Food and Drug Administration
Meeting on the Safety and Labeling of Genetically Modified Organisms
Chicago, Illinois
November 18, 1999
Michael F. Jacobson, Ph.D., Executive Director
Center for Science in the Public Interest
"Monsanto should not have to vouchsafe the safety of biotech food....
Our interest is in selling as much of it as possible. Assuring its
safety is the FDA's job"
--Phil Angell, Director of Corporate Communications, Monsanto,
quoted in New York Times Magazine, October 25, 1998
"Ultimately, it is the food producer who is responsible for assuring
safety."
-- FDA, "Statement of Policy: Foods Derived from New Plant
Varieties" (GMO Policy), Federal Register, Vol. 57, No. 104
(1992), p. 22991
Thank you very much for the opportunity to participate in this meeting.
CSPI is a nonprofit consumer-advocacy organization that since 1971 has focused
on food safety and nutrition. A decade ago we led efforts to win passage of the
Nutrition Labeling and Education Act. More recently, we have worked hard to
obtain greater funding and greater authority for the FDA and USDA to fight food
poisoning. CSPI is funded largely by foundation grants and our almost one
million members; we do not accept funding from industry or government.
Genetic engineering is a powerful technology. Used properly, it could
greatly benefit farmers, consumers, and the environment. It holds out the
promise of increased yields, reduced use of pesticides, and greater nutrition.
But, if misused, it could cause great harm. Genetically modified -- or GM --
foods currently on the market do not appear to endanger (or benefit) consumers,
though GM crops certainly raise ecological concerns. Most consumers know little
about biotechnology. However, increasingly partisan propaganda on all sides
rapidly may replace ignorance with confusion. In such an environment it
behooves government -- as well as industry -- to build long-term public
confidence by establishing strict rules to protect the environment and ensure
safety and choice to consumers.
Safety
------
No obvious health problems have resulted from consuming biotech foods, but
it would be difficult to know if GM foods in fact have increased (or decreased)
disease rates. Immunotoxic or neurotoxic problems due to newly introduced genes
could be particularly difficult to identify. Still, there is no reason to doubt
the safety of any biotech foods on the market.
One obvious concern about GMOs is that they might cause allergic reactions.
In one prominent case, a company added to soybeans a Brazil-nut gene for a known
allergen. Thanks to appropriate testing, the problem was discovered and the
company never marketed the product. The FDA strongly encourages, but does not
require, companies to conduct studies when a gene is transferred from a plant
that is known to be a common allergen. Importantly, the Brazil-nut allergen
gene was identified only because the allergen was known and could be tested for.
But what if a protein newly introduced into the food supply causes occasional
allergic reactions" Or if a new gene did not encode an allergen, but turned on
dormant genes that did code for allergens" Or if a protein led to a behavior
disorder or autoimmune disease, interfered with a medicine, or had other adverse
effect" It would be difficult to identify such problems before or after
marketing.
Another concern is that levels of naturally occurring toxins, such as
solanine, might be increased in GM versions of plants. The FDA encourages
companies to screen for such substances, but does not require them to do so and
report to the FDA the results of their studies. It may be unlikely, but is not
inconceivable, that a genetically engineered food would engender a novel
toxicity, as suggested by the recent study, published in The Lancet, of biotech
potatoes.
Risks of allergic reactions may be small, but are real; other risks may be
speculative, but are not non-existent. The possibility of requiring routine
toxicity studies should be considered; at the very least more research in this
area should be conducted. It is impossible to prove with absolute certainty
that something is safe -- but it may be possible to do a better job to assure
safety than is now being done.
Currently, the FDA asks, but does not require, companies to submit data
only when biotech crops contain gene products from plants that commonly cause
allergies or contain genes that code for novel proteins, though apparently
companies are consulting with the FDA about every GMO. That kind of voluntary
system does not inspire maximum public confidence in the safety of a powerful
new technology.
We urge the FDA to review the safety of every GMO before it is marketed.
The FDA could require differing amounts of information depending on the product.
For instance:
* For GMOs made from gene transfers between closely related species, or
if the donor organism is a traditional food and does not cause allergies,
only notification and provision of specified summary data would be
required. The FDA, during a review period of specified duration (say, 60
to 90 days), could demand more information, if it wished.
* For GMOs containing genes from an organism that causes allergic
reactions, thorough testing for allergenicity would be required. GMOs
containing a gene for a common allergen would not be allowed.
