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Allergenic GM Papaya Scandal

How Prof. Joe Cummins uncovered the great scandal of how US regulatory agencies approved a GM papaya even though it carries a viral gene known to be a potential allergen.

Recently the United States regulatory bodies - Department of Agriculture, Animal and Plant Health Inspection Service (USDA, APHIS), the Environment Protection Agency (EPA) and Food and Drug Administration (FDA) - united in approving the commercial production of "Sunset" transgenic papaya that's resistant to papaya ringspot virus. It is modified with a gene for papaya ring spot virus coat protein, the expression of which prevents the virus from replication by silencing the virus' own gene [1].

The possibility that genetically modified (GM) crops may introduce novel allergens has been raised by many critics, and as part of the approval process, potential allergens have to be identified before the crops are released commercially. But the GM papaya was approved despite a recent report [2] showing that the papaya ringspot virus coat protein is a potential allergen because it contained a string of amino acids identical to a known allergen.

The US General Accounting Office (GAO) Report to Congress on Genetically Modified Foods [3] assured Congress and the public that the regimen of safety tests submitted to the FDA are adequate. "Companies that may wish to submit new GM foods for FDA evaluation perform a regimen of tests to obtain safety data on these foods, the degree of similarity between the amino acid sequences in the newly introduced proteins of the GM food and the amino acid sequences in known allergens, toxins, and anti-nutrients." GAO believed that when the sequence of a transgenic protein is found to be similar to that of allergens, further studies would be carried out, at the very least, before the GM crop or product is commercially released.

I contacted Dr. James Maryanski of the FDA by e-mail on 22 January, to alert him of the allergenic potential of the papaya virus coat protein and the relevant publication. In his reply (27 January), he wrote,

"FDA and EPA are aware of this recently published paper, though we have not had an opportunity to fully assess the findings of the paper. FDA is conducting a review of available scientific literature and intends to use this information to prepare draft guidelines for industry. Please note that the traits used to confer resistance to viral disease in papaya are pesticidal traits (plant incorporated protectants) regulated by EPA, not by FDA."

So, I was sent off to EPA, and guess what I found. The EPA's public information stated that coat protein of papaya ringspot virus and the genetic material necessary for its production had been granted "an exemption from the requirement of tolerance" [4] in 1997, which essentially means it is exempt from safety assessment, based on the belief that the material was safe for consumption by humans and animals. No mention was made of recent study on the amino acid sequence of the virus protein. For its part, the USDA APHIS also awarded Sunset Papaya a non-regulated status [5] in 1996, because the reviewers believed that the GM crop was not harmful.

GAO seems to be woefully misinformed about the safety assessment of GM crops, and may have modeled itself after giant accounting corporations such as RD Anderson.

This is a wakeup call for Congress and the public everywhere, who may have been misled into believing that GM food is the most strictly regulated of all foods, and that the US regulatory system is the best in the world.

  1. Tennant P, Fermin G, Fitch M, Manshardt R, Slighton J and Gonsalves D. Papaya ringspot resistance of transgenic Rainbow and SunUp is affected by gene dosage, plant development, and coat protein homology. European Journal of Plant Pathology 2001, 107, 645-53.
  2. Kleter G and Peijnenburg A. Screening of transgenic proteins expressed in transgenic food crops for the presence of short amino acid sequences identical to potential, IgE-binding linear epitopes of allergens. BMC Structural Biology 2002, 2, 8-19.
  3. United States General Accounting Office Report to Congressional Requesters "Genetically Modified Foods" GAO-02-566 May 2002.
  4. Rules and Regulations. Coat protein of Papaya Ringspot Virus and the Genetic Material Necessary for its Production; Exemption From the Requirement of a Tolerance. Federal Register August 22,1997 62, 44572-75.
  5. USDA-APHIS Petition 96-051-01P for the determination of nonregulated status for transgenic sunset papaya Lines 55-1 and 63-1 Finding of No Significant Impact September 1996.


As Europe Simmers Over War, Some Push for a Food Fight

By Justin Gillis
Washington Post Staff Writer
Saturday, February 1, 2003

Pressure is mounting on the Bush administration to launch a trade battle with Europe over genetically altered crops, with a chorus of farm groups and their congressional allies declaring in recent days that the nation has compelling moral and economic reasons to start such a fight.

At the same time, some voices in Washington are urging caution, warning that the nation could strain relations with key allies over a peripheral issue at a time when it needs every friend it can get for a potential war with Iraq.

The Bush administration's public utterances suggest it is moving toward filing a lawsuit against Europe in the World Trade Organization, setting off what could be a lengthy battle. While virtually no one believes Europe can be induced to accept additional gene-altered crops any time soon, many people in Washington have concluded that making an example of the Europeans in a trade suit would help stop the spread of anti-biotechnology sentiment to other countries.

