Unlike the rest of the world, the U.S. has very good regulatory agencies.
Polls show people trust them.
The polls actually show that this is a complete myth. In fact, the American
public becomes just as wary about genetic engineering as anybody else, as soon
as they know it's going on.
What the government really has done in the U.S. is collude with the biotech
industry to make sure that the public is kept in the dark about this
technology. FDA refused to require labeling of genetically engineered foods,
against the advice of its own scientists. In 1992, the majority opinion of the
scientists in the agency was that genetic engineering is different and should
be regulated differently. But the FDA put out what was a political document,
not a scientific document, that said genetically engineered foods are no
different than natural foods, and therefore they don't need to be labeled or
regulated any differently. And the other agencies pretty much fell in line
with that approach. ...
What about the U.S. Dept. of Agriculture in this issue? Have they been
cheerleader, or have they been protecting our interest?
The USDA has had over 5,000 applications for field trials of genetically
engineered crops. They've never denied a single application. The agency will
tell you, "Oh yes, but 13 were withdrawn." That's their idea of strict
regulation. It's a joke. The USDA has virtually no regulation. Field trials
go on when a company simply sends them a letter and says, "We're conducting a
field trial." And then the approval is granted.
Jane Henney, M.D.
It's important for folks to realize that foods that are produced or generated
using the tools of modern biotechnology come through three different review
processes before they are ever introduced as foods. One is done by the USDA,
and then there's one done by the Environmental Protection Agency [which looks]
at crops that may be resistant to a particular pesticide. Before that [crop] is
used or given approval, one also has to make some sort of assessment as to
whether that can be used in a food that would actually reach the American
marketplace. [If so,] then FDA would have to give an assessment too of the
human food safety issues surrounding that product. ...
FDA Commissioner during the Clinton Administration
With soybeans and corn, regulation has been voluntary so far?
In 1992, we developed a policy for foods that were being developed using the
tools of modern biotechnology. We did that to communicate to industry what we
saw as the issues around these foods, and what we would expect [them to do]
with respect to testing and food safety issues. ...
We clearly communicated that if foods were being changed using these methods,
... or if there was anything posed, like an allergen, we would require labeling
on those particular products. [The] industry, to the best of our knowledge,
... has complied with that. ... As we have held meetings on these matters, I
think we are satisfied that there were no safety issues missed. There was
nothing introduced into the marketplace that would have posed a problem. ...
However, ... in order to satisfy ourselves that we are seeing everything, and
to give consumers confidence that someone is watching this process very
closely, we're moving now into what we call a mandatory notification process.
We will assure ourselves that we will be seeing all of the things that are
being developed using the tools of modern biotechnology as they might move into
[Finding Cry9C in the Taco Bell shells indicates that] there is something wrong
with the system. Something happened. Again, we don't know what the company
did or did not do at this point. We don't know what a grower did or did not
do. We don't know where the chain broke. What we do know is that we responded
very quickly to ensure public health protection, [and it caused] us to look at
these so-called split registrations. ...
Acting Assistant Administrator, Office of Prevention, Pesticides, and Toxic
The split registration would enable the corn to only be fed to cattle, rather
than being allowed to go into the human food supply [for] direct human food
consumption. Even though the law contemplates split registrations--and in fact
directs the agency to allow those--given our experience with the taco
situation, it would be an extraordinarily high hurdle for a biotechnology
company to get one of these animal feed use exemptions again.
Has this technology been rushed to market, too easily accepted by
I certainly don't consider EPA a cheerleader either for or against the
technology. Our responsibility is to make sure that our licensing decisions are
based on sound science, that we make those decisions in an open, transparent
way, and that in the end, we're providing complete public health and
environmental protection. ...
Norman Borlaug, Ph.D.
I think it would be a disaster if we put regulations on now that would tie down
the use of biotechnology and make it so complicated. What would happen? The
private small companies--especially [the ones] that have many young people
engaged in this field--would have to close their laboratories. Their business
Distinguished Professor of International Agriculture, Texas A&M
Then in 20 years, when we have to have [biotechnology and] we open the spigot
in the research line, it's empty. ... This is why I plead that we are not too
aggressive in closing down things that are new. ... If these regulations are
tightened too much, it may kill biotechnology.
