What first brought you to this issue?
Back in 1983, the United States government approved the release of the first genetically modified organism. In this case, it was a bacteria that prevents frost on food crops. My attorneys immediately went into the federal courts to seek an injunction to halt the experiment. The position I took at the time was that we hadn't really examined any of the potential environmental consequences of introducing genetically modified organisms.
We were making the first step out of the age of chemistry and physics, and into the age of biology. All of our regulations had been set up in an era in which physics and chemistry ruled. It seemed to me that we needed to have a thorough and thoughtful global discussion on the potential environmental implications of reseeding the earth with genetically modified organisms. At that time, the only discussion that had been held was a 20- to 25-minute meeting in a congressional committee that was overseeing this particularly genetically modified organism for release.
So my attorneys brought litigation in the U.S. federal courts. The judge
ruled in our favor. We had an injunction that barred the government from
conducting this first experiment. Then the government appealed, and we won
in the appeals court. . . .
They had taken a bacteria that's normally found in nature, Pseudomonas
syringae, which plays a role, they believe, in the formation of rain. They
took the actual gene out that allows ice crystals to form, and they created
an ice-minus version of this bacteria. The idea was to seed our agricultural
regions with the ice-minus bacteria, which would edge out the traditional
bacteria that makes frost.
Absolutely. . . . What concerned us was the commercial introduction of this genetically modified organism. What if ice-minus were introduced, as they planned, across entire agricultural regions of the world, and it edged out the traditional ice-forming bacteria, which we think plays a role in rain patterns? There could be significant long-term ecological implications. . . .
When you introduce a genetically modified organism into the environment, it's not like introducing a chemical product, or even a nuclear product. Remember, genetically modified products are alive. So at the get-go, they're inherently more unpredictable in terms of what they'll do once they're out into the environment. Secondly, GMOs reproduce. Chemical products don't do that. Third, they can mutate. Fourth, they can migrate and proliferate over wide regions. And fifth, you cannot easily recall them to the laboratory or clean them up.
when we're dealing with genetically modified organisms, we're dealing with a
whole new genre of environmental and health questions, totally different
than when we introduce chemical or even nuclear products into the
environment. . . .
There was a regulatory vacuum, and there is a scientific vacuum. There has been ever since. Back in the mid-1980s, congressional hearings were held after we brought this litigation, and held up the first experiment. At that time, I went in front of Congress, along with the major agencies involved with this. And I asked Congress to make sure that, for every dollar spent in research and development to put these GMOs into the environment, we spend an equal dollar on the R&D to see if we can come up with a risk assessment methodology to judge the risk of introducing these into the environment. At the time, all the agencies--the Environmental Protection Agency, the U.S. Department of Agriculture, the National Science Foundation--pledged that they would devote whatever money was necessary to develop a methodology to judge risk. . . .
Here we are 17 years later. Those agencies never did come through. Even
the USDA, the only agency that has a budget, spends maybe $1.5 million. You
can't even do one risk assessment experiment with that amount of money. . .
The public should know that the liability issues here have yet to be resolved, or even raised. If you're a farmer and you're growing a genetically engineering food crop, those genes are going to flow to the other farm. You can't stop that from happening. So if a conventional farmer or an organic farmer goes to market and they find that their finished product has genes for herbicide tolerance or pest resistance, and they can't then sell their product, who's liable for those losses? The insurance companies aren't covering that. Should Monsanto be liable for these losses? Should the state government? Who's going to cover the losses? . . . The fact is, here's an industry with no long-term liability in place.
There is an analogy here with the nuclear industry. In the early days,
the nuclear industry realized that the chances of an accident were small,
but if an accident did happen, the damages could be enormous and not
coverable. So the nuclear industry went to the U.S. Congress to pass the
Price-Anderson Act. This act legislates that the nuclear companies are only
responsible for a certain amount of the damages, and then the government
pays the rest. The American taxpayer pays the bill. There's no comparable
legislation in place here. And believe me, the public would never accept
comparable legislation in place here. . . .
To begin with, the media played a very important role. The electronic media introduced this idea to the larger audience very, very quickly. We spent years and years and years meeting with activists all over Europe to lay the groundwork for a political response, as we did here. So this did not come as a surprise to any of the nongovernmental organizations. . . .
I think it hit on such a large scale in Europe because it touched the
nerve of two great political sensitivities: preserving biodiversity . . .
and preserving cultural diversity and the cultural identity of European food
and European agriculture. . . .
It's broader than that. Remember, half of these life science companies are U.S. and half are European. We do have Monsanto and Dupont in the U.S., but we also have Novartis and AstraZeneca and other companies in Europe. This was not a response to the U.S. This was a response to these new global companies who were beginning to embark on a radical new approach to agriculture that had tremendous significance--culturally, economically, and socially.
In an era where Europeans were feeling increasingly unable to control their individual destinies, and when there was more talk about globalization and a European Union, the last thing people felt they had some control over was their diet. So when Monsanto came in heavy and fast into the European market, the response was immediate, from the UK to France. The public said, "We don't want these foods. This isn't something that we have invited into Europe." . . .
In this country, the health concerns and the environmental concerns are
as deep as in Europe. All the surveys show that. But here, we didn't have
the cultural dimension. This is a fast-food culture. There is not a seamless
web between culture and cuisine in the U.S. market. So we had half the
response here. . . .
Let me respectfully disagree with that. There were different opinions
being expressed in Europe. For example, the environmental ministers and
those they consulted with in the ecological sciences were very much critical
and concerned about the introduction of GM foods in Europe. So there was a
constant battle in various countries between the environmental ministers on
one side, and the agricultural ministers and economic and trade ministers on
the other. . . .
Europe will not accept genetically modified foods. It doesn't make any difference in the final analysis what Brussels does, what Washington does, or what the World Trade Organization does. In fact, this is going to be an interesting test on how ephemeral the power is of these new international and inter-regional bodies are. . . .
I think the introduction of genetically engineered foods in Europe and in parts of Asia, and hopefully in America, is going to be considered one of the great financial miscalculations in the history of introducing a new commercial line into the marketplace. They're swimming uphill at these life science companies. I ask the life science companies, "When you look down the line, and the public response to genetic foods, do you see light at the end of the tunnel?" They can't tell me they do.
The fact is, as the public in Europe and increasingly in the U.S. and
Asia learns more about genetic foods, they become more concerned. Now, this
is important, because Monsanto argued all along, from the time we began this
discussion back in the 1980s, that people were just ignorant, and if you
made them aware and knowledgeable about genetic foods, they would tend to be
more supportive. The new surveys show us the exact opposite, which I've
always believed. The more knowledgeable people are in genetic foods, the
more likely they are to raise questions and be critical. . . .
Absolutely. President Clinton personally lobbied Prime Minister Blair in the UK to introduce genetic foods and Monsanto's products into the UK. Of course, Clinton and Blair are very much involved in third-way politics. They believe you have to move the marketplace and make sure there are no fetters to introducing new technologies. Both of these world leaders believe that the information sciences and the life sciences are the route into the 21st century. Blair went with Clinton, and championed introducing Monsanto's GMO seeds into the UK. The public reaction was instant and overwhelmingly in opposition, and Blair was caught by surprise. Here's a man who was wildly popular. His political cachet began to lose momentum the moment he sided with President Clinton and Monsanto. . . .
A few weeks later, the environmental ministers met in Europe to discuss a
moratorium. . . . The result of that was a de facto moratorium on the
introduction of any further GMO foods in Europe. This was a very, very
important turning point in this debate. With Europe establishing a two-year
moratorium, it meant U.S. farmers had to rethink their choices on whether
they put genetic seeds into the ground. Since Europe would not accept those
foods in export, American farmers didn't want to be caught holding the bag.
As a result, in the year 2000 growing season, for the first time in the
three or four years since introduction, the amount of seeds being bought
leveled off and began to go down.
Every survey that I have looked at in the last few years, when the public
is asked, "Do you want genetically engineered foods?" . . . a majority of
the respondents say they're concerned and 90 percent of the respondents in
the surveys say they want the mandatory labels so they can make a choice.
The industry's not stupid. The industry knows that if those foods are
labeled "genetically engineered," the public will shy away and won't take
them. In a sense, the industry's hiding from its own technology. . . .
Gerber is owned by Novartis, which is one of the two major players in the
GMO food industry. Just this week, Novartis' Food Division announced that
they would not accept any genetically modified food in any of their foods;
whereas Novartis' Agricultural Division is one of the two or three major
players in the world producing genetically engineered seeds. This is a great
commercial story, and I think the media missed this story. Here you have a
company where the executive board of the company is at odds with itself. . .
. When a company like Novartis--which is championing this technology--won't
actually accept the final product, what does it say about the product?
In classical breeding, genes are turned on and off when you cross strains. I have no problem whatsoever with classical breeding, because it's worked itself over 10,000 years and it's also part of the evolutionary schema. . . .
What's different here is that we have now technologies that allow these life science companies to bypass classical breeding. That's what makes it both powerful and exciting. In classical breeding, you can cross close relatives. Taxonomy is an anthropocentric discipline anyway. You can, for example, cross various wheat strains and corn strains, etc. . . . You can cross a donkey and a horse in classical breeding--they're very close relatives--and you can get a mule.
But you can't cross a donkey and an apple tree in classical breeding.
