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FOOD AND DRUG ADMINSITRATION
BEFORE THE SENATE HEALTH, EDUCATION, WELFARE, AND PENSIONS
"ASSURING CONSUMER CONFIDENCE IN GENETICALLY ENGINEERED FOOD"
REDRAFT 9/22/00 2:30 pm
Mr. Chairman and members of the Committee, thank you for
giving the Food and Drug Administration (FDA or the Agency)
the opportunity to testify today on its regulatory program
for foods derived from plants using the tools of modern biotechnology
-- also known as genetically engineered, or bioengineered,
foods. I am Joseph A. Levitt, Director of FDA's Center for
Food Safety and Applied Nutrition (CFSAN). Within FDA, CFSAN
oversees bioengineered plant products or ingredients intended
for human consumption. Our Center for Veterinary Medicine
oversees bioengineered plant products used as or in animal
feed, as well as bioengineered products used to improve the
health or productivity of animals (including fish).
We believe it is very important for the public to understand
how FDA is regulating the new bioengineered foods being introduced
into the marketplace and to have confidence in that process.
To that end, I appreciate this opportunity to describe our
policies and procedures to the Committee and to the public.
First, let me state that FDA is confident that the bioengineered
plant foods on the U.S. market today are as safe as their
conventionally bred counterparts. Since FDA’s 1994 evaluation
of the Flavr Savr tomato, the first genetically-engineered
plant food to reach the U.S. market, FDA has reviewed the
data on more than 45 other products, ranging from herbicide
resistant soybeans to a canola plant with modified oil content.
To date, there is no evidence that these plants are significantly
different in terms of food safety from crops produced through
traditional breeding techniques.
The topic of bioengineering has generated much controversy,
particularly about whether these foods should be labeled or
not. As I discuss in more detail later in my testimony, FDA
held three public meetings on bioengineered foods late last
year, the second one of which I chaired. We wanted to hear
the views from all, and importantly, we wanted to discuss
and obtain feedback on ways in which information on bioengineered
foods could be most appropriately and helpfully conveyed.
Partly in response to information gained from the public
meetings and comments received by the Agency, FDA announced
on May 3, 2000 that it will be taking steps to modify our
current voluntary process for bioengineered foods to establish
mandatory premarket notification and make the process more
transparent. Further, we will be developing guidance for food
manufacturers who wish voluntarily to label their products
regarding whether or not they contain bioengineered ingredients.
To ensure that the Agency has the best scientific advice,
we also are adding experts in this field to our foods and
veterinary medicine advisory committees. FDA is taking these
steps to help provide consumers with continued confidence
in the safety of the U.S. food supply and to ensure that the
Agency's oversight procedures will meet the challenges of
the future. The proposed notification rule and draft guidance
are currently under development.
Background on Food Biotechnology
Ever since the late 1800's, when Gregor Mendel discovered
that characteristics in pea plants could be inherited, scientists
have been improving plants by changing their genetic makeup.
Typically this was done through cross breeding and hybridization
in which two related plants were cross-fertilized and the
resulting offspring had characteristics of both parent plants.
In the breeding process, however, many undesirable traits
often appeared in addition to the desirable ones. Some of
those undesirable traits were eliminated through additional
breeding, which was time-consuming. Breeders then selected
and reproduced the offspring that had the desired traits.
Many of the foods that are already common in our diet are
obtained from plant varieties that were developed using conventional
genetic techniques of breeding and selection. Hybrid corn,
nectarines (which are genetically altered peaches), and tangelos
(which are a genetic hybrid of a tangerine and grapefruit)
are all examples of such breeding and selection.
Today, by inserting a single gene--or often, two or three
genes--into the plant, scientists are able to produce a plant
with new, advantageous characteristics. The new gene splicing
techniques are being used to achieve many of the same goals
and improvements that plant breeders historically have sought
through conventional methods. Today’s techniques can be used
with greater precision and allow for more complete characterization
and, therefore, greater predictability about the qualities
of the new variety. They give scientists the ability to isolate
genes and to introduce new traits into foods without simultaneously
introducing undesirable traits, as may occur with traditional
breeding. This is an important improvement over traditional
breeding. In today's debate about the merits and drawbacks
of bioengineered foods, it is critical to keep in mind that
this level of control actually decreases the likelihood
that unidentified, and possibly detrimental, substances will
be introduced into the plant.
