Genetic Roulette is Jeffrey Smith’s second book in which he makes unsubstantiated claims against biotechnology. In it, he details 65 separate claims that the technology causes harm in a variety of ways. On these pages each of those claims – addressed in the same eight “sections” that correspond directly with the book – are stacked up against peer-reviewed science.
Showing posts with label Safety. Show all posts
Showing posts with label Safety. Show all posts
Saturday, March 27, 2010
Tuesday, April 04, 2006
Allergies on the rise.
Allergies reach epidemic levels in Europe: experts
Last Updated: 2006-03-31 9:30:18 -0400 (Reuters Health)
A Reuters release from BERLIN (Reuters) - Explains that allergies such as hay fever are reaching epidemic proportions in Europe and a failure to treat them properly is creating a mounting bill for society and the healthcare system, experts said on Friday.
Last Updated: 2006-03-31 9:30:18 -0400 (Reuters Health)
A Reuters release from BERLIN (Reuters) - Explains that allergies such as hay fever are reaching epidemic proportions in Europe and a failure to treat them properly is creating a mounting bill for society and the healthcare system, experts said on Friday.
Sunday, February 26, 2006
Analysis of Pusztai Study on GM Potatoes and their effect on Rats
Analysis of Pusztai Study on GM Potatoes and their effect on Rats
By Dr. Nina V. Fedoroff
Willaman Professor of Life Sciences and Evan Pugh Professor
Huck Institutes of the Life Sciences (http://www.lsc.psu.edu/)
201 Life Sciences Building
Pennsylvania State University
University Park, PA 16802
Website: http://hils.psu.edu/lsc/fedoroff.html
On August 10th, 1998, Arpad Pusztai of the Rowett Research Institute in Aberdeen, Scotland appeared on the British TV show "World in Action." In the course of the interview, he announced that his experiments showed that rats fed a diet of potatoes expressing a gene coding for a snowdrop sugar-binding protein showed stunted growth and reduced immune function (Enserink, Science 281.1184). He is further quoted as saying that he would not eat GM food and that he found it "very, very unfair to use our fellow citizens as guinea pigs" (Lee and Tyler, 1999).
The study made headlines around the world. According to Science’s Martin Enserink, the Rowett Institute was flooded with calls from reporters even before the show aired. He quotes Rowett director Philip James saying that the Institute was faced with “a megacrisis we didn't remotely anticipate.” James is said to have examined the experiments and found them a total “muddle.” Pusztai’s laboratory was sealed, his notebooks were turned over to an audit committee and Pusztai was put on indefinite leave – he was out of a job. The audit committee’s report, released in October of 1998, concluded that Pusztai’s data did not support the conclusion that the transgenic plants had a deleterious effect on growth, organ development, or immune function in rats.
Pusztai, whom Rowett had been forbidden to talk to the press, got in touch with a number of scientists and asked them to review the audit report and his rebuttal to it, as well as a transcript from the World in Action show (Enserink, Science 283:1094-5). On February 12 1999, Professors Edilbert van Driessche and Thorkild C. Bøg-Hansen, colleagues who had collected the responses, issued a memorandum supported by more that 20 other scientists who had studied Dr. Pusztai's findings (Lee and Taylor, 1999).
Their memorandum stated (the following is largely verbatim from the WSWS website): "Those of us who have known Dr. Pusztai's work or have collaborated with him, were shocked by the harshness of his treatment by the Rowett and even more by the impenetrable secrecy surrounding these events. It is an unacceptable code of practice by the Rowett and its Director, Professor James, to set themselves up as arbiters or judges of the validity of the data which could have such a profound importance not only for scientists, but also for the public and its health." The memorandum concludes, "There is no doubt in our minds that the reviews will remove the stigma of alleged fraud and will restore Dr. Pusztai's scientific credibility."
One of the scientists who reviewed Pustzai's work, Dr. Vyvyan Howard, foetal and infant toxico-pathologist at the University of Liverpool, told the World Socialist Web Site, "I am working on some features of lectin toxicity and that is how I came to know Arpad Pusztai, who is certainly one of the world's experts in this field." Dr. Howard said that he believed Dr. Pusztai's data was (sic) sound. "We think it would pass peer review and be published and we are at a loss to really explain why the Rowett Institute came to the conclusion it did." Dr. Howard added that Pusztai's findings "are of considerable importance in the current debate on the safety and hazard assessment of genetically modified foods".
Professor S. Pierzynowski, from the Department of Animal Physiology, Lund University, Sweden, said, " I must stress that there is enough strong evidence that the work of the audit group was not objective and per se dangerous, not only for Dr. Pusztai, but generally for free and objective science." Joe Cummins, Emeritus Professor of Genetics at the University of Western Ontario, Canada described the Rowett Institute's treatment of Pusztai as "a great injustice", adding that the "Institute continues to look inward to cover up its mistakes".
These eminent scientists have not only raised serious concerns about the way research into GM food is being conducted, but that those who have dissenting voices are being suppressed and have had their careers ruined, and sometimes their health. Dr. Pusztai has suffered a mild heart attack brought on by the stress caused by trying to restore his scientific reputation and the credibility of his research. These concerns were echoed by Dr. Kenneth Lough, FRSE, a former principal scientific officer at the Rowett Institute between 1956 and 1987. He said, "In my view the evidence presented in the audit report must be considered as unsafe and is without justification for use against the scientific reputation of Dr. Pusztai. The Institute is at risk in sending the wrong signals to scientists in this field of research that any sign of apparent default will be treated with the utmost severity. The awareness will of course act as strong deterrent to those who wish to conduct research in this vitally important field." (end of stuff from WSWS).
But a committee of six eminent members of the British Royal Society, set up in April of 1999 to review the Pusztai data, reached the opposite conclusion. The committee sent out the material they received from Pusztai, the Rowett and other sources to scientists with expertise in statistics, clinical trials, physiology, nutrition, quantitative genetics, growth and development, and immunology. The committee reviewed the opinions it received and issued a summary statement in June of 1999. The consensus of these experts was that the experiments were poorly designed, the statistical inappropriate, and the results inconsistent. Their recommendation was that the experiments be repeated and the results published.
Pusztai jumped to his own defense with a detailed response (http://www.freenetpages.co.uk/hp/a.pusztai/). He and a colleague with whom he had worked for some years published their study in medical journal Lancet (Ewen and Pusztai, 1999). Lancet, in turn, came under sharp criticism from a number of quarters, including U.K.'s Biotechnology and Biological Sciences Research Council, which called the journal "irresponsible." But Lancet’s editor, Richard Horton, stood by the publication. Five of 6 reviewers had favored publication and he believed that it was appropriate for the information to be available in the public domain (Enserink, Science 286:656).
So what’s this all about? Why this titanic battle of experts? Why is Pusztai, until this incident considered an authority on the plant proteins called lectins, under such fierce attack? He’s written three books on lectins and published 270 research papers. Moreover, he’d worked at the Rowett Institute for 35 years. On the surface of it, his now-controversial research was perfectly straightforward: he fed genetically modified potatoes expressing a snowdrop lectin to rats and looked to see whether this food affected their physiology, particularly the gut, metabolic process and immune system. What are lectins? Should we worry about them? Should we share Pusztai’s concern and conclusion that genetic engineering itself results in "……possible gene silencing, suppression and/or somaclonal variation"?
The protein in question is called the Galanthus nivalis agglutinin after the Latin name of the snowdrop and it is abbreviated GNA. It was originally isolated from snowdrop bulbs and is a kind of protein that recognizes and bind to sugars on proteins. Such proteins are called ‘lectins’ as a group. Although lectins were first discovered in plants, they are now known to exist in animals in great profusion (Rudiger 2000). Many proteins – in all kinds of organisms – are decorated with sugar molecules – sometimes with long strings or branches of several sugar molecules. Such derivatized proteins are called glycoproteins.
Each glycoprotein has a different complement of sugar molecules, depending on what it does and where it does it. The sugar signature works like a zip code in the cell, determining where the protein is delivered by the machinery that produces it. When such decorations are on the surface – be it of a virus, a bacterium, or a cell – they serve as a recognition molecules. Lectins recognize the sugar molecules with such exquisite correctness and specificity that they have long been used to identify what sugars are present on a protein. Today it is increasingly recognized that the sugar ‘codes’ serve a large variety of internal functions. One of these is recognizing disease organisms.
So, for example, it has been known for a number of years that the AIDS virus HIV (human immunodeficiency virus) has mannose sugars on its surface and the ability of cells to recognize these surface sugars with their own lectins is part of the infectious process (Hammar 1995). Plant lectins like GNA, which recognizes mannose, bind to the virus and inactivate it. They also interfere with its ability to infect cells (Hammar 1995). Because of its ability to bind to these surface sugars, GNA has been used to purify the HIV surface glycoproteins, which were in turn used to produce an immune response, albeit not much of one (Gilljam, 1993). Similarly, Chlamydia trachomatis has surface mannose-containing glycoproteins that allows the organism to infect cells by binding to a surface lectin (Siridewa 1993).
Plants – no less than animals – have mechanisms for defending themselves from microorganisms and insects. Plant produce lectins as one of their defense strategies against insects (Carlini 2002). Indeed, a good deal of evidence has accumulated that GNA, which binds specifically to a sugar called mannose, is rather toxic to certain kinds of insects pests of important crop plants, including rice (Du et al. 2000; Fitches et al., 2001). GNA does not seem to affect ladybird beetles, considered to be a beneficial insect (Down et al., 2000), although it does affect parasitic wasps, also considered to be beneficial insects (Romeis 2003). Some lectins, including ricin, are quite toxic because they’re taken up by cells and block protein synthesis (Olsnes 2001). These are called ribosome-inactivating proteins or RIPs. But GNA doesn’t have this activity (Batelli 1997).
Better yet, Pusztai’s own studies showed that purified GNA wasn’t toxic to rats (Pusztai 1990). In fact, he and his colleagues had shown that GNA had a protective effect against bacterial infection with Salmonella, a nasty intestinal bug (Naughton et al., 2000). All of this made the gene coding for GNA an attractive choice for increasing the insect resistance of crop plants. To test this possibility, the gene was introduced into a number of different crop plants, including potatoes and rice. And it does, indeed, increase their resistance to some important insect pests (Rao 1998; Foissac 2000). Because GNA binds to the surface cells of insects guts and enters their blood stream, it is also thought to have potential as a vehicle for delivering more toxic peptides to insects (Fitches 2002).
Sugar signatures are ubiquitous in biology – and as yet, we know rather little about what they do. It is known, for example, that there are two critical kinds of cells – the T and B cells – that must interact for the body’s immune response to be activated. It has been reported that these interactions occur through a mannose-containing glycoprotein and that this interaction can be blocked by GNA (Savage 1993). Thus some of the same signature sugars central to important cellular functions. Pathogens take advantage of essential intercellular recognition mechanisms to gain a foothold, both by binding to the cell’s own lectins and by evading the immune response because they resemble the cell’s own molecules. So, for example, a lectin called DC-SIGN (dendritic dell-specific intercellular adhesion molecule-3 grabbing nonintegrin) binds sugars on the HIV envelope and facilitates infection of its target CD4 T cells (Geijtenbeek 2003).
The DC-SIGN lectin is referred to as an HIV ‘receptor’ because of this specific recognition of HIV, but it is actually a universal pathogen receptor (Geijtenbeek 2003). It normally captures viruses and other pathogens through their sugar-containing protein molecules and pulls them into the cell, where they are broken down and displayed on the cell surface to trigger a protective immune response (Kooyk 2003). HIV hijacks this system. It stays intact when it binds to DC-SIGN and rides along to be presented to its target T4 cells in an infectious form. This is a rather effective evasion system. It makes it quite unlikely that the body will successfully fight back by making antibodies, the body’s proteins that recognize and destroy pathogens. This is because the immune system learns early in life to discriminate between its own proteins and foreign proteins. But one particular HIV glycoprotein, gp120, has a dense cluster of mannose residues that has not been seen in any mammalian glycoprotein (Calarese 2003) and a few HIV patients make good antibodies to this protein. Recent work on one such antibody showed that it binds to the gp120 – the same protein to which DC-SIGN binds to promote viral infection – in a very unusual way. Antibodies generally recognize and bind to just one sugar residue, but this unusual antibody has an extended structure that permits it to recognize more than one mannose residue at a time. This is actually similar to the way that certain lectins recognize sugars because lectins consist of two or more identical proteins, each of which has a sugar-binding site (Hester 1996; Calarese 2003). The discovery of this unusual antibody raises new hope for stimulating the immune system to produce anti-HIV antibodies, immunizing people against AIDS.
But there are many kinds of lectins and they can have quite different effects. For example, Pusztai and his colleagues had reported 10 years earlier that a kidney bean lectin, phytohemagglutinin or PHA, caused the surface cells of rats’ intestines to turn over more quickly (Pusztai 1993). The younger replacement cells on the tiny surface projections – called villi – of the intestinal cells had a high proportion of proteins with mannose sugars at the ends of their sugar signatures. This made the cells more susceptible to bacterial overgrowth with Escherichia coli, a common gut bacterium, because the bacterium has projections – called fimbrae – that recognize and bind to mannose. Including GNA in the diet reduced the extent of bacterial overgrowth because the GNA binds to the mannose on the intestinal cells.
PHA is a normal component of red kidney beans – and people get sick from eating too much of it. Allergist David Freed recounts an incident that occurred in 1988 when a hospital had a “healthy eating day” in its staff canteen at lunchtime (Freed 1999). He recounts that 31 portions of a dish containing red kidney beans were served that day and over the next several hours, 11 customers were experienced profuse vomiting, some with diarrhea – typical food-poisoning symptoms. All recovered by the next day, but no pathogen was found in the food. It turned out that the beans contained an abnormally high concentration of PHA.
There are many different kinds of plant lectins and they are present in most plants, especially abundant in seeds, including cereals and beans, and in tubers, including potatoes. They tend to survive cooking and digestive enzymes. Pusztai and many other investigators have shown that they affect intestinal cells. It isn’t surprising that they occasionally cause symptoms of food poisoning (Freed 1999). As in insects, some can get into and through cells and into the blood stream. Some lectins are also potent allergens. So even through GNA appears to be a relatively benign lectin as evidenced by rat feeding studies, there is absolutely no doubt that a food expressing such a protein needs careful testing, first in animals.
Sensibly, the Scottish Office Agriculture, Environment and Fisheries Department (SOAEFD) commissioned a 3-year study in 1995 titled “Genetic engineering of crop plants for resistance to insect and nematode pests: effects of transgene expression on animal nutrition and the environment.” Its objective was "to identify genes encoding antinutritional factors which will be suitable for transfer into plants to enhance their resistance towards insect and nematode pests, but will have minimum impact on non-target, beneficial organisms, the environment, livestock fed on these plants, and which will present no health risks for humans either directly or indirectly through the food chain." The University of Durham and the Scottish Crop Research Institute were to provide the transgenic plants and the Rowett Research Institute was to do a chemical analysis of the transgenic plant materials. They were also to do both short-term (10 day) and long-term (3 months) rat feeding trials to determine whether the effect of the transgenic plant materials was similar to that of the parent lines.
The chemical analysis of the transgenic plants showed them to be quite different from the parent lines (http://www.rowett.ac.uk/gmo/ajp.htm) – although the audit report curiously concludes that they weren’t (http://www.rowett.ac.uk/gmoarchive/gmaudit.pdf). The researchers measured total protein concentration, as well as the content of several relevant proteins, including GNA, potato lectin and several others. All of these differed between transgenic lines and in comparison with the parental lines. Rats in Pusztai’s study were fed either raw or cooked potatoes. Non-transgenic potatoes were supplemented with GNA. The results showed that rats fed the transgenic potatoes had significantly lower organ weights. They found that GNA added to the potatoes made the animal’s lymphocytes, which are cells in the immune system, more responsive to stimulation by other lectins. By contrast, lymphocyte responsiveness was depressed in the animals fed the transgenic potatoes expressing GNA.
What these studies basically showed was that the transgenic potato lines were different from each other, as well as from the parental potatoes. A later study on transgenic potatoes came to the same conclusion (Down 2001). Here Pusztai jumped to the conclusion that these differences must be attributable to the fact that the plants were transgenic – and he went public with his conclusion. What he probably didn’t know – because he was neither a plant breeder nor a plant biologist – was that the very process through which the plants are put during the introduction of the transgene – culturing through a callus stage and then regeneration of the plant – can cause marked changes in both the structure and expression of genes.
