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ICMR Wants Overhaul Of GM Foods Regulation

by Ashok B Sharma
Financial Express
July 26, 2004

NEW DELHI, JULY 25: The Indian Council of Medical Research (ICMR) has raised some concerns over the safety of genetically modified (GM) food and has urged for an overhaul of the existing regulatory mechanism.

Citing some particular instances the ICMR study entitled 'Regulatory Regime for Genetically Modified Foods : The Way Ahead', said "the case of GM potatoes experiencing Galanthus nivalis lectin gene for insecticidal properties is an example of the potential of GM foods to cause toxicity. In a group of rats fed with GM potato damage to immune system and stunted growth was observed and the experiment had generated considerable controversy."

In case of the GM rice, soyabean and rapeseed the study said "currently developed plants with improved nutritive value include GM rice with enriched vitamin A and GM soyabean and rapeseed with modified fatty acid. The impact of such intended modification in nutrient level in a crop plants can affect nutritional status of the individual. There is also the potential for unexpected alteration in nutrient as it was observed in the case of GM rice (accumulation of xanthophylls, increase in prolamines). Such changes can affect nutrient profiles resulting in nutritional imbalances in the consumer."

The ICMR study has been circulated among concerned ministries and departments of the government.

The study noted that 73 per cent of the GM crops in the world are developed for herbicide tolerance while 18 per cent are developed for resistance to insects and 8 per cent developed contain both the traits. Only 0.1 per cent of GM crops are for yield improvement and vitamin enrichment. The study cautioned that GM crops for herbicide and pest resistance could have a potential for development of resistance in target organism. "This has been particularly observed in crops developed for insect resistance like cotton. This has resulted in the use of a 'refugia' while cultivating Bt crops. Similarly in the case of herbicide resistance crops like soyabean, a potential for development of superweeds due to spread of herbicide resistance from GM crops to weeds exists," the study said.

In context, the study suggested that more than herbicide resistance, India needs crops resistant to drought, temperature and soil stress and crops for nutritional enrichment, increased productivity and pest resistance. It also said that GM varieties which will eliminate the problem of naturally occuring toxins like the unusual toxic amino acids in Lathyrus satvus are important.

The study also said "although the cultivation of GM crops have been claimed to be profitable to farmers, the impact varies by year, location, crop etc." It cautioned that as modern biotechnology is being increasingly subjected to intetellectual property protection and is being generally developed by private sector companies, this could lead to reduced competition, monopoly of profits and exploitation of small farmers. GM crop production may harm small farmers in the developing countries as imported GM commodities will undercut local production. Modern agriculture biotechnology could lead to increased inequality of income and wealth because large farmers may capture most of the benefits.

The study expressed several other concerns relating to genetic pollution and pollen movement, health safety, allergenicity and potential for gene transfer but in the same breath it said "it is significant to point out that there has been no report of any adverse health effect of GM foods and there are no peer reviewed publications on the health effects of GM foods in humans."

Citing an example of pollen transfer, the study said "the transgenic material from a GM maize cultivated by a farmer can be transferred without the farmers knowledge to a non-GM maize cultivated in the neighbouring field. Such kind of pollen transfer varies with different environmental conditions."

Expressing concerns over health safety, the study said "the use of recombinant DNA technology in the production of GM foods involves transfer of genes from different species into food producing organism. Such a transfer is facilitated along with various regulatory elements obtained from bacterial or viral sources that are required to empower to produce the trait in the host organism. The safety of these components of the genetic construct is not clearly known as they have the potential to induce toxicity, transfer to gut flora or produce unintended effects leading to changes that are relevant from toxicological/nutritional perspective. Specific safety issues associated with GM foods include direct or indirect consequences of new gene product or altered levels of existing gene product due to GM, possibility of gene transfer from ingested GM food and potential adverse effect like allergenicity and toxic effects."

It said that crops modified for insect resistance have been shown to have the potential for allergic response like Sartlink corn. "The allergenicity potential of GM food has often been difficult to establish with existing methods as the transgenes transferred are frequently from sources not eaten before, many have unknown allergenicity or there may be a potential for genetic modification process to result in increase of an allergen already present in the food," the study said.

The study also expressed concern over the possibility of transfer of GM DNA from plant to gut microflora of humans and animals. "Of importance have been the antibiotic resistant genes that are frequently used as selection markers in the genetic modification process. Such genes have the potential to adversely affect the therapeutic efficacy of orally administered antibiotics," it said.


