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.
>
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>
> **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
>
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> 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
>
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> 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
>
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> 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
>
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> 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
>
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> 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
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> 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
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> **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.
>
> **Scientific, Safety, and Regulatory Issues**
>
> **Introduction**
>
> MR. LEVITT: Thank you. It is now time to begin the discussion of our
> first panel on the scientific, safety, and regulatory issues. In terms
> of logistics, I will ask each panel member to give brief opening
> remarks, about five minutes worth. These remarks will be followed by
> discussion among the panel members and questions from the FDA panel.
>
> Let me first review the three questions that we have asked our
> panelists to address to help us evaluate our current policy. These
> were printed in the Federal Register and are in your packets.
>
> The first question reads, has FDA\'s consultation process Dr.
> Maryanski described achieved its intended purpose? Based on experience
> to date, should this regulatory approach \"sunset,\" should it
> continue in its current state, should it be made mandatory, or
> otherwise be revised? So, how should we deal with the consultation
> process?
>
> Number two says, what newly-emerging scientific information related to
> the safety of foods derived from bioengineered plants is there, if
> any? Are there specific tests which, if conducted on such foods, would
> provide increased assurance of safety for man or animals consuming
> these foods? So, that is really focused on the kind of testing that is
> done.
>
> Three, what types of food products derived from bioengineered plants
> are planned for the future? Will these foods raise food safety issues
> that would require different approaches to safety testing and agency
> oversight? If so, what are those approaches? So, for that we ask you
> to look into your crystal balls and tell us what is coming down the
> pike.
>
> I am pleased to introduce the members of the first panel. You have in
> your packets additional biographical information. If I mispronounce
> anybody\'s name, please correct me. You ought to have your name spoken
> correctly. First is Dr. Peter Day. He is the Director for Agricultural
> Molecular Biology at Rutgers University.
>
> Next to him is Miss Carol Tucker Foreman. She is a Distinguished
> Fellow and Director of Food Policy Institute at the Consumer
> Federation of America.
>
> Nest is Dr. Rebecca Goldburg. She is a Senior Scientist and Manger of
> the Biotechnology Program at the Environmental Defense Fund.
>
> Next is Mr. Steven Druker, who is the founder and Executive Director
> of the Alliance for Bio-Integrity.
>
> Next to him is Dr. Samuel Lehrer, who is Research Professor of
> Medicine, Adjunct Professor of Microbiology and Immunology, and
> Adjunct Professor of Environmental Medicine with Tulane University
> Medical.
>
> Finally, we have Dr. Terry Etherton, who is Department Head and
> Distinguished Professor of Animal Nutrition, College of Agricultural
> Sciences, Department of Dairy and Animal Sciences at Penn. State
> University.
>
> We will go straight to the first panelist, and again ask if you could
> try to keep your remarks to about five minutes, and then we will come
> back for follow-up questions. Let\'s just start then with Dr. Day.
>
> **Panel Discussion**
>
> DR. DAY: Thank you, Mr. Chairman. First of all, I would like to
> congratulate Dr. Maryanski on an elegant and complete introduction.
> While he was talking I almost thought he was a plant breeder.
>
> Let me just make a few comments about the science. I will try to
> address the FDA\'s questions in the course of my comments. First of
> all, my own position is that the revolution that we are experiencing
> in the development of new varieties of crop plants is a continuation
> of a process that began hundreds or thousands of years ago.
>
> We have established a tradition, I think, since Asilomar in 1976, of
> being concerned about we are seen to be doing in our laboratory and
> experimental fields. The NIH guidelines were established. The NIH
> established a risk assessment research program and, as a result of
> these activities, we became more and more at ease with what were
> perceived as risks, sincere risks, 20 to 25 years ago.
>
> The process that the FDA has established, together with the other
> federal agencies, I think is working very well. I believe that the
> regulatory approach that is in position works satisfactorily. While I
> think it could continue in its current state, I think that it needs to
> be flexible to take account of new situations as they arise.
>
> Now, as I see it, the scientific risks fall into two categories. First
> of all, the risks to food and the question of food safety arises, and
> the FDA, like the other federal agencies, has chosen to focus on the
> product rather than the process by which it is produced. I think this
> is sound, and I know of no information that suggests that the process
> itself is dangerous. The product is what we should focus on. I think
> because the technology enables us to do things that are new and
> different we need to continue to focus on the product and to ensure
> that it is safe.
>
> The second area of concern, which is attracting a lot of attention, is
> the potential impact of biotechnology on the environment. Now,
> agriculture has a profound effect on the environment. I don\'t think
> any of us would dispute that. I see that biotechnology will have a
> much less severe effect than agriculture itself. No doubt, during the
> course of the morning we will be discussing specific instances but let
> me give you one instance, and that is BT corn \-- well, two, I would
> also like to refer to the herbicide resistant soybeans.
>
> In BT corn one has relieved the farmer of applying conventional
> pesticides and the untargeted effects that they have. The BT corn also
> has the advantage of reducing the incidence of mycotoxins in damaged
> ears fed to animals.
>
> The herbicide resistant soybean has replaced, by using one herbicide,
> five or six different herbicides that are conventionally used to
> control weeks in soybean crops. We can\'t go back to hoeing. While
> there are cultural methods that will limit weed development,
> herbicides are a cheap and effective method of week control that also
> have other benefits as far as the soil structure and the question of
> the number of tillage operations that are applied to fields \-- we can
> economize in fuel.
>
> Are there new things that are ahead? Yes. There is some concern over
> the horizontal spread of introduced genes and their impact on natural
> populations of plants. That horizontal spread has been a feature of
> conventional agriculture, of course. Many weeds in agricultural areas
> are associated with crops. For example, in Europe the introduction of
> canola and the spread of the seeds alongside roads has meant that
> canola has become quite a common weed.
>
> Now, one interesting new technology is the introduction of transgenes
> into chloroplasts. Chloroplasts are not transmitted in pollen, and
> some colleagues of mine at Rutgers have developed a method of
> introducing transgenes into chloroplasts, thereby limiting the spread
> of transgenes through pollen.
>
> The third FDA question asks what types of food products derived from
> bioengineered plants are planned for the future. I think what we have
> seen at the moment has had, unfortunately, rather little impact on the
> consumer since herbicide resistance and insect resistance don\'t
> really affect the product in the market in terms of its appeal to the
> consumer. There are a number of new things that are being developed
> that are more difficult to manage and that I think will be very
> impressive.
>
> We must also remember that biotechnology doesn\'t just contribute
> through the introduction of new genes. There are other technologies
> that involve, for example, marker-assisted selection and technologies
> that are based on the growing understanding of the construction of
> plant and animal genomes that enable plant and animal breeders to work
> with even greater precision than they do now.
>
> But perhaps what is most important is the potential that biotechnology
> has for the developing world, and I am thinking of examples like
> golden rice which has an increased content of vitamin A and an
> increased iron content, and crops like wheat which has been engineered
> to grow on aluminum toxic soils which limit production in many parts
> of the developing world.
>
> I don\'t think we can afford to ignore and to set aside the potential
> of this tool to do some remarkably important things to safeguard the
> world\'s food supply. Thank you, Chairman.
>
> MR. LEVITT: Thank you very much. We will just proceed right down the
> row. Carol Tucker Foreman?
>
> MS. FOREMAN: Thank you very much for conducting these public hearings
> on foods derived from bioengineered plants, and for the opportunity to
> appear on this panel.
>
> Consumer Federation of America is a non-profit association of 260
> pro-consumer groups which seeks to advance consumer interests through
> advocacy and education. Our members include state and local consumer
> organizations, senior citizens groups, consumer cooperatives and trade
> unions.
>
> In the past few months, Americans have become increasingly aware of,
> and increasingly concerned about genetically engineered foods. The
> concern seems to be driven by a number of factors \-- a sudden
> realization that by next year almost half of the corn, soybeans and
> cotton planted in the U.S. are likely to be transgenic crops; the
> vociferous rejection of these products by European consumers; the
> ongoing debate over the potential for environmental damage and
> economic concentration resulting from the rapid growth of genetically
> engineered foods; the utter absence of any direct consumer benefit in
> any of the products now on the market or anywhere close to being on
> the market; and, most importantly, the potential for some human health
> risk arising from the consumption of genetically engineered foods.
>
> The concern about genetically engineered food is in marked contrast to
> the public\'s acceptance of genetically engineered drugs. When faced
> with serious illness, most of us are willing to take some risks to
> combat the disease but food is different. Food is special. We eat to
> sustain life and health. Since food is so basic to us both physically
> and emotionally, it is really not surprising that consumers are
> extremely averse to any food-related risk, especially if that risk is
> perceived as imposed by someone else beyond our individual control and
> without any countervailing benefit. In short, we eat because it is
> good for us, not because it benefits those who grow, process or sell
> food.
>
> Industry and, to a certain extent, the government argue that decisions
> about the approvals of genetically engineered foods should be based
> solely on what is described as sound science. Industry and government
> insist that sound science says GE foods are safe and for many that is
> dispositive. Consumers aren\'t so sure. Good data and sound science
> are vital elements of good public policy but they aren\'t the only
> consideration. In science there aren\'t any final answers. Data are
> never complete; they are always evolving. The soul of the scientific
> process is challenge and revision as new data become available. Three
> years ago sound science told the Food and Drug Administration that it
> should approve the diet drug fen-fen, and last year\'s sound science
> told the Food and Drug Administration that it was best to withdraw
> that drug from the market.
>
> Food safety policy should be based on the best data and the best
> science but, in the end, the policy represents a choice among
> competing interests and values. Policy makers must balance industry\'s
> desire to bring new products to market and the farmer\'s desire to
> increase yield against the public\'s concern about safety.
>
> Public confidence in genetically engineered foods has been eroded by
> the sense that government has been too sensitive to the needs of
> industry. We all have to live with the impact of the circumstances
> governing the original policy on genetically engineered foods. On May
> 27, 1992 [The New York Times]{.underline} reported that Vice President
> Quayle announced details of a new government policy for streamlining
> regulation of these foods. Mr. Quayle, according to [The
> Times]{.underline}, told a briefing of industry executives that the
> policy was part of the Bush administration\'s regulatory relief
> program, and said the U.S. was the world leader in biotechnology and
> we want to keep it that way.
>
> It is really very difficult to persuade the public, after an
> introduction like that, that the government\'s primary interest is
> food safety. During Food and Drug Administration\'s consideration of
> an appropriate regulatory structure for GE foods, officials of the
> agency were extremely aware of the fact that if they required a prior
> approval of all of these new products it would suck up every bit of
> the agency\'s resources and there would be very little to apply to
> others. FDA now asks the public for its views on the process, and the
> answer is the process began under a cloud of political influence and
> managerial bean counting, and FDA has not dispelled that cloud.
>
> I believe that food biotechnology has enormous potential benefits to
> the world. They are benefits I would like to see realized, but there
> are none of those benefits to civil society at this point. FDA\'s
> present challenge is to develop a regulatory process that will assure
> public confidence.
>
> I have some suggestions for it. The government, beginning with the
> President, should make a clear statement that human safety is the
> first, second and third most important point in determining whether to
> approve GE foods, and that the government will assign sufficient
> resources to do the work required.
>
> Second, FDA should require submission for review and formal approval
> of all genetically engineered products prior to marketing. Last week,
> Dr. Michael Jacobson, of the Center for Science and the Public
> Interest, laid out examples of how the agency might require varying
> amounts of information depending on the specifics of the products.
>
> Third, consumers must have, and will have, a role in this debate. I
> propose that the agency create a special advisory committee on biotech
> engineered foods. The committee could help the agency shape the
> necessary questions and policy. I am a member of the Department of
> Agriculture\'s Meat and Poultry Inspection Advisory Committee which
> has worked exceptionally well over the past several years to help that
> agency shape policy and keep it transparent.
>
> In a field as new as this one, it may be useful to establish an
> independent quasi-governmental research institution that could raise
> key regulatory issues and sponsor research into them. The Health
> Effects Institute, which deals with clean air issues and is funded by
> government and industry, I think is an excellent model to look at.
>
> I have gone over my time so I want to just briefly address labeling.
> The agency has asked another panel to discuss that. Two quick points,
> labeling is not a substitute for assurance of safety. No food should
> be approved unless it is safe. The strong mandatory pre-approval
> process that I have suggested should eliminate the concerns of
> industry that people would assume a labeled product is less safe than
> its traditional counterpart. But for consumers, access to adequate
> information to make a rational decision in the marketplace is
> absolutely essential, and I am confident that the public will be more
> comfortable with this technology and more prepared to see it move
> forward if it has the assurance of some premarket review and approval
> and if the products are labeled. Thank you.
>
> MR. LEVITT: Thank you. Next is Dr. Rebecca Goldburg, Environmental
> Defense Fund.
>
> DR. GOLDBURG: I would like to begin by thanking the FDA for inviting
> me to speak today, and before I begin my remarks concerning FDA
> policy, I want to note that it is unfortunate that the FDA has
> scheduled this public hearing during the World Trade Ministerial
> meeting, in Seattle, because as a result a number of public interest
> representatives who might otherwise be at this hearing are now in
> Seattle.
>
> Well, to move on, in my brief remarks today I will first comment on
> food safety and then on FDA regulation of foods derived from
> genetically engineered crop plants, which I will refer to as
> genetically engineered foods.
>
> To most consumers, genetically engineered foods are essentially foods
> with added substances, usually proteins. As Jim Maryanski explained,
> this is because genes code for proteins. In most cases, these added
> proteins will likely prove safe for human consumption. Nevertheless,
> just as with conventional food additives, substances added to foods by
> genetic engineering may in some instances prove hazardous.
>
> One concern about adding proteins to foods via genetic engineering is
> that they may cause susceptible individuals to become allergic to
> foods that they previously could safely consume. Food allergies are a
> serious public health concern, affecting roughly two and a half to
> five million Americans. Allergic reactions cause discomfort and in
> some cases can cause life-threatening anaphylactic shock. Since known
> food allergens are proteins, foods with new proteins added via genetic
> engineering could sometimes become newly allergenic. This concern is
> real. One company has already dropped plans to commercialize soybeans
> with a Brazil nut gene after testing revealed the soybeans were likely
> to cause allergic reactions in Brazil nut allergic individuals.
>
> Unfortunately, there is currently no predictive methodology for
> testing the allergenicity of most proteins introduced to foods via
> genetic engineering. Testing is only possible for proteins from
> commonly allergenic foods, such as nuts. Proteins from commonly
> allergenic foods can be screened for so-called antibody-antigen
> reactions using blood serum available from individuals with common
> food allergies. However, for most proteins, including those from foods
> that are not commonly allergenic and those from non-food sources such
> as bacteria, no such testing is possible. In other words, most
> proteins added to foods via genetic engineering cannot be tested for
> allergenicity. Instead, industry scientists simply screen the
> biochemical characteristics of proteins to see if they are consistent
> with the characteristics associated with allergens. It remains to be
> seen how effective such screening will be in protecting the public
> health.
>
> Extremely troubling to me, FDA regulators have failed to assume a
> leadership role in addressing the potentially serious food safety
> risks from allergens added to foods via genetic engineering. Consider
> the following three points:
>
> First, although FDA co-sponsored a scientific meeting on food allergy
> in 1994, the agency has not used its scientific resources to develop
> and publish guidance to industry on how to assess the allergenic
> potential of proteins. FDA should develop such guidance. Given the
> existing uncertainties about assessment of potential allergens,
> guidance would both be helpful to industry and reassuring to
> consumers.
>
> Second, FDA\'s current policy concerning labeling of genetically
> engineered foods may not adequately protect public health. FDA at the
> moment does not generally require labeling of genetically engineered
> foods, although the agency will require labeling if there is evidence
> that a substance added to a food is allergenic. However, should an
> allergen added to a genetically engineered food not be detected by
> industry\'s current screening procedures, allergic consumers will
> likely not be able to avoid foods containing the allergen.
>
> EDF urges that FDA reconsider its policy for labeling of genetically
> engineered foods, not only as a matter of public information, the
> topic of the next panel, but also potentially to help some consumers
> avoid exposure.
>
> The third point is that FDA does not appear to be taking significant
> steps to sufficiently improve the scientific understanding of food
> allergens to develop predictive tests for allergenicity. FDA should
> assume a leadership role in funding and advocating support for
> scientific research that may result in the development of predictive
> testing methodology for food allergens.
>
> I would now like to turn to FDA\'s policy for regulation of
> genetically engineered foods, which appears to do more to protect the
> biotechnology industry than to protect consumers. As I stated earlier,
> most genetically engineered foods are essentially foods with added
> substances, at this point usually proteins. FDA\'s policy gives
> manufacturers who use genetic engineering to add substances to food
> considerably more discretion than manufacturers who use other
> technologies to add substances to food.
>
> Under the Federal Food, Drug and Cosmetic Act and FDA\'s current
> regulations, a food is adulterated if it contains an added substance
> unless either, (a) FDA has approved the safety of the substance by
> issuing a food additive regulation or, (b) the substance is what is
> called generally recognized as safe.
>
> The upshot is that FDA requires that manufacturers have scientific
> evidence to support the safety of substances traditionally added to
> foods or in food processing, for example, sweeteners or thickeners.
>
> In contrast, under FDA\'s 1992 policy, the agency will only require
> food additive petitions for substances added to foods via genetic
> engineering, and I quote, in cases where questions exist sufficient to
> warrant formal premarket review. In other words, FDA will only require
> data substantiating the safety of genetically engineered foods when
> there is already reason to believe that the foods might be hazardous.
>
> Thus, FDA\'s 1992 policy appears to significantly weaken the
> long-standing requirement under food safety law that food
> manufacturers must establish scientifically the safety of new
> substances added to food before selling them to the public, regardless
> of whether the manufacturers think they are safe. In other words,
> FDA\'s policy strongly favors food manufacturers at the expense of
> consumer protection.
>
> In response to the considerable public outcry that followed the
> publication of FDA\'s policy in 1992, the agency now recommends that
> manufacturers voluntarily consult with the agency before bringing
> genetically engineered foods to market. However, because these
> consultations are outside the regulatory system, they are not subject
> to public scrutiny and are not a satisfactory substitute for a
> regulatory program.
>
> The Environmental Defense Fund urges that FDA revise its 1992 policy
> to be more protective of consumers. In particular, we urge that FDA
> draft a new policy that would do the following two things:
>
> First, subject substances added to food via genetic engineering to the
> same regulatory requirements as substances added to foods via more
> traditional means. FDA should squarely place the burden on industry to
> substantiate scientifically the safety of substances added to foods
> via genetic engineering.
>
> Second, FDA should require manufacturers to consult with FDA before
> bringing genetically engineered foods to market. FDA does not now
> require such mandatory consultations for foods altered by more
> traditional means. However, at least for the near future, while
> genetically engineered foods are new and their potential hazards are
> not fully understood, it behooves FDA to require such consultations.
> Thank you very much.
>
> MR. LEVITT: Thank you. Next we have Mr. Steven Druker, Alliance for
> Bio-Integrity.
>
> MR. DRUKER: Thank you. I am very pleased to be here today, and I
> commend Commissioner Henney and Mr. Levitt for holding these meetings.
> I must say that I am still somewhat surprised to be here because I am
> one of the strongest critics of the FDA\'s current policy on
> bioengineered foods, and I have coordinated a major lawsuit to change
> it, a lawsuit which is currently pending in U.S. District Court. The
> fact that I am here suggests that the agency truly is open to hearing
> from all sides and, hopefully, it suggests that the agency is also
> open to change and that is very good because current FDA policy does
> require changing.
>
> Although it claims to be science based, numerous experts criticize it
> as scientifically flawed, and nine of these experts are so concerned
> that the policy is scientifically unsound and morally irresponsible
> that they have taken the unprecedented step of joining as plaintiffs
> in the lawsuit that my organization is spearheading to compel the FDA
> to institute mandatory rigorous safety testing of all genetically
> engineered foods.
>
> These scientist-plaintiffs are eminent, and their concerns deserve
> close attention. They include a professor of molecular and cell
> biology at the University of California, Berkeley, a respected
> molecular biologist at the State University of New York, and the
> associate director of targeted mutagenics at Northwestern University
> Medical School. This latter scientist routinely employs genetic
> engineering in the medical field, but he is deeply troubled at the
> extent to which it is being used in food production without adequate
> safeguards. Also included in our plaintiff group is Prof. Philip
> Regal, an internationally renowned plant biologist at the University
> of Minnesota. Dr. Regal has state, in a sworn declaration to the
> court, quote, there are scientifically justified concerns about the
> safety of genetically engineered foods and some of them could be quite
> dangerous, unquote.
>
> Why do these nine plaintiffs and so many other scientists regard FDA
> policy as unsound? They think the agency is disregarding the
> well-recognized potential for recombinant DNA techniques to produce
> unexpected toxins and carcinogens in a different manner and to a
> different degree than do conventional methods.
>
> Unfortunately, the FDA\'s official position ignores this heightened
> potential for the unknown, for unpredictable negative side effects.
