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Jane E. Henney, M.D. - Kansas State University

"This text contains Dr. Henney's prepared remarks. It should be used with the understanding that some material may have been added or deleted during actual delivery."

Remarks by:
Jane E. Henney, M.D.
Commissioner of Food and Drugs
U.S. Food and Drug Administration
for

Food Safety and Biotechnology: Are They Related?

Kansas State University

March 10, 2000

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The challenges facing us in the food safety arena are many. We have a much more varied food supply--we are eating different kinds of foods-from not only domestic sources-but from all over the world. We are preparing less food at home--eating more ready-to-eat foods when we do eat at home--and eating more meals in restaurants. A higher percentage of people are being fed in institutional settings. And, as you are aware, an increasing number of food-borne pathogens such as Salmonella and E. coli 0157-H7, as well as pesticides and additives create ever-increasing challenges to keep our bountiful and varied food supply safe.

But I want to use my time with you this morning, not talking about obvious food safety issues, but about a matter that some say poses safety concerns and see at the end of the hour whether you think so.

Advances in technology are being applied to change the production and characteristics of our food supply. The tools of modern biotechnology are contributing significantly to this change. As we all know, there has been and will continue to be keen interest, and in some quarters grave concern, regarding bioengineered foods, not just in this country but around the world. These concerns are many and varied--not only regarding the safety of food, but also the safety of the environment.

Foods modified using the tools of biotechnology or "genetically engineered," are crops that have been altered by the insertion of a single gene or multiple genes, to achieve a specific genetic and phenotypic change. Clearly, most agricultural crops and animals raised for food production have been genetically modified over the years--through hybridization or other breeding programs--to make them grow faster, taste better, resist drought and insects, have better nutrition, lower fat, etc. This has been going on for thousands of years through natural selection, and for more than a hundred years through the focused efforts of scientists and farmers who continually seek improvements in terms of nutrition and economic benefit.

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 hybridization in which two related plants were cross-fertilized and the resulting offspring had characteristics of both parent plants. Breeders then selected and reproduced the offspring that had the desired traits.

For more than a century, plant breeders have introduced thousands of genes resulting in hybrids as they developed new varieties of plants, and even created whole new foods, such as the broccoflower (a broccoli and cauliflower cross).

Clearly, these complex gene transfers may convey characteristics that are both desirable-for example, resistance to a pest--and undesirable-such as increased levels of toxins or anti-nutrients. It often takes crop developers several years of analytical studies, continued breeding, and test planting to make sure the new plants have the desired characteristics and are safe.

But 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. In today's debate about the merits or drawbacks of bioengineered foods it is important to keep in mind that this level of control actually decreases the likelihood that unidentified, and possibly detrimental, molecules will be introduced into the plant.

In the event that something unexpected does occur, the testing that developers generally conduct should identify a problem long before the product goes on the market. While foods are complex combinations of many different kinds of chemicals, a great deal is known about their makeup and the possible problems that could arise from the genes and proteins introduced by either traditional or recombinant DNA techniques.

Most genetic modifications make it easier to grow the crop. For example, about half of the American soybean crop planted in 1999 carried a gene that makes it resistant to an herbicide used to control weeds. About a quarter of U.S. corn planted last year carried a gene that produces a protein toxic to caterpillars, reducing the need for certain conventional pesticides.

Crop plants, which contain large quantities of protein and deoxyribonucleic acid, are safely consumed. The small amounts of genetic material introduced through biotechnology, and the resulting proteins, are unlikely to dramatically change that safety profile. But if problems did arise, they would most likely fall into one of three broad categories: allergens, toxins, or anti-nutrients.

As you are well aware, foods normally contain many thousands of types of proteins. While the majority of proteins do not cause allergic reactions, all known human allergens are proteins. The most common allergy-causing foods are 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 an allergen into the food supply.