What the public needs to understand is that these new technologies,
especially in recombinant DNA technology, allow scientists to bypass
biological boundaries altogether. You can take a gene from any
species--plant, animal, or human--and place it into the genetic code of your
food crop or other genetically modified organism. Crossing genetic
information from one species to another is something we've never seen in
10,000 years of classical breeding. . . .
Those very small bits can change in qualitative ways when GMO is introduced. Let's say you take a human growth hormone gene and place it into a salmon. That's just one gene. But if the salmon gets out into the marine ecosystem, and it's growing twice as fast and twice as big, it can destabilize millions of years of relationships in the oceans. So one gene can be very, very powerful. . . .
Where you're placing a gene from an unrelated species into the blueprint of the second species, it's like introducing exotic organisms from native to non-native habitats. Here in North America, we brought a lot of organisms over to this ecosystem from all over the world. Some of those organisms fit in; some of them died out; some of them became pests. If you're from the South, you know about kudzu vine; or in the North, Dutch elm disease or gypsy moth or chestnut blight or starlings. These are all non-native organisms. When we put them into North America, they had no natural pest enemies. We can't deal with them, and they cause billions of dollars of damage. Ecologists tell us that when we introduce a genetically modified organism with genes from unrelated species, it's somewhat analogous to introducing exotics. . . .
There's a second generation of genetically modified organisms being readied in R&D. These organisms are plants that act as chemical factories to produce genes that code for proteins to produce vaccines and chemicals and drugs and vitamins. . . . This all sounds very good, except no one has stopped for even a moment and paused and asked the following question.
When we seed millions of acres of land with these plants, what happens to foraging birds, to insects, to microbes, to the other animals, when they come in contact and digest plants that are producing materials ranging from plastics to vaccines to pharmaceutical products? There hasn't been as much as a single congressional hearing, and as far as I know, there hasn't been a single parliamentary debate anywhere in the world on introducing this second generation of pharmaceutical and chemical-producing plants.
They're introducing plants--corn, soy, cotton--that have
herbicide-tolerant genes and pest-resistant genes. If your corn has a
herbicide-tolerant gene, it means you can spray your herbicides and kill the
weeds; you won't kill your corn because it's producing a gene that makes it
tolerant of the herbicide. The problem here is that what makes it beneficial
also makes it environmentally harmful. It means you're going to be able to
kill a lot of weeds but not damage your corn. The problem is, you can't kill
all the weeds. That means that the more virulent weed strains will become
dominant and build up resistance quicker even than you had with
petrochemical-based farming. . . .
I know quite a few farmers all over the United States who have tried this and have said the opposite, that they have to use more herbicides, not less. The same holds true with BT. Monsanto says, "Look. We're going to introduce a little gene into the plant that codes for a pesticide." Every cell of the plant is producing that pesticide, so the insect tries to eat the plant and dies when it tries to digest the material. Monsanto says, "This is a leap forward. We're ending pesticides, groundwater contamination."
Well, yes and no. Yes, they're ending the use of pesticides. But now
they're introducing more toxin than they ever introduced with pesticides.
When you spray a pesticide, it's infrequent, it's periodic. When you are
putting the same toxin in the form of a gene into the plant, that plant is
producing that toxin 24/7, perpetually over millions of acres. . . . A major
study just came out in Science or Nature this year--a big
study--showing that, when you introduce the gene for toxicity, it is going
into the ground soil. . . .
A refuge is supposed to prevent what? The genes from flowing out of
sight? . . . This refuge idea won't stop insects from moving across
boundaries. That's absurd. How many farmers are actually creating these
refuges? . . . I've talked to enough farmers that say that it's too much
time and trouble to do it. Even if they did do it, and followed it chapter
and verse the way they're supposed to by the licensing arrangement, insects
will pass through refuges at will. The idea that you can constrain them is
absolutely absurd. Ask any good ecologist worth their salt, who's not on the
corporate payroll of Monsanto, and they'll tell you what I've just told you.
You're going to get insects all crossing the refuges. The insects that are vulnerable to BT will die. Those that aren't--the more virulent insects--will reproduce. That one gene resistance cannot deal with more virulent strains of the insects.
When you do classical breeding, you cluster for hundreds of genes in a
plant that allow it to be resistant to a particular insect. Here, it's like
one-gene resistance. It's like the French Maginot Line before World War II.
The French thought they had a strong wall against potential German invasion,
and the tanks went right over the wall. When you only have one-gene
resistance, it will only take a few growing seasons--we're not talking about
generations--for resistant strains of insects to build up and to overcome
that one gene. Then the companies will have to come up with another gene,
and another gene, and another gene. It's not defensible from a systems point
Monsanto says it does know the answer. The United States government
that's OK'd all of this says it knows the answer. They're saying that
refuges work. My question back to the U.S. regulatory agencies and to
Monsanto is, "You're saying the refuges work. Show me the results. Where are
the tests? Have you tested this across ecosystems around the world where
this is going to be planted? Where is your risk assessment methodology that
shows you that this is safe?"
There's been virtually nothing. The amount of field testing to develop a methodology for risk assessment is almost nil. What we have here is a lot of rhetoric about protocols, but with very little science to back it up in the fields. . . .
The other major problem with introducing GMOs is gene flow. This is as
significant as buildup of resistance, probably more significant. During
pollenations, genes flow everywhere. Now, of course the company will say,
"Well, the genes won't flow offsite. We have refuges, etc." Nonsense. There
has now been a number of peer reviewed studies . . . that show that genes
will jump way offsite during pollination, either by the wind or by transport
by insects, etc. If you have a herbicide-tolerant gene, or a pest-resistant
gene, and it flows off a site, what happens when wild relatives of those
crops are invaded by that pollen? . . . How do you deal with a whole
ecosystem where wild grasses and weeds have become herbicide-resistant,
pest-resistant, and viral-resistant?
The problem is that we know very little about how genes code for proteins and how they're turned on and off. So when you talk about all these fixes that they're going to come up with, you have to realize that whether a gene turns on and off and mutates depends, a great deal of the time, on the environmental factors and triggers. You can't get a guarantee that genes are going to turn on and off the way you want them to. You're dealing with life. It's too unpredictable.
If we had a risk assessment science in place, a really full-blown methodology, then maybe you could make some of these suppositions. But right now, these companies are running blind, saying, "We're going to make this fix and this fix and this fix." . . .
When I talk to environmental scientists, they're very, very uneasy about the idea that you can create a quick fix at each step of the way with this. It may be that everything the life science companies are telling us will turn out to be right, and there's no problem here whatsoever. That defies logic. When you introduce a powerful new technology that can radically change the environment, as they hope these technologies will, it's naive or disingenuous to think that that same introduction won't create equally troubling disharmonies and destabilization.
Remember, these are the same companies that brought us the petrochemical
revolution. They used similar arguments to the ones they're using now,
saying, "Look. We'll have a quick fix. We'll make sure that the chemicals
don't ruin the environment. All of the alarm on the other side is unfounded
and misguided." Now they're embarking on an adventure that's much more
radical than chemical introduction, and that is actually changing the
genetic instructions in microorganisms--plants and animals--and placing them
into the environment, a lot of it through clonal propagation, on a very
large scale. . . .
Yes, because what we're dealing with is the introduction of new genetic foods that have genes that code for proteins that we've never consumed. So when you place a Chinese hamster gene into your food crop, for example, and we consume it in raw or processed food, we just don't know what the reaction's likely to be. The fact is, we know that with traditional foods, 8 percent of children and 2 percent of adults have allergenic reaction to traditional foods. We spent a long part of our history testing various things we could eat, and a lot of people have died as part of this grand experiment to see what we could consume. . . .
Many of the genetically modified foods will be safe, I'm sure. Will most
of them be safe? Nobody knows. The fact is, even the Food and Drug
Administration, in internal documents by their own scientists that were
forced out in a lawsuit, suggested that these foods could pose some
potentially serious allergenic and toxic reactions among consumers.
The American public is not aware that there might be potential allergenic
and toxic reactions. . . . With regular food, at least people know which
foods they have an allergy to. People know if they have an allergenic
reaction to peanuts, for example. Here, you don't know, because the foods
aren't labeled. Because these genes that they're placing in the foods have
never been tested in the human diet, it's one big health roulette gamble. .
Only if you know they are allergenic. You can eliminate, for example, a
Brazil nut gene if you know that it will create an allergenic effect. The
problem here is, they're going to be introducing hundreds, then thousands
and thousands of genes that code for proteins that we've never consumed. We
simply don't know if they cause allergenic or toxic reactions. . . .
This is the Catch-22. So do you want to take the risk when you don't need
to? Maybe at some point down the line, the new genetics will tell us a lot
more about the genomic makeup of all of our creatures. . . . We may be able
to know which genes code for proteins against every single genetic profile
on earth. We don't have that now. I don't think the activists in the public
are over-reacting. I don't think there's any hysteria in the streets here.
What there is, is guarded and careful response. And I think the public is
saying, "Why should we be put in jeopardy? Why should we be the guinea pigs
in this experiment?" . . .
This is the same thing we faced with the nuclear industry and the petrochemical industry. Obviously, there were short-term benefits in introducing nuclear power and petrochemical-based technologies and agriculture. The problem is, nobody at the get-go wanted to look at the long-term potential environmental and health risks down the line. In the long run, we saddled the environment and future generations with tremendous environmental and health costs. So when you talk about cost-benefit, the problem is, the benefits are always here and now. The costs always come later. . . .
