Kingsbury on NSF, Biotech Regulation

David T Kingsbury, assistant director for biological, behavioral and social sciences at the National Science Foundation, has been described as the Reagan administration's point man on biotechnology. As chairman of the Biotechnology Science Coordinating Committee formed under the White House Office of Science and Technology Policy, Kingsbury was the principal architect of the Coordinated Framework for Biotechnology, which President Reagan signed last June. After receiving his Ph.D. in 1971, Kings

March 23, 1987

David T Kingsbury, assistant director for biological, behavioral and social sciences at the National Science Foundation, has been described as the Reagan administration's point man on biotechnology. As chairman of the Biotechnology Science Coordinating Committee formed under the White House Office of Science and Technology Policy, Kingsbury was the principal architect of the Coordinated Framework for Biotechnology, which President Reagan signed last June.

After receiving his Ph.D. in 1971, Kingsbury taught microbiology at the University of California at Irvine. In 1981 he became a professor of medical microbiology and virology at the University of California at Berkeley, from which he is now on leave. His research interests include pathogenesis of the slow viruses, infection by microbial pathogens and molecular diagnostic techniques in medical microbiology.

Kingsbury, who joined the NSF in 1984, is also an adjunct professor at George Washington University. He was interviewed in his NSF office in Washington last month by Tabitha M. Powledge, editor of The Scientist. This is an edited version of their talk.

Q: The National Science Foundation appears to be on the verge of really explosive growth. Where's the agency headed?
KINGSBURY: If all goes well, we're going to be transformed in the next five years from being a small agency into being something that's starting to border on middle size. I think there has been a recognition that the basic science information base in the United States had lagged through the latter part of the '70s. A lot of what we've been mining in the early '80s is material that came out of the late '60s. I think that was part of the reason there has been support for increasing the agency. I think that the director also is focusing a bit more on the engineering side of the equation, more than we have here in the past.

Q: And there's this new plan for the science centers.
KINGSBURY: I think it's worth focusing on what the three major focal parts of the NSF budget are: education and human resources, the science and technology centers, and support for NSF's standard basic science activities. In the 1988 budget those are roughly equivalent in terms of absolute dollars. That means that the percentage increase in the centers program is large, the percentage increase in education and human resources is large, and the percentage increase in the base is relatively small. But the absolute numbers are the same.

Over the next five years, the balance will change a little bit. Several things are going to happen. One is that NSF is going to be playing a much more significant role in education and human resource development. We're going to change from our recent focus on pre-college education and graduate fellowships. In '87, we've started the undergraduate research experience, and in '88 undergraduate training will be vastly expanded. We're also anticipating an enhanced number of graduate fellowships, and better postdoctoral experiences, and also more retraining experiences for faculty.

Q: You mean making space scientists into molecular biologists?
KINGSBURY: No, making old molecular biologists into new molecular biologists. Refurbishing people within their fields, getting them out so that they learn how to approach problems with the new technologies. Getting people who have been in smaller institutions back into the research environment so that they can not only do something on their own, but can also present the new technology in their teaching. Remember, the vast majority of undergraduates in the United States don't come out of the research universities; they come out of the smaller schools. The fact is, that's the major pipeline for people who go out into science and technology. It's also a very important element in general scientific literacy, which is not very good in the United States.

Science Research Centers

Q: What about the science research centers?
KINGSBURY: People want to view the science research centers as a unitarian notion, and they're not. Not everything is going to be like the engineering research centers. The basic notion of the centers is that they will be a unique kind of environment for multi-investigator, multi-disciplinary, problem-oriented research. But the way each one fosters that notion is going to be different.

Q: "Problem-oriented" suggests applied research, doesn't it?
KINGSBURY: I don't think that we should think of it as applied research. Some ERCs are focused on telecommunication systems or robotics. An ERC may be generic towards robotics, but it's not going to be focusing on everything in engineering, or everything in micro-electronics. It'll be focusing on a group of people—software people, hardware people, vision people—working together in an institute on the basic fundamental ideas about building a robot that can do something. That robot isn't going to be built to do anything in particular. The new science centers are going to have something of that nature to them. Gene expression might be one. No new pharmaceutical would be coming out of a center at work on gene expression, but there's going to be a lot of basic information someone else might use. But it's not going to be everything under the sun. We're not going to be funding a center where one faculty member is sequencing mouse DNA and another one is mapping Salmonella. They're going to be working to focus on regulation of gene expression, or whatever else the problem happens to be. And I think that's how we view it.

