g o v e r n m e n t & policy
AT LAST: A BIOSAFETY PACT Most parties are reasonably satisfied with the treaty on biotech organisms, but the effect on trade in transgenic commodities is unclear
Bette Hileman C&EN Washington
After a week of tough negotiations in Montreal, delegates from 133 countries finalized a treaty to reg
ulate trade in genetically engineered organisms (C&EN, Jan. 31, page 5). The agreement aims to protect the environment from risks posed by transgenic seed, agricultural commodities, microbes, and live animals.
Although there were sharp differences between, on one side, the views of the U.S. and other major exporters of genetically modified crops and, on the other, the European Union and the rest of the world, the talks in Montreal were far less bitter and rancorous than they had been in Cartagena, Colombia, less than one year ago. In February 1999, negotiations in Cartagena aimed at concluding a biosafety pact collapsed largely over differing approaches to the treatment of agricultural commodities.
Most parties were reasonably satisfied with the agreement concluded in Montreal, which is called the Cartagena Protocol on Biosafety, although the reasons for their satisfaction vary widely. "It is a treaty that protects the Earth's biological diversity without disrupting world food trade," said U.S. State Department Undersecretary for Global Affairs Frank E. Loy following the meeting.
And Benedikt Haerlin, Greenpeace International's campaign coordinator for genetic engineering, was also upbeat. 'This is a historic step toward protecting the environment and consumers from the dangers of genetic engineering," he said.
Industry representatives and envi
ronmentalists, however, had quite different opinions about the long-term effects of the agreement. And some members of Congress fear it will eventually dampen production and exports of transgenic crops. The worldwide acreage devoted to such crops has grown substantially since 1995. But U.S. exports of corn to Europe dropped precipitously last year because Europe refuses to buy shipments that may contain transgenic varieties.
Tent pitched by Greenpeace shielded demonstrators and delegates from the cold.
"Certainly, to the extent that the treaty facilitates good decision-making and information sharing, I think it will help trade," said Robert L Harness, director of international government affairs for Monsanto. Joyce Groote, chairman of the Global Industry Coalition, a lobbying group for more than 2,200 biotech companies, said that "the protocol is a very clear indicator that the biotechnology industry will continue to grow." And Richard Ballhorn, cohead of the Canadian delegation, added that the protocol will improve the market prospects for countries that are exporting genetically modified products.
Greenpeace's Haerlin took a different tack. 'The protocol... lays the foun
dation for a stronger future agreement that will eventually protect the environment from genetically modified organisms," he said. "It raises the awareness of importing countries, especially where there is no legislation in place yet about segregation and labeling, and it will instigate national legislation to this end."
Sen. Richard G. Lugar (R-Ind.), chairman of the Agriculture, Nutrition & Forestry Committee, said he thought the protocol would cause even more problems for U.S. farmers with regard to exports of transgenic commodities, especially to Europe, because under the protocol, shipments that contain such commodities must be identified.
Gary Goldberg, chief executive officer of the American Corn Growers Association, said that the agreement "will severely burden farmers and grain elevators, resulting in higher premiums paid for" conventional varieties.
The talks in Montreal took place under the auspices of the United Nations Convention on Biological Diversity. Un
der UN rules, they were considered a continuation of the February 1999 negotiations that were suspended in Cartagena, when delegates were unable to agree on the text of a protocol.
Under the treaty, countries will state whether they are willing to accept imports of genetically modified agricultural commodities on an Internet-based biosafety clearinghouse. Commodity shipments that may contain transgenic crops must be clearly labeled "may contain living modified organisms" on the manifest. Two years after the protocol comes into effect, the parties
will meet again to work out more detailed arrangements regarding labeling and segregation of commodities.
A stricter regime applies to genetically modified seeds, live fish, microbes, and other organisms that will be introduced directly into the environment. For these, the exporter must provide detailed information to the importer in advance of the first shipment. The importer then can accept or reject the shipment. The treaty also aims to ensure that importing countries, particularly those that do not now have regulations for biotechnology, develop the capacity to assess risks from bioengineered organisms. Pharmaceuticals made from
FEBRUARY 14, 2000 C&EN 6 5
government & policy
genetically modified organisms and foods processed from transgenic crops are not included in the scope of the protocol.