The variation that arises as a result of passage through tissue culture is called “somaclonal variation” and is both a nuisance and a potent source of new materials for plant breeding. The variation is both genetic (single base changes, deletions, insertions, transpositions) and epigenetic – this means modifications that can affect expression of genes, but not their structure. For plant breeders, this means that new materials and new varieties derived using culturing techniques must be evaluated for both their growth and their food properties. This is particularly important for potato breeding, because potatoes produce toxic substances called glycoalkaloids (Kozukue 1999). Glycoalkaloids are normally present in potatoes, can contribute to inflammatory bowel disease, and are concentrated by frying potatoes (Patel 2002). So potato breeders must carefully monitor these compounds, irrespective of the means by which new potato varieties are generated.
Unfortunately, Pusztai’s analyses of the chemical composition of the transgenic lines were rather superficial. And his quick leap to the conclusion that the variation he observed was attributable to the fact that they were transgenic was simply unwarranted. This mistake has proved costly to Pusztai himself. And unfortunately, the expertise battle that sprang up around the experiments has obscured the importance of carrying out well-designed experiments to evaluate the food qualities of transgenic crop plants expressing proteins that have the potential of affecting human health. Lectins are clearly in this category.
Pusztai has been criticized severely for the quality of his experiments. His experiments have been attacked for their small sample sizes, the use of inappropriate statistical procedures, and the fact that a diet of raw – or even cooked – potatoes is a bad diet for rats (people too), even when supplemented with a bit of extra protein. But oddly enough, in all that has been written about these experiments, no one seems to have seen their central flaw, which was that he did not use appropriate controls. A “control” is the part of an experiment that allows the researcher to examine the consequences of just the change (in this case) or the treatment (in the case of a drug) under study. In Pusztai’s experiments, the control potatoes had a different history than the transgenic potatoes and, in particular, that history included a culture procedure that induces somaclonal variation. The likeliest source of the variation he detected – and of the differences he attributed to the fact that they contained foreign DNA – was the culture procedure itself. In order to be able to attribute the deleterious effects of the transgenic potatoes to the newly introduced gene or to some other part of the introduced DNA, he would have had to make a comparison between potatoes that had the very same history, but either had or lacked the transgenic construct. This can be done, but the study that Pusztai participated in was simply not designed for such a test.
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GMO Pundit on this topic:
For a collection of comments and references on this first see
Rats fed bad diets have lots of changes in their guts, which is the best the Pundit can collect from the web and from his advisers.
but also here and here, Potatoes not perfect food, Genetic Roulette.
Academics Review on this topic
1.1—Pusztai’s Flawed Claims
By Dr. Nina V. Fedoroff
Willaman Professor of Life Sciences and Evan Pugh Professor
Huck Institutes of the Life Sciences (http://www.lsc.psu.edu/)
201 Life Sciences Building
Pennsylvania State University
University Park, PA 16802
Website: http://hils.psu.edu/lsc/fedoroff.html
On August 10th, 1998, Arpad Pusztai of the Rowett Research Institute in Aberdeen, Scotland appeared on the British TV show "World in Action." In the course of the interview, he announced that his experiments showed that rats fed a diet of potatoes expressing a gene coding for a snowdrop sugar-binding protein showed stunted growth and reduced immune function (Enserink, Science 281.1184). He is further quoted as saying that he would not eat GM food and that he found it "very, very unfair to use our fellow citizens as guinea pigs" (Lee and Tyler, 1999).
The study made headlines around the world. According to Science’s Martin Enserink, the Rowett Institute was flooded with calls from reporters even before the show aired. He quotes Rowett director Philip James saying that the Institute was faced with “a megacrisis we didn't remotely anticipate.” James is said to have examined the experiments and found them a total “muddle.” Pusztai’s laboratory was sealed, his notebooks were turned over to an audit committee and Pusztai was put on indefinite leave – he was out of a job. The audit committee’s report, released in October of 1998, concluded that Pusztai’s data did not support the conclusion that the transgenic plants had a deleterious effect on growth, organ development, or immune function in rats.
Pusztai, whom Rowett had been forbidden to talk to the press, got in touch with a number of scientists and asked them to review the audit report and his rebuttal to it, as well as a transcript from the World in Action show (Enserink, Science 283:1094-5). On February 12 1999, Professors Edilbert van Driessche and Thorkild C. Bøg-Hansen, colleagues who had collected the responses, issued a memorandum supported by more that 20 other scientists who had studied Dr. Pusztai's findings (Lee and Taylor, 1999).
Their memorandum stated (the following is largely verbatim from the WSWS website): "Those of us who have known Dr. Pusztai's work or have collaborated with him, were shocked by the harshness of his treatment by the Rowett and even more by the impenetrable secrecy surrounding these events. It is an unacceptable code of practice by the Rowett and its Director, Professor James, to set themselves up as arbiters or judges of the validity of the data which could have such a profound importance not only for scientists, but also for the public and its health." The memorandum concludes, "There is no doubt in our minds that the reviews will remove the stigma of alleged fraud and will restore Dr. Pusztai's scientific credibility."
One of the scientists who reviewed Pustzai's work, Dr. Vyvyan Howard, foetal and infant toxico-pathologist at the University of Liverpool, told the World Socialist Web Site, "I am working on some features of lectin toxicity and that is how I came to know Arpad Pusztai, who is certainly one of the world's experts in this field." Dr. Howard said that he believed Dr. Pusztai's data was (sic) sound. "We think it would pass peer review and be published and we are at a loss to really explain why the Rowett Institute came to the conclusion it did." Dr. Howard added that Pusztai's findings "are of considerable importance in the current debate on the safety and hazard assessment of genetically modified foods".
Professor S. Pierzynowski, from the Department of Animal Physiology, Lund University, Sweden, said, " I must stress that there is enough strong evidence that the work of the audit group was not objective and per se dangerous, not only for Dr. Pusztai, but generally for free and objective science." Joe Cummins, Emeritus Professor of Genetics at the University of Western Ontario, Canada described the Rowett Institute's treatment of Pusztai as "a great injustice", adding that the "Institute continues to look inward to cover up its mistakes".
These eminent scientists have not only raised serious concerns about the way research into GM food is being conducted, but that those who have dissenting voices are being suppressed and have had their careers ruined, and sometimes their health. Dr. Pusztai has suffered a mild heart attack brought on by the stress caused by trying to restore his scientific reputation and the credibility of his research. These concerns were echoed by Dr. Kenneth Lough, FRSE, a former principal scientific officer at the Rowett Institute between 1956 and 1987. He said, "In my view the evidence presented in the audit report must be considered as unsafe and is without justification for use against the scientific reputation of Dr. Pusztai. The Institute is at risk in sending the wrong signals to scientists in this field of research that any sign of apparent default will be treated with the utmost severity. The awareness will of course act as strong deterrent to those who wish to conduct research in this vitally important field." (end of stuff from WSWS).
But a committee of six eminent members of the British Royal Society, set up in April of 1999 to review the Pusztai data, reached the opposite conclusion. The committee sent out the material they received from Pusztai, the Rowett and other sources to scientists with expertise in statistics, clinical trials, physiology, nutrition, quantitative genetics, growth and development, and immunology. The committee reviewed the opinions it received and issued a summary statement in June of 1999. The consensus of these experts was that the experiments were poorly designed, the statistical inappropriate, and the results inconsistent. Their recommendation was that the experiments be repeated and the results published.
Pusztai jumped to his own defense with a detailed response (http://www.freenetpages.co.uk/hp/a.pusztai/). He and a colleague with whom he had worked for some years published their study in medical journal Lancet (Ewen and Pusztai, 1999). Lancet, in turn, came under sharp criticism from a number of quarters, including U.K.'s Biotechnology and Biological Sciences Research Council, which called the journal "irresponsible." But Lancet’s editor, Richard Horton, stood by the publication. Five of 6 reviewers had favored publication and he believed that it was appropriate for the information to be available in the public domain (Enserink, Science 286:656).
So what’s this all about? Why this titanic battle of experts? Why is Pusztai, until this incident considered an authority on the plant proteins called lectins, under such fierce attack? He’s written three books on lectins and published 270 research papers. Moreover, he’d worked at the Rowett Institute for 35 years. On the surface of it, his now-controversial research was perfectly straightforward: he fed genetically modified potatoes expressing a snowdrop lectin to rats and looked to see whether this food affected their physiology, particularly the gut, metabolic process and immune system. What are lectins? Should we worry about them? Should we share Pusztai’s concern and conclusion that genetic engineering itself results in "……possible gene silencing, suppression and/or somaclonal variation"?
The protein in question is called the Galanthus nivalis agglutinin after the Latin name of the snowdrop and it is abbreviated GNA. It was originally isolated from snowdrop bulbs and is a kind of protein that recognizes and bind to sugars on proteins. Such proteins are called ‘lectins’ as a group. Although lectins were first discovered in plants, they are now known to exist in animals in great profusion (Rudiger 2000). Many proteins – in all kinds of organisms – are decorated with sugar molecules – sometimes with long strings or branches of several sugar molecules. Such derivatized proteins are called glycoproteins.
Each glycoprotein has a different complement of sugar molecules, depending on what it does and where it does it. The sugar signature works like a zip code in the cell, determining where the protein is delivered by the machinery that produces it. When such decorations are on the surface – be it of a virus, a bacterium, or a cell – they serve as a recognition molecules. Lectins recognize the sugar molecules with such exquisite correctness and specificity that they have long been used to identify what sugars are present on a protein. Today it is increasingly recognized that the sugar ‘codes’ serve a large variety of internal functions. One of these is recognizing disease organisms.
So, for example, it has been known for a number of years that the AIDS virus HIV (human immunodeficiency virus) has mannose sugars on its surface and the ability of cells to recognize these surface sugars with their own lectins is part of the infectious process (Hammar 1995). Plant lectins like GNA, which recognizes mannose, bind to the virus and inactivate it. They also interfere with its ability to infect cells (Hammar 1995). Because of its ability to bind to these surface sugars, GNA has been used to purify the HIV surface glycoproteins, which were in turn used to produce an immune response, albeit not much of one (Gilljam, 1993). Similarly, Chlamydia trachomatis has surface mannose-containing glycoproteins that allows the organism to infect cells by binding to a surface lectin (Siridewa 1993).
Plants – no less than animals – have mechanisms for defending themselves from microorganisms and insects. Plant produce lectins as one of their defense strategies against insects (Carlini 2002). Indeed, a good deal of evidence has accumulated that GNA, which binds specifically to a sugar called mannose, is rather toxic to certain kinds of insects pests of important crop plants, including rice (Du et al. 2000; Fitches et al., 2001). GNA does not seem to affect ladybird beetles, considered to be a beneficial insect (Down et al., 2000), although it does affect parasitic wasps, also considered to be beneficial insects (Romeis 2003). Some lectins, including ricin, are quite toxic because they’re taken up by cells and block protein synthesis (Olsnes 2001). These are called ribosome-inactivating proteins or RIPs. But GNA doesn’t have this activity (Batelli 1997).
Better yet, Pusztai’s own studies showed that purified GNA wasn’t toxic to rats (Pusztai 1990). In fact, he and his colleagues had shown that GNA had a protective effect against bacterial infection with Salmonella, a nasty intestinal bug (Naughton et al., 2000). All of this made the gene coding for GNA an attractive choice for increasing the insect resistance of crop plants. To test this possibility, the gene was introduced into a number of different crop plants, including potatoes and rice. And it does, indeed, increase their resistance to some important insect pests (Rao 1998; Foissac 2000). Because GNA binds to the surface cells of insects guts and enters their blood stream, it is also thought to have potential as a vehicle for delivering more toxic peptides to insects (Fitches 2002).
Sugar signatures are ubiquitous in biology – and as yet, we know rather little about what they do. It is known, for example, that there are two critical kinds of cells – the T and B cells – that must interact for the body’s immune response to be activated. It has been reported that these interactions occur through a mannose-containing glycoprotein and that this interaction can be blocked by GNA (Savage 1993). Thus some of the same signature sugars central to important cellular functions. Pathogens take advantage of essential intercellular recognition mechanisms to gain a foothold, both by binding to the cell’s own lectins and by evading the immune response because they resemble the cell’s own molecules. So, for example, a lectin called DC-SIGN (dendritic dell-specific intercellular adhesion molecule-3 grabbing nonintegrin) binds sugars on the HIV envelope and facilitates infection of its target CD4 T cells (Geijtenbeek 2003).
The DC-SIGN lectin is referred to as an HIV ‘receptor’ because of this specific recognition of HIV, but it is actually a universal pathogen receptor (Geijtenbeek 2003). It normally captures viruses and other pathogens through their sugar-containing protein molecules and pulls them into the cell, where they are broken down and displayed on the cell surface to trigger a protective immune response (Kooyk 2003). HIV hijacks this system. It stays intact when it binds to DC-SIGN and rides along to be presented to its target T4 cells in an infectious form. This is a rather effective evasion system. It makes it quite unlikely that the body will successfully fight back by making antibodies, the body’s proteins that recognize and destroy pathogens. This is because the immune system learns early in life to discriminate between its own proteins and foreign proteins. But one particular HIV glycoprotein, gp120, has a dense cluster of mannose residues that has not been seen in any mammalian glycoprotein (Calarese 2003) and a few HIV patients make good antibodies to this protein. Recent work on one such antibody showed that it binds to the gp120 – the same protein to which DC-SIGN binds to promote viral infection – in a very unusual way. Antibodies generally recognize and bind to just one sugar residue, but this unusual antibody has an extended structure that permits it to recognize more than one mannose residue at a time. This is actually similar to the way that certain lectins recognize sugars because lectins consist of two or more identical proteins, each of which has a sugar-binding site (Hester 1996; Calarese 2003). The discovery of this unusual antibody raises new hope for stimulating the immune system to produce anti-HIV antibodies, immunizing people against AIDS.
But there are many kinds of lectins and they can have quite different effects. For example, Pusztai and his colleagues had reported 10 years earlier that a kidney bean lectin, phytohemagglutinin or PHA, caused the surface cells of rats’ intestines to turn over more quickly (Pusztai 1993). The younger replacement cells on the tiny surface projections – called villi – of the intestinal cells had a high proportion of proteins with mannose sugars at the ends of their sugar signatures. This made the cells more susceptible to bacterial overgrowth with Escherichia coli, a common gut bacterium, because the bacterium has projections – called fimbrae – that recognize and bind to mannose. Including GNA in the diet reduced the extent of bacterial overgrowth because the GNA binds to the mannose on the intestinal cells.
PHA is a normal component of red kidney beans – and people get sick from eating too much of it. Allergist David Freed recounts an incident that occurred in 1988 when a hospital had a “healthy eating day” in its staff canteen at lunchtime (Freed 1999). He recounts that 31 portions of a dish containing red kidney beans were served that day and over the next several hours, 11 customers were experienced profuse vomiting, some with diarrhea – typical food-poisoning symptoms. All recovered by the next day, but no pathogen was found in the food. It turned out that the beans contained an abnormally high concentration of PHA.
There are many different kinds of plant lectins and they are present in most plants, especially abundant in seeds, including cereals and beans, and in tubers, including potatoes. They tend to survive cooking and digestive enzymes. Pusztai and many other investigators have shown that they affect intestinal cells. It isn’t surprising that they occasionally cause symptoms of food poisoning (Freed 1999). As in insects, some can get into and through cells and into the blood stream. Some lectins are also potent allergens. So even through GNA appears to be a relatively benign lectin as evidenced by rat feeding studies, there is absolutely no doubt that a food expressing such a protein needs careful testing, first in animals.
Sensibly, the Scottish Office Agriculture, Environment and Fisheries Department (SOAEFD) commissioned a 3-year study in 1995 titled “Genetic engineering of crop plants for resistance to insect and nematode pests: effects of transgene expression on animal nutrition and the environment.” Its objective was "to identify genes encoding antinutritional factors which will be suitable for transfer into plants to enhance their resistance towards insect and nematode pests, but will have minimum impact on non-target, beneficial organisms, the environment, livestock fed on these plants, and which will present no health risks for humans either directly or indirectly through the food chain." The University of Durham and the Scottish Crop Research Institute were to provide the transgenic plants and the Rowett Research Institute was to do a chemical analysis of the transgenic plant materials. They were also to do both short-term (10 day) and long-term (3 months) rat feeding trials to determine whether the effect of the transgenic plant materials was similar to that of the parent lines.
The chemical analysis of the transgenic plants showed them to be quite different from the parent lines (http://www.rowett.ac.uk/gmo/ajp.htm) – although the audit report curiously concludes that they weren’t (http://www.rowett.ac.uk/gmoarchive/gmaudit.pdf). The researchers measured total protein concentration, as well as the content of several relevant proteins, including GNA, potato lectin and several others. All of these differed between transgenic lines and in comparison with the parental lines. Rats in Pusztai’s study were fed either raw or cooked potatoes. Non-transgenic potatoes were supplemented with GNA. The results showed that rats fed the transgenic potatoes had significantly lower organ weights. They found that GNA added to the potatoes made the animal’s lymphocytes, which are cells in the immune system, more responsive to stimulation by other lectins. By contrast, lymphocyte responsiveness was depressed in the animals fed the transgenic potatoes expressing GNA.