> Instead, the agency focuses almost exclusively on the factors that are
> known and are predictable \-- the transferred genetic material and the
> substances it is known to produce. In effect, it is evaluating each
> transgenic substance as if it were an ingredient mixed into a
> preexisting food rather than as a factor that can cause unpredictable
> deleterious changes in the developmental process of a food organism.
> As one of our plaintiffs, the respected molecular biologist Prof.
> Liebe Cavalieri has stated, such an approach is \"simplistic if not
> simple minded.\"
>
> Although the FDA\'s official statements ignore these unpredictable
> kinds of negative effects of genetic engineering, its own scientists
> are well aware of them. This came to light when the FDA had to give us
> copies of its files during the course of the lawsuit. You know, the
> agency is asking us to bring forth to them any newly emerging
> scientific evidence. Well, this evidence that I am about to share with
> you is not new, but it is newly emerging and it is unfortunate it took
> a lawsuit to pry it out of the government\'s own files.
>
> I will only be able to give you a brief summary, a brief taste of some
> of the memoranda that are from the FDA\'s own scientists, in their own
> files. FDA microbiologist, for instance, Dr. Louis Pribyl stated:
> \"There is a profound difference between the types of unexpected
> effects from traditional breeding and genetic engineering.\" He added
> that several aspects of gene splicing \"may be more hazardous.\"
>
> Similarly, Dr. E.J. Matthews of the FDA\'s Toxicology Group warned
> \"genetically modified plants could \... contain unexpected high
> concentrations of plant toxicants,\" and he cautioned that some of
> these toxicants could be unexpected and could \"be uniquely different
> chemicals that are usually expressed in unrelated plants.\"
>
> Also, the head of the FDA\'s Center for Veterinary Medicine wrote in a
> memorandum to Dr. Maryanski, \"CVM\" \-- that is the Center for
> Veterinary Medicine \-- \"believes that animal feeds derived from
> genetically modified plants present unique animal and food safety
> concerns.\"
>
> Also, Mitchell J. Smith, who was head of Biological and Organic
> Chemistry Section at the Center for Disease Control and the Center for
> Science and Nutritional Safety at FDA, wrote in a letter to Dr.
> Maryanski that the agency\'s proposed policy on genetic engineering
> turns FDA\'s prior practice on its head.
>
> The numerous in-house critiques of the agency\'s proposed policy are
> best summed up by Dr. Linda Kahl, an FDA compliance officer, who
> protested that the agency was \"trying to fit a square peg into a
> round hole by trying to force an ultimate conclusion that there is no
> difference between foods modified by genetic engineering and foods
> modified by traditional breeding practices.\" She declared, \"the
> processes of genetic engineering and traditional breeding are
> different and, according to the technical experts in the agency, they
> lead to different risks.\"
>
> It is important to note that was not Dr. Kahl expressing her own
> opinion. She was carefully summarizing the many memoranda from the
> technical experts that are in the file, and that is a fair summary.
>
> In light of the unique risks, FDA scientists advised that genetically
> engineered foods should undergo special testing. The Division of Food
> Chemistry and Technology cautioned, \"some undesirable effects such as
> appearance of new, not previously identified toxicants may escape
> breeders\' attention unless genetically engineered plants are
> evaluated specifically for these changes. This Division, as well as
> many other FDA experts, recommended that such tests had to include
> rigorous toxicological testing.
>
> Not only was the agency aware of uncertainties within its own ranks,
> it also knew there was considerable disagreement about the safety of
> genetically engineered foods in the scientific community at large. For
> instance, FDA biotechnology coordinator, Dr. James Maryanski,
> acknowledged in a letter to a Canadian health official, on October 23,
> 1991, that there was not a scientific consensus about safety. He also
> admitted, \"I think the question of the potential for some substances
> to cause allergenic reactions is particularly difficult to predict.\"
>
> Nonetheless, the FDA not only disregarded the warnings of many of its
> own scientists about the unique risks of gene-spliced foods, it
> covered them up and it has taken a public position that is quite
> opposite. It\'s official policy statement declares: \"The agency is
> not aware of any information showing that foods derived by these new
> methods differ from other foods in any meaningful or uniform way.\"
>
> Now, I invite the members of this audience to consider the sampling of
> statements from FDA\'s own scientists I just shared with you and then
> to consult our web site, www.biointegrity.org, where we have posted
> the original versions of these documents, photocopies, along with many
> other such memoranda, and you consider in your own minds whether you
> can accept the FDA\'s claim that it has no information about
> meaningful differences \-- if you can accept that as a good faith
> attempt to represent reality or whether, instead, it appears to you as
> a ploy calculated to deceive the public and evade the law.
>
> So, a strong case can be made that FDA policy violates sound science
> and, therefore, a strong case can be made that it does violate the
> law, the U.S. Food, Drug and Cosmetic Act. In this statute, Congress
> instituted the precautionary principle and definitively decreed that
> no new substance shall be added to our food unless that substance has
> been demonstrated to be safe through standard scientific testing.
>
> While the FDA agrees that the foreign genes that get inserted into a
> plant, along with the substances it produces, are in principle food
> additives, it maintains they are exempt from regulation because they
> fall into the exception for substances that are generally recognized
> as safe, or GRAS. However, as already noted, FDA records indicate such
> manipulations are not even recognized as safe among the agency\'s own
> scientists, let alone by a consensus in the scientific community.
>
> Second, the law is explicit that any recognition of safety must be
> based on \"scientific procedures,\" and both the FDA and the courts
> have heretofore consistently interpreted \"scientific procedures\" as
> referring to studies published in peer-reviewed literature. Moreover,
> the FDA\'s own regulations emphasize that the tests supporting a
> general recognition of safety \"require the same quantity and quality
> of scientific evidence as is required to obtain approval of the
> substance as a food additive.\" This means, in the FDA\'s own words,
> that the tests must demonstrate \"a reasonable certainty that the
> substance is not harmful under its intended conditions of use.\" Yet,
> neither the FDA\'s records nor the scientific literature indicate that
> such a test exists for even one genetically engineered food.
>
> In fact, the main test that attempted to demonstrate the safety of a
> bioengineered food through standard toxicology tests failed to do so.
> That food was the Flavr Savr tomato, the first genetically engineered
> organism that the FDA reviewed. In commenting on those tests, Dr.
> Robert J. Scheuplein, director of the FDA\'s Office of Special
> Research Skills, stated that the tests raised by failed to resolve a
> safety issue. He wrote, \"the data fall short of a demonstration of
> safety or of a demonstration of reasonable certainly of no harm which
> is the standard we typically apply to food additives. To do that we
> would need, in my opinion, a study that resolves the safety questions
> raised by the current data.\" Yet, the FDA approved that product
> anyway on the grounds it was generally recognized as safe, even though
> the law requires such recognition to be based on precisely the kind of
> test that had failed to demonstrate safety. Interestingly, FDA
> officials claimed that the Flavr Savr passed muster so well that the
> rigor of its testing will not have to be repeated for other
> bioengineered foods.
>
> So, although the generally recognized as safe exemption was intended
> to permit marketing of substances whose safety has already been
> demonstrated through sound testing, the FDA is now using it to
> circumvent testing and to approve substances based on inferences drawn
> from less rigorous forms of analysis \-- inferences that are dubious
> in the eyes of several of its own as well as many other experts.
>
> Moreover, it is very important to make clear that although government
> officials repeatedly boast that no genetically engineered food has
> ever caused any harm to human beings, once such food did kill dozens
> of Americans and permanently disabled over 1500 others. That was a
> genetically engineered food supplement of the amino acid L-tryptophan.
> It cased those deaths in the late 1980s. By the way, only that batch
> of genetically engineered L-tryptophan caused that problem. It was
> later found that those batches contained some very highly toxic
> contaminants at very low levels. They escaped standard pharmacological
> testing. The pharmacologic analytic tests showed those supplements to
> be pure but they killed people and they permanently destroyed the
> lives of over 1500 others.
>
> On July 18, 1991, Douglas L. Archer, then the Deputy Director of
> FDA\'s Center for Food Safety and Applied Nutrition, was invited to
> testify before Congress on this tragedy. In his written remarks he did
> not once mention the word genetic engineering or indicate that the
> L-tryptophan supplement in question had been genetically engineered.
> Rather, he blamed the problem on food supplements in general.
>
> Yet, just a few months after his testimony, on September 27, 1991, Dr.
> James Maryanski, responding to questions from the Government
> Accounting Office doing an independent study of that tragedy, admitted
> his own memo in the record, \"I said that we have no new information,
> that we do not yet know the cause of EMS\" \-- that was the specific
> ailment that killed the people \-- \"nor can we rule out the
> engineering of the organism.\" It couldn\'t be ruled out then. The
> process of genetic engineering was questionable and dubious then and
> it remains dubious, and many eminent scientists believe that genetic
> engineering itself is still the most probable cause for those deaths
> and disabilities.
>
> MR. LEVITT: Excuse me, Mr. Druker, in fairness to the other panelists,
> if we could try to wrap up \--
>
> MR. DRUKER: Okay, I will wrap up \--
>
> MR. LEVITT: \-- and we will have additional time for questions.
>
> MR. DRUKER: I am sorry, but this information is very important and has
> not been brought to light, and it should have been by now. I am sorry,
> I will wrap up.
>
> The FDA says it is now in a listening mode. If its ears are truly
> opened, then its conscience should have been touched. You know, we are
> not involved in some abstract academic debate. What is at stake is the
> safety of the nation\'s and ultimately the world\'s food supply. All
> relevant evidence has to be considered, and the FDA claims that its
> processes are transparent and clear and, yet, all of this evidence I
> have just brought forth has been obfuscated, at best, by the agency.
>
> Mr. Levitt and Commissioner Henney, when you hear my remarks I really
> implore you to consider very carefully whether the agency\'s current
> policy is scientifically sound; whether it is in line with the
> precautionary principles mandated by U.S. law; whether it really
> serves the public or, as Dr. Goldburg and others have said, better
> serves the interests of the biotechnology industry.
>
> If, God forbid \-- if genetically engineered foods do kill and cripple
> again, those that continue to make statements that are dubious will
> have it on their own conscience. It is time for change. Thank you very
> much.
>
> \[Applause\]
>
> MR. LEVITT: Thank you, Mr. Druker. Again, as with any of the speakers
> today, if people have additional written information they would like
> to submit to the docket to be sure it gets in the record, we, by all
> means, are happy to accept that and, again, we will have additional
> time for questioning after all the speakers are done.
>
> Next, we have Dr. Samuel Lehrer of Tulane University Medical Center.
>
> DR. LEHRER: Thank you very much.
>
> \[Slide\]
>
> My task this morning is to address the issue of genetically modified
> foods with regard to allergenicity. In particular, I would like to
> consider the safety assessment of these foods in a very short period
> of time so that you understand what the process is and address the
> issues of are we doing enough; is there more that we can do?
>
> \[Slide\]
>
> First we just need to consider food allergy. Allergies occur in about
> one to two percent of the adult population and four to six percent of
> the pediatric population. Almost all food allergies are due to eight
> foods or food groups.
>
> Symptoms of food allergy can be highly variable, and most food
> allergies are IgE-mediated immunological reactions, and this is very
> important because this distinguishes true food allergies from other
> food intolerances which have a metabolic or toxic basis.
>
> \[Slide\]
>
> Food allergens generally are proteins, but it is important to remember
> that not all proteins are food allergens. Generally, plants contain
> tens of thousands of proteins, yet, very few of these proteins are
> allergenic. Most allergens are stable for digestion and processing,
> and major allergens tend to be abundant proteins within a food. They
> are in a food in high concentrations. Many food allergens have been
> cloned and characterized.
>
> \[Slide\]
>
> Now, when we consider biotechnology\'s use in terms of improving food
> supply, as Dr. Day indicated, this has been around literally for
> thousands of years. But what distinguishes the old biotechnology from
> the new biotechnology is genetic engineering, and genetic engineering,
> as some have already said, is a method that facilitates the
> identification and selection and transfer of genes in coding of a
> specific protein into the genome of another organism. This method
> precisely determines which proteins are introduced into the organism
> and where they are expressed.
>
> Now, most proteins that are introduced into crops are not stable to
> digestion or processing, and most applications require only minute
> amounts of new protein or even no protein at all to have the desired
> effect. So, these last two points, if you remember what I said in the
> previous slide about allergens, suggest that the likelihood of these
> proteins being allergenic is minimal.
>
> Interestingly, biotechnology is even being used to reduce the
> allergenicity of some foods. For example, a group in Japan is
> producing hypoallergenic rice, and I believe that several groups are
> attempting to do this with other crops in the United States.
>
> \[Slide\]
>
> When we consider the concerns about genetically modified crops we
> first need to identify the risks. What are they? How can these risks
> be assessed, and how can they be minimized? This assessment must be
> based on accepted scientific principles. This is very important and
> this is something the other panelists have said already. Also, the
> criteria should be the same as that used for other foods. Finally, we
> need to consider how these risks relate to the benefits provided by
> the genetically modified food.
>
> \[Slide\]
>
> To address these issues, as Dr. Goldburg mentioned, the FDA, EPA and
> USDA sponsored a conference in 1994 on the scientific issues related
> to the potential allergenicity of transgenic food crops, and this was
> one of the first meetings to address this issue and discuss some of
> the concerns involved.
>
> In 1995, there was a series of meetings on the allergenicity of
> genetically modified foods sponsored by the Allergy and Immunology
> Institute and the International Food Biotechnology Council, in
> Washington, D.C. These meetings resulted in the publication of a
> monologue and critical reviews in [Food Science and
> Nutrition]{.underline}, in 1996. This monologue addressed
> allergenicity in general of foods and, in particular, genetically
> modified foods, and proposed a decision process in which we can
> address these issues.
>
> This decision tree was based on utilizing immunochemical procedures
> for testing for allergens, as well as comparing the physical chemical
> properties of the introduced proteins to known allergens, and this is
> utilizing the most current technology available. Actually, in response
> to some of the issues that Dr. Goldburg raised, I might mention that
> most of the foods that we eat today could not pass this process.
>
> \[Slide\]
>
> I just would like to review briefly application of this decision
> process. Dr. Goldburg already mentioned the Brazil nut protein that
> was expressed in soybean during and it was later shown that this was
> actually a major Brazil nut allergen. Contrary to what she was saying,
> to me, this is an example of how the system works because we were able
> to identify the product; development was stopped and the product was
> never marketed, in spite of the fact that it was being developed as an
> animal feed.
>
> \[Slide\]
>
> So, in conclusion, I believe that the probability of an introduced
> protein, that it will be allergenic, is extremely low. There are
> definitive methods to detect the transfer of known allergens and
> measure changes in native autologous allergens.
>
> Through the combination of genetic and physical chemical criteria, I
> believe that it provides assurance that proteins from sources with no
> allergenic history will not pose significant concerns about
> allergenicity.
>
> Now, I also want to add, as Dr. Goldburg mentioned, that although we
> are basing all of these assessments on the available technology,
> technology can be improved and I think that we should be directing
> more efforts in terms of developing better models in which we can
> better assess the allergenicity of new foods being developed by these
> new technologies. But, based on the current technology, I believe that
> we are doing everything possible to identify the allergenicity. Thank
> you.
>
> MR. LEVITT: Thank you very much, and our final presentation will be
> from Dr. Terry Etherton.
>
> DR. ETHERTON: Thank you, Mr. Levitt. Mr. Levitt, members of the Food
> and Drug Administration and listening panel, thank you for giving the
> Federation of Animal Sciences Societies the opportunity to provide
> comments today on the scientific and safety issues of livestock feeds
> derived from plants developed using biotechnology techniques.
>
> As background, I have conducted research in the areas of endocrine
> regulation of nutrient metabolism and the development of novel
> biotechnology products for application in animal agriculture. I am an
> expert in the use of numerous feeds by livestock, including digestion
> and absorption of nutrients for milk production and growth.
>
> The Federation of Animal Sciences Societies, or FASS, is a
> professional organization made up of approximately 10,000 scientists
> in academia, government and industry which exists to serve society
> through the improvement of all aspects of food animal product. FASS
> represents the combined membership of the American Dairy Science
> Association, the American Society of Animal Science and the Poultry
> Science Association.
>
> As requested, Mr. Levitt, we will comment on newly emerging scientific
> information related to the safety of feeds derived from genetically
> modified crops. It has been estimated that the supply of food required
> to adequately meet human nutritional needs over the next 40 years in
> the global village is quantitatively equal to the amount of food
> previously produced throughout the entire history of humankind. This
> poses a daunting challenge to the global village for several reasons.
> First, virtually all land suitable for farming worldwide is being
> farmed. Secondly, destruction of tropical rain forest or wildlife
> habitat is not a viable option for environmental considerations.
>
> Thus, the only feasible solution is to develop new technologies that
> enhance food product efficiency. Genetic modification of crops for our
> livestock has been conducted for many years. Plants to supply feeds
> for livestock have been improved over the years because new plant
> varieties were developed using conventional techniques of plant
> breeding and genetic selection.
>
> Crops to supply feed for livestock produce through modern methods of
> biotechnology are emerging from research and development to the
> marketplace. Crops developed using modern methods of biotechnology are
> referred to as genetically modified crops as opposed to crops using
> conventional plant breeding. Both conventional and biotechnology
> techniques have benefited agriculture.
>
> Corn grain, whole plant chopped corn and soybeans from the currently
> genetically modified crops have been fed to livestock and compared
> with conventional feeds to determine the effects on feed consumption,
> digestibility and animal responses. Chickens, sheep, beef cattle and
> dairy cattle have been used in this research.
>
> These data indicate that the chemical composition of the genetically
> modified and conventional feeds are substantially equivalent, and are
> well within the normal range of values reported in the scientific
> literature. These data indicate that feed consumed, digestibility of
> feeds, nutrient absorption, growth, milk production, milk composition
> and health of livestock fed genetically modified and conventional
> feeds were equivalent.
>
> The digestive process in all livestock breaks down the nutritional
> components in feeds, including protein and amino acids and DNA and
> nucleic acids. Because the nutrients in these feeds are broken into
> smaller components, the plant proteins have not been detected in milk
> and the plant proteins would not be expected in meat and eggs. These
> data, and our understanding of nutrient digestion, absorption and
> metabolism indicate that these genetically modified feeds are safe for
> livestock to consume. In addition, the food products of livestock
> consuming these feeds are safe for human consumption, and will be of
> benefit to the nutrition and well being of the world\'s population,
> especially children in developing countries.
>
> In conclusion, FASS strongly recommends that science be the basis for
> acceptance of genetically modified feeds for livestock. FASS endorses
> the use of biotechnology techniques to improve agricultural plants and
> animal products. FASS also believes that agricultural biotechnology
> has the capability to improve the supply of livestock feeds and
> healthful animal and plant food products and, thereby, help to meet
> the nutritional needs of the growing world\'s population.
>
> In closing, Mr. Levitt, I thank you for the opportunity to provide
> this testimony. FASS is highly supportive of the existing FDA
> consultation process, and I would like to leave you with the
> perspective that we now live in an era where the greatest proportion
> of people in recorded history have the luxury of dying of old age
> diseases, and we have the safest food supply that humankind has ever
> seen. Thank you.
>
> **Panel Answers FDA Questions**
>
> MR. LEVITT: Thank you. Let me thank all the panelists, and the
> audience for being so attentive during all of these presentations.
>
> We will now proceed to a little more of a Q&A format. What we will do,
> so everyone knows what to expect, is I will start with a question and
> I will just ask everybody down the line to provide an answer to it,
> and we will just kind of go right in order. We will then go right down
> the line and, hopefully, magically that will occur about the time we
> are supposed to take our lunch break. If not, you know, we will watch
> the time as it goes along.
>
> I will start with something you have already been prepared to answer,
> as a way of kind of easing into this, and a number of you have
> answered it directly or indirectly but I think it would be nice to
> just kind of get together the views, if you will, together in the
> proceedings. That really is the first question the FDA asked in the
> Federal Register with regard to the current consultation process on
> how it ought to be modified, if at all.
>
> I will read you the question again which says, has FDA\'s consultation
> process achieved its indented purpose? Based on experience to date,
> should this regulatory approach \"sunset,\" should it continue in its
> current state, should it be made mandatory, or would it be otherwise
> revised? So, I think you have all the potential possibilities there.
> We will start with Dr. Day.
>
> DR. DAY: My view is that it isn\'t broken and it doesn\'t need to be
> fixed. I think that if the FDA is flexible and reactive to new
> problems as they arise, then they will continue to safeguard our
> interests in the way they have so far.
>
> I don\'t accept the hypotheses as scientific facts. Some of the
> statements that Mr. Druker made are hypothetical; they have not been
> shown to occur. So, that is my comment, Mr. Chairman.
>
> MR. LEVITT: Thank you. Miss Foreman?
