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Challenges to Public Policy

The following is a talk given by Dr. Donald Kennedy at the "Winding Your Way through DNA" symposium, which took place at the University of California San Francisco in 1992. Dr. Kennedy was President of Stanford University at the time. Excerpted from the transcripts with permission of the University of California, San Francisco.

How do we regulate new technologies? How do we try to balance the costs and the benefits they will bring us? I think the regulation of recombinant DNA is perhaps the ideal case study in science and public policy, and for several reasons. First, it offers an unparalleled sweep of new opportunity. Those who are practicing the technology, let alone the investors, see exciting prospects of new medications, new agricultural crops, new means of remediating environmental problems. It is, in short, the source of stupendous possibilities.

But second, each opportunity affords an array of potential problems: unwanted side effects, unanticipated social costs, unforeseen public health and environmental risks. But these, not in themselves unusual because they often accompany newly introduced technology, are compounded by a very special kind of drama - the specter of genetic monsters running amuck, and some feel, furthermore, that in undertaking this kind of work we have begun to interfere with a process so fundamental in nature that we may be guilty of the sin of hubris. And that reservation - so deep, that at times in the history of this business, it has seemed almost theological - has been of profound significance in the politics of recombinant DNA regulation.

Moreover, this is one of the very few instances in which scientists themselves, the very developers of the technology, were the first to recognize its potential risks and to call public attention to the need for evaluating them. Perhaps partly as a result, scientists were given more than the usual amount of responsibility for the early development of regulation in this area. In the view of some, that's made the process more sensible, more appropriately suited to the nature of the risk, and in the view of others, it has removed critical issues from public scrutiny and thereby reduced accountability.

So there's lots to argue about. It's a fascinating exercise, and partly because it illuminates a special part of the American character. On the one hand, we're a creative people bursting with entrepreneurial zeal, fearless about risk, and on the other we're full of suspicion and concerned about what others may do to us - in particular, what our own government may do to us. On the one hand, we believe that our leaders owe us a measure of protection against hazards, but on the other hand, we deeply resent any intrusions on personal freedom, even when those intrusions are for exactly that kind of protection.

You've already heard more than I'm able to tell you about the early history of regulating recombinant DNA technology. I'll just point out that my Stanford colleague, Paul Berg, had recognized the hazards of working with animal viruses like SV40 well before the issue of recombinant DNA technology itself came to the fore, and he organized a conference to deal with those issues. So there was a precedent when Paul and other colleagues assembled a group of scientists, first to co-sign a moratorium letter that temporarily halted their research and was published in Science Magazine. And then he organized the now-famous Asilomar Conference, at which the issue of recombinant DNA regulation was first considered in 1975. That meeting, and the cloud of controversy that developed around it and lingered long afterward, set the tone for much of what followed.

I have to remind you what the times were like. Rock'n'roll was not a lot more than a decade old. The last wisps of tear gas had barely faded from Bay Area campuses. Much attention was still being given to the democratization of science, and there were still straight-faced proposals that research laboratories should be converted into cadres in which everyone voted on the design of experiments. Those who think that political correctness dominates campuses today either never knew or do not remember what it was like when the New Left was still fairly new.

In that climate, the assembly at Asilomar tried to accomplish something truly ambitious. Scientists, engaged in a new and exciting area of research, in which the biological nature of organisms could be manipulated in novel and much more directed ways, had sensed the difficulty and called a halt in their work. The recommendations they formulated in full public view at Asilomar were regarded by many as a landmark of social responsibility in science. But not everyone was happy - and how could they have been in times like those?

The assaults came quickly. From the scientific Right, the argument was that the new technology presented no problems at all, and that even to talk about regulating it might put notions of control into the wrong heads. Let's not tell Junior he can't stuff beans up his nose! And from the Left, from Science for the People and other organizations, the argument was that the entire premise of Asilomar was wrong, that scientists had no right to assume the task of self-regulation. That belonged to the public at large.

In the immediate aftermath of the conference, the scientists who conceived it and carried it out received praise from most quarters as befitted a self-sacrifice initiated in the public interest. But as time wore on, they were acquainted with a lesson that many have learned in other contexts - those who start a revolution seldom stay to direct a new state. Indeed, they are soon overtaken by the very events they start, as Gorbachev, and soon, perhaps, Yeltsin, can testify. And in just the same way, those who raise difficult questions about control can expect to lose some of it in the longer run. Some of the pioneers may have expected that, others may have hoped that by raising questions themselves they could actually guarantee continued control, much as some advocates of voluntary professional accreditation hope to avoid the sterner grip of State oversight.

Well, what were the arguments and beliefs being brought at that time, marshaled at that time, in support of the idea of research regulation? The first was surely a fear of the unknown, a concern that public health hazards of unanticipated severity could result from new genetic combinations produced in this way. This specter of bacterial monsters, "The Bug that Ate Cambridge," even spawned a number of local regulatory initiatives in academic communities around the country.