Q: How set are these plans? Are they still in the process of formulation?
KINGSBURY: Well, at one level they are, and at another level they are not. We've got a program announcement on the biological research centers. We've formulated our plans in mathematics and physical science plus a couple of other areas where we've got center ideas that have percolated up from the programs, not down from the director's office. One of those is a national center for geographic information. The notion there is that we will form a multi-agency, multi-investigator focal center for compiling and transforming a whole pile of geographic-based data, which will include maps, weather information and economic information. It really is a social science center for people interested in demography, regional science, resource utilization, regionalization, a whole series of things like that.

A Science Department?

Q: Is NSF trying to turn itself into a Department of Science and Technology?
KINGSBURY: Oh, I don't think so. Heavens no. If it is, they haven't told me. A Department of Science and Technology has the problem of breaking apart existing agencies, getting into all kinds of jurisdictional problems, amalgamating things in a very awkward way. It would be difficult, and you'd never get the Defense Department to go along with it. So you'd always have the Department of Science and Technology and the Defense Department. And that would be embarrassing because their budget would be so much larger and it would really highlight that the Defense Department spends all the money.

I think one of the things worth keeping in mind in talking about the NSF budget is that there still is a major focus on the individual investigator. I don't want people to think the entire budget is being turned into science centers proposals. It's just not true. People have to understand that our approach to education now is twofold. One is formal, through the science and engineering education directorate. The other is that we have enormous numbers of these activities scattered throughout the disciplinary directorates that are there because they are discipline-specific. The needs of one community of established investigators for retraining and workshops are quite different from those of another community, so it has to be the disciplinary group that makes those decisions. Likewise with the undergraduate program; I think people have missed that. It really has gotten by them how heavy the educational component of the budget is.

Q: One complaint I have heard about the science center idea is whether or not it makes sense to organize basic research in that team way. People say it may make sense for engineering topics to be organized by centers, but it is not an applicable model for basic research.
KINGSBURY: Let me address the basic science question. There are some things NSF does that people don't call centers, but that really are, and that are doing pure basic science. For example, we run this network of long-term ecological sites around the country. They are large areas that are completely isolated and set aside for basic ecological research. They're usually run by a university, not by a department, not by an investigator, frequently by consortia of universities. Investigators come in and study different aspects of the ecology, from soil microorganisms to birds or whatever. That is a multidisciplinary research center that's problem-oriented. We don't call them centers, we call them long-term ecological sites. And they are very, very basic; you can't get much more basic than that. But that's a research center. It's all a matter of your perception. And the label.

Biotech Regulation

Q: What are the most important features of the new biotechnology regulations that came into being last year?
KINGSBURY: They define what's going to be regulated in a coordinated way so that everybody is using the same definition, and also define agency jurisdiction as best we can given overlapping authority.

Q: Are they still being modified?
KINGSBURY: Specific rule-making is going on at the Environmental Protection Agency and at the Agriculture Department, so in that sense, yes, they are changing. But the fundamental policy statement really hasn't changed. Also, in the Coordinated Framework as we published it in June 1986, the Agriculture Department had proposed research guidelines that were comparable to the draft guidelines at the National Institutes of Health. We've determined that it's unnecessary to have that duplication; we're trying to make one single set of guidelines, a modified set of NIH guidelines, that all the agencies will utilize. That process is coming along quite well.

The area that needs to be changed (or expanded, really) is related to large-scale production and release of new organisms into the environment. Guidelines devised by the NIH Recombinant DNA Advisory Committee (RAC) really didn't deal with release into the environment. Yet, Agriculture wants to put plants out into the field, so that's where we had to expand it. We also are defining containment of greenhouses and things of that sort, which were not in the original guidelines.