This is why I've been involved in this discussion for more than 25 years
now. I wanted to make sure that this be the first scientific and technology
revolution in history in which the public thoroughly discussed all the
potential benefits and all the potential harms, in advance of the technology
coming online and running its course.
The issue here is, how do we apply that science in the commercial arena, in our social life, and in the political life of the country and civilization? I believe there's a hard-path and a soft-path way to move into the age of biology. . . .
What's the hard path? Genetic foods. You turn that little piece of corn into a soldier in the fields, a little warrior. That little piece of corn is armed with all sorts of weapons--a gene for pest resistance and viral resistance and herbicide tolerance. This is hard path, old-fashioned nineteenth-century applied science. It's reductionist; it's not a systems approach; and it won't deliver ultimately in the field.
What's the soft path? We could use this same information we're learning on genomic nature of our plants and our ecosystems to create a sophisticated, market-driven, cheap, efficient organic-based approach to agricultural production in the 21st century. In the soft path, there's no gene splicing between species. Instead, we upgrade classical breeding with state-of-the-art genomic science. . . . You use the genomic information in your plants to find out which strains are best integrated into the environment. The environment's not the enemy. The environment's the partner. . . .
What I'm suggesting to you is that this could be a renaissance. We may be
on the cusp of a future which could provide a tremendous leap forward for
humanity. Instead of playing God and being an architect and creating a
second genesis, and trying to rearrange millions of years of genetic
blueprints, what we ought to be doing is understanding the genomic makeup of
the world around us and how genes interact with environments and ecosystems.
Then we can be a steward, so we can better integrate our social and
productive activity into nature's activity. . . .
Many of the mainstream agricultural scientists, especially at the
agricultural schools, but at all of our major universities, are tied into
all sorts of contractual relationships and consulting relationships with the
life science companies. There's been a growing debate in recent months about
the close commercial ties between our academic institutions involved in this
research, and the companies that are in the life science field. You really
can't find a good molecular biologist or geneticist worth their salt who
isn't involved in some equity relationship or consulting relationship or
involved in some startup companies.
. . . You may have seen in the New York Times, where there's been
some big stories in the last few months . . . about the change in the
relationship between the academy and the academic sector and the commercial
sector. We have biologists across the United States and around the world
whose research grants depend on corporate financing. We have major players
in the agricultural field, as well as the other sciences, who are all
involved in equity relations and have stock options and are part of these
companies. You can find some independent scientists, but they are few and
far between. We now have whole labs, especially in our schools, that are
contracted out to Monsanto and Novartis. . . .
One thing I've learned over these last 30 or 40 years is that people make history. There's no fait accompli to any of this. We're on the cusp of a revolution in science. . . . The biotech century is going to be as complicated as the Industrial Revolution. Remember, in the Industrial Revolution there wasn't one agenda. For every capitalist, there was a socialist. For every entrepreneur, there was a trade unionist. For every Enlightenment philosopher, there was a Romantic poet. There were many agendas and issues. It was complex. There was great upheaval. . . .
We now have an opportunity, though, to do something we didn't do in the
industrial age, and that is to get a leg up on this, to bring the public in
quickly, to have an informed debate. If ever there was a scientific and
technological revolution that cried out for everybody's involvement, this is
it. This revolution affects the most intimate aspect of life on earth: our
own biology, and the biology of our fellow creatures. . . .
Let me take some responsibility, since I spawned much of this opposition.
It's a little bit disingenuous for some of the life scientists to say they
want to feed the world, when they create terminator genes designed to made a
seed sterile so it can't be reused by farmers. We are already producing
enough food to feed the world. We already have technology in place that
allows us to produce more than we can find a market for. Here in the U.S.
and in Europe, we pay farmers not to produce. The issue here isn't producing
enough food. The issue really with feeding the world is, how do we create
the effective mechanism, so the fruits of the technologies we already have
in place can be shared equitably?
No. If we really want to talk about feeding the world, we have to talk about eating lower on the food chain. The fact is, we've had a great change in agriculture in the twentieth century. . . . Today, one-third of all the food grown in this world is feed grain, which is then consumed by animals, so that the wealthier people on the planet can eat high up on the food chain with grain-fed meats.
The interesting thing is, while we die of diseases of affluence from
eating all these fatty meats, our poor brethren in the developing world die
of diseases of poverty, because the land is not used now to grow food grain
for their families. Rather, it's used to grow feed grain for the animal
husbandry industry. If we would only find it in our hearts as a species to
move down the food chain so that we could free up the land, so that instead
of a third of it being grown for feed grain, it's grown for food grain, we
could feed the world today and tomorrow and for many years in the future. .
We have less than 10 life science companies in the world that have bought up all the independent seed companies in the last several years. They're now turning those seeds into intellectual property, so they have a virtual lock on the seeds upon which we all depend for our food and survival. The issue here is, can companies like Monsanto use their control of intellectual property to force the rest of humanity to accept their terms in the commercial arena?
When Monsanto provides a seed to a farmer, there's no traditional sale. There's no seller, there's no buyer, there's no exchange of the property. When Monsanto enters into a licensing agreement with a farmer, the farmer is being given access to the Monsanto network and being allowed to use the intellectual property in that seed for one growing season. That means the new seeds at harvest, which traditionally farmers have considered their own, now belong to Monsanto. If the farmer uses those new seeds, it's a violation of the intellectual property agreement.
Monsanto, if they had their way, would probably never want to sell
another seed again. They'd much rather that every farm in the world enter
into a licensing agreement and have to access the seeds, the intellectual
property in those seeds, 24/7, every growing season. . . . That's chilling
in its potential impact.
There is now a precedent-setting antitrust lawsuit in the federal courts.
The 10 largest antitrust law firms in the United States have gone into the
federal courts charging Monsanto with creating a global conspiracy in
violation of the antitrust laws, to control the global market in seeds. The
plaintiffs are farmers in the U.S. and France. . . .
Yes. The antitrust litigation currently in the federal courts in the U.S.
against Monsanto will be the test case in the life sciences, just as the
Microsoft case was the test case in the information sciences. As we move to
a network-based global economy, the real issue here is, can companies like
Microsoft in the information sciences, and Monsanto in the life sciences,
control these networks by controlling the intellectual property in the
software or the wetware?
Interesting enough, the chief litigator for the government was David
Boies. His law firm is also involved in our litigation. The litigation's
being spearheaded by Michael Hausfeld, one of the distinguished trial
lawyers and litigators in the United States. So this is going to be a great
test case. . . . I think it's going to set the framework, if you will, for
the life science revolution, as Microsoft and that case has set the
precedents for the future of the information science revolution.
How long has your family been farming this part of Minnesota?
My father and mother moved to Martin County in the late 1930s, so they've been farming here. I was born in the 1040s, and my brothers were born in the 1930s and 1940s. So our family operation has been in southern Minnesota for a number of years, and it's worked out fine.
My father started with 240 acres of tillable land, which, at that time,
was quite a bit. He rented that, and most of it was pasture then, because
they had a lot of livestock. Their operations were made from livestock back
in those days. Today we've expanded this operation through my brother and my
two sons. We're at about 2,700 acres. That's a fairly large operation . . .
probably the top 10 percent, because we run a lot of livestock with it. But
if you split it up four ways between four families, then it's only 600-700
acres apiece. That's a pretty small operation. So it depends on how you look
at it. how you share machinery, and how you try to make agriculture
profitable today. It sometimes varies, but that's what we're working at.
One of the most difficult parts of farming is weather. It changes every hour, every day, and every month. . . . As far as the livestock part of it, it's disease and things like that. So these are really the most difficult parts of it. We have grain prices. We have prices that vary. But our yields and our diseases and our weather are probably our biggest concern. Once we could get those protected in some insurance program or some form like that, then we can move on into really worrying about price.
Right now, in the United States, it is very difficult to make it in grain farming, because of the price of corn and soybeans, which we raise here. Prices are really quite low at this time.
With the way the industry has gotten into what you'd call science, agriculture has changed. In the last ten years, it has turned to what I call agricultural industrialization, which has become so exciting. I envy my sons, because they're just getting started in a time that I think is very important. Sure, we went through the mechanical part and production part. Now we're into the science part of it. We're going to be raising things on this land in 10 or 15 years on this soil that we haven't even dreamt of. And that's exciting to me, because when I was in college, that was what I was into--research.
This is where we're going. We will raise different crops. It might be
corn, but the corn will be different. The kernel will be made of different
parts, and we will raise what the consumer wants or what can be used. Today
the consumer wants this product, but in ten years, they don't know what they
want yet, and we don't know what we're going to be raising. That's what's so
exciting about it.
Of course, I was fortunate enough to come in after hybrid corn. That was a big, big change in corn yields, when we produced hybrid corn. Before that, they just took a kernel of corn out of the field, and they broke it and planted the kernel. They took the best ears and planted the kernels. But once we got the hybrid corn, we upped our yields tremendously. We doubled them. The fact is, we're increasing our yields from 1 percent up to 4 percent every year. I think, in the next 10 to 20 years, that we're going to increase it faster.
Now we're understanding how the kernel is put together. We're understanding the genomics. We're understanding the genes. We're going to be moving into production that is unheard of. As we do that, we're going to call corn an energy source. Now, we've used it mainly for livestock. Years ago, when I was a little kid, we used it for livestock. Then we got into human consumption. Now we're getting into all sorts of energy: energy for livestock, energy for humans, and energy for automobiles. As we do this, this corn is going to be an energy source that's going to just be unbelievable.
