Critics Rip U.S. Biotechnology Panel

A new report says a White House committee has failed to properly oversee the nation's biotech policies. WASHINGTON--The Biotechnology Science Coordinating Committee, which was created to address the scientific problems arising from the burgeoning biotechnology industry, is being criticized for failing to do its job. The government body has been accused in one recent report of overstepping its charter by encroaching on the authority of other federal agencies and of hiding its work from the public. And a rare open meeting of the group, held last month to let outsiders comment on what improvements are needed, generated complaints about closed meetings, a preoccupation with regulation, and insufficient interest in tracking progress in the field. While the committee has spent a great deal of time over the past five years on regulatory matters, says Margaret Mellon, director of biotechnology policy for the National Wildlife Federation, "little has been heard from the BSCC on scientific issues. And its efforts in the regulatory arena, besides being of questionable legitimacy, have undermined the development of sound federal biotechnology regulatory policy. Instead of a healthy public debate, what BSCC has fostered over the past four years is unproductive infighting." Mellon was one of eight speakers at the December 21 meeting of BSCC called to let the public express its views on the committee's past and future. Although only Mellon wanted to see it dissolved, all were critical of its record. Alan Goldhammer, executive director of the Industrial Biotechnology Association, urged the committee "not to lose sight of its original purpose to identify gaps in scientific knowledge and facilitate cooperation among the various federal agencies." As an example of an unfulfilled BSCC promise, he cited the committee's lack of progress in developing a database on the introduction of modified organisms into the environment. Such information, Goldhammer said, would help companies planning future releases. BSCC was created in 1985 as a way to cope with the growing demand by scientists and those in the biotechnology industry to have one government body that would address the scientific questions relating to the study, testing, and eventual marketing of products derived from genetically engineered organisms. Housed within the Office of Science and Technology Policy (OSTP), it consists of representatives from the National Institutes of Health, the National Science Foundation, the Department of Agriculture, the Food and Drug Administration, and the Environmental Protection Agency (EPA). Its first major effort was a widely praised 1986 document that created a coordinated framework for regulating such activity in the field. However, that framework cedes to each agency the right to set up its own mechanism to regulate activity within its jurisdiction. Unfortunately, the result is a tangled sea of advisory committees and still-pending regulatory requirements through which scientists and companies must navigate. Its first chairman, NSF's David Kingsbury, promised Congress in 1986 that BSCC would steer clear of regulatory matters and confine itself to the many scientific questions facing the field. But BSCC has never been able to separate the two activities. In 1987 Kingsbury was pushed out in the midst of a protracted federal investigation into his ties to various biotech firms. (Although he was cleared of any wrongdoing, the microbiologist later left government to take a position at George Washington University.) Soon after Kingsbury's departure, the committee, whose work had been fairly accessible to public scrutiny, disappeared behind a veil of secrecy common to many bodies that fell under the jurisdiction of former presidential science adviser William Graham. Its meetings were closed, no agendas were published, and no official minutes were kept. In the spring of 1988, its new chairman, then-NIH Director James Wyngaarden, became embroiled in debate over an EPA proposal to regulate the release of genetically engineered organisms. When BSCC, with the backing of the Office of Management and Budget (OMB), succeeded in blocking the plan, EPA officials showed their unhappiness by refusing to attend any more meetings. The boycott effectively paralyzed the committee for almost a year. Things haven't gotten much better for the committee under the Bush administration. It was October before the group resumed its monthly meetings. And last month its new chairman, NSF's John Moore, relinquished his duties after deciding to leave government (The Scientist, Jan. 8, 1990, page 9). His slot was filled by Luther Williams, senior scientist to NSF Director Erich Bloch (The Scientist, June 12, 1989, page 2). OSTP Director Allan Bromley immediately named Williams to succeed Moore as chairman of BSCC even though Williams has not previously served on the committee or worked directly on the issues it faces. Despite the sharp criticism it has been receiving, BSCC seems unlikely to change its behavior measurably. Bush administration science officials insist that regulatory questions are part of its charge and that secrecy is an essential element. They dismiss any unhappiness about its conduct as part of the normal process of setting federal policy. "It's important for BSCC to comment on proposed regulations," says Wyngaarden, associate director for the life sciences at OSTP, which oversees BSCC. "Without that role, why exist at all? As for public meetings, it's impossible for BSCC to conduct its business in the open. This is a body that reports to the executive office of the president. It's not a public body, and it's not covered by the same rules that pertain to government advisory groups." Although its history is familiar to