>
> MS. FOREMAN: Yes, thank you. I think I made it perfectly clear in my
> prepared statement that I think this system was born under a cloud and
> that cloud has deterred public confidence in the system. I don\'t
> think you can magically determine that these products are safe any
> more than we are magically going to finish in time for lunch \--
>
> \[Laughter\]
>
> \-- and I am hungry! A mandatory approval system doesn\'t cost the
> agency anything except resources, and the public ought to be prepared
> to make those resources available. It will cost the industry something
> but not very much, if one believes Dr. Maryanski about the
> consultative process. It rewards the industry by increasing public
> confidence in that process, and all you have to do is look around the
> country today and see what is happening out there, and you realize
> people are not confident with the process as it exists right now. And,
> you know, it just doesn\'t work to try to insult people into
> purchasing your products. It doesn\'t work to sit there and say,
> \"Jane, you ignorant slut, if you don\'t believe this is safe it\'s
> because you\'re stupid.\" You have to persuade the public that the
> government has a process that protects the public\'s interest.
>
> MR. LEVITT: Thank you. Dr. Goldburg?
>
> DR. GOLDBURG: Well, as I made clear in my statement, I think there is
> good reason to improve FDA\'s policy so that it is more protective of
> consumers. As Carol pointed out, I don\'t think that will come at a
> terrible cost to industry, and maybe some benefit because consumers
> might feel more secure about the safety of the food supply. As it now
> stands, I think that a voluntary system is in the future highly
> susceptible to problems should companies choose not to go along with
> crossing t\'s and dotting i\'s for the Food and Drug Administration.
> For example, Dr. Lehrer noted the example of the Brazil nut gene in
> the soybeans as an example of how the system worked; that the problem
> with the Brazil nut allergen was detected before the product ever
> reached market. I would like to point out that that example was
> entirely independent of the regulatory system. The company that
> created the soybeans, Pioneer Hi-Bred, behaved very responsibly and
> hired a good scientist to do the analyses, and when the analyses came
> back chose voluntarily to withdraw the product. There is no guarantee
> to consumers, however, that in the future all the companies will
> behave so well, and that is why I think many of us would like a system
> that more squarely places the burden of proof on industry to
> demonstrate the safety of the foods it is producing.
>
> MR. LEVITT: Thank you. Mr. Druker?
>
> MR. DRUKER: Mr. Levitt, you asked us to address specifically whether
> the purpose of the current consulting system has been achieved. It
> depends on what its purpose is. If its purpose is to give the illusion
> that the Food, Drug and Cosmetic Act is being followed and that these
> foods have really been established safe before they are marketed, then
> it is serving its purpose because that is the illusion that is being
> given.
>
> But if you really want to follow the law and make sure that no
> genetically engineered food product reaches the market, reaches
> American dinner tables without having been demonstrated to a
> conclusive level that it is safe, then there needs to be a change
> because, as I mentioned, and I would invite Dr. Day or anyone else
> here to cite one example of a single genetically engineered food that
> has been established safe through scientific testing, published in the
> peer-reviewed literature, to the standard required by law.
>
> We have many of our scientific plaintiffs who have signed sworn
> declarations submitted to the court saying they are not aware of a
> single such study. As I already mentioned, the FDA\'s own scientists
> say that the studies on the Flavr Savr tomato were inconclusive and
> raised a safety issue that was not resolved.
>
> So, if you want to be in compliance with sound science, as you claim;
> if you want to be servants of the law, then change the policy. Require
> mandatory safety testing, and require that every genetically
> engineered food be established safe to reasonable certainty of no harm
> before it appears on American dinner tables.
>
> MR. LEVITT: Thank you. Dr. Lehrer?
>
> DR. LEHRER: Yes, I believe that the system is effective now. Can it be
> improved? Yes. I think that as technology improves, we probably can
> make better decisions addressing some of these questions. I might be
> actually overlapping with point two but, in general, I think the
> system is functioning well.
>
> DR. ETHERTON: Mr. Levitt, as I said in my comments, and would like to
> emphasize that they reflect those of the FASS membership, we believe
> that the consultation process has achieved its goal and are supportive
> of it continuing in its current state. Thank you.
>
> MR. LEVITT: Thank you very much. I will next turn to Mr. Hubbard.
>
> MR. HUBBARD: Dr. Day, it has been well stated that consumer anxiety in
> Europe is much higher on this issue than in this country, although I
> think Ms. Foreman mentioned that it is increasing. Can you give us
> some of your perceptions of why it is higher in Europe? Is it consumer
> enlightenment? Can you tell us more about that?
>
> DR. DAY: Well, I think there are several reasons. One is that the
> public\'s confidence in government science in Britain was severely
> shaken by the mad cow disease epidemic, particularly the risk of
> contracting Creutzfeldt-Jakob syndrome from the prion that is
> responsible for that disease.
>
> I think too that the consultative process that we have in this country
> is better than it is in Britain. I don\'t know of an agency in Britain
> that would hold a hearing of this kind, and I think that this kind of
> meeting is extremely important in allowing people to express their
> concern so that we can have the kind of discussion that we are having
> here this morning. That happens to a much less well-developed extent
> in the U.K.
>
> MR. LEVITT: I think I would like to give the other panelists an
> opportunity to respond to that question, if you would like, in terms
> of why consumer concerns appear to be greater in Europe than they are
> here.
>
> MS. FOREMAN: I agree with Dr. Day in terms of the history of
> government regulation and the utter failure of the government in Great
> Britain to deal with mad cow disease responsibly. More recently you
> had the utter failure of the government in Belgium to deal with the
> dioxin and, in fact, to mislead the public. That has not been the case
> here, and the agency is to be applauded for beginning this process of
> consultation.
>
> But I think the real difference is that this has simply been an issue
> for a longer period of time in the European countries than it has been
> here, and maybe on January 1 we will all wake in concern and
> genetically engineered foods will have disappeared in the United
> States \-- don\'t bet on it. I have a feeling that we are in for a
> long and painful process here that could be cut off if you will decide
> to take some steps that are reassuring to the public, that is, a
> mandatory review and approval and, as Becky and I keep saying,
> doesn\'t cost the industry an awful lot and may reward them as well.
>
> MR. LEVITT: Thank you. Dr. Goldburg?
>
> DR. GOLDBURG: Well, I think there is a myriad of reasons for the
> differences, some of which have already been elaborated on and I
> can\'t go into completely. I must say though that I have been involved
> in issues concerning the use of genetic engineering in agriculture for
> 13 years now at the Environmental Defense Fund, and was involved in
> the early stages of the development of federal regulations for
> biotechnology, and at the time those regulations were established
> biotech products were all in the R&D stage. So, to the extent that
> what was going on received media attention, the concerns to consumers
> were all hypothetical. They were in the future. These foods were
> prospective.
>
> I think the debate in Europe has unfolded in a different way. When
> regulatory systems started being developed, when consumers started to
> think about these issues the foods were real \-- they were on their
> table. Therefore, I think there is a lot more concern.
>
> Agreeing with Carol, I don\'t think we have seen the last of the issue
> here. Although the U.S. public to date has not expressed the same kind
> of concerns we have seen in Europe, I think people are growing in
> their awareness that many genetically engineered foods are now on
> their tables, and want some assurance, some independent oversight of
> the safety of these foods.
>
> Finally, I would like to point out one other difference in
> biotechnology perception in Europe and the U.S., and I think that has
> to do with how at least some individuals in the scientific community
> receive the technology. I think it is important to consider that
> biotechnology is the baby of the U.S. scientific community and, as
> such, people in this country \-- scientists in this country have all
> sorts of interests in its development, and that is less true in
> Europe.
>
> For example, in Europe we saw a very critical report on genetically
> engineered foods come out of the British Medical Association. I don\'t
> think we would see that here. I think there are important cultural
> differences not only among the public but also in the scientific
> community.
>
> MR. LEVITT: Thank you. Mr. Druker?
>
> MR. DRUKER: Yes, there are several reasons. One, as has been
> mentioned, the FDA has in many respects, over the last 30-some years,
> performed very well and admirably, and gained the respect of the
> American public. I can think of the thalidomide drug which many
> European governments unwisely approved. The FDA took a precautionary
> approach and saved a lot of agony. Tobacco quite recently \-- the FDA
> has become a great champion of public health when it comes to wanting
> to regulate tobacco. So, you have gained some laurels and I think that
> transfers to your stance on genetically engineered food.
>
> Also, of course, there is a difference of media coverage though within
> Europe and the U.S. The American media has tended, by and large, to
> just report the promotional statements of the industry spin doctors
> and of the government spokespeople who continue to say that there is
> really no risk and these foods have been guaranteed safe. U.S.
> Secretary of Agriculture, Dan Glickman, has been saying for years
> these foods have been proven safe. So, people believe it. They aren\'t
> aware that they are only assumed to be safe on the basis of
> hypotheses, which is not adequate.
>
> Also, of course, the mad cow disease incident in Great Britain really
> has I think heightened concern in Great Britain and in Europe.
> Relevant to that, I think it is important to note that the scientist,
> the main scientist in Great Britain who predicted that there would be
> a mad cow disease type of problem well before it happened, Dr. Richard
> Lacey, who has an M.D. and also has a Ph.D. in genetics, and is
> professor of medical microbiology at the University of Leeds in the
> United Kingdom, predicted that and the British government ignored him
> for a long time. Then, lo and behold, he was right.
>
> Now, Richard Lacey cannot be a plaintiff in our lawsuit because he is
> not a U.S. citizen but he has submitted a sworn declaration to the
> court, and he has said that he believes, along with the rest of our
> plaintiffs, that the same potential for widespread problems from
> genetically engineered foods exists as it did several years ago in the
> mad cow disease episode before the problem became completely manifest.
> He reminded the judge that mad cow disease has about a 12-17 year
> latency. So, the fact that we haven\'t seen people dropping dead in
> droves yet from genetically engineered food should not give us great
> confidence because things can be building up. And, he is not a scare
> monger; he is an eminent scientist. But, he has said that the claims
> about the safety of genetically engineered food rests far more on
> wishful thinking than on solid scientific evidence, and he has told
> the court that these foods should not be on the market unless they can
> be demonstrated safe through rigorous testing, testing which is
> currently absent.
>
> DR. LEHRER: I agree with much of what has been said by my fellow
> panelists, with probably one major exception. First, I think mad cow
> disease is an important reason why Europeans are somewhat distrustful
> of what is told to them about their food supply, or are more concerned
> about their food supply because of their experience with this disease.
>
> In addition, I have several Europeans in my laboratory and we have had
> extensive discussions on this very topic, and I think there are
> cultural differences between Europe and the United States with regard
> to food. I think the Europeans have a very intimate relationship with
> their foods. Americans do to a degree, but also Americans eat very
> quickly. Fast food started in the United States. Americans don\'t
> necessarily have the same cultural relationship with food that
> Europeans do and this may contribute to the process.
>
> Another possibility has been raised in terms of biotechnology being
> developed in the United States, and a lot of these products that are
> being developed are being developed by large American corporations
> that want to market them in Europe, and I think there may be some
> concerns about that in terms of large American companies marketing
> these products there. That may have contributed to it.
>
> I do disagree with the issue of media coverage. Maybe we are reading
> different articles, but my experience has been that I find the media
> tends to sensationalize topics. Particularly with genetically
> engineered foods, many of the articles that I have read, for example,
> with the Brazil nut expressed in soybean, have titles which suggest
> problems in the food supply rather than that this has been identified
> and it is not being marketed. So, at least my experience has been that
> the media does not downplay this in the United States.
>
> MR. LEVITT: For the record, that was Dr. Samuel Lehrer. Finally, Dr.
> Etherton?
>
> DR. ETHERTON: My observation reflects several points that Dr. Lehrer
> shared and Dr. Day. What I would say is that early on scientists, like
> myself, that were engaged in discovery research in plant and animal
> biotechnology discovered that an important element of developing
> products was to become engaged as an advocate to talk about the need
> for new technologies, their evaluation as far as safety to the
> consumer. The rate-limiting step in developing these technologies and
> their implementation is not the discovery or a new technique or the
> idea, it is eventually to talk to the American public about the need
> for and safety, and it is very difficult to talk about these because
> they are complex biologies. A high proportion of people in the United
> States haven\'t had a lot of science education. And, historically I
> think American scientists became more engaged earlier \-- scientific
> organizations did, and I think that is built on the fact that there is
> a cultural difference. I think the people who got on a boat and came
> to North American three or four hundred years were a different gene
> pool than those that stayed behind.
>
> \[Laughter\]
>
> MR. LEVITT: Thank you. Next we will turn to Dr. Stephen Sundlof,
> Director of our Center for Veterinary Medicine.
>
> DR. SUNDLOF: Thank you, Joe. First of all, I would like to compliment
> the panel on a very stimulating discussion. I learned a lot.
>
> I heard two things and, although they are not mutually exclusive, I
> would just like to explore them a little bit. On the one hand, I heard
> that using modern biotechnology you can more precisely transfer
> specific characteristics, specific traits to these genetically
> modified crops as opposed to through traditional plant breeding where
> you may get a number of gene expression products. So, that is one
> comment.
>
> The other comment that I heard also was that there is a potential for
> unknown expression products to occur. So, the question that I would
> like the panel to address is, first of all, I would like to get some
> kind of a sense of the magnitude of the risk. How likely is that
> occur? The example that was given was the L-tryptophan supplement,
> dietary supplement. As a follow-up to that, has the technology
> improved that would make such an expression product less likely to
> occur now than it did back when that incident occurred?
>
> DR. DAY: I must admit that I have not seen a complete account of the
> tryptophane story. The most recent one that I read, however, indicated
> to me that the contaminant problem arose because the company making
> the tryptophane from a genetically engineered microbe omitted a
> purification step. I have not seen any evidence confirming that the
> contaminant was a problem of the genetically engineered organism per
> se. The genetically engineered organism produced more tryptophane and
> the company making the product could make a short cut by eliminating
> the purification step which caused the problem. I am open to be
> corrected on that by other panelists who may have more up to date
> information.
>
> We regard to the question of unpredictable effects from introducing
> transgenes, first of all, the transgene and the associated DNA that
> carries it into the recipient organism can be characterized, and it is
> characterized; the DNA sequence is known. There is the possibility, by
> having flanking sequences of DNA that are homologous to those already
> in the organism, of some control over where it is located.
>
> Now, yes, one has to admit that there is the potential that it might
> have an unpredictable effect. But, when you are comparing that
> operation with what is quite frequently done in conventional plant
> breeding of taking plants that have been isolated from each other
> maybe for hundreds or thousands of years, and they are brought
> together by plant collectors in gene pools and term plasm banks, and
> they are inter-crossed, sometimes with great difficulty because there
> are sexual sterility barriers, and the genetic differences between
> those individuals are very considerable, much more so than the
> precisely characterized DNA that is in an insert, then I think you
> have a much, much greater probability of unpredictable effects.
>
> Jim Maryanski referred to one instance, the product of an unusually
> high level of solanine in a potato variety called Lenape that was
> introduced. It was a hybrid, or derived from hybridization of the
> cultivated potato with a wild Mexican species, and that variety had to
> be withdrawn. He used it as an example of post-release regulation.
>
> None of our food is one hundred percent safe. It may be contaminated
> with microorganisms, spoilage organisms. This is the most important
> problem that we face in our food supply. As a biologist, I can\'t give
> the critics one hundred percent assurance of anything biologically
> because of the nature of the materials that we work with. All I can
> say is that in my opinion, and of many other scientists, the
> comparative risk is much smaller.
>
> MS. FOREMAN: Well, I was going to pass on this and leave it to the
> scientists, but since I spend a great deal of my time dealing with
> microorganisms and their contamination of food products, I just want
> to say, Dr. Day, that in that case the public has some warning about
> the presence of danger, and the capacity by handling food products
> carefully to avoid that danger. That may not be the case when you are
> dealing with these genetically modified organisms. So, now back to the
> scientists.
>
> DR. GOLDBURG: I would like to briefly first comment on L-tryptophan.
> At one point a number of years ago, I spent some time looking at the
> L-tryptophan problem and came to the conclusion really that no one
> knows or is likely to ever resolve what caused the problem with
> L-tryptophan. The manufacturer of the L-tryptophan, a company called
> Show Denko, changed two steps in the production process for
> L-tryptophan, both changing a purification step and the genetic
> engineering of the organism. So, whether the problem was caused by one
> or both of these process changes is unclear. A researcher at the
> National Institute of Health, names Esther Sternberg, invested
> considerable time trying to isolate contaminants in problematic
> L-tryptophan that might have caused the disease and was left with a
> myriad of confusing research results. So, while I think it would be
> wrong to say that genetic engineering caused the L-tryptophan problem,
> it would also be wrong to rule it out as a potential cause.
>
> On to the predictability of genetic engineering, as Dr. Day said, it
> is absolutely true that the genetic sequences that are introduced to a
> food via genetic engineering, or to a crop plant, are well known or
> can be very well known. However, there are some very serious limits to
> how precisely genetic sequences can be put into the chromosomes of
> plants. It is generally not known or not controllable where inserted
> gene sequences land in plant chromosomes, and there is some potential
> there for gene interactions that could have so-called pleiotropic
> effects. Certainly, there has been a lot of study of these effects
> with genetically engineered flowers, looking at flower color, and many
> unexpected effects have been documented.
>
> Whether or not there is more variability in selective breeding or
> genetically engineering I don\'t think we know yet. Genetic
> engineering is still new and I think we are still finding out to what
> extent unexpected effects pose serious health concerns.
>
> I must say, as someone who works to represent environmental and
> consumer interests, my biggest concerns about genetically engineered
> foods come from the really unlimited universe of gene products that
> can be introduced to foods via genetic engineering, and that is what
> makes them really different than traditionally bred crop plants.
>
> MR. DRUKER: Just to say one more point about the L-tryptophan, or
> maybe a couple of points, the reason, by the way, that we cannot
> conclusively rule out genetic engineering or conclusively show it was
> some lax behavior on the part of Showa Denko in their testing
> procedure is that all of the relevant evidence was destroyed before
> the international team of experts could come to the lab and actually
> make the determination. So, it will remain a mystery.
>
> But the fact is, as Dr. Maryanski admitted to the GAO, genetic
> engineering as a process cannot be ruled out. It could not be ruled
> out in 1991 when he made that statement. It still can\'t be ruled out.
> And, the law requires a reasonable certainty of no harm. There is
> reasonable doubt about the process of genetically engineering itself
> \-- and those strange toxins that were produced are the kinds of
> unexpected toxins that the FDA scientists were warning about in the
> statements I read earlier and that many of the scientific experts who
> are plaintiffs in our lawsuit warn about.
>
> What is troubling is that the government tries to deny that any
> genetically engineered food has caused harm. Did then, and recent
> statements continue to boast that no genetically engineered food is
> even caused as much as a sniffle or a sneeze. It is just running away
> from reality.
>
> Now, on the question of whether gene-splicing techniques are more
> precise, again as has been acknowledged, they are precise to the
> extent that you know exactly what genetic material you are putting in.
> They are far less precise in terms of being able to gauge adequately
> what the ultimate effects are going to be and that, of course, is what
> most directly relates to the issue of food safety.
>
> I think it is very important just to give a perspective on what is
> going on from what we already know about information science. Genomes,
> DNA is an informational code. We already know a lot about
> informational codes from our own man-made computer software. And what
> we have learned is that those codes, when they get to a certain level
> of size and complexity \-- we can no longer control what happens when
> we do input. Even when software engineers make a very well calculated
> change to a system that they have completely designed and they have
> the whole understanding of how that system is supposed to interact as
> a whole, we have learned \-- we, meaning the human race \-- that we
> cannot control the unintended effects. In fact, it is to the extent
> that the standard textbooks on software engineering will say if you
> find an error in a program, the best procedure is to leave it alone
> because, by trying to fix that error, the likelihood of creating some
> unintended effect somewhere else in the system is great enough that it
> is better to live with an error than you know about than fix it and
> create one that you don\'t yet know about.
>
> Now, compared to even the most complex man-made computer software
> program the genome of a living organism is far greater and far less
> understood by the human brain. We know very little about it. We know
> it is far more unpredictable and, yet, we are intervening and making
> changes that we should know could make deleterious negative side
> effects that we cannot predict.
>
> It is very interesting, and then I will end, but I think it is
> sobering and I would like the FDA officials to consider \-- the FDA
> currently regulates medical devices, and in that capacity it regulates
> software that runs those devices. If a pacemaker or an x-ray machine
> \-- these are run by software \-- if a company wants to make a change
> in the software code that already is known to be safe, if they make a
> change the FDA requires them to go through rigorous regression testing
> to put that system through almost every possible permutation and
> combination to make sure that no unintended consequences came out.
> Why? Because that is the industry standard. We know that that can
> happen when we change informational systems. Yet, when it comes to
> food safety, the biotech companies are making semi-random insertions
> into the most complex informational systems in the universe and the
> agency says we assume that is the same thing as doing what has been
> happening in a very holistic, natural way for hundreds of thousands,
> millions of years. Go right ahead. You don\'t need to do any testing.
> I think that that dichotomy is so gross that it deserves further
> consideration.
>
> MR. LEVITT: Dr. Lehrer?
