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9/26/00 HEARING

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 Act.

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 process.

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 feed uses;
  • 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 response; and,
  • 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 plant.

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 labeling requirements.

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 change.

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.

Public Outreach

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 these foods.

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 submitted.

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 these products.

As to specific concerns, there were four basic points of view:

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.

New Initiatives

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 foods.

Additional Activities

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 food biotechnology.

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 have.

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