Genetically Engineered Foods May Pose National Health Risk

By Jeffrey M. Smith
July 30, 2004

In a study in the early 1990’s rats were fed genetically modified (GM) tomatoes. Well actually, the rats refused to eat them. They were force-fed. Several of the rats developed stomach lesions and seven out of forty died within two weeks. Scientists at the FDA who reviewed the study agreed that it did not provide a "demonstration of reasonable certainty of no harm." In fact, agency scientists warned that GM foods in general might create unpredicted allergies, toxins, antibiotic resistant diseases, and nutritional problems. Internal FDA memos made public from a lawsuit reveal that the scientists urged their superiors to require long-term safety testing to catch these hard-to-detect side effects. But FDA political appointees, including a former attorney for Monsanto in charge of policy, ignored the scientists’ warnings. The FDA does not require safety studies. Instead, if the makers of the GM foods claim that they are safe, the agency has no further questions. The GM tomato was approved in 1994.

According to a July 27th report from the US National Academy of Sciences (NAS), the current system of blanket approval of GM foods by the FDA might not detect "unintended changes in the composition of the food." The process of gene insertion, according to the NAS, could damage the host’s DNA with unpredicted consequences. The Indian Council of Medical Research (ICMR), which released its findings a few days earlier, identified a long list of potentially dangerous side effects from GM foods that are not being evaluated. The ICMR called for a complete overhaul of existing regulations.

The safety studies conducted by the biotech industry are often dismissed by critics as superficial and designed to avoid finding problems. Tragically, scientists who voice their criticism, and those who have discovered incriminating evidence, have been threatened, stripped of responsibilities, denied funding or tenure, or fired. For example, a UK government-funded study demonstrated that rats fed a GM potato developed potentially pre-cancerous cell growth, damaged immune systems, partial atrophy of the liver, and inhibited development of their brains, livers and testicles. When the lead scientist went public with his concerns, he was promptly fired from his job after 35 years and silenced with threats of a lawsuit.

Americans eat genetically modified foods everyday. Although the GM tomato has been taken off the market, millions of acres of soy, corn, canola, and cotton have had foreign genes inserted into their DNA. The new genes allow the crops to survive applications of herbicide, create their own pesticide, or both. While there are only a handful of published animal safety studies, mounting evidence, which needs to be followed up, suggests that these foods are not safe.

Rats fed GM corn had problems with blood cell formation. Those fed GM soy had problems with liver cell formation, and the livers of rats fed GM canola were heavier. Pigs fed GM corn on several Midwest farms developed false pregnancies or sterility. Cows fed GM corn in Germany died mysteriously. And twice the number of chickens died when fed GM corn compared to those fed natural corn.

Soon after GM soy was introduced to the UK, soy allergies skyrocketed by 50 percent. Without follow-up tests, we can’t be sure if genetic engineering was the cause, but there are plenty of ways in which genetic manipulation can boost allergies.

  • A gene from a Brazil nut inserted into soybeans made the soy allergenic to those who normally react to Brazil nuts.
  • GM soy currently consumed in the US contains a gene from bacteria. The inserted gene creates a protein that was never before part of the human food supply, and might be allergenic.
  • Sections of that protein are identical to those found in shrimp and dust mite allergens. According to criteria recommended by the World Health Organization (WHO), this fact should have disqualified GM soy from approval.
  • The sequence of the gene that was inserted into soy has inexplicably rearranged over time. The protein it creates is likely to be different than the one intended, and was never subject to any safety studies. It may be allergenic or toxic.
  • The process of inserting the foreign gene damaged a section of the soy’s own DNA, scrambling its genetic code. This mutation might interfere with DNA expression or create a new, potentially dangerous protein.
  • The most common allergen in soy is called trypsin inhibitor. GM soy contains significantly more of this compared with natural soy.

The only human feeding study ever conducted showed that the gene inserted into soybeans spontaneously transferred out of food and into the DNA of gut bacteria. This has several serious implications. First, it means that the bacteria inside our intestines, newly equipped with this foreign gene, may create the novel protein inside of us. If it is allergenic or toxic, it may affect us for the long term, even if we give up eating GM soy.

