January 2000
headlines and summaries

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U.S. accepts trade agreement for altered food

January 30
Washington Post

MONTREAL, Jan. 29 – The United States today accepted under pressure a new international trade agreement that could speed the labeling of genetically engineered foods on the world market, a move that puts new pressure on U.S. farmers to separate the increasingly controversial foods from the overall supply.

The pact, adopted by delegates of 140 countries after being endorsed by the United States, would allow a country to ban the import of a genetically modified food without full scientific proof that it was unsafe.

The United States pioneered the use of genetics in agriculture and is the world's leading producer of genetically altered food. The United States and a small group of food exporters had resisted the new regulations, but after five days of contentious negotiating agreed to endorse the package. In return, other nations agreed to put off for at least two years from the pact's implementation proposals to track and regulate global shipments of the gene-altered foods.

The United States could point to numerous concessions it had won. However, many conference participants thought that over the long term the accord would legitimize notions that bioengineered foods are specialized products that must be treated differently than foods that are not altered. This could speed the spread of labeling.

Many consumers, given the choice, prefer non-engineered foods. Europe has required consumer labeling in stores; in the United States the practice has remained voluntary and rare. If consumer resistance to genetically altered foods increases – and international environmental groups are waging well-financed campaigns to try to make that happen – U.S. farmers that have embraced the technology may have to reconsider its use.

Frank E. Loy, an undersecretary of state and head of the U.S. team in Montreal, described the agreement as "not perfect." He said, however, that laying out rules will "make it easier for all of us to harness the promise of this technology to feed the world's growing population using less land, less water, less pesticides." Though nations can ban the import of the products, U.S. officials said the deal requires that barriers to the products be based on scientific findings, not baseless fear or protectionism.

U.S. opponents called the accord a victory for their side, saying it will increase people's right to control what they eat. "This is about the right to choose for consumers," said Margot Wallstrom, commissioner of environment for the European Union, which contends that despite U.S. findings of safety the new foods and organisms may harbor unknown health and environmental hazards. "This is a victory for all of us."

In sessions leading up to the agreement, announced at 4:40 a.m., bargaining had as much to do with economics as the environment. U.S. farmers sold the world about $50 billion in farm goods last year, much of it genetically engineered, and are anxious to continue doing so. Other nations worry the technology will put their own farmers at a disadvantage in international competition.

Even without global rules, consumer boycotts and pressure from foreign governments are pushing farmers and grain companies to develop economical ways to separate out foods that contain genetically modified organisms (GMOs). The gene-altered foods now are mixed with regular crops once they leave the fields.

The United States has pioneered the use of genetics in agriculture, in which scientists tinker with the genetic life codes of plants and animals to give them attributes not found in nature, such as special resistance to pests. The products must be approved by the Food and Drug Administration before they can be used commercially.

Last year more than a third of the corn, soybeans and cotton planted in the United States was of genetically altered varieties, and much of the crop was exported.

In the 1990s many foreign countries, encouraged by environmental groups, began taking exception to shipments of gene-altered foods. People in the biotech industry express dismay at the reception the technology has received, saying the opposition is based on ignorance and political manipulation.

Today's agreement is an elaboration of a Convention on Biodiversity that came from the 1992 Earth Summit in Rio de Janiero. The United States never ratified the original convention and was not a formal participant in the Montreal talks. As the world's largest food exporter, however, U.S. cooperation was needed and the Clinton administration has said it will abide by the negotiated protocol.

Under terms of the agreement, a biosafety clearing house will operate to help countries share technical data on new engineered products. The rights of nations to regulate the import of the products was affirmed.

The United States did not oppose provisions that require prior notification to nations being sent genetically engineered seeds and living organisms intended for introduction into the environment – this information already is provided under other agreements. Scientists say these products need special care and can have detrimental effects if not properly cultivated.

The big fight centered on a notification system for foods produced from engineered seeds and exported. Most of the world wanted such a system, but U.S. negotiators countered that such notification would tie up international trade in red tape at the cost of billions of dollars and to no purpose.

