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 new plant varieties, including genetically engineered
varieties. I am Dr. James Maryanski, Biotechnology Coordinator, in FDAs Center for
Food Safety and Applied Nutrition (CFSAN).
FDA believes it is very important for the public to understand how government is
overseeing the new foods being introduced into the marketplace and to have confidence in
that process. To that end the Agency appreciates this opportunity to describe its
processes and procedures to the Committee and to the public, and to clarify what
bioengineered food products are and how FDA regulates them.
For almost two decades FDA has been studying genetic modification techniques for
drug-biologic development, as well as the development of new foods, and the Agency has
carefully developed policies to accommodate the changing and evolving world of
biotechnology. The evidence shows that we are meeting our goal of ensuring that these new
products meet the same safety standards as traditional foods.
Mr. Chairman, you asked us to describe our legal authority and the regulatory
procedures that industry follows to market a bioengineered food product. Before addressing
those topics specifically, I would like to provide some background on food biotechnology.
First, let me explain what we mean when we refer to food biotechnology or genetically
engineered foods. 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. Food products produced through modern methods of biotechnology
such as recombinant DNA techniques and cell fusion are emerging from research and
development into the marketplace. It is these products that many people refer to as
"genetically engineered foods." The European Commission refers to these foods as
Genetically Modified Organisms. The United States
uses the term genetic modification to
refer to all forms of breeding, both modern, i.e. genetic engineering, and conventional.
The new gene splicing techniques are being used to achieve many of the same goals and
improvements that plant breeders have sought through conventional methods. Todays
techniques are different from their predecessors in two significant ways. First, they can
be used with greater precision and allow for more complete characterization and,
therefore, greater predictability about the qualities of the new variety. These techniques
give scientists the ability to isolate genes and to introduce new traits into foods
without simultaneously introducing many other undesirable traits, as may occur with
traditional breeding. This is an important improvement over traditional breeding.
Second, todays techniques give breeders the power to cross biological boundaries
that could not be crossed by traditional breeding. For example, they enable the transfer
of traits from bacteria or animals into plants.
In conducting its safety evaluations of genetically engineered foods, FDA considers not
only the final product but also the techniques used to create it. Although study of the
final product ultimately holds the answer to whether or not a product is safe to eat,
knowing the techniques used to create the product helps in understanding what questions to
ask in reviewing the products safety. That is the way FDA regulates both traditional
food products and products derived through biotechnology.
Turning now to your first question on FDAs legal authority over genetically
engineered foods, FDA has authority under the Federal Food, Drug, and Cosmetic (FD&C
or the Act) 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 the United States
Department of Agriculture (USDA). Pesticides are regulated
primarily by the Environmental Protection Agency (EPA), which reviews safety and sets
tolerances (or establishes exemptions from tolerance) for pesticides. FDA monitors foods
to enforce the tolerances set by EPA for pesticides.
Bioengineered foods and food ingredients (including food additives) must adhere to the
same standards of safety under the Act that apply to their conventional 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 safety
standards of the Act.
FDA relies primarily on two sections of the Act to ensure the safety of foods and food
(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 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, substances that are
intentionally added to food are food additives, 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 because, for
example, there is a long history of safe use in food. Generally, whole foods, such as
fruits, vegetables, and grains, are not subject to premarket approval because they have
been used for food for lengthy periods of time.
Under FDA policy on foods derived from new plant varieties, a substance that would be a
food additive if it were added during traditional food manufacture is also treated as a
food additive if it is introduced into food through genetic modification of a food crop.
For example, a novel sweetener bioengineered into food would likely require premarket
approval. Generally, under Agency policy, 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.
In our experience to date, we have not seen substances of that type. The substances
intentionally added to food via biotechnology to date have been well-characterized
proteins, fats, and carbohydrates, and are functionally very similar to other proteins,
fats, and carbohydrates that are commonly and safely consumed in the diet and so will be
presumptively generally recognized as safe. Importantly, our authority under section 409
permits us to require premarket approval of any food additive and thus, to require
premarket review of any substances intentionally introduced via bioengineering that are
not generally recognized as safe.
