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ATDEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION

BIOTECHNOLOGY IN THE YEAR 2000 AND BEYOND
PUBLIC MEETING

Tuesday, November 30, 1999


10:00 a.m.

Cohen Building

330 Independence Avenue, N.W.

Washington, D.C.



C O N T E N T S
PAGE

Welcome and Opening Remarks
Joseph A. Levitt

Director, Center for Food Safety and Applied Nutrition, FDA 9


FDA Panel
William Hubbard

Senior Associate Commissioner for Policy, Planning & Legislation


Stephen Sundlof, D.V.M., Ph.D.

Director, Center for Veterinary Medicine


Catherine Copp

Office of the Chief Counsel


L. Robert Lake

Director, Regulations and Policy, Center for

Food Safety and Applied Nutrition
James Maryanski, Ph.D.

Biotechnical Coordinator, Center for Food

Safety and Applied Nutrition
Session 1. FDA Policy: 1994 to the Present
James Maryanski, Ph.D. 19
Session 2. Scientific, Safety and Regulation Issues
Introduction
Joseph A. Levitt 40
Panel Discussion
Peter R. Day, Ph.D.

Director, Biotechnology Center for Agriculture

and Environment, Rutgers University 43
Carol Tucker Foreman

Distinguished Fellow and Director, Food Policy

Institute, Consumer Federal of America 46
Rebecca J. Goldburg, Ph.D.

Senior Scientist, Environmental Defense Fund 52



C O N T E N T S(Continued)
PAGE

Steve M. Druker, J.D.

Founder and Executive Director, Alliance for

Bio-Integrity 58


Samuel B. Lehrer, Ph.D.

Research Professor of Medicine, Adjunct Professor

of Microbiology and Immunology and Adjunct

Professor of Environment Medicine, Tulane University Medical Center 69


Terry D. Etherton, Ph.D.

Department Head and Distinguished Professor,

Department of Dairy and Animal Sciences,

The Pennsylvania State University 73


Panel Answers FDA Questions 77
***
Session 3. FDA Policy: Labeling 121
Session 4. Public Information and Labeling
L. Robert Lake

Office of Regulations and Policy, Center for

Food Safety and Applied Nutrition, FDA 123
Panel Discussion
Mario Teisl, Ph.D.

Assistant Professor, Department of Resource

Economics and Policy, University of Maine 127
Mildred M. Cody, Ph.D., R.D., L.D.

Associate Professor of Nutrition, Georgia

State University 133
Richard Caplan

Environmental Advocate, U.S. Public Interest

Research Group 137

Richard Frank

Outside Counsel to Food Distributors

International 142


Kendal Keith, Ph.D.

President, National Grain and Feed

Association 147


C O N T E N T S(Continued)
PAGE

Robert Cohen

Founder and Executive Director of America's

Dairy Education Board 151


Panel Answers FDA Questions 160
Summary Remarks
Joseph A. Levitt 193

Director, Center for Food Safety and Applied

Nutrition
***
Session 5. Scheduled Public Presentations

Joseph Mendelson

Legal Director, Center for Food Safety 196
Patricia O'Leary

Consumer 197


Dr. Jeffrey Barach

VP, Special Products, National Food

Processors Association 199
Jeff Stein

Director of Regulatory and Government Affairs

Novartis Seeds 201
Gary Goldberg

CEO, American Corn Growers Association 202


Rita Melnick

Consumer 204


Dr. Charles Santerre

Associate Professor, Department of Foods and

Nutrition, Purdue University 205
Dr. Ariane Van Buren

Director of Energy & Environmental Programs,

Interfaith Center on Corporate Responsibility 207
Charlotte Brody, R.N.

Organizing Director, Center for Health, Environment and Justice 208



C O N T E N T S(Continued)
PAGE

Elizabeth Rice-Arnold

Associate Director, Institute of Science, Technology and Public Policy 209
Dr. Thomas Hoben

Professor of Sociology and Food Science, North

Carolina State University 211
Robin Woo, Ph.D.

Deputy Director, Georgetown University Center

for Food and Nutrition Policy 212
John A. Thomas, Ph.D.

