Does the controversy over genetic modification strike you as ironic?
I don't like the word "genetically modified food." Virtually all of our foods
have been genetically modified. Take the apple, for example. There are
literally dozens of varieties of apples. How did we get those dozens of
varieties? We genetically modified the apple through conventional breeding.
We crossed one kind of apple with another apple, and we produced very different
apples--different color, different flavor, different functions. So almost all
of our foods have been genetically modified in some way. What's different now
is that we have some new techniques to do it. I usually like the idea of
genetic engineering or recombinant technology. All of our foods, just about,
are modified genetically.
Some people say that traditional crossbreeding is natural, and therefore, is
That's kind of what you think because they've been around a long time. But
there are lots of examples, for example, the potato, which, by the way, comes
from South America. It was originally purple. We bred out the purple because
we like white. The potato contains a naturally occurring chemical that's quite
toxic, called glycoalkaloid. Those glycoalkaloids in some potatoes, as a
matter of fact, have caused severe human poisonings or near-death. When you
breed potatoes, it's possible to breed high levels of that toxicant into a
potato. As a matter of fact, there are a number of breeds of potatoes that
have high levels. Fortunately, they did not make the marketplace--for that
A professor of food science and toxicology at Cornell University, Hotchkiss compares
genetic engineering to traditional crossbreeding of plants, explains how
science evaluates risk and how toxicity is tested. He also discusses why
allergenicity is the most difficult risk issue with foods, why the current U.S.
regulatory framework is adequate, and the problems that would arise if
mandatory labelling is introduced. (Interview conducted September 2000.)
Another example of the risks of traditional breeding is celery. Celery
naturally contains a photoactive toxicant, that is, a chemical that becomes
toxic when it hits sunlight. There was a case in California where a new
variety of celery was bred that, unknown to the people who bred it, had high
levels of this toxicant in it. It was planted. People went along, harvested
this, and the workers who harvested this came out with a very severe skin rash.
Why? Because it had the high level of toxicant resulting from the commercial,
normal kind of breeding. So the normal kind of breeding can produce risks,
just as any other genetic or other kinds of breeding can produce risks.
The way the FDA regulates food, people haven't had to do all the research in
advance and prove that it's safe before they release it.
Yes. In the examples of traditional breeding, that's correct. FDA has not
required pre-market approval. In other cases, FDA does require
pre-market approval--additives in foods, for example, or colors or other things
that are added.
They require pre-market approval?
For conventionally bred products, no, FDA has not required pre-market approval.
The examples I gave you might suggest that maybe they should, but they haven't.
In other cases, FDA does require pre-market approval, particularly for things
added directly to foods. In the area of genetically engineered food crops, FDA
has required certain submissions, and has changed its policy as it has learned,
like the rest of us, more and more about this technology and how it's applied.
The FDA's responsibility is to assure safety, and if pre-market approval is
required in their opinion to do that, then they will require that.
What does "food safety" mean?
The term "food safety" really, in my view, is a misnomer, a strong misnomer.
Safety implies a non-event. You say something's safe, nothing bad happens.
But it is impossible, particularly for science, to prove non-events. There's
no way that anyone can prove a thing will not happen. So science deals in
risks. Science looks at the size or the probability that a risk may occur.
It's impossible for science to go around and assure people that things are
safe, simply because science cannot address non-events.
So you look at risks. What is the risk of conventionally bred celery? What is
the risk of breeding celery through genetic modification? That's the way
science looks at it--that there is always some size of risk. Then it's really
up to society to gauge whether that risk is acceptable or not.
What kinds of things might go wrong with a tomato?
Tomato is a great example, because up until the middle 1800s, a tomato was
thought to be quite toxic, because it belongs to a plant family that is quite
toxic in itself. People didn't eat tomatoes. So it's possible that, in
breeding a tomato by whatever technique, you could introduce a gene which
produces more of that toxic substance. FDA would be very interested in that.
Tomato is also very important because it's a mildly acidic food. If you make
it less acidic, you change the way it must be processed and you have an
increase of botulism in a tomato. That's another thing FDA would be concerned
with. So there's quite a long list of things that FDA would want to know about
No matter how that tomato was made?
However it was made, yes. As a matter of fact, I think you could logically
argue that the technique of genetic engineering produces a much more specific
change in the tomato, where breeding produces a whole range of unknown changes.
I use the example of anybody who is a parent--you know that you cannot predict
what the offspring from a mating will be. It's true of the tomato as well.