Decisions on whether to allow imports are to be based on risk assessments, which, according to the protocol, should be "carried out in a scientifically sound and transparent manner," taking into account risks to human health. However, if the scientific data available for a risk assessment are incomplete or conflicting, countries are allowed to invoke the precautionary principle when deciding whether to accept an import. In other words, they do not have to interpret a lack of complete scientific knowledge or consensus as an absence of risk.
This proved to be one of the most contentious issues the delegates dealt with. The U.S. and several allies in the so-called Miami group—consisting of Canada, Australia, Argentina, Uruguay, and Chile—strove to put the precautionary principle only in the preamble to the treaty, so that it would be merely an expression of intent without ^™ the force of law. The rest of the world, especially the EU, tried to include the principle in the article that explains how risk assessments are to be carried out. In the end, the EU managed to get almost the exact words it had suggested into the risk assessment section of the protcol.
Another contentious issue that is part and parcel of the struggle over the precautionary principle was deciding the relationship between the Cartagena Protocol and World Trade Organization rules. WTO rules say import bans must be backed up by conclusive scientific evidence, a more rigid standard than the precautionary principle. Before the negotiations started, the Miami group had been pushing to make WTO rules dominant, while the EU and most other countries had been trying to ensure that the protocol would supercede or be equal to WTO rules. The final agreement states that WTO rules and the biosafety protocol should be "mutually supportive"—in other words, on an equal plane. At the same time, the protocol is not to affect the rights and obligations of nations under any existing international agreements.
Encino (left) and Gilman were among the farmers brought by Greenpeace to the meeting.
This statement has practical consequences. Under trade law, countries have not been able to ban an import unless conclusive scientific evidence shows it will cause harm. If WTO rules were to take precedence over the biosafety protocol, the language in the protocol regarding the precautionary principle would have little practical effect.
How the "mutually supportive" rela-
Transgenic crop acreage has increased rapidly worldwide Millions of acres3
100
1996 1997 1998 1999 a Excludes China. Source: International Food Policy Research Institute
Most commonly planted transgenic crop is soybeans
Crop
Herbicide-tolerant soybean Bt corn3
Insect-resistant/herbicide-tolerant cotton
Herbicide-tolerant canola Herbicide-tolerant corn
Million acres
35.8 16.5 6.2
5.9 4.2
Share of transgenic
acreage
52% 24
9
9 6
TOTAL 68.6 100%
Note: Statistics are for 1998 Bacillus thuringiensis (Bt). Source: International Food Policy Research Institute
Crop is modified with a gene from
tionship will play out when a country brings a case to WTO alleging unwarranted bans on transgenic imports is unclear. Loy believes the result will be fair. 'We think that when any dispute organization takes into account the totality of factors it has to consider, we are confident that we are going to end up with a satisfactory result," he said following the meeting.
Overall, the U.S. and industry, which have shared views, lost on several key points, including the treatment of the precautionary principle, the inclu
sion of commodities, and, to an extent, on the relationship between the protocol and WTO. Industry would have preferred that commodities be totally excluded from the protocol. In many respects, the final protocol reflected the publicity surrounding the talks.
The negotiations took place in the midst of a publicity war between environmental and consumer groups on one
side and industry organizations on the other. Industry hired the largest Canadian public relations firm, National Public Relations, to handle its campaign during the meeting. But when it came to the sheer number of press releases and press conferences, and the attention received, the environmental and consumer groups were the clear winners.
Environmentalists staged demonstrations that were designed not just to attract the attention of the delegates, but also the attention of the North American public, which has been slower to respond to the biotech debate, and to capture media attention around the world, Haerlin said.
On the Saturday before the meeting's formal opening on Monday, an estimated 600 to 1,000 people marched on Montreal's streets, protesting transgenic food.
Protests continued throughout the week of formal negotiations. Each day, environmental groups came up with a startling new image. On Monday, Greenpeace erected in front of the conference center a giant 21-foot inflatable corn cob with bloodshot eyes and large fangs that appeared to be devouring butterflies. On Wednes-
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g o v e r n m e n t & policy • H day, about a dozen young people dressed in black tights and sporting colorful 6-foot butterfly wings ran back and forth in front of the conference building.
On Thursday, Greenpeace erected a white tent at the building's entrance, and Biotech Action Montreal held evening candlelight vigils for biosafety "to enlighten Canadian negotiators," the group's signs said. All night on Friday, in single-digit temperatures, protesters stood outside near the tent chanting, "Hey, hey, ho, ho, GMOs [genetically modified organisms] have got to go," and drumming rhythmically on metal poles near the building.
