Genetic Concern welcomes food safety trade protocol
Irish Times 3feb00

The new bio-safety protocol on GM food trade means an international acknowledgement of the environmental risks associated with such produce, says Irish campaign group Genetic Concern.

After five years of protracted negotiations 140 countries agreed to the protocol last weekend. Its significance in stark contrast to the World Trade Organisation talks collapse in Seattle is reflected in the agreement by all sides that environmental concerns and trade rules have been reconciled, notwithstanding the possibility of a legal challenge to some of its provisions.

Much of its benefits in allowing countries to decide whether to accept GM food imports and to set their own rules on genetically modified organisms could be undermined, however, by a long lead-in time for its ratification, Genetic Concern spokeswoman Ms Jo Goldsmid said this week.

Despite US reservations (and with EU insistence), it also accepts the guiding influence of the "precautionary principle" in the event of scientific uncertainty. This, Ms Goldsmid said, was "really promising". However, it will require the signatures of 50 countries before it is ratified, which may take until 2003. The contentious issue of labelling GM foods may not be resolved for a further two years. The US administration welcomed a comprehensive set of rules balancing the goals of trade in GMOs and protection of the world's ecosystems. The undersecretary for global affairs and head of the US delegation, Mr Frank Loy, said this should make it easier to harness the promises of biotechnology "to feed the world's growing population, using less land, less water, fewer pesticides".

Green Party MEP Ms Nuala Ahern said key demands from green groups had been taken on board. These included acceptance that the protocol would not be subordinate to the WTO, and set procedures for GM commodities. She added that it was a pity that measures on traceability and segregation of GM foods were not being enforced.

Meanwhile, Green TD Mr John Gormley has dismissed the move by Monsanto to change its name to Pharmacia following its recent $50 billion merger with the US-Swiss drugs giant Pharmacia & Upjohn. It was a public relations exercise in the face of "terrible publicity" surrounding its GM food business, he said.

Such a drastic move reflected the strength of feeling against the company. "Monsanto and their GM crusade will not succeed in any guise," he predicted.

Cloning: What hath genomics wrought?

February 3
Los Angeles Times column by Jeremy Rifkin

     Occasionally, a great change in history comes about quickly and without warning, transforming the very way we perceive ourselves and the world around us for generations to come. Such was the case when the world first heard about Dolly the cloned sheep. Now, Ian Wilmut, the Scottish scientist who cloned Dolly, has made history a second time, and the new development is likely to have an even greater impact on the world than the first.
     The British patent office has just granted Wilmut's Roslin Institute patents on his cloning process and all animals cloned using the process. The patents have been licensed to Geron Corp., a California-based biotech company. There is something more, however. The patent also includes as intellectual property--i.e., patented inventions--all cloned human embryos up to the blastocyst stage, which is a cluster of about 140 cells. For the first time, a national government has declared that a specific human being created through the process of cloning is, at its earliest phase of development, to be considered an invention in the eyes of the patent office. The implications are profound and far-reaching.
     It was less than 135 years ago that the United States abolished slavery, making it illegal for any human being to own another human being as property after birth. Now the British patent office has opened the door to a new era in which a developing human being can be owned, in the form of intellectual property, in the gestational stages between conception and birth.
     Regardless of where people may stand on the question of abortion, one would think that everyone would be shocked at the idea that a company might be able to own a human embryo as an invention.
     Parents, when they read about this extraordinary patent decision, should ask themselves whether their children and future generations will be well served ethically if they grow up in a world where they come to think of embryonic human life as intellectual property, controlled by life science companies. What happens to our children's most basic notions about the distinctions between human life and inanimate objects when the former comes to be regarded by law as mere inventions, simple utilities to be bartered like so many commodities in the commercial arena?
     And, if cloned human embryos are, in fact, considered to be human inventions, then what becomes of our notion of God, the creator? What will future generations say when their children ask, where do babies come from? Will they say they are the inventions of scientists and the property of life science companies?
     Geron makes the point that it has no intention of cloning a full-birthed human being, but only wants to use cloned human embryos as research tools. Still, this breathtaking patent marks the first commercial step into a brave new world of human reproductive technology and designer babies, where gestational human life becomes subject to ownership and commercial exploitation in ways that challenge our very notions of what it means to be a human being. It is possible that in the not-too-distant future parents will order up their children the way they buy other products, making babies the ultimate shopping experience in a post-modern world.
     Geron and the life science companies would argue that without patents they would not have the financial incentives to provide cures to deadly diseases and improve human health. Yet the question arises: What is wrong with an economic system in which advancing the human condition depends on allowing a few commercial enterprises exclusive right to claim cloned human embryos as their intellectual property?
     For several years, genomic companies have been engaged in a fierce battle to locate, isolate, define and patent plant, animal and human genes, the raw resources of the coming biotech century. Now, with the British patent office making the first stages of human life a patented invention, a new, even more ominous threshold has been crossed.
     Step by step, the groundwork is being laid for redefining the building blocks of life--the genes, the chromosomes, the cells, the organs, the tissues and now cloned human embryos--as private property, exploitable in the biological market place. Where will this journey end?