Trade sources say administration lawyers are working on the case, but are not likely to file until they get clearance from President Bush and his Cabinet. Two trade experts following the issue closely said a group of Cabinet secretaries is scheduled to take up the issue as early as Monday. But it has already been three weeks since Robert Zoellick, the nation's top trade ambassador, publicly declared his desire to sue, and farm advocates, growing impatient, are peppering the administration with letters demanding immediate action.

"The European Union's moratorium on agricultural biotechnology has been in place for over four years with no end in sight," said a letter to President Bush this week that was signed by House Speaker J. Dennis Hastert (R-Ill.) and nine other congressmen.

In a remark characteristic of the rising chorus, Charles E. Grassley (R-Iowa), chairman of the Senate Finance Committee and a vigorous advocate of farm interests, told the publication Inside U.S. Trade this week that the administration should "get off of its duff and make a decision."

At the same time, warnings to move slowly, if at all, have come from surprising quarters in recent days -- including some of the administration's ideological allies in its effort to open world markets and advance the cause of free trade.

Clyde Prestowitz, once a trade expert in the Reagan administration and now president of the Economic Strategy Institute, a Washington group that advocates trade liberalization, has warned that a suit over biotech crops could backfire, inflaming European public opinion and causing domestic political difficulties for key American allies.

"It will be a disaster. It's just going to feed anti-American sentiment in Europe," Prestowitz said, adding that the rest of the world will see the suit as "another case of American bullying."

Starting in the mid-1990s, American farmers planted millions of acres of corn and soybeans genetically engineered to resist weeds and bugs. American consumers have raised few objections, with the crops used to make many of the ingredients now found on the nation's grocery shelves. But resistance in Europe has been intense, with opponents dubbing the plants "Frankenfoods" and major grocery chains refusing to sell them.

To create biotech crops, one or two genes are added to the tens of thousands of genes in a plant, giving the plant the ability to make, for example, a protein that fights off worms. Such proteins are readily broken down in human digestion. American regulators, including the Food and Drug Administration, have concluded that biotech food is safe to eat, though some environmental questions linger.

A few biotech crops are approved for sale in Europe, but when a political controversy over the issue erupted there in the late 1990s, most countries imposed moratoriums on further approvals. They did not pretend to base these on scientific assessments. Recently, many scientific groups in Europe, including the French National Academy of Medicine, have stated that the food is safe.

Visiting Washington the other day, the French minister of agriculture, Herve Gaymard, said the European public was traumatized in the 1990s by public-health scandals, including mad-cow disease that spread to humans through British beef. Scientists told the public there was little to worry about, only to be proven wrong. Gaymard counseled patience as the European public slowly regains its confidence in science.

"You can imagine how much the Europeans have been shocked," Gaymard said, adding that public opinion is nonetheless beginning to move on the issue of gene-altered crops. "Wait a little bit until there is more acceptability of these products, and then the question will be naturally settled."

The administration view is that the United States has waited more than a little bit already, and the time for tougher action is at hand. "In my position, I've waited two years to try to see if we could work with them quietly and make improvements," Zoellick said in his remarks three weeks ago. "I don't see things getting improved."

Most legal experts say the administration, if it decides to sue in the World Trade Organization, will have a compelling case. That's because, to prevent countries from using safety concerns as a pretext for protecting domestic markets from foreign competition, the world's trade rules require that bans or restrictions imposed in the name of public health be based on scientific evidence. The World Trade Organization, in Geneva, would not be able to compel Europe to accept the crops even if the United States won, but it could authorize retaliation against European imports into this country.

Some experts in Washington fear a trade suit could backfire, however. "The more you try to force them, the more you're going to provoke a fight," said Julia Moore, a researcher at the Woodrow Wilson International Center for Scholars who supports the technology but not the tactic of suing.

Some experts see geopolitical implications. . The biotech-foods debate comes just as the administration is trying to win European support for the nation's campaign against Iraqi dictator Saddam Hussein.

Bush's national security adviser, Condoleeza Rice, "is probably not over there thinking about soybeans in connection with Iraq, but she should be," Prestowitz said, calling for a "a lot more quiet discussion" with the Europeans. "We have allies in Europe. We don't give them much to work with."

A tipping point in American sentiment came recently, when several African countries balked at accepting gene-altered American grain meant to feed starving people, saying they feared the grain would contaminate their domestic seed supply and hurt future exports to Europe.

