
Jane Shapiro, spokeswoman for Monsanto Canada, declined to comment on the reasons the company withheld data from regulators.
The meetings were arranged at the request of potato growers from Prince Edward Island, New Brunswick, Alberta and Manitoba. The growers were worried that as a result of Monsanto's incomplete submissions to the government, the company's new potatoes would not be approved in time for spring planting, which would put them at a competitive disadvantage with U.S. farmers.
Patton MacDonald, executive director of the New Brunswick Potato Agency and one of those present at the meetings, said he first heard the potatoes were held up in the regulatory system at a seed-industry conference last December. By early 1999, when federal regulators still hadn't approved the products, he decided to mobilize the support of farmers' groups and senior provincial mandarins, he said.
The second meeting, which included a half-dozen senior executives from Monsanto's Canadian and international divisions, was called to find ways to ensure the regulators got the information they needed so the product could be approved quickly, said Mr. MacDonald.
"They (Monsanto) brought their heavy artillery and we were glad about that, because we thought we would get the answers."
But the resulting deal did not mean Monsanto's potatoes received rubber-stamp approval, said Grant Watson, the CFIA's national manager of the variety section, who attended the meetings.
"It was not a case of, 'Well, you give us something and we'll review it and sign it off.' No, it doesn't work that way. There are critical things that need to be met, and as long as the data answered all our questions, then we're prepared to look at time and make the decision within 30 days."
But the memo also shows the deal was not arrived at easily, because Monsanto refused to sign an agreement allowing all parties to talk openly about its confidential business information. The company eventually agreed to a verbal waiver.
Dr. Brill-Edwards said such tactics point to deliberate efforts by Monsanto to prevent damaging information about its products from reaching the potato growers. "It's like a courtroom where you don't want the evidence against you to get out."
According to the memo, government inspections on past "confined field trials" conducted by Monsanto showed the company performed poorly. As a result, the CFIA was concerned that Monsanto would "not be able to adequately manage a larger scale 'field trial.' "
Date: 27 Nov 1999 08:41:11 -0600
From: Marcus Williamson firstname.lastname@example.org
There is a public discussion going on about the WTO on the BBC website at :
Lots of good arguments coming out against the WTO! Haven't seen anyone yet supporting the WTO...
Date: 27 Nov 1999 22:04:57 -0600
From: Judy_Kew@greenbuilder.com (Judy Kew)
From: Jean Staffen email@example.com
This article mentions an FDA hearing last May, the National Academy of Sciences stacked and rushed panel and the Summit on the Hazards of Genetically Engineered Foods which last June presented 500,000 signatures on petitions for labels on genetically engineered foods to the government and pertinent agencies.
Please send as far and wide as possible.
Editor, The Konformist http://www.konformist.com
Barbara Keeler writes about health and the environment in news articles and in nutrition, health, science, and social studies textbooks.
Steve Urow is the LA coordinator of the Campaign for Food Safety, and the founder of the Greenpeople online eco©friendly business directory.
by Barbara Keeler and Steve Urow
"Apparently the public is entitled to every slimy detail in the Starr report but not relevant information about what we feed our children," complained one South Bay consumer at a recent Food and Drug Administration public forum, referring to the proposed phase-out of labels on irradiated food, and to unlabelled genetically engineered (GE) foods.
The consumer pointed out that food and drug law gives the FDA ample authority to require labels on GE foods. However, the FDA, ignoring warnings and concerns raised by their own scientists, ruled that GE foods are too similar to their conventional counterparts to require labels. Even so, panel members responded to requests for labels on GE foods, by asserting that safety was their first concern and their decisions were "based on science."
The May 12 forum at the California Science Center, intended to meet the requirements of the FDA Modernization Act of 1997, was called "Public Input on Public Health, FDA Listens to You." An announced goal was strengthening the science base of the agency.
Did the FDA listen? Was the input put in? Based on their comments, FDA representatives did more defending than examining of their science base. For example, when a consumer presented scientific studies establishing risks of genetically modified organisms and irradiated foods, panel members replied that different scientists present different findings. They were unmoved when another consumer cited warnings in the FDA's own literature about dangers of life-threatening allergic reactions, antibiotic resistance, and increased toxicity.
Panel members did not mention that scientific studies need funding, and most scientific studies examining the benefits and safety of drugs, food additives, GE or irradiated foods, and other consumer products are funded by the suppliers. Consumers did raise the question of bias in both the science base and the FDA evaluation of scientific studies. Several panel members bristled, telling one consumer her concerns were unfounded. They declared that they had seen no evidence of bias that served the interest of industry.
The listeners need not look far for such evidence they could read it in government documents or pick up a newspaper. Just in the last few months they could have read about members of the FDA panel that reassessed the risks of Rezulin, and the money they had received from its manufacturer; manufacturers of FDA approved drugs that force their funded researchers, through threatened loss of funding, to suppress or delay publication of negative evidence concerning the drugs they test; and FDA's primary fatty-acid expert on an FDA panel that ignored recommendations of experts at NIH and WHO and advised FDA to ban DHA in infant formula.