We're doing the same thing with soybeans, as we move off into what uses we have for them. As we breed the soybean for different uses--for different human consumptions, for different animal consumptions, for different energy consuming or whatever it is--we're going to be able to double our production out here.
It seems strange that people worry about our environment, that when we increase production, we're harming the environment. No, we're not. You take a stalk of corn and you look at the number of leaves--16-17 leaves on that--every leaf is taking carbon out of the air and putting it back in the soil. So in all this carbon problem that we're having in the world, every stalk of corn is a tremendous grabber of carbon out of the air and putting it back. If we can double our production and double our number of leaves out here, look what we're doing.
We can do this by putting two ears on the stalk instead of one, because
today, most of our stalks have one ear. Once we go to two ears on that
stalk, with the same nutrients in the soil, by shortening the stalk, look
what we've done. Now our energy source in the world can be corn, can be a
renewable, and all the energy comes from the sun. So we're not depleting
anything. We're just turning it around. It's so fantastic, what we're
learning about corn and soybeans out here. . . .
It's kind of like taking livestock, where you take one breed of livestock . . . and cross it with another. You get the best genes from both races and you cross them, and you come up with a crossbreed that's superior to either breed. When you take hybrid corn and you take a certain corn that the breeders have developed in their research, you put that in what they call a male row. The male row is called that because the pollen of a corn is on the tassel. As the pollen falls off, it falls on the silk of the ear. . . . If that pollen lands on the silk, you get a kernel. If it misses a silk, you have a bare spot there. You won't have a kernel. Through the breeding of corn, they've been able to cross these things and make a hybrid out of it that produces a lot more corn per acre. That move was tremendous in corn production in the United States.
Today, now they're taking the corn apart, and they're learning all the genes there are in a corn through the chromosomes, and they're mapping that corn. Now we're finding out how many genes are really in it. Now when we cross a gene, we can make a corn that can grow on a soil that's depleted in water, or one that's on a soil that has excess water, or one that's on a shorter growing season. When I'm talking about growing season--it takes so many degree days to make an ear of corn. If you're in northern Minnesota, you only have maybe 80 days. If you're in Texas, maybe you have 160 days. So you develop that corn to raise it in the area you live in.
This moving of genes back and forth is going to make our production
tremendous. That's going to help our renewable source of fuel for energy,
whether it's for livestock feed, for animal consumption, or for human
consumption, or for running whatever you want in energy.
. . . BT is mainly for European corn borer. We plant this corn, because then the European corn borer bites into the stalks and passes away. Well, if you get some corn borer resistant to that, then you're going to have an area in the field that you can't protect. So we leave 20 percent of a field. We leave strips in the field so that corn borer can still cross-pollinate itself, you might call it. That's not what they call it in corn borer, but that's what I call it in corn.
If we're planting corn out here in this field, and we get a year of a high corn borer moth, they burrow into the stalk, and then it rots the inside of the stalk. They burrow into the shank that holds the ear, and it rots that. And the wind comes up and the corn falls off. Now, to keep that from happening, if we don't have BT corn, we spray our field with an insecticide. . . . What happens then is that we can't get selective. We spray for one type insect, and we might get four or five types of insects. And we don't want that. By putting BT corn in here . . . we don't have to worry about killing the insects we want to keep here.
. . . If the European corn borer does not cut the stalk, we don't get an infection inside. We don't get other things into that stalk. . . . Mycotoxins are developed through these scars, as you might call them, in corn plants, or corn ears. Mycotoxins are what we want to keep out of our corn for human consumption, animal consumption, and whatever it is. We can do that much easier through BT corn--keep the mycotoxins down, and improve the quality--and then we don't have the loss in the field of the ear droppage.
If you're going to go through all the work of producing an ear, you want
to harvest it, because you're going to use it for somebody to eat, some
animal to use, or some energy source. Now we have it. We don't have to worry
about it falling off in the field and losing it. And then that turns around
to be a weed in our beanfield the next year. Now we got to go back and
control in the beanfield. So we add another chemical to control it the next
year in a beanfield. So this type of thing with the BT is fantastic for the
years that we have a high corn borer rate. Now, some years we don't have
that high rate. We can check the year before for moth, so we kind of bury
that. We don't always have to use it, and that helps on our refuges, too.
We rotate our crop to control diseases. The more we can control by
rotating a crop, the less insecticide or pesticide we have to use. I'm a
farmer, and I don't care to use insecticides or pesticides. The less I can
use, the better I feel about it. It keeps it off the soil, keeps it off of
me, and keeps it off of everybody else. So we really like that. We rotate
our crop from corn one year to beans the next year, so we don't get some
kind of disease buildup. . . .
We've used BT corn for about five years. One year it really was an advantage. It saved us 20 bushels, or better, per acre. Well, even at $2 a bushel of corn, that's $40 an acre. . . . Every year it seems to be a protection. . . .
We have Roundup Ready soybeans. We've used those for four years. It's a way to control noxious weeds in there, with a surface-applied chemical--not on the soil surface--but on the plant surface. It does not get in the soil. Some of our herbicides we put in the soil. This one we put on the top. We don't have to put anything on the soil. We have no carry-over. It's gone. It's a very friendly herbicide. So that's why we use that on some of our acres--it's so friendly.
We pay a tech fee to get to use it. That's a fee to the company that
developed it. That's why we don't maybe use it on all, because we don't care
to pay that kind of a fee. But there are times when it's great, and
environmentally, it's really friendly, because there's no carry-over from it
and it doesn't harm anything but just that plant.
Financially, it's kind of a wash. It's a convenience, because we can control a lot of weeds with it, yes. You have to understand, and I hope the consumer understands, that technology is really a benefit to the consumer, not the producer. To a lot of people, that's hard to understand. But ultimately, the consumer is the one that benefits, because if we can produce this crop at a less cost, they buy it at less cost, and they're the ones that benefit. . . .
That's what we're here for. We're here for the consumer. It's people.
That's the only reason you're on this earth--for people. If you weren't on
here, why would we exist? So I don't have any problem with that. Just don't
make it so I can't make a profit.
Well, change is difficult to all of us. . . . I can remember when I was a little kid and we had polio. They got this vaccine. You took a shot of this vaccine. People said, "You can't put that in me, because that's really polio." Look at what it did. Do we hear about that anymore? No. But there was a fight. You could hardly get penicillin on the market. You take penicillin off the market today, and you're going to have a fight. This is what happens as we do anything in change. This is what's going to happen in this biotechnology in agriculture. There's a fear out there that we're going to create something. . . .There are things out there that people have no need to fear, but they are afraid.
The greatest part about this biotech thing is that the research has been done over and over and over again. We're not out there destroying humans. We're not out there causing problems. We're doing a ton of research, and we're backing it up with more research to make sure it's okay. If we run into an allergy, they drop it. They're doing the research on it.
God gave us a mind. He created the world, okay? I'm along with that. But he also gave us the mind to make it better than what he did. He said, "I'm starting this. You make it better." And we are. I can think of nothing in the past that I think is fabulous. But I can see a lot of things in the future that are going to be really fabulous. . . .
We have rice that they're developing today, called Golden Rice, where you put the vitamin A and the iron into the rice when you plant it in soil. We can have children who will be able to see when they're 60, but they're going blind today at 30. Just because we in the United States have all these things doesn't mean the world has the same things. If I can make a child see until they're 60 instead of 30 by just putting it in the grain--because I can't get the vitamin A and the iron there any other way they plant it--I'll do that any day of the year. I'd be very, very disappointed in anybody that fights that.
. . . I'd like to be the age of my son instead of my age, because he gets
to do all this, and I'm going to be gone. In the meantime, I'm having fun
with it, and we're developing it. I hope we can stop the fear that's out
there that something's going to happen here. We're not going to turn into
Draculas or something on this thing. We're doing enough research. We know
what's there and what isn't there. But we also know we're going to save a
lot of people's lives and we're going to create a much better universe.
We're not going to have carbon problems in the future. We're not going to
have all these things. We're going to solve problems with this, instead of
creating more problems.
After you've been through some of those regulatory things that they go
through, you will feel very comfortable that they're doing a fantastic job.
The regulatory industry is doing great. . . . If you don't think they're
doing a good job, go watch them. If you try to put something on the market
today, it's very difficult. I feel a little bit sorry for the people that
are doing the research, because they're doing a lot of research and can't
get it on the market because they have to test over and over and over and
over, and prove this over and over again. So they are doing a good job of
making the research people prove that it's safe and it's working. Yes.
Well, I kind of like their groups. I don't like it when they go crazy with it, but I like their groups, because they make us do the research, and somebody has to do that. So I'm not against that at all, because I'm an activist. I'm an activist on ethanol and things like that, and corn. So I'm not against activists. But once we get the scientific fact and we get the facts right on the table, then let's accept them. It's the same with myself. If I'm an activist on something and I don't care for it, if somebody proves it to me, then I have to say, "Okay, that's fine. We've got it where we know what it is. Let's go with it." . . .
That's why I feel safer in the United States--because we have those
groups. They have made it so that we do the research. They haven't let us
just go wild and do these things. So I'm comfortable with them. I don't have
any problem with them. I sit down and talk with them. I don't have any
problem with that. I like those people that question things, but who
question it correctly. I don't have a problem with that. I think it's great.