Professor Emeritus, Department of Pharmacology and Toxicology, University of Texas Health

Science Center 214
Roy Fuchs

Monsanto 215


Dr. Jim Tozzi

Chairman, Federal Focus 217


Margaret Wittenberg

Vice President of Government and Public

Affairs, Whole Foods Market, Inc. 219
Tony Anderson

First VP, American Soybean Association 220


Koari Takise,

Research Assistant, Japan Offspring Fund 222


Sandy Smith

Pennsylvania Environmental Network, Pennsylvania for Responsible Agriculture, Sludgebusters and York Greens 223


Leah Porter

Executive Director of the American Crop Protection Association's Biotechnology Committee 224


Joe Lemienx

Healthfood Store Owner 226


Steven Menchey

Manager, Science and Environment Issues,

National Cotton Council 227
Eric Johnson 229

Citizen


C O N T E N T S(Continued)
PAGE

Christy McCullum (Rodney Leonard)

Institute for Agriculture and Trade Policy, Defenders of Wildlife and CNI 230
David Abbott

Chairman, American Feedd Industry Association

Past President, Purina Mills, Inc. 231
Dr. John Haeglen

Scientist, Institute of Science Technology

and Public Policy 233
Joey Green

Intern Organic Farmer 235


Charlotte Arnold

Policy Director with the International Center for Technology Assessment 236


Dr. Michael Hansen

Research Associate, Consumer Policy Institute,

Consumer Union 237
Anne K. Vidaver, Ph.D.

Chair, Committee on Agriculture and Food

Microbiology, Professor and Chair of the

Department of Plant Pathology, University

of Nebraska 239
Andrew Jacobson

President, Natural Food Division, Hain

Food Group 240
Fred Yoder

Board Member, National Corn Growers

Association 241
Terry Medley

Dupont Nutrition and Health 243


Tim Debus

United Fresh Fruit and Vegetable Association 244


Dr. Clive James

Chairman, ISAAA, The International Service for

the Acquisition of Agribiotechnology

Applications 246




C O N T E N T S(Continued)
PAGE

Dr. Sue A. Tolin

Professor of Plant Pathology, Department of

Plant Pathology, Physiology and Weed Science,

Virginia Polytechnic Institute and State

University 247


Susan B. Davis, MS, RD

Nutrition Consulting Services 249


Robert Gray

Organic Trade Association 250

Dr. Rob Donaldson

Professor and Chair, Department of Biological

Sciences, George Washington University

American Society of Plant Physiologists 252


Dave Schmidt

Senior VP Food Safety, International Food

Information Council 253
Valerie Frances

Citize 255


William Freese

Citizen 256


Percy Wooton, M.D.

Past President, American Medical Association 258


Joachim Messing, Ph.D.

Rutgers, the State of New Jersey 260


James A. Riddle

President, Independent Organic Inspectors

Association 260
Fred Betz

Jell, Schwartz & Connolly, Inc. 262


Philip Councell, Jr.

President, Maryland Grain Producers

Association 263
Robert Hutchison

Maryland Grain Producers Utilization Board 265


Douglas P. Monro, Ph.D.

Calvert Institute for Policy Research 267



C O N T E N T S(Continued)
PAGE

John D. Graham, Ph.D.

Director and Professor, Harvard Center for

Risk Analysis 268


Hilary Melcarek

Information Coordinator, National Coalition

Against the Misuse of Pesticides 270
Ann Ferrera

Consumer 271


Mark Schonbeck, M.D.

Virginia Association for Biological Farming 272


Amory Weld

Consumer 274


Diane Beany

Organic and Ecological Advocate 275


Yang-Chu Higgins

Consumer 277


Theresa Need

Director, Farmworker Health and Safety

Institute 278
Closing Remarks
Joseph A. Levitt

Director, Center for Food Safety and Applied

Nutrition 280
P R O C E E D I N G S

Welcome and Opening Remarks

MR. LEVITT: Good morning. My name is Joseph A. Levitt. I am Director of the Center for Food Safety and Applied Nutrition here, at the Food and Drug Administration. It is my pleasure both to be hosting and chairing this meeting, and to be welcoming all of you here today.

This, as you all know, is the second of three public meetings on foods produced by utilizing the tools of modern biotechnology, sometimes called genetic engineering or bioengineering.

As FDA Commissioner, Jane Henney, noted at the Chicago meeting, we knew there would be keen interest in this issue but, to be honest, we really did not anticipate it quite at this level, which explains our need to obtain a facility with a larger seating capacity. I apologize for the inconvenience this change may have caused, but I think if it means we can all be together in the same room it will be well worth it. We tried diligently to contact everybody directly that had signed up for the meeting, either by telephone, by e-mail or by fax, and we hope that we were able to reach everybody. We also have people posted at the other people, if people do go to the wrong place, and we will welcome them here later.

As I mentioned, today's meeting is the second of three public meetings that FDA has planned on this topic. The first public meeting was held a little more than a week ago, on November 18th, in Chicago, Illinois. That meeting included 11 panelists representing diverse viewpoints, 84 scheduled speakers and 96 press representatives. There is clearly a lot of interest. More than 300 individuals also observed the meeting at the overflow room and, happily, here we have a larger room so we don't have the need for an overflow room here. The third meeting will be held in Oakland, California on December 13th.