Crop plants contain large quantities of deoxyribonucleic
acid (DNA), and this DNA is safely consumed by people and
animals. FDA has found no evidence to indicate that the DNA
inserted into plants using bioengineering presents any safety
problems. Also, the small amounts of the resulting proteins
are unlikely to change dramatically the safety profile of
the plant as well. But if safety concerns should arise, they
would most likely fall into one of three broad categories:
allergens, toxins, or anti-nutrients. FDA
has extensive experience in evaluating the safety of such
substances in food.
As to potential allergens, foods normally contain many thousands
of different proteins. While the majority of proteins do not
cause allergic reactions, virtually all known human allergens
are proteins. The most common allergy-causing proteins are
in these foods: milk, eggs, fish, nuts, wheat, and legumes--particularly
peanuts and soybeans. Since genetic engineering can introduce
a new protein into a food plant, it is possible that this
technique could introduce a previously unknown allergen into
the food supply or could introduce a known allergen into a
"new" food. The second possible problem is the introduction
of toxins into the food crop. It is possible that a new protein—as
introduced into a crop as a result of the genetic modification--could
cause toxicity. The third possible issue is the introduction
of anti-nutrients, such as molecules that inhibit digestive
enzymes like trypsin, or that cause alterations in the amounts
of nutrients normally found in a food--for example, a reduction
of Vitamin C.
It is important to note that the kinds of testing typically
conducted by developers of a bioengineered food crop
address all of these potential concerns. In the event that
something unexpected does occur, this testing provides a way
to detect such changes at the developmental stage, and defer
marketing until any concern is resolved.
Legal and Regulatory Issues
FDA regulates bioengineered plant food in conjunction with
the United States Department of Agriculture (USDA) and the
Environmental Protection Agency (EPA). FDA has authority under
the Federal Food, Drug, and Cosmetic (FD&C) Act to ensure
the safety of all domestic and imported foods for man or other
animals in the United States market, except meat, poultry
and egg products which are regulated by USDA. (Note that the
safety of animal drug residues in meat and poultry is regulated
by FDA's Center for Veterinary Medicine.) Pesticides are regulated
primarily by EPA, which reviews safety and sets tolerances
(or establishes exemptions from tolerance) for pesticides.
FDA enforces the pesticide tolerances set by EPA. USDA's Animal
& Plant Health Inspection Service (APHIS) oversees the
agricultural and environmental safety of planting and field
testing of bioengineered plants.
Bioengineered foods and food ingredients must adhere to the
same standards of safety under the FD&C Act that apply
to their conventionally-bred counterparts. This means that
these products must be as safe as the traditional foods in
the market. FDA has broad authority to initiate regulatory
action if a product fails to meet the standards of the FD&C
FDA relies primarily on two sections of the FD&C Act
to ensure the safety of foods and food ingredients:
(1) The adulteration provisions of section 402(a)(1).
Under this postmarket authority, FDA has the power to remove
a food from the market (or sanction those marketing the food)
if the food poses a risk to public health. It is important
to note that the FD&C Act places a legal duty on developers
to ensure that the foods they market to consumers are safe
and comply with all legal requirements.
(2) The food additive provisions (section 409). Under
this section, a substance that is intentionally added to food
is a food additive, unless the substance is generally recognized
as safe (GRAS) or is otherwise exempt (e.g., a pesticide,
the safety of which is overseen by EPA).
The FD&C Act requires premarket approval of any food
additive -- regardless of the technique used to add it to
food. Thus, substances introduced into food are either (1)
new food additives that require premarket approval by FDA
or (2) GRAS, and are exempt from the requirement for premarket
review (for example, if there is a long history of safe use
in food). Generally, foods such as fruits, vegetables, and
grains, are not subject to premarket approval because they
have been safely consumed over many years. Other than the
food additive system, there are no premarket approval requirements
for foods generally.
In 1992, knowing that bioengineered products were on the
horizon, FDA published a policy explaining how existing legal
requirements would apply to products developed using the tools
of biotechnology (57 FR 22984; May 29,1992; "Statement
of Policy: Foods Derived from New Plant Varieties").
