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'Frankenfish' or tomorrow's dinner?

October 17
Washington Post

FORTUNE, Prince Edwards Island - Amid the winding coves and family farms that grace this northern island sits an unassuming, dimly lit warehouse. Inside, dozens of large plastic tubs roil with fish as water pumps hum and the smell of the ocean fills the air.

It's a decidedly low-tech spot, but a technological revolution is underway. The first animals genetically engineered for American dinner plates are being raised here--salmon spliced with genes that make them grow two to four times faster than nature's best.

The U.S. Food and Drug Administration is reviewing an application to sell the fish, a decision that will likely influence the fate of scores of other biotech animals being brought to life in dozens of similar labs around the world for humans to eat.

Pigs engineered to have less fat, chicken designed to resist illness-causing bacteria, beef that can grow twice as fast on less feed--they are all in the pipeline. Advocates say animal biotechnology can supply abundant food at increasingly low cost.

But with opponents of genetic engineering already questioning whether soybeans and corn endowed with new genes are safe for people and the environment, the prospect of a genetically engineered animal has sparked intense controversy.

Opponents call the salmon "Frankenfish" and question the ethics of implanting genes from one animal species into another. The salmon is economically unnecessary, they argue, and could wreak havoc with the environment by outcompeting endangered wild salmon.

"This has gotten so much bigger than we ever imagined," said Arnold Sutterlin, an aquaculture specialist with A/F Protein, an American-Canadian company that is producing the salmon. "We just thought we were making a better fish."

The company says there is nothing mysterious about what it is doing, and has been unusually public about its efforts and plans. A steady stream of scientists, government officials, even tourists tramp through the warehouse. Some visitors received samples of the salmon--which looks and tastes the same as other farmed fish--but the Canadian government put a stop to that.

To create the salmon, scientists spliced into their eggs a growth gene from the Arcticpout, a fish that thrives in very cold water. That gene allows the salmon to act like a colder water fish, which means its growth promoter genes remain more active than a normal salmon. That could be a boon to fish farmers because their salmon would be ready for market earlier, and would grow on less food.

But even usually sober scientists worry that not enough is known about such fish to risk the damage that their release into the wild could cause. And some researchers argue that conventional crossbreeding of fish can achieve many of the same results as genetic engineering, with fewer risks.

"There are so many difficult questions raised by these fish, and we just don't know the answer to many of them," said Robert H. Devlin of Fisheries and Oceans Canada, who has also been raising and studying biotech salmon in British Columbia since the early 1990s. He said that research is underway worldwide to genetically modify at least 25 aquatic species, ranging from flounder and carp to lobster and shrimp.

"We need to know more about possible environmental impacts, since they could be substantial," he said. "There are real potential benefits here, but I haven't seen the scientific studies showing that the risk is under control."

The stakes are especially high in the case of the salmon because both wild Atlantic salmon and some species of Pacific salmon are depleted or even officially endangered--the result of decades of overfishing and habitat destruction. These wild fish now share many of the same waters as the millions of salmon growing in fish farms along the northern Atlantic and Pacific coasts, and many scientists are concerned about what might happen if the engineered salmon escape.

"It doesn't make sense to roll these dice unless we're sure that they won't come up snake eyes," said William Miller, science adviser to Interior Secretary Bruce Babbitt.

The most prominent reason for concern is the "Trojan gene" hypothesis of Purdue University's William Muir. Using a different kind of genetically engineered fish, Muir found that larger, faster-growing biotech fish are more likely to succeed in mating than conventional fish. But the offspring of those biotech fish are genetically less well adapted to survive. Consequently, Muir believes, biotech fish could quickly decimate a fish population by their increased ability to produce damaged young. Muir has proposed further research into this hypothesis, but has been unable to get funding.

Elliot Entis, president of A/F Protein, says that his company's studies have not found that its salmon end up being larger than wild salmon at sexual maturity, meaning they would not have a mating advantage. He also calls the Trojan gene hypothesis beside the point: Fish breeding technology can render the biotech fish almost 100 percent female and infertile, he said, and that means they simply can't reproduce.

In addition, the company has proposed that fertile versions of the fish be raised only in tanks on land, and that only sterile fish be allowed to be raised in the traditional ocean cages now commonly found off Maine, Atlantic Canada, Chile and Norway. Even some critics of genetically modified salmon acknowledge that that could protect wild salmon from damage being done by fish farming.

