Our point of view is that we're skeptical of many of the benefits. We're worried about the uncertainties and the risks. This leads us to believe that for the most part these products will not be useful in a sustainable agriculture. Moreover, because they may present risks, they should be carefully regulated. That, then, leads us to do a considerable amount of work urging the three agencies involved--the Food and Drug Administration, the Department of Agriculture, and the Environmental Protection Agency--to improve their regulatory schemes.

			A senior staff scientist with the Union of Concerned Scientists, she talks about why bioengineered plants present a new kind of uncertainty in crossbreeding and the lack of substantive testing to date. Rissler also discusses why U.S. regulatory agencies seem satisfied with this new technology and the difference between genetic engineering for medicines vs. for food. (Interview conducted October 2000.)

But you're not saying that GM crops are inherently more dangerous than traditional crops?

No. We're not opposed to genetically engineered crops across the board. We do see this as a powerful new technology. This is where we part company with a lot of agricultural scientists, who see this as nothing more than an extension of traditional breeding. . . .

With traditional crossbreeding, you also introduce genes and have uncertainties as to how those genes will act.

You have a different sort of uncertainty with genetically engineered crops--at least that's what I'm told by ecological genetics folks. With traditional breeding, you may be moving segments of chromosomes, large pieces of DNA, but it's essentially within the same genome makeup, the same chromosomal makeup. What might happen with the genetic engineering is that these genes are inserted randomly, haphazardly. Contrary to what the industry says, it's not a precise thing.

In genetically modified organisms, are genes inserted more haphazardly than in crossbreeding?

Yes, because with crossbreeding, there is a particular chromosome that gets exchanged. Occasionally there may be some inversions. But what happens in gene splicing is that these genes go in haphazardly. The engineers can't tell you where the genes go. They may lodge in other genes. That is, they may interrupt other series of gene functions.

Now, I think it is possible that we may find out, once we've gathered a lot of data, that in fact there may not be a lot of unexpected changes. I don't know. My goal is to have the data that say that these crops are as safe as traditionally bred ones, and not operate on the assumption that they are. . . . The government and the industry have been too eager to assume that these plants, these crops, are substantially equivalent to existing ones. . . . But I don't think that they have done the kind of testing that a lot of us would want, to really establish the substantial equivalence.

I can understand why industry and government have taken this route. For many years, they have been successful in reversing the burden of proof. The industry is not forced to prove relative safety. Rather, the burden of proof is on people like us to show that there's some risk. . . .

The industry claims they went to FDA in 1992 and worked with them and asked them to regulate them, and that they've done this voluntarily. . . .

My sense is that industry did not want to be regulated very much. They wanted to be regulated a little bit, so that they would have some protection. Then they could say, "Well, we did everything the government wanted."

Under the Food, Drug, and Cosmetics Act, there were no regulations. . . .

But there could have been a choice. In 1992, the Food and Drug Administration produced a policy that it had been working on for many years. In that policy, it said, "We will treat them, for the most part, as substantially equivalent. Only under certain circumstances will we add any required regulatory mechanisms."

Thousands of people commented and said, "This is not strong enough. We want labeling. We want required food safety testing. We want these to be treated like chemical additives." Well, the Food and Drug Administration ignored those thousands of comments, and proceeded to treat these products really as ordinary food, except under unusual circumstances. As a result, there is only a voluntary scheme. The FDA has yet to require a single test of any foods on the market.

The FDA's reasoning is that if they labeled GM, they'd have to label stuff done by traditional crossbreeding.

I don't think so at all. I think there's a very easy way to determine that these products are genetically engineered. You just label them as genetically engineered. It's like irradiated food. That is labeled. . . . The FDA continues to say that there are no safety issues associated with irradiation, but they require that food be labeled as irradiated. That's because there was a great citizen outcry calling for labeling of irradiated food. The FDA has the power to require labeling if there is enough pressure to convince them to do it. It doesn't have to even be for safety.

Some labels are marketing standards, right?

Yes. There are process-based labeling. Certainly, irradiation is an example of an FDA-imposed, process-based labeling.

The issue of labeling is separate from the research. If you produced a new product with traditional crossbreeding as opposed to with genetic engineering, why would one require more regulation? If a tomato has been produced by crossbreeding, you can call it a tomato. But if a tomato has been produced by adding a gene . . .

