Congress And Administration Closer To Regulating U.S. Biotech Industry

While a workable policy for modified organisms stays unresolved, scientists laud recent developments WASHINGTON--Congress and the Bush administration are moving along parallel tracks in search of a more efficient and comprehensive system to regulate the testing and mass production of genetically modified organisms. Most industrial scientists, academics, and environ- mentalists hail this movement as a sign of progress toward resolving this major obstacle for the biotechnology industry. At the same time, they do not expect the decade-long debate and agonizing delays in drawing up regulations to end anytime soon. Biotech companies are dependent on federal approval to introduce new or genetically modified organisms. But regulation by individual agencies is only the last step in a long process involving these organisms. Two recent developments highlight both the issues remaining before such regulations can be laid down, and how hard it will be to find common ground. The first is a draft by the executive branch of a set of principles to govern the definition of such organisms. This so-called scope of oversight document appeared July 31 in the Federal Register (vol. 55, No. 147, p. 31118-21) after two years of debate on the subject among the relevant agencies and top administration officials. The second is a bill, introduced July 10 by Rep. Robert Roe (D-N.J.), to create a uniform federal system to handle the regulation of such organisms and their release into the environment. The legislation, called the "Omnibus Biotechnology Act of 1990" and referred to the Science, Space, and Technology Committee that Roe chairs, reflects what he calls "a crisis in the biotechnology industry and in the public" caused by the government's failure to issue regulations that both protect the public and foster commercial development. The First Step The problem with both the executive branch document and the congressional bill, say those who follow the issue, is that neither is capable of unblocking the regulatory logjam. The scope document, which suggests how various agencies should define these modified organisms, is not linked directly to the regulatory process. That means agencies such as the Environmental Protection Agency must still come up with their own statutory approaches to regulating products within their jurisdiction, a process that has been en- snared for several years in political wrangling. At the same time, Roe admits that his bill is only a first attempt to address the issue. In fact, his committee staff this month intends to assemble a task force drawn from throughout the biotechnology community. Their input, to be offered over the next four to six months, will be used to modify the legislation when it is reintroduced next year. In the meantime, biotech experts are reacting cautiously to what is on the table. "The scope principles are fine, but now what?" says Richard Lotstein, a regulatory specialist for the agricultural biotechnology division of CIBA-GEIGY Corp. in Research Triangle Park, N.C. "As for the proposed legislation, we feel that no new laws are needed. All the relevant federal agencies have sufficient authority to regulate biotech- nology. What they need is to decide how they want to do it." Lotstein's complaints about federal foot-dragging are echoed by David Drahos, senior research leader for the St. Louis-based Monsanto Co., which has been impeded by both environmentalists and government regulators in its efforts to field-test genetically modified organisms. "There's a great deal of frustration on our part that a technology that has never caused any problems would be required to go through all these regulatory hurdles," says Drahos. Still, most biotech companies realize that they cannot function without some type of regulatory process. "We need them [federal agencies] to review our products to gain the public trust," says Drahos. "And we need a process that looks at what the public is concerned about." Industry isn't alone in calling for action. Even environmental groups are anxious to see the government come up with a uniform set of principles and practices to regulate a technology that didn't exist 20 years ago and that in another 20 years is expected to be one of the country's biggest and most important. "The federal framework for biotechnology regulation remains fundamentally flawed and will not support commercialization of the technology," says Margaret Mellon, biotechnology specialist for the National Wildlife Federation, which advocates a legislative solution to the problem. "A solid legal foundation is essential to support the oversight of products on the scale at which they will [someday] be released." More Guidance Limited as they are, the scope principles were nearly two years in the making. They are meant to expand on a 1986 document that was the government's first real attempt to reach common ground on the subject of genetically engineered material. But the scope document made its debut only after the relevant agencies--notably EPA on one side of the debate and the Department of Agriculture and the Food and Drug Administration on the other--de- spaired of reaching a consensus. "It began as an aid to EPA and USDA, which were developing regulations about what organisms should be regulated," says Rachel Levinson, assistant director for the life sciences within the Office of Science and Technology Policy (OSTP) in the executive office of the president. "It was meant to supplement existing regulations by providing