. . .
Within a cornfield? I hope there's none in mine, because it's a noxious weed, to me. So we have destroyed it in our field. We have it in ditches. We have it on our lakes. We keep them there, and that's where it should be. That's where the monarch butterfly feeds off of it, and it works fantastic. . . .
Now, maybe we can set up so that we don't have that pollen in the BT.
Then we don't have that problem with it. I don't have a problem against the
activists finding this out. Nothing. Let's just prove that it doesn't do
harm. So that's where I back the activists. "Look at what we found here.
Let's do the tests on it. Let's check it out and let's prove that it's right
or wrong." So I'm all for finding out to make sure we're not on the wrong
track on this. I don't want to get rid of monarch butterflies. I kind of
like them. I do play with them out here in the fields and so I like them
Well, there's what I call a concentration of companies in the United States. I don't care for that. I'm out here farming, and I'd just as soon not have a monster-size farm, because I like a lot of farmers around. It helps rural America. It develops rural America. The more farmers I can have out here, the more towns they can have out here, the more jobs that are available out here. . . . I don't care for the concentration of big business and moving it out of rural America. The concentration of big business doesn't give me a competitive advantage when I'm purchasing or selling. So that is a concern.
Now, if your research department of your company has developed this certain product, and they want to control it, it's theirs. I mean, they really did develop it. But . . . I think that sharing this information is way more important than controlling it. If we lived like Abraham for 600 years, then controlling it would be way more important. But we don't live that long. Let's share it. Let's make it better for human use. . . .
I think we're going to see that. I think we're going to see the companies
go to the farmer, and the farmer saying, "Hey, I will use this product, but
let me have a percent of your profit. Then together, look what we can do for
the consumer." See, that ties the chain together now. We've got people
working together as people, instead of the company coming out here, saying,
"I have this product that's going to cost you so much an acre, and you'll
make so much." But then in five years they say, "Well, I want this much more
per acre." Well, wait a minute. See? That's where people don't come
together. This whole world is about people. We have to remember that. If we
tie that together and tie it back, we will get this high concentration of
industry realizing that money is not the answer. People are the answer.
That's an interesting subject matter, isn't it? Does this make larger farmers? Or does it make smaller farmers? What does it have to do with farming? What does it have to do with rural America when you do this? It's a very, very touchy subject when you get into that. Now you're talking about a different thing, because today my sons and I could farm 20,000 acres. We can do it. The technology is there. Do we want to do that? I don't know, because then I don't have rural America anymore. And rural America, to me, is what I live for.
That's why I think agriculture should move into production and processing, to the consumer. We should get a part of that whole step. If I'm getting something from the processing--which, in Minnesota, I own into some ethanol plants who process the corn to ethanol and then a protein and then an oil--if I own part of that, that some of that money can come back to supplement my production of agriculture. Look at what it does. Now I don't need the monstrous production to make the same amount of money. It's important to me, very important, that we tie these together. And that's what I like with the big companies--share in the profit, and join together on that, instead of becoming monstrous farms. . . .
If we're going to subsidize rural America, let's subsidize it through the processing end of it and through the production end of it, and keep rural America. Still, I can decide if I want to raise corn, beans, or whatever it is, and I can go from there. We can do that. It's not impossible. It's right in our fingertips to do it. But we have to work with the government to do it. We can't do this privately. It won't work. As much as people don't like the government in the United States, we still have to work through them. We can set that up through them, through advantages.
They've had tax advantages for corporations and all these. This
encourages larger corporations. We need to turn around and set that
encouragement in private enterprise, like the United States was built. The
United States was built on private enterprise. We can do it out here without
the big corporations. We can still have private farms, we can have private
businesses in town, and set up advantages tax-wise to create that. That's
how we're going to get around this. They're worried about the biotech
ruining us? Biotech's going to help us in that process. This thing all ties
back and makes it better yet.
It's getting smaller and smaller. Our small towns that were big towns are now what they call bedroom communities and retirement areas. I know of rural Minnesota personally, because I live in it, and really, I think the whole United States is that way. We can turn that around and turn back to making these towns viable, because you have suburbia, as you call it, and suburbia's just expanding like crazy. Well, that can happen. We can have the same thing now. With the new technology today--TVs and hand-held computers and everything--you can live out here and do the same thing. Look what happens. We spread the people back out.
We don't do it the way Europe did. We don't pay people to stay in the
country. We create the opportunity for them to stay in the country. That's a
whole different philosophy that does the same thing. That's why I think we
can do it even through the biotech industry. . . . We can turn it around. We
can turn it around through opportunity rather than payment, too.
Yes. What some people call it is IP, that's "identity preserved." What it does is, you will raise this corn for this pig, this corn for turkeys, this corn for an ethanol plant, this corn to make clothes out of. We make clothes today out of cornstarch and cotton that are biodegradable. They don't get thrown in a landfill. We have all that technology. Now we're going to raise it for those things. Maybe this field will be used for that. Maybe that field across there will be used for that. So then we can get down and we can identity-preserve each field for what they're going to use it for. Then we'll put the plant out here in rural America that processes that to move it on. Now look at what we got.
The opportunities are there. We just have to create them. But we have to
create them through the government, through tax incentives and through those
types of things. That's the clue to this thing that has to tie in with it.
They all have to tie together. So I don't envy our congressmen or our
senators, because we have to tie those things together. We will get that
done, too. As we get this biotech thing cleared up and get it moving ahead,
we will get these other things coming. We have all this structure in place.
We're just moving it together to get it done. And it's going to happen.
There are certain parts of the country that use BT corn more than others, because corn borer moves in certain areas of the country more than other areas. For a certain part of the country, it's very, very important. In other parts, it's not quite as important. So they're saying, "Okay, if it's not important here, let's just not raise corn there." "Well, yes, they're going to raise corn there. Let's use the BT."
If you've ever been around here when you've sprayed an insecticide
. . . we put leather gloves on and coveralls on, so it doesn't get on us. That is not a fun thing. That is not something I even want to dream about. I don't even want the thing in my machine shed with my grandkids around. Those are the type things we don't have to have with this BT corn. And then we don't have to spray over the top. "Oh, am I killing ladybugs? I don't want to do that."
See, that type of thing has made it so much more convenient on BT corn.
If I go out and see moth the year before starting to build up, or if I'm
worried about European corn borer, I can go out and plant it now. It costs
me. It costs me just as much as spraying. But it's so much better for the
environment than spraying. Those type things we're going to come up with
down the road. . . .
I've noticed a benefit. Three out of five years that I've used BT corn,
I've noticed a benefit from it. So I've gained from that. The other two
years, I didn't gain anything, but it was still a protection. . . . And as
we go, we'll find advantages. We will be able to take a stalk of corn and
plant it on a hill that produces this amount, or in a valley that produces
this amount. We will change our planting as we go across a field. But we
have to have the technology before we can do that. That's where we will
become very, very efficient out here. That's where the profit comes into the
farming, too, when we do those things. So there are ways that the farmer
makes profit on this--just not every year. But it's same with every
business. You don't make a big profit every year either. . . .
We do that. You talk about activists--you might call me an environmentalist, an activist. I am. I live here. I'm going to farm here, and my children are going to farm here, and my grandkids hopefully are going to farm here. So I am an environmentalist. I'm an activist on that, and I'm trying to do the best job we can do to make it possible for them to farm. It's the same as we do with the fertilizer. If we over-fertilize, it costs us money. We don't want to do that. That's number one. Number two is, what happens to fertilizer? Does it stay in the soil? Does it go in the air? Does it get in the groundwater? We don't want that, either.
We do the same thing with our livestock. We have a lot of pigs. We feed the corn to the pigs. We take the waste from the pig, the nutrient from the pig, and put it back on the soil. It's just a cycle. It's a kind of a sustainable cycle. It's not what you call organic farming, because we still use some pesticides on certain conditions when we need them. But it's sustainable agriculture's theory, and it works. That's what we're out here trying to do. That's building our soils, building the organic matter back up to what it was years ago, and using the livestock wastes of the nutrients to do that, and then using the biotech to plant the best crop we can in that system.
It all goes together. I guess I am an environmentalist activist. I fight
for that, I guess. I do a lot of very minimum tilling to keep the wind down,
to keep the erosion down, and it's one of those things that happen.
Yes. We'd like to use it solely, but it takes a lot of manpower to have that much livestock around. Also, livestock's a seven-day-a-week job. You remember, it's morning and night, seven days a week. If you talk to a lot of people, they'll say, "Wow! You don't get the weekends off?" No. You have to share to get a weekend off. Well, that's a different lifestyle now. So you have to enter into that, too.
But we would like it if we could use all animal waste for our nutrients,
because I don't care to pay Kuwait for my nitrogen, or Canada for my potash,
or South America for my phosphorus. I'd just as soon have it here and use it
right around and turn it around, and use the sun for the energy. We have the
things to do it. Now we have to create the opportunity and a possibility for
us to do it that way. . . .
Oh, I think organic farms have their place. I'm all for organic farming. I'm for it, and if people want to eat food from organic farms, I'm for that too. The only thing is, if everybody was organic farming, your production would be a little lower. We couldn't feed as many people. We couldn't do as much stuff with it. The price would go down anyhow, because everybody's doing the same thing. So that's not the answer to what we're talking about here. But organic farming, I'm all for that. Anybody who wants to do that, I'm with him on that. . . .
