g o v e r n m e n t & policy

BIOSAFETY TREATY STALLS Talks to craft a treaty to regulate trade in genetically engineered organisms break down over agricultural commodities

Bette Hileman C&EN Washington

After 10 days of talks in Cartagena, Colombia, delegates from 138 countries failed to reach agree­

ment on a treaty to regulate international trade in genetically modified products.

The agreement, called the Biosafety Protocol to the United Nations Conven­tion on Biological Diversity, aims to pro­tect biological diversity of species from dangers posed by cross-border move­ments of transgenic seeds, plants, fish, and other organisms. If approved, it would have required an exporting coun­try to obtain permission from an import­ing nation before it could make the first shipment of certain categories of trans­genic organisms.

The talks were suspended in the early morning of Feb. 24 when the U.S. and five other large agricultural exporters, called the "Miami group," rejected a com­promise proposal supported by nearly ev-

U.S., Argentina, and Canada are the major producers of transgenic crops

Note: In 1998, Spain, France, and South Africa produced minor amounts of transgenic crops; China produced an unknown amount, a Estimate. Source: International Service for the Acquisition of Agri-Biotech Applications

ery other nation. The meeting was to be the last in a series of six negotiating ses­sions that started in 1996. This was the first environmental treaty in at least 16 years in which an agreement was not

reached by the scheduled deadline, said Michael Williams, a spokesman for the UN Environment Program. Talks may re­sume sometime before May 2000.

The Cartagena talks stalled over three major issues. One was whether genetical­ly modified agricultural commodities— those intended for food, feed, or process­ing—should be included under the scope of the protocol. That is, delegates could not agree about whether to require a per­mit from an importing country before a genetically modified commodity, such as soybeans or cotton, could be exported for the first time.

Another issue was labeling of the products. Some countries wanted all bio-engineered organisms, including agricul­tural commodities, to be clearly labeled.

A third contentious issue concerned the relationship of this protocol to other international treaties, especially those ne­gotiated under the World Trade Organi­zation (WTO). Most developing nations and the European Union (EU) wanted the biosafety protocol to take prece­dence over WTO rulings if a transgen­ic organism poses a serious danger to bio­logical diversity. The Miami group—the U.S., Canada, Australia, Argentina, Chile, and Uruguay—wanted the WTO rulings to be at least equal to, or perhaps superi­or to, rulings under the biosafety proto­col. (The Miami group is named after a meeting the countries held in Miami in 1997, where they worked out a common policy.)

The highly polarized meeting did not technically end on the final day but was

Biosafety protocol traces origin to 1992 Rio meeting The efforts to negotiate a biosafety pro­tocol began at the Earth Summit in Rio de Janeiro in 1992. There, govern­ments from around the world signed the United Nations Convention on Bio­logical Diversity. The goal of this con­vention is the conservation of biodiver­sity. Currently, 175 parties have rati­fied the convention. The U.S. signed it, but has not ratified it.

Negotiations for a separate biosafety protocol were set up at a second con­ference of the parties to the Biodiversi­ty Convention in Jakarta, Indonesia, in November 1995. At this meeting, del­egates decided on what is called the Jakarta mandate, which states that the future biosafety protocol would specifi­cally focus on "the transboundary movement of any living modified or­ganism resulting from modern biotech­nology that may have adverse effects

on the sustainable use of biological diversity."

A series of six working group meet­ings was planned to fashion a protocol. At the first meeting, in Aarhus, Den­mark, in 1996, governments listed ele­ments for a protocol and outlined the in­formation required to guide their work.

By the end of the third working group meeting in 1997, the delegates pro­duced a consolidated draft text to serve as a basis for negotiation. They ad­dressed issues including socioeconom­ic considerations, liability and compen­sation, illegal traffic in transgenic organ­isms, and trade with nonparties to the protocol. However, consensus was not reached on any issue.

At the fifth working group meeting in Montreal in 1998, the delegates re­duced the draft text from 45 to 40 arti­cles. Thirteen articles remained entirely

bracketed, however, indicating that del­egates had not agreed on the key ele­ments of a protocol, let alone the arti­cles' contents. Polarized positions were taken over the protocol's scope. Coun­tries were lining up on opposing sides concerning whether the products of transgenic organisms and bulk agricul­tural commodities would be covered under the scope of the protocol.

The sixth working group meeting was held Feb. 14-21 in Cartagena, Colom­bia, and was followed by a conference of the parties to the Convention on Biolog­ical Diversity. These meetings stalled over the issues of whether permits would be required for bulk shipments of transgenic agricultural commodities and over the relationship of the biosafe­ty protocol to other international agree­ments, such as those under the World Trade Organization. Biosafety negotia­tions were suspended until sometime before May 2000.

