By Artemis Dona and Ioannis S. Arvanitoyannis
Critical Reviews in Food Science and Nutrition, 49:164-175 (2009)
As genetically modified (GM) foods are starting to intrude in our diet concerns have been expressed regarding GM food safety. These concerns as well as the limitations of the procedures followed in the evaluation of their safety are presented. Animal toxicity studies with certain GM foods have shown that they may toxically affect several organs and systems. The review of these studies should not be conducted separately for each GM food, but according to the effects exerted on certain organs it may help us create a better picture of the possible health effects on human beings. The results of most studies with GM foods indicate that they may cause some common toxic effects such as hepatic, pancreatic, renal, or reproductive effects and may alter the hematological, biochemical, and immunologic parameters. However, many years of research with animals and clinical trials are required for this assessment. The use of recombinant GH or its expression in animals should be re-examined since it has been shown that it increases IGF-1 which may promote cancer.
Nearly fifteen years have passed after the introduction of genetic modifications (GM) in food and new GM food are added in the existing list of foods. Who could imagine that there would come a day when the pig would be as "fat -free healthy food" as a fish or that the ice cream our children eat would contain a protein from the fish? Are GM safe to human health? Studies concerning their safety are still few when one considers the toxicity studies that must accompany the application of any novel drug for approval by the corresponding drug administration. The results from most toxicity studies available in literature are reviewed and the significance of these findings is discussed. In the absence of adequate safety studies, the lack of evidence that GM food is unsafe cannot be interpreted as proof that it is safe. Furthermore, if they are not considered safe for human consumption why should they be approved for animals? Humans can inadvertently consume foods that contain GM products fed to animals, i.e., crops modified for enhanced productivity in animals. This was the case when traces of a StarLink GM crop, restricted for use only in feed, were found in taco shells already in the market. One has to wonder what will happen if we start consuming food crops contaminated with GM crops containing genes for the production of drugs and industrial chemicals that have never been assessed for their toxicity? (Margulis, 2006). The debate over its safety continues. One should not forget that every single GM food through the food chain will eventually reach the consumer. Issues such as the concern of the public for possible hazards due to the consumption of a GM food have already been discussed, but there is always something to add. However, prior to discussing these issues one must take into account in brief the regulation of testing for GM food safety.
By Bill Tomson
Dow Jones Newswires
February 02, 2009
The U.S. Department of Agriculture wants to cement into law its authority to do nothing when unapproved biotech material is discovered in crops, and that has raised concerns by groups worried about the purity of food, U.S. exporters and foreign importers. New authorities are needed to deal with the rapidly advancing field experiments of genetically modified crops, according the USDA's Animal and Plant Health Inspection Service's plan to control the industry. But the agency also made it clear there are plenty of conditions under which it will do nothing if those experiments end up in the food supply. Biotech seed developers comply with "stringent regulations" to keep experiments from ending up in commercial grain supplies, according to a letter to USDA's Aphis from Penny Hunst, biotech regulatory leader for Dow AgroSciences, a wholly owned subsidiary of The Dow Chemical Company (DOW). But sometimes unapproved biotech material ends up as a "low-level presence" in public feed and grain.
How Low Is A "Low-Level Presence?"
When a "low level presence" of unapproved biotech material is dicovered, it's likely not a problem, according to the Aphis plan, if there is no threat that it will lead to the creation of a widespread "plant pest" or "noxious weed." Nowhere in the plan does the agency define what a "low level presence" is, and that has concerned people like Bill Freese, a senior policy analyst at the non-profit group Center for Food Safety. "What might the actual level of unapproved [genetically engineered] crop contaminating commercial supplies be? Does 'low-level' mean 0.01% presence of the contaminant, 0.1%, 1% or 10%?" Freese said in a letter to USDA's Aphis. "The failure to provide any information whatsoever on quantity, measurement or procedures to determine quantity with respect to 'low level presence' undermines the legitimacy of this policy from the start." But Aphis, in explaining why it needs to establish the authority to decide that "a low level presence of [genetically engineered] plant materials in seeds or grain may not be cause for agency remedial action," said it will "not predetermine a specific level that is considered non-actionable because this determination should always be made case-by-case." No reason was given why it must be "case-by-case" and Aphis would not make available experts to discuss the logic.