>
> DR. LEHRER: I am going to restrict my remarks to allergenicity with
> regard to unintended or unpredicted effects. In my opinion, with the
> current assessment methods in place, I think it is highly unlikely
> that we would have unanticipated allergen being expressed. Certainly,
> when we are dealing with the transfer of proteins from known food
> allergens or altering known foods which contain allergens, this is, I
> would say, almost absolute.
>
> With sources of proteins or genes from foods in which we have no
> information about the allergenicity, I believe based on the levels of
> expression, the digestibility of these proteins, and the comparison of
> properties with known allergens, that it is highly unlikely that there
> would be an unanticipated allergen being expressed. Nevertheless, we
> base this on current technology and, as Dr. Goldburg mentioned, I
> think we can improve our risk assessment and decision-making process
> as technology improves, and I think that we need to devote efforts
> toward that so that we can even minimize an already low or minimal
> risk.
>
> MR. LEVITT: Thank you. Dr. Etherton?
>
> DR. ETHERTON: Thank you. I would like to share that the probability of
> their being an unpredictable or unlikely side effect is very, very
> small. It is important to appreciate, and you heard this morning that
> there is a very, very extensive regulatory and oversight process that
> FDA plays out. This is really the flagship organization in the world,
> and there is a lot of stuff that they require scientists to provide
> that work for companies. There is oversight by advisory panels and, as
> you have heard, there are some emerging technologies. We are now
> standing at the gate where, when a genome is sequenced \-- in other
> words, when we have all of the information for the entire sequence of
> a plant or animal and know all the genes, we will then be able to
> evaluate what are called array techniques, that is, a way to look at
> expression of all these genes to see which are turned on or off.
>
> My point is that when you engineer a plant or animal using very
> precise techniques, I might add, so we can target them out to precise
> locations, then we can look at that effect on all other genes in the
> animal, whether they are turned on, off or are unaffected. That will
> be a powerful step forward.
>
> We also know a lot about structure of proteins and function and, as
> information technologies evolve, we in fact now have very powerful
> ways to predict function. Then, the obvious point is that you evaluate
> this in an experimental setting and provide those data to the
> appropriate regulatory agency to assure that these are as safe as know
> using existing technologies, which are really very powerful. Thank
> you.
>
> MR. DRUKER: If I could just add something to that because on the
> question specifically you asked about the magnitude of risks. In that
> memorandum from Dr. Linda Kahl, of the FDA, she mentioned that there
> is no data that addresses the relative magnitude of the risks. Then
> she says, are we asking the scientific experts to generate the basis
> for this policy statement in the absence of any data? It is no wonder
> that there are so many different opinions. It is an exercise in
> hypotheses forced on individuals whose jobs and training ordinarily
> deal with facts.
>
> So, there isn\'t solid evidence, and I think what you were just
> speaking about is a hypothetical possibility in the future but,
> according to all of the scientists who are plaintiffs in our lawsuit,
> there is no way to reliably predict what the side effects can be of
> the genetic engineering process right now. If it is in place now and
> you can completely predict with great accuracy, then we should know
> about it.
>
> MR. FOREMAN: For those of you out there in the audience who are just
> ordinary people, you might suggest that a little humility up here
> would be a very good thing. That is what they said, yes, nuclear power
> plants \-- they are regulated all the way down the line. There is no
> threat there. There is no threat from dioxin. Every time I hear
> somebody say there is no risk there all of my alarm signals go off.
>
> I think the agency is, frankly, quite humble about the risks involved
> in this, and the scientists who are engaged in it would be well
> advised to be humble too.
>
> DR. ETHERTON: If I could just inject, my comments were clear and
> succinct to the point that there is a lot of value associated with the
> scientific method to create and discover new ideas that, then, are
> subject to critical scrutiny and evaluation by regulatory agencies. If
> you talk to any credible scientist in the world, they embrace that
> philosophy, and I don\'t wish my comments to be construed as saying
> that the scientific method has all the answers. There is nothing that
> is risk free. But we have to bring some process to the issue of how do
> you establish there is something good, bad, truthful or not truthful,
> and in the realm of biological sciences we have hundreds of years of
> developing this infrastructure that we call science. It is wondrous.
> It is confusing to a lot of people but it is a marvelous technique
> that many of us have great faith in and, importantly, very
> importantly, this goes through a regulatory oversight process.
>
> I would submit first-hand evidence with bovine somatotropin \-- I
> mean, there is stacks and stacks and stacks of data that FDA has from
> all the companies that were seeking approval, and they went through
> lots and lots of processes to comply with the law, and all I am saying
> is that process is what we have today based on science. I think it is
> very good to make these decisions about is something suitable for
> entry into the food chain.
>
> MS. FOREMAN: Just for the record, that is the one product out there
> that was subject to a mandatory pre-approval process and post-approval
> monitoring because it had to go through the new animal drug
> application process.
>
> DR. ETHERTON: But in part that was because it was the first animal
> biotechnology that went through FDA and there was a learning process
> on both sides.
>
> MS. FOREMAN: Well, if you want to apply that to all these other
> products I might feel a little better about them.
>
> MR. DRUKER: Also, that is not a very good example because that
> product, the bovine growth hormone \-- it has become clear, and there
> is another lawsuit right now against the FDA brought by the Center for
> Food Safety challenging it because evidence finally came to light
> through the Canadian government that there was important evidence that
> was suppressed by Monsanto originally.
>
> No other industrialized country in the world has approved that
> product, only the United States. By the way, it was approved during
> the era at the FDA when the deputy director for policy, Michael Taylor
> was there. Mr. Taylor had been an attorney representing the interests
> of Monsanto. Then he became appointed deputy commissioner of policy.
> He approved bovine growth hormone, made by Monsanto. He was overseeing
> the policy that approved genetically engineered foods in principle,
> and subsequent to that he went to work directly for Monsanto as vice
> president for public policy. This is hardly the kind of regulatory
> process that should instill consumer confidence. So, again, that
> example shows how weak the arguments are I think.
>
> MR. LEVITT: It looks like the one thing we were able to predict is a
> diversity of views. On this question I will give Rebecca Goldburg the
> last word.
>
> DR. GOLDBURG: Okay, I will try and keep my remarks very brief. I
> wanted to just briefly touch on the matter of certainty of allergies
> since it was brought up and it was one focus of my comments.
>
> Dr. Lehrer, I am somewhat surprised about your feeling so assured
> about the capability of assessing the allergenicity of many proteins.
> My understanding is that you are currently the biotech company
> Agrevo\'s consultant to look at the allergenicity of Agrevo\'s quinine
> CBT toxin for use in corn, which is now being evaluated by the U.S.
> Environmental Protection Agency for its allergenicity. While the
> characteristics of that toxin are somewhat unusual in terms of the
> protein stability, EPA, I understand, has enough uncertainties about
> assessing the allergenicity of that protein that it is planning
> tentatively to hold a science advisory panel meeting on the matter.
>
> So, I would say that there is still a lot to learn about how best to
> assess allergenicity, and while there has been some good work done to
> point towards the sorts of characteristics that allergens have, bit
> steps, there is still a long way to go. Thanks a lot.
>
> MR. LEVITT: Thank you. We are approaching the time for the lunch
> break. Carol Tucker Foreman was right again; we will not get there
> early. On any one of these items we could probably spend an entire
> day.
>
> What we will do, I will give Jim Maryanski the opportunity to ask one
> question of the panel. Then I have kind of a short wrap-up question
> and then we will break for lunch.
>
> DR. MARYANSKI: Thank you, Mr. Levitt. We have had a lot of discussion
> about unexpected effects. FDA, of course, spent a good bit of its \'92
> policy addressing that issue. We have heard about the complex problem
> of L-tryptophan. Of course, it is even more complex than has been
> presented because there were over two dozen cases of EMS linked to
> L-tryptophan that occurred before engineered strains were used. We
> also, of course, have cases of the disease that were apparently
> induced by a related compound, hydroxy-tryptophan. So, the story is
> very complex.
>
> We also have, of course, many products that are produced by
> fermentation, as that product was, that are on the market, and have
> been on the market for many years, ever since insulin was produced by
> fermentation. Of course, there are many pharmaceuticals and food
> ingredients that are produced through that technology.
>
> But the question I really want to come back to, we were talking about
> what, if anything, should be done to change FDA\'s approach to looking
> at these products. If we are to consider asking companies to come in
> either on a mandatory basis or some other basis, we would have to
> think about what is the scope; what would be the nature of the
> products that we would want companies to come in and talk to us about?
> Because, of course, it does mean committing our resources, our
> scientists, to making those reviews, and those reviews would be
> extended reviews that would, of course, take away time from our other
> public health protection activities.
>
> So, I would be interested in hearing from the panel what kind of
> products they would think would really be the products that should
> fall under a review or a notification by FDA.
>
> I would also like to ask the panel if they are aware of any scientific
> information. As I have heard it this morning, it sounds more like it
> is primarily a matter of enhancing public confidence which is, of
> course, important. But I am not aware of any scientific information
> that has been found by any other government \-- and there is a number
> of these products that have been approved by countries around the
> world. So, in those evaluations I have not heard any different
> decisions than have been made in this country.
>
> So, I would like to ask the panel if they are aware of any scientific
> findings by others that would bear on the safety of these products,
> and what would be the scope of products that should come to FDA in any
> system that we have in place? Thank you.
>
> MR. LEVITT: Just for clarification, Jim, when you say scientific
> findings, do you mean results from studies?
>
> DR. MARYANSKI: Yes.
>
> DR. DAY: That is a very broad question, and I find it difficult to be
> concise in answering. But let me start by saying that I don\'t think
> we should treat the products of genetic manipulation any differently
> from those of conventional plant breeding, and I think this has
> occurred to others in the past. That is, if you are concerned about
> unpredicted effects, well, apply these to the products of crosses,
> hybridizations, between distantly related species in a plant breeding
> program.
>
> Now, the difficulty comes in identifying what is a complete test of
> safety. There are tens of thousands of different proteins produced by
> plants. In the analysis of the Flavr Savr tomato, Calgene concentrated
> on the obvious nutritional components of tomatoes, and they looked to
> see if known toxicants \-- there is an alkaloid called tomatine which
> is present in unripe fruit, to see if that were increased. They looked
> at a variety of other compounds, but how could they claim to have
> looked at everything because if they had looked at everything they
> would still be looking, and one questions what the value of such a
> complete analysis, assuming that it is possible, would be.
>
> So, I think we are faced with identifying standards that are going to
> be impossible to realize. If we insist on doing this, then we are
> going to drive up the cost of our food, and my question is why are we
> doing this? What evidence is there to convince us that this is a real
> risk either in the products of conventional plant breeding or of
> genetic manipulation?
>
> MS. FOREMAN: Dr. Maryanski, I laid out, based on Mike Jacobson\'s
> suggestions last week, three different levels of review that you might
> use if you wanted to require some differentiation in review, and I am
> not going to go through them here; they are in my written comments.
>
> Science is a part of the process of making public policy, and it is
> only one part. The other part does involve whether or not the public
> is confident with the process.
>
> Dr. Day, I would be willing to bet you money that you are not going to
> see any reduction in the price of food in the United States as a
> result of the introduction of BT corn or any of the other products of
> biotechnology. The basic commodity price is such a tiny portion of the
> cost of food. We pay today for having our food wrapped two or three
> times, and processed and reprocessed, and then cooked for us so we can
> take it out and take it home. If the relationship between commodity
> prices and food prices were anywhere close to being tight, we would be
> out there buying pork for a dime these days.
>
> Again, I just want to finish \-- I am probably the most sympathetic
> person in the public interest community up here to the products of
> biotechnology, but none of those that have been developed yet have any
> benefit to the consuming public. We keep hearing that there are those
> in the pipeline that will, but they are way back in the pipeline, way,
> way back. When they move to the front of the order and you begin to
> see vitamin A rice out there being used in developing countries to
> stave off blindness among a hundred million children that are at risk
> of it, then I may feel a lot differently about this process. It is
> that balancing that I think the larger public has in mind with regard
> to this process.
>
> DR. GOLDBURG: I am not sure i can answer your entire question, Jim,
> although I know, or at least I suspect that at one time you wrote
> EDF\'s 1991 70-page proposal to the Food and Drug Administration about
> how the agency should regulate genetically engineered foods, and I
> think that proposal still stands.
>
> That said, I would like to make a couple of comments. One is that I
> disagree with Peter Day and I don\'t think that the products of
> genetic engineering should be treated the same as those of traditional
> plant breeding. I think there are important differences between
> genetically engineered foods and those derived from traditional plant
> varieties.
>
> With genetic engineering the entire universe of genetically encoded
> traits is now available to put into crops and, therefore, into foods.
> For example, one can breed potatoes with other cultivated potatoes or
> maybe related wild potatoes. You can\'t breed a potato with a fish, or
> a chicken, or a moth, or a bacterium or a virus and, yet, all or most
> of those things have been done with genetic engineering.
>
> So, I think that this universe of new traits, not new proteins at the
> moment, but in the future also altered biochemical pathways in plants
> that may produce new oils, new secondary plant products, all sorts of
> things opens up a universe of large changes to food that merit
> government regulation in a way that traditional plant varieties have
> not.
>
> That said, I am not aware of any examples of dangerous products other
> than the ones I am sure you are already aware of, Jim, like the Brazil
> nut gene.
>
> Finally, I think that when you ask this panel or ask in general are
> these products dangerous, I think you are asking the wrong question.
> Foods are not like pesticides. We don\'t ask are they dangerous; we
> ask are foods safe, and that is the question that the Food and Drug
> Administration should be asking.
>
> DR. MARYANSKI: If I could follow up, because we have a number of foods
> that come to market that I think, as Dr. Day indicated, are from germ
> plasm that is obtained from possibly inedible plants. We have plants
> that have been crossed, like broccoflower, where they are typical
> foods but they are plants that we know have many natural toxins. Are
> these examples that you would exclude from particular oversight by
> FDA?
>
> DR. GOLDBURG: Well, I would welcome a look by FDA at this juncture at
> products of selective breeding. Although I have emphasized the
> differences between genetic engineering and traditional breeding, it
> is true that there are a number of techniques now commonly employed by
> traditional plant breeders, like embryo rescue, that have opened up
> the range of new traits that can be inserted into plants and into
> foods. It is conceivable that some of those inserted traits may bring
> some safety problems. It is possible that some breeding may elevate
> levels of secondary plant compounds that are dangerous to people. And,
> I think the FDA could do more to look at those products in addition to
> genetically engineered foods. If the current concern over genetically
> engineered foods motivates a greater look at plant breeding, I think
> that is a good thing.
>
> MR. DRUKER: Following up on Dr. Goldburg\'s points, Dr. Maryanski, in
> the case of making wide crosses between a potato with wild relatives,
> we already know what factors in potatoes are potentially problematic
> and so the way we were able to know to get those potatoes off the
> market was that people did experiments, and they found out that those
> levels were higher.
>
> In the case of genetically engineered food, what many of the FDA\'s
> own scientists, and many scientists outside the agency that are suing
> it, and many others are saying is that there is a risk that we cannot
> completely quantify at the time, but a risk in the minds of reasonable
> scientists that there could be the production of toxins, carcinogens,
> allergens and other anti-nutritive elements that are completely
> unexpected.
>
> Again I will refer you to the memoranda from Dr. Matthews from the
> Division of Food Chemistry and Technology, that is the problem; it is
> the unknown factor. Dr. Day, you were saying, well, you can\'t expect
> Calgene to have tested for everything; they would still be testing.
> What we can expect, and what the law demands, is that they must be
> tested and confirmed safe to a reasonable certainty they will not
> produce harm.
>
> In the case of a genetically engineered food, the only way to begin to
> approach that standard is to subject each food to, first, rigorous,
> long-term animal feeding studies, and the, if it passes those studies
> it would have to move on to clinical and human feeding studies because
> animals are often not the best model.
>
> One reason the industry does not want to do that is that in the case
> of using a whole food that would be a very long, expensive and
> difficult process, but that is the law. If you don\'t want to follow
> the law, then the thing to do is to go to Congress, say, look, this is
> a great new technology; we think it will feed the world. Change the
> law. But that would bring the process out into the open and debate,
> and you would have many experts to tell you there are many other ways
> to feed the world without using genetic engineering. It is not a do or
> die technology. If it has so many inherent safety risks we don\'t need
> to use it. Or, we need to change the law. But, let\'s not do it
> surreptitiously, claiming we are following sound science and following
> the law when, in effect, we are violating sound science and violating
> the law.
>
> Just to end with that point again, the mere fact we can have,
> obviously, people like Dr. Day and Dr. Etherton who can stand here and
> say I don\'t think there is a risk, but I can point to myriads, or at
> least scores and scores of other well credentialed experts who say
> they do think there is a risk. The law says, and the courts are clear,
> that you can\'t have food safety issues decided on competing
> hypotheses. They need to be based on solid evidence.
>
> I again invite you, Dr. Maryanski, if you have solid evidence that
> even one genetically engineered food has been confirmed safe to
> reasonable certainty of no harm, then bring it forth because clearly
> the Flavr Savr tomato wasn\'t and no other genetically engineered
> food, in my knowledge and the knowledge of our scientists, has passed
> that standard, and that is the situation that we are faced with. So, I
> think we need to be honest and forthright, and if genetic engineering
> cannot pass legal muster, so be it. Let\'s focus our resources on
> other ways for feeding the world.
>
> MR. LEVITT: Dr. Lehrer?
>
> DR. LEHRER: I agree with Dr. Day that first and foremost we should
> base any decisions on sound scientific principles. These decisions
> should not be made on emotion or hearsay. They should be made on terms
> of sound science. I think that is extremely important. hat
>
> I do not believe that genetically modified foods should be treated any
> differently than other foods. In other words, I don\'t think that we
> should raise the bar for these foods to pass. We should use the same
> approach that we are using for other foods in our tests. Actually, in
> some cases, even with allergy, we have done this because many of the
> foods that we now have would not be accepted, such as rice, corn,
> peanut, soybean, which all contain allergens and if they had to go
> through the approval process they would not be released.
>
> Finally, I agree with two of the former speakers who indicated that
> they felt that the public being involved, particularly in terms of
> these kinds of conferences, is a very positive approach because I
> think that this will give the public an opportunity to express their
> concerns about these products. These concerns can be taken into
> account by the FDA. I think also the public may learn a little more
> about what goes into the process of assessing the risk of these
> products.
>
> MR. LEVITT: Thank you. Dr. Etherton?
>
> DR. ETHERTON: Thank you, Mr. Levitt. I would just echo the comments
> that Dr. Lehrer shared with you, that decisions about safety and
> efficiency with which new plants or animals produce food be based
> using scientific method, and the power of science and, as I have said
> earlier and will reiterate again, to go through a very rigorous, due
> diligence-based review by experts that is an inclusive, not exclusive,
> process and, as you have heard today, an opportunity where the public
> may comment.
>
> My view and that of FASS is that the Food and Drug Administration is
> doing everything within the powers that science has, legal policy that
> mandates food approval, and guidelines that they set forth. We have a
> very good system. It might need to be tweaked but it has served us
> well for many, many years. Thank you.
>
> MR. DRUKER: I forgot, Dr. Maryanski, that in specific answer to what
> you asked, there are studies in the scientific literature that have
> documented the production of unexpected toxins in genetically
> engineered plants, and have documented the suppression of native gene
> expression by the insertion of foreign genetic material. In fact, some
> of those are referenced in literature that is in your own scientific
> record. If you would like some of that, I am sure that I could get
> some of our scientific plaintiffs to prepare you a memorandum on it.
> Thank you.
>
> MR. LEVITT: Thank you, all. This really has been a terrific panel.
> Before everybody leaves, I am going to ask the panelists to answer
> quickly one \-- I won\'t say one simple question but one short
> question with, hopefully, a short answer.
>
> That is, if you could look ahead a year from now and say a year from
> now we all reconvene, and the FDA during that year had done \"blank,\"
> what would that be? I would like to say if there was one thing FDA
> could do in the next year, you know, what would that be.
>
> While you are thinking about that, because I kind of sprung that on
> you, let me just say a couple of things to the people in the audience.
> Number one, I have to really compliment all of you. I have been to a
> lot of these meetings and rarely do we find an audience that is so
> attentive, that stays through every bit whether it feels like
> lunchtime or not. Clearly, there is a lot of interest from the public
> in this issue. I wanted to comment on that.
>
> When we break for lunch, there is a cafeteria in this building
> downstairs. There are public eating places within a short walk. If you
> wander over towards the Metro station at Federal Center Southwest, you
> will find a number of luncheon places. If everybody doesn\'t go to the
> same place, there will probably be room enough to accommodate
> everybody.
>
> With that, I have given you enough advance notice now. This afternoon,
> a lot of people, for their whole trip get only two minutes. You have
> had a couple of hours over here. You get between thirty seconds and
> one minute to role model for everybody else. A year from now, what
> would you like to see FDA have done?
>
> DR. DAY: Mr. Chairman, could you start at that end?
>
> \[Laughter\]
>
> MR. LEVITT: All right. I was waiting for that. Why not? A little
> variety!