Compromise language reached by U.S. and European negotiators provided for the group to put this question off for two years. U.S. negotiators sold the delay on the logic that if market forces move the industry toward a system of segregation within the two-year period, the United States would be unlikely to fight incorporating the system into the rules.

The United States also won language that it said would help prevent nations from raising false concerns to get out of market-opening terms under the World Trade Organization.

Environmentalists were not happy about the two-year postponement on labeling talks. "It's very unfortunate that there is no segregation [of GMOs], no traceability," said Mika Railo of the activist group Greenpeace. "But there's a good foundation. We will work to improve it."

Gene therapy run amok?

January 30
Washington Post editorial

THE DISCLOSURE of worse-than-shoddy research practices at the University of Pennsylvania's Institute for Human Gene Therapy sends a cold shiver through the field. Even ardent supporters of gene therapy--the promising but as yet unrealized hope of curing people's inherited disorders by giving them new genes--are hard-pressed to explain why a well-regarded research institute would cut corners, ignore safety checks, fail to file required documents with the government and otherwise appear to disregard established procedures for the protection of human subjects in experiments.

Critics have long expressed concern (which we share) that gene therapy research is vulnerable to abuse because it is mostly backed by venture capital. Researchers who are also investors, such as Penn principal investigator James Wilson, may be tempted to oversell the promise of experiments and keep "adverse events" quiet lest they depress stock prices. Dr. Wilson has said financial interest plays no role in his research decisions. And no federal conflict-of-interest rule prevents public research money from being used together with private funding; such mingling is common.

The Food and Drug Administration, investigating after 18-year-old Jesse Gelsinger died in a Penn experiment, has now shut down all seven pending trials in the institute, including attempts to cure cystic fibrosis and breast cancer. The FDA cites 18 violations that include failure to inform patients of risks, failure to follow the trial's own rules as to which patients (including Mr. Gelsinger) were healthy enough to qualify as subjects, failure to notify the FDA in timely fashion of serious side effects and failure to halt the experiment as required when four patients suffered those side effects.

This is all the more shocking when you consider that these researchers were working in an area where even the most meticulous and conscientious experiments carry risk: Experiments with gene therapy frequently involve people already suffering life-threatening conditions, who may be more vulnerable to unexpected side effects. All this calls, at the very least, for scrupulous reporting of risks to the patients concerned, backed up by strong oversight.

Further investigation--Penn has said it will form an outside committee, while Sen. Bill Frist intends to hold hearings--will likely probe the degree to which the FDA missed danger signs in confidential reports, waking up only when public reports emerged through NIH. Biotech companies have been calling for less disclosure to NIH, but this disaster argues for more.

Montreal talks agree on rules for biosafety

January 30
New York Times

Delegates from more than 130 nations today adopted the first global treaty regulating trade in genetically modified products, setting up an international framework for the increasingly heated and divisive debate about foods made with biotechnology.

The biosafety treaty, forged after a week of intense negotiations that often pitted the United States against almost everyone else, allows countries to bar imports of genetically altered seeds, microbes, animals and crops that they deem a threat to their environment.

But virtually all of the proposed provisions that Washington had feared would cripple world food trade and endanger billions of dollars a year in American farm exports were watered down or eliminated. This led some European delegates and environmentalists to complain that the accord had been unduly weakened.

Whether the treaty heightens consumer concern or helps ease it, the debate surrounding genetically altered food is sure to continue. European consumers, in particular, are wary of risks to human health and the environment and have become increasingly militant in their rejection of food that contains genetically modified grains or soybeans.

About half the soybeans and one-third of the corn grown in the United States last year contained foreign genes making the crops resistant to herbicides or insects, and European resistance has cost American farmers millions of dollars in lost exports.

Some of the European intensity in the debate stems from food scares unrelated to genetic engineering, such as mad cow disease in Britain and dioxin-tainted chickens in Belgium. Some also has arisen from their dislike of what is often called the American culinary imperialism of companies like McDonald's.