I don't think they're out there condemning me for not doing it, because if I did it and so did everybody else, their price would go down. So I don't think they're doing that.
It's another way of farming and it's okay. I don't have any problem with
it. But if we're going to move to what I want as a renewable energy source,
whether it's energy for food or energy for everything else, we have to move
in that direction. Everybody can't organic farm to do that, then. So that's
fine. There are all sorts of farming out there. . . .
The merits are good and the direction's correct. . . . I don't think it's the whole answer, though, and that's my point. It's not the answer to everything, and maybe the way I'm doing things isn't the answer to everything. But we join them together and we get the answer to everything. Then I'm happy. Then we can get the job done. If you want to pay more for your food that's organic, that's fine. Go ahead and pay for it. I don't have any problem with that.
I don't worry in the United States about what I eat, because I think it's
the safest place in the world to eat anything. It's been proven. We live
longer. We enjoy life more. We have the best food, I think, and we're
creating better food. I am not one bit afraid of anything. I eat the BT
corn, I eat the Roundup Ready soybeans when I'm combining them. They're
safe, to me. . . .
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.
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 reason.
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
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.
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.
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.
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 that tomato.
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.
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. . . .
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.
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 peanuts.
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.
. . . 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.
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 carefully regulated.
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.
That's different. In conventional breeding, you cannot cross species. In
recombinant technology, it's very possible to cross species.
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 foods.
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
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.
No, I don't think so. . . . And I think criticism of FDA has come from
both consumers and industry.
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.
Voluntary labeling is certainly an option for the industry, and one they
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?
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
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.
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
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.
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.
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.
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
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.
Certainly they're widely used in a variety of food manufacturing
settings, in everything from cheeses to high fructose corn syrup.
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.
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.
BST was labeled in some parts of the country. It was voluntary in other
parts of the country.
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.
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.
That would be my prediction.
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.
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.
Has food always been genetically modified?
Yes. I think we would consider all of the crops that we have as crops
that have been subjected to some type of genetic modification. Now, of
course, we have the newer techniques--recombinant DNA techniques--of
introducing a single gene or a few genes. . . .
Yes. The first product that FDA reviewed was insulin produced through fermentation. That was approved in 1982. We even had experience prior to that, because of a scientist who had first raised questions about the safe use of this technology. That led to the development at the National Institutes of Health of guidelines for research.
So when the questions started to be raised about the application of these
techniques in the food sector, FDA had a lot of experience from the research
guidelines through NIH and from its own experience in reviewing the first
Yes. The first food ingredient was something called chymosin, or what
people may know better as rennet. It's the enzyme used to clot milk to make
cheese. That enzyme was produced in a bacteria as the first product of
modern biotechnology. FDA made a decision on rennet in 1990. We had a
petition with an opportunity for public comment, and we received no comments
from the public at all, at that time.
Yes. Of course, there were other things--enzymes used to make high
fructose corn syrup, for example, which is used in soft drinks.
. . Things like bread and cheese and soft drinks, and the vitamins and amino
acids and so forth. But they are often not things that people would see in
the grocery store. In other words, when you buy a loaf of bread, you may not
realize that the enzymes used to produce that bread have been genetically
modified. That they're very minor components of the food, I guess, is the
Yes. . . . That's about the time that FDA was becoming aware that
agriculture was going to be a big sector of the biotechnology industry.
Under the mechanisms that we regulate food safety, we do not routinely
review new varieties of corn and potatoes and things that one would think of
as food before they go to market, even though there are several hundred new
varieties developed in the U.S. every year. Nevertheless, we do have
authority over the safety of that food.
Yes. The law places the legal responsibility on the purveyor--the person
who's selling the product--to provide a safe and wholesome product to the
consumer. The law also gives FDA broad enforcement authority to take action
if there is something that's unsafe about the product.
We actually spent several years at FDA looking at what would be the impact of this technology on the food supply. The government had decided that, as a matter of policy, biotechnology would be regulated under the existing statutes, which for FDA meant that we would regulate foods under the Food, Drug and Cosmetic Act. We had to be sure that in fact that statute was adequate.
So our scientists examined all aspects of this technology relative to
food production--looking at how similar the products would be, how they
would be different, what kinds of safety testing would be appropriate for
these products. After careful consideration, we felt that we were dealing
with foods that we're well familiar with, in the sense that these are new
varieties of corn and potatoes, soybeans. . . .
Under the Food, Drug and Cosmetic Act, food additives--things like spices, flavors, preservatives, and sweeteners--are required to be approved by FDA before they can be used in food. The definition of a food additive does have exemptions for substances that are Generally Recognized As Safe (GRAS). Congress, in enacting the requirement for food additives, recognized there were many substances that had been safely used in food, and did not want a pre-market review of all of those substances, such as sugar and vinegar and so forth. They also said that . . . if it's generally recognized in the scientific community that the use of the substance is safe in food, that it would be exempt from the pre-market approval requirement.
So we have a large class of substances--enzymes, many flavors, and many
common food substances, such as vinegar and sugar and salt and pepper and so
forth--that are added to food, but that do not undergo pre-market approval,
because they are generally recognized as safe.
Yes. FDA has said that, in looking at modifications by genetic engineering, there can be new substances in the food, such as a protein or an enzyme. To the extent that those substances are similar to proteins or enzymes that we have consumed safely, we would consider those to be essentially similar to substances that have been accepted as GRAS, and so we will not require pre-market approval for those substances.
We do have the legal tool to require pre-market approval if genetic
modification is used to introduce a substance that's very different, and we
don't have a basis to believe that that substance is generally recognized as
safe. . . .
Yes. There is the possibility that someone could change the potato in a
way that would be significantly different. If, for example, through gene
technology, a protein were introduced that was very different from proteins
that we've safely consumed, FDA has authority to require pre-market approval
for that protein as a food additive. . . .
We have felt from the beginning that when there is a new technology--and we consider recombinant DNA or modern biotechnology to be a new technology--it's prudent practice for developers to discuss products that are produced by this new technology with FDA before they enter the marketplace. Then we can be sure that there's nothing about this technology that has not been resolved in terms of food safety. . . .
In terms of a product like BT corn, where the corn is modified to produce
a substance that is a pesticide, that pesticide substance is evaluated by
EPA under the pesticide laws and regulations. But the corn itself, in terms
of its use in human food, still falls under FDA.
"Substantial equivalence" is a difficult term, and it's not a legal term
in the U.S. . . . We use that concept as a way of comparing the new product
with its counterpart, in terms of how similar, how different it is, so that
we can focus the testing on making sure that any differences in the product
are also safe.
In terms of the testing that we have seen, those products, except for the
introduced trait, are similar in all other aspects that have been measured.
In other words, the corn is still the same corn in terms of its starch
content and its other nutrients. Whatever is typical of that particular
plant has not been altered.
We had what we thought was quite a bit of interest in this in the early
1990s, when we were in the process of reviewing the first products,
including the Flavor-Saver tomato. We had a very open public process, and
FDA did receive many comments about this technology at that time. Once we
completed that public process and made the decision for the first products
to go to market, there were then several years when we really received very
little input from the public. It's only been within the past couple of years
that the level of concern has once again been raised. . . .
Allergenicity is not a new topic, and it's something that we do take very seriously. Because genetic material can be moved from different sources--from one plant to another, or from one non-food source to another--there is the possibility of introducing new proteins into the food. We know that there are, of course, many proteins that make up the food supply. A few of those proteins are allergens. . . . So one has to be very cognizant of possible allergenicity when a new protein is introduced into a food, whether that's by a gene transfer modification, or whether it's by a simple addition in the manufacturing process.
FDA indicated in its early policy that we would be particularly concerned
if genetic material were transferred from a food that we know causes
allergic reactions, such as peanuts or fish or soybeans. In that case, we
actually feel that developers should assume that they have transferred an
allergen, unless they can scientifically demonstrate that they have not. . .
We actually think the risk is very low, based on our discussions with scientists who are expert in the field of food allergy. The reason is that there are ways to scientifically assess the possible allergenicity of a protein that's derived from a source, where we know that individuals are allergic to that food. We've actually had an example where a soybean was developed with a protein from Brazil nut. There are individuals who are allergic to tree nuts, including Brazil nuts. The scientific procedures did demonstrate that that protein was an allergen, and that product was discontinued.
In terms of proteins that would come from sources that are not known to
be allergens--bacteria, for example--the feeling from the scientists was
that, while there's always some chance that a protein could be an allergen,
it wasn't very likely that most proteins would be allergens, particularly if
they did not exhibit characteristics that are typical of food allergens.
Food allergens, for example, tend to resist digestion. The proteins that
have been introduced into foods, to this point in time, have all been shown
to be readily digestible, and not similar to any known toxins or allergens.
. . .
There are two aspects to that. One is the genetic material that's introduced that produces a new substance, such as a protein. That's where we can determine what the protein's function is, whether it's digestible, and whether it has any similarities to known toxins and allergens.
Then there's a second area of question, which is about the food itself.
Foods contain many different substances, some of which would be harmful to
people if they were present in levels that are higher than what is typical
of the crops that we now have. So we do make sure that companies run the
analyses to make sure that substances that are typical of the food are
present at levels that are acceptable. . . .