The expert had worked for Ross Products, a formula company opposed to the addition of DHA. Found in breast milk and used in formula worldwide, DHA is important to vision and brain development. Meanwhile, FDA expresses no concern about the GE ingredients ubiquitous in infant formula.
In May, panel members could have read about the 25 million dollar research contract between Novartis, a leading producer of GE food seeds, and plant geneticists at UC Berkeley, giving Novartis 30 to 90 days to review research publications. From the National Academy of Sciences web site, they could learn that until recently one of these UC Berkeley plant geneticists was to sit on a panel convened by NAS to assess risks and benefits of specific genetically modified food crops. According to FDA panel members, EPA, FDA, and USDA regulators share science databases, so committee findings and recommendations will doubtless become part of the FDA science base.
The proposed composition of this NAS panel exemplifies the potential for bias that pervades the science base examined by government regulators. The NAS formed the committee to conduct an urgent and rushed study of genetically modified crops containing pesticide genes, such as crops producing bacillicus thuringiensis (Bt) toxins in their tissues. The study was generated by complaints about overregulation.
At issue is the fact that the Environmental Protection Agency regulates these crops as pesticides; the companies make a pesticide claim, and the food plants, including parts consumers eat, are indeed engineered to kill insects. With the panel not yet finalized, an NAS spokesperson has already told callers that such regulation is inappropriate.
Of 12 proposed members, seven have past or present financial ties to the biotech or pesticide industry. For example, an attorney and a scientist have represented Monsanto and the biotech industry against federal regulators, four additional members receive direct or indirect funding from companies such as Monsanto and Novartis that produce genetically modified seeds, and another is a consultant for the pesticide industry.
As first proposed, the panel included none of the many qualified scientists whose findings raise concern about the risks of GMOs. It lacked scientists representing the environmental or consumer sector. During the first public comment period, the web document providing information about the proposed members failed to disclose the biotech industry funding of several members, including the plant geneticist from UC Berkeley. After a flood of letters from consumers, the plant geneticist from UC Berkeley stepped down, the NAS disclosed biotech funding sources on the posted bios of proposed members, Dr. Rebecca Goldburg, Environmental Defense Fund, was added.
NAS received more than 500 comment letters, most objecting to the composition of the panel, but how often do similar potentially biased studies escape the attention of consumer, health, and environmental advocates? How many studies are conducted by an industry - funded committee? How often does a venerated body such as the NAS confer legitimacy and an impression of objectivity on what may be a biased process?
The industrialization of academic research is taken as a given so much that after Goldburg's nomination, some consumer protesters dusted off their hands, gloating that they had achieved representation. What's wrong with this picture? We contend that one scientist representing the public sector in other words everyone and seven scientists tied financially to affected industry a narrow vested interest is an inappropriate balance in a panel assessing the risks and benefits of unlabeled GMOs that every citizen will consume. Even equal representation of the public sector everyone and the biotech industry a narrow vested interest would be unbalanced.
Unfortunately this panel is probably better balanced than the overall body of research that comprises the science base of regulatory agencies. Who has the resources and incentive to fund such research, other than the affected industries? Where do the peers who review the research obtain their funds?
To FDA regulators who decide which studies to dismiss or ignore, we say that if a study manages to struggle out of the scientific community without industry funding, it merits close examination and should be weighed seriously by regulators. Funding sources of both researchers and peer reviewers should factor into the equation when regulators weigh and balance conflicting findings.
Meanwhile, qualified scientists have presented sufficient findings and raised sufficient concerns to warrant labeling genetically engineered foods at the very least. Some were presented June 17 at the National Summit on the Hazards of Genetically Engineered Foods. When FDA representatives were handed 500,000 signatures on petitions for labels on genetically engineered foods. Labeling would only stigmatize the foods, they claimed this in spite of warnings in FDA's own literature about dangers of life-threatening allergic reactions, antibiotic resistance, and increased toxicity.
FDA is also considering phasing out labels of irradiated food. Prudent consumers deserve the right to weigh all evidence for themselves. Such evidence should include the funding of studies that form the science base of regulatory decisions, and the financial ties of the advisors who evaluate them. Only then can they make informed choices.
Hello? FDA? Are you listening?
If you are interested in a free subscription to The Konformist Newswire, please visit http://www.eGroups.com/list/konformist and sign up. Or, e-mail firstname.lastname@example.org with the subject: "I NEED 2 KONFORM!!!" (Okay, you can use something else, but it's a kool catch phrase.)
Visit the Klub Konformist at Yahoo!: http://clubs.yahoo.com/clubs/klubkonformist
Green Homes For Sale: http://www.greenbuilder.com/realestate
Green Building Pros: http://www.greenbuilder.com/directory
Date: 28 Nov 1999 10:47:48 -0600
Source: Omaha World-Herald, Publication date: Nov 27, 1999, © 1999, NewsReal Inc.
Armed with a new U.S. patent to genetically transform corn, Pioneer Hi-Bred International is suing three competitors to prevent them from using it.
The patent, issued, gives Des Moines-based Pioneer rights to a method for genetically engineering corn using gene gun technology, a process that involves blasting genetic material into plant cells.