Concern about genetically altered food has also risen in the United States, where the Food and Drug Administration held public hearings on the subject recently and some members of Congress are calling for food with genetically modified ingredients to be so labeled.

Despite the continuing controversy, when the biosafety protocol was finally approved at around 5 a.m., weary delegates from all sides stood up and applauded and hailed it as a significant achievement.

"By reaching an agreement today, I hope we have taken an important step toward depolarizing the debate about biotechnology," said Frank E. Loy, United States under secretary of state for global affairs. "Conversely, failure to reach an agreement today would have exacerbated tensions over this issue."

Chee Yoke Ling of the Third World Network, an environmental group based in Malaysia, said that the treaty had "a lot of holes." But she added, "I think it's historic in the sense that international law is recognizing that G.M.O.'s are distinct and have to be regulated separately." G.M.O. stands for genetically modified organism.

Biotechnology company executives said the new treaty could actually help the industry by countering a perception that biotechnology is not adequately regulated. "I think it will give some members of the public a stronger feeling that there is appropriate amounts of oversight," said Steven J. Daugherty, director of government and industry relations at Pioneer Hi-Bred International, the huge seed company.

But no one thinks the controversy will go away. Indeed, the treaty could make consumers even more aware of the issue.

Delegates said the treaty represented a rare recent success in balancing environmental protection with free trade, interests that are often difficult to reconcile.

Talks on these topics broke down at the World Trade Organization meeting last year in Seattle, and huge protests were held by environmentalists, foes of biotechnology and others.

The biosafety talks themselves broke down a year ago in Cartagena, Colombia, when the United States and a handful of other big agricultural exporters blocked a treaty agreed to by virtually all the other countries.

Here in Montreal, demonstrations were small. And the atmosphere in the negotiating halls was far more positive than in Cartagena.

Still, early this morning, it appeared that history might repeat itself. The United States and Canada refused to agree to a requirement -- supported by virtually all the other countries -- that shipments of genetically altered commodities like corn or soybeans identify the specific variety. The two countries said such a requirement would be unworkable, requiring different strains that are now intermingled to be segregated and tracked from field to dock.

A tense standoff ensued for hours.

Finally, frowning and grumbling, the Europeans backed down, and the treaty requires stating only that the shipment "may contain" genetically modified organisms.

Industry officials said genetically modified crops would not have to be segregated.

The new treaty will be known as the Cartagena Protocol on Biosafety and will go into effect after being ratified by 50 countries.

The protocol is an outgrowth of the Convention on Biological Diversity forged in Rio de Janeiro in 1992. Because the United States never ratified the convention, it cannot become a party to the biosafety protocol. But American industry will have to comply with the rules when exporting to countries that are parties. And federal officials here said the government would honor the treaty.

The new biosafety protocol is mainly concerned with protecting the environment from the consequences of genetic engineering. For instance, genes that make crops herbicide resistant could spread by pollination to weedy relatives, creating super-weeds. Or fish given genes to make them grow faster might out-compete others for food or mates.

The protocol is not really aimed at risks to human health from food made using biotechnology, although it does contain some vague language saying that such risks should be taken into account.

The treaty also does not address whether food containing genetically altered ingredients, like corn flakes made with bio-engineered corn, should be labeled as such on store shelves. It deals only with labeling commodities like wheat or corn during international shipments.

The key requirement of the treaty is that exporters must obtain permission in advance from the importing country before the first shipment of a particular "living modified organism" meant for release into the environment, like seeds, microbes or fish to be put in a river.

But advance notice and permission will not be required for exports of agricultural commodities meant for eating or processing rather than for release into the environment. Washington had argued that requiring such advanced notification would have tied up food trade in red tape.

According to the compromise in the treaty, when a crop is approved for commercial use in one country, that country must send information about that crop to a central clearinghouse. Other countries can then decide whether to prohibit the imports.

There are other deletions from the protocol that American industry cheered but that some environmentalists said weakened the accord. The treaty, for instance, does not apply to human pharmaceuticals. And advance permission is not required for shipments of genetically altered organisms intended for what the protocol terms "contained use," such as a vial of cells for use in a research laboratory.