It's still a tomato, but it has a genetic additive, and it should be treated as a tomato with a chemical additive. . . . When I was at the Environmental Protection Agency, we were trying to write rules that said that genetically engineered microbes should be looked at differently under the Toxic Substances Control Act. The Reagan Administration and a lot of other folks were opposed to that because they, too, bought into the idea that we should regulate the product, not the process. . . .

Over the years, they lost that argument, because the process is regulated in the United States. We do have this regulatory apparatus that is directed at genetically engineered organisms. And it means that the USDA regulates the crops in a way it does not regulate traditional crops.

Our argument at the EPA was--and my argument is--that, as a general matter, this is a new technology. It is a technology that brings with it a significant amount of uncertainty. It hasn't been applied. It hasn't been monitored much in the environment. . . . To the extent that one has resources to try to ensure safety to the environment and to public health, you direct those resources at the things that cause the most uncertainty or present the most risk.

That's why I don't look at traditionally bred crops. There may be some that are troublesome, but as a general matter, they are not. We know very little about the long-term impacts of genetically engineered food and they should be subject to more scrutiny. . . .

We've accepted genetic engineering in other aspects of life--insulin, medical applications. We don't appear to have a debate anymore about it.

Yes. Well, the difference to me is that the people who use the genetically engineered pharmaceuticals are people who profit from it. They take the risks, but they profit directly from the genetically engineered insulin, for example. In the food area, I don't think people see that they're gaining anything. And they're being asked to take risks that they don't even know about. The people who profit really are not the people taking the risk.

I think there's a sense that big corporate agribusiness is once again telling us that one of their products is good for us. In a June 1954, Time magazine, there's a beautiful color ad that says, "DDT is good for me." It shows a woman oh-so-excited, and it says, "DDT is good for the household. It's good for the farm. It's good for everything." So if you just replace that with, "Biotechnology is good for me," see, these same people who once told us that pesticides were good for us are now saying, "Well, those pesticides, they're dangerous. But you take these biotech products. They're much safer." I think there's more cynicism and more skepticism that agribusiness is telling us really what's good for us.

On the other hand, it's argued that biotechnology has such enormous potential that what you're seeing now is just the beginning of the technology. . . .

Yes, and that may change people's minds. I wish we could know that these genetically engineered crops are being subject to sufficient scrutiny to separate the safe from the risky. And I wish that they were labeled. You've heard industry say, for example, that there is no evidence that these foods are harmful. After all, people in the United States have been eating them for several years now. . . . They're now saying, "Well, there's no evidence of harm." . . . How would we know if someone had gotten ill from genetically engineered food, if it's not labeled? . . .

Are you saying that, until it's labeled, it can't be tracked?

Yes, that's right. . . . The absence of evidence is not absence of harm. Look at the fact that we're not able to track whether there've been any problems, and the fact that there are very few papers in the published literature on the safety of genetically engineered food for human consumption. It doesn't lead to great confidence in that statement that we have no evidence of harm.

How do you deal with the fact that the regulatory agencies seem on board with the technology?

I think it has to do with dollars. As far as universities are concerned, this is the gravy train. They can have patents. They can get money from big agribusiness. They're getting support for their research that they're not getting from the land grant colleges themselves. . . . Now, in terms of government, I think there's been a huge lobbying over the last 15 years by agribusiness for acceptance of this technology and for light regulation of this technology.

People in the regulatory agencies think regulation here is vastly superior to elsewhere in the world. . . . I'm sure they would not agree that it was lightly regulated.

It is lightly regulated. Just because you have a meager regulatory scheme and it's better than anyplace else in the world, we shouldn't improve it? People might say that about tobacco: "Well, if we had far less regulation of tobacco, we'd still be better than most places in the world." Should we stop, then? . . .

Ranking food safety issues, is the risk of allergenicity top of the list?

That's what I've heard food scientists say. And I believe that. . . . Marion Nestle wrote an editorial for the New England Journal of Medicine a few years ago, in which she said that there were three kinds of allergens--known allergens, uncommon allergens, and unknown allergens. The known allergens are the seven common allergens that FDA would regulate more stringently if they were put into food. The uncommon allergens . . . would not be regulated. And then there are the unknown allergens. With genetically engineered foods, we're putting proteins from a lot of organisms that we don't typically eat--like petunias, like soil organisms--and there could be some new allergens that are unknown. Again, we can't trace the effects because the food is not labeled.