What these studies basically showed was that the transgenic potato lines were different from each other, as well as from the parental potatoes. A later study on transgenic potatoes came to the same conclusion (Down 2001). Here Pusztai jumped to the conclusion that these differences must be attributable to the fact that the plants were transgenic – and he went public with his conclusion. What he probably didn’t know – because he was neither a plant breeder nor a plant biologist – was that the very process through which the plants are put during the introduction of the transgene – culturing through a callus stage and then regeneration of the plant – can cause marked changes in both the structure and expression of genes.
The variation that arises as a result of passage through tissue culture is called “somaclonal variation” and is both a nuisance and a potent source of new materials for plant breeding. The variation is both genetic (single base changes, deletions, insertions, transpositions) and epigenetic – this means modifications that can affect expression of genes, but not their structure. For plant breeders, this means that new materials and new varieties derived using culturing techniques must be evaluated for both their growth and their food properties. This is particularly important for potato breeding, because potatoes produce toxic substances called glycoalkaloids (Kozukue 1999). Glycoalkaloids are normally present in potatoes, can contribute to inflammatory bowel disease, and are concentrated by frying potatoes (Patel 2002). So potato breeders must carefully monitor these compounds, irrespective of the means by which new potato varieties are generated.
Unfortunately, Pusztai’s analyses of the chemical composition of the transgenic lines were rather superficial. And his quick leap to the conclusion that the variation he observed was attributable to the fact that they were transgenic was simply unwarranted. This mistake has proved costly to Pusztai himself. And unfortunately, the expertise battle that sprang up around the experiments has obscured the importance of carrying out well-designed experiments to evaluate the food qualities of transgenic crop plants expressing proteins that have the potential of affecting human health. Lectins are clearly in this category.
Pusztai has been criticized severely for the quality of his experiments. His experiments have been attacked for their small sample sizes, the use of inappropriate statistical procedures, and the fact that a diet of raw – or even cooked – potatoes is a bad diet for rats (people too), even when supplemented with a bit of extra protein. But oddly enough, in all that has been written about these experiments, no one seems to have seen their central flaw, which was that he did not use appropriate controls. A “control” is the part of an experiment that allows the researcher to examine the consequences of just the change (in this case) or the treatment (in the case of a drug) under study. In Pusztai’s experiments, the control potatoes had a different history than the transgenic potatoes and, in particular, that history included a culture procedure that induces somaclonal variation. The likeliest source of the variation he detected – and of the differences he attributed to the fact that they contained foreign DNA – was the culture procedure itself. In order to be able to attribute the deleterious effects of the transgenic potatoes to the newly introduced gene or to some other part of the introduced DNA, he would have had to make a comparison between potatoes that had the very same history, but either had or lacked the transgenic construct. This can be done, but the study that Pusztai participated in was simply not designed for such a test.
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GMO Pundit on this topic:
For a collection of comments and references on this first see
Rats fed bad diets have lots of changes in their guts, which is the best the Pundit can collect from the web and from his advisers.
but also here and here, Potatoes not perfect food, Genetic Roulette.
Academics Review on this topic
1.1—Pusztai’s Flawed Claims
Wednesday, February 01, 2006
Why tryptophan is bad for people who have chemical imbalances related to histamine and serotonin.
This post is a continuation, with all the fine print, and gory pathological detail, of a post that starts at GMO Pundit as follows:
By a strange twist of fate, GMO Pundit is ideally placed to alert readers to a real hazard - excessive tryptophan intake in the wrong circumstances - that is widely misunderstood in the community, and is a previously falsely diagnosed risk.
The main point of this posting is to help people avoid ill health - that is avoid generalised muscular pains (myalgia, called EMS) - that might be caused by ill-advised self-medication with tryptophan, or excessive intake of foods rich in tryptophan. Such intake is commonly taken because it is perceived to help overcome mental depression caused by chemical imbalances in the brain.
By a strange twist of fate, GMO Pundit is ideally placed to alert readers to a real hazard - excessive tryptophan intake in the wrong circumstances - that is widely misunderstood in the community, and is a previously falsely diagnosed risk.
The main point of this posting is to help people avoid ill health - that is avoid generalised muscular pains (myalgia, called EMS) - that might be caused by ill-advised self-medication with tryptophan, or excessive intake of foods rich in tryptophan. Such intake is commonly taken because it is perceived to help overcome mental depression caused by chemical imbalances in the brain.
Sunday, December 18, 2005
Inclusion of risks and benefits in public policy decisions.
This in an exchange starting with an article by Daryll E. Ray in South West Farm Press.
Rick Roush argues in the follow up that Daryll is ignoring benefits.
Producers argue for sound science, some consumers prefer precautionary principle
Dec 14, 2005 9:40 AM
By Daryll. E. Ray
The precautionary principle is what our mothers were talking about when they told us that it is better to be safe than sorry.
U.S. agricultural and trade negotiators have been pressuring the Japanese to reopen their market, which has been closed to U.S. beef since BSE (Bovine Spongiform Encephalopathy or mad cow disease) was first detected in the U.S. herd at the end of 2003. The U.S. is also in a trade dispute with the EU (European Union) over the EU s restrictions on the importation of GMO (genetically modified organism) crops. In both cases the United States has argued that, on the basis of sound science, both of these trade restrictions ought to be lifted.?
Primedia Business - Southwest Farm Press, Click Here!
On the face of it, it would seem that the U.S. argument is very strong. After all, how could and why would one argue against sound science? For their part, the Europeans and the Japanese defend their actions on the basis of the precautionary principle. The precautionary principle is what our mothers were talking about when they told us that it is better to be safe than sorry. As long-term readers of this column know, we have written about these issues before. Our analysis of these two trade disagreements has been based on two ideas. The first is couched in economic terms arguing that the customer is always right.
If the Japanese are willing to pay for the BSE testing of every head of beef, the idea that the customer is always right would suggest that we would agree to the testing. Likewise, if the Europeans want non-GMO grain, then U.S. farmers ought to be working to provide them with non-GMO grain.?
Our second idea has been to identify why customers might assess the risk of GMO grains differently than the producers. After all, growing GMO crops makes it easier for producers to control weeds and insects. While producers receive the benefits, customers take the risks if at a later time it were to be shown that GMO crops posed some health risk. It makes no difference how low the probability of that event is? The probability is nonzero and therefore important in minds of some customers.?
This past summer we read a paper presented by Priya Om Verma and William R. Freudenberg at the 2005 Rural Sociological Society Annual Meeting that took a different look at the conflict between those advocating for the use of sound science and those advocating for the use of the precautionary principle in decision making. Verma and Freudenberg, of the University of California, Santa Barbara, argue that the precautionary principle may be the more scientific of the two approaches. ??The core of their analysis reduces the two arguments to their essentials. Those using the sound science as the justification for their policies - pressuring Europeans to buy GMOs or Japanese to purchase U.S. beef - are arguing that something is safe unless it is proven to be hazardous.
Thus, declaring something is safe runs the statistical risk that it is not.?Those supporting the precautionary principle are arguing that when there is a potential risk to life and safety, the prudent course of action is to err on the side of caution, risking the chance that one may reject an action or product as unsafe when in fact it may be safe.?Hurricane Katrina and the flooding of New Orleans provide us with a chance to apply these concepts to a situation most of us are familiar with. Those officials who supported cutting back on levee repairs were arguing that the likelihood of a Category 3 hurricane that would cause a breach in the levees was very small and that the money would be better spent elsewhere.
This is the sound science argument which takes the risk assuming the levees will hold when in fact they won t. Those who were arguing for the levee expenditures and protecting the wetlands surrounding New Orleans were basing their argument on the precautionary principle. As we have seen, the sound science argument favors short-term economic gain over against the potential of catastrophic long-term costs. In this case we can see that an ounce of prevention would have been worth more than a pound of cure.?Applying this back to the case of GMO sales to the Europeans, the United States is arguing in favor of immediate economic gains from increased trade over and against long-term health and/or safety problems that may arise if it were to turn out that GMOs pose a risk that does not show up for 10, 20, or 30 years.
Similarly, in the case of the sale of beef to the Japanese, the United States is arguing that the extra cost of testing each head of beef sold to the Japanese is unnecessary, given the low chance that any one animal would have BSE. The Japanese are arguing that given the long-term risks - if one imports enough untested beef, sooner or later a BSE positive animal will slip through - the cost of testing is a small price to pay for increased long-term safety.??As Verma and Freudenberg note, statistics teach us that these two risks are closely related. As one reduces the chance of making a short-term error - rejecting a product as unsafe when it is in fact safe - one increases the chance of making a long-term error.
There is a tradeoff between these two types of errors. We cannot have our cake and eat it too.?Their argument that the precautionary principle may be the more scientific of the two approaches is based on their contention that the precautionary principle recognizes the reality of scientific unknowns and acknowledges . . . scientific uncertainty.
They go on to say, Under conditions of scientific uncertainty, judging what is an acceptable level of risk for society is an inherently political responsibility . . . These are value-laden processes that reflect differing perspectives regarding what ought to be society s preferences for short-term economic risks versus longer-term risks to health and the environment.
Daryll E. Ray holds the Blasingame Chair of Excellence in Agricultural Policy, Institute of Agriculture, University of Tennessee, and is the Director of UT s Agricultural Policy Analysis Center (APAC). (865) 974-7407; Fax: (865) 974-7298; dray@utk.edu; http://www.agpolicy.org. Daryll Ray s column is written with the research and assistance of Harwood D. Schaffer, Research Associate with APAC
Not Just Sound Science or Precaution...But Risks and Benefits
RE
>http://southwestfarmpress.com/news/051214-sound-science-principle/
- Rick Roush, rtroush.at.ucdavis.edu (On Agbioview)
Dear Prof. Ray:
Your analysis with the example of GM crops is interesting, but overlooks the documented advantages of GM crops to consumers, including reduced and safer pesticide residues in the environment, maybe even on food, reduced erosion due to reduced tillage, and reduced fuel use, never mind the health advantages to farm workers. Of particular interest ought to be reduced fumonisins in corn. There has even been some evidence of lower costs to consumers. I realize that consumers may not care about farm workers, but this has to be seen as a selfish attitude with regard to the people who produce food and fiber. On the other hand, consumers express considerable interest reducing the environmental foo[t] print of ag. That is why many of us who actually do pest management see advantages to the crops.
Perhaps it is up to decision makers to consider these issues even if busy and media-overloaded consumers fail to become aware of them. This is not just about "GMO crops mak(ing) it easier for producers to control weeds and insects". It's not just about a precautionary principle and sound science. It is about considering all of the risks and benefits, including the known risks of failure to adopt new technologies, as well as the hypothetical risks of doing so. If you are unaware of the refereed literature for these benefits, I am sure that my colleagues and I would be happy to offer some.
Response to Roush on Agbioview 'More on 'Sound Science or Precautionary Principle'
- Harwood D. Schaffer, hdschaffer.at.utk.edu
Rick, I am Daryl Ray's research associate and thought I would take the time to respond to your email. It appears to me that you have confused a discussion of research methodology with a discussion of the content of that research. In our article we were talking about methodology and in your response you were talking about the content of that research.
In our article we took out some of the technical language contained in Verma and Freudenburg's article. In the original they contended that arguments for "sound science" as the basis of making public policy decision in matters like BSE and GMOs indicated a preference for reducing the chance of committing a Type I error. Similarly then those using the "precautionary principle" indicate a preference for reducing the number of Type II errors. No matter where one comes down on the details of the arguments, that is the nature of the issue at hand. For any given technology one cannot reduce the risk of committing a Type I error without at the same time increase the risk of committing a Type II error. I infer from your comments that you have confidence in the technology and therefore are concerned about reducing the possibility of committing a Type I error. From a statistical point of view you then have to admit that there is a concomitant shift in the risk of committing a Type II error.
In either case you are correct: the issue is not one of science vs. non-science. Rather it is a matter of difference in risk preferences with some striving to reduce the risk of committing a Type I error while others are trying to reduce the risk of committing a Type II error. Those risk preferences are influenced by values and at that point values become a relevant part of the discussion and decision-making process in a democratic society.
Our purpose in writing the article was to present the issue of the trade-off between "sound science" and "precautionary principle" between Type I and Type II errors to a general audience that is not as well versed in statistical issues as you are.
Thanks for your response and your interest in public policy issues.
Sincerely yours, Harwood Schaffer, Research Associate, Agricultural Policy Analysis Center, PhD candidate, Department of Sociology, University of Tennessee
Response to Harwood, from Rick Roush, rtroush.at.ucdavis.edu
Dear Harwood :
No, I have not confused a discussion of research methodology with a discussion of the content of that research. Your approach and discussion is all about a one-sided view of the precautionary principle that considers only risks to the new technology, not known hazards of the current technologies. The only mention of the word "benefit" in your article was in the context of benefits to producers, with consumers taking all of the risks. This is an inadequate research methodology, where the benefits to consumers are never considered. Reality is not that simple.
I suggest that you have never had to make real world regulatory decisions, as I have, or this would be clearer to you. It is a key role of government to study issues and make some decisions for a general public that hasn t the time or expertise to study the questions in detail. I work on this for ag, but have to trust other experts to make technical decisions for the military, power generation and distribution, local transit, sewage, water supply, etc. I suggest that it even extends to social welfare. If one went solely with what the majority of the public wanted, Mississippi would not have been integrated in the 1980s when I lived there. In fact, there still was no public kindergarten when I arrived, because it was seen as welfare for black kids; Governor William Winter had to force it through against popular sentiment.
Here in California, it has been the role of government to make tough decisions on the mechanics of cars that people buy and other tactics to reduce air pollution, for example, even if individual consumers don t like them because of extra costs and inconvenience. There are limits on the number of fish you can catch, and protections for national and state parks, even if there is no direct, short term benefit to consumers. I see current GM crops as in the same vein; there is overwhelming evidence that they are reducing the environmental footprint of human habitation with essentially no risk to consumers.
What about the risks? We accept the risks of allowing planes to fly overhead because of the benefits to travelers and the airlines, even though we know that some planes occasionally will kill the innocent below who did not specifically accept the risks (as with the recent Southwest flight). This is not just a recent phenomenon; in old New York City, being kicked or otherwise injured by horses was a common source of mortality even for those who didn t own or work with them, but horses were tolerated for their overall benefits.
Your methodology for GM crops does not consider their benefits to consumers as the general public, but focuses on the fears that people have about the risks. You have enhanced this by comparing BSE, with known risks and relatively low cost risk avoidance, with GM crops, where there are no known risks and the costs of avoidance (stopping their use) are enormous.
Reducing the risk of a Type I error seems warranted whenever the Type II error is not distinguishable from zero. In this case, the overwhelming evidence is that current GM foods are at least as safe as anything produced conventionally. At least they get a safety review; most of what we eat has never been reviewed for safety, and even for some cases that have been assessed and score badly at least in some circumstances (like transfats, peanuts, and raw milk), we continue to allow them on the market! No GM crop would be allowed with those risks; we banned Starlink even though there was good evidence that it wasn t allergenic.
No, our disagreement is not about the content of research, but about the philosophical framework of research methodology for risk assessment.
Sincerely, Rick
Rick Roush argues in the follow up that Daryll is ignoring benefits.
Producers argue for sound science, some consumers prefer precautionary principle
Dec 14, 2005 9:40 AM
By Daryll. E. Ray
The precautionary principle is what our mothers were talking about when they told us that it is better to be safe than sorry.
U.S. agricultural and trade negotiators have been pressuring the Japanese to reopen their market, which has been closed to U.S. beef since BSE (Bovine Spongiform Encephalopathy or mad cow disease) was first detected in the U.S. herd at the end of 2003. The U.S. is also in a trade dispute with the EU (European Union) over the EU s restrictions on the importation of GMO (genetically modified organism) crops. In both cases the United States has argued that, on the basis of sound science, both of these trade restrictions ought to be lifted.?
Primedia Business - Southwest Farm Press, Click Here!
On the face of it, it would seem that the U.S. argument is very strong. After all, how could and why would one argue against sound science? For their part, the Europeans and the Japanese defend their actions on the basis of the precautionary principle. The precautionary principle is what our mothers were talking about when they told us that it is better to be safe than sorry. As long-term readers of this column know, we have written about these issues before. Our analysis of these two trade disagreements has been based on two ideas. The first is couched in economic terms arguing that the customer is always right.