internal guidance to each agency to make sure that their regulations covered all relevant activities." But the discussions turned acrimonious and ground to a halt last fall. "It was a painful process," says Levinson. "They couldn't come to a consensus." At that point the issue was kicked over to the Council on Competitiveness, chaired by Vice President Dan Quayle, and its Working Group on Biotechnology, then headed by former National Institutes of Health director James Wyngaarden and now run by the Office of Economic Development's Larry Lindsey. While those groups had enough political clout to eventually allow the scope principles to see the light of day, the detour did nothing to resolve any problems that individual agencies might have with the document. "I think that the scope principles were a good-faith effort to implement EPA's rules under TSCA [the Toxic Substances Control Act]," says Suzanne Huttner, associate director for biotechnology and education programs for the University of California system. "But EPA has already said that its current regs prohibit it from following the principles, and I think that the scope principles will fail because EPA will stick to its guns," she says. EPA officials declined to comment, but noted that they are developing proposed regulations. Many observers are more concerned about how the agencies finally decide to regulate genetically modified organisms than they are about what definitions are used. But they see the scope principles as a positive sign. "I'm optimistic that the government seems to be willing to allow regulation to proceed," says David Glass, vice president for government and regulatory affairs at Biotechnica International in Cambridge, Mass. "And I'm not terribly troubled by having each agency go off on its own to determine the appropriate regulations. But what I don't want to see happen is for the White House to prevent EPA from going ahead with its proposed rules because they are still collecting comments on the scope principles. That would be a disaster." For CIBA-GEIGY's Lotstein and other industrial scientists, the need for action is key. "It is now extremely important that the process move forward quickly," his company wrote in a formal comment to the notice in the Federal Register. (Some 35 comments were submitted by the October 1 deadline for public reaction.) "The scope principles should be adopted, hopefully with only minor revisions, and implemented to facilitate federal rulemaking." The power to make that happen, however, now lies outside the reach of the government panel that initiated the scope principles. That group, known as the Biotechnology Science Coordinating Committee (BSCC), has been given a more narrowly defined mission in the hope of avoiding future snafus, says OSTP's Levinson. She says the new body, called the Biotechnology Research Subcommittee (of the Committee on Life Sciences within OSTP), is supposed to look at such things as the research and training needs of the biotechnology community. Policy issues, she adds, will be handled by the vice president's Council on Competitiveness through its Working Group on Biotechnology. That structure is doomed to failure, according to Greg Simon, a staff member of the House science committee. "These people have debated for the past 10 years how to regulate something that is already going on," says Simon. "And what they've come up with is a system that's unenforceable for the agencies, unworkable for industry, and unfathomable to the public." Roe's bill attempts to break that deadlock by having the BSCC (keeping its original name) answer to Congress rather than to the executive branch. The committee will be better able to foster a coordinated federal approach to biotechnology and the issues of environmental release, Simon says, given a clear mandate to address these issues and to hold open meetings. Regulating Organism Release Other parts of the Roe bill would provide a common structure for individual agencies to follow in examining questions relating to the release of genetically modified organisms. Industry appears to be talking a wait-and-see attitude toward specific provisions of the bill that would create a permit process and allow certain exemptions for organisms deemed safe. "We think the idea of permits is a reasonable one," says Pamela Bridgen, executive director of the Association of Biotechnology Companies, a Washington, D.C., trade group. "I think the idea [behind the bill] is to clarify current procedures so that companies know such basic information as whether to go to EPA or USDA, and whether the process for field tests is the same as for large-scale commercialization." One important question for Bridgen's industry constituents is whether a legislative approach is preferable to the current regulatory logjam. She admits that it's a difficult choice. "In general companies would prefer a regulatory fix rather than a legislative one," she says. "But they have seen how long it can take under regulation. So far, we are trying to do both--work with the agencies to streamline the process, and work with Congress to see what legislation is appropriate." It's also a tough call for environmentalists. Although the National Wildlife Federation favors a bill like Roe's, NWF's Mellon says that pushing for new legislation is always a gamble. "Everybody approaches the Hill with trepidation," she says, "because you never know what will come out in the end."

Congress And Administration Closer To Regulating U.S. Biotech Industry

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