But critics warn that the precautions offered by A/F Protein to keep their salmon infertile and away from wild fish are not foolproof--and point to the recent discovery of unapproved biotech corn in taco shells as an indication of how easily things can go wrong. Even the escape of a handful of fertile biotech salmon, they say, could have enormous negative consequences.

Salmon farmers and their organizations worldwide have also voiced strong opposition to the salmon, calling them the solution to a problem that does not exist. The rapid growth of the salmon farming industry in the past decade has already caused the price of salmon to plunge in the last decade. Of even greater concern, the salmon farmers worry that consumers won't want biotech fish, and their entire industry could be harmed as a result.

Yet Entis said that opposition is considerably thinner than it appears. His firm already has orders for 15 million biotech salmon eggs, and major international salmon growers are contacting him all the time, he said.

"They are concerned about some scientific issues, and they are concerned about whether consumers will accept it," he said. "But they also understand that our fish would reduce their costs dramatically, and they are always looking for something like that."

The company has also found significant interest in his biotech fish eggs abroad--especially in Chile (already a major salmon producer,) in China (which could grow salmon in its northern waters) and Southeast Asia (which has an interest in biotech tilapia), he said. The company hopes to open offices soon in Singapore and Santiago, Chile.

While American attention is focused on the risks of biotech fish, many poorer countries are more interested in the potential benefits, according to Eric Hallerman, a member of the National Academy of Sciences' biotechnology committee. China and Cuba are already raising biotech carp and tilapia, he said, and China is raising engineered carp as well.

"In those underdeveloped countries, they are eager to move ahead with commercial uses of biotechnology in fish production," he said. "This technology can definitely increase productivity by significant amounts, and that is very important in countries where people don't get the protein they need."

Because issues raised by the salmon are new and complicated, the FDA made the unlikely decision to review the fish not as a food, but rather as an animal "drug" since it changes the growth rate of the animal. Aware of public concerns about biotech products, the FDA plans to hold public hearings on the salmon and other possible animal biotech products before taking any action.

"This is the index case, the first product like this to approve or not approve," said Stephen F. Sundlof, director of the FDA Center for Veterinary Medicine. "These are issues as complicated as any we expect to see in a [genetically engineered] animal. We expect this to provide a good model for how to regulate similar products in the future."

Because it's unlikely the fish would pose any danger to human health, a large part of the FDA's assessment of biotech salmon will involve measuring environmental risks. That has led some to suggest the wrong agency is reviewing the application. FDA officials said that experts from the Environmental Protection Agency and the agencies that oversee marine life will also participate, but the ultimate decision will be made by the FDA.

Officials said it will take at least a year to finish the required human health and environmental studies; others predict considerably longer. But even if the FDA approves the salmon, anyone who wants to farm the fish in coastal waters may have to get approval from the U.S. Fish and Wildlife Service and the National Marine Fisheries Service, which have both voiced opposition recently.

Because of a loophole in the rules governing the importing of animal drugs, engineered salmon raised abroad could reach American markets sooner. That loophole was initially written to cover the importation of meat raised abroad with chemicals that aren't used and haven't been approved in the United States. However, it could also allow biotech salmon to be imported if the FDA finds them to be safe for human consumption before tackling the more complex and time-consuming process of determining environmental safety.

Val Giddings, vice president for food and agriculture of the Biotechnology Industry Organization, believes there is no reason for the FDA to dawdle on approving the salmon. "This is not rocket science," he said. "It's a straightforward question of risk assessment."

But antibiotech and environmental groups have "ginned up a lot of protest about salmon," so approval is uncertain, he said.

"If [the FDA] screws it up, the salmon case would definitely have spillover effects on the industry," he said. "But the positive impact of an approval would actually be disproportionally larger, and would reaffirm the role of the agency while being another nail in the coffin of the protesters. It would open the door to lots of terrific innovation."


Genetically engineered food crops focus of food fair, harvest fest

October 16
Bangor (Maine) Daily News

BANGOR — Last month’s recall of taco shells made with genetically engineered corn — a product not approved for direct human consumption — is “just the tip of the iceberg,’’ a Vermont activist said Saturday.