By way of introduction, and to ensure consistency between the three FDA public meetings, my opening remarks will mirror those very closely that were provided by Commissioner Henney in Chicago. As she did, I would like to take a moment to stress that we, at the Food and Drug Administration, are very pleased to have this opportunity to share our experience with you and to listen to your views on these very important subjects.

We recognize that there is not only a great deal of interest in this topic, but also that there are widely differing and, admittedly, very strongly held views on the subject of biotechnology. While, at FDA, we wish to listen to everyone, we also ask that we all listen to each other so that the community at large can gain a better understanding of the spectrum of use, and I know that actually in this room I chaired a number of public meetings and have really come to really see the value -- as I usually say at the beginning, "I'll make a deal: I'll listen to each of you if you all listen to each other" -- and I have found that that really has helped a lot in terms of sometimes bridging the views and gaining a better understanding across the board, and I look forward to that pattern continuing today.

Now, FDA has a long history of public health protection, as you all know. Our current law dates to the early part of the century. Over the years, we have faced many new developments that affect the food supply. For example, in the 1950s the use of preservatives and other chemicals in food led to concerns of our food safety. More recently, FDA has been in the forefront of efforts, as part of the President's Food Safety Initiative, to reduce food-borne illness.

Throughout its history, the Food and Drug Administration has based its regulatory decisions on sound science with protection of the public health as our foremost criterion. This is central to FDA's mission and tradition, a tradition that continues with FDA's oversight of products developed using modern biotechnology.

Now, let me briefly describe our efforts in the area of biotechnology, and after I have finished Dr. Jim Maryanski will speak much more extensively to this. In 1982, FDA approved a new insulin product, the first consumer product developed using modern biotechnology. Since that time the agency has had extensive experience in evaluating the safety of products developed using this new technology. The use of the tools of biotechnology in foods began in the mid-1980s.

FDA completed its review of the safety of chymosin or rennet preparation, the milk clotting enzyme used to make cheese, in 1990. At that time, FDA received no public comments about the safety of this ingredient. Recently, however, the use of the tools of modern biotechnology to produce new varieties of food crops has raised a number of questions about the environmental effects of these crops and about the safety and labeling of foods derived from them.

I should note that some questions, such as those regarding human health and food safety and feed safety, as well as food labeling, fall direction under FDA's authority. However, others such as those regarding environmental safety and the effects on the plants themselves, generally fall under the authority of other agencies or departments of the U.S. government, such as the Environmental Protection Agency or the U.S. Department of Agriculture. Suffice it to say, today we will be focusing on those issues that fall under FDA's jurisdiction.

I would like to take this opportunity to briefly explain how FDA oversees the safety of foods developed using the tools of biotechnology, and to briefly share the experience that we have had in evaluating the safety of these foods over the past five years since the first such whole food, the Flavr Savr tomato, entered the market.

FDA introduced our current policy for regulating foods developed using the tools of biotechnology back in 1992, after an extensive scientific review. The policy was discussed publicly during a joint meeting of FDA's Food Advisory Committee and Veterinary Medicine Advisory Committee in 1994. Since that time, firms have completed food safety discussions with FDA involving over 40 consultations on new varieties of foods made using the tools of biotechnology.

Now, as Dr. Henney articulated clearly at the Chicago meeting, we believe that our policies and processes in this area are well-grounded in science, and that we have an excellent track record in applying our policy. We believe that our oversight has been substantive, credible and appropriate. We have now had five years of experience with our consultation process. In a few minutes you will hear more from FDA about the specifics of our experience, the testing that has been performed by developers of new varieties, the kinds of information that have been reviewed by the agency, and the regulatory and scientific grounding for our approach to oversight of these products.

It is our goal to have our review and regulatory processes be as open and transparent as possible. We seek each of your views about whether we need to consider making adjustments to our current system in order to attain those goals.

Now, because of the recent attention that has arisen, we feel it is a very appropriate time to review our experience and solicit views from a variety of interested parties. We want to hear your suggestions on how we might improve our approach to safety assessment as well as how disclosure of information to the public would be best achieved.

Now, let me take a moment to briefly explain the format and logistics for today's meeting. This morning we will focus on issues concerning the safety assessment of these foods and FDA's regulatory oversight of them. There will be a brief overview of our current approach to safety assessment and the experience that FDA has had over the last five years, and FDA representatives will provide that. We will then ask our invited panelists to discuss issues related to questions that we believe will help FDA evaluate its current approach to safety assessment. So, we have both a presentation of what we have been doing as well as views from others on how we have been doing and ways we might improve and strengthen the system.

