From ice-nine to ice-minus; regulating altered genes

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FROM ICE-NINE TO ICE-MINUS

Regulating Altered Genes

A new presidential policy directive regulating the development and release into the environment of the products of biotechnology, signed by Ronald Reagan on June 18, greatly relaxes restrictions on what many environmentalists see as an already dangerously underregulated industry. It follows months of alarming news reports that genetically altered living organisms have been illegally or improperly released into the environment. The incidents reveal a profound conflict among scientists over what impact those organisms may have on plants, animals and the ecosystem.

At the heart of the debate are genetically altered organisms developed as pesticides, animal vaccines and frost protectors for plants. Although much of the research is conducted at universities, each project involves private companies that hope to profit enormously. The stakes are high. According to a report from the General Accounting Office, the Agriculture Department alone, which oversees some agricultural applications of biotechnology, is reviewing eighty-seven gene-altered products that could be ready for field tests within a few years. Other agencies, such as the Environmental Protection Agency, responsible for microbes that act as pesticides, and the Food and Drug Administration, which monitors human and animal drugs, expect many more companies to seek approval for field tests soon.

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The most controversial organism is a form of the common bacterium pseudomonas, which a company in Oakland, California, called Advanced Genetic Sciences (AGS) wants to market under the name Frostban. It is a “deletion’ product–altered by removing genes, the basic hereditary units, rather than by adding genes from another organism. Dubbed “ice-minus’ by the press, the bacterium colonizes on leaves, inhibiting frost formation when temperatures drop to a few degrees below freezing. Crops now destroyed by minor cold snaps could survive them if sprayed with the product.

The E.P.A. issued a field-test permit for the company but rescinded approval in March, after revelations that AGS had violated the agency’s rules by injecting ice-minus into trees on the roof of its corporate office and by testing the organism in an open greenhouse. The agency fined the company $20,000–later reduced to $13,000–the first E.P.A. penalty levied for gene-splicing tests and one of the largest fines ever ordered for a violation in agricultural research.

But the E.P.A.’s action did not presage tough regulation in the future. The new Federal policy assumes that deletion products, created by the removal of one or two genes and alterations involving “regulator genes,’ which control functions of other genes, are benign. Both categories are virtually exempt from review. On September 29 the National Institute of Health’s Recombinant DNA Advisory Committee seemed to fall into line with this policy when it voted to drop its special scrutiny of deletion products.

Some leading scientists expressed outrage at this part of the new framework. “It is a medieval scientific view that a deletion is automatically less risky,’ Jonathan King, professor of molecular biology at the Massachusetts Institute of Technology, told The New York Times. “This decision has the look of a response to commercial pressures to weaken regulations.’

On July 15, Jeremy Rifkin, a prominent opponent of genetic engineering, filed suit against the E.P.A. in U.S. District Court to halt all approvals of field tests for genetically altered organisms. Rifkin claims the government adopted its new biotechnology policy without preparing an environmental impact statement and without keeping adequate records of the policy’s development, as required by Federal law. A lengthy legal battle is sure to follow. The case will probably be heard before the end of the year.

Fear of molecular alteration is deeply rooted in the public mind. In Cat’s Cradle, a popular 1974 novel by Kurt Vonnegur Jr., scientists develop a substance that freezes water at very high temperatures. “Ice-nine,’ which allows troops to cross rivers on solid ice, even in summer, eventually destroys the earth. Nearly every informed person in this debate views the prospect of a wildly proliferating microbe laying the ecosystem to easte as farfetched. Many genetic engineers complain that some critics nevertheless fuel controversy by playing on such public fears. They further argue that genetic manipulations are akin to age-old agricultural crossbreeding, or the use of live, attenuated viruses as vaccines.

The critics counter by saying they don’t have to evoke science fiction to make their point. They cite the disastrous precedent of Dutch elm disease, caused by a fungus, which virtually eliminated the American elm from many parts of the country, and the blight that similarly destroyed the American chestnut tree. Both were caused by the unintentional introduction of foreign organisms.

Most scientists doubt that microbes released in a small test could survive long in the environment. Genetic alteration usually weakens organisms and thus reduces their prospects for successful competition against infinitely more numerous, naturally adapted microbes. But no scientist will rule out the possibility.