Exporting Contaminated Grain
Japan, one of the largest importing markets for U.S. corn, told the USDA directly that the plan "may have a significant impact on international trade." In particular, Japan said it wanted to know if USDA's Aphis would take action if it found a "low level" of unapproved biotech traits in grains or oilseeds being exported. Aphis has not yet answered Japan, one of the largest buyers of U.S. grains and oilseeds, said Aphis spokeswoman Rachel Iadicicco. But a Japanese government official, who asked not to be named in this story, said both governments continue to negotiate how to handle trade when unapproved biotech enters feed and food supplies. Japanese consumers, the official said, are extremely "sensitive" to the issue. Concerns that unapproved biotech traits may be hidden among the millions of tons of corn, soybeans, wheat and rice imported from the U.S have been stoked in recent years by several occurrences where commercial seed and grain supplies here have been contaminated and some of that contamination has made it overseas. Dow AgroSciences in February 2008 reported discovering traces of an unapproved biotech material in three lines of corn seeds. The USDA said the unapproved biotech seed was plantedon about 53,000 acres of U.S. farm land in 2007. In August 2006, an experimental rice developed by Bayer CropScience, a division of Bayer AG (BAYRY), somehow made it into supplies of non-biotech rice. Exports to Europe dried up immediately after traces of the unapproved rice were found in Germany, Italy and other countries. In March 2007, another of Bayer's unapproved rice was found in BASF AG's (BASFY) non-biotech rice. Almost immediately, Mexico began detaining shipments of U.S. rice at its border. Switzerland's Syngenta AG (SYT) revealed in March 2005 that it inadvertently sold unapproved Bt10 corn seed instead of the approved Bt11 to U.S. farmers who planted it on 37,000 acres from 2001 through 2004. In June 2005, Japan discovered corn it had bought from the U.S. was contaminated with the unapproved Bt10 trait. Steve Hensley, regulatory affairs director for the USA Rice Federation, told the USDA in a letter that there should be stricter confinement rules for experimental biotech crop field trials. He also noted that foreign countries are far quicker to shut down imports because of a contamination than the U.S. is on imports. USA Rice, Hensley said, "cannot fathom, under the restrictions imposed upon U.S. rice for the low-level presence of a GE event in our export supply, why the agency would suggest that we unilaterally allow those same countries to ship to the United States low-level amounts of traits that have not been rigorously tested and approved in the U.S."
Reason Not To Act
Often in recent years the USDA has sought to calm consumer and importer fears by insisting that the experimental biotech crops released into commerce were perfectly safe because they were very similar to GMOs that were already approved. The USDA's Aphis, in its proposed rule, listed several "factors" that would allow it do nothing, but the first states that "a decision not toorder ... remedial action" would be if a genetically engineered "plant of the same species expressing nearly identical proteins or substances has already been approved." Biotech seed companies like Monsanto Co. (MON), Syngenta, and Dow AgroSciences lauded the Aphis plan. Monsanto pledged "strong support" in a letter to the agency and the company pledged "to continue to implement stewardship and quality management systems to avoid, to the extent possible, the presence of regulated material in commercial seed or grain." The government considers unapproved biotech seed to be "regulated," whereas once they have been approved they become "unregulated." Syngenta, in a separate letter from Nafta Regulatory Affairs Head Lawrence Zeph, said the company also supports the Aphis plan because it recognizes "that large-scale field testing of [genetically engineered] organisms" could cause unapproved material to end up "at low levels in the food supply." It's appropriate, Zeph said, "to establish science-based criteria by which regulated material would be considered 'not-actionable' by the agency."
By Martin Webber
February 06, 2009
US researchers have criticised claims that genetically modified (GM) crops can help feed a hungry world.
GM crops have been a "spectacular under-performer" in terms of yields, according to Doug Gurian-Sherman of the Union of Concerned Scientists.
Recent yield gains are just as likely to result from conventional breeding techniques as they are from genetic engineering, he says.
GM crops cover about 10% of all commercial farmland globally.