Can you test food for toxicity?
The conventional toxicology is to take a group of animals--most often rats,
because we know a lot about them and they're cheap--and feed them very high
levels of the chemical of interest. You can do that. You can produce 5
percent or 10 percent of an animal's diet as that single chemical, and get some
idea about the toxicity. You cannot do that with whole foods, because the
chemicals that make up whole foods are all in relatively small amounts.
So if a tomato had a toxic component to it, if you fed nothing but tomato to a
rat, that rat would get very ill, simply from eating nothing but tomatoes,
because you can't live exclusively off tomatoes. You can't concentrate a
tomato enough to make it significant in a rat toxicity assay. So it is just
not possible to test whole foods. The outcome, scientifically, would just have
very little meaning.
So you must understand what makes up a tomato. What are the components of a
tomato? What are the components of concern? Are those components toxic? And
what are the levels in the whole tomato? That's really the approach that FDA
and those interested in the safety of this new technology use. . . .
An early rat study with potatoes ran into some of these problems.
Exactly. You cannot test whole foods on animals. There are statistical
reasons as well. In the U.S., there are 265 million residents. In order to
assure safety, you'd want a very high level of probability. How many rats
would it take you to assure yourself that you're going to protect all 265
million people? It would take a huge study, because the sensitivity of the
study is very low.
What about allergenicity?
Allergenicity is a very difficult issue and, in my view, the most difficult
risk issue with foods, whether it comes from conventional or recombinant kinds
of technologies, simply because allergenicity is very, very difficult to
predict. Probably the most allergenic food is peanuts. There's a protein in
peanuts that is a very serious allergen for a very, very small portion of the
population. It's very difficult to find out who that population is, unless
they've had a very bad accident or episode with this peanut protein. Even if
you did do that, you wouldn't need to test the peanut protein on them, because
you already know. What does that mean in terms of allergenicity or safety?
It's very difficult.
The approach is certainly that you would be very suspicious, and probably would
not use peanuts as a source of genetic material for transferring into any other
food source, because you would be concerned about the issue of allergenicity of
There was a case that was picked up like that, wasn't there?
Exactly. There was a case that occurred before it demonstrated severe
allergenicity in the population, as I understand it. But nonetheless, I think
that case demonstrated that you would not want to use peanuts for such a source
of genetic material.
From a regulatory standpoint, how safe is the U.S. food supply?
. . . Of course, we want in general to think that we have no risk with our
foods, because of the special place that foods plays in our society. So we
want to reduce that risk, and people are all the time trying to reduce those
risks. Scientists interested in food safety typically weigh the risks, the
size of the risk, and logically start at the largest risk and kind of work
their way down. These days, most food safety experts think that the largest
risk is due to disease-causing bacteria associated with foods.
From a regulatory standpoint, compare crops produced by traditional
crossbreeding versus recombinant methods. What's the same, and what's
Genetically produced crops are much more closely regulated, and there are some
differences. One difference is what's called the vector--the carrier for the
new genetic material that comes into the new plant or animal source. That's
different than conventional breeding, and the safety of that vector must be
Another difference is the selection process. Typically, when you change the
genetic material of a plant or animal or bacteria, whether it's by conventional
crossbreeding or by recombinant DNA technology, you have to select out
organisms. Typically, for recombinant DNA, that's done by putting in an
antibiotic resistance marker. You select by resistance to a particular
antibody. That's different, and that's a very serious issue. It's an issue
that requires close scrutiny and close regulation.
So there are differences, and those differences have led the Food and Drug
Administration and other agencies around the world to take a much closer look
at recombinant technology compared to conventional breeding.
What about using transgenes?
That's different. In conventional breeding, you cannot cross species. In
recombinant technology, it's very possible to cross species.
Some things are new with this technology. But our regulatory agencies have
argued that we can handle them within the existing framework.
My own view is that the current laws and powers given to FDA, and, to some
extent to USDA, are more than adequate to address the issues. Those laws
basically say that foods must be safe; that it has been interpreted as low
risk; that it must not be fraudulent in any way; and that certain information
must be provided to consumers. I think that those laws give the regulatory
agencies ample authority to ensure that in fact the new technologies meet those
standards--the same standards that are applied to conventionally bred products
or food additives or color additives or all the other things that are in our
Critics say the agencies have been either asleep at the wheel or
cheerleaders for this technology, and have rushed ahead too quickly. What do
That's a common criticism of anything people don't like--that somebody should
step in. I think what people have to realize is that the Food and Drug
Administration operates under a very specific law, or set of laws, that tell it
exactly what it cannot and can do. It has a very long judicial history of law.