This afternoon the focus will shift to issues surrounding disclosure of information to the public. Again, a brief presentation will be provided by FDA, followed by a panel discussion. Finally, we have reserved nearly three hours later this afternoon to hear the views of as many members of the audience that signed up ahead of time as we possibly can. However, due to certain time restraints we do need to conclude our meeting promptly at seven o'clock p.m. Because we want to ensure that everyone is able to present his or her views, we are asking that all those presentations be limited to two minutes. Again, we did this in Chicago and actually the system really works.

When you checked in this morning, all of those that are presenting this afternoon, you all should have received a folder with a number on it. That number indicates the order in which public presentations will be made, and we will go through the logistics of that this afternoon on exactly how to go about doing that.

Now, because we have limited time for public comment at the microphone, I would like to remind everyone here that we also welcome written comments. We have established a public docket that will display all the information that the agency has received from all its public meetings. The FDA home page highlights these public meetings and provides the latest registration information, as well as easy access to reviewing pertinent information and submitting comments directly through the Internet. As many of you know, and hopefully all of you will know when you leave today, the FDA home page is very simple: www.FDA.gov. We are also transcribing the three public meetings on this topic. The transcription of each meeting will be made available in the docket and on the Internet as quickly as possible, and our goal is to do that within 15 working days of each meeting. Information about how to access the public docket and submit comments is in your registration packet which you should have received on the way in, if not, you can get one at the break, as well as on the FDA Internet home page that I already referenced.

Finally, just before we begin, I would like to extend a special thank you in advance to the members of both our panels for agreeing to come and share their views with us, with you and with each other. We have attempted to assemble panels with members who represent the spectrum of interested parties. Each, no doubt, has strongly held views and useful information for all of us to consider. We have relied in large part on umbrella organizations, including consumer organizations, professional societies and trade groups, to represent their members or to identify for us panelists for this and future meetings, and for their cooperation we thank them. We trust that the members of the panels will express a diversity of views, explaining those views and establishing a dialogue among the panelists to ensure that the issues are fully disclosed.

I would also like to add my thanks, along with those of Commissioner Henney, to all of the FDA staff who have devoted a great deal of time and energy to making today's meeting possible. That includes our staff at FDA headquarters and, in particular, our employees in the Office of Consumer Affairs, as well as our field staff, especially those from the FDA Chicago district as well as the Baltimore district offices. Their flexibility regarding the many logistical challenges raised by today's meeting are certainly greatly appreciated. Also, as I mentioned before, I have held several meetings in this room and I can tell you, it has never looked better.

FDA is primarily here, again, to listen and to answer questions. Our goal is not to reach a conclusion by the end of the day. We are engaged in the process of listening, not pronouncing. Therefore, we will not engage in debate on these issues primarily because we want to hear the views of others.

I would also note that FDA is in litigation over this policy, and we need to be respectful of the court decision-making process as well.

Today's discussion and those that will follow will no doubt stimulate our thinking. I welcome your individual input and our collective working together. Again, thank you very much for your attention during these introductory remarks.

Let me now take a moment to introduce my colleagues on the FDA panel. On my right is Mr. William Hubbard, Senior Associate Commissioner for Policy, Planning and Legislation in the Office of the Commissioner. To his right is Dr. Stephen Sundlof, Direct or of our Center for Veterinary Medicine. To his right is Miss Catherine Copp, senior lawyer in our Office of Chief Counsel. At the far end of the table is Dr. James Maryanski, the Biotechnology Coordinator in my Center, the Center for Food Safety and Applied Nutrition at the FDA. To my immediate left is Mr. Robert Lake who is Director of the Office of Regulations and Policy in that same center, the Center for Food Safety and Applied Nutrition.

Now, since you have certainly heard more than enough from me, I would like to turn to the substantive part of the program and to Jim Maryanski who, as I said, is the Biotechnology Coordinator in my center. Jim will provide, as I mentioned, an overview of really what FDA's policy is and how we have gone about applying that policy, the kind of testing that companies are doing, and how we have gone through the whole safety assessment process. It is my pleasure to introduce Jim Maryanski.



FDA Policy: 1994 to the Present

James Maryanski, Ph.D.

DR. MARYANSKI: Thank you, Mr. Levitt. Good morning, ladies and gentlemen.

This morning I will give you a very brief overview of FDA's role in protecting public health and its role in assuring the safety of foods produced through modern biotechnology. I will give you a broad-brush picture of the policy and approach that we have in place for assuring the safety of these products, and give you a sense of the kind of testing that is being done for food safety for these products. I will also share with you some of the experience that we have had in working with companies over the past five years so that you have a sense of what we are doing today, why we are doing it, and how we got to where we are now.

[Slide]


The Food and Drug Administration, as many of you know, is an agency in the U.S. government in the Department of Health and Human Services. There are other public health agencies that are part of this Department: The National Institutes of Health, for example, and the Centers for Disease Control and Prevention and FDA are all public health agencies within this larger Department.