If the Japanese are willing to pay for the BSE testing of every head of beef, the idea that the customer is always right would suggest that we would agree to the testing. Likewise, if the Europeans want non-GMO grain, then U.S. farmers ought to be working to provide them with non-GMO grain.?
Our second idea has been to identify why customers might assess the risk of GMO grains differently than the producers. After all, growing GMO crops makes it easier for producers to control weeds and insects. While producers receive the benefits, customers take the risks if at a later time it were to be shown that GMO crops posed some health risk. It makes no difference how low the probability of that event is? The probability is nonzero and therefore important in minds of some customers.?
This past summer we read a paper presented by Priya Om Verma and William R. Freudenberg at the 2005 Rural Sociological Society Annual Meeting that took a different look at the conflict between those advocating for the use of sound science and those advocating for the use of the precautionary principle in decision making. Verma and Freudenberg, of the University of California, Santa Barbara, argue that the precautionary principle may be the more scientific of the two approaches. ??The core of their analysis reduces the two arguments to their essentials. Those using the sound science as the justification for their policies - pressuring Europeans to buy GMOs or Japanese to purchase U.S. beef - are arguing that something is safe unless it is proven to be hazardous.
Thus, declaring something is safe runs the statistical risk that it is not.?Those supporting the precautionary principle are arguing that when there is a potential risk to life and safety, the prudent course of action is to err on the side of caution, risking the chance that one may reject an action or product as unsafe when in fact it may be safe.?Hurricane Katrina and the flooding of New Orleans provide us with a chance to apply these concepts to a situation most of us are familiar with. Those officials who supported cutting back on levee repairs were arguing that the likelihood of a Category 3 hurricane that would cause a breach in the levees was very small and that the money would be better spent elsewhere.
This is the sound science argument which takes the risk assuming the levees will hold when in fact they won t. Those who were arguing for the levee expenditures and protecting the wetlands surrounding New Orleans were basing their argument on the precautionary principle. As we have seen, the sound science argument favors short-term economic gain over against the potential of catastrophic long-term costs. In this case we can see that an ounce of prevention would have been worth more than a pound of cure.?Applying this back to the case of GMO sales to the Europeans, the United States is arguing in favor of immediate economic gains from increased trade over and against long-term health and/or safety problems that may arise if it were to turn out that GMOs pose a risk that does not show up for 10, 20, or 30 years.
Similarly, in the case of the sale of beef to the Japanese, the United States is arguing that the extra cost of testing each head of beef sold to the Japanese is unnecessary, given the low chance that any one animal would have BSE. The Japanese are arguing that given the long-term risks - if one imports enough untested beef, sooner or later a BSE positive animal will slip through - the cost of testing is a small price to pay for increased long-term safety.??As Verma and Freudenberg note, statistics teach us that these two risks are closely related. As one reduces the chance of making a short-term error - rejecting a product as unsafe when it is in fact safe - one increases the chance of making a long-term error.
There is a tradeoff between these two types of errors. We cannot have our cake and eat it too.?Their argument that the precautionary principle may be the more scientific of the two approaches is based on their contention that the precautionary principle recognizes the reality of scientific unknowns and acknowledges . . . scientific uncertainty.
They go on to say, Under conditions of scientific uncertainty, judging what is an acceptable level of risk for society is an inherently political responsibility . . . These are value-laden processes that reflect differing perspectives regarding what ought to be society s preferences for short-term economic risks versus longer-term risks to health and the environment.
Daryll E. Ray holds the Blasingame Chair of Excellence in Agricultural Policy, Institute of Agriculture, University of Tennessee, and is the Director of UT s Agricultural Policy Analysis Center (APAC). (865) 974-7407; Fax: (865) 974-7298; dray@utk.edu; http://www.agpolicy.org. Daryll Ray s column is written with the research and assistance of Harwood D. Schaffer, Research Associate with APAC
Not Just Sound Science or Precaution...But Risks and Benefits
RE
>http://southwestfarmpress.com/news/051214-sound-science-principle/
- Rick Roush, rtroush.at.ucdavis.edu (On Agbioview)
Dear Prof. Ray:
Your analysis with the example of GM crops is interesting, but overlooks the documented advantages of GM crops to consumers, including reduced and safer pesticide residues in the environment, maybe even on food, reduced erosion due to reduced tillage, and reduced fuel use, never mind the health advantages to farm workers. Of particular interest ought to be reduced fumonisins in corn. There has even been some evidence of lower costs to consumers. I realize that consumers may not care about farm workers, but this has to be seen as a selfish attitude with regard to the people who produce food and fiber. On the other hand, consumers express considerable interest reducing the environmental foo[t] print of ag. That is why many of us who actually do pest management see advantages to the crops.
Perhaps it is up to decision makers to consider these issues even if busy and media-overloaded consumers fail to become aware of them. This is not just about "GMO crops mak(ing) it easier for producers to control weeds and insects". It's not just about a precautionary principle and sound science. It is about considering all of the risks and benefits, including the known risks of failure to adopt new technologies, as well as the hypothetical risks of doing so. If you are unaware of the refereed literature for these benefits, I am sure that my colleagues and I would be happy to offer some.
Response to Roush on Agbioview 'More on 'Sound Science or Precautionary Principle'
- Harwood D. Schaffer, hdschaffer.at.utk.edu
Rick, I am Daryl Ray's research associate and thought I would take the time to respond to your email. It appears to me that you have confused a discussion of research methodology with a discussion of the content of that research. In our article we were talking about methodology and in your response you were talking about the content of that research.
In our article we took out some of the technical language contained in Verma and Freudenburg's article. In the original they contended that arguments for "sound science" as the basis of making public policy decision in matters like BSE and GMOs indicated a preference for reducing the chance of committing a Type I error. Similarly then those using the "precautionary principle" indicate a preference for reducing the number of Type II errors. No matter where one comes down on the details of the arguments, that is the nature of the issue at hand. For any given technology one cannot reduce the risk of committing a Type I error without at the same time increase the risk of committing a Type II error. I infer from your comments that you have confidence in the technology and therefore are concerned about reducing the possibility of committing a Type I error. From a statistical point of view you then have to admit that there is a concomitant shift in the risk of committing a Type II error.
In either case you are correct: the issue is not one of science vs. non-science. Rather it is a matter of difference in risk preferences with some striving to reduce the risk of committing a Type I error while others are trying to reduce the risk of committing a Type II error. Those risk preferences are influenced by values and at that point values become a relevant part of the discussion and decision-making process in a democratic society.
Our purpose in writing the article was to present the issue of the trade-off between "sound science" and "precautionary principle" between Type I and Type II errors to a general audience that is not as well versed in statistical issues as you are.
Thanks for your response and your interest in public policy issues.
Sincerely yours, Harwood Schaffer, Research Associate, Agricultural Policy Analysis Center, PhD candidate, Department of Sociology, University of Tennessee
Response to Harwood, from Rick Roush, rtroush.at.ucdavis.edu
Dear Harwood :
No, I have not confused a discussion of research methodology with a discussion of the content of that research. Your approach and discussion is all about a one-sided view of the precautionary principle that considers only risks to the new technology, not known hazards of the current technologies. The only mention of the word "benefit" in your article was in the context of benefits to producers, with consumers taking all of the risks. This is an inadequate research methodology, where the benefits to consumers are never considered. Reality is not that simple.
I suggest that you have never had to make real world regulatory decisions, as I have, or this would be clearer to you. It is a key role of government to study issues and make some decisions for a general public that hasn t the time or expertise to study the questions in detail. I work on this for ag, but have to trust other experts to make technical decisions for the military, power generation and distribution, local transit, sewage, water supply, etc. I suggest that it even extends to social welfare. If one went solely with what the majority of the public wanted, Mississippi would not have been integrated in the 1980s when I lived there. In fact, there still was no public kindergarten when I arrived, because it was seen as welfare for black kids; Governor William Winter had to force it through against popular sentiment.
Here in California, it has been the role of government to make tough decisions on the mechanics of cars that people buy and other tactics to reduce air pollution, for example, even if individual consumers don t like them because of extra costs and inconvenience. There are limits on the number of fish you can catch, and protections for national and state parks, even if there is no direct, short term benefit to consumers. I see current GM crops as in the same vein; there is overwhelming evidence that they are reducing the environmental footprint of human habitation with essentially no risk to consumers.
What about the risks? We accept the risks of allowing planes to fly overhead because of the benefits to travelers and the airlines, even though we know that some planes occasionally will kill the innocent below who did not specifically accept the risks (as with the recent Southwest flight). This is not just a recent phenomenon; in old New York City, being kicked or otherwise injured by horses was a common source of mortality even for those who didn t own or work with them, but horses were tolerated for their overall benefits.
Your methodology for GM crops does not consider their benefits to consumers as the general public, but focuses on the fears that people have about the risks. You have enhanced this by comparing BSE, with known risks and relatively low cost risk avoidance, with GM crops, where there are no known risks and the costs of avoidance (stopping their use) are enormous.
Reducing the risk of a Type I error seems warranted whenever the Type II error is not distinguishable from zero. In this case, the overwhelming evidence is that current GM foods are at least as safe as anything produced conventionally. At least they get a safety review; most of what we eat has never been reviewed for safety, and even for some cases that have been assessed and score badly at least in some circumstances (like transfats, peanuts, and raw milk), we continue to allow them on the market! No GM crop would be allowed with those risks; we banned Starlink even though there was good evidence that it wasn t allergenic.
No, our disagreement is not about the content of research, but about the philosophical framework of research methodology for risk assessment.
Sincerely, Rick
Friday, December 16, 2005
Follow-up debate from Cell Biologist Professor David Schubert' s comments.
Cell Biologist Professor David Schubert has expressed a nicely put different perspective of GM food in the top Journal Nature Biotechnology:
A different perspective on GM food
As with good weblog postings, the comments and rejoinders to this contribution are at least as important as the initial posting. Nature Biotechnology carried these:
Divergent perspectives on GM food
Reply to 'Divergent perspectives on GM food'
Fortunately, the debate on Schuberts perspective continues unabated today. The following collection are some recent interesting remarks on Agbioview:
AgBioView from http://www.agbioworld.org December 14, 2005
Re: Schubert - Is Plant Breeding Different from GM?
Martin Mieschendah, martin.mieschendahl.at.uba.de
There is no doubt than genetic engineering breeding may lead to unintended effects (see e.g. Table. 6 in H. Kuiper et al.: Assessment of the food safety issues related to genetically modified foods, The Plant Journal 27(6), 503-528, 2001). But these risks are not different from those of conventional breeding.
To my knowledge so far only conventional bred plant varieties causing negative effects to the consumers have found its way to the market and had to be withdrawn. These were the potato variety Lenape that contained very high levels of toxic solanine, a pest-resistant celery variety that caused rashes in agricultural workers as it contained seven-fold more of the carcinogen psoralen than the control celery, and a traditionally bred squash that caused food poisoning (see e.g. AG Haselberger: Codex guidelines for GM food include the analysis of unintended effects, Nature Biotechnology 21-7, 739-741, 2003).
Favorite Papers for 2005: Safety in Conventional Status Quo? From Wayne Parrott
This past year I have been setting aside some papers that have crossed my desk. They caught my attention because they highlight the normal behavior of plants and agroecosystems. Everyone of these papers is about NON-transgenic crops and conventional agriculture. They caught my attention because if any single one of these had been associated with transgenes, an uproar would likely have ensued.
I wanted to call these to your attention because they highlight the lack of perspective and the double standard that continues to persist in the field. I've added my editorial remarks after each title. Enjoy.
===
Can almond nectar & pollen poison honey bees? (Kevan & Ebert. 2005. Am. Bee J. June 507-509)
- Yes, the pollen is toxic.
Mediation of pathogen resistance by exudation of antimicrobials from roots (Bais et al., 2005.Nature 434:217-221)
- Plants make and secrete toxins into the soil that kill potential pathogens
Reduced fitness of the Colorado potato beetle on potato plants grown in manure-amended soil (Alyokhin & Atlihan. 2005. Environ. Entomol. 34:963-968)
- Nice organic fertilizer can have negative impacts on potato beetles. Who knows what happens to those poor critters who depend on potato beetles for their livelihood.
Long-term effects of crop management on Rhizobium leguminosarum biovar viciae populations. (Depret et al., 2004. FEMS Microbiol. Ecol. 51:87-97)
- Normal crop rotations can alter soil microbial populations-- my guess is far more than Bt exudates ever could.
Copper amendment of agricultural soil selects for antibiotic resistance in the field. (Berg et al., 2005. Lett. Appl. Microbiol. 40:146-151)
- Perhaps Cornell's Environmental Impact Quotient should be amended to increase copper's hazards?
*******
Andrew Apel comments on this further:
In regulatory matters, the doctrine of substantial equivalence has acted more or less effectively as a counterweight to the precautionary principle. Under the doctrine, if novel products are substantially equivalent to those currently on the market, they can be treated in a substantially equivalent way. However, application of the doctrine has been restricted to food and feed products.
Wayne's "Favorite papers for 2005" and other papers presented here in a similar vein suggest that the doctrine of substantial equivalence deserves to be extended to cover environmental impacts and genetic modifications. This would yield interesting avenues of inquiry and force valid comparisons.
The making of inappropriate comparisons plagues agricultural research. Consistently, trials of novel crops and crop protection products compare trial results to either "organic farming" results, or to "no farming at all" results. Quite credible scientists engage regularly in this sort of "comparison bias," which is inherently weighted against technology, and especially against novel technology. There will always be a side-effect not encountered in "organic farming" or "not farming at all," and if this side-effect is even notionally adverse, the technology being tested automatically becomes questionable.
Extending the doctrine of substantial equivalence to environmental impacts and genetic modifications would get around these improper and often ridiculous comparisons.
So for instance, one might ask, are Bt crops substantially as poisonous to honeybees as almonds? If so, should they be regulated in the same manner as almonds? (Which is to say, not at all)
One might also ask, is the impact of RR crops on soil microflora substantially equivalent to the impact of root-expressed antimicrobials in weed populations? If so, should RR crops be regulated in the same manneras weeds? (Which is to say, not at all)
From: "Roger and Carolyn Morton" Subject: re: Schubert - Is Plant Breeding Different from GM Date: Thu, 8 Dec 2005 00:09:45 +1100
I found the Schubert piece on Is Plant Breeding Different from GM? refreshing in that he actually talks science rather than ideology. However, I have three factual bones to pick.
1. The assertion that the recombination events of conventional breeding are non-mutageneic is wrong. Below are three references where the recombination junctions of mutants produced by convetional breeding have been analysised. This data shows how the recombination events of conventional breeding are mutagenic. And since the production of a conventional plant variety requires many cycles of crossing there will be a large number of mutatgeneic events happening in the production of a conventionally bred variety. Thus, conventional breeding and GM breeding are very similar in this regard.
Anderson PA, Lawrence GJ, Morrish BC, Ayliffe MA, Finnegan EJ, Ellis JG. Plant Cell 1997 Apr;9(4):641-51 Inactivation of the flax rust resistance gene M associated with loss of a repeated unit within the leucine-rich repeat coding region. M Parniske and JDG Jones Proc. Natl. Acad. Sci. USA. 1999 96: 5850-5855 Recombination between diverged clusters of the tomato Cf-9 plant disease resistance gene family D Leister, J Kurth, DA. Laurie, M Yano,T Sasaki, K Devos, A Graner, and P Schulze-Lefert Proc. Natl. Acad. Sci. USA. 1998 95 : 370-375 Rapid reorganization of resistance gene homologues in cereal genomes.
2. Another point I would take issue with is Schubert's assertion kanamycin resistance is uncommon in bacterial pathogens and that we should be wary of kanamycin resistance as a marker gene in plants. Isn't the point of the argument that kanamycin resistant bacteria are everywhere, we eat them all the time and they live in our guts? So how does adding a tiny fraction more kanamycin resistance DNA going to increase any risks? Does Schubert have evidence to refute these facts?
3. I would also call into question Schubert's claim that transpositional mutagensis does not happen in conventionally bred crops. What about corn? Isn't it common knowledge that transposons are mutagenic and active in the corn crop? - reference anyone? I think transposons are probably active in all crop plants - we just have not discovered them. For example a mass screening for rust resistance genes in Flax revealed a mutation that when examined further was discovered to be caused by a flax transposable element (JE. Luck et al Plant Journal 16 p365 1998) It had not been discovered because no-one had done a mass screening in the Flax plant.
Subject: Schubert - Is Plant Breeding Different from GM - post script
Date: Thu, 8 Dec 2005 16:55:57 +1100
Further on Schuberts talk about GM vs conventional breeding. Schubert makes the point that "for the last 10,000 years, humans have selected and bred plants that did not make them sick and promoted their health."