FDAs authority under current law, both pre- and postmarket provisions, is
sufficient to ensure the safety in the marketplace of foods derived from new plant
SYSTEM OF REGULATIONS
Because FDA determined that bioengineered foods should be regulated like their
conventional counterparts, FDA has not to date established any regulations specific to
bioengineered food. In 1992 FDA published its "regulatory roadmap" policy
document, the "Statement of Policy: Foods Derived from New Plant Varieties." The
statement explains FDAs views about regulating human foods and animal feeds produced
from new plant varieties, including crops developed by the newest methods of molecular and
cell biology (such as recombinant DNA methods and somaclonal variation) and those
developed using traditional techniques. The policy focuses on the traits and
characteristics of the foods, and applies to all new varieties of food crops, no matter
which techniques are used to develop them.
This science-based policy was developed through careful consideration of new
developments in biotechnology. FDA scientists had carefully followed the developments in
research over the previous several years to determine the types of commercial foods and
food ingredients likely to be developed by recombinant DNA techniques. We also considered
scientific principles for assessing safety that had been developed and agreed upon by
several prestigious scientific groups, including the National Academy of Sciences (NAS),
the Food and Agriculture Organization (FAO), the World Health Organization (WHO), and the
Organization for Economic Cooperation and Development (OECD) in developing FDAs
In formulating FDA policy, we reviewed new foods under development through
biotechnology, and found they shared certain common characteristics: (1) Recombinant DNA
techniques are being used to introduce copies of one or a limited number of
well-characterized genes into a desired food crop. The introduced gene or genes then
become integrated in the plant and are passed to successive generations of plants by the
natural laws of genetics; (2) In most cases, these genes produce proteins, or proteins
that modify fatty acids or carbohydrates in the plant, in other words, common food
substances; (3) The proteins, fatty acids, and carbohydrates introduced into food crops
are well characterized and not known to be toxic and they would be digested to normal
metabolites in the same manner that the body handles the thousands of different proteins,
fat and carbohydrates that make up our diet today.
Since newly introduced substances in foods derived using recombinant DNA techniques
would be proteins, fats or carbohydrates, we then examined the safety questions that
should be addressed before products reach the market. We identified four broad safety
issues that should be evaluated: (1) the need to ensure that new substances, that is,
newly introduced proteins, fats, or carbohydrates are safe for consumption; (2) the need
to ensure that the changes in the food, such as the level of natural toxins in the food,
if any, stay within normal safe levels; (3) the need to ensure that significant nutrients
stay within normal range; and (4) the need to analyze the potential for introduced
proteins to cause allergic reactions. We incorporated these and other issues into a
comprehensive guidance to industry that is central to our policy.
The guidance in our policy statement provides a "standard of care" to help
plant developers ensure that the products they develop meet the safety standards of the
FD&C Act. It also provides guidance to industry on those situations in which
developers should specifically consult with FDA on issues such as labeling, design of
appropriate test protocols, and whether a food additive petition would be required.
I would like to highlight some activities that we have engaged in following publication
of our 1992 policy. In response to comments we have received regarding potential
allergenicity of foods derived from bioengineered plants, we hosted a "Conference
on Scientific Issues Related to Potential Allergenicity in Transgenic Food Crops" in
1994. We hosted this conference in cooperation with the EPA, and USDA. The goal of the
Conference was to foster a dialogue among scientists on food allergy and new
varieties of food crops developed by gene transfer to assess current information regarding
what makes a substance such as a protein a food allergen and what means are available to
assess allergenic potential. FDA has gained valuable insights on these issues from this
Also in response to comments we received to the 1992 policy, FDA sought to develop
sound scientific principles regarding the safety of the use of antibiotic resistance
marker genes in the development of bioengineered plants intended for food use so as to
provide sound scientific guidance to crop developers regarding the safe use of antibiotic
resistance marker genes. We consulted with outside experts having expertise
in relevant fields including gene transfer and antibiotic resistance. The purpose
of the consultations was to determine whether circumstances exist under which FDA should
recommend that a given antibiotic resistance gene not be used in crops intended for food
use, and if so, to delineate the nature of those circumstances. Based on these
consultations, FDA issued in September 1998, guidance on the use of antibiotic resistance
marker genes in bioengineered plants intended for food use and requested comments on that
Finally, we should point out that the 1992 policy is not static. The policy was based
on our research with respect to products that were in the development pipeline at the
time. Since the statement was developed, we have not seen any products we did not
anticipate, but it is important to point out that we are keeping abreast of new
developments in this rapidly evolving technology and will modify the policy if necessary.