3 6 MARCH 15,1999 C&EN

Millions of acres

U.S. Argentina Canada Australia Mexico

TOTAL

1997

20.0 3.5 3.2 0.2 0.2a

27.1

1998

50.6 10.6 6.9 0.2 0.2

68.5

Burrows: seeds versus commodities

suspended until some time before the Conference of the Parties to the Conven­tion of Biological Diversity convenes in May 2000. Under UN rules, terminating the meeting would have made it much more difficult to resume negotiations and build on progress achieved in Cartagena.

The countries plan to meet again to try to complete a biodiversity protocol, if they can find some common ground be­forehand. "We will see through some in­formal meetings whether there is any basis for reconvening," said Rafe Pom-erance, deputy assistant to the secretary of state and alternate head of the U.S. delegation.

The conflicts in Cartagena stemmed in part from radically different views of genetically modified organisms (GMOs). The Miami group considers GMOs es­sentially the same as conventional crops. It believes that very few transgenic organ­isms would pose dangers to biodiversity and that virtually none would threaten human health.

The rest of the world, including most developing nations and the EU, believes it is very likely that some GMOs will be­come biological time bombs, causing se­rious damage to biodiversity or human health.

At previous negotiations over the pro­tocol, countries tended to split into two camps over most issues—developed na­tions versus developing. But in Cartagena, the power struggle was essentially trilater­al, with the Miami group on one side, most developing countries on the other, and the EU in the center, trying to broker a middle ground between the opposing sides.

Both industry and environmental

groups played major roles at the meeting. A global industry coalition representing 2,200 firms—agricultural commodities, food processors and retailers, and re­search companies—decided on a unified position concerning GMOs and sent a number of representatives. The coali­tion's positions on most issues were virtu­ally identical to the views of the Miami group. Environmental groups, represent­ed by dozens of people, held views simi­lar to the most extreme opinions of devel­oping nations.

The handling of exported agricultural commodities was by far the largest stick­ing point in the negotiations. At the start of the meeting, the EU and a bloc of de­veloping nations—which included all of them except for those in the Miami group—wanted these commodities ex­plicitly included under the protocol. The protocol would then require a permit from the importing nation before a com­modity could be shipped for the first time under a system called advanced informed agreement (ALA). The ALA process would involve doing a risk as­sessment on the commodity and label­ing it clearly as genetically modified.

The eventual draft protocol, which the Miami group rejected on Feb. 24, explicitly included under the ΑΙΑ proce­dure only organisms, such as seeds, fish, and microbes, that are intended to be introduced into the environment. But another provision in the draft protocol allowed a nation to decide with domes­tic legislation that a particular commod­ity must require an ΑΙΑ "It had a loop-back where you could declare addition­al products into the ΑΙΑ in a unilateral manner," Pomerance said.

Environmental groups at the confer­ence said they wanted commodities un­der the scope of the protocol partly be-

Margulls: genetic transfers will be rapid

cause commodities can spill and thus be transferred into the environment, and some commodities end up being used as seed even if that was not the original in­tention. "With those kinds of categories, how do you differentiate between seeds and commodities?" asked Beth Burrows, director of the Edmonds Institute in Ed­monds, Wash., a public interest group de­voted to the sustainability of ecosystems.

Burrows conceded that, in the short run, it would be expensive to separate transgenic crops from conventional crops in commodity shipments and to require an ΑΙΑ for the first shipment to each country. "But in the long run, it will be cost-effective to do this, because the con­fidence it will bring to the industry may result in more business," she claimed. She compared instituting an ΑΙΑ proce­dure for commodities to the government regulation that required railroads to switch to standard-sized tracks. "In the first few years, that may have been pretty brutal to some owners," she said. Similar­ly, with transgenic commodities, separat­ing, labeling, and requiring an ΑΙΑ proce­dure might at first "feel like a huge cost to little avail," she explained.

Some environmental groups also wor­ry that transgenic genes from commodi­ties—especially those that end up being sold as seed—will flow into conventional agricultural species and into closely relat­ed wild plants. This could create super-weeds if the genes for herbicide or insect resistance flow into wild plants, the groups contend, or it could permanently change the wild species that are now used as a gene bank for creating new va­rieties. "Genetic transfers will be rapid,

MARCH 15,1999 C&EN 3 7

Soybeans and corn dominate the transgenic crop market

Millions of acres

Soybean Corn Cotton Canola

TOTAL

1997

12.6 7.9 3.5 3.0

27.0

1998

35.8 20.5

6.2 5.9

67.4

Note: Transgenic potatoes also play a minor role in the market. Source: International Service for the Acquisition of Agri-Biotech Applications

g o v e r n m e n t & policy even into nonagricultural species," said Charles Margulis, genetic engineering campaigner for Greenpeace.

