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Safety Regulations The clebate about the safety of recombinant DNA research began almost as soon as the first such experiments were reported. In 1971 a molecular biologist proposed to combine DNA from a monkey tumor virus, known as SV40, with a plasmid from the bacteria Escherichia coli. This immediately raised fears among some scientists that the modified E. coli, containing monkey virus DNA, might somehow infect humans and cause cancer. Though this possibility seemed unlikely, it could not be dismissed for several reasons. First, E. cold commonly reside in the human intestine. If the recombinant molecule were inadvertently in- gested by a human, it might be able to establish itself in the intestine. And second, though the virus has not been shown to cause cancer in humans, it does cause cancer in mice and hamsters and also causes human cells in culture to grow abnormally. After his colleagues voiced such concerns, the molecular biologist voluntarily cleferred his experi- ment. When a small group of molecular biologists met at a Gordon Confer- ence in 1973, they again discussed the potential hazards of recombinant DNA experiments. After the meeting, they wrote a letter to Science to alert the broader scientific community to their concerns. In the letter they suggested that the National Academy of Sciences investigate the hazard, which it did. in 1974 a National Academy of Sciences committee recommended a worldwide moratorium on certain types of recombinant DNA experimentssuch as those that would introduce into bacteria viral genes or genes that confer antibiotic resistance- until the safety hazards could be assessed. They also called for an international confer- ence on the issue and suggested that the National Institutes of Health establish an advisory committee to develop safety guidelines for future recombinant DNA research. All three suggestions were followed. 69
70 GENETIC ENGINEERING OF PLANTS The conference was held the following year at the Asilomar Center in Pacific Grove, California. By that time the scientists were not only concerned about the cleliberate transfer into E. cold of a harmful gene, such as a gene from a cancer virus or a toxin, but they also wondered about the unforeseen hazards of combining genes of two different spe- cies even if those genes were thought to be harmless. Since such recombinant organisms clid not exist in nature, the scientists could not predict with accuracy what risk they might pose, not only to human health, but also to plants, animals, and the environment. Nor was the debate confined to the scientific community. The public became increasingly concerned about both the safety questions and the moral and philosophical implications of the new technology. In creating novel organisms, scientists would have the power to alter the course of evolution. Many individuals, including some scientists, questioned whether scientists should be entrusted with such power. They also asked who should decide these issues the scientists or the public. Yet at Asilomar, the discussion was focused on scientific issues. The participants agreed that the moratorium should be liftect for the vast majority of recombinant DNA experiments, provided that appropriate precautions were taken. The safety strategy they suggested was that recombinant microorganisms be contained and that the level of contain- ment correspond to the level of estimated risk of each experiment. Containment would be achieved through two methods: biological, the i- c' use of enfeebled strains of bacteria that could not survive outside of the laboratory; and physical, the use of laboratory procedures and equipment to prevent inadvertent release. A committee of the NIH, now known as the Recombinant DNA Ad- visory Committee, or RAC, translated those recommendations into guidelines. These guidelines, adopted in 1976, specify the physical and biological containment conditions under which recombinant DNA ex- periments can be performed. The guidelines are binding only for federally funded research. To date, ndustry has voluntarily complied with the guidelines, following pro- cedures suggested in the guidelines for obtaining project approval. In research conducted since 1979, the alleged hazards have not ma- teriaTized. As knowledge accumulated, the guidelines have gradually been relaxed that is, the containment levels required for certain ex- periments have been lowered. Now most experiments can be performed at the lowest biological and physical containment level. Nonetheless, some safety questions still remain. One is the risk posed by the intentional release of novel organisms into the environment. Researchers have engineered microorganisms that, in the laboratory,
SAFETY REGULATIONS 71 can degrade a dioxin or others that might be used to clean up oil spills. The major uncertainty is whether they will disrupt the balance of the ecosystem in which they are released. The concern is not with genetic engineering per se. The introduction of any species to an ecosystem it does not normally inhabit can have unexpected results. There are many examples of organisms that have become serious pests after they were released into a new area. In IS69 the gypsy moth (Porthetria dispar) was introcluced into Massachusetts as part of a silk production experiment. It is now a serious forest pest in much of the Northeast. Prickley pear cactus (Opuntia) was introduced into Australia from Latin America and posed a serious threat when it spread into grazing land. The South American cactus moth (Cactoblastis cactorum) was deliberately introcluced into Australia to bring the cactus under control. The Need for Continued Diligence . Ray Thornton was an active participant in much of the early debate over recombinant DNA regulation both as a former U.S. congressman anc} as chairman of the RAC from 1980 to 1982. He is now president of Arkansas State University. As he described, he addressed another con- vocation at the National Academy of Sciences seven years ago. "As ~ stand here, ~ can't help but have a sense of deja vu. This room was filled with people concerned about whether there should be a mor- atorium on all recombinant DNA research. There were placards, there were protesters, there was heckling from the audience. It took a good bit of courage at that time to stand in this auditorium and suggest that the needs of science called for us to move forward cautiously and care- fully in this area. That has changed over the past seven years, and today we recognize the enormous potential benefits that this new technology, this new way of doing things has made possible. "Perhaps it may also require a bit of courage to suggest to this group today that there is still a continuing need to be aware of the safety, ethical, and moral issues of genetic engineering." Thornton remincled the audience that these technologies provide an opportunity to direct the course of evolution, particularly to speed it. On a practical level, such changes can disrupt an ecosystem. On a philosophical level, this new ability may undermine man's reverence for life. Many researchers and observers of the field think that if scientific work proceeds intelligently and prudently, and if scientific directions and developments are open to public scrutiny, then the safety issues
72 GENETIC ENGINEERING OF PLANTS can be resolved. Others, Thornton said, are less convinced that humanity is prepared to cope with the moral and ethical aspects of genetic engi- neering. To ciate, scientists have been able to pursue recombinant DNA re- search with remarkable freedom, Thornton said. The use of voluntary guidelinesrather than legislationis a novel approach and is far more flexible than the regulations governing the atomic, pharmaceutical, and chemical industries. He sees this freedom given to genetic engineering as a reflection of the public's confidence in the scientific community; of the public's belief that safety issues will be openly and honestly cTis- cussed. "Only a handful of serious safety questions remain for RAC to con- sider," Thornton said. Among those is the release of genetically engi- neered organisms into the environment. "We're not talking about work- ing with new organisms in the laboratory. We're talking about what recombinant life forms can be put in an oil well." Other issues may emerge as the genetic engineering of plants nears application. In deciding what, if any, regulatory approach to take, the RAC or any other oversight bocly will need to draw on the knowledge of agricultural scientists, ecologists, and others. "One of the things that may have gone wrong six or seven years ago, that may have contributed to the public outcry over recombinant DNA research, is that the mo- lecular biologists who were involved did not have the benefit of input from immunologists, epidemiologists, and others who couIcl have helped them to assess the dangers. Because of this lack of knowledge, the restrictions initially applied were perhaps too severe. We have an op- portunity to learn from that mistake. By drawing on the expertise of a number of disciplines, we can develop an approach that both satisfies the concerns for safety, yet does not unduly restrict the application of new research methocls."