We actually know quite a bit about the characteristics of allergy-causing proteins. They are small, with a molecular weight of between 10 and 70 kiloDaltons. They are stable molecules that resist destruction during processing, cooking, and digestion; and they include unique epitopes that can stimulate the immune system, inducing the production of IgE in the blood.

If a plant developer used a gene from an allergy-causing plant, FDA would presume that the modified food had become allergenic and would carefully evaluate the developer's determination of the safety of the modified food. To date, all proteins added to foods through genetic engineering are easily digested or destroyed during processing and have been shown to lack similarity to known allergens.

The second possible problem is the introduction of toxins into the food crop. It is possible that a new protein--or a change in a protein--as a result of the genetic modification, could cause toxicity.

A third possible issue is the creation of anti-nutrients, such as molecules that inhibit digestive enzymes like trypsin, or that cause alterations in the nutrients normally found in a food--for example, a reduction of Vitamin C in tomatoes.

All of these potential problems can be readily identified by the kinds of testing typically conducted by developers of a new food crop. Since FDA's 1994 evaluation of the Flavr Savr tomato, the first genetically-engineered food to reach the U.S. market, FDA has reviewed the data on more than 45 other products ranging from herbicide resistant soybeans to corn that incorporates a bacterial gene to protect it from insects. To date, there is no evidence that these plants are significantly different in terms of constituents or food safety from crops produced through traditional breeding techniques.

There was a commentary recently published in Nature that challenged the concept of the similarity between traditional and biotechnology-derived plants--a concept called substantial equivalence in Europe. Although FDA uses the concept of substantial equivalence in the evaluation of genetically modified plants, this concept is a starting point in the agency's safety evaluation but is generally not determinative. It may seem logical to argue that since genes merely code for proteins and proteins are a normal constituent of foods, then proteins introduced through genetic engineering that are similar to proteins already in the food supply and generally safe could themselves be considered safe. But we take a slightly different approach.

Since analyzing its policy regarding foods developed using the tools of modern biotechnology, FDA has always maintained that decisions related to these foods must be grounded in science-a language that crosses all borders. The FDA's position is that foods developed using these techniques should be regulated on the basis of safety, not the method by which they were developed.

In 1992, knowing that bioengineered products were on the horizon, FDA published a policy explaining how existing legal requirements for food safety apply to products developed using the tools of biotechnology. It is our responsibility to ensure the safety of all foods on the market that come from crops, including bioengineered plants, through a science-based decision-making process. This process includes public comment from consumers, outside experts and the industry.

In 1994, after such a public discussion on genetically engineered foods, FDA established a consultative process under the Food, Drug and Cosmetic Act, our principal authorizing legislation, to help companies comply with the Act's requirements for any new food, including bioengineered food, that they would like to introduce into the market. Under the Act, FDA can remove any food from the market that fails to comply with the law. Since that time, companies have used the consultative process more than 45 times as they sought to introduce genetically altered plants in the U.S. market.

Typically, the consultation begins when a company develops a new plant that it expects to market in two to three years. Company scientists and other officials will meet with our scientists at FDA 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. FDA also asks developers to evaluate the stability of the inserted genetic material.

After the studies are completed, companies provide summaries of all the safety and nutritional assessments to FDA for review. The agency evaluates the information for all of the known hazards and also for the unexpected, since plants do undergo changes other than those intended by the breeders.

If our scientists have more questions, 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 all of FDA's questions about the product have been answered.

Labeling, either mandatory or voluntary, of bioengineered foods is a controversial issue. FDA's governing law does set labeling requirements for all foods. The law stipulates that when labeling is complete, the information on a label must be truthful and not misleading. The food label must carry information that is material and should reflect a significant change in composition of the food, and a food must be declared by its common or usual name. All foods, whether derived using biotechnology or not, are subject to these labeling requirements.