Our responsibility is to protect the American public. In terms of
products that are developed by a technology--whether it's a new technology
or a conventional technology--our role is to ensure that the products are
safe. Our role is not really to make a judgment about whether they should be
placed in the marketplace or not. . . . We are not here to impede products
from being developed and introduced into the market if they are safe. We are
here as the gatekeeper to close the gate if a product is not going to be
safe for consumers. . . .
That's an important question, because yes, it is the characteristics of the ultimate food product that we're interested in, in terms of whether that product is safe for consumers. But it is important to know how a product is produced, because that often gives you a window into questions about safety. Different processes may raise different issues.
. . .
I don't think it really gives us problems. It's just that it's been
difficult to find terminology that everyone can understand and accept around
the world. We have always thought about genetic modification as something
that applies to all methods of altering plants, animals, microorganisms,
that are used for producing goods, such as foods and agriculture. Today that
term is being applied more specifically to the modern techniques of
biotechnology. . . .
In our view, we'd have to label all the foods in the market if we just
simply said the broad definition of "genetic modification."
That is really the main issue. The actual legislation in Europe is a
little bit broader than just recombinant DNA. It includes some other sort of
modern techniques, but excludes from their definition the more traditional
kinds of techniques, such as hybridization. . . .
First of all, you have the plant that has been developed for a particular purpose, and there may be several varieties of that plant that have been developed by recombinant DNA techniques--several varieties of BT corn, for example. But there may be other varieties of corn, and there are other varieties of corn, that have been developed by different methods of plant breeding. All of those varieties of corn will be processed together. They will be shipped together. Then the processed products will then be introduced into many different kinds of products. So it's very difficult to distinguish which products contain material from modern biotechnology or any other particular technology.
In terms of the food label itself, it can be very complicated, because
you have many ingredients in the food. An ingredient such as an oil, for
example, may or may not contain DNA or protein, depending on whether that
oil is highly refined or only partially refined, and whether it's a
composite of many different varieties that were used to make that oil. . . .
We have considered that issue. We do regulate animal feeds. The feeds, of
course, in some cases, contain new proteins. Those proteins, as I've
mentioned earlier, have been shown to be readily digestible. So we would not
expect any new material or different material to accumulate in the meat or
in the milk of animals that are fed feeds that are derived from plants that
have been developed by modern biotechnology.
For us, it's more a question of the law that we have. We do, of course, have mandatory labeling for significant changes in the food. If there's a new allergen in the food that people would not expect, that must be labeled. If a consumer needs to know how to cook or prepare the food differently, that must be disclosed on the label. If the food has a different nutritional value, those kinds of changes have to be disclosed for a food developed by modern biotechnology, just as they do for other foods.
But the question about the method--which is really the question that many people would like to know--is a difficult one. Under our law, we are required to make information available if it's material to the product. We have looked very carefully at the use of recombinant DNA techniques, and we do not have any information that the simple use of the techniques creates a class of foods that is different in safety or quality from foods developed by other methods of plant breeding. So we don't have a legal basis to require manufacturers to disclose that information on the label.
The manufacturers are free to disclose whether the product is developed
by modern biotechnology or not developed by those processes, as long as they
do so in a way that is truthful and doesn't mislead the consumer.
When we look at labeling, we don't just look at the specific words, such as "produced using modern biotechnology." We have to look at the whole food label. What image does that convey to the consumer? What message will a consumer take away from that food label? So if the product says, "This product was not produced using modern biotechnology," but it has a happy face or sunshine or something that conveys that this product is better than its competitor, then we think that would be misleading to the consumer. If it's simply a factual statement that this product was or was not produced by modern biotechnology, then we would think that would be suitable labeling.
. . .
This was a case of a product that was not approved for use in food. It was approved by EPA for use in animal feed. The company that developed this particular plant believed that they had a management program that would ensure that the growers of this corn would channel that product into feed use, and keep it out of the food supply. In fact, the company did explain that plan to FDA. Obviously, it didn't work.
We did begin to receive reports that there had been some methods of
detecting the Cry9C, the name of this protein, in taco shells. We initiated
a full investigation into the matter. . . . As a result of that
investigation, we did determine through analytical methodology that in fact
the Cry9C protein was present in the taco shells that had been provided by
the Kraft Company.
I don't think we know that exactly. . . . Nevertheless, Kraft recalled
the products. . . .
We have no information to suggest that there is a health problem with
this product. At the same time, it had not completed the review process.
There were questions about whether this particular protein might have some
of the characteristics that are similar to food allergens.
We have to be very cognizant about the complexity about the food supply,
that it's very difficult to separate something that's used in feed from
something that may also be used in food. That's something that all the
agencies will be looking at very carefully.
What we want to have in place is a process where products complete the
regulatory system before they go to market. I think that's the most
important thing, from FDA's perspective. That's why we're moving to a
mandatory notification system, to make sure that we are in fact informed
about all products before they go to market.
We think we have the authority. We're going to publish a proposal and
explain the legal basis that we believe that we can require companies to
notify us, under the existing law.
The process that's been in place since the early 1990s is based on the 1992 policy, which provides comprehensive guidance to developers about the kinds of issues that should be taken into account during the development and testing of these products. What FDA has said right from the beginning is that we want companies to come in and talk to us about these products early on, early and often, even when they're on the drawing board. . . .
That gives an interchange between the FDA scientists and the company
scientists about the design of tests. So when the company then goes forward
with the testing, they have FDA's advice in the beginning. Once they've
completed all the testing, then we ask them to provide information to us, so
that we can evaluate whether in fact they have done the correct testing and
whether they've answered the relevant safety issues before these products go
to market. . . .
We don't have the resources to do product development kind of testing. On
the other hand, as I said, our scientists do interact with the company
scientists. They look at the company scientists' data. That's our first line
of making sure that the data is sound. Under our system, the data that
supports a safety of product is always available, under the Freedom of
Information Act, to anyone who would like to review it. So all scientists
who are interested--or others, for that matter--can review that data. Of
course, there is a federal law against defrauding the government. So it's
not in anyone's interest to provide false information to the agency. . . .
It doesn't seem that way to those of us that have been working in this area for many years. Our scientists have spent many hours reviewing data on the technology as well as the specific products. . . . In reaching our decision on the Flavor-Saver tomato, we discussed the scientific approach that had been used by the company. That was the approach put forward in our 1992 policy, with our Food Advisory Committee, which is a committee of experts from outside FDA consisting of academic, industry, and consumer representatives.
One of the things that the committee concluded was that the product did
not raise substantial public health issues. They felt that it was
appropriate for the company and FDA to have gone through this elaborate
process over several years of review of this product, but in fact they
suggested that we find a simpler way, if there were going to be products
that would be similar to that. . . .
No. This is something that FDA has done in a very deliberate manner:
looking at the science first; looking at the types of products and our
regulatory system; and really trying it out through the consultation
process. It's been a very deliberative and publicly open process.
Given the roots of the company, what was the attraction of biotechnology? Why was this an area that the company chose to go into?
Monsanto has been investing in biotech since the mid- to late 1980s. The big attraction for Monsanto was really twofold. One, we believed then, and believe very strongly today, that fiber development and pesticides was no longer a viable business opportunity. From an environmental point of view, it didn't really make sense, either. So we stopped all chemical investment, and really redirected our energy towards biotech. That was the first main thread.
The second thread, the one that really drove our company to make the
biotech investment, was a future view on food requirements. The answer that
we developed was that we believe that the world needs about 35 percent to 40
percent more food produced on every acre. Chemicals weren't the answer to
that next increment of production. It was in genetics. It was in better
seed. So, really, that's been driving us for more than ten years now. . . .
Yes. That's true. That's been a real breakthrough in the industry--we're
selling information. When the farmer purchases Monsanto seed, or a biotech
seed, he's purchasing a piece of information that allows him to grow crops
either in a different environment, or to grow them with a reduction in the
amount of pesticides that he uses. We charge for the use of that
information. So that's a new development.
It's a very traditional system. When he buys seed, he also enters into a
licensing agreement with Monsanto for the use of that particular gene. The
gene contributes to his production by allowing him to control insects more
effectively, or control weeds more effectively, or, in the future, to grow a
crop that has improved qualities in terms of oils or proteins. That's a
license fee that he pays on an annual basis, and he pays depending on the
use of that seed.
That's the intellectual property that we own that's quoted in that seed.
To put it in perspective, you can't force a farmer into doing something that
he or she doesn't want to do. That's been my experience around the world.
We've seen these technologies growing very quickly. These are technologies
that are generally cheaper than the existing technologies, or the historical
system that he has used in the past. They're cheaper, more effective, and
reduce the pesticide inputs. That's what, I think, has led to a very fast
The first few crops for Monsanto have been soybeans and corn, and we've done work in rice and cotton and wheat. But the first commercial crop was soybeans. The breakthrough in soybeans was in making the crop tolerant to an application of Roundup, which, in turn, reduced the amount of herbicide that was applied in the crop, and reduced the input costs to the farmer. So it was about 30 percent cheaper and more effective than any system that he'd used previously.
Then the next broad platform of technologies was insect control, and that
was insect control in corn and in cotton. BT cotton, or cotton that's
tolerant to insects, has really been a breakthrough in how insects are
controlled in the crop. Historically, the crop was sprayed eight to ten
times with insecticide, usually flown over the top of the crop. Today, the
cotton crop is grown with one or two applications, and the crop is made
tolerant--the crop has a protein coded inside it where, if bugs chew on the
leaves, they're killed. So non-target insects, bugs that shouldn't be
killed, are left undamaged. . . .