Also, Pioneer filed a lawsuit in U.S. District Court in Des Moines, alleging patent infringement by [Monsanto Co.], Monsanto's seed unit DeKalb Genetics Corp. and Novartis Seeds Inc.
Monsanto is based in St. Louis. DeKalb Genetics operates out of DeKalb, Ill. Novartis is based in Basel, Switzerland.
Pioneer, which is owned by Wilmington, Del.-based DuPont, seeks an injunction against the companies to prevent their use of the patented process and the sale of products derived from it. Pioneer also is seeking damages for the alleged infringement.
Officials with Pioneer, Monsanto and DeKlab also could not be reached for comment
The lawsuit is one of many that has pitted major players in the seed industry against each other.
The legal battles coincide with a trend in the industry to patent plant genetic material, as well as technology and processes used to genetically engineer crops.
Date: 28 Nov 1999 10:52:08 -0600
The Des Moines Register, Publication date: Nov 21, 1999, © 1999, NewsReal, Inc.
Growing concerns over genetically engineered crops may knock the wind out of the sails of companies large and small that have invested millions developing agricultural biotechnology, according to some industry experts.
A dispute that erupted in Europe in the mid-'90s, when biotech- based seed products first hit the market, has spread to other major U.S. export markets, including Japan, South Korea and Russia. Those and other nations are enacting special labeling requirements for food made from the high-tech crops.
Pressure for labeling in the United States is also increasing. Last week, the U.S. Food and Drug Administration began a series of public hearings intended to address the labeling issue and other aspects of the controversial crops.
Meanwhile, U.S. farmers are turning their attention to the next growing season, and questioning whether to plant genetically modified seed.
"No one is saying don't grow genetically modified hybrids next year," but farm group leaders are urging growers to carefully consider their options, said Stewart Reeve, director of communications for the National Corn Growers Association in St. Louis, Mo.
His and other commodity groups have encouraged growers to be sure that whatever they plant has been approved in export markets.
"My message is definitely do not plant unapproved varieties," Roy Bardole, a Rippey farmer and vice president of the American Soybean Association, said last week during a national conference call between farmers and industry officials.
The potential losers in the debate include [Monsanto Co.] of St. Louis, which has seen its stock price plummet this year, and Pioneer Hi-Bred International Inc. of Des Moines, recently acquired by DuPont.
The stakes are enormous, said Neil Harl, an Iowa State University agricultural economist. Since 1996, major players in the seed and farm chemical industries have spent about $15 billion acquiring seed companies.
Also affected are dozens of so-called boutique ag biotech businesses that have sprung up in recent years to support the big companies' efforts to integrate biotechnology into crop production.
"This could have a huge impact on the seed industry," said Neil Harl, who has followed the controversy closely and testified before Congress on changes in the seed industry.
Marc Baas, U.S. ambassador to the World Trade Organization, who visited with Register editors and writers last week in Des Moines, agreed.
"The next five to 10 years are going to be rough" for agribusinesses and for U.S. trade and regulatory officials, he said.
Sano Shimoda, president of BioScience Securities Inc. in Orinda, Calif., an investment banking business that specializes in agriculture and biotechnology, said the situation surrounding genetically modified crops is "out of control."
"Perceptions are driving the reality of the marketplace, and the realities are based on limited knowledge, on no knowledge, on misinformation," he said. Companies including Pioneer and Monsanto "are being bombarded by psychological warfare."
"The marketplace is calling the shots, irrespective of the science," said Shimoda, a former Wall Street analyst and widely quoted expert on the new crops.
The warfare surfaced in Chicago last week, as activists with such groups as Greenpeace protested outside the federal building where the FDA held the first of three public hearings into food safety and genetically engineered crops. Other hearings will be held on Nov. 30 in Washington, D.C., and on Dec. 13 in Oakland, Calif.
Opponents of the crops are taking their case directly to consumers. The environmental group Friends of the Earth said it will launch a series of demonstrations at U.S. grocery stores this week to push for special labeling on foods produced from genetically modified crops.
Biotechnology backers also turned out in force last week in Chicago, distributing information about the benefits of biotech- based crops as part of a broad-based campaign to counter critics.
People close to the controversy contend such efforts are necessary if agricultural biotechnology is to survive, although they concede proponents of the technology face a prolonged battle.
Shimoda said some Wall Street analysts believe agricultural biotechnology is dead in the water. He disagreed, but said it will take a year or two to turn the tide in favor of biotech.
"It's never too late, but the snowball was rolling down hill, and they have to stop the snowball and roll it up the hill," he said.
Richard Wolfson, PhD
Consumer Right to Know Campaign, for Mandatory Labelling and Long-term Testing of all Genetically Engineered Foods,
500 Wilbrod Street Ottawa, ON Canada K1N 6N2
tel. 613-565-8517 fax. 613-565-1596 email: email@example.com
Our website, http://www.natural-law.ca/genetic/geindex.html contains more information on genetic engineering as well as previous genetic engineering news items. Subscription fee to genetic engineering news is $35 (USD for those outside Canada) for 12 months, payable to "BanGEF" and mailed to the above address. Or see website for details.