* For GMOs in which gene products were different from traditional foods
or were present in significant quantity, food-additive petitions and more
extensive safety testing (possibly including animal feeding studies) would
be required.
In the 1970s, recombinant-DNA laboratory research was new and highly
controversial. A rigorous safety system was implemented, allaying public
concerns. The same apprach should be taken with genetically modified foods. We
recognize that it is impossible to prove absolute safety, but consumer
confidence in genetically engineered foods would be maximized if the FDA
implemented a mandatory pre-approval process.
Labeling
A second key issue is labeling. Labeling, of course, should not be a
substitute for safety; every biotech food should be safe. Yet, even assuming
that biotech foods are as safe as conventional foods, several considerations
indicate the need for labeling:
For people with multiple or severe allergies, or with general safety
concerns, GMOs raise warning flags. Those people fear that foods they were
always able to consume might harbor new substances to which they might be
sensitive.
Second, many people are troubled by potential ecological effects of GM
crops, such as harm to wildlife or promotion of pesticide-resistant insects or
weeds.
Vegetarians and people with certain religious beliefs may wish not to
consume foods containing gene products derived from animals. Other people
believe it is simply unethical to move genes between distant species, such as
putting a gene from an animal into a plant.
Regardless of what one thinks of the validity of those concerns, labeling
would enable those consumers to avoid biotech foods. Labeling is supported by
most Americans, according to public-opinion polls.
The FDA should adopt a strict definition of the term "GMO-free" and allow
marketers of foods that meet that definition to make a label claim. The FDA
also should require foods containing significant amounts (say, more than 1%) of
biotech ingredients to disclose that fact on labels. If such a food contains a
possible allergen, the label should indicate the food from which the genes were
obtained (for example, "contains [food] protein"). Furthermore, any significant
reductions in nutritional value or signficant changes in sensory characteristics
should be indicated on labels.
One concern that is raised by GMO labeling is that it might mislead some
consumers into thinking that GM foods are significantly less safe, or that
GMO-free foods are significantly more safe, than other foods. The FDA should
conduct consumer research to assess whether additional explanatory language
might be appropriate.
In summary, biotechnology could offer real benefits. Whether those
benefits are realized depends, in part, on whether the FDA establishes new
approval and labeling requirements that maximize public confidence.
Thank you once again for the opportunity to present CSPI's views.
Toxicology Forum
Safety and Labeling of Genetically Modified Organisms
Washington, DC
February 7, 2000
Michael F. Jacobson, Ph.D., Executive Director
Center for Science in the Public Interest
Thank you very much for the opportunity to participate in this meeting.
CSPI is a nonprofit consumer-advocacy organization that since 1971 has focused
on food safety and nutrition. A decade ago we led efforts to win passage of the
Nutrition Labeling and Education Act. More recently, we have worked hard to
obtain greater funding and greater authority for the FDA and USDA to fight food
poisoning. CSPI had not been involved in the biotech controversy until last
November when I was invited to participate in the FDA"s meeting in Chicago. I
hardly claim to be an experienced expert on this issue. However, CSPI"s late
arrival on the scene has enabled us to take a fresh look at the issue.
Though CSPI is sometimes accused of being anti-everything in the world of
food, we have a decidedly middle position on genetically engineered foods. We
believe that if used properly, they could greatly benefit farmers, consumers,
and the environment. They hold out the promise of increased yields, reduced use
of pesticides, and better nutrition. But, if misused, they could cause great
harm.
Slide Critics
* "Danger of violent allergic reactions"
* "Frankenfoods"
* "Ecological roulette"
* "Forever altering our genetic legacy"
* "Pandora"s pantry"
* "Boosting chance of disaster"
Critics are effectively generating questions, some valid, some not, about
biotechnology. They are using everything from the Internet to full-page
newspaper ads to guerilla theater to press their case. Their objections range
from accusations of great risk to health to irrevocable ecological damage to
monopolization of the seed industry. In such an environment it behooves those
-- in government, industry, philanthropic foundations, and the academic
community -- who hope to reap benefits from biotechnology to address valid
concerns and build long-term public confidence by establishing strict rules to
protect the environment and ensure safety and choice to consumers.
Though you may decry the critics"s tactics and condemn the critics, it is
worth noting that government and industry have not exactly paved a smooth road
for public approval. This juxtaposition of quotes is revealing:
Slide "Monsanto should not have to vouchsafe the safety of biotech
food.... Our interest is in selling as much of it as possible.