>
> DR. ETHERTON: I would argue that FDA needs more resources to higher
> additional folks, with resources and expertise in a number of areas,
> to allow them to be positioned to accelerate the review process once
> data has been submitted by the private sector companies. That would
> help.
>
> MR. LEVITT: Thank you. Next?
>
> DR. LEHRER: I agree with that. I would like to see more funding
> available to improve risk assessment methods, and I also think this
> type of forum is very useful for the public and should be continued.
>
> MR. DRUKER: I would like to see the U.S. Food and Drug Administration
> uphold its statutorily mandated responsibility to protect the safety
> of the nation\'s food supply, and not to allow any new food additive
> on the market unless it has been established safe through sound
> scientific principles. If it does do that, then as a natural outcome
> all genetically engineered foods would have been recalled from the
> market; no new ones would be approved until each and every one was
> established safe according to the sound scientific principles that
> Congress wanted to be in place to protect our food supply.
>
> DR. GOLDBURG: I would like FDA to revise its 1992 policy in three
> ways. One is to remove the provisions of the policy that lower the bar
> for substances added to foods via genetic engineering compared to
> those added via food processing.
>
> I would like FDA to institute a mandatory notification requirement for
> marketing of genetically engineered foods.
>
> Finally, I would like FDA to revisit its policy for labeling of
> genetically engineered foods.
>
> MS. FOREMAN: I knew if we stayed around long enough I would agree with
> Dr. Etherton on something \--
>
> \[Laughter\]
>
> \-- which is the need for more resources for the Food and Drug
> Administration. If Jim Maryanski gets hit by a car going out to lunch,
> there is no biotechnology program at the Food and Drug Administration.
> It is as close to a one-man shop as has ever existed in government.
>
> Your rule-making never takes only a year, but I would like you to have
> begun the process of having some mandatory review and approval based
> on the concerns raised by different kinds of genetically modified
> organisms, and certainly a policy for mandatory labeling.
>
> MR. LEVITT: Dr. Day, you had the first word and you will have the last
> one.
>
> DR. DAY: Thank you. Clearly, FDA is going to do some very deep
> thinking after this session and the one it is going to hold in
> California. FDA has a great responsibility, clearly, because it plays
> such an important role in food safety.
>
> I agree with the other panelists that FDA should reconsider how it
> sets about making its decisions, but I would urge them not to lower
> bars but to recognize that there are risks in the food supply from
> genetic manipulation and from conventional breeding, and I would hope
> that by this time next year they will be well advanced with further
> public debate to present a new approach. I doubt if we can all be
> satisfied with it, but clearly they need to continue to hold this in
> the light and reach a reasonable conclusion.
>
> MR. LEVITT: Thank you, all. If we could have a round of applause?
>
> \[Applause\]
>
> Again, I thank everyone. My clock says it is a couple of minutes after
> one. We will reconvene promptly at two o\'clock in this room.
>
> \[Whereupon, at 1:05 p.m. the proceedings were recessed, to be resumed
> at 2:00 p.m.\]
>
> AFTERNOON PROCEEDINGS
>
> **Session 3: FDA Policy: Labeling**
>
> MR. LEVITT: If I could have everybody\'s attention, please? It is two
> o\'clock and it is time to get started with this afternoon\'s session.
>
> Before we get going, I have a couple of announcements. The first is a
> call to see if there is anybody in the audience that is hearing
> impaired and needs a sign language interpreter. We do have an
> interpreter available, and if there is anybody here who needs that
> service we will be more than happy to provide it. Please identify
> yourself to him. He is standing over here, to my right and to your
> left. Thank you for being available.
>
> Second, if I could just make a request for people with cell phones \--
> while we couldn\'t quite hear them up here, I did get a number of
> comments from people in the audience. If you are in the audience and
> you have a cell phone, if we could ask you to turn it off while you
> are in here. Obviously, if you need to make a call you can go out into
> the hall and do that.
>
> Finally, I think I will go ahead and introduce the panelists now, even
> though it will be a moment before we get to them, and in so doing note
> that we have one substitution from your program \-- after Mr. Lake, of
> course.
>
> On my immediate left is Dr. Mario Teisl, assistant professor,
> Department of Resource Economics and Policy, University of Maine.
> Welcome down from New England.
>
> Next, we have Dr. Mildred Cody, associate professor of nutrition,
> Georgia State University. So, we have northeast; southeast.
>
> Next, we have Richard Caplan, environmental advocate, U.S. Public
> Interest Research Group. Welcome.
>
> Next is our one substitution. I would like to welcome Richard Frank,
> and attorney with the law firm of Olson, Frank and Weide, who is
> outside counsel for the Food Distributors International and he is here
> substituting for Mr. John Gray who is listed on your program.
>
> Next, we have Dr. Kendal Keith, president, National Grain and Feed
> Association.
>
> Finally, we have Robert Cohen, founder and executive director of
> America\'s Dairy Education Board.
>
> Our format this afternoon will be similar to this morning. We will
> begin with a summary of FDA\'s policy and program in the area of
> public information, including labeling. Mr. Robert Lake, who is our
> Director of Regulations and Policy and really, if you will, the senior
> person at CFSAN in terms of length of experience and knowledge on
> issues. Bob, welcome and we will look forward to hearing your
> presentation.
>
> **Session 4: Public Information and Labeling**
>
> MR. LAKE: Thank you. Actually, I had two slides. They both somehow
> managed to disappear but I have my hard copy so I will use that as
> prompts.
>
> Again, let me add my welcome to all of you. This afternoon we are
> focusing on information, at least on this panel, and that includes
> labeling but it also includes other kinds of information.
>
> As with safety, the governing statute is the Federal Food, Drug and
> Cosmetic Act which contains the definitions and standards that govern
> food labeling as well as food safety.
>
> The principal requirement of the Act as it relates to labeling is that
> labeling cannot be false or misleading. The statute also, of course,
> has a number of very specific requirements. Most of you are familiar
> with the nutrition label on your food panel. That is mandated by
> statute and implemented by FDA regulations. But things as basic as the
> name of the food, I mean, that is a requirement that you identify what
> the food is on the food label.
>
> Indeed, that is one of the areas where our labeling policy relative to
> biotechnology comes into play because if you modify something like
> canola or soy oil in a way that you change its characteristics \-- and
> Dr. Maryanski used the example this morning of a soy oil that was
> modified to emphasize one particular fatty acid which made it more
> acceptable for high temperature cooking, but it would not have been
> proper to identify it as regular soy oil because its characteristics
> had changed. So, in situations like that we require that the name of
> the product be modified to reflect the nature of the change.
>
> The Food, Drug and Cosmetic Act also makes provision for labeling of
> material facts when you either have something on labeling that is
> incomplete \-- it is sort of like once you start to tell a story you
> have to tell the story, that kind of notion, but also the notion that
> you need to tell people the consequences of characteristics of a
> product. This is another area where existing labeling policy with
> regard to genetic engineering comes into play.
>
> Obviously, the presence of an unexpected allergen in a food has
> consequences to the consumers of those foods who might be allergic to
> that substance and, therefore, should that occur, FDA\'s existing
> policy would require labeling to alert the consumer that there is
> something in this product that might be an allergen that has been
> introduced by this technology, should that occur.
>
> The other possible consequences that could affect labeling under
> existing policy would be significant changes in nutrition, or anything
> else that fundamentally altered the consumer\'s expectations with
> regard to the characteristics of the food.
>
> We expect to hear this afternoon some discussion about mandatory
> labeling. We also expect to hear some discussion about voluntary
> labeling. Voluntary labeling raises the challenge of what is the
> message that the label is intended to convey to consumers; also raises
> the question of what the consumer\'s interpretation of the words on
> the label are going to be.
>
> Again, going back to what I said a moment ago, label statements have
> to be truthful and not misleading. It is really the misleading
> component that is an issue here because it is possible to put truthful
> information on a label in a way that causes consumers to draw a
> conclusion that is false. So, this is the challenge that always faces
> anyone designing a food label, and it is a constant challenge to the
> Food and Drug Administration in our enforcement activities to try to
> assure that label statements, as they are commonly understood, will
> not mislead consumers.
>
> The other thing I would like to emphasize is that while labeling is
> something that we are going to hear a lot about this afternoon, from
> our standpoint it should be part of a larger discussion about
> providing information to consumers. Statements on a label are
> certainly one way of doing that, but there are other possibilities as
> well that could be used either individually or in conjunction with
> each other. For instance, the growing popularity of the worldwide web
> raises the issue of whether more information could be made available
> on the web. We have also some experience with 1-800 numbers, hotlines,
> things of that sort, and whether that kind of mechanism might be
> useful as a way of providing some information. There is also the
> possibility of brochures that would be perhaps made available in
> grocery stores or other retail outlets to provide additional
> information, and there may be other possibilities that I have not
> mentioned. We are hopeful that both in the panel discussion and later
> when we get to individual comments from the floor that perhaps there
> may be some ideas that we haven\'t thought about that might be worth
> considering.
>
> So, with that, let me sit down and turn the program back over to Mr.
> Levitt for the next panel. Thank you.
>
> MR. LEVITT: Thank you very much for kind of setting the context for
> this afternoon\'s discussion. Again, discussion will focus on
> providing information to consumers. Our first speaker is Dr. Mario
> Teisl, from the University of Maine, and again I would ask that each
> speaker try to limit yourself to about five minutes, and that will
> allow plenty of time for questioning and discussion back and forth.
> Dr. Teisl?
>
> **Panel Discussion**
>
> DR. TEISL: Thank you. Thanks for inviting me. Good afternoon. There
> are many possible labeling strategies for genetically engineered
> foods. We could go on for hours, but to keep things simple I am going
> to discuss FDA\'s current policy and a policy where all genetically
> engineered foods exhibit a label stating something like this food may
> contain genetically engineered components. Components of this
> alternative usually state that it is a consumer\'s right to know that
> a food is genetically engineered.
>
> Today I would like to use a benefit-cost paradigm to show that both of
> these approaches are limited. Under this paradigm, a labeling policy
> is justified if the policy\'s benefits are greater than its costs. But
> what are the costs and benefits of a labeling policy?
>
> In general, the benefits of labeling can be measured by the label\'s
> ability to allow consumers to make choices congruent with their
> preferences. Firms that produce these goods also benefit as they are
> rewarded for the provision of these attributes.
>
> However, labeling is not free. There are financial costs, the costs of
> providing the information and verifying the information. Some
> proportion of these financial costs will be passed on to the consumers
> in the form of higher food prices, reduced product choice or possibly
> increased taxes or reduced ability for the FDA to monitor some other
> food safety problem.
>
> More importantly in terms of labeling is that labeling can impose
> cognitive costs on some consumers. Simply increasing the amount of
> information content on a label may actual decrease the consumer\'s
> ability to process other more important label information. In
> addition, requiring specific information to be placed on a label
> imposes an opportunity cost in that the limited space on the product
> label could have been devoted to other potentially more useful and
> important information. Because information content is competing for
> valuable space on the label, labeling requirements have to be
> justified in terms of the importance of the required information. A
> prescription such as \"more information is better\" does not
> necessarily characterize an optimal labeling policy.
>
> Now I would like to look at the current debate surrounding the
> labeling of genetically engineered foods. Under the benefit-cost
> paradigm, FDA\'s current policy is justified but limited \-- justified
> because when health and safety are concerned the benefits of a
> labeling policy are likely to outweigh the costs. However, the policy
> is limited in that there may be other consequences, for example,
> environmental consequences, that are important enough to consumers
> that a regulated labeling program makes sense under a benefit-cost
> framework. On the other hand, the consumer right to know position is
> also limited in that taken to the extreme all product attributes, no
> matter how irrelevant, would have to be disclosed. A decision to
> impose labeling requirements should recognize both the benefits and
> the costs.
>
> Now that I have presented a viewpoint that [a priori]{.underline} does
> allow foods to be labeled as genetically engineered, I want to present
> the attributes of a successful labeling program and analyze how a
> simple GE label would fare.
>
> The success of labeling programs is usually continent on five points.
> First of all, the label information must be new to consumers. The
> information must be understood by the consumer. The information allows
> consumers to differentiate products. It is seen as important by
> consumers and the information is seen as credible.
>
> Let\'s take these points one by one. Point one, the information on the
> label is new to the consumer. By all indications, this we be true for
> even a simple GE label.
>
> Point two, the label information is understood by the average
> consumer. Here we have a problem. Although most consumers in the U.S.
> are aware of the term genetically engineered, the majority does not
> correctly understand this term.
>
> Point three, label information must allow consumers to differentiate
> products. Again, here is a problem. A simple GE label will not allow
> most consumers to differentiate products in the matter they most
> desire because the process of genetic engineering can produce a wide
> variety of consequences. When making food choices, a consumer may want
> to know whether the food contains an allergen, or that the food
> contains higher than normal levels of antioxidants, or whether the
> food\'s production harms butterflies. A label that simply states \"may
> contain genetically engineered components\" is not helpful because it
> does not provide enough detail. Imagine if FDA replaced the nutrition
> facts panel with a good food label.
>
> Point four, the label information is seen as important by a
> significant portion of the population. Given the previous point, it
> seems that a genetically engineered label would provide important
> information only to consumers who want to avoid genetically engineered
> foods simply because of the process. I do not know of any directed
> research that has indicated that a significant portion of the U.S.
> population desires such a label solely to avoid the process.
>
> I have to clarify what I mean by directed research. It is a common
> tendency for consumers to state that they want more information. If
> you ask them if they want more information about GE foods, they will
> say yes. However, you may find that consumers don\'t actually use this
> information until you experimentally test it. I will just defer
> discussion of point five for the moment.
>
> Given the above, a sound labeling policy for genetically engineered
> foods will probably include the following: Number one, mandatory
> labeling of GE foods that are significantly altered from consumer
> expectations of the food.
>
> Number two, mandatory label of any foods, not GE foods, that provide
> significant consequences. Further, the definition of consequences
> should be broadened to include the possibility of non-health and
> process-related attributes.
>
> Number three, labeling falling under the aforementioned point should
> focus on the consequence, not the process.
>
> Number four, only if directed research indicates that a majority of
> Americans want to know about genetically engineered foods, over and
> above knowledge of the consequences, should a genetically engineered
> label be made mandatory, buying this condition of voluntary labeling
> approach, similar to that of the kosher label, would be much more
> appropriate.
>
> Now back to point five, the information is seen as credible \-- the
> credibility of a label is at least partially a function of who is
> perceived as monitoring and enforcing the labeling program. It is
> unclear to me who should promulgate and enforce these labeling
> regulations because traditionally FDA and several other government
> agencies have been overseeing programs focusing on health and safety
> labeling, while other agencies have been charged with monitoring
> environmental claims. Further, I am not sure whether a label should
> even be administered by a governmental agency. Consumers often state
> that they find third-party non-governmental organizations to be much
> more credible. However, a governmental agency may be more credible
> than a non-governmental organization that has low name recognition.
>
> One thing is clear though, whatever labeling policy we do proceed
> with, whether it is voluntary or mandatory, the labeling of the
> product should be standardized so as to decrease consumer confusion
> and increase label credibility.
>
> I would just like to finish by pointing out that given the low level
> of consumer understanding of genetic engineering, the concepts, the
> complex nature of genetic engineering and its many possible many
> consequences, and the space constraints of many food packages product
> labels may not be the best method of disseminating information about
> genetically engineered foods.
>
> Possible alternatives to labeling have already been mentioned. For
> example, placing a list of foods made with genetically engineered
> components on the Internet, or publishing it as a book, similar to the
> Greed Guides that currently assist environmentally concerned consumers
> in making their product choices. Thank you.
>
> MR. LEVITT: Thank you very much. Next is Dr. Mildred Cody, Georgia
> State University.
>
> DR. CODY: Good afternoon. This afternoon I am representing the
> American Dietetic Association. ADA\'s mission is to promote optimal
> nutrition and well being for all people by advocating for its 70,000
> members. This 83-year old organization provides a sound analytic
> bridge between scientific research and consumer interest.
>
> We commend the Food and Drug Administration for holding this series of
> meetings to share information about biotechnology. Few issues have
> engendered such interest and emotion, with views ranging from highly
> positive to highly negative.
>
> ADA has actively monitored biotechnology issues since the early 1990s,
> and continues to bring a unique perspective to the complex issues
> surrounding biotechnology and its potential impact on our lives. ADA
> members have expertise in science and consumer education, both of
> which bear on the questions surrounding food and food products derived
> from biotechnology.
>
> We are committed to providing our clients, the American consumer, with
> accurate, science-based information on bioengineered foods in a way
> that is both understandable and balanced. ADA\'s position is that
> biotechnology techniques have the demonstrated potential to be useful
> in enhancing the quality, nutritional value and variety of food
> available for human consumption. Biotechnology can also increase the
> efficiency of food production, the efficiency of food processing, the
> efficiency of food distribution and waste management.
>
> As part of the ADA five-year review cycle, we are reassessing this
> position, which will be published in the summer of 2000. With all
> food, nutrition and health issues related to biotechnology, we see our
> educational efforts for health professionals and their audiences as a
> major ongoing task. For example, ADA has launched an intensive
> three-year media and public education campaign on food safety. This
> campaign was developed after an ADA study showed a significant gap
> between knowledge and practice on a number of key issues related to
> food-borne illness. In less than six months this campaign has reached
> more than forty million consumers across the United States.
>
> As we have heard today, biotechnology is broadly used in medicine and
> is increasingly applied to food production. While ADA believes that
> the U.S. regulatory system, based on scientific processes and public
> input, serves the nation\'s economic and consumer interest well, that
> does not imply that there isn\'t work to do. It will take a continuous
> effort for the regulatory system to keep pace with advancements in
> biotechnology.
>
> In these meetings, numerous organizations and individuals have offered
> recommendations on how improvements should be made. We urge federal
> regulators to look carefully at the merits of these new ideas and
> approaches, and refine the U.S. system to best promote the safety of
> the U.S. food supply; to allow the continued advancement of food
> product and science techniques to serve over-arching economic,
> environmental and health needs; to increase the availability of
> nutrient-rich, high quality foods so that all may have access to
> healthful diets; and to provide useful, scientifically-based
> information to those who wish to know more, including health
> professionals and self-informing consumers.
>
> This last point is where I will focus the remainder of my remarks. A
> recent national consumer survey found that two out of three consumers
> support foods produced through biotechnology and have confidence in
> FDA\'s current policy for food labeling biotech foods.
>
> We cannot afford to undermine this existing consumer confidence
> surrounding biotechnology. ADA supports labeling approaches that let
> consumers make informed decisions in their food selections. As we
> know, many complex factors affect food choices. The questions are can
> we develop labels that provide useful information without being
> misleading or confusing? Is the food label the best place for
> information on biotechnology, or would other mechanisms of
> communication better serve the public?
>
> Healthcare providers, such as qualified dietetics professionals,
> translate sound science concerning safety and health needs to help
> individuals make appropriate food choices. In this light, we see the
> need for a comprehensive approach to biotechnology information
> dissemination and education. The coordinated oversight of
> biotechnology by FDA, USDA and EPA needs to be strengthened by the
> contributions of scientists and industries, healthcare professionals
> and educators, consumer organizations and others into a concerted
> national information initiative. No one group \-- not government or
> industry, not scientists or consumer advocates \-- can successfully
> address the information and trust gaps developing around
> biotechnology. But, together each can play to their strengths in
> support of a safe, nutritious and consumer-valued food system.
>
> We believe U.S. consumers, accustomed to a system that has served them
> well, have been patient as the information on biotechnology comes
> together and is made available to them. It is now time to act. The
> American Dietetic Association stands ready to work with FDA and others
> in developing a communication strategy focused on bioengineered foods
> that will help consumers make informed food choices to optimize their
> health.
>
> Thank you for allowing me the opportunity to share the American
> Dietetic Association views on this important issue, and thank you for
> your attention.
>
> MR. LEVITT: Thank you very much. Our next speaker is Richard Caplan,
> U.S. Public Interest Research Group.
>
> MR. CAPLAN: Good afternoon, and thank you all for your interest in
> this subject. My name is Richard Caplan and I am a clean water and
> food safety advocate with the U.S. Public Interest Research Group, or
> USPIRG. USPIRG is the national office for the state PIRGs advocate
> groups with offices around the country, working on consumer rights,
> good government and environmental issues. For over twenty-five years,
> the PIRGs have been one of the nation\'s leading non-profit,
> non-partisan organizations working in the public interest.
>
> We are gathered here today on what, I have no doubt, will prove to be
> a historic day. November 30, 1999, as I am sure most of you know, is
> an international day of action with regard to the World Trade
> Organization. Today, in cities around the world people are rising up
> to speak out against the non-accountable trade body that has made
> decisions antithetical to good governments. Rulings of the WTO have
> resulted in the weakening of U.S. environmental laws, demonstrating
> that the ultimate goal of the organization is to make trade and money
> superior to people and their true needs.