Some delegates admired the demonstrators. "I was especially impressed by the people who went out in the cold to demonstrate over biosafety and gave strong support for the conclusion of the protocol. We are all winners here, but they are the real heroes," said Margot Wallstrom, European commissioner for environment.
Battling press conferences featuring farmers illustrated a sharp contrast. The Global Industry Coalition flew in four
farmers from the Midwest and Canada. "We believe in our science," said Bob Boeding of the National Corn Growers Association. "I guarantee you we wouldn't do anything that would harm our families," he added. W. Earl Geddes of the Canadian Wheat Board said the food chain is a just-in-time delivery system. "If a protocol comes in that stops food from moving into countries voluntarily, there will be hungry people," he said.
The next day, Greenpeace countered with its "Farmers Against Genetic Pollution." Dressed in native garb, they came from five countries, three continents, and spoke four languages. The farmers delivered similar messages—that transgenic crops pose a threat to organic farming and may destroy the genetic diversity of wild species.
'The presence of genetically modified crops in nearby fields may, because of cross-pollination, preclude farmers from growing certain organic crops," said Steve Gilman, a farmer from Stillwater, N.Y. Crops cannot be sold as organic if they are mixed with genetically modified varieties. Also, Bt crops—those that are
modified with a gene from the bacterium Bacillus thuringiensis—may soon destroy the usefulness of Bt spray, he explained, because Bt crops are now so widespread that insects are likely to become resistant to the Bt toxin. As a consequence, organic farmers will no longer be able to use Bt spray, the "only beneficent nontoxic pest control available to them," he warned.
Porfirio Encino from the Mexican Rural Association of Collective Independent Interests explained that Mexico is a center of origin for several crops, such as corn. This means that Mexico has many wild varieties that breeders use to improve existing commercial crops. But transgenic crops are likely to cross with these wild plants, destroying Mexico's rich assortment of wild species, he said.
The battle for public attention also included scientists. The Global Industry Coalition issued a letter signed by 600 researchers, which extolled the benefits and safety of biotech crops. "We, the undersigned members of the scientific community, believe that recombinant DNA techniques constitute powerful and safe means for the modification of
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organisms and can contribute substantially in enhancing quality of life by improving agriculture," it said.
Environmentalists countered with a letter signed by 230 scientists. "Current [genetic modification] techniques, which exploit living processes, are unreliable, uncontrollable, and unpredictable. . . . Furthermore, those techniques are inherently hazard-ous, as are many [genetically modified] organisms and products," the letter claimed.
Environmental groups also staged several press conferences that featured scientists or their work. Steven M. Druker, executive director of the Alliance for Bio-Integrity, an advocacy group based in Iowa City, Iowa, described how the Food & Drug Administration arrived at its regulations for transgenic crops. The agency decided that genetically modified crops are "substantially equivalent" to conventional crops and pose no special risks, although many of the agency's own scientists said transgenic crops are different
and do pose unusual risks, he said. He obtained this information recently from FDA memos that came to light during the discovery process for a lawsuit.
Stewart Magin-nis, senior forest
Loy (left) and Haerlin
officer at World Wildlife Fund International, spoke about risks posed by genetically modified trees that are under development for planting in fast-growing plantations. Their pollen travels at least 100 meters and sometimes as far as 600 km,
so their genes are likely to flow into wild tree populations, he explained. Also, trees are monitored far less than ordinary field crops, so any impacts the trees
might have on beneficial insects or wildlife would not be easily observed. Furthermore, since trees grow for at least a decade before they are harvested, their genetic material has a long time to become unstable, especially when subjected to extreme conditions, he said.
Jeff Ruch, executive director of Public Employees for Environmental Responsibility, a national alliance of local, state, and federal professionals, described how the Environmental Protection Agency approved a genetically engineered bacterium, Rhi-zobium meliloti It is a seed inoc
ulant designed to enhance the uptake of nitrogen in alfalfa. In 1997, most members of EPA's own scientific advisory committee recommended against approval, saying the bacterium was likely to change the soil ecology and had not
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been shown to be more effective than ordinary rhizobia, Ruch said. But EPA approved the modified bacterium anyway, while limiting its production to 500,000 lb. "Because the statutes [used for transgenic organisms] did not contemplate the regulation of life forms, the people at EPA who are involved in decisions about [genetically modified] organisms are trapped in a bad system," he said.