Assuring its safety is the FDA's job."
--Phil Angell, Director of Corporate Communications, Monsanto,
quoted in New York Times Magazine, October 25, 1998
"Ultimately, it is the food producer who is responsible for assuring
safety."
-- FDA, "Statement of Policy: Foods Derived from New Plant
Varieties" (GMO Policy), Federal Register, Vol. 57, No. 104
(1992), p. 22991
Safety
No obvious health problems have resulted from consuming biotech foods. To
be honest, though, it would be difficult to know if GM foods in fact have
increased (or decreased) disease rates. Immunotoxic or neurotoxic problems, as
distinguished from acute allergic reactions, due to newly introduced genes could
be particularly difficult to identify.
Consumers are leery of biotech foods because they don"t know what they are,
the term genetic modification is a bit scary sounding, and because they
themselves are not deriving any benefits from the current products. Those
products are benefitting primarily farmers and the seed and chemical companies.
When the benefits are enjoyed by one party, but possible risks are borne by
another, that"s a formula for suspicion. Still, there is no reason to doubt the
safety of any biotech foods currently on the market.
Slide
* Allergic reactions
* Increased levels of natural toxins
* Novel toxicity (Ewen and Pusztai in The Lancet)
* Lack of proof of safety
Although existing GM foods appear to be safe, there are some legitimate
concerns raised by the new technology. One key concern is that they might cause
allergic reactions. In one prominent case, a company added to soybeans a
Brazil-nut gene for a known allergen. Thanks to appropriate testing, the
problem was discovered and the company never marketed the product.
The FDA strongly encourages, but does not require, companies to conduct
studies when a gene is transferred from a plant that is known to be a common
allergen. Importantly, the Brazil-nut allergen gene was identified only because
the allergen was known and could be tested for. But what if a protein newly
introduced into the food supply causes occasional allergic reactions" Or if a
new gene did not encode an allergen, but turned on dormant genes that did code
for allergens"
Another concern is that levels of naturally occurring toxins, such as
solanine, might be increased in GM versions of plants. The FDA encourages
companies to screen for such substances, but does not require them to do so and
report to the FDA the results of their studies. It may be unlikely, but is not
inconceivable, that a genetically engineered food would engender a novel
toxicity, as suggested by the recent study, published in The Lancet, of biotech
potatoes. Or what if a protein caused a behavior disorder or autoimmune
disease, interfered with a medicine, or had other adverse effect" It would be
difficult to identify such problems before or after marketing.
While advocates claim that genetic engineering works with surgical
precision, accidents do appear to happen -- just as they might with conventional
breeding. New Scientist recently ran a brief article about genetically
engineered soybeans that had a problem. During a hot summer in Georgia, their
stems split open. Apparently, high levels of lignin, a tough form of cellulose,
caused the unexpected problem.
Risks of allergic reactions may be small, but are real; other risks may be
speculative, but are not non-existent. It is impossible to prove with absolute
certainty that something is safe -- but it may be possible to do a better job to
assure safety than is now being done.
Currently, the FDA asks, but does not require, companies to submit data
only when biotech crops contain gene products from plants that commonly cause
allergies or contain genes that code for novel proteins, though apparently
companies are consulting with the FDA about every GM food. That kind of
behind-closed-doors voluntary system does not inspire maximum public confidence
in the safety of a powerful new technology.
Ecological Concerns
Slide
* Transfer of genes to related wild species
* Harm due to fauna (e.g., Monarch butterfly) due to engineered pesticides
(e.g., Bt toxin)
* Development of pesticide resistance in insects and weeds
* Loss of genetic diversity in crops
* Herbicide-tolerant crops increase chemical dependency in agriculture
Aside from questions of safety for consumers, GM crops raise genuine
ecological concerns. Whether it"s the effect of Bt corn on Monarch butterflies
or the spread of genetically engineered characteristics to wild relatives or the
development of pesticide resistance in insects or weeds, GM crops deserve the
closest scrutiny. After all, the self-propagating nature of living organisms --
be they fish or wheat -- means that once a problem occurs, it might be almost
uncontrollable. The U. S. Department of Agriculture and the Environmental
Protection Agency face challenges that are as great as or greater than those
faced by the FDA in regulating GM crops -- But questions have been raised about
the rigor of those agencies" scrutiny and judgment. To obtain independent
advice on environmental concerns, USDA recently established an Advisory
Committee on Agricultural Biotechnology. It has also commissioned an ongoing
review by the National Academy of Sciences of its regulatory process. Those
committees should help guide USDA cautiously into the future and inspire greater
public confidence.