That concern has tended to disappear over time, at least with respect to the standard microbial work, as various recombinant strains have been handled safely over the years. But from the beginning, as I mentioned earlier, there were other less explicitly stated but often deeper worries, and some of them are still with us and are still reflected in the controversy. One is political - the view that certain experiments are bad science and should not be done or, if done, only done under the supervision of non-scientists with the proper views. Another is more theological than political - it says that evolution is a process so delicate and so important that it should not be tinkered with in any way. Some very distinguished biologists expressed that view early on, although without explaining why hybrid corn is okay.

Well, after Asilomar, something very like a popular rebellion grew up from a fusion of these elements I've just mentioned. The energy of that counter-reformation, I think, was added to considerably by some of the original scientists who, having blown the whistle, swallowed it later and said there wasn't a problem after all. They were probably right, but that reversal didn't do much to buttress public reassurance about the stability of expert opinion.

I remember my own most colorful experience with that occurred at a National Academy of Sciences Forum in early 1977 in Washington, when a very staid and stuffy gathering was suddenly punctuated by the arrival of a noisy group called the Peoples' Business Commission led by Jeremy Rifkin, a very colorful figure at the time. I was on the stage. I thought I was in the middle of a sit-in for some time, and I remember very well that they carried signs saying, "Don't Xerox Life!" The theological theme important then, somewhat important still.

At exactly this time, the government was trying to figure out how to regulate this new technology, particularly research on it. Most of the scientists had been supported by the National Institutes of Health, and its director at the time, Donald Fredrickson, was given charge of an interagency committee on recombinant DNA, on which I represented the Office of Science and Technology Policy in the White House, because I was on loan to them half time. Its task, the task of the Committee, was to work out the appropriate mode and jurisdiction for recombinant DNA research and, although the exercise was pretty good by the normal standards of government deliberation among agencies, it did resemble a feeding frenzy for turf at the time. There were 25 federal agencies, some of them supported research, some of them, like the State Department, were just interested.

Others were regulatory agencies, and they showed a considerable appetite for doing what they were put on earth to do. Regulatory agencies regularly obey the two-year-old with the hammer rule: If you give a two-year-old a hammer, it is amazing how much stuff needs hammering. And the regulatory agency thirsted for this new array of nails, and the Environmental Protection Agency in particular laid sweeping claims to regulatory policy. But in fact, it turned out that none of the statutes that existed, not the OSHA statute, not EPA's, not any of the regulations, the Toxic Substances Control Act, the Public Health Service Act - none provided adequate statutory authority, so it was decided in the end that legislation was needed and then the prospect really began to scare everybody.

The legislative course was confusing. The Senate Health Subcommittee under Senator Kennedy's chairmanship drafted proposals in which a public commission would share responsibility with the Secretary of Health, Education and Welfare, as it was then. A corresponding version in the House was a plain vanilla version without the public commission. As these competing visions of regulation wound their way through the legislative process of hearings and so forth, concern was ebbing because research with the disabled strains of bacteria was lowering the estimates of risk, and the scientific community got more and more concerned about the appetite for new legislation, particularly since the subcommittee's staff of the Senate subcommittee substantially rewrote the original Administration bill and made it much more difficult and disadvantageous from the viewpoint of the scientists.

Well, eventually the legislative push simply lost its momentum, and the Secretary of HEW was encouraged to use all existing statutory authorities and to create the Recombinant Advisory Committee, and to just go ahead and get the job done. And that is exactly what happened. In the end, the perception of public health risk and its gradual ebbing was the decisive political factor.

The other major concern referred to by one distinguished biologist as "the manipulation and deformation of nature," did not eventually figure significantly in the political struggle, so the NIH guidelines were left in place, and what we had at the end of the process was what Roger Knowll called "professional self-regulation." That is exactly the place in which it wound up, and I think the test of time applied reasonably says that it has worked reasonably well.

But now we take a great leap forward in time and also change the focus. I think intervening events have done little to change the view I just expressed about research regulation, but now the focus shifts and comes to the application end of the new technology, not the research and development end, and here a similar exercise in trying to coordinate federal regulatory authority got absolutely nowhere under the Federal Coordinating Council for Science, Engineering and Technology, an arm of the Office of Science and Technology Policy. There was an effort to create a biotechnology science coordinating committee, which mandated something called the coordinating framework, and then stopped agreeing and started fighting and, in the end, there was never a major jurisdictional problem resolved. Important bases were left untouched and, perhaps most important, agencies were left free to claim their own regulatory turf, and there is no present coordination, a matter that is a cause for some concern.

Well, why is this so exciting? It's exciting because of transgenic plants; there are some wonderfully ingenious things happening. Bombarding plant cells with tiny metal particles coated with DNA and getting them to change - it's quite extraordinary to one who left active biology 15 years ago, I can tell you, and now there's an extraordinary capacity to produce beneficial alterations in the agricultural economy, not just of the United States, but of the world, but it has encountered significant obstacles.