Environmentalists, as well as delegates from Europe and developing countries, said the most significant achievement was inclusion in the treaty of perhaps the strongest formulation to date of the "precautionary principle." This states that a nation can take action to protect itself -- in this case by barring import of a genetically modified organism -- even if there is a lack of scientific certainty that it would be dangerous.

All night talks in Montreal yield deal on genetically modified foods

January 29
Nando Times

Just before dawn, Colombia's environment minister Juan Mayr announced to a conference hall full of delegates that the yearlong stalemate had ended.

"The adoption of this protocol represents a victory for the environment," Mayr said, fighting back tears. "But don't forget that this only represents the beginning. We have still before us a great challenge."

The Biosafety Protocol to the U.N. Convention on Biodiversity provides rules intended to protect the environment from damage by genetically modified plants, animals and bacteria.

The protocol allows a country to ban imports of a genetically modified product if it feels there is not enough scientific evidence showing the product is safe. It also provides rules for the transport and labeling, requiring that the words "may contain living modified organisms" appear on all shipments of genetically altered commodities, such as corn and cotton.

"The text is good from our point of view - very good," said Adrian Bebb, an environmental activist with Friends of the Earth.

Environmentalists and a few scientific studies have raised concerns that genetically modified organisms could wipe out native species, disrupt natural cycles and cause other ecological damage.

The European Union and developing nations argued that countries should be allowed to refuse imports of a genetically modified product if little is known about its environmental effect.

But the United States and its partners disagreed, saying many of the proposed rules would restrict trade.

On Saturday, U.S. negotiators said they were satisfied with the final agreement.

"On balance we think this is an agreement that protects the environment without disrupting world food trade," said head U.S. delegate David Sandalow.

Negotiations stretched hours beyond Friday night's deadline as delegates struggled over the intricacies of the deal.

In one of the main compromises, the United States and its supporters were able to amend rules that would have required labels to give specific details on what genetically modified materials are in a product.

Under the compromise, for two years after the protocol comes into effect, labels must say only that a product may contain such materials, without specifics. During those two years, negotiators will work out more specific labels.

Negotiators also reached a compromise on the thorny issue of how the protocol would relate to the World Trade Organization. After months of debate over which treaty should prevail, it was finally decided that the two should be "mutually supportive," with a specific statement in the document declaring that nothing in it is "intended to subordinate this Protocol to other international agreements."

Peter Hardstaff, a trade expert with the Royal Society for the Protection of Birds, said that wording effectively leaves the relationship between the two treaties to the WTO's dispute resolution panel.

"This is continuing the muddle about trade versus international environmental protection," Hardstaff said.

Talks last February in Cartagena, Colombia, ended in disarray when the United States and five other countries - Canada, Australia, Argentina, Chile and Uruguay - rejected a draft agreement favored by 125 other countries.

The situation has changed since then, with major U.S. food producers such as Archer Daniels Midland, Gerber and the Iams pet food company either demanding that genetically modified products be segregated or refusing to use them altogether. Protests at the WTO talks in Seattle last month also suggest that the American public has concerns about genetically altered food.

"In the year since Cartagena, it has become obvious that the position of the (United States') group is increasingly isolated," said Philip Bereano, a University of Washington professor who has been following the talks.

Genetically modified crops are already widespread. About 70 million acres of genetically engineered plants were cultivated worldwide in 1999. In the United States, genetically engineered varieties account for about 25 percent of corn and 40 percent of soybeans.

U. Virginia researchers use glowing frogs to investigate eye genetics

January 28
Cavalier Daily (UVA paper)

CHARLOTTESVILLE, Va. -- Remember when you were young and couldn't sleep at night because you were afraid of glowing, green-eyed creatures? Perhaps your parents told you that they didn't exist to ease your troubled mind. They were wrong.

Researchers at the University of Virginia are combining a gene from a frog that controls where a protein is active with a green florescent protein known as GFP from a jellyfish. This unique biological blending creates frogs with eyes -- and nervous systems -- that literally glow a bright, neon green.