[Slide]


The Federal Food, Drug and Cosmetic Act is the federal law in this country that gives FDA oversight over most of our food supply. We have authority over all of the food except for meat, poultry and egg products that are regulated by the Department of Agriculture. So, it is this Act that provides the legal tools for FDA to assure the safety of all of the products under its authority, including foods developed by modern biotechnology.

Our policies are always based on the best science that is available, and that is a very important aspect in our policy and we have spent a number of years studying the science of modern biotechnology and its possible impact on the food supply and food safety.

FDA is responsible for foods that are on the market, in commerce, in the United States and foods that are imported into the United States. So, both domestic and imported foods fall under our authority. Of course, our goal is public health protection. That is our mission. We are here to ensure that the food supply is safe and wholesome.

[Slide]


I would like to give you just a very brief overview of how products produced by modern biotechnology fit within the broader framework of the U.S. government because there are several agencies that are involved in looking at various issues that are related to the regulation of these products. FDA, of course, is responsible for food safety and labeling for foods that fall under our authority. The Department of Agriculture, and particularly the Animal Plant Health Inspection Service, APHIS, is responsible for ensuring that plants either moved and grown in this country or imported into the country do not pose problems for agriculture. That department has regulations for permitting field testing, as well as for the petitions that allow the commercial growing of plants produced by modern biotechnology.

[Slide]


The Environmental Protection Agency, EPA, also has a very important role because they have responsibility for ensuring the safety of pesticides. So, pesticides must be registered by EPA.

To give you an example of a product and show you how it fits within these three agencies and departments, the BT corn, that is the corn that has its own built in pesticide that you have undoubtedly heard about -- that corn would fall under the Department of Agriculture for consideration of whether it would pose any risk to agriculture under the Plant Pest Act and the Plant Quarantine Act. That product also would fall under EPA because the BT is a pesticide. So, the BT would be registered as a pesticide by EPA.

The food products and products for animal feeds, such as high-fructose corn syrup that would be used in soft drinks, for example, those products would fall under FDA. So, that product is one for which the company would have to go to all three government agencies to complete whatever regulatory requirements are necessary for that product.

[Slide]


In the late 1980s, the Food and Drug Administration began to receive a lot of questions about the use of recombinant DNA techniques and the possible impact on the food supply. At that time, we were already reviewing petitions from companies for food processing enzymes such as chymosin and alpha amylase, the enzyme that is used to make corn sweeteners -- chymosin, of course, also is known by the name rennet that is used for the milk clotting step in making cheese. We were very familiar with food ingredients produced by this technology.

But, at that time, we began to receive many questions about whole foods -- soybeans, corn, potatoes, tomatoes -- and how would those products be regulated; and what kind of safety testing should be done to ensure the safety of those products. So, we spent a number of years with our scientists in FDA and working with scientists in other agencies and other governments around the world to work out a system, an approach by which foods could be tested by the firms to establish that they were safe for marketing.

In fact, when Calgene, which was the company that developed the Flavr Savr tomato, approached FDA and asked us to review all of their safety data for the product that they were developing, which was the Flavr Savr tomato, that was the first time really that FDA had been presented with the question of how do we apply modern scientific methods to show that a food, a whole food such as a tomato, is safe to eat. So, we spent a good deal of time looking at that and other questions related to the use of modern biotechnology and its impact on the food supply.

And we published a policy in 1992, in the Federal Register, which was a statement of policy. It was intended to answer the questions that we were receiving at the time. It was essentially a snapshot of the technology based on the kinds of products that were being developed, and how we felt those products could fit within the existing framework under the Federal Food, Drug and Cosmetic Act. The policy that was published applies to all methods of plant breeding. That is, if foods are derived from plants that have been developed by cross-hybridization, the traditional methods in agriculture, or any of the other number of methods that plant breeders use to introduce new traits into plants, or by the new recombinant DNA or bioengineering techniques that we refer to as modern biotechnology, we felt that all foods should meet the same standards of safety under the Act and, therefore, the policy applies to all foods. It applies to both human foods and products that are used as animal feeds. So, it covers fruits and vegetables and grains, as well as the products that are derived from agricultural crops such as vegetable oils or food starch.

[Slide]

The policy really explains how foods have always been regulated, and how products that are derived by modern biotechnology can fit within the framework by which foods are regulated. FDA has two tools that it uses primarily to assure the safety of foods under the Food, Drug and Cosmetic Act. The Act places the legal responsibility for ensuring the safety of food on the developer of the product and gives FDA very broad authority to take action against the developer or to remove the product from the market if it does not comply with the law.