And I agree - we have done this. But what happens when a conventional plant breeder wants to find, say, a new insect or disease resistance gene for her pet crop? She goes out into the populations of wild relatives of her pet crop plant. Wild relatives that have not been subjected to 10,000 years of selection for low toxicity. She then crosses these with her pet crop plant, selects her resistant line and does a few backcrosses to dilute out the "other" genes. Now, what screening is done on this new conventionally bred crop to determine if it still contains toxins from the wild relatives? The answer is NONE. Why is this OK? If Schubert says the GM crops have this hypothetical risk of throwing up toxic metablolites and comounds novel to the diet and that this should require them to be subject to "metabolic profiling" then why shouldn't conventionally bred crops which also have the same hypothetical risk be also subject to the same "metabolic profiling"?
AgBioView from www.agbioworld.org: December 9, 2005
From: "Bruce Chassy" Subject: RE: Schubert - Is Plant Breeding Different from GM - post script Date: Thu, 8 Dec 2005 12:54:49 -0600
A response to Roger and Carolyn Morton. Both you and Schubert may have both over-looked the published literature a bit. But rejoice, there's already limited published evidence to support your claim.
See for example:
Gareth S. Catchpole, Manfred Beckmann, David P. Eno, Madhav Mondhe, Britta Zywicki, Janet Taylor, Nigel Hardy, Aileen Smith, Ross D. King, Douglas B. Kell, Oliver Fiehn, and John Draper. 2005. Hierarchical metabolomics demonstrates substantial compositional similarity between genetically modified and conventional potato crops. PNAS 102:14458-14462
This paper demonstrates that transgenic potatoes are virtually identical to their parental counterpart while assorted cultivars of potatoes display much greater metabolic variance. We should be clear, however, that this finding applies to potatoes. More research is needed is needed to determine if these findings can be generalized to all crops or if metabolomic screening could add anything to the safety assessment paradigm. It is quite another question to ask if we need any additional data to make a determination of safety. Food toxicologists, nutritionists and food safety experts who have evaluated the currently employed food safety paradigm are virtually unaminous in saying we do not. A point I will argue further on another day.
It should not be surprising that in spite of what Schubert claims, the people who are actually doing metabolic profiling feel that it is not yet suitable as a safety assessment technique. It is a technique that is both being researched and which they feel may be more useful in research than in regulation. Another way to say this is that Schubert is right in arguing metabolomics could be a powerful technique some day. What its exponents will admit is that we do not yet know for what it will be useful nor do we know how to interpret the results. One could not possibility expect them to make a stronger statement if they want continued funding for their research.
Bruce M. Chassy, Ph.D.
Professor of Nutritional Sciences
University of Illinois at Urbana-Champaign
A different perspective on GM food
As with good weblog postings, the comments and rejoinders to this contribution are at least as important as the initial posting. Nature Biotechnology carried these:
Divergent perspectives on GM food
Reply to 'Divergent perspectives on GM food'
Fortunately, the debate on Schuberts perspective continues unabated today. The following collection are some recent interesting remarks on Agbioview:
AgBioView from http://www.agbioworld.org December 14, 2005
Re: Schubert - Is Plant Breeding Different from GM?
Martin Mieschendah, martin.mieschendahl.at.uba.de
There is no doubt than genetic engineering breeding may lead to unintended effects (see e.g. Table. 6 in H. Kuiper et al.: Assessment of the food safety issues related to genetically modified foods, The Plant Journal 27(6), 503-528, 2001). But these risks are not different from those of conventional breeding.
To my knowledge so far only conventional bred plant varieties causing negative effects to the consumers have found its way to the market and had to be withdrawn. These were the potato variety Lenape that contained very high levels of toxic solanine, a pest-resistant celery variety that caused rashes in agricultural workers as it contained seven-fold more of the carcinogen psoralen than the control celery, and a traditionally bred squash that caused food poisoning (see e.g. AG Haselberger: Codex guidelines for GM food include the analysis of unintended effects, Nature Biotechnology 21-7, 739-741, 2003).
Favorite Papers for 2005: Safety in Conventional Status Quo? From Wayne Parrott
This past year I have been setting aside some papers that have crossed my desk. They caught my attention because they highlight the normal behavior of plants and agroecosystems. Everyone of these papers is about NON-transgenic crops and conventional agriculture. They caught my attention because if any single one of these had been associated with transgenes, an uproar would likely have ensued.
I wanted to call these to your attention because they highlight the lack of perspective and the double standard that continues to persist in the field. I've added my editorial remarks after each title. Enjoy.
===
Can almond nectar & pollen poison honey bees? (Kevan & Ebert. 2005. Am. Bee J. June 507-509)
- Yes, the pollen is toxic.
Mediation of pathogen resistance by exudation of antimicrobials from roots (Bais et al., 2005.Nature 434:217-221)
- Plants make and secrete toxins into the soil that kill potential pathogens
Reduced fitness of the Colorado potato beetle on potato plants grown in manure-amended soil (Alyokhin & Atlihan. 2005. Environ. Entomol. 34:963-968)
- Nice organic fertilizer can have negative impacts on potato beetles. Who knows what happens to those poor critters who depend on potato beetles for their livelihood.
Long-term effects of crop management on Rhizobium leguminosarum biovar viciae populations. (Depret et al., 2004. FEMS Microbiol. Ecol. 51:87-97)
- Normal crop rotations can alter soil microbial populations-- my guess is far more than Bt exudates ever could.
Copper amendment of agricultural soil selects for antibiotic resistance in the field. (Berg et al., 2005. Lett. Appl. Microbiol. 40:146-151)
- Perhaps Cornell's Environmental Impact Quotient should be amended to increase copper's hazards?
*******
Andrew Apel comments on this further:
In regulatory matters, the doctrine of substantial equivalence has acted more or less effectively as a counterweight to the precautionary principle. Under the doctrine, if novel products are substantially equivalent to those currently on the market, they can be treated in a substantially equivalent way. However, application of the doctrine has been restricted to food and feed products.
Wayne's "Favorite papers for 2005" and other papers presented here in a similar vein suggest that the doctrine of substantial equivalence deserves to be extended to cover environmental impacts and genetic modifications. This would yield interesting avenues of inquiry and force valid comparisons.
The making of inappropriate comparisons plagues agricultural research. Consistently, trials of novel crops and crop protection products compare trial results to either "organic farming" results, or to "no farming at all" results. Quite credible scientists engage regularly in this sort of "comparison bias," which is inherently weighted against technology, and especially against novel technology. There will always be a side-effect not encountered in "organic farming" or "not farming at all," and if this side-effect is even notionally adverse, the technology being tested automatically becomes questionable.
Extending the doctrine of substantial equivalence to environmental impacts and genetic modifications would get around these improper and often ridiculous comparisons.
So for instance, one might ask, are Bt crops substantially as poisonous to honeybees as almonds? If so, should they be regulated in the same manner as almonds? (Which is to say, not at all)
One might also ask, is the impact of RR crops on soil microflora substantially equivalent to the impact of root-expressed antimicrobials in weed populations? If so, should RR crops be regulated in the same manneras weeds? (Which is to say, not at all)
From: "Roger and Carolyn Morton" Subject: re: Schubert - Is Plant Breeding Different from GM Date: Thu, 8 Dec 2005 00:09:45 +1100
I found the Schubert piece on Is Plant Breeding Different from GM? refreshing in that he actually talks science rather than ideology. However, I have three factual bones to pick.
1. The assertion that the recombination events of conventional breeding are non-mutageneic is wrong. Below are three references where the recombination junctions of mutants produced by convetional breeding have been analysised. This data shows how the recombination events of conventional breeding are mutagenic. And since the production of a conventional plant variety requires many cycles of crossing there will be a large number of mutatgeneic events happening in the production of a conventionally bred variety. Thus, conventional breeding and GM breeding are very similar in this regard.
Anderson PA, Lawrence GJ, Morrish BC, Ayliffe MA, Finnegan EJ, Ellis JG. Plant Cell 1997 Apr;9(4):641-51 Inactivation of the flax rust resistance gene M associated with loss of a repeated unit within the leucine-rich repeat coding region. M Parniske and JDG Jones Proc. Natl. Acad. Sci. USA. 1999 96: 5850-5855 Recombination between diverged clusters of the tomato Cf-9 plant disease resistance gene family D Leister, J Kurth, DA. Laurie, M Yano,T Sasaki, K Devos, A Graner, and P Schulze-Lefert Proc. Natl. Acad. Sci. USA. 1998 95 : 370-375 Rapid reorganization of resistance gene homologues in cereal genomes.
2. Another point I would take issue with is Schubert's assertion kanamycin resistance is uncommon in bacterial pathogens and that we should be wary of kanamycin resistance as a marker gene in plants. Isn't the point of the argument that kanamycin resistant bacteria are everywhere, we eat them all the time and they live in our guts? So how does adding a tiny fraction more kanamycin resistance DNA going to increase any risks? Does Schubert have evidence to refute these facts?
3. I would also call into question Schubert's claim that transpositional mutagensis does not happen in conventionally bred crops. What about corn? Isn't it common knowledge that transposons are mutagenic and active in the corn crop? - reference anyone? I think transposons are probably active in all crop plants - we just have not discovered them. For example a mass screening for rust resistance genes in Flax revealed a mutation that when examined further was discovered to be caused by a flax transposable element (JE. Luck et al Plant Journal 16 p365 1998) It had not been discovered because no-one had done a mass screening in the Flax plant.
Subject: Schubert - Is Plant Breeding Different from GM - post script
Date: Thu, 8 Dec 2005 16:55:57 +1100
Further on Schuberts talk about GM vs conventional breeding. Schubert makes the point that "for the last 10,000 years, humans have selected and bred plants that did not make them sick and promoted their health."
And I agree - we have done this. But what happens when a conventional plant breeder wants to find, say, a new insect or disease resistance gene for her pet crop? She goes out into the populations of wild relatives of her pet crop plant. Wild relatives that have not been subjected to 10,000 years of selection for low toxicity. She then crosses these with her pet crop plant, selects her resistant line and does a few backcrosses to dilute out the "other" genes. Now, what screening is done on this new conventionally bred crop to determine if it still contains toxins from the wild relatives? The answer is NONE. Why is this OK? If Schubert says the GM crops have this hypothetical risk of throwing up toxic metablolites and comounds novel to the diet and that this should require them to be subject to "metabolic profiling" then why shouldn't conventionally bred crops which also have the same hypothetical risk be also subject to the same "metabolic profiling"?
AgBioView from www.agbioworld.org: December 9, 2005
From: "Bruce Chassy" Subject: RE: Schubert - Is Plant Breeding Different from GM - post script Date: Thu, 8 Dec 2005 12:54:49 -0600
A response to Roger and Carolyn Morton. Both you and Schubert may have both over-looked the published literature a bit. But rejoice, there's already limited published evidence to support your claim.
See for example:
Gareth S. Catchpole, Manfred Beckmann, David P. Eno, Madhav Mondhe, Britta Zywicki, Janet Taylor, Nigel Hardy, Aileen Smith, Ross D. King, Douglas B. Kell, Oliver Fiehn, and John Draper. 2005. Hierarchical metabolomics demonstrates substantial compositional similarity between genetically modified and conventional potato crops. PNAS 102:14458-14462
This paper demonstrates that transgenic potatoes are virtually identical to their parental counterpart while assorted cultivars of potatoes display much greater metabolic variance. We should be clear, however, that this finding applies to potatoes. More research is needed is needed to determine if these findings can be generalized to all crops or if metabolomic screening could add anything to the safety assessment paradigm. It is quite another question to ask if we need any additional data to make a determination of safety. Food toxicologists, nutritionists and food safety experts who have evaluated the currently employed food safety paradigm are virtually unaminous in saying we do not. A point I will argue further on another day.
It should not be surprising that in spite of what Schubert claims, the people who are actually doing metabolic profiling feel that it is not yet suitable as a safety assessment technique. It is a technique that is both being researched and which they feel may be more useful in research than in regulation. Another way to say this is that Schubert is right in arguing metabolomics could be a powerful technique some day. What its exponents will admit is that we do not yet know for what it will be useful nor do we know how to interpret the results. One could not possibility expect them to make a stronger statement if they want continued funding for their research.
Bruce M. Chassy, Ph.D.
Professor of Nutritional Sciences
University of Illinois at Urbana-Champaign
Sunday, December 11, 2005
Biotechnology - Bio-ethics, Risk, and Regulation
Hyperlink to Return to GMO Pundit Main Page
Links to Notes on Bioethics, Risk, and Regulation.
- John Ziman's advice on scientific ethics and process.
- Balanced essay in readable English on the pros and cons of GM foods from Tufts daily
- The Full Monty on animal feeding tests of GM foods.
- Nuffield Bioethics.
- Africa Harvest
- US National Academy of Sciences
- Australian Government Office of the Gene Technology Regulator
- Agbioview
- Food and Chemical Toxicology
- Poisonous Plant Websites
- AFAA The Ethical Dimension
- CDC Report on Starlink
- Council for Biotechnology Information on Substantial Equivalence Concept
- OECD on LMOs
- Pew Initiative on Food and Biotechnology
- Food Standards Australia and New Zealand FSANZ
- European Food Safety Organisation
- The Plant Journal on Food Safety and Golden Rice
- University of Florida on Risk Assessment
- Selected Links to GMO Pundit Posts
- International Journal of Biotechnology (IJBT) special issue
- Environmental Health Perspectives Journal
- Public Library of Science Biology
- Let Them Eat Precaution: How Politics Is Undermining the Genetic Revolution in Agriculture
- ITSSD on the Precautionary Principle
- Rob Wager, Department of Biology, Malaspina University-College BC
- EFSA EU Food SAfety, Opinion on horizontal gene transfer of antibiotic markers (lateral transfer)
- ISB Database of the benefits and safety of biotechnology
- European Policy Forum - Code of Conduct for NGOs.
- SciDev.Net. Diverse opinions.
- Transgenic Research Risks with Herbicide Tolerant Wheat
- Unintended Consequences of delaying and frustrating health improvements for the poor in the name of Precaution.
- The Unintended Costs of Saying No.
- Regulatory Slowdown in US Agencies.
- The Truth About Bt crops in India and Africa. Jul 2006.
- Survival of crops in nature.
- Agricultural Legal Liability and the Law. Oct 2006
- Swiss study on ecological risks of crops. November 2006.
- IFT Report on organic foods and their safety and nutrition. November 2006
General Format for List:
SOURCE
......#Document
Two heads good, three heads better
Roger Sandall, December 2005
Progress in science
Progress in science is difficult, mistakes are made, careers go up and down and some are ruined. Pioneers like Wegener with his theory of continental drift may face stiff opposition that takes decades to overcome. Yet the edifice of science is something far grander and nobler than any New Cynic will ever understand. It is also of central importance for a humane and reasonable civilization. Science is one of those areas of human activity where disagreement does not lead to bomb-throwing or blowing other people up. But since the late John Ziman (who died in January 2005), a notable physicist in his day and a Fellow of the Royal Society, has already expressed these matters more eloquently and with rather more authority than myself, I shall close by quoting from the chapter “Dissent and Selection” in his [1968] book :
Experienced scientists know that real progress in research is slow and painful, and that many experimental observations and plausible arguments will not stand up for long under expert questioning. If science is to evolve, it must continually purge itself of misconceptions, follies, and practical errors: there must be preserved a central store of absolutely reliable knowledge, from which to draw in evaluating novel ideas and on which, very slowly and carefully, to build. In order that science may retain its reliability and credibility, each scientist is expected to exercise critical vigilance over his own work and the claims of his contemporaries…
The facts demonstrate that a healthy scientific community can accommodate intellectual controversy without breaking down. Consider, for example, the history of Wegener’s hypothesis of continental drift. Here was an immense revolution of thought, grossly overdue despite the almost pathological conservatism that had to be overcome by its advocates. Yet by the standards of most human institutions, academic as well as overtly political, it was a very gentlemanly affair, in which the evolution of scientific knowledge was not disgraced by silenced voices or broken heads.
Although the majority of the leading geologists of the time were unconvinced by Wegener’s theory, and no doubt cautioned their students against it, it was not suppressed and forbidden as ‘heresy’. There were several set-piece public debates and conferences on the subject, and books and papers supporting Wegener’s interpretation continued to be published. It is likely that some of the protagonists did not fare quite so well in their academic careers as hindsight would now consider deserving; but when, eventually, new evidence from rock magnetism vindicated Wegener’s bold and imaginative hypothesis, the ‘old gang’ were not swept into scholarly oblivion by the ‘revolutionary’ supporters of the new orthodoxy of plate tectonics.
This truly remarkable and civilized behavior amongst scientists we take for granted: these are the standards against which occasional pathologies are judged. And if those who rule society—aristocrats or democrats, capitalists or socialists, conservatives or radicals—want scientific knowledge on which they can rely, they must not allow the inner tension of science to slacken, break, or overbalance.