Yes. I think I'd summarize it by saying we underestimated the consumer
concern in Europe. Our approach at that time, three years ago, was very
largely focused on the science, and ensuring that we had satisfied the
regulatory authorities. We never looked at the broad stakeholders involved,
and I don't think we entered into . . . a dialogue with a lot of the other
non-scientific groups involved in this discussion.
Certainly compared to last summer in Europe, it's my perception that things have got better. They've got better because ... UK scientists are now prepared to stand up and talk about the potential benefits of these technologies. This isn't just about Monsanto. This is much broader. So, that wasn't there before. That's the first thing.
The second thing--and it's a continuing frustration, not just to Monsanto, but to the whole industry--is that there's a European regulatory system which is running very, very slowly at the moment. It's the relative fragmentation of that system, I think, that has led to some of the trade questions on our ability to export crops from the U.S. into Europe.
If you compare Europe, for instance, and Japan, the Japanese system is probably one of the best regulatory systems in the world today. . . . The Japanese system is very similar to the system here in the U.S. You have a USDA-FDA-EPA triangle, and it seems to work.
I think that there's a very distinctive difference between the U.S. and
Europe. At the moment, consumer confidence continues to be very high here in
the U.S. Consumer confidence in the regulatory system in Europe, in general,
and the UK in particular, is very low at the moment.
I guess what I would say in response is, over the last three years, these crops have continued to grow. There are more than 100 million acres of biotech crops worldwide. The reality is that 2.5 million farmers in China this year will grow BT cotton, and they'll grow it with less insecticides. I think we'll see the same in India. I spent a lot of time in India in the last few years. You get young people, usually women, walking through fields in a cloud of insecticide.
These are technologies that can change the way that small farmers farm.
So I don't worry too much about getting caught in the crosshairs, as much as
how do these technologies advance farming techniques, and what impact we can
have on the world. I think that's how you have to focus.
Monsanto, in particular, and the industry in general, need to do a better
job of communicating the benefits of these end technologies. On a broader
scale, when you look at regulatory bodies, there are probably more education
needs in explaining to the consumer what biotechnology is. There are many,
many very good examples of what these technologies can bring to society at
large. We need to do a much better job of explaining what these technologies
are. . . .
From a food safety point of view, these are products, these are crops,
these are technologies that have been more widely tested than any other food
product that came before them in history. They are very, very widely
tested--not just here in the U.S.--but in Japan, and even in Europe. If you
look at some of our most recent technologies, they are moving through the
scientific regulatory system in Europe with flying colors at the moment. The
debate is moving away from food safety. I think the debate is moving, now,
particularly in Europe, toward one of environmental impact, and about
planting these seeds in other parts of the world.
a whole battery of tests generated around allergenicity. Monsanto's first
product, Roundup Ready Soybeans, has been extensively tested for allergens
and food allergens. It passed all the food allergen tests here in the U.S.,
and in Japan, and, incidentally, passed all the allergen tests in Europe
four years ago. So despite a lot of the discussion at the moment, the
soybean products have been in public commerce for almost five years. There
are very, very wide degrees of testing.
When we look at growing these crops, what I've seen in terms of environmental impact varies, depending on where you are in the world. The discussion is the U.S. is a different discussion from the discussion in Europe, for instance. The European discussion is largely driven by the fact that agriculture in rural areas and leisure areas are intermingled.
If you look particularly at the UK, the UK government has asked for
additional specific tests on the environmental impact within a UK context. I
feel fine about that, because of crop rotations, because of the crop
separation, and establishment of barriers. Finally, and most importantly,
the highest level of pesticide use in the world today is in Europe. In the
areas where . . . most of Europe's wheat is grown, the crops see eight to
ten applications of fertilizers and pesticides in the growing season.
Potentially, in the next three to five years, the introduction of biotech
into these crops will reduce pesticide use. Potentially--that's what tests
need to establish--biodiversity will improve. So as I look at some of the
questions around biodiversity, I'm really interested in getting the trials
done. My frustration is in not being able to generate the trials and the
Well, it's less the moratorium, because the moratorium permits field
trials. It's more the destruction of field trials. A lot of the groups who
are advocating more information and more scientific study are synonymously
the same groups that are destroying the trials that generate that. . . .
Resistance is something that we take very, very seriously. We've made investments in these technologies for a decade, so it's in our interests to make sure that they'll last for another 10 or 20 years. We've developed BT technologies. We've worked very, very closely with the regulatory systems here in the U.S., and now in Asia, China, and India, to guarantee that we have built natural refuge systems where we can ensure that there's no buildup of resistance. That's the first leg of the strategy.
The second leg is that we're constantly looking for new genes, so that we
continue to present the insect populations with additional challenges to
avoid the buildup of resistance. But it's something that, as a commercial
enterprise, but also as a farming community, they take very, very seriously.
Nobody wants to go back to spraying ten applications of insecticide. They're
growing a cotton crop in Australia in some areas that they couldn't grow
cotton before, because the insects had developed resistance to synthetic
insecticides. So there's a community around the world that's very focused on
avoiding the buildup of resistance.
We set a contractual obligation with growers, when they buy our seed, to
maintain refuges. That is monitored closely, and it's to the extent now in
the U.S., that if a farmer does not abide by that refuge program, we refuse
to sell him seed that second year. . . .
Labeling is an interesting discussion. Let me tell you the Monsanto view on labeling today. We believe very strongly, very strongly, that these products are safe. And in their safety, there is no need to label, and that's the position that has been held by the FDA. The FDA labeling requirements are really triggered by, if a product is essentially the same, then there is no labeling requirement.
In other parts of the world--again, in Europe, and in some emerging in Asia--labeling is a requirement, and we obviously follow those labeling requirements. If you take somewhere like the UK, the average supermarket in the UK today has 20,000 to 25,000 products or lines. Many of those today are labeled as containing a biotech or modified soy protein, and have been labeled for the last three years. The data that I've seen suggests that that hasn't changed consumer behavior at all. . . . And that would certainly be the case in Holland, which had blanket labeling regulations way before the UK.
My final point is that I think a voluntary labeling scheme here in the
U.S. leads to food companies generating an extra expense by labeling. A
consumer is presented with that expense in terms of a price, I would assume.
The consumer learns the choice, and whether to select that product, and pays
the premium associated with it. I think we'll probably see some form of
voluntary labeling program emerging here in the U.S., in the future, in some
There's never been a requirement here in the U.S. As I said at the beginning, I don't see the need for it, when we've run through years and years of safety testing before these products are released. On that basis, from a consumer point of view, there is no substantive difference. . . .
I think that there are a lot of lessons in the StarLink issue. Here at Monsanto--StarLink isn't one of our products--we've had a number of internal policies which would have avoided that for us. One, we would never commercialize a product until we had food and animal feed approval. That's just been an internal policy, because of the difficulty in separating. So we would never go forward until we had both approvals. That's one thing.
Two, we would never commercialize a product until we had approval here in
the domestic U.S. market and in Japan, because most of the export flows in
commodities go from here to Japan. We would never commercialize until we had
the secure export market established as well. I think that, for the industry
in general, StarLink has been a pivotal turning point in the recognition
that there are limits to what you can do in channeling. Before you
commercialize a product, you just need food and feed approval.
The identity preservation and keeping commodities separate, or trying to
maintain separate fractions in grain.
I can't comment on what Aventis has done on their compliance. I can tell
you what we've done here in the last couple of years in our channeling
efforts. We audit every step in the process, and we're working this through
web sites, through direct farmer communication, and all the way to the
processors and receivers of that grain. But I think the broader view in this
is, one, making sure that you have your export markets secured and clearly
identified before you commercialize; and two, making sure that you food and
feed approval before you take these products to market. . . .
We successfully mapped the rice genome earlier this year, and surprised many scientists around the world by opening up access to that genome. So today you can access the whole mapped rice genome, free of charge. Whether you're in Beijing as a plant breeder, or whether you're in Bangalore, you can access the Monsanto rice genome and use that as a platform for additional research. . . . I think it helps society. It helps the rice crop--a third of the world still depends on rice as their daily staple. And in the long term, it potentially could help us by gaining further insight into the genetic makeup in rice, and through rice, into wheat and corn. . . .
The reality is that 24,000 people a day still die of hunger. The majority
of that 24,000 are children. I believe that for corporations like Monsanto
going forward, we've got a responsibility in how we use these technologies
to benefit people that are less privileged than the West is today. So,
golden rice, and recently announced golden mustard, provide a
vitamin-enriched basic food source that helps prevent night blindness. It
also makes contributions by strengthening the immune system that makes
children less predisposed to immune diseases like AIDS. These are things,
that three years ago, we as a company would never have considered. . . .
We are doing this not because of PR, and sometimes when we make these
gifts, that's the first question. What we have seen today after a few months
with the rice genome work and after a few months between Monsanto and Zenica
with golden rice, is a recognition that this is a genuine gift given in good
faith. And given the gift, it then allows people to make additional
scientific developments without Monsanto being involved. I think that's the
key. We give the gift, and then it's up to the recipient to develop it. So
for us, there's no additional work required, other than making sure that
it's a gift given in good faith. . . .