To give you an example, there was a potato developed in the 1970s that had an excessive level of a natural substance that occurs in potatoes. That product could make people sick. Fortunately, it did not make any consumers sick; it was discovered before. But FDA and USDA worked together to remove that product from the market, and that is what we call our postmarket authority.

We also have authority to assure the safety of food additives. In fact, a food additive must be approved by FDA before it can be used in food. There are a number of exemptions under the law for substances that are added to foods that are not food additives. For example, pesticides are exempt from a definition of food additives because they are regulated by EPA as pesticides.

Substances that are generally recognized as safe, what we call the GRAS, GRAS food ingredients, are also exempt on the basis that those substances are recognized by experts familiar with food safety as being safe for use in food -- salt, vinegar, spices, food-processing enzymes, a number of things that have been commonly used in food are considered to be GRAS.

We have applied this to the developments of modern biotechnology, as well as other methods of introducing new substances into food, in the context that if a gene is introduced into a plant and the result of that gene is a new protein that is present in the food, if that protein is not generally recognized as safe it would be a food additive, subject to premarket review by FDA. We have said that most of the modifications that have occurred to date result in new proteins in food that are either derived from other food crops or are very similar to foods that are already safely consumed in the food supply, and we have said that these proteins will be presumed to be generally recognized as safe.

What we have here is the legal tool though to assure that if this technology, or any other technology, is used to introduce a substance which is not generally recognized as safe it would require premarket review and approval by FDA before the food could be used in the market.

The most important part of the policy that we published in 1992 was the guidance to industry. The guidance to industry part of our policy provides information about the kinds of issues related to food safety that developers should take into account in bringing new foods to market. It really provides a yardstick for the developer to determine whether they are meeting the standards that FDA expects them to meet under the Act. We consider this to be a standard of care. When we published the policy in 1992, this was really the first time that we had put down on paper what the standards would be for agricultural crops in terms of food production.

[Slide]

In 1992, when we published this policy, we did ask for public comments, and one of the comment that we received from many people was that there should be notification to FDA about foods produced by modern biotechnology. As part of the review of the Flavr Savr tomato, that review was conducted over the period of time that we published the 1992 policy and, as part of our evaluation and determination of whether that policy was an appropriate policy, we had a meeting that was a public meeting of our Food Advisory Committee where we presented our scientific approach to looking at the safety of foods, to that committee, and we used the Flavr Savr tomato as an example of a product produced by modern biotechnology that had been tested by the kinds of methods and approach that we felt were appropriate.

During that committee meeting -- our Food Advisory Committee is a group of experts from outside of FDA that is composed of academic representatives, industry representatives and public interest representatives -- those committee members had an opportunity to look at the approach scientifically that we were recommending to companies, and this product as an example of the kind of testing that would be done under this approach.

The committee members felt that this was an appropriate approach given the characteristics of the product, and many members of the committee, including consumer representatives, suggested to FDA that this product really did not raise substantial food safety issues, and that if there were to be similar products produced by this technology, that FDA may need to have a more abbreviated way to look at these products. We had spent about three years of very intensive review, looking at all of the data produced for that particular product. That was a very useful review for the first product and it helped us in establishing our policy.

But, we agreed with the committee members that another approach would be needed for most products. So, we established what we are now calling our consultation procedures. These are procedures that are not legally binding on companies but FDA strongly recommends that companies follow them in bringing products to market.

We have discussed this approach through this consultation procedure with our Food Advisory Committee and our Committee for Veterinary Medicine, and we showed them seven products that companies had consulted with FDA. Again, they agreed with us that that seemed to be an appropriate level of oversight at that time given the nature of the products that were then coming to market.

[Slide]

There are several principles that I think are important to keep in mind in thinking about how we approach looking at the safety of foods. Today in the grocery store, if you think about the grocery store, meat, poultry and egg products, of course, are regulated by the Department of Agriculture but if you visualize yourself walking up and down the aisles, all of the other products fall under FDA and those are the fruits and vegetables, the cereals, all the packaged foods, all the additives that you see on the label on the ingredient statement of the package. So, there is a very broad number of foods that fall under our authority, and it also means that our food supply is very diverse. Think about the diversity of foods that we have in our grocery stores today. So, our policy applies to all of those products.

In asking whether a new product is safe, we ask whether that product is comparable. Is it similar to its conventional counterpart? Because the products of modern biotechnology to date are all derived from common food crops that have been used in agriculture for many years. So, it is a process of comparing the new product with the traditional product. How different is it? How similar is it? And, are those differences, differences for which additional testing would be needed?

The approach that we use at FDA for establishing the safety of food additives is one that we realized would not work as well for whole foods. Whole foods are complex mixtures of chemicals. The paradigm that we have for food additives relies on testing of single chemicals.