There are allergen tests. But you don't think they're very good?

Allergenicity testing is pretty primitive. As a matter of fact, that is a criticism that we have of the government. They've had 10 years now in which they have said allergenicity is likely to be the biggest problem, and they have done very little to advance the science of predicting allergenicity.

Are there any other food safety concerns? What about toxicity?

The FDA produced a document in 1992, in which it laid out some of the possible food safety issues. One was allergenicity. One was that new toxicants could be produced, as a result of activating or changing some pathway. They didn't think it would happen often--and I don't think it will either--but that's a possibility. The FDA also said that nutrients could be diminished, and that antibiotic resistance markers might contribute to the background of antibiotic resistance. . . .

There are some possible positive effects of genetically modified foods that have gotten zero publicity: fungal things, fumonisins and aflotoxins. That would be on the other side of the ledger. . . . As for environmental effects, you can use less pesticides, or have a more targeted effect.

The context in which I talk about this is the context of advocating for sustainable agriculture. We want the U.S. agriculture production to be sustainable, that is, one that is less harmful to the environment than what we have now. . . . I would certainly agree that the BT cotton in many places in the South looks to have a good effect on reducing pesticides. I don't want to give that a blanket approval, because it's not quite clear to me what the level of pesticide use would have been without BT cotton. . . .

I would say that certainly the reduction in pesticide use is good. . . . But if I'm interested in long-term sustainable methods, I don't think the BT cotton passes. Resistance is going to develop because of the vast use of the BT toxin. Insects are going to develop resistance. So not only will this be a short-term product, but organic growers will also have lost BT sprays.

So it's partly that they might develop resistance, but mainly because they're using a resource of organic growers?

We want people to farm differently, that is, to adopt long-term sustainable methods that would require crop rotation, that would require perhaps inter-cropping--some way to keep pests under control without this constant use of pesticide after pesticide. . . . I don't want to imply that every farmer is free out here to convert to sustainable methods. It's not that simple. It takes changes in farm policy. And USDA has come a ways in appreciating sustainable agriculture. But we don't see that biotechnology is getting us to sustainable agriculture.

. . .

So your primary concern is resistance management? Is that your main point?

It is. But with the BT corn, we are worried about the effect on monarchs and other butterflies. Now, of course, the argument is that this is not as bad as the synthetic pesticides. Well, I don't think it is. But do we really want to replace one technology that is harmful to the environment with another technology that's harmful to the environment? . . .

But genetically modified crops are arguably much less harmful to the environment. . . .

It depends on where you want to compromise. There's another issue here with corporate control of the food supply. . . . We're headed toward a time when there will be just a few corporations that control the food supply from the farm to the plate. And that is not in the best interest of a strong world economy. It's not in the best interests ultimately of healthy food and healthy people. . . .

Some say the greatest beneficiaries of this technology will be people in the developing world. What do you make of these arguments?

I think it's a ploy. It's a ploy to convince relatively well-to-do people in the industrialized world to approve of this technology. It's playing on the guilt of relatively well-off people, that somehow if they don't approve of this technology by agreeing to buy the products, the result will be people dying of starvation in the developing world.

You don't believe this technology can help people in the developing world?

The biggest problem behind hungry people is lack of money. It's not technology. There's plenty of food right now, and there're people starving. Putting vitamin A in rice, making high-protein corn--perhaps they have some value. But the better approach would be that people could buy food that would give a well-balanced diet, instead of having to pile all the nutrients into one type of food or two types of food. So I don't think we ought to be deluded. Technology is not the obstacle to feeding people. It's poverty. . . .

But vitamin A rice might have some value in areas where there's blindness.

Well, that is more complicated than Time magazine's cover portrayed. I think that the best solution would be to help people have the wherewithal to have a well-balanced diet.

How about the idea of edible vaccines? Do you not see any benefit?

I don't think it's as easy. These are ideas that people have, and I think they have noble purposes. I think that the problems are more complicated. For example, how are you going to be sure, say, if an edible vaccine is in bananas, that someone doesn't overdose on vaccines by eating too many bananas? . . . I don't mean to be disparaging of all these scientists who have really noble goals. But I do see people perhaps overlooking more practical but less sensational solutions to very important problems. . . . It seems the sexy thing to do--to apply biotechnology to a range of problems, without really considering that there may be simple, practical, feasible alternatives.

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