For the past three years, University Biology Prof. Robert M. Grainger and his troop of researchers have engineered green-eyed Xenopus tropicalis frogs to understand how the different parts of the amphibian embryo develop and work in conjunction with each other.

With embryos "you start out with a simple structure and you end up with something very complex," Grainger said. "And it's amazing that at least most of the time it works out right."

Grainger's lab is one of the first to use X. tropicalis for genetic studies.

Funded by the National Institutes of Health, Grainger's research specifically investigates how genes within the eye of a frog function in its development.

THE EXPERIMENT

Evolutionarily speaking, organisms often share a common bond: for instance, Pax6 is a gene present in every animal species from the frog to the human. The function of Pax6 is to assist in the formation of the eye. Mutations in this gene can cause aniridia, which is an absence of the iris and the leading genetic cause of blindness in humans.

In general, while one component of a gene codes for the production of specific proteins, another component can control where the protein gets expressed.

For Grainger's experiments, the control region (from the frog) directs the gene's activity to the eye. The GFP (from the jellyfish) is the marker that indicates to researchers where the gene is expressed in the frog by illuminating the particular cells with a striking glow.

"Seeing the frogs' eyes glow is a spectacular sight, truly a marvel of modern science," said David Z. Rose, a fourth-year College student and assistant in Grainger's lab.

The frogs' eyes glow because of a little genetic magic. Frog sperm DNA is cut in specific places, using restriction enzymes. Next, the sperm is combined with the GFP of the jellyfish DNA. The sperm carrying the new DNA is injected into a female's egg cells, which incorporate the DNA permanently into the genome. The frogs thereafter can pass on their glowing features to their offspring.

Armed with this technique, scientists can understand the functions of the Pax6 gene. And with more restriction enzymes, researchers can chop Pax6 into increasingly smaller pieces until the gene no longer functions. This genetic slicing allows scientists to determine the key region responsible for controlling gene expression.

"This is a very important lesson in biology, that genes are not active everywhere but they are only active in certain parts in the body, and this green protein tells you that in a very dramatic sort of way," post doctoral researcher Nicolas Hirsch said.

A NEW RESEARCH TOOL

The X. tropicalis frog is a fairly new addition to the group of animals commonly used in genetic testing, which for decades has included flies and mice. X. tropicalis is smaller than the previously used X. laevis frog, whose four sets of chromosomes (known as tetraploidy) posed many obstacles for geneticists. In contrast, X. tropicalis has two copies of its genes, which makes it more conducive to research -- and mutation. It also develops much faster than X. laevis, reaching sexual maturity in under five months. Like X. laevis, it can be induced to lay eggs at any time with the injection of specific hormones. This gives researchers a relatively constant supply of eggs instead of having to wait for the frogs to lay a fresh batch each spring.

The transparency of X. tropicalis tadpoles further facilitates the scientists' studies.

"I think the greatest advantage is that [X. tropicalis] combines two areas of science: genetics with embryology," Hirsch said. "Being able to watch the gene expression in the living embryo is a powerful tool for research."

Grainger agreed, adding that the large eggs and large embryos lead some people to believe they are the best tools to study early development.

WHERE IT'S ALL LEADING

Valuable information about human genetically based diseases can emerge from Grainger's work. After all, frogs develop in similar ways to humans and allow for testing that would not be acceptable in humans. Conceivably, they might engineer frog embryos with the same deficiencies as humans and try to treat them for the disease, Grainger said.

He said he plans to develop the frogs as an educational and research tool for the science world at large. He added he hopes to see the frog made available to high school and college students.

"This is a dramatic example of gene expression," Grainger said. "Another goal is making it known to the scientific community that we have these animals and they are available for people to use in their research," Hirsch said.

What's in the future for transgenic X. tropicalis?

"Frogs with green brains or green gills or green muscles," Hirsch said. "We could study the development of lots of different tissues."

"Florescence is spooky," Grainger said. "Once people see something like this they never forget it."