So, we had to come up with a different way to look at the safety of foods, and that is a multi-disciplinary approach where we look at many different kinds of scientific information. One of the important pieces of information that is rarely talked about are the considerations that developers do all the time in bringing new varieties to market, looking at their agronomic characteristics and their quality characteristics, and those are very important in determining whether a product can be successfully marketed. Plant breeders have been very successful at avoiding products that FDA would have to remove from the market on the basis of public health.

We also have new tools for safety assessment that are not available through other methods. The tools of molecular biology that are the tools of modern biotechnology also allow the scientist to determine the identity and the function of the substances that are added to foods. This is something that cannot be done by other methods of plant breeding, and so we have a very powerful new tool in not only developing new foods but being able to assess the safety of those products. So, that information, taken along with information that I will show you in a moment, of the composition of the food and assuring that the food is what we expect in terms of its vitamins, its nutrients and other normal components of the food -- this kind of information is information that we believe generally establishes that the food is as safe as other foods on the market.

There could be circumstances where testing in animals would be warranted but this is not routinely recommended because feeding whole foods to animals can produce very complicated results, and it is very important to design the studies appropriately but generally scientists around the world, including the World Health Organization and the Food and Agriculture Organization, have agreed that this approach is scientifically a sound approach for assessing the safety of foods.

[Slide]


There could be circumstances where we would require testing in addition to what I have just described. For example, if the genetic modification of a crop leads to an unusual protein or a new chemical in the food, or the substance has some similarity to an allergen or a toxin, then additional testing would be required. You may have heard about a potato developed in Europe that contains lectin. Certain lectins are known to be very toxic, and if that potato were presented to FDA we would expect that there would be considerable safety testing that would be required to establish the safety of that product. So, testing is really based on the characteristics of the product on a case by case basis.

[Slide]


I would like to just give you a very broad-brush picture of the kind of issues that breeders take into account for food safety in looking at whether a food can be marketed. This focuses on two aspects. First, of course, there is an intended change in the plant or the food based on the modification that has been made. So, it is important to make sure that if there are new substances that will actually be present in the food that those substances are safe to consume. So, it is important to understand the identity of the substance and its structure and function in the food. That substance should also be assessed, particularly if it is a protein, for whether it would be an allergen. You will hear more about that later this morning. Of course, it is important that the substance be digestible like other substances in the diet. Dietary exposure is something that is very important in food safety. How much do we eat is the question. Is this something that is a very trivial component of the food, or is it a major component of a food?

Nutrition, of course, is a particularly important issue. If the modification has been done to change the nutritional properties of the food, then an evaluation would have to be done in terms of how would that affect our dietary intake of that nutritional component. Nutrition is also important in animal feed. Many animals have diets that are primarily one crop and, so, altering the nutrition of that crop could alter the nutritional value for the animal. So, that is an important consideration for the feed that is fed to animals.

We also ask developers to look at whether there have been any unintended or unexpected changes that would be in the food as a result of the change that has been made. All methods of plant breeding are known to result in unintended changes in plants. Plant breeders routinely evaluate a number of agronomic traits to determine whether the plant is performing as it would normally perform.

But in addition to those ways of avoiding unexpected effects, we have asked developers to take some extra steps to minimize or reduce the likelihood that there will be unintended effects that could affect public health. That is done first by ensuring that the genetic material that has been introduced in the plant is introduced in a way that it is stable in the plant; it does not move around in the plant's genome, and that reduces the likelihood of additional unexpected changes.

We also ask developers to do extensive analysis of the food for vitamins, minerals, nutrients and other components of the food that are typical of that food to assure that those components that are important to the food are present at the levels that are expected. Those levels are known to vary over many conditions of growth. The genetic background of the plant, the environmental conditions under which it is grown, whether it is a year of a lot of rain or it is a year of drought will affect the composition of the food. So, in analyzing these important components in the food it is important to take into account the range that is typical for plants that have been accepted in the commercial market.

[Slide]


I would like to now very quickly give you some examples of the kind of information, using soybean as an example, to show you just a bit of the information that companies are presenting to FDA as they look at these products in terms of food safety.

I have mentioned that agronomic and quality factors are important. Breeders evaluate plants over several generations, in multiple field sites, in different locations. That is to determine whether the plant performs in a manner that is to be expected. I have shown just some examples here. This is plant morphology, flower color, time of flowering, resistance to disease, seed size and quality, percentage composition of oil or protein. These are just a few of the many characteristics that plant breeders typically evaluate for soybeans and bringing a new variety to market.