A paper published in Nature last year [395,25 (1998)] shows that transgenic genes flow 20 times more readily than genes that are part of a plant's original genome. This finding indicates that gene transfer may be much more of a problem than most scientists originally thought, says Philip L Bereano, repre­sentative of the Council for Responsible Genetics, a public interest advocacy group concerned with the social and en­vironmental effects of biotechnology.

Environmental groups are also con­cerned that unless transgenic commodi­ties are labeled, people could develop al­lergies to the novel proteins in the crops and have no idea what they are reacting to. There are no standard allergen tests for these novel proteins because people have not consumed them until recently, said Beatrix Tappeser of Forum Environ­ment & Development, Freiburg, Germa­ny, a nonprofit group concerned with the relationship between environment and development. 'That is one of the con­cerns of the European public," she said.

Tappeser also worries that the antibi­otic-resistance marker genes used in 95% of the transgenic crop species will be transferred to microbes in the guts of hu­mans or animals and create antibiotic-resistant microbes. During development of a transgenic crop, marker genes are used to verify that the transgene of inter­est actually has been transferred into the seed. Transgenic corn is a special prob­lem because it has ampicillin-resistance marker genes, Tappeser said, and ampi-cillin is commonly used as an antibiotic in humans. Marker genes can be removed during seed development, but doing so is expensive.

In contrast, the Miami group and in­dustry organizations insisted that agricul­tural commodities cannot be included un­der the protocol without huge disrup­tions to trade. "Ifs just a fact that there is no way to apply the ΑΙΑ procedures... to trade in bulk commodities without seri­ously disrupting commodity trade and fundamentally changing the way it takes place," said David B. Hegwood, who is a consultant working for a number of com­modity organizations.

First, there is no easy way to tell whafs in any particular shipment because bulk commodities are commingled, Hegwood said. "You can always tell through testing, but that is a very expensive and time-consuming process," he noted.

Also, Hegwood added, "there is no way to track what's in a particular ship­ment." For example, he said, "let's say the EU had approved GMO-A and Brazil had approved GMO-B, but not GMO-A. There would be no way of guaranteeing that either the EU or Brazil would not get the particular GMO it had banned."

L. Val Giddings, vice president for food and agriculture at the Biotechnology Industry Organization, Washington, D.C., described the problem this way: "Commodity shipments very often pass through multiple hands on the way from farmer to consumer. Multiple varieties are commingled and mixed at various steps along the way, and very often the ultimate destination of these commodi­ties is determined in transit. Container ships full of the stuff heading across the Atlantic often don't know if they are going to ports in Rotterdam, London, or Spain until they are halfway across the ocean." Requiring AIAs for commodities "is a prescription for absolute utter chaos," he said.

Furthermore, Giddings said, there is no reason to require AIAs for commodi­ties because "no one has put forth a credible argument that they pose any risk to biodiversity. Native wild species, such as wild species of corn in Central America, are more at risk from a wan­dering cow than they are from varieties grown by farmers, whether transgenic or conventional," he claimed.

"The main threats to biodiversity come from clear-cutting forests and re­placing them with agriculture," Giddings said. Transgenic crops are making posi­tive contributions to biodiversity, he ar-

Hegwood: no way to track

Bereano: much more of a problem

gued, because they are increasing yields, thus reducing the acres of forest that are cut for farmland. They are also reducing the volumes of pesticides that must be used on cropland, resulting in less pesti­cide runoff to water bodies, he noted.

Commodities probably would not have been such a hotly contested issue if the market for transgenic crops were not rising almost exponentially. Global sales of transgenic crops estimated at $75 mil­lion in 1995 increased almost 20-fold to $1.2 billion and to $1.5 billion by 1998. Nine countries were growing transgenic crops in 1998, and 20 to 25 are expected to be producing such crops in 2000.

At the outset of the meeting, some countries were also pushing for inclusion of processed products—such as canola oil made from genetically engineered canola—in the ΑΙΑ procedure under the protocol. Also, early on, some nations ad­vocated the inclusion of pharmaceuticals made from transgenic organisms and transgenic organisms intended for use in laboratories or closed industrial facilities. But all of these categories were eventual­ly excluded from ΑΙΑ procedures.