According to the narrow logic of bureaucratic planning, it is a wasteful, irrational system that ought to be made efficient and economical. But by encouraging innovation, yet conserving past achievement, by calling the gambling competitive spirit from each of us, yet making us also the guardians of truth and the judges of quality, it is remarkably successful as the source of many wonders.
......# A 'modified' debate over GMOs
Julie Thayer
Posted: 4/26/06
Is it safe to eat genetically modified foods (GMOs)? Will they be destructive to the environment? Are GMOs the answer to world hunger? These questions remain largely unanswered as the debate over genetically modified organisms continues to rage.
People all along the political spectrum alternatively champion their potential and castigate their pitfalls. It's an important debate, but before jumping into the turbulent, scientific waters, you'll need to learn the basics...
A GMO is any living organism - plant or animal - that has genetically altered genes, resulting from the combination of DNA molecules from more than one species. This process is called genetic engineering, and is an example of biotechnology.
Although it sounds like science-fiction, we regularly come into contact with products of biotechnology in our daily lives. It is used to brew beer, produce antibiotics, and improve food crops and livestock through breeding.
But with the technology in its relative infancy and the long-term consequences still unclear, some experts want developers of GMO technology to wait until more research is conducted before unleashing a potential hazard into the world.
Others stress that the technology is safe and that the path should be cleared immediately as they believe GMOs are an important humanitarian tool and could bring life-saving benefits to the developing world.
Despite opposition, many food crops have already been genetically modified. Currently, the majority of genetically modified food crops are grown in the United States (note that many European countries refuse to import GMOs as they feel their safety has not been fully verified).
According to the Pew Initiative on Food and Biotechnology, in 2004, 45 percent of corn, 85 percent of soybeans and 76 percent of cotton being grown in the United States were GMOs.
GMO technology is used to increase shelf life of crops and provide resistance to drought, disease, pesticides and herbicides. By increasing resistance to insects and drought, supporters of GMOs believe that adoption of the technology by developing countries could lead to increased crop yields. Such an increase in food availability, they argue, could potentially combat hunger... continues at link.
.....# Readable summary about Food Safety Testing
......# Home page
......# Papers on GMOs
Africa Harvest
Africa Harvest has a new Biofortification Programme, financed by the Bill and Melinda Gates Foundation. Here a snapshot on the Africa Harvest activities taken from their website: http://www.ahbfi.org/. Inside you will find more information about the SuperSorghum project, which makes good progress in its first year. See in the websites for contact addresses.
http://supersorghum.org/
......# Africa Harvest: A Snapshot
Africa Harvest Biotech Foundation International (AHBFI) is incorporated in the United States as a non-profit organization that is dedicated to using technology as a tool to fight hunger, malnutrition and poverty in Africa. The foundation’s headquarters is located in Nairobi, Kenya and there are operational offices in Johannesburg, South Africa and Washington D.C., United States.
Africa Harvest’s plan is to implement needs-driven programs and provide practical solutions to challenges facing resource-poor smallholder farmers in rural communities. The Foundation believes in undertaking projects that focus on the Whole Value Chain (WVC) Strategy, which it has developed and refined, over the years. The uniqueness of the WVC Strategy is that it looks at agricultural products and projects through an inverted pyramid; this means that an end user or customer is identified before focusing on issues such as agricultural production (inputs such as seedlings, fertilizers and water), product distribution and marketing. This way, project beneficiaries are able to make money from the sales of whatever is produced in excess of home consumption requirements.
Africa Harvest’s strength is derived primarily from the expertise of its core staff in consortium building; capacity building; planning, design, implementation, monitoring and evaluation of development projects; and includes the implementation of socio-economic impact studies. Its institutional expertise is best utilized through on-the-job training and mentoring of others to implement the projects together.
Moreover, owing to its Pan-African focus, the Foundation has indigenous knowledge, cultural understanding and a trusted relationship with African leaders, farmers and international organizations. As a result, Africa Harvest is seen as a sincere and honest partner in the cause of poverty and hunger alleviation.
......# Super Sorghum.
......# Safety of Genetically Engineered Foods: Approaches to Assessing Unintended Health Effects, Committee on Identifying and Assessing Unintended Effects of Genetically Engineered Foods on Human Health, National Research Council (2004)
.....# Link to readinding the above report on-line for free.
......# Genetically Modified Pest-Protected Plants: Science and Regulation (2000) Board on Agriculture and Natural Resources (BANR)
......# Ecological Monitoring of Genetically Modified Crops: A Workshop Summary (2001)
......# Field Testing Genetically Modified Organisms: Framework for Decisions (1989)
......# Biological Confinement of Genetically Engineered Organisms (2004) Committee on the Biological Confinement of Genetically Engineered Organisms, National Research Council
Australian Government Office of the Gene Technology Regulator
......# Webpage
Agbioview
......# The Safety of Foods Produced Through Biotechnology
......# Comments from CS Prakash, Agbioview Newsletter 22 March 2006:
One of the myths perpetuated by activists opposed to GM crops in tricking the gullible public and media is this bogus assertion that 'biotech crops do not reduce pesticide use'.Various studies show significant reduction in pesticide usage due to biotech crop adoption. See reports by USDA ( http://www.ers.usda.gov/publications/aer810/aer810fm.pdf ) and also the National Center for Food and Ag Policy which says that "biotechnology-derived crops planted in 2004 reduced the use of pesticides in crop production by 62.0 million pounds. This represents a further 34% decrease in pesticide usage compared with 2003.
http://www.ncfap.org/whatwedo/pdf/2004ExecSummaryA.pdf
Much of the confusion and distortion arises because of the diverse types of pesticides and herbicides with varying levels of toxicity being used. Farmers are now switching to safer, less-toxic herbicides because of the herbicide-tolerant GM crops. See USDA's document "Genetically Engineered Crops: Has Adoption Reduced Pesticide Use?" from year 2000:
http://www.ers.usda.gov/publications/agoutlook/aug2000/ao273f.pdf
Further, in countries such as China farmers planting Bt cotton have reported 80% reduction in pesticide usage and fewer hospital visits due to pesticide poisonings.
Society of Toxicology
September 25th, 2002
Executive Summary
The Society of Toxicology (SOT) is committed to protecting and enhancing human, animal and environmental health through the sound application of the fundamental principles of the science of toxicology. It is with this goal in mind that the SOT defines here its position on the safety of foods produced through biotechnology (genetic engineering). These products are commonly termed genetically-modified foods, but this is misleading since conventional methods of microbial, crop and animal improvement also produce genetic modifications and these are not addressed here.
1. There is no reason to suppose that the process of food production through biotechnology leads to risks of a different nature than those already familiar to toxicologists or that cannot also be created by conventional breeding practices for plant, animal or microbial improvement. It is therefore important to recognize that it is the food product itself, rather than the process through which it is made, that should be the focus of attention in assessing safety.
2. We support the use of the substantial equivalence concept as part of the safety assessment of biotechnology-derived foods. This seeks to establish whether the new food is significantly different from existing foods that are generally considered to be safe for consumers, and it provides critical guidance as to the nature of any increased health hazards in the new food. To establish substantial equivalence, it is necessary to conduct extensive comparative studies of the chemical composition, nutritional quality, and levels of potentially toxic components in both the engineered and conventional crop or animal. Any notable differences between the existing and new organism would require further evaluation to determine whether there is a likely to be a higher level of risk from the consumption of the foods derived from the engineered form. Through this approach, the safety of current biotechnology-derived foods compared to their conventional counterparts can be assessed with reasonable certainty using established and accepted methods of analytical, nutritional and toxicological research.
3. Extensive studies of this type have established that the level of safety to consumers of current genetically engineered foods is likely to be equivalent to that of traditional foods. Verified records of adverse health effects are absent, although the current passive reporting system probably would not detect minor or rare adverse effects.
4. The changes in composition of existing foods produced through biotechnology are slight. Assessing safety may be more difficult in the future if genetic engineering projects cause more substantial and complex changes in a foodstuff. Toxicologists are currently limited in their ability to assess the risks presented by complex mixtures, and they have not yet developed methods by which whole foods (as compared to single chemical components) can be fully evaluated for safety. Progress also needs to be made in developing definitive methods for the identification and characterization of proteins that are potential allergens and this is currently a major focus of research. A continuing evolution of toxicological methodologies and regulatory strategies will be necessary to ensure that the present level of safety of biotechnology-derived foods is maintained in the future.
Conclusions
1. The responsibility of toxicologists is to assess whether foods derived through biotechnology are at least as safe as their conventional counterparts and to ascertain that any levels of additional risk are clearly defined. In achieving this, it is important to recognize that it is the food product itself, rather than the process through which it is made that should be the focus of attention. In assessing safety, the use of the substantial equivalency concept provides guidance as to the nature of any new hazards.
2. There is no reason to suppose that the process of BD food production leads to hazards of a different nature than those already familiar to toxicologists. The safety of current BD foods compared to their conventional counterparts can be assessed with reasonable certainty using established and accepted methods of analytical, nutritional and toxicological research.
3. A significant limitation may occur in the future if transgenic technology results in more substantial and complex changes in a foodstuff. Toxicologists are currently limited in their ability to assess the hazard presented by complex mixtures, and have not yet developed methods by which whole foods (as compared to single chemical components) can be fully evaluated for safety. Progress also needs to be made in developing definitive methods for the identification and characterization of protein allergens and this is currently a major focus of research.
4. The level of safety of current BD foods to consumers appears to be equivalent to that of traditional foods. Verified records of adverse health effects are absent although the current passive reporting system would probably not detect minor or rare adverse effects . However, this is no guarantee that all future genetic modifications will have such apparently benign and predictable results. A continuing evolution of toxicological methodologies and regulatory strategies will be necessary to ensure that this level of safety is maintained.
***
Food and Chemical Toxicology
Volume 42, Issue 7 , July 2004, Pages 1047-1088
Safety Assessment, Detection and Traceability, and Societal Aspects of Genetically Modified Foods European Network on Safety Assessment of Genetically Modified Food Crops (ENTRANSFOOD)
Assessment of the safety of foods derived from genetically modified (GM) crops
A. König, A. Cockburnb, R. W. R. Crevelc, E. Debruyned, R. Grafstroeme, U. Hammerlingf, I. Kimberg, I. Knudsenh, H. A. Kuiperi, A. A. C. M. Peijnenburgi, A. H. Penninksj, M. Poulsenh, M. Schauzuk and J. M. Wall
AbstractThis paper provides guidance on how to assess the safety of foods derived from genetically modified crops (GM crops); it summarises conclusions and recommendations of Working Group 1 of the ENTRANSFOOD project. The paper provides an approach for adapting the test strategy to the characteristics of the modified crop and the introduced trait, and assessing potential unintended effects from the genetic modification. The proposed approach to safety assessment starts with the comparison of the new GM crop with a traditional counterpart that is generally accepted as safe based on a history of human food use (the concept of substantial equivalence). This case-focused approach ensures that foods derived from GM crops that have passed this extensive test-regime are as safe and nutritious as currently consumed plant-derived foods. The approach is suitable for current and future GM crops with more complex modifications. First, the paper reviews test methods developed for the risk assessment of chemicals, including food additives and pesticides, discussing which of these methods are suitable for the assessment of recombinant proteins and whole foods. Second, the paper presents a systematic approach to combine test methods for the safety assessment of foods derived from a specific GM crop. Third, the paper provides an overview on developments in this area that may prove of use in the safety assessment of GM crops, and recommendations for research priorities. It is concluded that the combination of existing test methods provides a sound test-regime to assess the safety of GM crops. Advances in our understanding of molecular biology, biochemistry, and nutrition may in future allow further improvement of test methods that will over time render the safety assessment of foods even more effective and informative.
POISONOUS PLANTS SITES:
......# Cornell
This is a growing reference that includes plant images, pictures of affected animals and presentations concerning the botany, chemistry, toxicology, diagnosis and prevention of poisoning of animals by plants and other natural flora (fungi, etc.).
......# Indiana Plants Poisonous to Livestock and Pets
Cooperative Extension Service, Purdue University
......# Canadian Poisonous Plants Information System
Derek B. Munro
Biological Informatics Specialist
......# FDA Poisonous Plant Database
AFAA
......# Agbiotech: The Ethical Dimension
CDC
......# Report on the Health Implications of Starlink Bt protein Cry9c
Investigation of Human Health Effects Associated with Potential Exposure to Genetically Modified Corn
Executive Summary
On October 25, 2000, the U.S. Food and Drug Administration (FDA) requested technical assistance from the Centers for Disease Control and Prevention (CDC) in investigating adverse event reports (AERs) of human illnesses that were potentially associated with consumption of genetically modified corn products. Prior to these reports, a protein named Cry9c had been inserted into genetically modified StarLink corn; it subsequently and inadvertently was introduced into the human food supply. CDC conducted an epidemiological investigation that included (1) reviewing the AERs, (2) administering questionnaires to all people who experienced adverse health effects and manifested signs and symptoms consistent with allergic reaction, (3) obtaining relevant medical records, and (4) collecting serum samples for temporary banking. The investigation concluded that 28 people had experienced apparent allergic reactions. These people had also reported eating corn products that may have contained Cry9c protein. With the endorsement of U.S. Environmental Protection Agency s Scientific Advisory Panel which convened on November 28, 2000, CDC recommended that the banked serum samples be evaluated to see if they contained evidence of an allergic response to the Cry9c protein.
An FDA laboratory developed an enzyme-linked immunosorbent assay (ELISA) method to detect antibodies to the Cry9c protein. CDC sent coded serum samples to FDA for analysis, including serum samples from the affected people and historically banked serum samples collected before Cry9c entered the food supply. CDC also sent serum samples from people identified as being highly sensitive to a variety of allergens. The ELISA method found that none of the CDC-submitted samples reacted in a manner consistent with an allergic response to the Cry9c protein.
These findings do not provide any evidence that the reactions that the affected people experienced were associated with hypersensitivity to the Cry9c protein. The difficulties of this investigation highlight the importance of evaluating the allergic potential of genetically modified foods before they become available for human consumption
Council for Biotechnology Information
......# Discussion of Substantial Equivalence Concept.
Substantial equivalence," or SE, is an internationally recognized standard that measures whether a biotech food or crop shares similar health and nutritional characteristics with its conventional counterpart. Biotech foods that are substantially equivalent have been determined to be as safe as their conventional counterparts. Products that are not substantially equivalent may still be safe, but must undergo a broader range of tests before they can be marketed.
AgCare Fact Sheet FS008.
FAO/WHO. 1996. Biotechnology and Food Safety. No. 61. Report of a Joint FAO/WHO Consultation. Rome, Italy.
FAO/WHO. 2000. Safety Aspects of Genetically Modified Foods of Plant Origin. Report of a Joint FAO/WHO Consultation, WHO. Geneva, Switzerland.
OECD
......# LMOs and the Environment: An International Conference, Raleigh-Durham, the United States, 27-30 November 2001
......# Consensus Documents for the work on the Safety of Novel Foods and Feeds
......# Consensus Documents for the Work on Harmonisation of Regulatory Oversight in Biotechnology
.......# Safety Evaluation of Foods Derived by Modern Biotechnology: Concepts & Principles.
......# GM Food Safety - Facts, Uncertainties, and Assessment (pdf,English)
01-Jan-2000 Reports from the OECD Edinburgh Conference on the Scientific and Health Aspects of Genetically Modified Foods and the OECD Consultation with Non-governmental Organisations on Biotechnology and Other Aspects of Food Safety.
......# Modern Biotechnology and the OECD (pdf,English)
07-Jun-1999 Scientific understanding of how living things are put together and how they grow and develop based on instructions coded in their DNA is advancing rapidly. The knowledge already acquired and being accumulated.
Pew Initiative on Food and Biotechnology
......# Research, Articles
......# Ethics , Public Opinion
Food Standards Australia and New Zealand
......# Publications
European Food Safety Organisation
The Plant Journal
......# Review of GM food safety 2001
......# Golden Rice and Beyond
University of Florida
......# Biotechnology Risk Assessment Data: Facts and Conclusions
GMO Pundit Links (Partial)
......# Natural Genetic Engineering is commonplace in conventional food crops and important for their vigour.
......# Cancer Distraction.
......# Direct evidence for high genetic variability of conventional food crops.
......# Tryptophan safety.
......# David Schubert and allegations of Biotech Fraud.
......# Fedoroff discusses Pusztai claims.
......# CSIRO Pea project risk discussions.
......# Collected scare stories (JIGMOD) with rebuttals.
......# Does farming harm health?
......# Are non-GM potatoes Bad for You too?