Declared a recent letter to the White House from the National Corn Growers Association and the U.S. Grains Council, "This is not only an agricultural issue, but also one that fundamentally challenges the humanitarian ideals of developed nations to help starving people around the globe."


U.S. Delays Challenge to Europe's Ban on Modified Food

By Elizabeth Becker
February 4, 2003

WASHINGTON, Feb. 4 - With war looming in Iraq, the Bush administration has decided against antagonizing its European allies and has postponed filing a case against the European Union for its ban on genetically modified food, according to senior administration officials.

"There is no point in testing Europeans on food while they are being tested on Iraq," a senior White House official said, speaking on background.

Robert B. Zoellick, the United States trade representative, had warned that the administration would decide by this week whether to sue the Europeans for what he called their "immoral" opposition to genetically modified food that was leading to starvation in the developing world.

But a cabinet meeting to consider the suit was canceled this week as European agricultural officials came to Washington to argue for patience.

The conflict will resurface soon, however. Mr. Zoellick said in an interview that he believed genetically modified food could help alleviate hunger worldwide and that he wanted the European opposition to be confronted and unfounded fears erased so that developing nations would accept food from genetically modified crops.

Experts agree that the United States could win a case at the World Trade Organization and force a lifting of the four-year old ban.

The ultimate resolution of this case, however, will rest on labeling — not food aid — and promises to pit European ideas of food regulation against American notions about free trade.

Many European consumers are demanding labels that identify which food has been genetically modified, while the American agricultural industry is just as strongly opposed to labeling, saying it gives the food a negative connotation.

"The U.S. is afraid that by starting to distinguish which food is genetically modified, then they will have to distinguish energy standards, toxic standards that are different than those the European promotes," said Lori Wallach, director of Public Citizen's Global Watch. "It's using trade agreements to determine domestic health, safety and environmental rules."

Agriculture Department officials say this is nonsense, that the United States does not require labeling, so why should Europe.

"That implies that there is something wrong with genetically modified good," said Elsa Murano, the Agriculture Department's undersecretary for food safety. "It would be another kind of trade barrier."

The agricultural industry also complains about the cost of the proposed labels.

"Labeling is a sham," said Mary Kay Thatcher, lobbyist for American Farm Bureau, a powerful agricultural group. "It would be so expensive, it would shut down our exports."

Franz Fischler, the European farm commissioner, said in an address here today that the problem could be resolved within the year if the United States agreed that the products deemed safe would be labeled as genetically modified.

His remarked were echoed earlier here by Margaret Beckett, the British minister in charge of food and the environment, who said both sides of the argument had to understand the serious cultural differences underlying the disagreement.

"Extravagant claims are sometimes made on either side of the argument," she said. "Whether we like it or not, there is an expectation of traceability and labeling of all kinds of products among European consumers. You are not going to convince them that G.M. products should be an exception to what is the norm."

While European nations agree on the need for labeling in the face of deep consumer fears, American lawmakers have had a more mixed record.

Although it took 12 years of lobbying by farmers, chefs and environmentalists, the Agriculture Department last year created an official organic label to show consumers what produce has been raised without conventional pesticides or fertilizers, antibiotics or growth hormones.

In last year's farm bill, Congress included a provision opposed by much of agribusiness that requires that all meat, fish and produce be labeled with its country of origin within two years.

"The United States is not monolithic," said John Audley of Carnegie Endowment. "Business groups may have to yield on labeling while activists will have to yield on allowing genetically modified food to be sold and let consumers decide what they want."

Already, Canada has complained that the new country of origin labeling will restrict its trade with the United States, especially its meat. In a study released last month, Canadian officials also complained about the cost and suggested that the new provision should be withdrawn.

That is unlikely until the European ban on genetically modified food is lifted and the issue of labeling is confronted head on.


F.D.A. Says Food Supply May Contain Altered Pigs

By Andrew Pollack
The New York Times
February 6, 2003

The Food and Drug Administration said yesterday that it was investigating the possibility that genetically engineered pigs might have been illegally sold for use as food.

The agency said it did not consider the pigs to present any risk to public health. Still, the incident is the latest of several that call into question whether regulations are adequate to assure that the food supply remains safe as plants and animals are increasingly engineered to produce drugs and other products.

The pigs were created at the University of Illinois as part of an experiment to see if they could be made to grow faster without injections of antibiotics, a common practice that has raised safety concerns.

Some pigs were given a cow lactation gene to promote increased milk production for their young, university officials said. Others were given a synthesized gene for insulin-like growth factor 1, which was designed to improve their digestion. Some pigs contained both genes, they said.