As the public would later learn, the problem involved far more than one brand of hard taco shells, according to Brian Tokar, a Vermont author, lecturer and activist in the peace, anti-nuclear and environmental movements since 1970.

Other products more recently deemed contaminated include tortilla chips, corn tortillas, tostados and other yellow corn products made with contaminated flour traced to a Texas corn mill.

Genetically engineered ingredients are created by changing the genetic makeup of plants by inserting as little as one new gene. The changes often are made to make plants resistant to disease and pests.

The possible health effects include allergic reactions, but they aren’t currently known due to lack of adequate testing by government and industry, Tokar said.

The public’s right to know what it is eating was among the issues addressed by Tokar, a faculty member at the Institute for Social Ecology at Goddard College and the featured speaker at the Peace and Justice Center of Eastern Maine’s annual Safe Food Fair and Harvest Supper at the Unitarian Universalist Church.

The event was organized in cooperation with several local and regional groups, including the Maine Organic Farmers and Gardeners Association, Greenpeace, New England Resistance Against Genetic Engineering and Maine Right to Know, one of numerous groups across the nation working to require the labeling of genetically engineered food.

According to published reports, the corn at issue, known as StarLink, was approved in 1998 for use as animal feed but not for humans because of concerns that it could cause allergic reactions.

An estimated 45 million bushels of StarLink corn was grown this year by U.S. farmers in more than 20 states. Reports are starting to surface, however, that some farmers weren’t told to segregate StarLink to ensure that it did not enter the human food chain.

To Tokar and others at the forefront of the labeling battle, the StarLink corn debacle underscores the need for stronger government regulation over genetically engineered crops.

Corn, Tokar said, is just one crop affected by bioengineering. Others include soy, canola and cotton, all of which make their way into ingredients of other foods. How many and which ones remain unknown, largely because the United States — unlike its counterparts in the European Union — still lacks labeling regulations for genetically altered food.

The lack of labeling, he said, takes away consumers’ right to know what they are eating and feeding their families.

The food fair featured workshops on the environmental and health surrounding genetically engineered foods, as well as public education, action and political responses to the technology.

The event also offered displays and information about a range of topics, ranging from organic farming and environmentally safe methods for controlling plant pests to soil and water testing to safe food handling, storage and preserving.

Genetically engineered food was not on the menu for the harvest supper. Dinner consisted of predominantly organic and local dishes, including homemade soups, breads, vegetables and desserts.


Biotech food industry has long way to go

Consumers still wary of genetically modified products, international conference is told

October 17
Montreal Gazette

The public's anxiety over genetically modified food seems to be leveling off, but the industry still has a long way to go to convince consumers that biotech foods are beneficial, an industry spokesman said yesterday.

"We're having trouble explaining the benefits to the consumer because they're indirect," said Bob Ingratta, director of government regulatory affairs at Monsanto.

Biotechnology is used in the production of pharmaceuticals, he said, but the public can see a direct gain from new drugs and seems willing to accept that the benefits outweigh any risks that might be involved.

It's much harder to convince the public that they stand to gain from technologies that improve crop yields or reduce the amount of pesticides a farmer uses, he said. "Activists are telling them there is no benefit, even though they are the ones who wanted us to reduce pesticides."

And Canadians are blessed with an abundance of food, he said, making it harder for them to see the need for increased production, which is crucial in Third World countries.

Ingratta was in Saint-Hyacinthe yesterday to take part in a panel discussion on the safety of biotech foods being held in conjunction with Bio Agro Contact 2000, an international conference on the development and marketing of agri-food biotechnologies.

While biotechnology in pharmaceuticals is a big industry in Quebec, biotechnology in food is a small but growing sector, said Serge Hebert, president of the conference's steering committee. The event attracted about 350 people.

Although the industry has been growing, so has public concern. Various groups have been questioning the safety of foods produced by genetically altering plants and animals.

Panelists agreed such fear is natural. All new scientific endeavors, from the automobile to electricity, were initially feared by many, they said. People worry about the long-term safety of the altered foods and whether allergens are being transferred. Some actually fear such foods might change their own genetic make-up.