Biotech firm eyes future

Hopes products will fight world hunger

February 2
Los Angeles Times

MALIBU, Calif. - Worldwide protests against genetically engineered crops are on the rise. America's trading partners are calling for labeling of foods that contain ingredients from genetically modified plants. Federal regulators are re-examining the rules for assuring the safety of biotech foods.

Against this tumultuous backdrop, a handful of young companies are busily inventing the next generation of biotech plants, crops that promise increased food production and improved nutritional content or that offer a renewable, low-cost supply of medications and chemicals.

These small firms see this as a golden age of plant biology, and they are betting that the controversies will cool and the world will warm to their innovative products.

One of the promising, emerging companies is Ceres Inc., started in 1997 by a UCLA professor and his corporate partners with more than $50 million in private capital.

Investors in Ceres and other companies are hoping that by the time a new generation of genetically modified crops is ready, three to five years from now, the public will be satisfied that the crops present no hazards to consumers or to the environment.

Racing against competitors, which include the large seed producers as well as smaller firms, the company now employs 80 scientists as it rushes to exploit new developments in plant biology. The advances include the rapid decoding of genes, discovering their functions and finding efficient ways to transplant desirable genes from one species into another.

UCLA biologist Robert B. Goldberg, a co-founder of Ceres, says the company is "trying to position itself to be the premiere plant genomics company in the world and compete with DuPont and Monsanto and Novartis."

Goldberg says that unearthing just a few important genes from the tens of thousands present in a few species of plants will be enough to put the company over the top.

And the company already may have some of them, licensed from UCLA and other University of California campuses. These are genes that can boost grain tonnage by increasing the size of seeds, by growing seeds not just from flowers but in leaves, and by producing seeds without pollination.

Cranking up food production will be increasingly important to feed a growing world population, more important in many parts of the world than advances in genetic engineering that lead to new medications, says Richard Flavell, Ceres' chief scientific officer.

"In that part of the world where 3 billion people suffer from nutritional deficiency, your first thought is not how to get medicine to people, but `How do I feed them?' " Flavell said.

The hiring of Flavell was a coup for the fledgling company. He's the former director of the John Innes Centre in England, a world leader in plant genetics.

"To kick-start the firm," Flavell said, the company has farmed out its gene sequencing - the decoding of the chemical building blocks of plant DNA - to Genset, a French company that has one of the world's largest factories for deciphering plant, animal and microbial genes.

And it is working closely with scientists at University of California campuses in Los Angeles, Santa Cruz, Berkeley and Davis.

"The business strategy is to get immediate access to mature programs," he said, by licensing technology already developed and working with established researchers.

Eventually, Ceres could develop its own line of seeds.

"We want to be a product company and not just a technical supplier," Flavell said.

Goldberg helped found the company after a successful collaboration with Plant Genetic Systems in Belgium that led to a new method for creating plant hybrids that is widely used in the seed industry.

That work, Goldberg said, convinced him of the power of collaboration in producing improved plant varieties, and he set out to also establish a non-profit institute that would bring together academic scientists from several campuses.

Walter De Logi, the head of Plant Genetic Systems, and venture capitalist Edmund "Ned" M. Olivier of Oxford Bioscience Partners raised the money to start Ceres and fund the Seed Institute at the four UC campuses and the University of Utah. In exchange for providing $5.75 million over five years to underwrite university researchers, Ceres gets first crack at the rights to their inventions.

Company executives say they have no immediate plans for a public stock offering. They say they have enough capital to last a couple more years.

Biosafety talks conclude in surprising accord

February 2
Environmental News Network

The Biosafety Protocols negotiated in Montreal this past weekend are being cautiously praised by both environmentalists and industry representatives. The agreement on rules to regulate the international trade of genetically modified organisms has been extremely controversial and five years in the making.

Greenpeace called the agreement a historic step toward protecting the environment and consumers while industry representatives called the rules "workable."

The significance of establishing the precautionary principle, which environmentalists have lobbied for across many issues, can not be understated," said Philip Bereano of the Council for Responsible Genetics.

Under the protocols the precautionary principal allows countries to refuse to accept a shipment on the basis that it might cause harm to the environment or human health. Bereano, who is a professor at the University of Washington in technology and public policy, attended the Montreal meetings in his capacity as a representative of a non-government organization (NGO).