The F.D.A. said that from April 2001 until last month, 386 of the offspring of the genetically engineered pigs were sold to a livestock dealer who might have sold them for use as food. While the university insisted that the offspring had not inherited the foreign genes and were thus not genetically engineered, the drug agency said it could not verify that. In any case, the offspring were not supposed to have been sold for food without permission, the agency said.

"They were not to release them without our permission and this is their potential violation," Dr. Lester Crawford, F.D.A. deputy commissioner, said in a telephone news briefing, adding that the university could face fines or be required to stop certain research.

Dr. Crawford said the agency did not consider the animals harmful because animals have the proteins produced by the genes anyway, and there would be no extra residue of these proteins in the meat.

Bill Murphy, associate chancellor for public affairs at the university, said testing was thorough. He said the university had been doing this since 1999 and had discussed its testing program with the F.D.A. in 2001.

"It was a surprise to hear them say today that they never knew those pigs were going to market," Mr. Murphy said, adding that Illinois did not think it had to ask for permission to sell those pigs because they were not genetically engineered.

Mr. Murphy would not reveal the researchers involved, saying the university feared vandalism by those opposed to genetic engineering. It has stepped up patrols of its animal laboratories.

While genetically modified crops are now consumed, there have been no genetically engineered animals used as food. To increase milk production, many dairy farms inject cows with a cow growth hormone made using genetically engineered cells, but the cows themselves are not genetically engineered.

The drug agency is now evaluating an application for the first genetically altered animal for use as food - salmon engineered to grow quickly. A report by the National Research Council last year urged the agency to be cautious in allowing foods from transgenic animals on the market.

There does appear to have been an incident in 2001 in which meat from genetically engineered pigs was eaten. Three transgenic pigs produced at the University of Florida that were supposed to be destroyed were stolen by a technician, who gave them to a butcher. Sausages made from those pigs were served at a funeral, according to a report by The Associated Press.


Debate Begins over Biotech Wheat

AP/ February 4, 2003

BISMARCK, ND -- A North Dakota lawmaker wants to hold seed manufacturers financially responsible if pollen from their biotech wheat drifts to neighboring organic fields.

The state Senate's Judiciary committee listened to witnesses Monday during an initial hearing on state Sen. Bill Bowman's bill.

"I'm not saying you can or can't plant [biotech wheat]," Bowman said. "But if you do, liability concerns have to be addressed."

Critics of the bill have denounced it as an obstacle to technology.

John Olson, a Bismarck attorney and lobbyist for St. Louis-based Monsanto Co., said Bowman's bill presumes that biotech wheat is harmful. The wheat must be approved by the federal Food and Drug Administration, Olson said.

"It bothers me that [the bill] suggests this is a contaminant in the food chain," Olson said.

Monsanto is developing a wheat variety resistant to the company's Roundup herbicide. The genetic changes, the company says, will allow a farmer to spray the herbicide without harming the wheat plants.

Monsanto has already rolled out biotech versions of corn, canola and soybeans that are in use in North Dakota.

Related link: Monsanto Defeats GE Wheat Regulation Effort in North Dakota


Scientists Witness Migration Of GM Cell Material

By Steve Connor Science Editor
The Independent - UK
February 5, 2003

A technique for producing "environmentally friendly" GM crops has been called into question by a study showing how easily alien genes can be transferred around a plant.

Scientists have found that genes can jump from one region of a plant cell to another, making more likely the prospect of an introduced gene contaminating the plant's pollen and escaping into the wild.

The research, led by Jeremy Timmis of Adelaide University in Australia, focused on the DNA of chloroplasts - the photosynthetic structures inside a plant cell - which lie outside a plant's nucleus.

Some researchers have suggested that by modifying the DNA of chloroplasts, GM crops might be created with beneficial traits that cannot be transferred to the plant's pollen and be released into the wild. Pollen is made using DNA from the cell's nucleus.

But Dr. Timmis has shown in a study published in the journal Nature that genes introduced into the DNA of a chloroplast can indeed jump into the chromosome of the cell's nucleus. By modifying the genes of chloroplasts, therefore, the theoretical possibility exists to generate GM pollen that could cross-fertilise with related species of plants, producing GM wild flowers or "superweeds" resistant to weedkiller.

Dr. Timmis's team used a gene that confers resistance to an antibiotic as a "marker", to see how frequently this alien DNA could move from the chloroplast to the nucleus of a tobacco plant. They found DNA is transferred at a frequency of one in approximately 16,000 tobacco pollen grains.

Peter Riley, of Friends of the Earth, said: "This research suggests that this is a bit of a shock to scientists. They didn't expect the genes to jump from chloroplast to nucleus so readily. It underlines the fact that we must know more about plant genetics before we start manipulating the DNA of crops."