Jim Maryanski, Ph.D.
Explain the concept of GRAS.
Under the Food, Drug, and Cosmetic Act, food additives--things like spices and
flavors and preservatives, 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 there could be
scientific information, if it's generally recognized in the scientific
community that the use of the substance is safe in food, that 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 do not undergo pre-market approval because
they are generally recognized as safe.
This could apply to genetically engineered enzymes, for example?
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
So a potato is a potato is a potato, if it's not checked.
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. ...
Jane Rissler, Ph.D.
Under the Food, Drug, and Cosmetics Act, there were no regulations [of
genetically modified organisms] ...
But there could have been a choice. In 1992, the Food and Drug Administration
produced a policy that it had been working on for many years. In that policy,
it said, "We will treat them for the most part as substantially equivalent.
Only under certain circumstances will we add any required regulatory
Thousands of people commented and said, "This is not strong enough. We want
labeling. We want required food safety testing. We want these to be treated
like chemical additives." Well, the Food and Drug Administration ignored those
thousands of comments, and proceeded to treat these products really as ordinary
food, except under unusual circumstances. As a result, there is only a
voluntary scheme. The FDA has yet to require a single test of any foods on the
We label everything in the U.S. You can look on a label on processed food and
you can see the whole history of that food. Why would we make an exception
when it came to GMO ingredients?
[What about] labeling? [People are saying] "I don't believe it's unsafe,
but I still want to know what I'm eating"?
I generally agree with that. I think labeling is coming. I spoke last year
about the fact that those companies that did not begin to go down the [road] of
labeling were making a very bad marketing decision. Some people say, "You
shouldn't label because the information on the label isn't useful, or you label
only for health reasons." But we label for nutrition reasons now. You buy
your food; it tells you how much fat, how much carbohydrate, what the calories
are. I don't have any problem with labeling, as long as it's done sensibly.
... My prediction is, within 5 years or so, these things will all be labeled.
Joseph Hotchkiss, Ph.D.
What would be the problems with mandatory labeling?
If you're going to label anything in a food, you have to be able to enforce the
truthfulness of that labeling. If you're going to say "GMO free," for example,
you have to first define what that means, and develop a system for enforcing
it. If I 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.
Someplace, you're going to have to draw the line. 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 if you were a purist?
You would ban an awfully lot of foods. As a matter of fact, if you went to the
extreme with this issue, I would guess that there would be a majority of foods
that would have to carry that kind of label.
Would an animal that has consumed a genetically modified crop be a
That depends on what kind of regulations they put forth. In my view, it should
not be [considered genetically modified]. 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
What would be your prediction if some of these things came to pass? Take
the worst case scenario.
My prediction, if the worst case labeling came in, that it would have very
little effect on the technology, the implementation of that technology, or the
food products that we enjoy. 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.
Jim Maryanski, Ph.D.
I'm trying to get an idea of the complexity of mandatory labeling. What
kinds of problems would you have to wrestle with?
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 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. ...
Would you like to be faced with mandatory labeling?
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.
Now, the manufacturers are free to disclose whether the product is developed by
modern biotechnology or not, as long as they do so in a way that is truthful
and doesn't mislead the consumer. ...
Jane Rissler, Ph.D.
The FDA's reasoning is that if they labeled GM, they'd have to label stuff
done by traditional cross-breeding.
I don't think so at all. I think there's a very easy way to determine that
these products are genetically engineered. You just label them as genetically
engineered. It's like irradiated food. That is labeled. ... The FDA
continues to say that there are no safety issues associated with irradiation,
but they require that food be labeled as irradiated. That's because there was
a great citizen outcry calling for labeling of irradiated food. The FDA has the
power to require labeling if there is enough pressure to convince them to do
it. It doesn't have to even be for a safety. ...
