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Source: Science, July 3, 1998 v281 n5373 p29(2).

Title: Arms control enters the biology lab.(laboratories may be required
to submit to inspections under the Biological and Toxin Weapons
Author: Helen Gavaghan

Full Text COPYRIGHT 1998 American Association for the Advancement of Science

Some biotechnology companies and academic biology labs could soon find themselves caught in the highly charged world of arms control. Facilities and labs that handle potentially worrisome types of biological agents could be required to file reports detailing the materials they possess and submit to regular inspections. The reason, Negotiations that resumed last week in Geneva may finally put some teeth into the Biological and Toxin Weapons Convention (BTWC), an arms control agreement that is currently based entirely on trust; it has no mechanism to check whet her signatories are complying.

Although the convention was negotiated in 1972, verification was not considered a high priority until recently, largely because few military experts considered biological weapons to be a major threat. But revelations about the extent of the former Soviet Union's biological weapons program, and recent discoveries by United Nations inspectors of Iraq's widespread efforts, have injected a sense of urgency into the discussions. Both the European Union and the Clinton Administration are now pushing for a compliance protocol to be negotiated for the BTWC by the end of this year. And in a speech last month, U.S. Secretary of State Madeleine Albright underlined the message: "The [biological weapons convention] needs enforcement teeth if we are to have confidence it is being respected around the world." Tibor Toth, the Hungarian ambassador chairing the talks in Geneva, told a meeting of industrialists, diplomats, and academics in Vienna in May, "it is not now a question of whether but of when and how."

That prospect has come as a wake-up call to biotech industry and microbiology researchers worldwide. Industry trade organizations, particularly in the United States, have long been aware of the issue, but individual companies and institutions are only now realizing they soon may become involved. "Until recently," says Brad Roberts from the Institute of Defense Analysis in Washington, D.C., "the U.S. [biotech and pharmaceutical] industry hoped tills issue would just go away."

The negotiations that reopened last week in Geneva will determine how extensive and intrusive the verification provisions are likely to be. Some of the 158 countries that have signed the treaty are proposing that facilities judged to fall under the treaty should declare what potential biological warfare agents they possess, be subject to site visits to check the declaration, and be given a thorough inspection if a violation of the convention is suspected. "The idea is to force those countries running a biological weapons program to lie," says Patrick Lamb, of the U.K.'s Foreign and Commonwealth Office. Once a country is forced to lie, he says, discrepancies are likely to show up between its declarations and intelligence reports, giving the United Nations grounds to act.

The critical issue is which facilities would have to make these declarations. Because many of the pathogens and toxins that could be used as weapons, as well as the equipment to manufacture them, also have civilian uses, hundreds of facilities in any country could potentially fall under the scope of the treaty. And, unlike the manufacture of nerve gases--which are prohibited by the chemical weapons convention--only small quantities of a biological agent are needed to produce an offensive weapon that multiplies in its host organism.

At the Vienna meeting, many diplomats and arms control specialists were talking of devising a combination of "triggers" that would bring no more than a few tens of facilities per country under the convention. These will probably include any facility that has worked on offensive or defensive biological weapons, any facility currently working on biological defense measures, and any facility working with the most stringent biocontainment standards of biosafety level 4. If such activities were used as standalone triggers, most signatory countries would only have a handful of facilities that needed to make declarations, and some may have none.

Other triggers under discussion include biosafety level 3, work with listed pathogens or toxins, expertise in genetic manipulation or creating aerosols of pathogens, and production microbiology. As stand-alone triggers these would in many countries force declarations from as many as several hundred facilities, many of which would be of no interest to the convention, says Graham Pearson, former head of the U,K. Chemical and Biological Defence Establishment at Porton Down. However, Pearson says, combinations of, say, biosafety level 3 and other triggers would be more discriminating and could be tailored to require no more than 10 or so facilities per nation. "The aim," says Tony Phillips, who is providing technical advice to the British government, "is to catch the facilities most relevant to the treaty."

Industry's response to these efforts to minimize the number of facilities affected by the treaty may come as a surprise to the diplomats, however. Gillian Woollett of the regulatory department of the U.S. Pharmaceutical Research and Manufacturers Association (PhRMA) says that if just a few companies are singled out to make declarations, their reputations could be tarnished. PhRMA, says Woollett, would prefer that a broad range of companies be required to make a declaration under the convention, but that these declarations be kept as short as possible.

PhRMA is, however, far more leery about opening up industrial labs to routine inspections to verify the declarations because of problems of commercial confidentiality. "By looking at the way equipment is linked an expert can learn about our whole production process, or work out how easily prototype equipment could be scaled up. One bug casually wiped from a surface could tell you everything about the protein product produced, its promoters, and the environment in which it thrives," says Woollett.

That sentiment seems to be widely shared in industry. Helmut Bachmayer, head of corporate biosafety at the Swiss drug giant Novartis International in Basel, for example, fears that the already heavily regulated pharmaceutical and biotech industries will run the risk of industrial espionage without making the world a safer place. "You cannot stop the bad guys if they intend to make biological weapons," says Bachmayer. And following a May meeting held by the European Union in Brussels to try to get the biotech industry on board, Roger Wils from Janssen Pharmaceutica in Belgium said, "There were a lot of nice beautiful words, but I'm not sure anyone can guarantee confidentiality." Wils says he left the meeting with the sense that the protocol would lay open his company's entire research program.

Although reluctant to submit to routine inspections, American and European industry accept the need for investigations when a treaty violation is suspected. Such "challenge inspections" could be politically damaging both for the accuser and the accused, and much discussion is currently focused on what circumstances would require challenge inspections to be instigated.

Concerns over confidentiality also worry those few academic researchers aware that their labs might fall under the scope of the protocol. It is still unclear how many labs will be affected, but it is almost certain that the activities of some academic institutions will trigger the need for a declaration. According to Otto Doblhoff of the Institute of Applied Microbiology at the University of Agricultural Sciences in Vienna, the large number of concurrent activities in a modern biology lab will also make visits and inspections more difficult for academic institutions than for production facilities. And in a research world of tight budgets and limited resources, completing the paperwork for a bioweapons compliance declaration could be an onerous burden on researchers. Nevertheless, Doblhoff believes a compliance protocol for the BTWC is essential and could be made workable.

Industry in the United States and Europe is beginning to accept the inevitability of the impending compliance protocol, however, and is becoming engaged in the negotiations on technical issues. Both PhRMA and the European Federation of Pharmaceutical Industry Associations are completing position papers. Lynn Klotz, a biotechnology and biobusiness specialist with the Federation of American Scientists, says the PhRMA paper is much less combative than its earlier statements. Klotz attributes this softened position to a series of White House--sponsored meetings where government and industry exchanged views. "At the first of these, there were maybe three industrialists and 30 White House staffers. That balance has now changed," says Klotz.

Moreover, says Malcolm Dando of the Department of Peace Studies at the University of Bradford in the U.K., industry knows that their governments are not going to fit them into an arms control straitjacket: "The diplomats know that biobusiness is a growth area for the 21st century and that they must protect the intellectual property of their national industries." 

Helen Gavaghan is a writer in Hebden Bridge, U.K.

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