Q: The RAC will continue in existence, but RAC-like bodies are being set up in the other agencies?
KINGSBURY: Only in Agriculture and NSF there will only be three of those bodies. What we're talking about here is research guidelines, not product approvals. EPA has product approval committees and will continue to use them. EPA and the Department of Energy both fund research, but they will use either Agriculture's committee or NSF's committee. That was all part of the November 14, 1985-June 26, 1986 combined Federal Register notices. Those two together made the complete package
Q: What's been the response from industry? I have heard public praise, or at least acceptance, but some private grumbling.
KINGSBURY: That's an interesting situation. In general I think the industry has been quite comfortable. They're grumbling because they think we've over-regulated them a little bit. I think we did too, quite honestly. At the same time, I don't think we did it excessively.

I think we've accomplished a lot. People now have a much better feeling for the fact that something's in place and it's working. And in fact it is working. There have been a number of approvals of field trials, especially for plants. And there have actually been examples of USDA-EPA interaction on plants with pesticidal properties that have been approved and planted. A lot of us think that's a good accomplishment.

Q: What's the response been from scientists?
KINGSBURY: Oh, the scientific community got all excited over this. They were really upset. We woke them up, especially the agricultural community. This room was full of paper with all the responses that came in from the Ag schools.

They had such a long history of just doing this stuff. It never occurred to a lot of them that some of these regulations would apply to them. Huge numbers of organisms, of different species, have been put into fields to enhance fertility and to colonize leguminous plants and to do attempted colonization of nonleguminous plants. In 1895 a company in the Midwest introduced a product which was live microorganisms put on fields to enhance fertility. It was used for a long time and is still used. So the agricultural community has this incredibly long history, well over 100 years now, of environmental release of organisms. How many varieties of plants have they introduced? Thousands, literally thousands, of new cultivars. And it never occurred to them that they should go out and file an environmental assessment for every new cultivar.

The other thing that bothered them was the definition of a plant pest, because everything is a plant pest. We're plant pests: We go out and walk on the grass and break it, cut down trees, and so on. They thought that would really get in their way, so they all of a sudden responded. We got lots of letters.

Q: Jeremy Rifkin aside, have you heard much about this from the public?
KINGSBURY: No, not much. I've got limited experience, though. I did a Cable News Network one-hour call-in show. A lot of people called in and asked all kinds of questions, but none of them seemed particularly concerned over environmental introduction of genetically engineered organisms. One person was concerned about whether EPA had the expertise to be able to make the right judgments.

Q: Do you expect the new regulations to really settle the turf disputes among the various agencies or do you think they're going to continue to arise?
KINGSBURY: There's always going to be some low-level turf disputes. It's intrinsic to the government's way of doing things because the government's made up of people and people do that. For the most part, I'm fairly satisfied that we solved it. The area where one can see the most disagreement is between Agriculture and EPA, but at the moment the two agencies are working quite nicely together.

Q: Are other countries modeling what they want to do on what's been done here?
KINGSBURY: Yes, there's a good indication of that. We've had a very close relationship with the European Community. There's a great deal of interest in our policies and there's a willingness on the part of at least some of the EC people to go with almost an identical policy. They have the same problem we have, an environmental group that wants to be a little bit more radical than their commercial group. In general, they're tracking reasonably closely what we've done. The Organization for Economic Cooperation and Development seems to be pretty well in line with that same notion. And the Japanese have been in to see me, and they're paying attention through the OECD.

My personal focus right now is on Latin America, or the Americas as a whole. We've got good interaction with Canada. The Canadians have really got their ducks in a row as far as I can see; they're doing fine. As you go south of the United States, it's hard. There's no good overriding body that you can deal with like the EC or the OECD. They need to be aware and they need to have something in place so that people can go there to do research if they want to.

Some Regulatory Lessons

Q: Does the experience of regulating biotechnology hold any lessons about the process? What have we learned about devising regulations that might be applicable to other areas of our lives?
KINGSBURY: I don't know what the answer to that is because I still don't fundamentally view myself as a regulator.

Q: I'm talking more about the process of devising regulations rather than doing the actual regulating.
KINGSBURY: I know what you mean. The process is done in a fishbowl, and it's silly not to acknowledge that. If we were going to do this again, I guess I would try to make sure that the process was even more open than it has been. There are things that people want to say to other people that they are just not going to say in front of a hundred public interest groups. But the minute you close the door, they think that you're saying something terrible. When that happens, it slows you down.

My second recommendation for regulation is to be absolutely sound scientifically. It seems to me that's the smartest thing to do: be up-front, do it scientifically, and let people know what's going on, so that there's no mysteries.

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