The same study verified that the promoter, which scientists attach to the inserted gene to permanently switch it on, also transferred to gut bacteria. Research on this promoter suggests that it might unintentionally switch on other genes in the DNA—permanently. This could create an overproduction of allergens, toxins, carcinogens, or antinutrients. Scientists also theorize that the promoter might switch on dormant viruses embedded in the DNA or generate mutations.

Unfortunately, gene transfer from GM food might not be limited to our gut bacteria. Preliminary results show that the promoter also transferred into rat organs, after they were fed only a single GM meal.

This is only a partial list of what may go wrong with a single GM food crop. The list for others may be longer. Take for example, the corn inserted with a gene that creates its own pesticide. We eat that pesticide, and plenty of evidence suggests that it is not as benign as the biotech proponents would have us believe. Preliminary evidence, for example, shows that thirty-nine Philippinos living next to a pesticide-producing cornfield developed skin, intestinal, and respiratory reactions while the corn was pollinating. Tests of their blood also showed an immune response to the pesticide. Consider what might happen if the gene that produces the pesticide were to transfer from the corn we eat into our gut bacteria. It could theoretically transform our intestinal flora into living pesticide factories.

GM corn and most GM crops are also inserted with antibiotic resistant genes. The ICMR, along with the American Medical Association, the WHO, and organizations worldwide, have expressed concern about the possibility that these might transfer to pathogenic bacteria inside our gut. They are afraid that it might create new, antibiotic resistant super-diseases. The defense that the biotech industry used to counter these fears was that the DNA was fully destroyed during digestion and therefore no such transfer of genes was possible. The human feeding study described above, published in February 2004, overturned this baseless assumption.

No one monitors human health impacts of GM foods. If the foods were creating health problems in the US population, it might take years or decades before we identified the cause. One epidemic in the1980’s provides a chilling example. A new disease was caused by a brand of the food supplement L-tryptophan, which had been created through genetic modification and contained tiny traces of contaminants. The disease killed about 100 Americans and caused sickness or disability in about 5-10,000 others. The only reason that doctors were able to identify that an epidemic was occurring, was because the disease had three simultaneous characteristics: it was rare, acute, and fast acting. Even then it was nearly missed entirely.

Studies show that the more people learn about GM foods, the less they trust them. In Europe, Japan, and other regions, the press has been far more open about the potential dangers of genetic manipulation. Consequently, consumers there demand that their food supply be GM-free and manufacturers comply. But in the US, most people believe they have never eaten a GM food in their lives (even though they consume them daily). Lacking awareness, complacent consumers have been the key asset for the biotech industry in the US. As a result, millions of Americans are exposed to the potential dangers, and children are most at risk. Perhaps the revelations in the reports released on opposite sides of the planet will awaken consumers as well as regulators, and GM foods on the market will be withdrawn.

To become more informed of the dangers of GM foods, to download a letter to food manufacturers, and to learn how to avoid buying and eating GM foods, see

This is the first in a regular column about genetically modified foods by Jeffrey M. Smith. He is the author of Seeds of Deception: Exposing Industry and Government Lies about the Safety of the Genetically Engineered Foods You're Eating, and the Director of the Institute for Responsible Technology.


Potential Dangers in Modified Foods Seen by Report

By Ira Dreyfuss
Associated Press
July 28, 2004

WASHINGTON - Federal regulators should look more closely at the potential health effects of some genetically modified plants before they can be grown as commercial crops, a scientific advisory panel said.

It also said regulators should check for potential food safety problems after people eat the products.

The report by a committee of the National Research Council and Institute of Medicine said regulators should target tighter scrutiny at genetically engineered varieties that have greater levels of biological differences from current plants.

The analyses also should look more closely at conventionally developed plants if there are indications that naturally occurring chemicals in the conventional plants could have unintended health effects, the report said.

Some chemicals in plants can create allergic reactions or otherwise make some people sick. To prevent such problems, the study recommended a case-by-case approach to the applications based on compounds in conventional as well as biotech plants, rather than the current focus on biotech varieties. The report said, however, that biotech plants would probably have greater risk.

The compounds to be examined could be new ones not normally in the plants, as well as naturally occurring ones that are above or below healthful levels, the report said.

To help regulators make their approval decisions, a database should be developed to list the levels of certain compounds, including healthful substances such as proteins and dangerous ones such as allergens, the report said.

The report also said the government should develop better ways to see if genetically modified foods cause health problems. Among these could be systems to trace foods with greatly altered levels of those compounds through the food supply, and to check populations to see if there are health problems among people who eat the foods.