>
> The WTO offers an interesting link to our topic today of bioengineered
> foods. Just last week, the director general of the WTO, Mr. Michael
> Moore, phone the head of the World Health Organization and told her
> explicitly not to bring up the issue of biotechnology in the WHO right
> now because, as he said, I have too much on my plate. Unfortunately
> for those of us who care about public health, Dr. Brunman agreed and,
> thus, again as in so many other issues it is the consumer who must
> rise up to speak out against government complacency.
>
> Since the public hearing held by the FDA in Chicago, on November 18,
> an interesting report was published in [New Scientist]{.underline}
> magazine that further raised the vaunted claims of the proponents of
> bioengineered foods, demonstrating speculation upon which their claims
> are based.
>
> It seems that the stems of genetically engineered soybeans were found
> to crack open in hot climates, resulting in crop losses of up to forty
> percent. It is important to note that this is not the first example of
> the promises of DNA experiments gone wrong. Problems have included a
> massive crop failure of genetically engineered cotton in 1997. A list
> of controversial claims by proponents of this risky technology is
> long, including the safety of recombinant bovine growth hormone or
> rBGH.
>
> As mentioned on the earlier panel, rBGH has been rejected in every
> major industrialized nation. In fact, a recent report by Health Canada
> indicates that the FDA misreported the findings of Monsanto\'s
> ninety-day rat feeding study. Even the heavily corporate-influenced
> Kodak\'s alimentary commission has refused to certify the safety of
> rBGH despite heavy pressure from the United States. Yet, we are forced
> to eat and drink products from cows injected with rBGH in secret
> because of prohibitive labeling requirements written for the FDA by a
> Monsanto employee. Surely, one would think products that are
> ecologically risky or offer no benefit to the consumer would not be
> allowed, but that does not appear to be the case here.
>
> Regarding ecological risk, it was recently reported on the front page
> of [The New York Times]{.underline} that, quote, scientists who study
> the approvals \-- and we are now talking about the USDA \-- say the
> department has frequently relied on unsupported claims and shoddy
> studies by the seed companies, end quote.
>
> In an analysis of 8,200 university research trials of genetically
> engineered Roundup-ready soybeans, published this summer, revealed
> that farmers planting the soybeans are using two to five times more
> herbicide than farmers growing conventional varieties. This is in
> addition to the fact that the trials displayed an overall yield drag
> of 5.3 percent. The study also correctly points out that failure to
> test the crops for increased residues of Roundup, an herbicide that
> despite being linked in studies to non-Hodgkin\'s lymphoma, had its
> allowable residue limit increased by the EPA under pressure from
> industry.
>
> The failure to adequately establish a system for premarket safety
> testing, the failure to demonstrate that these products are necessary
> or useful, as well as the profound ethical issues raised by altering
> the genetic code of living things in the laboratory and then releasing
> them in the wild, among many other reasons, have all resulted in the
> call to the FDA to change the way they are handling this issue, and
> the call is not a new one.
>
> When the agency published its statement of policy in 1992, the public
> overwhelmingly indicated their desire for the labeling of these foods,
> a request that was ignored by the FDA. Surveys between then and now
> have demonstrated the same strong and unwavering sentiment and, yet,
> the public\'s desires have been stonewalled.
>
> Earlier this month, University of Maryland\'s program on international
> policy studies released the results of a poll that they conducted
> which, again, demonstrated the support of over eighty percent of the
> American public for labeling regimes of bioengineered foods. As other
> countries around the world are beginning to demonstrate, the labeling
> of these foods can be easily accomplished. The American public
> deserves no less.
>
> The science of genetic engineering can be said to be crude,
> unreliable, uncontrollable and certainly unpredictable. The
> overstatements from industry that these products are safe simply
> because they have spent millions of dollars testing them is simply not
> true. Recent history has many examples, including cyclamates and
> silicone breast implants, teaching us that safety pronouncements from
> industry and regulatory agencies can later prove disastrously wrong.
> The United States must have strong regulatory oversight of
> biotechnology rather than allowing these products to be rushed onto
> the market before we know their long-term effects.
>
> Labeling and long-term safety testing are only two steps in that
> process and we should not go another day without them. It is unfair,
> unsafe and unwise. As the evidence continues to come out, it is no
> longer rhetorical to ask what the industry is trying to hide by not
> labeling these foods, and why the insurance companies will not touch
> bioengineered food.
>
> The failure to properly handle this radically new technology does not
> fall solely on the shoulders of the FDA. Quite the contrary, the
> hearings they have organized are a wonderful opportunity to hear from
> many Americans who otherwise would not have direct contact with the
> agency.
>
> There are several actions that need to be taken that are out of the
> FDA\'s hands, including ratification of the conventional and
> biological diversity for which it is shameful that the United States
> has not signed. But the FDA can, and should at a minimum do what it is
> obligated to do under the law of the Food, Drug and Cosmetic Act, as
> they were reminded in a recent letter from nearly fifty members of the
> U.S. House of Representatives \-- label all bioengineered foods and
> require long-term premarket safety testing. Thank you.
>
> \[Applause\]
>
> MR. LEVITT: Thank you. Next is Richard Frank, counsel to the Food
> Distributors International.
>
> MR. FRANK: Good afternoon. Thank you. I am Richard Frank, outside
> counsel to Food Distributors International, and I am pleased to have
> the opportunity to speak to you today on behalf of our members and
> industry and to share our thoughts on genetically modified foods and
> labeling questions.
>
> Food Distributors International is a trade association comprised of
> food distribution companies that supply and service both independent
> grocers and food service operations throughout the United States,
> Canada and nineteen other countries. We represent the mid-section of
> the food distribution chain between manufacturers on one hand, and
> retailers and restauranteurs on the other. We appreciate the interest
> and concerns of food manufacturers, but we also appreciate the
> interest and concerns of retailers and restauranteurs who must
> ultimately be beholden to their consumers.
>
> Food biotechnology is extremely important to the future to agriculture
> and food product in the U.S. and the rest of the world. Biotechnology
> will enable us to increase crop yield, improve the nutrient content of
> foods, produce foods with better processing and storage
> characteristics and drastically reduce pesticides and other substances
> of environmental concern. In our view, the potential rewards of food
> biotechnology are enormous. It would be the height of folly to forego
> those rewards because of hypothetical risks which, even if proven
> true, are small and soluble.
>
> We were talking about food safety this morning. I have worked my
> entire career with FDA. You vote with your dollars. You have very
> limited dollars. FDA, through my entire career, has thrown their
> dollars in the food area at food safety. They are throwing their
> dollars today at food safety. It may be a little late for the
> discussion on genetically modified organisms, but the reason it is
> late is that it is not our most pressing food safety issue at all, and
> that is why FDA\'s limited resources have not really come in this
> direction until the press basically led them there.
>
> On the issue of labeling, FDI and its members strongly support the
> FDA\'s current policy. That policy requires labeling of genetically
> modified foods only if a genetic modification results in a significant
> change in the composition, nutrition or quality of the product. We
> oppose a blanket mandatory labeling requirement of all genetically
> modified foods.
>
> We agree with the FDA that only material information should be subject
> to mandatory labeling, and the standard for determining what is
> material must be based on science, not opinion polls. If a genetically
> modified food is not materially different from its conventional
> counterpart, for example, if it is as safe, of equal quality and has
> the same functional and nutritional characteristics, mandatory
> labeling simply is not justified.
>
> FDI does, however, support voluntary labeling. If a food manufacturer
> wants to indicate that its product does or does not contain
> genetically modified ingredients, it should be free to label the
> product with a positive statement about the modification and how it
> has changed the characteristics of the product or, for example, a
> biotech-free claim, provided that the statement is truthful and not
> misleading.
>
> As the FDA has required in the past, a biotech-free label should meet
> two prerequisites. First, it must be substantiated. For example, if a
> bag of corn chips is labeled biotech-free, the manufacturer should be
> required to substantiate the claim by means of testing, procedures for
> segregating non-biotech corn or other reasonable means. We assume that
> a biotech-free claim would be allowed for foods containing a de
> minimis level of genetically modified ingredients. A level must be
> set.
>
> Second, it must be clear from the context that no inappropriate claims
> of superiority are implied. If the context implies that a food label
> biotech-free is safer or higher in quality, then that claim is
> misleading unless it can be substantiated.
>
> Voluntary labeling means that the marketplace rather than government
> regulators will determine whether consumers truly value this
> information. Similar to the current labeling scheme for organic foods,
> it has the advantage of putting the cost of labeling, which may be
> substantial, on consumers who want biotech-free foods rather than
> spreading those costs among all consumers. Consumers who do not care,
> do not have to pay.
>
> FDA policy on food biotechnology must not only ensure that genetically
> modified foods are safe, of equal importance, as Carol said this
> morning, it must ensure that consumers have confidence that
> genetically modified foods are safe. Given the widespread use of this
> technology, it would be very unfortunate if a large segment of the
> public believed these foods are hazardous. We believe this would
> require a multi-faceted educational effort which includes consumer and
> environmental groups, industry and government jointly explaining what
> food biotechnology is to the consumer, how it works and what it does
> to their food.
>
> The Fight Back Food Safety Program might serve as a useful precedent
> where all sectors of the public, consumer and environmental groups,
> government and industry got together to work on food safety.
>
> One means of ensuring increased consumer buy-in would be to improve
> the transparency of FDA regulation and oversight. FDA might not want
> to hear this, but the consuming public is not yet convinced completely
> that these products are safe. If they are not convinced, at the end of
> the day the products won\'t sell. So, we need FDA to work with us and
> to step up to do the research and convince the public, if appropriate,
> that these products are completely safe. Better coordination between
> FDA, USDA and EPA would also be helpful.
>
> Our industry is in the middle. It would be unfair to say that this
> thing is not broken at all, and it would be unfair to say it is
> totally broken. The truth is that there is a wonderful technology here
> with promise to feed the world, or at least a much higher proportion
> of it. We also need to educate the public on what this technology is
> and inform them where it is appropriate.
>
> So, we need FDA to do what it has always done well, and that is to be
> in the middle and, after they have heard all of the rhetoric on both
> sides, to come up with some informed decisions and policies.
>
> Thank you for giving us this opportunity to share our views.
>
> MR. LEVITT: Thank you. Our fifth speaker on this panel is Dr. Kendal
> Keith, National Grain and Feed Association.
>
> DR. KEITH: Director Levitt and members of the panel, we appreciate the
> opportunity to present this statement today.
>
> Our thousand members of our association are commercial businesses that
> own and operate more than five thousand grain elevators, feed mills
> and processing plants throughout the U.S.
>
> First, let me briefly comment that we are not aware of scientific
> evidence that would warrant FDA changing its science-based 1992 policy
> statement that provides the regulatory framework for foods produced
> from biotechnology-enhanced commodities.
>
> To reduce the risk of product liability, as well as putative and
> costly prospect of having products removed from the market, it is our
> understanding that seed companies and technology providers have
> customarily entered into voluntary consultations with FDA on the
> safety and efficacy of biotechnology-enhanced commodities before
> releasing the products to the marketplace. However, to further enhance
> consumer confidence, we do not oppose FDA making this consultation
> process mandatory for agricultural commodities.
>
> We are absolutely confident, based upon first-hand experience with the
> agency, that FDA professionals have the scientific expertise,
> objectivity and background necessary to critically and impartially
> analyze and render science-based decisions on safety.
>
> Now, let me turn to public information issues that are raised in the
> Federal Register notice. We believe that FDA\'s 1992 policy concerning
> the labeling of foods produced from biotech-enhanced ingredients is
> scientifically sound. Therefore, we are opposed to and recommend
> against any government mandated labeling regime. To require labeling
> of products based on unsubstantiated and unscientific grounds would
> ultimately undermine public confidence in FDA and the food system.
>
> However, our association does not oppose voluntary labeling provided
> it is consistent with U.S. law. We recognize that voluntary labeling
> means that FDA will be called upon to develop guidelines to ensure
> that such labeling is not false or misleading, and we would offer the
> following recommendations:
>
> If FDA proceeds to develop guidelines for voluntary labeling, we
> recommend that it do so for voluntary negative labeling. That seems to
> be the source of consumer demand to date.
>
> The NGFA recommends also that if FDA develops guidelines for voluntary
> labeling, it confine the efforts at this time to food products, not
> animal feed. The available scientific data, we think, we very clear
> and demonstrates that the proteins in biotech-enhanced commodities are
> fully digested by the animal and are not transferred to meat, milk or
> eggs.
>
> Also, it is logical to assume that if FDA develops guidelines for
> voluntary labeling it is going to need to develop some kind of
> criteria. That could result in FDA stipulating a tolerance, or it
> could result in FDA creating a detailed and cumbersome process and
> certification approach. Frankly, we think that both of these
> approaches are problematic. As a matter of principle, our association
> believes that procedures concerning the process used to ensure the
> delivery of commodities, substantially free of biotech-enhanced
> traits, are best left to contractual arrangements in the marketplace
> between buyer and seller.
>
> This issue of voluntary labeling though does raise another important
> issue of interaction and cooperation between government agencies, in
> this case between FDA and USDA. If FDA develops guidelines for
> voluntary labeling it will be even more important that our industry
> have the tools necessary to detect the presence of biotech-enhanced
> traits in raw agricultural commodities. The NGFA believes it is the
> biotechnology firms and seed companies that bear the principal
> responsibility to develop new testing technology in the commercial
> marketplace that will quickly and accurately determine whether grains
> or oil seeds contain the biotech-enhanced events. We submit that
> USDA\'s FGIS, or Grain Inspection and Packaging Stockyard
> Administration, does have a role in developing a process for
> validating the tests and accuracy and repeatability of such testing
> devices.
>
> Finally, we believe there is merit in FDA\'s signaling its intentions
> on whether it plans to develop guidelines for voluntary labeling as
> soon as possible. We understand the pressure the agency is under, but
> we also understand that farmers today are trying to make decisions on
> the next planting season which is coming up very soon, in the spring
> of 2000.
>
> We thank you again for the opportunity to comment today. We sincerely
> respect and appreciate what FDA is trying to accomplish in providing
> objective information on the food safety to the public. Thank you.
>
> MR. LEVITT: Thank you very much. Our final speaker on the panel is
> Robert Cohen, founder and executive director or America\'s Dairy
> Education Board.
>
> MR. COHEN: Hi, everybody. I have to apologize first, I don\'t have a
> prepared statement like the other panel members here. All I am going
> to give you are some facts.
>
> I have a copy of the Federal Register. It says here, advertising this
> meeting, FDA is not aware of information that would distinguish
> genetically engineered food as a class from other foods. I am going to
> give you some information today, guys. The greatest controversy in FDA
> history was the approval process for Monsanto\'s genetically
> engineered bovine growth hormone. We shouldn\'t be here today. We
> should not be in this room, and I shouldn\'t be here because in 1994
> Congress had a Bill that was going to require mandatory labeling of
> all foods that were influenced by genetic engineering. And, I waited,
> and I got my congresswoman to co-sponsor that Bill; 181 Congress
> people co-sponsored that Bill.
>
> You know what, I learned how Congress works that year because for six
> months they stalled the Bill; twelve members of the Dairy Livestock
> and Poultry Committee, they stalled the Bill until the 1994 session of
> Congress expired and the Bill died. And, I was so upset I investigated
> these twelve men and found that collectively they took \$711,000 in
> PAC money from companies with dairy interests, and four of the members
> of the committee took money directly from Monsanto.
>
> We have a lot of political intrigue and some real science here \-- we
> have science fiction. We have a combination of John Grisham, and we
> have a combination of Stephen King because Nikita Krushev said that
> what the scientists have in their briefcase is terrifying. I have some
> interesting things in my briefcase to share with you today.
>
> When Monsanto made their genetically engineered bovine growth hormone,
> they noticed a couple of problems right towards the end, right before
> approval. They noticed that laboratory animals were getting cancer,
> and they noticed that cows were getting mastitis, ulcers on their
> udders; they were putting more pus and bacteria into the mild. So,
> Monsanto arranged \-- we heard from Dr. Maryanski this morning. Dr.
> Maryanski talked about the pure Food, Drug and Cosmetic Act. What he
> didn\'t tell you was that in 1958 Robert Delaney, a Congressman from
> New York, put in a Delaney Amendment. It was named after him. The
> Delaney Amendment stated that if a food additive caused cancer it was
> not to be approved \-- pretty good law, right?
>
> Well, Monsanto got their attorney, Michael Taylor from the firm of
> King and Spaulding \-- by the way, when they started in 1979 they
> groomed their attorney now in the Supreme Court, Clarence Thomas, the
> same law firm \-- Monsanto\'s attorney, Michael Taylor wrote and
> minimized the Delaney Amendment, he wrote a scientific paper that was
> published in [The Journal of Toxicology]{.underline} \-- lawyers, they
> write in law review journals but this lawyer wrote in [The Journal of
> Toxicology]{.underline} a de minimis interpretation of the Delaney
> Amendment which became the new protocol, the new standard operating
> procedure at FDA. They minimized cancer. Michael Taylor was hired by
> the Food and Drug Administration and became the second most powerful
> man there, Monsanto\'s attorney. He wrote the standard operating
> procedures. In other words, we see cancer; ignore it.
>
> Margaret Miller, Susan Sechen, Monsanto\'s scientists, were hired by
> the FDA to review Monsanto\'s own research. Margaret Miller knew cows
> were getting mastitis. The first week at the FDA, December 3, 1989,
> she was given broad power \-- and here is an effect of genetic
> engineering nobody has considered \-- she knew cows were getting sick
> from the genetically engineered hormone; she changed the amount of
> antibiotics that farmers could have in their milk. She changed it from
> one part per million to one part per hundred million. This is a fact.
> She increased it by 100 times.
>
> There is a hero of mine in the audience, Michael Hanson from Consumers
> Union. Consumers Union tested milk in the New York Metropolitan area
> and found the presence of 52 different antibiotics in milk samples.
> FDA published, on August 24, 1990, the first time ever in a
> peer-reviewed journal, in [Science]{.underline} \--
> [Science]{.underline} was started by Thomas Edison, in the 1880s \--
> they published a review of bovine somatotropin, BGH, the genetically
> engineered cow hormone. It that review there were seven tables from
> data. Five of those tables came from one study, authored by Richard
> Odaglia and Deslex. This is the famous 90-day study. Guess what, it
> was actually a study lasting for 180 days.
>
> When I first heard about this in 1994, I flied a Freedom of
> Information Act request for that study and I say from the data that
> the average spleen of a lab animal increased 46 percent. I called the
> FDA and spoke to Dick Teske and said, 46 percent? You said there were
> no biological effects. He said, that is not statistically significant.
> I said, well, let me see the raw data. He said, it is a trade secret.
> I called Monsanto. They laughed at me; they said it is a trade secret;
> you will never see it. I am smart. I filed a Freedom of Information
> Act request, but I didn\'t realize you can\'t find out the study.
>
> I went to federal court. I said, Your Honor, spleen increase of 46
> percent, that is leukemia. I met with FDA on April 21, 1995 and found
> out that this was actually a 180-day study. In Canada they had the
> study. I have a letter here, an internal memorandum: This is to advise
> you that the copies of reports, letters, etc. for drug submissions
> have been stolen from my files. This was stolen from a scientist\'s
> file in Canada. They stole the second half of the 90-day study.
>
> We have real science here. I am going to talk briefly about the real
> science because when Monsanto made this hormone they had to tell the
> FDA \-- they had to draw a chart of every amino acid, the 191 amino
> acids. When FDA wrote their paper in [Science]{.underline} magazine,
> they wrote that one amino acid changed. It was a different hormone
> than the naturally occurring one. At the same time, somebody hired C.
> Everett Koop to come and say that genetically engineered milk and good
> old wholesome milk is indistinguishable. Well, it wasn\'t.
>
> Well, something happened to the hormone that Monsanto made. The FDA
> said there was one change; the end amino acid was methionine. But if
> there was a change in the middle of the protein there could be
> disastrous results. They cited Jerome Moore. I got Jerome Moore\'s
> paper. He said if there is a middle of the chain protein change there
> could be Alzheimer\'s, or sickle cell anemia, or diabetes. Monsanto,
> four months after the hormone was approved, one of their scientists,
> Bernard Violand, published, in the July 3, 1994 issue of the journal
> [Protein Science]{.underline} evidence that Monsanto made a mistake.
> Oops! Monsanto created a freak amino acid. Did you ever see that
> movie, \"The Fly\" with Jeff Gold where the fly comes in and he
> becomes half human and half fly? Monsanto created a freak amino acid.
> Monsanto admitted it but didn\'t tell the FDA. Gentlemen, the hormone
> that is on the market today is different than the one you tested for
> seven years.
>
> Monsanto spent 500 million dollars, submitted 55,000 pages of
> information to you, learned late in the process that they created a
> freak amino acid. That is what was tested on laboratory animals, and
> it didn\'t matter because FDA said to Monsanto, you know something, it
> is safe because when you pasteurize milk you destroy the hormone.