Why did the Montreal talks succeed in finalizing a protocol, while the Cartagena negotiations less than a year earlier collapsed?
One reason may be that Juan Mayr, president of the session and Colombia's environment minister, took the unusual step of personally inviting 50 environment ministers to participate in the last two days of the Montreal proceedings. More than 40 accepted the invitation. They may have been able to make tough political decisions that would have been difficult without their presence. Mayr was the only environment minister to attend the proceedings in Cartagena.
Another reason for the success of the
talks was that Mayr used unusually good negotiating skills to push the delegates toward agreement. Even when the situation appeared almost hopeless, he
Clockwise from left: Maginnis, Mayr, Ruch, and Wallstrom.
urged the delegates on, giving each negotiating group a deadline for creating compromises on specific issues. "My optimism for reaching an agreement is increasing day by day," he said often, almost as a mantra. And he combined his determination with levity. On Friday, about eight hours before the scheduled end of the talks, he gave the head of each group a toy bear. This innovative conflict-resolution technique may have helped facilitate the talks in some small way.
After the talks concluded, delegate after delegate praised Mayr's skill. "The atmosphere has been good, in spite of difficult negotiations, very much due to the chairman, Minister Mayr," Wallstrom said.
Another reason for success may be that the trade, sales, and consumer acceptance situation surrounding genetically modified
crops has changed a great deal over the past year. U.S. exports of corn to Europe declined to almost zero last year because of European reluctance to accept ship-
European Commission adopts precautionary principle plan A major source of contention among nations at the Montreal meeting was whether the precautionary principle should be included in the operating section of the protocol. At the conclusion of the meeting, the precautionary principle was included and two days later the European Commission (EC), the administrative arm of the European Union, issued its formal policy on the matter.
The EC laid out how the EU will use the precautionary principle. This concept holds that policymakers should regulate a substance or activity when preliminary scientific evidence indicates grounds for health or environmental concern but cause-and-effect relationships have not been fully established.
"Recourse to the precautionary principle presupposes that potentially dangerous effects deriving from a phenomenon, product, or process have been identified, and that scientific evaluation does not allow the risk to be determined with sufficient certainty," the EC said in early February. "The precautionary principle is not a justification for ignoring scientific evidence and taking protectionist decisions."
According to the EC, the precautionary principle should be incorporated into risk analysis, a process that involves the scientific assessment of risk, policy decisions to manage risk, and communication of risk. In particular, the precautionary principle applies to risk management.
Control measures imposed under the precautionary principle should be proportionate to the levels of health and environmental protection set by policymakers, the EC said. "Determining what is an acceptable level of risk for the EU is a political responsibility." However, "incomplete risk assessments may greatly reduce the range of options open to risk managers."
Measures put in place under the precautionary principle should be based on potential economic and non-economic benefits and costs of controls or lack of controls. "This is not simply an economic cost-benefit analysis," the EC said, but should include considerations of public acceptability and efficacy of various control options. In addition, there should be no discrimination in the way the precaution
ary principle is applied across comparable situations.
As new scientific data come to light, governments should review policies implemented under the precautionary principle and amend them as necessary, the EC said. "Measures based on the precautionary principle should be maintained so long as scientific information is incomplete or inconclusive, and the risk is still considered too high to be imposed on society," given the politically selected level of acceptable risk.
Government action taken under the precautionary principle should also assign responsibility for producing the scientific evidence necessary for a more comprehensive risk assessment, the EC said. In cases where a company wants market approval for a product that a government agency has deemed dangerous, the business will have to provide data showing its product is safe before it can sell the good. When no such premarket authorization is needed, "it may be up to the user or to public authorities to demonstrate the nature of a danger and the level of risk of a product or process."
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ments that contain genetically modified corn. U.S. soy exports to Europe also declined, though for a variety of reasons (C&EN, Nov. 11,1999, page 11).
During the 2000 growing season, it appears that U.S. sales of genetically modified seeds will level off or decline, rather than rising as in previous years. Monsanto and Novartis predict that sales in most parts of the U.S. will be about the same as last year. But after a survey, the American Corn Growers Association predicted that transgenic corn seed sales would decline about 20%.