a small group of scientists, environmentalists, and industry representatives, a larger audience has become aware of the committee's problems only after the Administrative Conference of the United States held a series of meetings this fall to discuss the workings of BSCC. The conference, an independent agency created by Congress in 1964 to improve the way that government conducts its business, had asked University of Kansas law professor Sidney Shapiro to delve into the issue. And on December 14 it adopted a three-page recommendation that recognized BSCC's past shortcomings. The 100-member body of government officials and private citizens called on the president to "make coordination of the government's activities relating to biotechnology a high priority." The Shapiro report, which uses language quite a bit stronger than what is contained in the final resolution adopted by the conference, spells out BSCC's failures in a section entitled "Where BSCC Went Wrong." It says that BSCC tried unsuccessfully to combine its role as a clearing house and forum for discussion with an attempt to impose consensus among federal agencies on biotechnology policy. Those two roles "do not mix well," writes Shapiro, and the result is a "dysfunctional" committee whose closed-door approach has "delegi-timized" its role in coordinating policy. Shapiro suggests that BSCC be transformed into a new, larger committee that conducts most of its business in the open and that cedes to OMB all responsibility for achieving consensus. "If an agency doesn't believe that its participation [in BSCC] is worthwhile," says Shapiro, "then BSCC isn't going to work. You can't force an agency to cooperate and share data. At the same time, OMB should ask BSCC what the scientific issues are when an agency proposes a rule to regulate biotechnology. But that's quite different from BSCC telling an agency that it has come up with a bad rule." Some members of Congress also believe that BSCC has abandoned its role as a clearinghouse. But they say that the government must do more, not less, to regulate potential problems with the release of genetically engineered organisms. "The administration's attempt to coordinate biotechnology regulation through the BSCC has been a dismal and dangerous failure," declares a November 14 letter to the Administrative Conference signed by seven congressmen who play leading roles in overseeing the federal scientific establishment. "We believe a thorough, independent, and expeditious review of the adequacy of the present regulatory system is appropriate and necessary to safeguard both public and private interests." The signees include the chairmen of several committees that shape federal policies toward science. They are also disturbed about the lack of public access to BSCC. The authors note that the language in the recommendation ultimately adopted by the conference, which calls for public proceedings when appropriate, "reverses the natural order of things in our democracy. The BSCC should open its meetings unless there are matters of a confidential business or personal nature." Sen. Al Gore (D-Tenn.), one of the authors, underscored the problem during an October hearing before his research subcommittee by telling Wyngaarden that "extraordinary actions are needed to restore trust in the BSCC process." BSCC's problems stem in part from its existence as one of the group of panels operated out of OSTP and known by their acronym as "Fix-its" (for Federal Coordinating Committees for Science and Engineering Technology - FCCSET). Because OSTP has a tiny budget and a small staff, it relies on larger agencies like OMB to exercise its will. As one NIH official notes, "BSCC doesn't have any power. If it does something that an agency doesn't like, that agency is free to ignore it." But those who have headed BSCC disagree that it is a weakling among federal bodies. Kingsbury, for one, says that Shapiro's distinction between being a clearinghouse and focusing on policy is bogus. "If you don't want to be cooperative, you can stand up and say, `Hey, we're talking about policy,' " he says. "But it's my impression that the discussion about the EPA regs involved a scientific question of defining release. Besides, everybody knows that policy decisions have their roots in the West Wing [of the White House], not in some group of assistant secretaries that don't have upward clearance." Kingsbury also defends the need for secrecy. "You need a chance to get together and argue with your peers in an environment of colleagiality, and in a nonthreatening manner. There are things going on that you, as a government official, need to know about that can't be discussed in public." Asked repeatedly at the December meeting whether BSCC would meet more frequently in the open, Moore said that "we plan to have more frequent public meetings, to keep the public informed and to provide them with an opportunity for input." But he acknowledged that this was his last meeting and that he couldn't speak for the entire committee. At the same time, the comments of Wyngaarden and those who spoke at the Administrative Conference meeting one week earlier - including several officials prominent in the Reagan and/or Bush administrations - seem to offer a more likely description of the future. "Meetings that are open except for those dealing with proprietary issues will lead to one of two results," predicted James Miller, former director of OMB, during debate at the conference. "Either every meeting will be closed, or the meetings will be meaningless. I don't think that BSCC stands much chance of coordinating biotechnology policy in this administration if it conducts its business in public."

Critics Rip U.S. Biotechnology Panel

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