The 1992 policy was designed to answer developers’ questions
about these products prior to marketing to assist them in
meeting their legal duty to provide safe and wholesome foods
to consumers. The basic principle of the 1992 policy is that
the traits and characteristics of the foods should be the
focus of safety assessment for all new varieties of food crops,
no matter which techniques are used to develop them.
Under FDA policy, a substance that would be a food additive
if it were added during traditional food
manufacturing is also treated as a food additive if it is
introduced into food through bioengineering of a food crop.
Our authority under section 409 permits us to require premarket
approval of any food additive and thus, to require premarket
review of any substance intentionally introduced via bioengineering
that is not generally recognized as safe.
Generally, substances intentionally introduced into food
that would be reviewed as food additives include those that
have unusual chemical functions, have unknown toxicity, or
would be new major dietary components of the food. For example,
a novel sweetener bioengineered into food would likely require
premarket approval. In our experience with bioengineered food
to date, however, we have reviewed only one substance under
the food additive provisions, an enzyme produced by an antibiotic
resistance gene, and we approved that one. In general, substances
intentionally added to food via biotechnology to date have
been well-characterized proteins and fats, and are functionally
very similar to other proteins and fats that are commonly
and safely consumed in the diet and thus are presumptively
generally recognized as safe.
In 1994, for the first bioengineered product planned for
introduction into the market, FDA moved deliberately, following
the 1992 policy. We conducted a comprehensive scientific review
of Calgene's data on the Flavr SavrTM tomato and the use of
the kanamycin resistance marker gene. FDA also held a public
meeting of our Food Advisory Committee (the Committee) to
examine applicability of the 1992 policy to products such
as the Flavr SavrTM tomato. The Committee members agreed with
FDA that the scientific approach presented in the 1992 policy
was sound and that questions regarding the Flavr SavrTM had
been addressed. The Committee members also suggested that
we remove unnecessary reviews to provide an expedited decision
process on the marketing of bioengineered foods that do not
raise substantive scientific issues.
In response, that same year, FDA established a consultative
process to help companies comply with the FD&C Act’s requirements
for any new food, including a bioengineered food, that they
intend to market. Since that time, companies have used the
consultative process more than 45 times as they sought to
introduce genetically altered plants representing ten different
crops into the U.S. market. We are not aware of any bioengineered
food product on the market under FDA’s jurisdiction that has
not been evaluated by FDA through the current consultation
Typically, the consultation begins early in the product development
stage, before it is ready for market. Company scientists and
other officials will meet with FDA scientists to describe
the product they are developing. In response, the Agency advises
the company on what tests would be appropriate for the company
to assess the safety of the new food.
After the studies are completed, the
data and information on the safety and nutritional assessment
are provided voluntarily to FDA for review. The Agency evaluates
the information for all of the known hazards and also for
potential unintended effects on plant composition and nutritional
properties, since plants may undergo changes other than those
intended by the breeders. Specifically, FDA scientists are
looking to assure that the newly expressed compounds are safe
for food consumption, there are no allergens new to the food,
no increased levels of natural toxicants, and no reduction
of important nutrients. They are also looking to see whether
the food has been changed in any substantive way such that
the food would need to be specially labeled to reveal the
nature of the change to consumers.
Some examples of the information reviewed by FDA includes:
- The name of the food and the crop from which it is derived;
- The uses of the food, including both human food and animal
- The sources, identities, and functions of introduced genetic
material and its stability in the plant;
- The purpose or intended technical effect of the modification
and its expected effect on the composition or characteristic
properties of the food or feed;
- The identity and function of any new products encoded
by the introduced genetic material, including an estimate
of its concentration;
- Comparison of the composition or characteristics of the
bioengineered food to that of food derived from the parental
variety or other commonly consumed varieties with special
emphasis on important nutrients, anti-nutrients, and toxicants
that occur naturally in the food;
- Information on whether the genetic modification altered
the potential for the bioengineered food to induce an allergic
- Other information relevant to the safety and nutritional
assessment of the bioengineered food.
It should be noted that if a plant developer used a gene
from a plant whose food is commonly allergenic, FDA would
presume that the modified food may be allergenic unless the
developer could demonstrate that the food would not cause
allergic reactions in people allergic to food from the source
If FDA scientists have more questions about the safety data,
the company either provides more detailed answers or conducts
additional studies. Our experience has been that no bioengineered
product has gone on the market until FDA’s questions about
the product have been answered.