However, the primary focus should be on the preapproval process, "and we would hope that, for the most part, there wouldn't be a great deal of postmarket tracking," said the committee chairwoman, Bettie Sue Masters, a professor of chemistry at the University of Texas Health Science Center in San Antonio.

The report said that genetic engineering of food crops, although relatively new, appears to be a safe technology and that there is no evidence it has harmed health. Committee members emphasized that current biotech crops have gone through extensive safety checks.

Current biotech crops do not need the tracing or re-examination, said Dean DellaPenna, a professor of biochemistry and molecular biology at Michigan State University. The committee's job was to evaluate what could be done for new applications, he said. "What we are talking about is from this point going forward," he said.

The committee did not intend for researchers to identify every one of the thousands of compounds in plants, but to focus on the "handful" that might cause problems, DellaPenna said.

The committee did not consider the cost of implementing its recommendations, DellaPenna said. "We are proposing what we think would be ideal recommendations, and it is certainly up to the agencies and Congress to determine how they go forward."

The report was done for the Food and Drug Administration, the Agriculture Department and the Environmental Protection Agency, which oversee biotech crop applications.

Michael Phillips, vice president of agricultural science and regulatory policy at the Biotechnology Industry Organization, a biotech trade group, said the report should "lay to rest the few naysayers who continue to question the safety of these crops."

Consumer advocates said the report also supported their positions. "The report clearly and correctly states that biotech foods could have unintended consequences," said Gregory Jaffe, biotechnology project director of the Center for Science in the Public Interest.

The National Research Council and the Institute of Medicine are arms of the National Academy of Sciences, a private, congressionally chartered organization that advises the government on scientific and technical matters.


GE Papaya Scandal in Thailand

Thailand/Khon Kaen
July 27, 2004

Illegal GE seeds found in packages sold by Department of Agriculture

We warned the Thai government over a year ago not to play with genetically engineered (GE) papaya but they didn't listen. Although trials of the engineered food crop are banned, it seems they couldn't resist having a go themselves. Now they have left the whole country's papaya crop wide open to contamination.

Independent laboratory tests carried out in Hong Kong showed that packages of papaya seeds being sold by the Department of Agriculture's research station in the province of Khon Kaen contained GE seeds. We identified one of the fields at the research station as the source of the GE seeds. It turns out that the experimental field was only segregated from the other papaya by barbed wire and banana trees.

"This is potentially one of the worst cases of genetic contamination of a major food crop in Asia as this station is one of the largest suppliers of papaya seeds in the country," said Varoonvarn Svangsopakul, our GE campaigner in Southeast Asia. "This is the hard evidence we needed to prove that GE contamination has broken in Thailand."

Thai activists sealed off the GE papaya at the agricultural research station of the Department of Agriculture. Dressed in protective suits they removed the GE papaya fruit from the trees then secured them in hazardous material containers. They also demanded that the government complete this process and immediately destroy all papaya trees, fruit, seedlings, and seeds in the Khon Kaen research station to prevent further contamination.

"The purpose of the ban on field trials imposed in 2001 was to prevent GE contamination. But we now have proof that not only has this ban failed, but the Department of Agriculture itself has committed a crime that threatens an essential food with widespread contamination," said Svangsopakul.

Last year we warned the Thai public of the environmental and health risks posed by GE papaya and called on the government to stop all planting of the crop anywhere in the country. We also pointed to Hawaii as an example of GE papaya gone wrong.

When GE papaya was introduced into Hawaii the biotech industry said it as a 'solution' to the papaya ringspot virus problem. But instead it has caused serious environmental and economic problems for farmers. The selling price of GE papaya has fallen to 30-40 percent below production costs, and the price that farmers get for their GE papaya is 600 percent lower than the price for organic papaya.

The consequences of growing GE papaya in Thailand are feared to be even more serious than Hawaii. Not only is green papaya eaten as a daily staple food, it is also grown everywhere - in farmers' fields, schoolyards and gardens.

"We've been calling for an end to this genetic experiment on the grounds that genetically modified organisms (GMOs) are uncontrollable. There can no longer be any doubt that this is true. And the government must take action to stop this experiment now," said Jiragorn Gajaseni, Executive Director of Greenpeace Southeast Asia. "The government must act now to impose a total ban on GE field trials, including those in government restricted areas and experimental stations, and must launch an investigation into this environmental crime."

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