[Slide]

Products that have been produced by modern biotechnology are also looked at in terms of the molecular changes that have been made: What genetic material has been introduced? What is new? What are its characteristics? Are there any new proteins that are going to be produced in the food or other substances such as fatty acids or carbohydrates that will be new substances in the food as a result of the change that has been made in the plant: And are those substances safe for consumption? The components of the food in terms of nutrients, anti-nutrients are important in soybeans.

Soybeans also are a food to which some individuals are allergic, and companies are looking at the native allergens in soybeans to be sure that those have not been increased through the genetic change that has been made. Companies are also doing some animal feeding studies with these foods for wholesomeness of the foods before they come to market.

[Slide]


The analyses that are done for typical components of the food are done comparing the new variety, which is called transgenic here, with its parental strain or its appropriate control. What is not shown here is that these values then are also compared to the range that is typical for that crop for these components. This is showing carbohydrate, fat, protein, fiber analysis -- fiber is very important in looking at whether a feed product is digestible for animals.

[Slide]


Mineral analysis -- minerals are an important component of foods.

[Slide]


Fatty acid analysis for the oils. I am showing here only a few of the fatty acids that are typically analyzed in soybeans. All the data that I am showing you very quickly are composite data that we have derived from the information that has been submitted to us.

[Slide]


The protein quality of the food is very important, and the amino acid profile is an indicator of the quality of that protein.

[Slide]


Soybean has a number of substances that are considered to be anti-nutrients, and developers are also analyzing those substances to be sure they are in the levels that have been accepted as safe.

[Slide]


At this point in time, we have about a little over 40 crops for which developers have completed food safety discussions with FDA. There are ten crops at this time for which we have completed consultations. This is sugar beet, canola, corn -- corn is the largest; there are 12 varieties, cotton, potato, soybean, flax, raddichio, squash and tomato. Those are the crops that have been modified by modern biotechnology and companies have completed food safety discussions with the agency at this point.

As you can see, at this time there is a relatively limited number of food crops that have been developed by this technology. There also is a limited number of traits that have been introduced into these crops in terms of improvements in the crops. These are for herbicide tolerance, insect resistance, viral resistance that provides resistance to common diseases in agriculture. There are tomatoes that have improved ripening, and there are a number of vegetable oils that have been developed. For example, there are two vegetable oils that are different from their traditional counterparts. There is a vegetable oil called high oleic soybean oil, which is a soybean oil that is very different from traditional soybean oil. It has a very elevated level of a fatty acid called oleic acid, and that oil can be used as a high temperature frying oil, whereas soybean oil cannot typically be used as a high temperature frying oil without prior processing of the oil.

[Slide]

I would also like to give you a sense of the time that developers work with the agency before these products come to market. On your left, it says pre-submission. This is the time that companies discuss the kinds of testing that they will do on foods developed from plants through modern biotechnology. This is 15 to 20 months. These are also just examples. I have selected seven consultations at random just to give you a sense of what is typical. It is about a year to two years that companies discuss with FDA the kinds of tests that they will do, and the results of those tests.

This side is post-submission. Post-submission is the time when developers submit to us a summary of the safety and nutritional data that they have developed. That is when they are really saying to FDA, "we feel we have done all the testing that is appropriate and necessary to meet all the provisions of the Food, Drug and Cosmetic Act." FDA then looks at this information to determine whether there is any reason why we would take action against this product if it went to market. In other words, does it contain an unapproved food additive? Will it be mislabeled? Is its nutrient profile something that would not be acceptable in the food? Is there a new allergen in the food? These are the kinds of questions that we are looking at. On the average, it takes about five months for us to complete that process.

You can see in the yellow boxes that there are some that are very short. There are a number of products which may be the second or third generation of a product where both FDA and the company are very familiar with the kinds of testing that would be needed for that product, and so the consultation process is also very much more abbreviated.

But, I think what is important is that companies do come in a considerable period of time ahead of when they want to market the product. That is very important. Our policy has always been that our door is open, and we encourage companies to come early and often, particularly when a product is a new product that we are not familiar with.

[Slide]


I would just like to close by reminding you of the standard of food safety. Foods developed through the methods of modern biotechnology must be as safe as other foods on the market. That means that the food must not only be safe and wholesome; any substances that are added to the food must either be food additives that have been approved by FDA and regulated by FDA, or they must be generally recognized as safe. There may be pesticides that are regulated and approved by EPA. But this is the standard that we hold these foods to. We will not accept a lower standard for any new food.

Thank you for your attention.

[Applause]

MR. LEVITT: Thank you very much. We will be making copies of those slides you have seen up there publicly available on the web page and you can be looking for those also.

Let me now take the opportunity to welcome to the stage -- and maybe somebody is going to show you the easiest way to get here -- our first panel. I will introduce you after you are up here as you move to our first panel discussion. It is a little tight up here but we will get to know each other very well today.




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