Labeling, either mandatory or voluntary, of bioengineered
foods is a controversial issue. Section 403 of the FD&C
Act sets labeling requirements for all foods. All foods, whether
derived using bioengineering or not, are subject to these
Under section 403(a)(1) of the FD&C Act, a food is misbranded
if its labeling is false or misleading in any particular.
Section 201(n) of the FD&C Act provides additional guidance
on how labeling may be misleading. It states that labeling
is misleading if it fails to reveal all facts that are "material
in light of such representations (made or suggested in the
labeling) or material with respect to consequences which may
result from the use of the article to which the labeling or
advertising relates under the conditions of use prescribed
in the labeling or advertising thereof or under such conditions
of use as are customary or usual."
While the legislative history of section 201(n) contains
little discussion of the word "material", there is precedent
to guide the Agency in its decision regarding whether information
on a food is in fact material within the meaning of 201(n).
Historically, the Agency has generally limited the scope of
the materiality concept to information about the attributes
of the food itself. FDA has required special labeling on the
basis of it being "material" information in cases where the
absence of such information may: 1) pose special health or
environmental risks (e.g., warning statement on certain protein
diet products); 2) mislead the consumer in light of other
statements made on the label (e.g., requirement for quantitative
nutrient information when certain nutrient content claims
are made about a product); or 3) in cases where a consumer
may assume that a food, because of its similarity to another
food, has nutritional, organoleptic, or functional characteristics
of the food it resembles when in fact it does not (e.g., reduced
fat margarine not suitable for frying).
FDA does not require labeling to indicate whether or not
a food or food ingredient is a bioengineered product, just
as it does not require labeling to indicate which breeding
technique was used in developing a food plant. Rather, any
significant differences in the food itself have to be disclosed
in labeling. If genetic modifications do materially change
the composition of a food product, these changes must be reflected
in the food’s labeling. This would include its nutritional
content, (for example, more folic acid or greater iron content)
or requirements for storage, preparation, or cooking, which
might impact the food's safety characteristics or nutritional
qualities. For example, one soybean variety was modified to
alter the levels of oleic acid in the beans; because the oil
from this soybean is significantly different when compared
to conventional soybean oil, we advised the company to adopt
a new name for that oil, a name that reflects the intended
If a bioengineered food were to contain an allergen not previously
found in that food, information about the presence of the
allergen would be material as to the potential consequences
of consumption of the food. If FDA determined that labeling
would be sufficient to enable the food to be safely marketed,
the Agency would require that the food be labeled to indicate
the presence of the allergen.
FDA has received comments suggesting that foods developed
through modern biotechnology should bear a label informing
consumers that the food was produced using bioengineering.
While we have given careful consideration to these comments,
we do not have data or other information that would form a
basis for concluding under the FD&C Act that the fact
that a food or its ingredients was produced using bioengineering
is material within the meaning of 201(n) and thus, is a fact
that must be disclosed in labeling. Hence, we believe that
we have neither a scientific nor legal basis to require such
labeling. We are developing, however, draft guidance for those
that wish voluntarily to label either the presence or absence
of bioengeneered food in food products.
Although FDA is confident that its current science-based
approach to regulating bioengineered foods is protecting the
public health, we realized we had been quietly looking at
and reviewing these products and making decisions related
to their safety while the public was largely unaware of what
we were doing. When trade issues erupted last summer with
Europe--and in the World Trade Organization meetings in Seattle—it
raised public concern that there might be safety issues with
New technologies typically raise complex questions – scientific,
policy, and even ethical. In light of the newness of this
technology and the apparent concern, FDA held the three public
meetings I previously mentioned. The public meetings had three
purposes: to determine whether there were any new scientific
or labeling issues that the Agency should consider; to help
the public understand FDA's current policy and become familiar
with what we are already doing; and to explore the ways in
which information on bioengineered foods could be most appropriately
and helpfully conveyed.
FDA asked specific questions on both scientific and safety
issues as well as about public information issues. We heard
from 35 panelists and over 250 additional speakers in the
three meetings. More than 50,000 written comments have been
What did we learn at these meetings?