GETTING A BIOTECH PRODUCT TO MARKET
Finally you asked us to describe the procedures industry follows to get a biotech food
product to market. 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 Calgenes data on the Flavr SavrTM
tomato and the use of kanamycin resistance marker gene, and 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 develop a more expedited process for FDA and the industry to reach
decisions on the marketing of other bioengineered foods that do not raise substantive
Subsequently, FDA established an informal process by which firms can inform the Agency
that they have completed a food or feed safety assessment. FDA requests that firms submit
a summary of their assessment to the Agency. It is our expectation and experience
that all firms have complied with this request for all plant varieties that have been
commercialized to date. This process has worked well to date and permits the Agency to
identify and resolve any safety or regulatory issues before products reach the market.
The goal of FDAs evaluation is to ensure that human food and animal feed safety
issues or other regulatory issues (e.g. labeling) have been addressed prior to commercial
distribution. Agency scientists evaluate the available information to determine whether
any unresolved issues exist, regarding the food variety that would necessitate legal
action by the Agency if the product were introduced into commerce. Examples of such issues
may include the potential for significantly increased levels of plant toxicants or anti-nutrients, reduction of important nutrients, new allergens, or the presence in the
food of an unapproved food additive. FDA considers a consultation to be complete when all
safety and regulatory issues are resolved. In 1994, FDA discussed this consultation
process during a joint public meeting of the Agencys Food Advisory Committee and its
Veterinary Medicine Advisory Committee. The Committee members agreed with FDA that, based
on the types of bioengineered foods and feeds under development, the consultation
procedures provide an appropriate level of government oversight.
The Agency encourages developers to consult early in the development phase of their
products, and as often as necessary. When a firm has accumulated the information that it
believes is adequate to ensure that the product complies with the relevant provisions of
the FD&C Act, the Agency recommends that the developer inform FDA about the
bioengineered foods intended to be introduced into commercial distribution by providing a
summary of the companys safety and nutritional assessment which Agency scientists
review for unresolved safety or regulatory issues.
The safety and nutritional assessment summary should normally contain sufficient
information for Agency scientists to understand the approach the firm has followed in
identifying and addressing relevant issues. Some examples of this information would
- The name of the food and the crop from which it is derived;
- The uses of the food, including both human food and animal feed uses;
- The sources, identities, and functions of introduced genetic material;
- 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
- Information on whether the genetic modification altered the potential for the
bioengineered food to induce an allergic response; and,
- Other information relevant to the safety and nutritional assessment of the bioengineered
I would like to briefly go back to one of the items I just mentioned that we consider,
and one that is a frequently raised concern about bioengineered food - - food allergens.
As we have described in our policy, foods derived from new plant varieties are
regulated by FDA under the existing framework of the FD&C Act. Labeling, by law, is
limited to identifying significant changes in a foods composition, and it must not
mislead consumers. Thus, for example, if a tomato had a soybean gene introduced into it,
labeling would be needed to alert consumers to the presence of the potential allergen,
unless it could be demonstrated scientifically that the soybean allergen was not present.
It is also possible that if the Agency concluded that labeling alone would not adequately
protect consumers, FDA would object to the marketing of the product.
Similarly, if a copy of a new gene introduced into a carrot produces a protein that
significantly changes the composition of the vegetable, the name "carrot" may no
longer accurately describe the product and a new name would be required.
In conclusion, Mr. Chairman, FDA takes seriously its mandate to protect consumers in
the United States
and to ensure that the United States
food supply continues to be
one of the safest in the world. FDAs process for evaluating bioengineered foods is
one in which the public can have confidence that food biotechnology products must meet the
laws safety standards. FDAs 1992 policy statement and our guidance documents
make clear that premarket clearance is required if there is scientific uncertainty about
the safety of food derived from bioengineered plants. The policy also makes clear that
labeling will be required if the composition of the genetically modified food differs
significantly from what is expected for that food, or if the genetically modified food
contains potential allergens.
Mr. Chairman, we are confident that our approach is appropriate. It allows us to ensure
the safety of new food products and also allow the use of safe, new biotechnology
techniques that give manufacturers the ability to produce better products and provide
consumers additional choices.
I would be happy to answer any questions the Committee may have.