Genetic Engineers Call for Regulation

CARDIFF, WALES--Scientists at the First International Conference on the Release of Genetically Engineered Microorganisms here have called for international guidelines on dissemination of new organisms. But they stopped short of formal recommendations on international regulation of genetic engineering. Deciding against a final communique, they deputized a member of the UK government’s watchdog committee over recombinant DNA, John Beringer, to carry their concerns to the Organization for Economic Cooperation and Development. The OECD, whose members include the United States as well as European countries, issued a mild report on environmental release two years ago. The question will be whether the group has the clout to devise regulations that can apply uniformly around the world and, more crucial, whether such regulations are enforceable. The call to action was precipitated by several papers presented at REGEM 1, as the meeting was called, which took place here last month. Although REGEM 1 was planned as a scientific meeting, the corridors and bars of the magnificent St. David’s Hall buzzed with regulatory concerns. Delegates returned again and again to problems posed by the present wide global disparities in regulation, ranging from a Danish law prohibiting release to no regulations whatever in many countries. Discussion focused in particular on a report describing the controversial experiments with a recombinant rabies vaccine carried out in 1986 in Argentina. Fermentation technologist Faustino Sineriz, standing in for Jose La Torre of the Argentine Health Ministry, told the REGEM 1 attendees that "No permission or consent was ever requested from Argentina’s authorities for this investigation." Rita Colwell, director of the Maryland Biotechnology Center and chair of REGEM’s scientific program committee, said "What this incident tells us is that all countries urgently require regulations for the conduct of all experiments involving the release of engineered organisms, whether in the medical, agricultural, or any other field. Indeed, those regulations need to be harmonized throughout the world because microorganisms do not recognize political frontiers or follow local laws and guidelines as to how they should behave." Colwell’s remarks were echoed by Beringer, who chairs the Planned Release Subeommittee of the UK’s Advisory Committee on Genetic Manipulation. "What we have heard about today may seem a crassly incompetent experiment. No doubt it was carried out in good faith. But we need to remember that where there are no regulations, releases are bound to occur." Beringer went on to assure the group, "I shall be raising the Argentinian episode, as one example of the crazy situation in which some countries have tough guidelines while others have none, at a forthcoming OECD meeting. The uniform approach which I hope will emerge—sooner rather than later—will benefit us all." The controversy began in September 1986 when Argentina’s sanitary authorities learned of a field test of the rabies vaccine on 40 cattle at Azul, near Buenos Aires. The vaccine had been made by incorporating parts of the rabies virus into vaccinia, formerly used for small-pox immunization. The test grew out of an exclusive agreement between the Wistar Institute in Philadelphia and the Pan American Health Organization. PAHO did not inform Argentina of the experiment. "The protocol clearly shows that the aim of the investigation was to assess the possible effect of the recombinant virus on vaccinated animals as well as on those in contact with them and on the humans directly involved'" Sineriz said. Three out of the four human caretakers of the animals had developed rabies antibodies by six months after the experiment began, he reported as had both immunized and contact animals. Sineriz emphasized that the Argentine government has not queried the experiment itself, only the way it was planned and implemented. "The way this field trial was conducted clearly violated ethical and legal principles and could have consequences that will affect the development of a new generation of vaccines not only in Argentina but also throughout the rest of the world," he warned the scientists. "Ecological organizations will use this situation to protest against the development of recombinant DNA products and their use in the environment. If they succeed in their actions, the development of new products that could be ex- tremely important for humans, plants, animals and the environ- ment will be seriously endan- gered." Dixon is European Editor of THE SCIENTIST.

Genetic Engineers Call for Regulation

Interested in reading more?

Become a Member of