First and foremost, no information was presented that indicates
there is a safety problem with any bioengineereed food or
feed now in the marketplace.
In general, we heard support for strengthening FDA’s premarket
review process for bioengineered foods, in varying degrees.
Views on labeling were very strong and much more polarized.
Overall, we heard from many points of view that FDA needs
to take additional steps to increase consumer confidence in
As to specific concerns, there were four basic points of
1) One group was concerned primarily with anything that
could possibly harm the environment, with food safety
being a secondary concern.
2) A second group was concerned about the possibility
that there might be unknown long-term food safety problems,
despite the absence of any scientific information that
would support the existence of such problems.
3) A third group said they were not so concerned about
food safety – they would eat bioengineered foods – but
still wanted to know what technologies and ingredients
were involved in producing their food.
4) A fourth group speaking for developing countries,
said they need this technology and do not want it limited
or taken away.
As I mentioned, FDA announced on May 3, as part of an Administration
initiative, that we will be taking steps to strengthen the
premarket notification program for bioengineered foods. We
also intend to provide guidance to food manufacturers who
wish voluntarily to label their products regarding whether
or not they contain bioengineered ingredients. Our goal is
to enhance public confidence in the way in which FDA is regulating
bioengineered foods. We want the public to know, loud and
clear, that FDA stands behind the safety of these products.
As part of this initiative, we will be proposing regulations
to make it mandatory that developers of bioengineered plant
varieties notify FDA at least 120 days before they intend
to market such products. FDA will require that specific information
be submitted to help determine whether the foods pose any
safety or labeling concerns. The Agency will be providing
further guidance to industry on the scientific data needed
to ensure that foods developed through bioengineering are
safe for human consumption. To help make the process more
transparent, the Agency has made a commitment to ensuring
that, consistent with information disclosure laws, consumers
have access to information submitted to FDA as part of the
notification process and to FDA’s responses in a timely fashion.
The proposed rule on premarket notification and the draft
labeling guidance are both high priorities for the Agency,
and we intend to publish each of these later this fall. Both
will provide a full opportunity for public comment before
final policies are established. Let me assure you that when
we come to a decision regarding these matters, FDA will operate
in an open, transparent manner so that the public can understand
our regulatory approach and continue to provide us with feedback
about its impact. As a scientific organization we are comfortable
with debate over complex scientific issues, and welcome the
discussions that have occurred at public meetings to date.
It is important that the public, including the scientific
community, clearly understand FDA's policy on bioengineered
Before closing, let me briefly describe a few other activities
of Agency involvement in the food biotechnology subject area.
In our May 3 announcement FDA stated our intention to augment
our food and veterinary medicine advisory committees by adding
scientists with agricultural biotechnology expertise. FDA
will use these committees to address over- arching scientific
questions pertaining to bioengineered foods and animal feed.
More specifically, I am restructuring the Food Advisory Committee
so that it will contain several special focus subcommittees.
One of those subcommittees will have scientists with expertise
in bioengineering, and will focus on issues pertaining to
As I am sure you are aware, the National Academy of Sciences
has formed a new standing Committee on Agricultural Biotechnology.
FDA has participated in several of its meetings, including
one just last week, on September 18, in which two FDA experts
made presentations. We think the work of this committee is
very important. We are formalizing our relationship with it,
particularly with regard to exploring what the potential is
for any unknown long term health effects to result from consumption
of bioengineered food.
FDA is actively participating in the work of the U. S. Codex
Committee on food labeling, which is considering issues on
policies for possible labeling of foods derived using bioengineering.
In addition FDA is participating in the newly formed Ad Hoc
Committee on Foods Derived from Biotechnology. This committee
is especially important because its initial focus is to develop
principles and guidelines for the evaluation of the safety
of bioengineered foods. FDA is providing an international
leadership role in this committee to develop harmonized policies
for assessing the safety of bioengineered food.
There have been recent allegations of the improper use of
a genetically engineered corn approved for use by EPA as a
pesticide, but only as animal feed. FDA has taken the allegations
seriously and immediately initiated a vigorous investigation.
Based on additional testing, on Friday, September 22, Kraft
decided to recall the product.
Mr. Chairman, thank you again for the opportunity to address
these issues. I am happy to answer any questions you might
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