FDA has to operate within the laws, and I have not seen anybody challenge them
successfully to say that they are not operating under those laws.
What does that mean in relation to this? Is FDA doing all that it can?
Because of the law, they can't do more?
Certainly, you can always do more, I suppose. But what it really says to me is
that FDA is exercising its authority to ensure low risk or safe foods. It has
done so with the genetic technology just as it has done with hundreds of other
technologies, going back to pasteurization of milk. It's a new technology for
them. They're likely to stumble and make a few mistakes along the way, because
they don't understand the technology either. They have to learn the
technology. It's expanding very rapidly. But I think their hearts are in the
right place with it. I think the laws are adequate.
You don't think they're giving this technology an easy ride?
No, I don't think so. . . . And I think criticism of FDA has come from both
consumers and industry.
Why can't genetically modified food be labeled?
There are two sides to that argument. One says, "Listen, people have the right
to know what's in their food. And if they want to know if it's from
genetically modified sources, then they have a right to know that." The other
side of that argument is, "Listen, all of our food's been genetically modified.
It's been processed. It's likely to have pesticides added to it. It may have
come from outside the country. It may have gone through several processes.
Where do you stop? Where should we put things on the label, and when should we
not put things on the label?"
I think FDA basically looks back at their laws and says, "What does our law
require on the label?" In my view, I'm not so sure that the current laws tell
FDA that they have to put anything more than things to do with the safety of
food, or things to do with economic protection, fraud, or providing nutrition
information. A specific law tells FDA that foods must have nutrition
information. So within their current laws, it's hard for me to see that they
really have the authority to make that label mandatory.
What would be the difference between voluntary and mandatory
Voluntary labeling is certainly an option for the industry, and one they can
Can you show us the kind of labeling?
There's a lot on the label on a food product. . . . The majority of what the
company puts on a label is voluntary. But some of the labeling, in terms of
things like ingredients, nutritional facts, manufacturer, is all required by
law. So there are things that are required by law, and there are things that
are not required by law. Some things are optional, and are not required by
law. FDA will require, though, that whatever is put on this label, whether
it's optional or required, be truthful.
So if you want to regulate, or if you want to label and say "From a GMO," or
whatever, you must have a way of assuring the consumer that this is GMO food,
or from a GMO, or whatever your label says. That probably is one of the
difficult issues in voluntary labeling that FDA would have to address. How can
you assure the consumer that you're telling them the truth?
Would labeling cost a lot of money?
Labeling always costs a lot of money. It was argued, for example, when
nutritional labeling came in, that it would cost the industry billions of
dollars. That may or may not be true. On the other hand, if the consumer
wants that, those prices are always passed on to the consumer. If the consumer
demands that, then I say go ahead and label it, if that's really the case. The
consumer will just have to bear the burden of that labeling cost.
The FDA is a medically based agency. If this technology moves from input
traits to output traits--for example, oils beneficial to the heart--does the
FDA have responsibility to promote that? Or is its duty just to ensure that
claims are honest?
The FDA is part of the Public Health Service, and says that they are part of
promoting good health. But in my view, in reality, they are more of a
regulatory agency, and they have greatest responsibility for preventing
unhealthy situations, to label products. But it is really not FDA's
responsibility to tell people what they should and should not eat, or what's
good for them and what's not good for them.
The line between foods and drugs is blurring, and has blurred over the last
decade, and is likely to blur even more, and present FDA with new challenges in
that area. FDA will be faced with the issue of allowing the industry to put
forth foods that seem to have good health benefits, and finding a way to make
those honest claims, while still allowing them access to the consumer.
There are three agencies. Do you want to say a couple of words about the
You have to understand that FDA does not have responsibility for environmental
risks. That's primarily with EPA. There are three risks with any kind of new
technology, including genetically modification. There's a food risk--that's
what we mostly are talking about. There's an environmental risk. Those
issues, particularly as they revolve around the monarch butterfly and ecology,
lie primarily with EPA. There's also a risk to the animal when you talk about
genetically altering animals. That risk lies primarily with USDA.
So there are three agencies that kind of share some of the risk regulation in
these areas. You have to understand that the laws, as written in the U.S.,
pretty clearly divide up the pie amongst those three regulatory agencies.