>
> They performed this research up in Ontario by Paul Groenwegen, and I
> got his study. To this day, FDA thinks \-- it is on your web page \--
> that ninety percent of the bovine growth hormone is destroyed by
> pasteurization. What Paul Groenwegen did, working with Ted El Sasser
> and Brian McBride, two Monsanto scientists, was to pasteurize milk for
> 30 minutes at 162 degrees Fahrenheit, and when I read that I said,
> wait a second, milk is pasteurized for 15 seconds at that temperature,
> not 30 minutes. They intentionally tried to destroy the hormone. They
> only destroyed 19 percent of it. Somebody lied.
>
> At that moment, FDA said to Monsanto because you destroy it by
> pasteurization, you don\'t have to do further toxicology studies. You
> don\'t have to develop a test for this hormone in milk. And, you know
> what, it is now safe to drink. They developed a zero day withdrawal;
> they determined it was safe to drink.
>
> We have a lot of political intrigue here. We have an interesting
> situation with revolving door policy at FDA. I mean, where is the
> ex-FDA commissioner? Guess who he is working for. He is working for
> Monsanto \--
>
> MR. LEVITT: Mr. Cohen, I need to jump in. I think in fairness of time
> and the fact, as I think you know, this panel is supposed to be
> addressing labeling \--
>
> MR. COHEN: Yes, I know, but we have a labeling issue here. We have a
> right to know. I listened to comments here about multi-faceted
> educational efforts we need. That is called brain-washing. I don\'t
> want a multi-faceted educational effort; I want a double helical
> structure on a piece \--
>
> \[Applause\]
>
> \-- of food that I am going to buy in the supermarket because I have a
> right to know, because the bottom line is mistakes were made, and when
> I hear from the American Dietetic Association, I want to remind you
> that Monsanto gave you \$100,000 to set up a toll-free hotline about
> the bovine growth hormone. Mistakes were made. We have political
> intrigue here, and the bottom line is we have a right to know what we
> are eating. Thank you.
>
> \[Applause\]
>
> MR. LEVITT: Thank you. Before we get to the questions \-- I will take
> a little responsibility for this, I note that I neglected to read at
> the beginning of the panel and I will read it now for the record and
> to kind of set the stage for the questions.
>
> There were three questions that were in the Federal Register devoted
> to the public information labeling which we would like to try to get
> addressed as we get into the questions. The first one is should FDA\'s
> policy requiring labeling for significant changes, including changes
> in nutrients or the introduction of allergens, be maintained or
> modified? Should FDA maintain or revise its policy that the name of
> the new food be changed when the common or usual name for the
> traditional counterpart no longer apples? Have these policies
> regarding the labeling of these foods served the public?
>
> So, that question really goes to when FDA currently requires labeling,
> is that the right thing to do? That is what that question says.
>
> Number two, should additional information be made available to the
> public about foods derived from bioengineered plants? If so, what
> information? And, who should be responsible for communicating such
> information?
>
> So, that is do we need to do more?
>
> Three, how should additional information be made available to the
> public, for example, on the Internet, through food information phone
> lines, on food labels, or by other means?
>
> Mr. Lake addressed some of that in terms of when he made his opening
> comments. So, I just wanted to get those kind of on the record and
> kind of, you know, focus us a little as we get into the questions and
> answers.
>
> In fairness to the FDA people who have sat here patiently all day, I
> am going to start with the people who did not get to ask questions
> this morning. So, we will start with Catherine Copp. We will go to Mr.
> Lake, and then we will try and see if we can make one run through.
>
> **Panel Answers to FDA Questions**
>
> MS. COPP: Thank you, Joe. I would like to ask the panel, and I think
> there are several members who are particularly well suited to address
> this question, about helping us get some ideas about the means to
> assess the misleading or not misleading nature of labeling, primarily
> voluntary labeling. In particular, my question is this, if the agency
> were to support a policy of voluntary labeling that would allow
> something like GMO-free or not genetically engineered, what would be a
> credible way to assess consumer understanding of that term and avoid
> what I believe Mr. Frank referred as an implied claim of superiority?
> So, what kind of information can be utilized to assess that and rule
> out, frankly, that implied claim.
>
> Maybe, Mr. Teisl, you could start because you did talk about consumer
> perception? Thank you.
>
> MR. TEISL: Yes, typically when you provide information on a food label
> you need to have a large enough percentage of the U.S. population to
> understand what it is the label is talking about. If it is information
> that is new or confusing or vague several things can happen. One is
> the label doesn\'t do anything. You know, if a label says something
> and most people don\'t know what that means, well, you are not going
> to get much of a reaction.
>
> Alternatively, what could happen is that people will refer back to
> either their prior expectations of the food or just relate to what
> they have heard in the media. Okay? Not just the media but alternative
> sources of information.
>
> For example, if I was going to say what about putting an irradiation
> label on food, I think most Americans don\'t really know what
> irradiation is. And, we have actually done some research where we have
> looked at people\'s reaction to it, and you have two reactions. Some
> people say, oh, well, that means like nuclear power stuff, and things
> like that, and I don\'t like that. On the other hand, some people say,
> oh, well, that reduces the level of [E. coli]{.underline} in food. I
> heard that and I like that.
>
> But here, with respect to biotechnology, you could have really quite a
> range of information being put out, and all truthful information. I
> mean, you are going to get some information in the media that says,
> you know, rBGH promotes ulcerations in cattle udders, and things like
> that, and that has some health concerns. You will also see that, well,
> you know, they are developing cauliflower with increased levels of
> beta carotene and that is good for cancer risk reduction.
>
> What happens there is that if you slap just a biotechnology or
> genetically engineered labeled on a food, you know, you are going to
> get different reactions from different people not based on what their
> perceptions are but given what kind of information they have already
> picked up on. To me, if you just provide a GE label, it is not so much
> that it is misleading but it probably will not reduce uncertainty in
> consumers\' minds about what the food is but will, actually, possibly
> increase the uncertainty that people have because, you know, in the
> background over the last several years or months they have heard all
> these different things about genetic engineering.
>
> So, is it misleading? In a sense it is misleading because what the
> consumer really wants to know is how does this affect me, and how does
> this affect the environment, how does this affect the health of my
> family and, if anything, it is those consequences that need to be
> conveyed directly, particularly with respect here because there is a
> diverse array of consequences possible. So, really the thing is that
> if you just slap a GE label what you are doing is you are requiring
> the individual to go out and learn about it. Even after they have
> learned about it, they may be even more uncertain about the food
> product than they were in the beginning. So, does that answer your
> question?
>
> MR. COHEN: May I comment on that?
>
> MR. LEVITT: Yes, please.
>
> MR. COHEN: I like simple and stupid. I am drinking some simple and
> stupid water here and there is a kosher label on it; I know what it
> means. I want to see a double-helical structure on everything that is
> genetically engineered without an explanation. I just want the right
> to know. Monsanto, out there, you are going to win because if you put
> a double-helical structure on everything that is influenced by genetic
> engineering, tomorrow wake up and ninety, ninety-five percent in your
> supermarket are going to have that label. Then, the public\'s
> perception is going to be, my goodness, it is not so bad.
>
> For the record, I may talk against Monsanto and genetically engineered
> milk, I believe that one day genetic engineering is going to solve a
> lot of our problems. I believe in genetically engineered foods. I
> watched a robot in \"Forbidden Planet\" make a hundred bottles of
> whisky. I grew up on this stuff. I don\'t believe in mistakes, but I
> believe in genetically engineered foods. You can win. You are
> paranoid; you are scared that the public is not going to buy your
> product if it has a label. Do it for all products. Today\'s [New York
> Times]{.underline} said that there were between ten and thirteen
> million species of life on this planet. You are not going to be able
> to monitor each one and the cost is going to be prohibitive. Just put
> a label on it so we know.
>
> \[Applause\]
>
> MR. LEVITT: Would other panelists like to address the question of
> consumer understanding of the labeling?
>
> DR. KEITH: Just briefly. Of course, we support voluntary labeling not
> mandatory but, in my mind, the best thing you could do is establish
> some kind of a standard. The grain handling system, the grain
> marketing system cannot deliver grain with one hundred percent purity
> of either biotech or non-biotech. So, there has to be some reasonable
> tolerance established if we are going to go to that kind of a
> standard. Over time, the public understanding will grow as to what
> that means. For those consumers to whom it is important, they will
> have a choice. I think that is what we would stand behind. We need to
> serve consumers. We want, as an industry, to have access to the
> maximum number of consumers. To do that, you have to give choice.
>
> MR. FRANK: A couple of points, first of all, FDA\'s policy with regard
> to food safety aspects \-- I think your labeling policy needs to
> support your food safety policy. So, if you have concluded that these
> products are GRAS, at least some of them, then you have to have a
> labeling policy which, in essence, concludes that a statement that
> suggests superiority or that suggests that a genetically modified food
> is inferior or unsafe, that would be misleading because I think that
> would run contrary to your conclusion that the product is GRAS.
>
> MR. LEVITT: Excuse me, so when you say \-- correct me if I am wrong,
> you are supporting voluntary labeling, how do you have a voluntary
> label that says something like GM-free without it being misleading
> under that paradigm?
>
> MR. FRANK: I don\'t think GM-free by itself necessarily would be
> misleading. With regard to BST, you required, and the court upheld,
> the conclusion that there had to be another statement that there is no
> evidence that BST-free is any safer or necessarily any different than
> milk that was coming from animals that were given BST. Now, that is
> the conclusion that you reached in that case and that certainly would
> be a good precedent.
>
> A couple of other points, it is almost impossible to confront the
> issue of the right to know. I mean, do you want a rose in your garden?
> Why, of course you want a rose in your garden. Would you like a hot
> fudge sundae? Of course. Would you like it to be fat-free? That is
> even better. So, it is really hard to confront or to respond to people
> who want more information.
>
> So, at least this early you have to say to yourself if the information
> is at least marginally useful people should have a right to it. But
> let\'s look at fish for a second. He wants to know whether or not
> these things have genetically modified organisms in them. Well,
> salmon, is it from a river near Seattle or is it from a river in New
> York? Well, I want to know because it matters to me because the water
> may be different. But salmon is not labeled that way simply because it
> is just not important enough; it does not rise high enough in the
> interest scale. Now, if someone is proud of salmon from near Seattle,
> they will say so.
>
> What state does it come from if it is meat? Is it Kansas beef or is it
> Nebraska beef? Now, that is important. And, if you are a farmer from
> Kansas you might want to buy Kansas beef, and if Kansas beef farmers
> are proud, then they will label their products Kansas beef, as long as
> it is true.
>
> So, voluntary labeling allows people to extoll the virtues of their
> product. They can say that it is GMO-free. The question is does this
> rise to the level where it should be mandatory? And, I say no because
> you have determined basically that these products are safe. Only if
> you have an allergenicity problem, if you have a nutritional problem,
> or a significant quality difference do you require the labeling.
>
> The final model I want to put on the table, and this goes back to my
> crazy thought that combined consumer education may be a good idea
> where consumer groups and industry and government come together \--
> pasteurization \-- now, there aren\'t too many people in this room who
> drink milk that is not pasteurized, if you drink milk at all, but when
> pasteurization first came out the public was totally alarmed. The
> Robert Cohen\'s of the world ran around and said, \"my God, we\'re
> heating milk; we\'re killing milk; we\'re making it unsafe for our
> babies.\" There was a huge hoopla about pasteurization, and that
> probably was a decent thing to do because it was a new technology and
> people weren\'t that comfortable with it. Now pasteurization is not
> only welcomed, it is demanded. Ninety-seven, ninety-eight percent of
> the milk in this country, if you are willing to drink the milk at all
> \--
>
> MR. COHEN: I am not.
>
> \-- but the vast majority of the milk in this country is pasteurized
> and consumers demand it. Why? Because they are educated.
>
> The other end of that is irradiation, which some people call cold
> pasteurization. Now, the public, for the most part, is just beginning
> to understand the benefits of irradiation. Some people would prefer
> not to have it, but it can make your meat and poultry, for example,
> even safer than it already is. But people are very concerned about
> buying something labeled \"irradiated.\" It is because the environment
> out there is not yet hospitable to that type of term.
>
> What I am suggesting is that consumer education, along with a
> voluntary labeling program may help consumers better understand what
> GMOs are, and they may deduce they don\'t want them, or they may
> decide that, indeed, they are positive. But, we do need some education
> here.
>
> MR. LEVITT: Thank you. Any other comments on this question, please?
>
> DR. CODY: I think that labeling, voluntary or mandatory is not going
> to be useful without public education. With public education, the
> public can contribute to this dialogue. Without education it is very
> difficult to make a contribution, to make your wishes known. Also,
> with education consumers can make personal food choices with more
> confidence. Whether they choose this food or this food, they know why
> they have made those choices. So, I would submit that labeling without
> education is really not effective, regardless of how we measure it.
>
> MR. CAPLAN: Just very quickly, first of all, the issue of voluntary
> labeling is somewhat moot because voluntary labeling is already
> allowed. Products can be labeled as GE-free currently. So, whether or
> not to establish a regime of voluntary or mandatory is somewhat of a
> false dichotomy because voluntary labeling is allowed and the question
> should be when are we going to institute a mandatory labeling regime?
>
> The question of information to consumers is somewhat troubling to me
> because at what point do you say that all information \-- for example,
> should consumers have to know what the USRDA for vitamin C is in order
> to have that be labeled on a product? There shouldn\'t be exams as one
> enters the supermarket in order to determine what information they can
> or cannot be provided with. I think the reality is that consumers do
> know about this subject and, when asked, do want to know about this
> information.
>
> So, in terms of what kind of information they are or are not entitled
> to, I think given that the American public has repeatedly asked for
> this information, I think they should be allowed to. Finally, I would
> just point out that the label that is current proposed on the Bill in
> the U.S. House for labeling is decidedly neutral. It simply states
> whether or not a product does contain genetically engineered food.
> There is no value judgment there. It is very straightforward. It is
> not misleading. It is not vague.
>
> MR. LEVITT: Thank you.
>
> \[Applause\]
>
> I will turn to Mr. Lake.
>
> MR. LAKE: Thank you. In the opening remarks a couple of the panelists
> talked about a desire to have FDA set standards, so I am going to
> challenge each of the panelists to give us some of your thinking about
> that. Again, I am going to start at this end and work on down.
>
> The question really arises out of a couple of the answers really to
> this last question which suggested a problem that I have heard before,
> and that is that things may be at a point today where it is literally
> not possible to guarantee that anything is absolutely free of
> genetically engineered material to some small extent.
>
> So, my question then, and I think this is particularly important if
> there is to be a lot of voluntary labeling of the GM-free variety,
> what is the appropriate standard for a cut-off for genetically free? I
> asked this question in Chicago and got answers ranging from a tenth of
> a percent to three percent. Let me ask each member of the panel what
> your thoughts on that would be.
>
> DR. TEISL: I am not a biologist or anything \--
>
> MR. LAKE: From a consumer perception perspective.
>
> DR. TEISL: Well, the thing is, of the research I have seen, no one has
> really asked that question. So, it is hard for me to say what most
> consumers think about this. I don\'t know what research you are
> quoting, but from several of the studies that I have looked at in U.S.
> markets, particularly a New Jersey study, people don\'t have a clear
> understanding of what genetic engineering is, particularly when
> compared to \-- they don\'t even have a clear understanding about
> traditional plant breeding, much less genetic engineering. So,
> without, you know, doing some really directed research where you first
> provide that information to survey participants then, after you have
> given them the information ask them, okay, now that you know this,
> what standard would you set at? I don\'t know of anyone that has done
> that yet. So, even if someone has asked it in a general survey, I
> don\'t think that number would mean anything, to tell you the truth.
>
> DR. CODY: First of all, I don\'t know what you would measure. If you
> look at a commodity in the marketplace you may have a mixture of
> soybeans that have come from this plant and this plant. If you can\'t
> tell which one is genetically bioengineered, then I think what you are
> looking at is a label that is similar to some of the labels that we
> see for fats and oils and for candies. So, you might see an oil that
> is labeled \"may contain\" soybean oil, cotton seed oil, peanut oil
> because you may have a mixture and, because you don\'t know, you label
> with all of those adjectives. You might also see a label that is
> similar to some of the candy labels now that say \"may contain
> peanuts\" not because the candy contains peanuts but there may be
> peanut dust from a previous line that has contaminated the product and
> may be an allergen for people who are reading that label. So, I think,
> you know, without being able to make a measurement it is hard to
> decide what amount would trigger a label declaration.
>
> MR. CAPLAN: My understanding is that technology currently available
> already allows us to detect the content of genetically engineered
> material in the range of one-tenth to one one-hundredth of one
> percent, and I expect that as the demand for products that do not
> contain genetically engineered material increases, our ability to
> further refine that technology will improve. So, I would advocate for
> a threshold that is as low as possible, as low as technologically
> possible.
>
> MR. FRANK: I have written down five reasons why you might want
> something on a label. The most important I wrote down is food safety.
> The second would be allergenicity. The third would be religious
> reasons. The fourth would be political reasons, and the fifth would be
> pure curiosity.
>
> It strikes me that the first two should definitely prevail \-- food
> safety or allergenicity. So, obviously, if there is a food safety
> problem with one of these products FDA is going to move forward and do
> something about it. Allergenicity does not require a product to come
> off the market. Peanuts cause allergies and we are not banning
> peanuts, so they should be labeled. So, if it is allergenicity, that
> should go as low as you can go.
>
> Then, for religious reasons, I guess that can be quite important to
> people. So, the level of detectability, how well can you detect
> something there that people would care about from a religious
> standpoint?
>
> For political reasons \-- I have less sympathy for that, and for pure
> curiosity I have no sympathy at all.
>
> \[Laughter\]
>
> So, it strikes me that the rule should be the level of detectability
> if you want to make a \"free\" claim.
>
> MR. LEVITT: Thank you. Any other comments on this?
>
> DR. KEITH: I would be concerned doing it on the basis of the level of
> detectability because just because you can detect it doesn\'t mean it
> is practically possible. The tighter you ratchet it down, the more
> impractical it is for someone to deliver that product consistently to
> the marketplace and actually provide a product that is relatively
> biotech free.
>
> MR. COHEN: FDA approved Monsanto\'s hormone as the label, and the
> people at the FDA, the commissioner, said it is indistinguishable from
> normal milk. It doesn\'t work; it is not bioactive. Many years later
> Canada reviewed it and they said that the ninety-day rat study
> submitted by Monsanto showed that rBST can be observed intact from the
> GI tract following oral administration. We learned new things about
> thalidomide \--
>
> MR. LEVITT: Right, so what level of detectability, in answer to the
> question?
>
> MR. COHEN: The answer is women, in your lifetime you make the
> equivalent of one tablespoon of estrogen. That is all. It works on a
> non-molecular level, many of these hormones, and we react to
> chemicals. You don\'t want to take just one nanogram of LSD; you will
> be in the sky with Lucy with diamonds. The bottom line is that if it
> has a product, keep it simple because you are looking at something
> that you are going to have twenty million different rules \-- make one
> rule. If it has any genetically engineered product in it, put a
> double-helical structure on it and then we have a right to know. And,
> it is simple because \-- you know this, tomorrow everything is going
> to have a label, or almost everything, and you solve the problem and
> the public will then accept it. Monsanto, you will win but give us the
> right to know.
>
> DR. TEISL: May I make one point?
>
> MR. LEVITT: Yes, one follow up.
>
> DR. TEISL: Yes, one thing that you have mentioned twice is that you
> want to keep it simple. The thing is, in labeling research what people
> want is not necessarily simple. What you are advocating is let\'s get
> rid of the nutrition panel on this thing and just call it \"good.\"
>
> MR. COHEN: No, I am not arguing that.
>
> DR. TEISL: That is simple but it is vague.
>
> MR. COHEN: Genetic engineering, radiation, kosher \-- these are
> different concepts here. It is a new era. We have the Internet out
> there which has pretty much leveled the playing field, and there are
> people who are not happy about the way things have gone.
>
> The fact that Robert Lake put me on this panel shows that there is a
> desire to listen to the public comment and to take the best shot at
> genetic engineering. I believe in the stuff. Don\'t let me fool you, I
> believe in genetic engineering.
>
> My family drove in the summer through the Midwest and we ate the BT
> corn because it is a protein. I don\'t think it is a problem. I have
> studied at the issues; I have looked at the research. I am not going
> to have them drink the milk because I have also studied the research.
> If I release what I have here, the second ninety days, this is trade
> protected information and I would go to jail for fifteen years. I am
> not going to release it, guys. But, the bottom line is we have a right
> to know whether it has been genetically engineered. Remember
> thalidomide. Remember the lessons we learned with diethylstilbestrol.
> Half of the things FDA approved, we learned a surprise within six
> months. Sometimes it is a good surprise, sometimes it is a bad
> surprise. Just give us the right to know.
>
> DR. TEISL: But just to respond to that, you may understand the
> research in terms of the biology and stuff like that, but if you look
> at the consumer research, the labeling research, the information
> dissemination research, it is not true that people just want a simple
> good or bad, or this or that. They want to know \-- here are the
> things I care about: I care about the safety of my food. I also care
> about the environment. You know, I want to know if my tuna is dolphin
> safe or not. I don\'t want to know if it is just good for the
> environment.