Environmental groups at the meeting wanted to include products made from transgenic crops and pharmaceuticals. They complained that 95% of the prod­ucts that should have been covered by the protocol were excluded and that the only materials that were definitely cov­ered in the final draft protocol were trans­genic seeds, plants, and animals intended for introduction into the environment In a statement, the nongovernmental organi­zations of developing countries com­plained that the draft protocol is "so filled

3 8 MARCH 15,1999 C&EN

Groote: protect biodiversity

with exclusions that almost nothing would be subject to the protocors procedures."

Another contentious issue was wheth­er human health effects should be con­sidered in the risk assessments done un­der the protocol. The Miami group and industry representatives said that the mandate for the protocol does not cover human health and that the health effects of foods are well regulated by other inter­national agreements. "The objective of this protocol is to protect biodiversity un­der the Jakarta mandate of the biodiver­sity convention," said Joyce Groote of BIOTECanada, an industry association in Canada. The Jakarta mandate, which was a decision the parties to the biodiversity convention reached in Jakarta in 1995, does not include human health, she said.

"We have a body called the Codex Al­imentants [under the World Health Or­ganization] which sets food safety stan­dards for international trade," said Melinda Kimble, head of the U.S. dele­gation and acting assistant secretary at the State Department. "This protocol is not an institution designed to deal with public health or human health issues," the State Department's Pomerance claimed.

In contrast, the EU and most other countries wanted human health risks evaluated with the risk assessments. They do not trust that the codex would take adequate precautions to protect hu­man health from transgenic crops. Even­tually, the Miami group compromised, and human health remained a part of the draft protocol.

The relationship between the biosafe-ty protocol and other international agree­

ments was also a source of enormous conflict The draft protocol contained "no clause that made sure countries had to operate under this protocol consistent with their obligations under other agree­ments," Pomerance said. In fact, until the final hours of the meeting when the EU presented its compromise, the protocol contained an article that allowed it to take precedence over other international trea­ties, such as those under the WTO.

The EU and most developing coun­tries contended that if there is a conflict between trade and threats to biodiversi­ty, the WTO dispute resolution body would likely rule in favor of trade. As a result, they said they wanted the bio-safety protocol to be able to trump the WTO when there are serious threats to biological diversity.

This is all part of the larger issue of how to protect trade and the environment simultaneously that relates to many dif­ferent international agreements, said Paul Hagen, a director at Beveridge & Di­amond, a law firm in Washington, D.C. How international trade agreements, such as the General Agreement on Tariffs & Trade, and multilateral environmental agreements, such as the Basel Conven­tion on the international shipment of haz­ardous waste and the biosafety protocol, are going to work together has not yet been sorted out, he explained.

One factor that probably made com­promise difficult in Cartagena is that the talks were taking place against a back­ground of intense and rising protests against transgenic crops in the U.K., Western Europe, and India. Some Euro­pean countries, such as Austria and Lux-

Giddlngs: prescription for chaos

embourg, have banned all transgenic commodities, and Norway has banned all crops having antibiotic-resistance marker genes. Public attitude surveys conducted in both Britain and Germany show strong sentiment against bioengi-neered agricultural products. A survey commissioned by Monsanto last year in Britain said "the broad climate is ex­tremely inhospitable to biotechnology ac­ceptance" (C&EN, March 8, page 27). Such strong public aversion to transgenic crops in Europe probably made it ex­tremely difficult for the European dele­gates to compromise on certain core issues.

The environmental groups at the meeting found the draft protocol pre­sented in the early morning hours of Feb. 24 very flawed, but they hoped it would be accepted. They believed that even a flawed protocol was better than none and might be a stepping stone to a stronger protocol in the future. They blamed the Miami group of agricultural exporters for the failure to reach con­sensus. 'The text had flaws because the U.S. at every point was attempting to wa­ter it down. But if the majority of the countries felt this draft text was the way to move forward, that is what should have happened," said Doreen Stabinsky of the Council for Responsible Genetics.

Some EU delegates say the Cartagena talks were a large setback for internation­al relations because the conflicts were so bitter. But Pomerance countered: "No, on the contrary, rejecting the protocol was quite a constructive step because when you reject a bad, unworkable agree­ment, that enhances the credibility of the process and makes people a little more careful about what they are doing. The worst thing for the process would have been to conclude the agreement. We were not willing to tie up trade in the world's food supply by a complicated per­mit regime."

But the developing countries coun­tered that their aim was not to cut back on trade. "It is not true that what we were asking for was to impede trade. We were asking for biosafety," said Joseph Gopo, the delegate from Zimbabwe.

The negotiators say they are now tired of this issue and need time to step back and rethink their positions. They will probably not be trying to find common ground, even informally, for a few months. If the serious gulfs in basic be­liefs about bioengineered organisms are not bridged, there indeed may never be a protocol.^

MARCH 15,1999 C&EN 3 9