Dr. Barry Commoner's Response to Readers


It is now several months since you commented (in a letter to the editor or by e-mail to CBNS) on the publication of my article, "Unraveling the DNA Myth," in the February 2002 issue of Harper's. I regret the long delay in responding to your comments; because of the large number of them that we received, it was impossible to respond to them individually. (By September 2002 there were over 400 responses to the article, commenting on it and/or requesting the list of references.) Instead, my colleague, Dr. Andreas Athanasiou, and I have taken the time to prepare an analytical response to the comments as a whole and a summary of how the value judgments (positive/negative) expressed in these comments were distributed among several identifiable groups of respondents. These analyses are now available on the new web site which we have just established to facilitate the work of our Critical Genetics Project.

The Critical Genetics Project is one of the programs of the Center for the Biology of Natural Systems at Queens College, City University of New York. The Project responds to the need to consider new ways of understanding the roles of the living cell's molecular constituents, such as DNA, RNA and protein, in the biology of inheritance. We plan to establish a searchable database of the relevant research and to prepare ongoing critical analyses of such research in publicly accessible forms. We invite you to visit our web site, initially for our analysis of the responses to the Harper's article and, over time, for its ongoing program as well.

Barry Commoner


Food Giants and Biopharm Companies Clash

By Patricia Callahan
Staff Reporter of the Wall Street Journal February 6, 2003

More Restrictions Are Sought For Genetically Altered Crops Crops That Are Altered for Medicines Should Be Sterile, Secluded, Group Says

Crops that are genetically altered to produce medicines risk contaminating the food supply, the food industry's largest trade group says. It is asking federal regulators to place more restrictions on them. Biotech companies already are turning cornfields and other food plots scattered across the Grain Belt into open-air pharmaceutical-manufacturing facilities, capitalizing on plants' abilities to make medically important proteins more quickly and at far less cost than fermentation factories can. While many in the food industry support using crop biotechnology to develop drugs, food executives are concerned that crops containing vaccines, enzymes, hormones and antibodies could get into the food supply, triggering costly recalls and liability issues. The trade group wants biotech companies to avoid genetically engineering food crops to make drugs unless they can prove using other plants isn't feasible.

The Grocery Manufacturers of America, along with nine food and restaurant industry groups, Thursday plan to recommend to the U.S. Food and Drug Administration restrictions on the nascent biopharming industry in an effort to protect the food supply from contamination. The Grocery Manufacturers, which represents Kellogg Co., General Mills Inc. and more than 100 other food companies, said it isn't confident that the current regulations are strong enough to keep drug crops off America's dinner tables.

If biotech companies plan to use food crops to make drugs or chemicals, they should be required to raise the pharma-crops in regions where food crops aren't grown, or render the altered plants sterile to prevent cross-pollination with food crops, the trade groups will say in the letter to the FDA recommending those and other preventative measures. Corn pollen, for instance, can travel for miles on the wind or on birds.

The government should consider cracking down on violators by withholding approval of that company's drug application, the food industry group said. "We want to make sure the risks are addressed upfront," said Karil Kochenderfer, biotech director at the Grocery Manufacturers. "It ... takes only one accident to upset years of research and promise."

Biotech industry officials hope biopharming will grow into a multibillion-dollar business by the end of the decade, and new regulations could either aid or impede that expansion. Plants such as rice and corn are popular with biotechnologists because much is known about their genetic makeup. Corn is being modified to produce compounds used to treat patients with cystic fibrosis and herpes. Rice, a self-pollinating plant, is being altered to create a protein used to treat fungal infections. Scientists extract the desired compounds for drug production and discard the plant.

The Biotechnology Industry Organization, which represents pharmaceutical and crop biotechnology companies, says the current regulatory system is working well to prevent pharma-plants from mixing with food crops. The federal government, for instance, requires inventors of these experimental crops to plant them at a time of year when they couldn't pollinate food crops and sow them at a distance from areas where related plants are grown.

As long as scientists are able to adhere to those regulations, they should be able to use whatever crops work best for a drug's development, said Lisa Dry, a spokeswoman for the Biotechnology Industry Organization, a trade group. "The system is not only set up to protect the food supply but to produce more drugs," she said.

Last year an experimental corn genetically modified to make a diarrhea drug nearly slipped into the food system in Nebraska. A farmer had contracted with ProdiGene Inc. to grow the corn in 2001. Some of the corn plants re-emerged last year in the farmer's soy field and mixed with the soy during harvesting. Government regulators quarantined the grain elevator and fined ProdiGene.

The biotech industry sees the incident as an example of a regulatory system that is working. The food industry sees it as a near miss.

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