Ingratta said there has been a lot of misinformation, spread widely at high speed over the Internet. The cost of fighting opponents is high, he said. His industry association will spend $50 million in North America this year.

A recent industry survey shows opposition is leveling off from the fever pitch it reached over the past six months, he said. But the industry has been far more successful in North America than in Europe.

North Americans are more willing to accept scientific explanations, he said, and have more faith in the government agencies that ensure the safety of their food.

Europeans have seen some major crises, such as mad-cow disease, and are not so confident in their governments, he said.

A solid regulatory framework capable of dealing with continually advancing technologies is essential, he said. The public has to be convinced the food is safe before the industry can start convincing them it is also beneficial.

And the industry still has to figure out the best way to prove the benefits, he said. Long-winded scientific answers are probably not the best approach, he said. People don't want to know how their food was produced - they just want to know if it is safe and nutritious.

"We may have been giving too much information, too much science," he said. "We have to translate that into consumer-friendly explanations."

And the industry has to encourage more public involvement in the development of regulations, such as labeling, he said.


Taiwan to require GMO product labeling in 2001

October 17
Reuters

Taiwan's health department said on Tuesday it would respond to consumer pressure and require all products made from genetically modified organisms (GMO) to be labeled by 2001.

Taiwan would first enforce the labeling on corn and soybean products, then gradually on other agricultural products, Chen Shu-kong, director of the health department's Bureau of Food Sanitation, told Reuters in a telephone interview.

``According to our information, there is no safety concern on genetically-altered foods. The labeling is to allow consumers the right to choose,'' he said.

``When the gene modification technology is applied to commercial production of other crops, we would expand the labeling to those products.''

Chen said his bureau would complete detailed guidelines for labeling GMO foods and map out regulations that would require GMO farm products to meet government safety standards by the end of 2000.

Chen said the health department had yet to decide how much GMO material would have to be in a product before it had to be labeled.

Chen said the decision on compulsory labeling was in reaction to mounting calls from consumers and environmental groups.

A survey conducted by private pollster Gallup Taiwan in September showed 74% of 1,083 respondents expected the government to enforce labeling on foods made from GMO crops.

The poll indicated nearly 70% of interviewees had heard of processed GMO foods, but only 11% said they would never buy genetically-modified products.

Taiwan is following other Asian countries on GMO regulations and labeling.

South Korea said it would require labeling of GM corn, soybeans and bean sprouts from March 2001, with other GM processed foods requiring labeling from July 2001.

In Japan, the government has ordered suppliers to provide proof that GMO foods meet the health ministry's safety standards, and will ban imports of foods containing unapproved GMOs from April 2001.

Proponents of GMO crops say the new technology contributes to better yields and lower production costs.

Taiwan's environmental groups hailed the government decision.

``The decision to requiring labeling is in line with people's expectations. At least it gives customers the right to know and the right to choose,'' said Ming-lone Liou, secretary-general of private Environmental Quality Protection Foundation.

Local food makers and traders said it was too early to say the move would cause a shift to non-GM crops, although food processors had said they would pass any additional costs on to consumers if prices of GM-free crops were more expensive.

Food conglomerate Uni-President Enterprises Corp , said it would comply with government regulations on modified foods, but that it would eventually opt for GMO-free products.


Eating away disease

A scientist hopes specially modified fruits and vegetables can vaccinate the world

October 11
ABCnews.com

Charles Arntzen wants to save the lives of millions of children threatened by deadly infectious diseases, and he wants to do it by feeding them a slice of a banana.
    
“We know what the problem is,” he says as he leans back in a chair on a courtyard at Arizona State University in Tempe. “We have 15 million kids dying every year in Third World countries from infectious diseases that could be prevented.
     “And we know what the solution is,” he adds. It is to inoculate those children with vaccines that can fight off diseases such as hepatitis B, cholera, and various deadly types of diarrhea.