"The historic trend for corn is an average improvement in yield of about 1% per year, which doesn't sound like much but it adds up over time," Mr Guarian-Sherman told BBC's Business Daily.
"If you take the 13 years that Bt (genetically engineered) traits have been commercialised, they've probably only added a couple per cent to yield.
"That's only a small fraction of what we continue to do with means other than genetic engineering," he added.
Yet GM crops have many fans, especially in the US where farmers have widely embraced the technology.
Charles Wilfong farms in a wide valley in the central Appalachian Mountains in West Virginia and likes the fact that the chemicals he sprays on his crop to control weeds, do not affect the corn.
He says corn yields have grown in recent years from 100 bushels to 150 bushels per acre.
"The seed technology is already in the pipeline that can double that to 300 bushels per acre in the very near future," he says.
"More and more of our corn is going to be used for ethanol," he explains.
"If we don't have this technology to bump up the yield there's not going to be enough corn."
Although Mr Wilfong clearly likes the genetically engineered seed he uses, he has also seen its price rise.
"I was out at Des Moines, Iowa, at Pioneer's research facility, back in the summer and some folks were talking that within the near future we'd probably be paying $500 a bag for seed corn instead of the $200 we're paying now," he says.
Almost half of all corn grown in the US is genetically engineered and for soybeans it is 80%.
The yield for soybeans has gone down however, according to Bill Freese at the Centre for Food Safety.
"What we've seen with the herbicide tolerant soybeans overall, is a 5-10% lower yield with the Round-up Ready soybeans - that's the herbicide tolerant soybean sold by Monsanto," he says.
But Michael Fromm, director for the Centre of Biotechnology at the University of Nebraska, who helped develop GM crops for Monsanto, points out that farmers who buy genetically engineered seed decide whether the price is worth the yield they achieve."
"There's absolutely no one making him buy those seeds," he says.
"They're voting for the transgenic seeds at higher cost for higher benefits."
There is controversy over whether the regulators have been too lax in allowing the biotech giants to buy up their competitors and dominate the market.
There has been widespread opposition to GM foods especially in Europe
Mr Gurian-Sherman says that in the last decade or so, firms including Monsanto and DuPont have been buying up dozens of seed companies - small and large - and are controlling more of the seed market.
"The huge independent seed corn company Pioneer is now owned by DuPont," he says.
"And more recently concentration was increased when the [US] Justice Department allowed Monsanto to purchase Delta & Pine Lands, two of the biggest cotton seed producers, so now you have a mega-cotton-seed producer and in that market you're talking around 90% concentration of the market."
But Mr Fromm points out that market concentration is not unusual and allows the big investment needed in new technology.
"Little companies can't bring these products to market," he says. "It's simply too expensive for the size of their budget."
Adding to the lack of choice is the fact that many university seed breeding centres have been closed down, according to Mr Freese.
"The private companies have pretty much taken over the seed market and encouraged universities and other public sector breeders to focus on more basic research and not actually breeding seeds for sale to farmers because they've always traditionally seen university breeding programmes as competition," he says.
This is bad news for David Runyan, a farmer in America's vast Midwest.
"I'm down to three varieties of soybeans that I can plant and I have the last variety of soybean that Illinois Seed Association put out," he says.
"That was two years ago and they are not growing any more public varieties of soybeans."
Even after years of research and near market dominance in four major crops in the United States, most of the promises for genetically engineered varieties are still in the future.
"What we've seen is that there's a lot of hype of genetic engineering and biotech," says Mr Freese.
"We see biotech companies often claiming that they are going to introduce miracle seeds with all sorts of fabulous properties - drought-resistance, extra nutrition, salt-tolerance.
"What's interesting though is that despite all of this hype, in 20 years we only have two traits that have been successfully developed."
Biotech scientist Michael Fromm believes no one can dispute that genetically engineered crops have been successful in the United States in terms of sales or acres planted in these crops.
He also feels the best is yet to come.
"It's important to realize it's still the beginnings of the capabilities there," he says.
"As in all of biology, we're really learning more and more about how human health works and how plants work and that advances our understanding of how to engineer plants for better benefits accelerates," he concludes.