Regulation
Slide New Regulatory Scheme
* Mandatory approval by FDA/USDA
* Labeling
Some people oppose genetic engineering on principle, and they will never be
satisfied by any amount of testing or regulation. Most people, though, are open
to biotechnology, but want to be assured that the foods are safe for themselves
and their families. And many people want to be sure that crops, even if safe,
won"t have long-term adverse effects on the environment. We need to upgrade the
regulatory system to respond to those concerns.
Slide Mandatory FDA Approval
* Known, safe proteins introduced: limited safety data would be required
* Common/strong allergens: Introduction should be prohibited.
* Introduction of genes from an organism that causes allergic reactions:
thorough testing for allergenicity would be required.
* gene products from non-food sources, or present in significant quantity,
or whose structure suggested a possible problem: extensive testing, possibly
including animal-feeding studies, and full food-additive petitions.
I think that the FDA"s recent series of public meetings was a useful step
in educating journalists and the public about how it monitors genetically
modifed foods. What"s needed now is action. A major substantive step would be
for the FDA to review the safety of all GM foods -- and approve the marketing of
those foods. Though companies have routinely consulted with the FDA, such a
secretive voluntary process leaves large loopholes that could result in problems
and that certainly gives ammunition to critics.
The FDA could require each new GM food to be supported by a food additive
petition, with the amount of evidence required varying according to the nature
of the food. For instance, a pure, protein-free vegetable oil would require
little toxicological data beyond characterization of the new gene constructs.
At the other extreme, the agency should simply ban common or strong allergens.
Genes from an organism that causes allergic reaction would require thorough
testing to establish that no allergen was inadvertently present in the food.
Finally, foods with gene products from non-food sources, or that are present in
significant quantity, or whose structure suggested a possible problem would
require more extensive testing, possibly including animal-feeding studies.
Labeling
Slide Reasons for Labeling
* people with multiple or severe allergies
* people with general safety concerns
* people troubled by potential ecological effects of GM crops
* Jews, Moslems, and vegetarians
* people who believe it is simply unethical to move genes between distant
species
* labeling is supported by most Americans, public-opinion polls show
The second component of an improved regulatory scheme is labeling.
Labeling, of course, should not be a substitute for safety; every biotech food
should be safe. Some critics of biotechnology undoubtedly want "GM" labeling
because in the current environment such a label is a kiss of death. Yet, even
assuming that biotech foods are as safe as conventional foods, several
considerations indicate the need for labeling, as this slide indicates.
Labeling of foods with or without genetically modified ingredients is,
obviously, a highly controversial issue. However, judging from what"s happening
to Europe, and increasingly in the United States, it may be inevitable. Rightly
or wrongly, it is clear that consumers want labeling. Off-label means of
providing information -- such as the Internet -- are not acceptable.
Slide Labeling Plan
* "GMO-free": FDA should adopt a strict definition of the term
* "Contains Biotechnology Ingredients": FDA should require labels on foods
containing biotech ingredients (say, more than 1%)
* Possible allergens: "contains [food] protein"
* Significant changes in nutritional value or sensory characteristics
* Labels should not lead consumers to think that GM foods are significantly
less safe, or that GMO-free foods are significantly more safe, than other foods.
The FDA should begin exploring those issues by means of consumer surveys and
focus groups.
Slide Public Acceptance of Biotechnology
* Public confidence in the safety of GM foods
* Public confidence that GM crops would not affect the environment
* Recognition of benefits to compensate for perceived risks
Perhaps the biggest challenge to biotech advocates is to convert
biotechnology from a negative to a positive. While PR campaigns in support of
GM foods might have an effect, the single most effective factor would be the
marketing of engineered foods that provide real benefits to consumers themselves
-- such as better-tasting vegetables or vegetable oils with a more healthful mix
of fatty acids. Until those foods are marketed, it looks like the biotech
industry will be skating on very thin ice.
In summary, biotechnology could offer real benefits. Whether those
benefits are realized depends, in part, on what course of action government and
industry take.
Thank you.