......# Farm Productivity Improvements important for Developing Countries
......# Harm from Delays.
......# Challenges of Future Rice Demand.
......# Strict Liability as a Tool to Stop Innovation.
......# Water Wars but Plenty of Food?
......# Gene Theft.
......# Benefits of Herbicide Tolerant Maize in Africa.
......# Improved Farm Efficiency Saves Land and Water.
......# Breaking the Cone of Silence on Genetic Risks.
......# What is JIGMOD and what is its Scientific Basis?
......# Pesticide levels in GM cropping
......# The narrow depressing view of biotechnology versus the imaginative happy perspective
......# Genetic Roulette, Jeffrey Smith.
......# Ban Terminator is ultimate insult to farmer' s intelligence.
......# GURTS, Terminators and crop coexistence.
......# Terminator Technology Unused.
......# Farming Utopia.
......# Unethical Public Debate by The Independent UK about Bjorn Lomborg. The Ends Justifying the Means.
......# Seed donation by Monsanto to Malawi farmers.
......# Concept to engineer male sterility in conifers-risk assessment from ISB.
......# Don't trust Mother Nature.
......# Risks of cisgenic (GM-lite) plants part1.
......# Risks of cisgenic (GM-lite) plants part2.
......# Issue of the "Precautionary Principle" Volume 4 - Issue 1 - 2002
Table of Contents
Pages Title and authors
1-3 Biotechnology and the precautionary principle
Calestous Juma, Derya Honca
18-33 Assessing the precautionary principle in the regulation of genetically modified organisms
Edward Soule
34-45 Biotechnology and the precautionary principle: right question, wrong answer
Gary E. Marchant
4-17 From principle to action: applying the precautionary principle to agricultural biotechnology
Katherine Barrett, Carolyn Raffensperger
46-60 The precautionary principle and biotechnology
Julian Morris
61-80 Negotiating the precautionary principle: regulatory and institutional roots of divergent US and EU positions
Ariane Konig
81-95 An ethical analysis of the precautionary principle
Marc A. Saner
96-114 A European innovation system in pharmaceuticals?
Jeremy Howells
Environmental Health Perspectives Journal
......# Genetically Modified Foods: Breeding Uncertainty
Public Library of Science Biology.
......# Scientific Illiteracy and the Partisan Takeover of Biology
Liza Gross
...continuesAmericans have long been ambivalent about science. Conflicting attitudes toward science are not uncommon among industrialized countries—Canadians, Europeans, and Japanese, for example, also appreciate the benefits of science but worry about potential impacts on society. What sets Americans apart is that their reservations center primarily around religion. And now, as the United States struggles to maintain its undisputed position as world leader in science and technology, religious ideology has spilled over into the public sphere to a degree unmatched in other industrialized societies. Religious groups are turning scientific matters like stem cells and evolution into political issues.
Though some see the growing influence of ideology over scientific issues as a threat to America's standing as global science leader, a leading analyst of public attitudes toward science sees it as an opportunity for increasing scientific literacy. “Even though the scientific community can feel besieged by this anti-science sentiment,” says Jon D. Miller, who directs the Center for Biomedical Communications at Northwestern University Medical School, “most people really haven't made up their mind about this issue and, in fact, really haven't even thought about it.” Rather than fretting about the cultural divide—or worse, doing nothing—Miller urges scientists to do their part to bridge the gap.
Since 1979, the proportion of scientifically literate adults has doubled—to a paltry 17%.
Miller has devoted his 30-year career to studying public understanding of science and technology and its implications for a healthy democracy. To possess what Miller calls civic scientific literacy, one must have the capacity to make sense of competing arguments in a scientific debate. Over the year leading up to the 2004 US election, Miller polled a national panel of adults to track their grasp of the ongoing debate about stem-cell research. A year before the election, over a third of adult respondents had never heard the term, even though the issue had dominated the headlines. By the eve of the election, only a few more respondents said they had heard about stem cells. How could so many people manage to remain oblivious to one of the most contentious issues of the election?
Most people don't have a cognitive framework for understanding stem cells, Miller explains. “Science happens so fast now that most adults couldn't possibly have learned about stem cells when they were in school.” And without this underlying schema, most people aren't going to pay attention to stem cells or any other unfamiliar scientific term. “People tune out things that they think are scientific or complicated,” he says. “If you are science averse and think you couldn't possibly know any science, the minute you hear ‘cell,’ ‘stem cell,’ ‘nanotechnology,’ ‘atomic,’ ‘nuclear,’ you turn the off switch.”
Jon D. Miller hopes that scientists will become politically engaged and oppose candidates who attack scientific research
As time went on, more people said they had a good understanding of stem cells—21% in 2004, up from 9% in 2003—but only 9% of respondents could define the term when asked, compared with 8% in 2003. And, surprisingly, the number of voters with strong opinions dropped significantly. A year before the election, 17% were opposed—“likely reflecting the influence of religious groups”—and 15% were in favor. As discussions raised distinctions between adult and embryonic stem cells and between morality and scientific benefits, most people realized the issue was more complex than they had originally thought. “At the end of the election, only 2% were strongly opposed and only 2% were strongly in favor,” Miller says. “It shows that a little bit of scientific literacy won't solve the problem when you have a debate.”...
To gauge the extent of fundamentalism's reach into American life, Miller evaluated adults' responses to three statements: the Bible is the actual word of God and is to be taken literally; there is a personal God who hears the prayers of individual men and women; and human beings were created by God as whole persons and did not evolve from earlier forms of life. In 2005, 43% of American adults agreed with all three statements.
“The age of nonpartisan science is gone.”
The era of nonpartisan science is gone, says Miller, who urges scientists and science educators to learn the rules of this new game and get behind moderate Republicans as well as Democrats to protect the practice and teaching of sound science. Given the partisan attack on evolution and stem-cell research, he thinks scientists need to learn more about how the political process works. They need to be willing to run for the school board, write $500 or even $5,000 checks to support moderate candidates, and defeat Christian right-wing candidates. “Scientists need to become involved in partisan politics and to oppose candidates who reject evolution or attack scientific research,” he says. “It takes time, money, and paying attention to the issues.”
Liza Gross is Science Writer for the Public Library of Science. E-mail: lgross@plos.org
Funding. The author received no specific funding for this article.
Published: April 18, 2006
DOI: 10.1371/journal.pbio.0040167
Copyright: © 2006 Liza Gross. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.
Citation: Gross L (2006) Scientific Illiteracy and the Partisan Takeover of Biology. PLoS Biol 4(5): e167
Let Them Eat Precaution: How Politics Is Undermining the Genetic Revolution in Agriculture - Edited by Jon Entine, AEI Press, 2006, $25"
......# How many children in the developing world have to die?
......# How politics in undermining agricultural research
Rob Wager Department of Biology
Malaspina University-College
900 Fifth Street
Nanaimo, B.C., V9R 5S5
Canada
......# Food Biotechnology: GM/GE/LMO
Food biotechnology is also known as genetically modified (gm) food or genetically engineered (ge) food or living modified organisms (lmo). Regardless of which term one uses it is food products that have been modified with recombinant DNA technologies. Modifying plant DNA is not new. Man has been modifying plant DNA for thousands of years. This group of techniques is far more precise than any method of plant breeding used in history. Critics have claimed products of these technologies are very dangerous. But the research says something completely different.
Twenty plus years of research has shown these products offer tremendous environmental benefits (tens of millions of pounds of insecticides not used each year). Greater yield on less land is a well-documented benefit of these crops. Every food biotechnology product is extensively evaluated for safety BEFORE it is allowed to be commercialized. Not a single case of harm has been documented after over two trillion (million million) meals.
Food biotechnology is not a panacea. It will not solve the worlds’ agricultural problems by itself. Nor is it the evil creation some would have the public believe. However, food biotechnology will become one of the main tools to combat the upcoming global water shortage, salinization of soil and pressures from the increasing human population.
A great deal of the web-based information on this subject is inaccurate, misleading or blatantly false. This site provides links to world experts in agriculture, health and science to allow the public easy access to accurate information.
The debate on this issue will not go away anytime soon. It is important for the public to learn what is real and what is pseudo-science as public policy based on pseudo-science is bad public policy.
Education is Power
EFSA
......# Opinion of the Scientific Panel on Genetically Modified Organisms on the use of antibiotic resistance genes as marker genes in genetically modified plants. (Question N° EFSA-Q-2003-109)
Opinion adopted by the GMO Panel on 2 April 2004, Last updated: 19 April 2004
Summary, Full opinion in pdf form is downloadable.Directive 2001/18/EC (EC, 2001) states that Member States and the Commission shall ensure that GMOs which contain genes expressing resistance to antibiotics in use for medical or veterinary treatment are taken into particular consideration when carrying out an environmental risk assessment. This is with a view to identify and phase out antibiotic resistance marker genes (ARMGs) in GMOs which may have adverse effects on human health and the environment.
The Scientific Panel on genetically modified organisms (GMO Panel) of the European Food Safety Authority (EFSA) has evaluated the potential risks associated with specific ARMGs taking into account their current usage in clinical and veterinary medicine, the likely occurrence of horizontal gene transfer from genetically modified (GM) plants to microbes and the potential impact of horizontal gene transfer where naturally occurring resistance to the relevant antibiotics exists in the microbial gene pool. These factors will impact on the likelihood of any adverse effects on humans or the environment of ARMGs used in GM plants.
The GMO Panel considers the frequency of horizontal gene transfer from GM plants to other organisms as very low for all ARMGs considered. This, in itself, is an important consideration with regard to any risk posed by the use of ARMGs. However, with respect to clinical importance the Panel has categorised ARMGs into three groups with different potentials for compromising human health and the environment. ARMGs in the first group include genes conferring resistance to kanamycin and hygromycin. In this group the nptII gene, which confers kanamycin resistance, has a 13-year history of safe use in food crops and resistance to this group of antibiotics is widespread in naturally occurring microbes in humans and the environment. The Panel is of the opinion that with regard to safety there is no rationale for inhibiting or restricting the use of genes in this category, either for field experimentation or for the purpose of placing on the market. The second group of ARMGs, which includes resistance to chloramphenicol, ampicillin, streptomycin and spectinomycin, should be restricted to field trial purposes and should not be present in GM plants to be placed on the market. Given their current importance in clinical usage, the GMO Panel recommends that ARMGs placed in the third group, which includes those conferring resistance to amikacin and tetracyclines, are not present in GM plants to be placed on the market or in plants used for experimental field trials.
Information Systems for Biotechnology News Report
CropLife International
http://www.isb.vt.edu/news/2006/news06.may.htm#may0605
......# Database of the benefits and safety of biotechnology
May 16, 2006CropLife International is making publicly available a database of published papers and reviews demonstrating the benefits and safety implications associated with the use of agricultural biotechnology products.
Agricultural biotechnology today is realizing economic, environmental, health, and social benefits for farmers and society in both industrial and developing countries. In 2004, 8.25 million farmers in 17 countries planted biotech crops – 90 per cent in developing countries. While studies recording, demonstrating, and quantifying these benefits exist, they can be difficult to locate and access.
The purpose of this database is to enable you quickly and easily to locate and access credible scientific information about the demonstrated benefits associated with the use of agricultural biotechnology products, and about their safety.
The database provides access to a selection of quality studies that highlight the global benefits of these products. The full list of papers is accessible for download.
European Policy Forum
......# INTERNATIONAL NGOs: AN INTERNATIONAL CODE OF CONDUCT. pdf
AN APPROACH PAPER.
By Frank Vibert
MARCH 2006.
Background
Over the last three years EPF has worked with various partners to discuss issues for democratic societies and for international governance raised by the role played by NGOs. In themselves, NGOs are neither good nor bad for democratic standards of governance – it all depends on how they play their role. What the discussions have aimed to illuminate is whether there are standards emerging from within the NGO movement itself, or from other sources, that can help define how that role should be played.
There are four main reasons for focussing on the questions of standards of behaviour. The first reason is to clarify how the norms of NGO behaviour fit within the norms of rule-based democratic systems of government. At the most general level the norms are those of free speech and right of peaceful association and assembly. The diverse, spontaneous and voluntary nature of the NGO movement exemplifies this aspect of democratic systems of government. However, more difficult questions are raised by the deep involvement of NGOs in both policy formation and policy delivery in modern systems of governance. Here the issue is not the general one about freedom of expression and association but the more precise one about how norms relating to regulatory governance impact NGOs.
Secondly, the related standards of governance – both in the private sector and in government have been changing quite rapidly and this presents a challenge to the NGO of the future. Currently, many of the large international NGOs ‘blend’ the roles they perform. They are both advocates and doers. They both argue for a cause and they deliver practical services. They act both as ‘outsiders’ mobilising grass roots support against government and business and as ‘insiders’ acting in close conjunction with government departments, international organisations and multinational business.2 The question is whether there are standards that will enable these different roles to continue to be combined or whether NGOs will increasingly be forced to choose between roles.
The third reason to look at standards is that there seems to be a gap in the development of standards at the international level. In a national context relevant standards often exist – for example those that govern not-for-profit organisations. At an international level, standards are much less clear. In relating to NGOs, each international organisation has tended to go its own way. Similarly, multinational corporations, often the target of NGO activity, have also tended to try to strike their own bargains with NGO interlocuters. NGOs themselves that operate across borders are beginning to develop their own standards, but it is not clear how well they tie into related norms of behaviour – either corporate or governmental.
Finally, the emergence of internationally agreed standards could help all the actors involved – governments and international organisations, businesses and NGOs themselves – to develop more predictable and reliable relationships. NGOs operate in a more questioning environment and are very much aware that reputational risk applies to all actors including themselves. International organisations and governments offer a variety of practices from the funding of NGOs, to accreditation, to exclusion. A variety of treatments may well be desirable but it also reflects great uncertainty about what is or is not appropriate... continues at link.
SciDev.net
......# Opinions about Agriculture. 28 April 2006
Arnoldo Ventura, science advisor to the prime minister of Jamaica, recently argued that a UN agreement intended to protect biodiversity from the potential threats posed by genetically modified (GM) organisms is wasteful and unnecessary (see Do we still need the Cartagena Protocol?).
Here, SciDev.Net readers from around the world respond to Ventura's criticism of the Cartagena Protocol on Biosafety. The opinions expressed do not necessarily reflect those of the individuals' institutions.
Hubert Zandstra, emeritus director general, International Potato Center (CIP), Peru
Too often, the environmental benefits of GM crops are ignored. Farmers growing them can substantially reduce their use of farm chemicals, whose threats to human health and the environment are increasingly well documented. Using conventional breeding approaches instead of GM technology to develop pest-resistant crops is not easy.
One area of continued concern is the impact of gene flow from GM crops to traditional varieties and wild relatives in regions where our major food crops originated. These dangers can be managed with practical protocols and constant vigilance.
Martin Livermore, consultant, Cambridge, United Kingdom
We have to get our priorities right: why continue to spend more time and effort on an issue when earlier concerns about GM have been shown to be unjustified, and when developing countries could be concentrating on using their genetic resources for the benefit of their citizens? International agreements such as the Cartagena Protocol foster bureaucracy and processes that are hard to stop. There are better ways to use our energies and resources than waste them pursuing the sterile path of the biosafety protocol.
Kavitha Kuruganti, Centre for Sustainable Agriculture, Secunderabad, India
While it is true that farmers and consumers in developing countries are yet to get involved in an informed debate on this matter, it is wrong to conclude that people are indifferent to it given that most countries have rejected GM technology.
Any new agricultural technology applied on a large scale in a developing country could have massive implications for poor farmers. Case-by-case assessments of GM technologies should therefore be broad, independent and scientifically robust, so that any negative effects are detected before it is too late. Research should include post-release monitoring when GM crops are first grown commercially. Such monitoring is almost non-existent and where it exists, it is extremely unscientific.
This is why there is a need to talk about strengthening biosafety regimes and why, more than ever, an international convention that regulates the movement of GM products across international borders is so relevant.
Merete Albrechtsen, Danish Institute of Agricultural Sciences, Denmark
Far too many resources are spent on fruitless discussions and meaningless experiments regarding GM safety. These resources should be used to implement biotechnology for the benefit of everyone.
Josias Corrêa de Faria, National Rice and Beans Research Center, Brazil
GM technology has been treated with the same kind of suspicion as nuclear weapons. While safety is important, there is no need for panic. After ten years of intensive research and growing GM crops, there is now strong evidence that genetic engineering is as safe as any genetic manipulation achieved through traditional crop breeding in the past. In Brazil, a lack of public understanding of GM technology is the main barrier to its acceptance.
Maria Scurrah, president, Grupo Yanapai, Peru
Saying that 8.5 million farmers in 21 countries grow GM crops hides the fact that most of these farmers are in Argentina, Canada and the United States. The really interesting country to watch is China, whose GM varieties are better suited to local conditions than are those of multinational corporations in other poor nations.