Inoculations Problematic
Although major progress has been made in inoculating children in much of the world, in the poorest of the poor nations, little has been achieved. That leaves about 20 percent of the world’s infants vulnerable to horrible diseases, according to the World Health Organization.
     Inoculating these impoverished children is almost impossible with the current technology, Arntzen says. Vaccines that are now available have to be injected, with the single exception of the oral polio vaccine. And injections are too expensive and too problematical in much of the world.
     “Vaccines need to be refrigerated from the point of manufacture to the point of use,” Arntzen says. “They usually need skilled medical delivery people because they are delivered by needles, and needles are potentially hazardous.” Contaminated needles may do more to spread disease than contain it.
     Although philanthropic organizations pick up most of the cost, hundreds of millions of children are left unprotected because an inoculation that may cost pennies to produce is simply out of their reach.
     What to do about all of that has consumed Arntzen ever since a 1990 conference in New York City, sponsored by the WHO. The Children’s Vaccine Initiative came out of that meeting, and it changed the life of Arntzen, then a plant biologist at Texas A&M University.

First Potatoes, Tomatoes
Arntzen figured some plants could be genetically modified to produce the proteins that would jump-start the human immune system so it could destroy disease-causing pathogens before they could do their damage. A hepatitis B gene, for example, added to a plant could cause the plant to produce proteins that would be consumed like any other food, and stimulate the immune system to fight hepatitis B. In other words, an edible vaccine.
     A short time after the New York conference, while visiting Bangkok, Arntzen watched a young mother soothe a crying baby by feeding the infant a slice of a banana. It struck him then that bananas were the junk food of the Third World, so easily grown that many children eat them as treats.
     Wouldn’t it be fantastic, he thought, if a crop that loves to grow in countries that desperately need inoculations could be engineered to produce the vaccine? That would provide a local source that could be grown, harvested and processed in the country where it would be used.
     Arntzen set out to do just that, a journey that would take him to Cornell University as president of the Boyce Thompson Institute for Plant Research, and now to ASU, where he wants to move the research he pioneered over the past decade from the lab to the outside world.
     He didn’t start out with bananas, one of the most difficult of all plants to genetically engineer. He began with tobacco, one of the simplest, just to prove out the principle. He had enough success to conclude that he was on the right track.
     He moved on to potatoes, and tomatoes, and before leaving Cornell completed very limited clinical trials showing that the desired immune response was produced in both mice and humans. There were no serious side effects, but the subjects had to eat a lot of potatoes, and they had to eat them raw. Cooking the potatoes would break down the proteins that provoke the immune response.
     Somehow, the vaccine production has to be beefed up so that no one has to eat a bag of raw potatoes to get inoculated, but researchers believe that’s only a matter of time. Arntzen sees the day when children will be given a medical version of an Oreo cookie, except the white stuff in the middle will be a slice of banana ready to do its part to save the youngster’s life.

Many Steps to Banana Cure
There are, of course, enormous hurdles to overcome before that can happen. Arntzen says any vaccine would have to be approved in this country before it could be tried oversees to avoid the appearance of using poor children as research subjects. That will involve costly and time-consuming clinical trials.
     And there is the problem of maintaining quality. William H. R. Langridge of Loma Linda University has stressed that it will be important to ensure that plants produce the vaccines in the right concentrations so that the dosage is consistent and correct. Langridge is working on an edible vaccine for cholera.
     Too much vaccine would have just the opposite of the desired effect, creating tolerance of the disease instead of provoking an immune response, Arntzen says.
     That means crops used to produce vaccines would have to be isolated from other crops and kept out the food chain. That could be done, Arntzen suggests, by making them sterile and unable to reproduce, and perhaps a lot less tasty than food crops.
     The beauty of the concept, however, lies in the fact that vaccines could be homegrown in crops around the world, involving local agencies and companies.
     “I’d like to ship seedlings” all over the world, where they could be grown and harvested as part of a local pharmaceutical operation, Arntzen says.

No Economic Push
The last thing he wants to see is all of this just chalked up to more research.
     “I don’t want this to end up as a standard academic lab that publishes a few papers and the dies,” Arntzen says. He and others fear that if they don’t do it, nobody will.
     For pharmaceutical companies, there’s more money to be found in reducing male baldness than in producing vaccines, he adds.
     “I know no pharmaceutical company is going to do it because there’s no driving economic reason for them to do it,” Arntzen says. “So I’m going to spend the next five years trying to make it so easy that anybody can do it.”
     If he succeeds, much of the world will see more of their infants live past childhood.

Lee Dye’s column appears weekly on ABCNEWS.com. A former science writer for the Los Angeles Times, he now lives in Juneau, Alaska.


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