Do you think people have a good idea about what these agencies do? What's
your judgment of the level of trust?
I think people have, in general, a very poor idea what these agencies do, and
understand them very little. I think that's not the public's fault. That's
the agencies' fault, for not letting people know that they're on watch, and
exactly what they're doing, and for not interacting with the public more. So I
almost exclusively blame the agencies for that.
The agencies always can work better with each other. In different cabinets,
there has been serious talk about combining food safety under one agency. I
like that. A lot of other people don't like that. There could be better
coordination. But clearly the agencies don't communicate to the public.
In terms of agencies of the government that people trust, FDA usually does
pretty well in most surveys. I think that, for a small agency--the FDA is only
7,500 people, and regulates one of the largest segments of our economy--FDA
usually rates pretty high in trust.
You used to work for the FDA?
I was a Public Health Service fellow, which is a little bit different than a
regular government employee. It's a system of bringing people into the
government for two years on short-term research projects.
Are you currently on the payroll of any major biotech company?
No, I'm not on the payroll or a consultant to any biotech companies. I have no
research money from biotech companies. I actually don't do direct genetic
modification of anything.
Your primary interest is food safety. Do you think this is
I think food occupies a very special place in the psyche of Americans, and for
people around the world. So we're always going to be concerned about the
application of technology to foods. Recent history shows that to be true. We
were concerned about BST, food colors, sugar in foods; a variety of issues.
The current issue happens to be something that's been called genetic
modification. I don't know what the next issue will be, but I predict it'll be
European public opinion has removed these products from the shelf. If that
happened here, what would the problems be with mandatory labeling?
If you're going to label anything in a food, you have to be able to enforce the
truthfulness of that labeling. If you're going to say "GMO-free," for example,
you have to first define what that means, and develop a system for enforcing
it. If I say that a food does not contain genetically modified organisms, what
do I mean by that? Do I mean that if I use soybean oil from a genetically
modified soybean, and I cook battered fish in it and then I freeze those fish,
does that fish contain a genetically modified organism or food, or doesn't it?
It's not clear. You're going to have to draw the line somewhere. What if you
use an enzyme in food processing? Theoretically, tiny amounts of that enzyme
could get into the food. Is that GMO or not GMO? So there are a lot of very
important details that would have to be developed around any labeling
initiative, in my view.
Are genetically engineered enzymes pretty widely used?
Certainly they're widely used in a variety of food manufacturing settings, in
everything from cheeses to high fructose corn syrup.
So what if you were a purist?
You would ban an awfully lot of foods. As a matter of fact, if you went to the
extreme with this issue, I would guess that there would be a majority of foods
that would have to carry that kind of label. If you label all foods with
anything, that's about the same, in my view, as labeling no foods, because
people still have to eat.
Would an animal that has consumed a genetically modified crop be a
That depends on what kind of regulations they put forth. But in my view, it
should not be. The genetic material from that crop does not become
incorporated into the genetic material of the animal. It is simply another
nutrient for that animal. But those are the kinds of issues that any labeling
initiative is going to have to face, and they are not easy issues.
What would be the effect of labeling?
BST was labeled in some parts of the country. It was voluntary in other parts
of the country.
What is BST?
BST is bovine somatotropin. It's the growth hormone that is given to cows to
have them produce more milk. It was very controversial a decade or so ago, and
there was a call for labeling of that issue as well. In my view, if labeling
was implemented, depending on how it was implemented, it probably would not
have a lot of effect one way or the other.
What happened in that case?
The BST labeling, as far as I know, has pretty much largely disappeared. It
didn't seem to steer consumers away from milk. It didn't steer them to
milk, either. It seemed to me that it had not much effect in the long term, in
the big picture.
Is that your guess, if we went that way?
That would be my prediction.
What would be your prediction if some of these things came to pass? Take
the worst-case scenario.
My prediction, if the worst-case labeling came in, is that it would have very
little effect on the technology, the implementation of that technology, or the
food products that we enjoy. I think if you look at past history, people look
at labels; they read labels; but it's not necessarily the prime reason that
they buy or do not buy products.
In polls, why do 80 percent of people want the information?
I think if you ask anybody, "Do you want more information?" what do they say?
"No, I don't want more information?" No. We're all inclined to say, "Yes, I'd
like to know more about the foods I eat." And I think that's true. But when
it really comes down to it, do people really need that kind of information?
Will they make buying decisions on that kind of information? Certainly, some
will. But in my view, a lot will not.