If you produced a new product with traditional cross-breeding as opposed to
with genetic engineering, why would one require more regulation? If a tomato's
been produced by cross-breeding, you can call it a tomato. But if a tomato's
produced by adding a gene for--
It's still a tomato, but it has a genetic additive, and it should be treated as
a tomato with a chemical additive. ...
When I was at the Environmental Protection Agency, we were trying to write
rules that said that genetically engineered microbes should be looked at
differently under the Toxic Substances Control Act. The Reagan Administration
and a lot of other folks were opposed to that because they, too, bought into
[the idea that we should] regulate the product, not the process. ... What
happened over the years is that they lost that argument, because the process
is regulated in the United States. We do have this regulatory apparatus
that is directed at genetically engineered organisms. And it means that the
USDA regulates the crops in a way it does not regulate traditional crops.
Our argument [at the EPA] was--and my argument is--that as a general matter,
this is a new technology. It is a technology that brings with it a significant
amount of uncertainty. It hasn't been applied. It hasn't been monitored much
in the environment. ... To the extent that one has resources to try to ensure
safety to the environment and to public health, you direct those resources at
the things that cause the most uncertainty or present the most risk. That's
why I don't look at traditionally bred crops. There may be some that are
troublesome, but as a general matter, they are not. We know very little about
the long-term impacts of genetically engineered food [and] they should be
subject to more scrutiny. ...
Martina McGloughlin, Ph.D.
[Critics] make stick the idea that although we've been modifying foods for
thousands of years, we're going to treat one process differently. Is that
Director, Biotechnology and Life Sciences Informatics Program, University of
read her interview
That's a complete departure, both from the original intent of regulations on
the U.S., and indeed on the European side, where the focus up until now had been
on the product, not the process by which it's produced. If you look at a
package of sausages, it doesn't say, "This was produced using extrusion
processes." Most people would never want to see how sausages are produced. ...
Agricultural practices or processing practices have never been a requirement of
labeling. And now suddenly they are, which is a total departure from the way
regulations have been put into place on both sides of the Atlantic.
So now they're singling out a particular process. If it's produced using
recombinant DNA ...
Yes. If it's produced using recombinant DNA technology, then you're required
to label it. There is a threshold level of 1 percent.
This decision [was] made at a parliament level; it had little input from the
scientists, because every scientist will tell you [that it is] impossible to
actually enforce those regulations because the type of tests that are out there
are notoriously inaccurate. ...
[Researchers at] KPMG ... determined that the overall costs of ... testing will
put between 5 to 15 percent of cost that will be passed on to the consumer, on
all of these products. Effectively, what you're doing is imposing a tax on a
technology that in fact is reducing environmental impact and potentially
increasing the healthfulness and safety of our food. ...
Nicholas Kalaitzandonakes, Ph.D.
Regarding Europeans and the issue of labeling genetically modified food:
They have to come up with a logical rationale for labeling food based on the
process by which it's made. Is this a real tricky problem?
Associate Professor of Agricultural Economics, University of
It is. ... From a practical perspective, if there is any real difficulty right
now in implementing labeling requirements in general, [it's because] we have a
non-standardized system. In other words, if you look at what the Japanese have
done with their labeling system, they require a five percent threshold, which
does not cover, for example, feed, oils, or highly processed foods. The
Europeans are moving towards a system that is much tighter, both in terms of
the thresholds and in terms of what is being covered. The Koreans want 2
percent threshold, and so on. The infrastructure in agriculture and food is
not able to handle all these different requirements. ...
How serious is this? What problems can this cause?
If we are going to implement labeling at a broad scale, that means that we are
going to have to deal with the issue of identity preservation and traceable
systems. In other words, we are going to have to be able to tell all along the
supply chain in agriculture and food, where this food came from, what is in
that food, and how it was produced. That's not what we do today and that would
be costly. The question is: How costly? Based on our research that we
published very recently, ... the cost is actually twice as large as we
originally thought, because of hidden costs.
What does that mean, practically? Consumers would pay for this?
Absolutely. Eventually, the consumers will have to pay for this.