The first obstacles came up when it was necessary to take the work out of the laboratory and start field trials. In the first instance, this came not with transgenic plants but when recombinant DNA technologies were used to move useful genes from one kind of bacterium to another. You've already heard about BT, the insecticidal protein from Bacillus theringiensis. Bear in mind, Bacillus theringiensis, the bacterium, has been used in absolutely unregulated or almost unregulated fashion by farmers for years. They mix up vats of it in the barn and spray it on. It is sprayed by air frequently. It is a microbial insecticide that is of proven effectiveness.

The idea now was to get it into a soil bacterium where it could live right near the roots of some valuable crop plant and then confer protection against pest insects more directly. So Monsanto incorporated the BT gene into a soil bacterium called Pseudomonas fluorescence, and laid plans for a field trial in St. Charles County near St. Louis.

Now the EPA, under the Insecticide, Rodenticide, and Fungacide Act, regulates that kind of work, and the EPA had to approve an experimental use permit. Monsanto applied, and the EPA sent it to a subgroup of their scientific advisory panel, and the advisory panel recommended a few changes, but said that it could go ahead. But that was not the only hurdle. Jeremy Rifkin, who we have met before, now in a coat and tie, filed objections to the permit application with the EPA, and he also wrote to the commissioners of St. Charles County seeking their intervention in disallowing the tests in their county. There was a substantial struggle. The EPA administrator declined to take the advice of the advisory panel and, in fact, did not approve the field trial.

Everybody learned something from that. Once transgenic plants came along, there was an enormous effort at public education. In the meantime, a National Academy of Sciences report on field testing of genetically modified organisms was published in 1989. It concluded that, and I quote directly here, "Crops modified by molecular and cellular methods should pose risks no different from those modified by classical genetic methods for similar traits." That seems to me to be a reasonable conclusion, but there's a more straightforward worry and now we turn to it.

Please remember that we are talking about food when we are talking about transgenic plants. Once the field trials are over, presuming that there is scientific success and we have a new crop, of course it has to be a tomato. Why everybody only works on tomatoes, someone has to explain this to me. But anyway, what we've got is a tomato and somebody has to be persuaded to eat it. And that brings into play a whole new domain of regulatory authority over which my old agency the FDA presides.

Let me give you one quick piece of background about FDA's regulatory authority. In the mid-1930s, when it was formulating what are the modern food safety laws, it faced an interesting dilemma. Food producers were beginning to do interesting things with chemistry. They could add stuff to process food to make it last longer or look prettier. There was some reason to believe that the reckless pursuit of those economic objectives might produce some adverse externalities for consumers. On the other hand, the woods were full of natural contaminants - bad stuff that got into plants while they were growing, or into fish while they were swimming around, before they were caught.

And Congress was fond - even fonder than it is now - of the yeoman American farmer, and was understandably reluctant to make life difficult for him over something he couldn't help, so Congress made a judgment that I think is fundamentally right and fair, although it sometimes makes government and its laws look foolish. The decision was, that when food processors add something to food, they have to prove it's safe. They have the prior burden of proof-of-safety, and when a natural contaminant is present, the burden is on the government to prove that the food isn't safe.

So a substance that's deliberately added, even if it's something that just migrates out of packaging into the food, is a food additive. It must be approved by a food additive petition, unless it's been out there forever - in which case it is so-called "generally recognized as safe," until evidence is produced that says it isn't.

Well, the problem must be obvious to you. There are some natural contaminants that are more dangerous than things we add, and that produces a public perception of inconsistency in the way the government is treating risks.

Now comes the challenge of genetically engineered crop plants. To be sure, the problems aren't new. Traditional plant breeding has given us very analogous ones in the past, but the new techniques do make possible the transfer of genes over much wider taxonomic distances than before, and that prospect worries people. The National Wildlife Federation speaks of, and I quote, "An open invitation to put any gene, human or chicken or bacteria, into our food," and this piece features a cartoon of fresh produce with the questioning label, "fish gene" above a stack of tomato sauce cans, what else?

Should the FDA regulate genetically engineered food? Obviously, if genetic engineering produces a new additive in the food, why shouldn't it be treated like a deliberately added substance that's part of food processing? There were serious worries that are quite beautifully summarized in this cartoon: the Little Shop of Horrors over there has come to life under the benign auspices of this mad scientist. And the FDA was urged by many to worry about those crop plants. In fact, it adopted a very reluctant policy, published a federal register notice earlier this year that said, here is some ways in which you can decide whether this might be harmful. Follow our decision tree, keep us informed, but we're not going to require even labeling, and we're not going to require a novel regime of food safety testing.

So they decided against a ham-handed grasp for regulatory authority and there the matter rests. My own view is that the FDA probably will be forced to extend its reach somewhat, at least with regard to labeling. But the challenge will be to do that without restricting our opportunity to reduce the dependence of our agriculture on energy and applied chemicals. As always with challenges that new science throws at old policies, that last chapter has yet to be written. I hope I've persuaded you that this particular challenge is complex, tricky, difficult, and that solving it will require much more than straightforward risk assessment or cost benefit analysis, and certainly more than simpleminded rhetorical admonitions that it's not nice to fool with Mother Nature.

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