By Ricardo Alonso-Zaldivar
February 6, 2009
WASHINGTON - The Food and Drug Administration made history Friday as it approved the first drug made with materials from genetically engineered animals, clearing the way for a new class of medical therapies.
GTC Biotherapeutics said regulators cleared its drug ATryn, which is manufactured using milk from goats that have been scientifically altered to produce extra antithrombin, a protein that acts as a natural blood thinner.
The drug's approval may be the first step toward new kinds of medications made not from chemicals, but from living organisms altered by scientists. Similar drugs could be available in the next few years for a range of human ailments, including hemophilia.
The FDA cleared the drug to treat patients with a rare hereditary disorder that causes a deficiency of the protein, putting them at higher risk of deadly blood clots. The injectable treatment will be marketed in the U.S. by Deerfield, Ill.-based Ovation Pharmaceuticals
About 1 in 5,000 people don't produce enough antithrombin protein, according to Framingham, Mass.-based based GTC. As a result, their blood is more likely to stick together, occasionally causing clots that can travel to the lungs or brain, causing death. Pregnant women with the disorder are at higher risk of miscarriage or stillbirth, because of blood clots in the placenta.
Patients with hereditary anithrombin deficiency are currently prescribed conventional blood thinners, like Plavix from Bristol-Myers Squibb and Sanofi-Aventis. That will not change with the new approval. ATryn is only approved for use when patients are undergoing surgery or having a baby, times when the risk of dangerous clots is particularly high. Those patients would receive the drug by intravenous infusion for a limited time before and after their procedures.
To make the drug, scientists at GTC put DNA for the human antithrombin protein into single cell embryos of goats. Goat embryos with the gene were then inserted into the wombs of surrogate mothers who gave birth to baby goats that produce the protein-charged milk.
Genetically engineered animals are not clones but rather animals that have had their DNA changed to produce a desirable characteristic.
Amid growing questions about the technology, the FDA last month issued guidelines for how it will regulate products made from genetically altered animals.
FDA said it will not allow any such products to be sold without first submitting them to scrutiny by independent advisers at a public meeting. The agency's panel of blood product experts recently concluded ATryn was safe and effective.
But consumer groups said the FDA's long-awaited policy will not require all genetically engineered foods to be labeled as such. And they said the government has not done enough to examine the potential impact of genetically engineered animals on the environment, particularly if some escape and begin to mate with animals in nature.
February 10, 2009
A P.E.I. aquaculture company is a step closer to getting its genetically modified salmon on the market.
Aqua Bounty Farms in Fortune, in eastern P.E.I., has been waiting more than a decade for federal approval in the United States. If the company gets the nod from the Food and Drug Administration, its salmon will be the world's first on the market.
FDA officials visited P.E.I. last fall to get a first-hand look at the facility in Fortune. A spokesperson from FDA wouldn't tell CBC News much about the application, but when asked how long before the salmon might be approved, the answer was "soon."
The advantage Aqua Bounty's fish offers fish farmers is the speed with which it grows. It normally takes about three years to raise Atlantic salmon on a fish farm, but with the addition of a couple of genes from the cold-water Chinook salmon, Aqua Bounty's fish grow twice as fast. The breeder is hoping to sell its eggs and smolts to other fish farms in North America.
But before any genetically modified salmon reaches the dinner table in the U.S. market, it needs the stamp of approval from the FDA, something the company has been waiting for a long time. It first applied for approval 12 years ago, and began submitting documentation seven years ago.
Aqua Bounty CEO Ron Stotish told CBC News last week it is understandable the FDA wants to take its time.
"For an animal like ours, the environmental aspects are a concern to many people and that's a fair concern," said Stotish.
"We've done everything to mitigate those concerns, and we believe we're producing an animal that's safe to eat, safe for the environment."
The main concern with genetically modified organisms (GMOs) is that they could escape into the wild and breed with wild populations. Stotish said that's why Aqua Bounty will only sell sterile salmon, and only females.
Stotish said he's eaten the GMO salmon.
"It's a very good fish. What most people realize when they actually see the fish, and have the opportunity to taste the fish, is it looks like a salmon, it behaves like a salmon, it is a salmon in every respect," he said.