“One can paint worst-case scenarios and these are plausible,’ said Martin Alexander, a soil microbiologist at Cornell University who evaluated the AGS test plan for the E.P.A. “One can paint no-problems scenarios and these are also plausible.’ He concluded that for ice-minus the risk is low enough to proceed.

But E.P.A. biologist Fred Betz told an agency panel reviewing ice-minus last year, “Under certain conditions that have not been tested, mutants may in fact have the ability to compete and displace their natural counterparts.’ Critics say organisms may spread beyond test sites, mutate and become pathogenic, or affect especially vulnerable individuals –the elderly, the sick and children–as well as plants or animals, in unforeseeable ways.

Most ecologists agree with the E.P.A.’s study group on biotechnology that the science of predictive ecology is in its infancy. There is no consensus about how much and what type of data is required to make decisions about the effects of genetically altered substances. Therefore, according to Sheldon Krimsky, professor of environmental policy at Tufts University and a leading authority on genetic engineering regulation, “the release of novel life forms [is] a game of ecological roulette.’

The Federal policy was designed to clarify vague and overlapping jurisdictions of several regulatory agencies. David Kingsbury, an assistant director of the National Science Foundation and the architect of the policy guidelines, said the newly coordinated system will result in more stringent oversight. But critics maintain that it is too soon to tell whether he is right. Each agency’s regulations still contain ambiguous language that contributes to gross misinterpretations and makes it easier to dodge the law. AGS claimed, for example, that injecting ice-minus under the bark of trees on the roof of its offices did not constitute an environmental release as defined by the E.P.A.

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There is little reason to be optimistic that the new policy will clear up such problems. The G.A.O.’s study of the Agriculture Department’s biotechnology oversight noted glaring flaws and gaps in the department’s rules. What’s more, agencies exacerabate the problem by sometimes ignoring the regulations they do have. The Agriculture Department violated its own rules by failing to consult its advisory committee before allowing the marketing of a genetically altered swine vaccine. In addition, the E.P.A. sections that evaluate many field-test projects are slated for a 44 percent budget cut, Krimsky noted. He said that even now the agency does not have enough molecular biologists and ecologists to assess all the products that are being introduced into the marketplace.

The Federal regulators’ apparent uncertainty about every announced field test or field-test plan has resulted in widespread suspicion among the public, and as a result several communities have established their own regulations. Monterey County, California, banned tests on ice-minus for months. These actions resemble the growing local resistance to other potentially dangerous technologies, such as nuclear waste disposal.

Ironically, it may be the so-called insurance crisis, rather than scientific or community opposition, that leads to more effective regulation of the biotechnology industry. Hardly any biotech firm or research institution in the United States has insurance for tests involving the release of altered organisms, according to Rifkin, and without coverage none could afford to pay the damages caused by an ecological debacle. Rifkin filed suit June 9 against the E.P.A. to compel the agency to enforce laws that require adequate coverage and to halt field testing until the question is resolved.

It is difficult to oversee or even to talk clearly about biotechnology because so many scientists are employed by or even own shares in companies that anticipate enormous profits from the new technology. “Most of the leading molecular geneticists, on whom we must depend for our understanding of the products generated by genetic engineering, have commercial affiliations,’ Krimsky said. Conflicts of interest are unavoidable. The public cannot properly evaluate their statements because it is unaware of the corporate links.

In addition to scientists’ direct financial involvement in biotechnology firms, industry funds may support up to 25 percent of all biotechnology research in American universities, according to two recent studies published in Science. Among faculty who receive industry support, 28 percent received at least half of their research funds from corporate sources.

Multinational firms, such as AGS, sometimes threaten to move overseas if U.S. regulation becomes too stringent. “What matters is that the research go forward,’ Joseph Bouckaert, chief executive of AGS, told The Wall Street Journal. “We will move forward, if not in this country then in Europe or Latin America.’ This prospect disturbs some scientists who fear that Japanese firms will come to dominate the biotechnology industry, as they have some fields of electronics. These scientists argue that delaying field tests may therefore be riskier than proceeding before all scientific questions are resolved.

According to Krimsky, the importance of the current debate over a handful of organisms slated for field tests far exceeds their likely dangers. These cases are making scientific history and could form the basis for regulations that will flow from the new White House policy for years, perhaps decades. Without effective oversight, Krimsky said, “people may find the Luddite position–absolutely no tampering in the biosphere–the only rational choice.’

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