GM crops may make farming easier by reducing the impacts of weeds and insect pests, but this does not necessarily make farming better or more sustainable. Herbicides used with GM crops are poisonous to animals such as frogs that play a key role in agricultural ecosystems, so it is still important to monitor the technology's ecological impacts.
Gabriel Melchias, head of the Department of Biotechnology, St Joseph's College, Tiruchirappalli, India
Argentina and the United States, both leading exporters of GM products, deny the Cartagena Protocol legitimacy by refusing to ratify it. But this does not undermine the agreement's validity or relevance. The lack of evidence of harm caused by GM crops does not imply that they are totally safe. If multinational companies are so sure there is no safety issue, why are they reluctant to label GM products as such?
Symon Mandala, senior science and technology officer, Ministry of Industry, Science and Technology, Malawi
The Cartagena Protocol is both irrelevant and obsolete. Instead, resources must be channelled into building scientific capacity in developing countries. This would help them to make informed decisions on GM technology and to harness and safely manage modern biotechnology to meet the challenges of development.
We need a better, more harmonised approach with a clear direction and timeframe to resolve concerns about modern biotechnology. Policymakers should base their decisions based on scientific data. Unfortunately, the debate seems to be dominated by politicians and other groups who choose to ignore scientific evidence.
Jaroslav Drobník, Faculty of Science, Charles University, Prague, Czech Republic
The 'biodiversity' rhetoric surrounding the Cartagena Protocol is just a populist cover for efforts to protect agricultural markets. Many non-GM crops developed using other methods pose even greater risks to biodiversity but we tolerate them because their benefits outweigh these risks. Salt tolerant rice varieties have been introduced in Asia, the centre of rice diversity. Mutant genes could spread to other varieties or wild relatives, potentially creating invasive, salt-tolerant weeds. There are clear risks to biodiversity but nobody is concerned because politicians take no interest in it.
David Garrido, biologist, Mexico
If the Cartagena Protocol is the only tool we have to stop multinational companies from controlling the world's crops, it is still useful, even if it is dominated by politics and emotion.
There are alternatives to using GM crops to make poor nations less dependent on rich nations. Here in Mexico we grow many organic crops that need no chemical inputs and can be sold for good profits.
Transgenic Research
......# A comparative risk assessment of genetically engineered, mutagenic, and conventional wheat production systems
Robert K.D. Peterson* & Leslie M. Shama
Agricultural and Biological Risk Assessment, Montana State University, 334 Leon Johnson Hall, Bozeman, MT,59717-3120, USA
Key words: biotechnology, genetically engineered crops, GMO, herbicide exposure, herbicide toxicity,protein risk
AbstractWheat (Triticum aestivum L.) varieties produced using modern biotechnologies, such as genetic engineering and mutagenic techniques, have lagged behind other crop species, but are now being developed and, in the case of mutagenic wheat, commercially grown around the world. Because these wheat varieties have emerged recently, there is a unique opportunity to assess comparatively the potential environmental risks (human health, ecological, and livestock risks) associated with genetically engineered, mutagenic, and conventional wheat production systems. Replacement of traditional herbicides with glyphosate in a glyphosate-tolerant (genetically engineered) wheat system or imazamox in an imidazolinone-tolerant (mutagenic) wheat system may alter environmental risks associated with weed management. Additionally, because both systems rely on plants that express novel proteins, the proteins and plants themselves may
Misuse of the "Precautionary Principle" often omits giving proper weight to the harm of stopping innovation. Scaremongering is not Harm Free.
impose risks. The purpose of our study was to examine comparatively the multiple aspects of risk associated with different wheat production systems in the US and Canada using the risk assessment paradigm.
Specifically, we used tier 1 quantitative and qualitative risk assessment methods to compare specific environmental risks associated with the different wheat production systems. Both glyphosate and imazamox present lower human health and ecological risks than many other herbicides associated with conventional wheat production systems evaluated in this study. The differences in risks were most pronounced when comparing glyphosate and imazamox to herbicides currently with substantial market share. Current weight-of-evidence suggests that the transgenic CP4 EPSPS protein present in glyphosate-tolerant wheat poses negligible risk to humans, livestock, and wildlife. Risk for mutated AHAS protein in imidazolinonetolerant
wheat most likely would be low, but there are not sufficient effect and exposure data to adequately characterize risk. Environmental risks for herbicides were more amenable to quantitative assessments than for the transgenic CP4 EPSPS protein and the mutated AHAS protein. Email: bpeterson-AT-montana.edu
The following links bring together some examples of this effect.
......# Bad science plus scaremongering causes measles.
......# Unintended adverse consequences of hastly anti-GM laws.
......# Benefits from GM protection against mycotoxins are left out of policy debate.
......# Anti-GM activism ignores what's best for children- better oral rehydration therapy.
The Unintended Costs of Saying No were realised by William Blake in 1790.
......# William Blake through Virginia Postrel and Freeman Dyson
Regulatory slowdown on GM crop decisions
19.jul.06
Nature Biotechnology, Vol. 24 No. 7, 748 July 2006
Greg Jaffe
To the editor: The speed of regulatory decision-making is an important constraint on the ability of industry to innovate and bring new products to market.
To determine whether the US federal government’s regulation of biotech crops has become more or less efficient and effective over time, I have analyzed eleven years of information from the US Food and Drug Administration (FDA) and the Animal and Plant Health Inspection Service (APHIS) of the US Department of Agriculture about genetically modified (GM) crops that have passed the mandatory or voluntary regulatory hurdles required before a crop can be commercialized in the United States.
The analysis shows that the time it took each agency to reach a regulatory decision more than doubled in the past five years for no explainable reason (see Table 1). That trend should worry those who believe that genetic engineering can be used safely and can benefit farmers, consumers and the environment in the United States, other developed countries and developing countries. Public discourse is needed to understand what factors account for the trends and whether and how they can be reversed.
Three federal agencies--APHIS, FDA and the US Environmental Protection Agency (EPA)--regulate GM crops using existing statutes that govern health, safety and environmental impacts of similar products produced by traditional methods1. I do not consider the EPA registration process here because that regulatory process only covers a small percentage of GM crops, whereas all GM crops go through APHIS and FDA...
...Data from submissions to APHIS involving cotton engineered with a phenotype to be herbicide tolerant also supports the conclusion that the increased length of the review time is not due solely to the potential risks of the product. Three petitions for nonregulated status for herbicide-tolerant cotton were submitted in the 1990s and the APHIS’s granting of those petitions took seven months (Calgene (Davis, CA, USA; now part of Monsanto) no.
93-196-01), five months (Monsanto no. 95-045-01) and four months
(DuPont (Wilmington, DE, USA) 95-256-01), for an average review time of 5.3 months. For the two petitions for similar products after 2000, the APHIS review time was 13 months (Aventis no. 02-042-01) and 9 months (Monsanto no. 04-086-01) for an average review time of 11 months.
Thus, although the US government tells the American public and the rest of the world that its biosafety regulatory system is fair, efficient and science based, in reality that system has become surprisingly slow at making decisions. One would expect that the regulatory pathway for biotech crops in the 21st century would be quicker and easier than in the 1990s for four reasons: first, regulators have become more experienced with products of this new technology; second, there has been no evidence of risks from any of the existing products; third, with fewer products to review between 2001 and 2005 (75% of all GM crops submitted to FDA and APHIS were concluded by 2000)2,3, there should be more agency resources for each product; and fourth, many of the recent products have similar risk profiles to products reviewed in the 1990s.
Even so, the time needed to make a regulatory decision has more than doubled at both APHIS and FDA in the past five years. In fact, this slower approach at APHIS has occurred during a time when APHIS consolidated its resources to regulate GM crops more efficiently and effectively4. APHIS announced almost two years ago that it might be revising its regulatory system for GM crops, but APHIS has not released the proposal to the public5.
Revising APHIS’s regulatory process to make its case-by-case assessment of individual crops a more risk-based system with different regulatory pathways for different potential products would be a start toward making the US biosafety regulatory system more efficient and effective. Both FDA and APHIS need to ensure that all future products receive an efficient review that is proportionate to the potential risks posed by a particular application. GM crops that are not novel and have been engineered with genes already used in previous applications should receive streamlined reviews commensurate with their lower risk so that scarce agency resources could be targeted to novel applications.
On the basis of the analysis in this paper, the US government needs to explain to the public why its ‘science-based’ regulatory system is taking longer to come to decisions about the safety of GM crops. The public wants assurances that federal regulators are ensuring the safety of products and are not considering nonscientific issues in regulatory decisions, which potentially could result in consumers losing confidence in the regulatory process. Similarly, unnecessary regulatory delay hurts developers by increasing uncertainty about the regulatory decision-making process and by increasing the cost of getting a product to market.
It has been 11 years since the first commercialized GM crops, and yet only a small fraction of the potential benefits from this powerful technology have been realized. The trends outlined here need to be analyzed and addressed if future benefits are to be realized. Only with a regulatory system that is efficient, transparent and protective of human health and the environment will the US public garner the benefits (and be protected from the risks) of GM crops.
Note: Supplementary information is available on the Nature Biotechnology website.
Gregory Jaffe, Biotechnology Project, Center for Science in the= Public Interest, 1875 Connecticut Ave., NW #300, Washington, DC
20009, USA. e-mail: gjaffe.at.cspinet.org=
Table 1 Average number of months for US government review and
decision on GM crops Time period- Average number of months USDA
took to approve GM crop petitions for nonregulated status - Average
number of months FDA took to complete voluntary consultations for
GM crops
1994–2005 8.6 8.55
1994–2000 6.1 6.5
2001–2005 15.4 15.2
1. Office of Science and Technology Policy (OSTP) Coordinated framework for regulation of biotechnology products. Fed Register 51, 23302 (1986). 2. http://www.isb.vt.edu/cfdocs/biopetitions1.cfm
3. http://www.cfsan.fda.gov/~Ird/biocon.html 4. United States Department of Agriculture (USDA). Statement: USDA Creates New Biotechnology Unit (http://www.aphis.USDA.gov/lpa/news/2002/08/ bioreorg. html) August 2, 2002. 5. United States Department of
Agriculture (USDA). Animal and Plant Health Inspection Service (APHIS). Fed Register 69, 3271–3272 (2004).
The Truth about Bt Crops in India and Africa.
......# CropLife Article.
Transgenic crops in natural habitats
......# Nature M. J. Crawley, S. L. Brown, R. S. Hails, D. D. Kohn, M. Rees, NATURE | VOL 409, page 682 | 8 FEBRUARY 2001
Although improved crop yields can be engineered by genetically modifying plants, there is ecological concern over whether these plants are likely to persist in the wild in the event of dispersal from their cultivated habitat. Here we present the results of a long-term study of the performance of transgenic crops in natural habitats.
Four different crops (oilseed rape, potato, maize and sugar beet) were grown in 12 different habitats and monitored over a period of 10 years. In no case were the genetically modified plants found to be more invasive or more persistent than their conventional counterparts.
In the late 1980s, there were three conjectural risks associated with genetically modified (GM) crops: that they would become weeds of agriculture or invasive of natural habitats; that the introduced genes would be transferred by pollen to wild relatives, whose hybrid offspring would then become more weedy or invasive; or that GM plants would be a direct hazard to humans, domestic livestock or beneficial wild organisms, for example by being toxic or allergenic. Our study assesses the grounds for the first two of these fears.
Population sizes of all crops declined after the first year as a result of increased competition from native perennial plants. In no case did the GM lines persist for significantly
longer than their conventional counterparts. For oilseed rape, seedling establishment was significantly lower for GM plants compared with conventional lines in six out of 12 cases, and were not significantly greater in any case.
These experiments involved GM traits (resistance to herbicides or insects) that were not expected to increase plant fitness in natural habitats. Our results do not mean that other genetic modifications could not increase weediness or invasiveness of crop plants, but they do indicate that arable crops are unlikely to survive for long outside cultivation.
New Article on Agricultural Biotechnology and Legal Liability
Authors: Stuart J. Smyth & Drew L. Kershen
Title: Agricultural Biotechnology: Legal Liability Regimes from Comparative and International Perspectives
ABSTRACT:
As agricultural biotechnology has become an agronomic alternative, discussion has emerged about what legal liabilities, if any, exists for those who create, distribute, and produce transgenic seeds and crops. Many governments have debated legal liability as related to agricultural biotechnology. In this article, the authors offer fresh insights on legal liability from comparative law and international law perspectives. The article begins by comparing Canadian and American legal liability regimes in agricultural biotechnology. Using this North American comparison as background, the article then discusses liability issues by contrasting the statutory regimes from Denmark and Germany. Once the comparisons and contrasts between Canadian, American, Danish, and German law have been presented, the article focuses on the on-going discussion of legal liability and agricultural biotechnology at the Meeting of the Parties (MOP) of the Cartagena Protocol on Biosafety (BSP). The authors posit that understanding the comparisons and contrasts between Canada, the United States, Denmark, and Germany assists greatly in understanding the issues and debates about legal liability and agricultural biotechnology at the international level in the BSP negotiations.
Citation: Stuart J. Smyth and Drew L. Kershen (2006) “Agricultural Biotechnology: Legal Liability Regimes from Comparative and International Perspectives,” GLOBAL JURIST ADVANCES, Vol. 6, No. 2, Article 3 available at http://www.bepress.com/gj/advances/vol6/iss2/art3
Persons interested in reading or having a full copy of the article should follow the link to the BePress GLOBAL JURIST ADVANCES webpage. On that page, persons can download a “.pdf” version of the article on the right hand side by clicking “View the article.” GLOBAL JURIST ADVANCES is a peer-reviewed on-line electronic journal.
A report out of Switzerland which looks at the environmental impact of GM crops over a 10 year period.
......# According to the site "GM cropping systems must be compared with the
existing alternative: conventional farming. In a large literature study by
Swiss Agroscope Reckenholz-Tänikon Research Station (ART), covering ten
years of research, the conclusion was made that GM crops are at least
similarly safe for the environment."
......# The full report can be accessed at:
http://www.art.admin.ch/dms_files/03017_de.pdf
The Inst. of Food Technologists
......# Scientific Status Summary to update readers on the organic foods industry.
FT Scientific Status Summary - Organic Foods
- Carl K. Winter and Sarah F. Davis, Journal of Food Science Online
Conclusions: The popularity of organic foods continues to grow dramatically: organic foods now constitute more than 2% of all food sales, and sales of organic foods in the United States surpassed $13.8 billion in 2005 (Organic Trade Assn. 2006). Consumers purchasing organic foods may do so for a number of reasons, including perceived benefits to the environment, animal welfare, and worker safety, and the perception that organic foods are safer and more nutritious.
This review discusses the differences between organic foods and conventional foods with respect to food safety and nutritional composition and makes clear that several qualitative differences exist. Organic fruits and vegetables possess fewer pesticide residues and lower nitrate levels than do conventional fruits and vegetables. In some cases, organic foods may have higher levels of plant secondary metabolites; this may be beneficial with respect to suspected antioxidants such as polyphenolic compounds, but also may be of potential health concern when considering naturally occurring toxins. Some studies have suggested potential increased microbiological hazards from organic produce or animal products due to the prohibition of antimicrobial use, yet other studies have not reached the same conclusion. Bacterial isolates from food animals raised organically appear to show less resistance to antimicrobial agents than those from food animals raised conventionally (IFT 2006).
While many studies demonstrate these qualitative differences between organic and conventional foods, it is premature to conclude that either food system is superior to the other with respect to safety or nutritional composition. Pesticide residues, naturally occurring toxins, nitrates, and polyphenolic compounds exert their health risks or benefits on a dose-related basis, and data do not yet exist to ascertain whether the differences in the levels of such chemicals between organic foods and conventional foods are of biological significance.
This review illustrates that tradeoffs exist between organic and conventional food production. Organic fruits and vegetables rely upon far fewer pesticides than do conventional fruits and vegetables, which results in fewer pesticide residues, but may also stimulate the production of naturally occurring toxins if organic crops are subject to increased pest pressures from insects, weeds, or plant diseases. Because organic fruits and vegetables do not use pesticides or synthetic fertilizers, they have more biochemical energy to synthesize beneficial secondary plant metabolites such as polyphenolic antioxidants as well as naturally occurring toxins. In some cases, food animals produced organically have the potential to possess higher rates of bacterial contamination than those produced conventionally since organic production generally prohibits antibiotic use.
The prohibition of antimicrobial agents also explains the apparent lower incidence of antimicrobial resistance in bacterial isolates of organic food animals, as some studies have shown a correlation between increased rates of antibiotic use and increased antimicrobial resistance.
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