If genetic modifications do significantly change the composition of a food product-including its nutritional content, for example, more folic acid or greater iron content; requirements for storage, preparation, or cooking, which might impact the food's safety characteristics or nutritional qualities-- these changes should be listed on the food's label. For example, one biotech version of the soybean was engineered to alter the levels of oleic acid and because the oil from that soybean is significantly different, we advised the company to adopt a new name for that oil, a name that reflects the intended change.

To summarize...in our regulatory process, we may start with the question of whether a bioengineered food is substantially equivalent to a traditionally produced food. That question may be used to help decide what tests are needed to evaluate the product. FDA's evaluation determines whether the modified food, given its characteristics, is safe and wholesome. Again, of the more than 45 products evaluated so far, there is no evidence to suggest that the foods modified by genetic engineering that are now on the market are unsafe.

Although FDA is confident that its current science-based approach to regulating biotech 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 WTO meetings in Seattle-it raised public awareness that there might be safety issues with these foods.

Because new technologies typically raise complex questions, and because of public concern, FDA held three public meetings over the past several months about genetically engineered foods. The meetings were intended to help the public understand FDA's current policy and become familiar with what we were already doing, determine whether there are new scientific issues the agency should consider, and explore the ways in which information on biotech foods could be most appropriately and helpfully conveyed.

What did we hear at these meetings?

The messages were largely divided into two distinct areas. First and foremost, there was not any current science presented that would call into question any decisions that have been made, or that would affect decisions made in the foreseeable future regarding these products.

The second major issue had to do with how the general public views biotechnology-derived foods. Here there were four basic points of view. First, there were individuals who did not resonate with the food safety issues, but didn't want anything that might harm the environment. Second, there was a group that could not document any current food safety issues, but were concerned about the long-term effects on people. Third, there were those individuals who will eat biotech foods-they don't think there are any safety issues-but... "We're Americans, and we like information. Just tell us whether the foods we are eating are genetically engineered or not." Finally, the fourth perspective was that developing countries need this technology, both for the health of their people, and for their countries' economic health.

What we will do?

Let me assure 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 the FDA's policy on genetically altered foods.

An additional lesson we can learn from the debate and dialogue in this area is that we have not been active enough in making sure our nation has an appreciation for science, as we do for the arts, for example. Scientists have become elite in what they know and with whom they communicate. So when topics like biotechnology arise, an appreciation for what scientists are saying may not resonate well with a public that has been left out of the debate and doesn't appreciate the scientific underpinnings going into these decisions.

This is very reminiscent of the book, "Two Cultures," by C.P. Snow, which called for a bridge across languages and understanding to break down barriers that arise between cultures when we fail to communicate and understand each other.

This debate creates a teachable moment for those of us in science. We must be bridge builders to move the science forward. We must listen...learn...and be able to teach.

The message I would like to leave you with today is that our experience thus far demonstrates that--in terms of food safety-the genetically engineered foods currently on the market are not significantly different from traditionally bred foods. We have not seen any unexpected safety risks from the foods currently on the market. However, we do know that as the science becomes increasingly complex, we need to be prepared to meet these emerging challenges.

Before I close I would like to spend a moment on a topic I discussed last evening. Since I became the Commissioner of FDA one of my highest priorities has been to enhance the science infrastructure of FDA. This goal is critical to the success of meeting all the other challenges we will be faced with in the future.

To keep pace with the rapidly changing technology we are seeing in virtually every area we regulate, our scientific capability must be current and flexible. This requires recruiting and retaining the best scientists-and by scientists I am referring to research scientists, reviewers, and our field investigators. In fact, we depend on institutions like KSU to train and inspire the next generation of scientists, planners, communicators, administrators, and others to preserve the FDA's world leadership role. I invite your participation in what we do--your comments to dockets or at future meetings; your role on advisory committees, and yes...consider us when you think about your own career. There is no better place to feel that your intellect will be stimulated and your work meaningful. This country provides us many opportunities and privileges--payment for those privileges can come from taxes, but it can also come with service.

Thank you for the opportunity to be here today.