"In addition, the provisions of this treaty signifies that GMOs (genetically modified organisms) are not the same as conventionally grown crops. Industry has been making this argument while at the same time taking out patents that say they're completely different. This treaty emphatically establishes that GMOs present different kinds of risks that require particular scrutiny. The agreement is a tremendous victory for the environment."

Genetically modified products include seeds, grains, processed food and feed that have been bioengineered for a specific trait, such as resistance to pests, increased production or delayed ripening times. Advocates of GMOs emphasize the benefits of bioengineering: less pollution from pesticides and fertilizers and increased production to help combat world hunger. Opponents fear that unleashing biologically altered organisms into the environment could lead to a catastrophic loss in biodiversity.

The United States and its biotech allies — Uruguay, Argentina, Canada, Chile and Australia — managed to scuttle agreements in 1995 and 1999, fearing that the rules would restrict trade. Public opinion against bioengineering, as demonstrated in Seattle in November and in many European countries over the last year, may have ultimately swayed the negotiators representing the United States and its five allies to reach a compromise.

The most important issue was the establishment of the right of countries to reject a shipment on the basis that it might have a negative impact on the environment or public health. Under the rules of the World Trade Organization, which is widely perceived to favor trade over environmental issues, a country had to show a preponderance of scientific evidence.

Which set of trade rules would take precedence — those of the World Trade Organization or the rules negotiated under the Biosafety Protocol — was a sticky issue. The negotiators essentially finessed the issue with language saying that the two agreements will be "mutually supportive" and that nothing in the treaty is "intended to subordinate this protocol to other international agreements." How this issue is resolved will largely determine the effectiveness of the Biosafety Protocols.

"That's all preambulatory language," says Bereano, "not operative language, and it doesn't have any legal weight. The importance of the document is in its flexibility. How the language is interpreted will be determined by the political and social realities of the future. But it's a huge step forward to be squabbling over language rather than the principal itself."

Labeling products that contained genetically engineered organisms was another big issue. The United States and its allies agreed to the label "may contain living modified organisms" without specifics. Negotiators will have two years from the time the treaty goes into effect to come up with more specific labels.

Negotiators also reached a compromise on the Advanced Informed Agreement procedure, which would have required countries exporting GMOs to notify each country when a shipment containing GMOs was scheduled. This was a major sticking point at the talks that took place in February 1999. Under the compromise, technical information will be posted to a central registry rather than to individual countries.

The issue over who pays if environmental damage from GMOs occurs was tabled and will be addressed at future negotiations.

The negotiations, which took place Jan. 24-28, were held under the auspices of the United Nations. The agreement is an adjunct to the 1992 Convention on Biodiversity. Juan Mayr Maldonado, Colombia's environment minister, headed the discussions.

Something for everyone

February 2
Montreal Gazette

The Cartagena Protocol on Biosafety, adopted in Montreal early Saturday by delegates from more than 130 countries, does an admirable job of balancing environmental and commercial interests. The deal was a compromise that gave everyone from Greenpeace to Monsanto something to celebrate, even if that also meant no one was entirely satisfied with the result, and that some points were left deliberately vague.

The protocol covers "living modified organisms," also known as genetically modified organisms. These are crops or seeds or fish that have had genes from other living things introduced into them in order to help them grow faster or be more resistant to pests or herbicides. Supporters of such innovations say they can help humanity by increasing crop yields or lowering pesticide use. But some environmentalists have raised concerns that these crops could have negative side-effects on the environment. Some people also wonder whether eating them could harm human health. Others have religious or allergy concerns.

The protocol's purpose is to protect the environment. It only touches on human health indirectly. Two classes of genetically modified organisms are covered. The first are ones that are intended for introduction into the environment (such as seeds or fish). They will require advance notification to the importing country. Commodities, such as grain or soybeans, make up the second category and are subject to less stringent rules. But they must bear a label saying they "may contain living modified organisms" if that is the case. The "may contain" label represents a victory for grain exporters. Some importing countries had been pressing for more specific information on each shipment.

(Processed food is not covered by the protocol, which only deals with plants or animals that are capable of reproducing themselves. Thus, grain is covered, but not flour.)

A major victory for environmentalists - and for importing countries wishing to exercise caution - was the acceptance of the so-called precautionary principle, which an importer can invoke to ban imports of genetically modified organisms it has reason to be concerned about, even in the absence of conclusive evidence that it will be harmful. That seems like common sense.

Another important issue - and one that was left open to interpretation - was how to deal with conflicts between countries' rights under the protocol and their rights under World Trade Organization rules. However, one would think that the precautionary principle should stand, except when it is demonstrably being misused for protectionist reasons.

Much work remains ahead, both in terms of clarifying and implementing the protocol and in reaching a better understanding of the benefits and drawbacks of genetically modified organisms. Still, the adoption of the Cartagena Protocol was a welcome sign that these issues can be addressed jointly, and that progress can be made.