Over the past year, consumer resistance to genetically modified food has risen around the world. Japan, South Korea, Australia, and New Zealand have joined the EU in demanding labels on transgenic food. A number of food and beverage companies, including Gerber, Frito-Lay, and Japanese beer makers Ki-rin and Sapporo, have decided not to buy transgenic crops. Consumer resistance has grown for a variety of reasons, including new scientific research. A
To pay for an electronic system to monitor and track nonimmigrant foreign students, a proposed rule
set forth by the Immigration & Naturalization Service (INS) may force the higher education community to charge foreign students and visiting scholars a fee and then hand the money over to INS (C&EN, Jan. 17, page 12).
University administrators have until Feb. 22 to provide comment to INS. Most of what they write about the proposed regulation is likely to be negative. This is true for both sides of the coin: collecting fees and the costs involved for schools as well as tracking foreign students and scholars.
According to David L. Goodstein, vice provost at California Institute of Technology, there are two major problems with the proposed regulation. First, it forces college and university administrators to treat different classes of students differently—something they have always tried to avoid. Second, it forces colleges and universities to do INS's work.
Under the proposed regulation, "we will be the only country to charge fees to students and visiting scholars," says
Cornell lab study showing that pollen from Bt corn kills monarch caterpillars did much to inflame passions against genetically modified food. No scientific consensus exists on whether Bt pollen kills a significant number of caterpillars or other beneficial insects in the field.
It may be that the rising consumer resistance to transgenic food strengthened the political push for a protocol. And seeing the tide of protest against transgenic food, industry may have believed it had to accommodate the rest of the world somehow and not push as hard as it did last year to totally exclude commodities from the protocol.
The protocol will open for signature in May 2000 and will enter into force after it is ratified by at least 50 countries. The U.S. cannot sign or ratify the pact until the Senate ratifies the biodiversity convention, which was negotiated at the UN Earth Summit in 1992. But even if it doesn't sign the pact, the U.S. must adhere to trade rules of protocol signatories.^
Jerry D. Wilcox, director of the International Office at the University of Texas, Austin. It's reasonable for INS to want to track foreign visitors, he says, but he and other university administrators believe that the agency has not considered the impossible position it has created for colleges and universities as well as the negative effect on scientific communication and cultural exchange.
When the idea for a better tracking service first arose in the mid-1990s, INS officials in Washington, D.C., had hoped for improvements in the agency's customer service. Instead, Congress intervened and designed a highly specific program that many people in higher education label an unfunded mandate. For some policymakers, the tracking program is as much about terrorism and national security as it is about monitoring of nonimmigrant students. For educators, the issue is maintenance of the U.S. education system and the growing international competition for the world's best students.
But as the debate continues—and a new tracking system goes undeveloped—the higher education community will probably end up swallowing a pill it
has vowed to resist: collecting a fee from nonimmigrant students and scholars to pay for the INS tracking system.
Congress' Illegal Immigration Reform & Immigrant Responsibility Act of 1996 is quite specific about what is required of colleges and universities, INS officals say. And now, only Congress can make changes to that legislation, whatever the comments of educators and other experts.
The INS plan, published in the Federal Register on Dec. 21, defines the new electronic tracking system and proposes that colleges and universities collect a fee currently set at $95 but not to exceed $100 to pay for it. The tracking system is known as CIPRIS, the Coordinated Interagency Partnership Regulating International Students.
Statistics on foreign student enrollment give some idea of the scale of the matter. For the 1998-99 academic year, the number of foreign students pursuing an education in the U.S. increased by about 2% to 490,933 students, according to "Open Doors," an annual report on international education published by the Institute of International Education (HE) with support from the State Department's Bureau of Education & Cultural Affairs.
The increase, HE says, continues a significant upward trend that has survived ripples in the world economy, such as the recent Asian financial crisis. Moreover, HE notes that foreign students contribute about $13 billion to the U.S. economy annually in money spent on tuition, living expenses, and related costs. HE and other groups say that a new fee is unfair to even the most well-off students. They say the fee will affect the ability of U.S. institutions to compete for foreign students.
Further development of the CIPRIS system is on hold until the issue of the proposed fee collection is somehow resolved—a process that will almost certainly stretch Congress' deadline for a functional CIPRIS system by 2001.
As originally conceived, the CIPRIS system was an attempt for INS to take advantage of available technology and improve the agency's ability to collect, store, and process information. In fact, the pilot program for CIPRIS—which began before any talk of a fee—was a success in the 21 states where it was tested, INS says.
But then Congress weighed in with expanded concerns, including a perceived growth in the threat from foreign terrorists. Along with a government
Educators decry INS plan to charge foreign students
74 FEBRUARY 14, 2000 C&EN