>
> For the last several years I have been focusing solely on
> environmental labeling of a lot of different products, and people do
> not react, nor do they want, nor do they trust a label that is just
> some sort of seal of approval that says, oh, this is environmentally
> friendly or this is good for you. What they think of that, is they
> think \-- pardon the expression \-- that it is a bunch of marketing
> BS. If you truly want a genetic engineering label to work, you are not
> going to just slap GE on the product because the chances are people
> are going to say, \"huh? What\'s that? That doesn\'t mean anything to
> me.\"
>
> If you want, with it is for environmental reasons or food safety
> reasons, an information piece on a product to actually affect consumer
> behavior, you have to tell them the information that is relevant to
> them. So, what you first have to do is find out what do consumers care
> about with respect to this food or that food.
>
> MR. COHEN: But, we are about to find out because I am going to ask
> them. We have some pretty angry people out there; I spoke to some
> before. Would you be content if the FDA, on every food \--
>
> MR. LEVITT: Again, we will have a lot of people that \--
>
> MR. COHEN: \-- would you be content with a warning label?
>
> \[Applause\]
>
> DR. TEISL: That is three of them.
>
> \[Laughter\]
>
> What you need to do \--
>
> \[Applause\]
>
> MR. COHEN: A simple label \-- raise your hands, anybody. All those not
> in favor of a simple label, raise your hand. Okay, it is split.
>
> MR. FRANK: The problem with the double-helix and the redura symbol
> more than anything else, is they are more of a political statement
> than an information statement, and I am not sure people fully
> understand them, and they are used for political purposes. I mean, I
> agree that you need to understand what goes on there, Joe.
>
> MR. LEVITT: Next, I will turn to Mr. Hubbard.
>
> MR. HUBBARD: Let\'s talk about a non-label. The food label that the
> FDA developed in the early \'90s has been very popular with consumers,
> and the agency has been fairly protective of making quick and easy
> changes to that.
>
> If, however, a consensus were to emerge among the government,
> consumers and industry that people want to know about GMOs and need to
> know but, yet, not put it on the actual package itself but provide the
> information through alternative means, such as the Internet and 800
> numbers, would that accomplish the objective that consumers are
> looking for, or would that make it too difficult?
>
> MR. COHEN: It is my perception that your perception is that the press
> and the small group of fanatics are stirring up emotions on this
> issue. That is my perception and I see at least one head shaking over
> here, yes. You believe there is no credible research despite the fact
> that Monsanto created the freak amino acid. We have evidence that
> mistakes were made. That is all I want to see, no more mistakes. I
> think the FDA should create an office called the office of the
> devil\'s advocate and look at this research and interact. If it is
> good and safe, great; I am all for it. I believe in it. But if you
> make a mistake, correct it. At least label it and identify it and give
> us a right.
>
> MR. LEVITT: I will tell you how I interpret that, I interpret that as
> you don\'t like the idea of information outside the label. But it
> would be useful if we tried to answer a little more directly to the
> questions asked, especially as we are repeating things that have been
> said before.
>
> MR. COHEN: You are correct, I don\'t want to see a lot of information
> on a label. It is too confusing. That is what many people want to do,
> confuse people. Keep it simple.
>
> MR. LEVITT: Okay. Do other panelists want to speak to the issue of
> should there be a way to provide this information to the consumers
> outside of the product label itself, through other available
> mechanisms such as the Internet, such as brochures or literature, or
> 800 numbers? If so, how would you go about designing that?
>
> DR. CODY: I would like to respond to that.
>
> MR. LEVITT: Please.
>
> DR. CODY: The big answer is yes, we would like to see better
> information, more information, accessible information. Having the
> information available in scientific literature is not enough. Most
> consumers in the United States do not have access to that literature
> and, if they did, reading it is not an option; it is too complicated.
> What we would like to see is information that is accessible. That
> means understandable. It means that people need to have access to
> information on more than one level. You may have scientists and health
> professionals and others with science backgrounds who get this much
> information but, in order to use that information, they have to know
> how to communicate it to people who have specific and general
> questions. That means that if I call a hotline and I am concerned
> about catsup, that I have someone who can address my concern within
> the context of catsup. They are not going to give me a thirty-minute
> lecture on the history of bioengineering. They are going to be able to
> answer my question and then perhaps take me a little bit further by
> sending me to a web site, sending me to a pamphlet, telling me
> somebody else I can contact.
>
> But that becomes cyclical. There are going to be people who start at
> the Internet and need to know how to send their question to someone.
> That is easy enough to do now. But most consumers are not able to take
> the information directly from the research literature. They are not
> able to take it from a very general statement to the specific, and
> answering questions takes more than just putting information out
> there. Thank you.
>
> MR. CAPLAN: I would absolutely support the dissemination of more
> information about foods produced through biotechnology through the
> Internet and through brochures but it is imperative that does not
> serve as a substitute for labeling, particularly as the vast majority
> of people do not have access to the Internet and would never be able
> to access that information, nor do I look forward to the prospect of
> people being issued a cell phone as they walk into the grocery store
> to call as they walk from product to product. I think information is
> useful. I think it should be out there, just as I support the
> provision of the food quality and protection act that has never been
> implemented, which was to provide information to consumers about
> pesticides on foods. I do think more information is a good idea, but I
> don\'t think it should substitute for labeling.
>
> MR. FRANK: I knew that my brethren from the University of Michigan and
> I would finally agree on something. More information is sorely needed.
> I mean, right now \-- and I think the industry deserves some blame for
> this; I think FDA deserves some blame for it \-- is that there has
> been virtually no consumer buy into these products; I am not sure
> consumers know what they are. Having FDA take the lead, maybe with
> USDA and EPA, with a fight-back type program \-- it doesn\'t have to
> be propaganda; not everything about GMOs is positive; some have failed
> but some are wonderful. I think as Carol said this morning, if we come
> out with a rice product that has vitamin A and iron in it that could
> help, you know, serve some of the needs in Asia, I think the consumers
> will gravitate to these products. So, consumer education, with you
> taking the lead in your magazine, on your web site \-- I saw Donna
> Matthews here this morning with Giant Food. They have done a wonderful
> job of doing brochures at the front of their stores. You know, maybe
> the wholesalers who I work with or the retailers could take the lead
> and do some brochures. But people really don\'t have any idea what
> GMOs are, and the press has been fairly sensational about it so what
> they are reading is not terribly positive.
>
> MR. LEVITT: Was there one other comment? You want to say one more
> thing?
>
> DR. TEISL: There was some confusion in my mind exactly what you meant
> by what other information do you want. Do you want information out
> there related to a particular food product that is on the label? Is
> that what do you mean, or are you just talking about general
> education?
>
> MR. HUBBARD: I think we are talking about a general approach, but
> let\'s say you have a given consumer who is concerned about GMO foods
> and wants to know that, and various web sites, 800 numbers, various
> other kinds of information other than label can get them there \--
> they can go to their cereal manufacturer or their bread manufacturer
> or whatever, and learn where the GMO-free products are and then go
> purchase those, is that a consumer benefit? Is that helpful as opposed
> to having literally millions of packages with a label on it that tell
> everyone, including many people who don\'t care to know this piece of
> information, would that be a useful option for FDA to examine?
>
> DR. TEISL: Well, I have a couple of comments. One is that there is a
> distinction between information that is provided on a label, where the
> benefit there is to allow consumers to make comparisons across
> products in terms of some sort of quality attribute, which is
> inherently different than an educational piece.
>
> Now, one approach, because some of these issues are so complicated, is
> that if a product were labeled that it has a genetically modified
> organism in it, blah, blah, blah, go to www. to learn more. If that
> approach is used, I think that is okay as long as the information is
> two-fold on that site. One is sort of general information about GMO
> but, if it is supposed to be linked to the label, that information has
> to link to that food product somehow so that if a consumer goes to
> that web site \-- what they want to know is how is that product
> different over and above just some sort of general information about
> genetic engineering.
>
> The other thing that I am a little worried about is that let\'s say
> FDA decides, okay, we are going to go start putting information about
> genetically engineered foods, blah, blah, blah, on the web, my
> concerns is that then we are going to be here a year or two from now
> debating, well, you know, the information you put on the web is not
> real; it is not supported by science, blah, blah, blah. Then you start
> getting into this controversy of what side are you taking. Are you
> taking Monsanto\'s side? Are you taking what the pure science says?
> That sort of thing. I mean, if I were a public policy official I would
> be a little concerned about deciding what types of information are
> going to be placed in some sort of information piece.
>
> DR. LEVITT: The next question is from Steve Sundlof.
>
> DR. SUNDLOF: Thank you. I heard Dr. Keith say that if there is
> labeling, whether it is voluntary or mandatory, there needs to be some
> verification method to determine the truthfulness of that labeling.
> The charge was that that responsibility should fall on the companies
> that develop biotech compounds. Short of actually developing
> analytical methods to detect genetically engineered organisms, are
> there other kinds of programs that you could envision which would give
> some assurance that the labeling was truthful?
>
> MR. COHEN: I would like to answer that. Leave it up to the
> manufacturer to put a label on. If you find out they are not telling
> the truth, you fine them. You take their food off the market. That is
> going to be a pretty good way to keep them honest.
>
> I went to your website. I went to FDA\'s website before I came here. I
> wanted to see information, what you had there on the bovine growth
> hormone. August 22, 1990, the Journal of the American Medical
> Association published a review, two independent doctors, of this
> hormone, David D. Barbano and Michael Daviday. David Barbano is the
> man who has written, on your website, a complete review of the
> hormone.
>
> When I went and I pulled that journal article, I found out that David
> Barbano worked for Monsanto. So when you talk about information on the
> Internet, how are we going to monitor what is going on? The answer is,
> monitor it by hoping that companies put the fact, the truth, that they
> label it.
>
> If somebody blows the whistle on them and you find out they are not
> telling the truth. It is up to you. You have been there pretty good as
> a regulatory agency. If somebody lies to you, fine them.
>
> DR. KEITH: Dr. Sundloff, I think it would be wise to put the burden
> back on the companies that want to make the claim and ask them, maybe,
> to submit periodic data on their compliance with that. We would expect
> any food company that delivers a product to the marketplace that
> wanted to label it as such would stand behind that in many other
> respects and would voluntarily do that.
>
> It is in their interest to do what they say they are doing and for
> their customers. So I would think you would get some very good
> voluntary compliance with that.
>
> MR. FRANK: I don\'t have any answers on what analytical method would
> be appropriate, but you have got a precedent with regard to health
> claims and nutrient content claims for food. The responsibility lies
> with the company. They don\'t have to periodically submit anything but
> FDA, periodically, you take samples when you have enough resources to
> do stuff like that, and you test products and you have a continual
> program of doing that.
>
> I can guarantee you if someone comes out with a GMO-free version of a
> breakfast cereal that companies who don\'t have a GMO version will go
> have that breakfast cereal tested. The competitive market will address
> that issue and you will be getting a direct or an indirect
> communication if, indeed, it is not GMO free.
>
> In terms of the analytical methods, that would have to be left to
> scientists.
>
> MR. CAPLAN: I would simply add that there would need to be a setup so
> that farm products can be tracked throughout the process with
> verification and periodically there would need to be analysis as to
> whether or not labeling claims were truthful. That is something that
> can be easily accomplished and should be in place to assess whether or
> not labeling claims of GE-free are, in fact, accurate, which is
> something that could easily be done as is being demonstrated abroad.
>
> MR. LEVITT: We will skip over Ms. Copp and jump to Dr. Maryanski.
>
> DR. MARYANSKI: Thank you. I think I would like to hear from the panel
> a little bit about regardless of whether labeling were done on a
> mandatory basis or a voluntary basis, we have to think about what
> foods are going to be labeled. If we think about the diversity of
> foods in the grocery store\--we have, of course, fresh fruits and
> vegetables, apples, pears, tomatoes and so forth, potatoes. We also
> have many processed foods, the ingredient label. There are a number of
> countries around the world that are thinking about labeling, either
> have implemented regulations or have them under consideration. I think
> that what appears to have happened is that there is a sort of an easy
> decision in the beginning that we should provide this information to
> consumers, somehow, but then the reality begins to set in when the
> labeling is actually done.
>
> So I guess what I would like to hear is if one is to provide
> information through labeling, how would one think about the kinds of
> foods that really would be labeled taking into account the spectrum of
> the whole foods to the processed foods to highly processed foods such
> as vegetable oils where scientifically there won\'t be a method to
> determine whether the oil is or is not derived from any particular
> kind of crop.
>
> So there is a gamut of things. We have, of course, enzymes used in
> foods. We have other ingredients that are essentially minor components
> of the food but are produced through organisms that are developed by
> modern biotechnology.
>
> So, in terms of thinking about labeling, we would have to think about
> the diversity of kinds of products in terms of what falls within the
> scope of labeling.
>
> MR. LEVITT: Who wants to start?
>
> MR. COHEN: My perception is that you believe that, twenty years from
> now, we are all going to be eating the stuff and not really care about
> the issue any longer. I think that is my perception of what you
> believe. I think that is the way it is going to be.
>
> I think our future is in genetically engineered foods. That being the
> case, it is just a matter of time before everything is so influenced.
> That is why it is important today to change it overnight, to put that
> label on, just a simple ladder turned sidewise, rotated, the double
> helical structure, Watson and Crick\'s structure of DNA.
>
> Put a simple label with no explanation and tomorrow America wakes up
> and goes, \"Wow. I didn\'t know that.\" And that is the end of the
> issue. It is simple.
>
> MR. FRANK: It is significantly more complex than that. The Department
> of Agriculture\--I learned this about a year ago\--they probably held
> since the late 1870s and 1880s, I am going to say maybe 5,000
> rulemakings in their history.
>
> The rulemaking that drew the most comments in the history of the
> Department of Agriculture is on organic. What is organic? How do we
> label it? First, there was a hew and cry we need to label for organic.
> And then, when all the people in the organic industry got together,
> there were 3,000 of them there with 100,000 ideas.
>
> So it was not and is not an easy issue to address. It strikes me that,
> first of all, there is a big difference between mandatory labeling
> where you have to say something includes a GMO and voluntary labeling
> where you are calling out a positive attribute or you are saying
> GMO-free.
>
> If you are focussing on the first model where you mandatorily label
> something as containing GMOs, how much? If it is a processed product,
> it is 1 percent? It is half a percent? What if it is citric acid which
> is an ingredient in tomato sauce which is in a jar or a can and the
> citric acid, which is one-tenth of 1 percent of the product, was made
> from bT corn?
>
> At that point in time, do you have a double helix on that?
>
> MR. COHEN: Yes.
>
> MR. FRANK: That is a political statement. It certainly is not a
> food-safety or an allergenicity issue. I think you need to take it
> both from the mandatory standpoint of where would it make sense, where
> would you draw the lines, where would you be communicating information
> of some value.
>
> And then, on the voluntary system, whether it be a positive or a
> negative statement, again, you need to look at where would you be
> providing value to the person buying the product.
>
> MR. CAPLAN: If I understood you correctly, Dr. Maryanski, you are
> asking because there is such a wide range of products affected, how
> would we institute labeling? Is that correct?
>
> DR. MARYANSKI: Yes. Are you proposing that everything should be
> labeled or is there some umbrella, some set of products that really
> would need to be labeled?
>
> MR. CAPLAN: I would propose that any product that has been made
> through techniques of genetic engineering would be labeled and,
> regardless of whether or not it is a fruit and vegetable which
> labeling can easily be accomplished for. Processed foods that contain
> genetically engineered material also can be tested and found to
> contain that material should also be labeled.
>
> So, regardless of how widespread the technology has become which was
> done, in a sense, secretly because people were not informed that it
> was happening regardless of what has happened in the past, if a
> mistake was made it should be corrected and products that were made
> through genetic engineering should be labeled as such.
>
> DR. KEITH: I think my response on that would be that we think the
> market has a wonderful way of finding out who really wants labeling.
> Companies have a way of sorting out consumers and their needs and
> finding out which customers really want that information. That is the
> reason we support a voluntary labeling approach at this stage because
> we think the companies may go out in the marketplace and find out who
> really wants that information and provide it as such.
>
> If you impose it on the entire system, you impose a cost on the entire
> food system. Everyone pays that cost whether they want the information
> or not.
>
> MR. LEVITT: Any other comments on this?
>
> DR. CODY: I think the very basis of labeling is you want to make a
> truthful claim or declaration. When you are talking about fresh fruits
> and vegetables in the marketplace, I don\'t really see how that would
> be possible in most grocery stores because short of labeling every
> single apple, every single banana and such, you wouldn\'t necessarily
> know because suppliers are bringing them in from all over.
>
> For highly processed products like sugar, oil and others, again, you
> wouldn\'t really know. There is not a way to detect it. I think we are
> talking about documenting a process most of the time and not a
> product. That becomes very complicated when you are looking at
> verification.
>
> So I think looking at individual foods becomes a bigger issue than
> just putting a label on everything, or putting a label on some things
> because they may contain the product. It needs to be much better
> thought out than that.
>
> DR. TEISL: I would like to respond. If you were to require a
> mandatory\--and, particularly, I think if you were going to have a
> voluntary labeling program, you would have to, I think, impose
> basically the same standards on everything. The reason I say this is
> if you say, \"Okay; only cereals have to be labeled but not cans of
> soup,\" that means consumers, when they go in the grocery store, have
> to know that there is a difference, a different standard, for
> different types of processed foods, for example.
>
> This is particularly true if it was voluntary because, otherwise,
> people would have no idea that this aisle has nothing labeled and this
> aisle has some things labeled. They wouldn\'t understand that there is
> a difference in the standard between those two aisles.
>
> The other comment is with respect to fresh foods, currently,
> individual apples are already labeled.
>
> DR. CODY: Some of them are.
>
> DR. TEISL: Most of them are in the stores that I shop at. So I don\'t
> see the idea, if you were going to have a label, that it would be that
> much more of a problem to have it on things like apples and stuff,
> unless maybe small stores; you might have an exemption for them. But I
> think consistency would be key.
>
> **Summary Remarks**
>
> MR. LEVITT: We are coming to the end of our time for this panel. Let
> me thank all the members of the panel. I will, as I did this morning,
> give everybody more or less 30 seconds for a quick wrap-up. For those
> who were not here this morning, the wrap-up question is; looking
> ahead, a year from now, if there was one thing that FDA could do in
> the area of public information, labeling or otherwise for genetically
> engineered products, that would be \"blank.\"
>
> Some people have already very clearly already said what that is so I
> am expecting some repetition. But I think it is nice at the end to
> kind of summarize, if you will. Again, I would ask people to limit it
> to labeling or to other areas of public information and to try to do
> that quickly.
>
> When we finish that, we will be taking a short break before we get
> into the final public presentations. Starting at the back, and as we
> have been doing, with Mr. Cohen.
>
> MR. COHEN: Remove genetically engineered milk from the market because
> the evidence is in. Label everything that has been influenced by
> genetic engineering so those Monarch butterflies with legs outside
> accept the fact that their foods are labeled. That\'s all they want.
>
> DR. KEITH: We would recommend serious consideration be given to a
> voluntary labeling regime for negative labeling on food products
> alone. Feed products should stand alone, different.
>
> MR. FRANK: We think that FDA should continue to show leadership and
> support its current policy and make it more transparent and encourage
> a nationwide education program and a debate, like this one. This is
> wonderful. People are learning things.
>
> MR. CAPLAN: I would support mandatory premarket safety testing and
> full environmental review of all genetically engineered products. I
> would not support, and I don\'t think the FDA should support, any
> products that have not had that examination on the market. And then,
> any products that do meet that test, should be labeled as genetically
> engineered.
>
> DR. CODY: In terms of labeling, to conduct some social marketing-based
> tests to determine what consumers want, and then some studies to
> determine what consumers understand now and what they need to
> understand in order to use the labeling effectively.
>
> MR. LEVITT: Dr. Teisl, you had the first word at the beginning. You
> will have the last word here.
>
> DR. TEISL: I guess the main things I would like to see is that simple
> labels\--i.e., some sort of general, vague disclosure\--was not put
> forward because I don\'t think that helps people make choices. I think
> what helps people make choices and, incidently, increases the
> credibility of a label, is that relevant details about\--not just the
> food quality or safety but also other information about the food, the
> production, the environmental consequences of the food, are also
> detailed.
>
> I think if you are looking for something that is really going to
> effect consumer behavior and allow people to make choices that fit
> what they want, you need to keep it detailed and provide the
> consequences and not just some sort of vague disclaimer of whether it
> is GE or not.
>
> MR. LEVITT: Thank you.
>
> Let me again thank all the members of the panel for this second series
> of presentations. My clock says that it is five minutes to 4:00. We
> are a couple of minutes behind, but not too bad. We will reconvene in
> fifteen minutes at about ten minutes after 4:00.
>
> Thank you very much.
>
> \[Break.\]
>
> **Public Presentations**
>
> MR. MENDELSON: I am No. 2 on the list. My name is Joseph Mendelson. I
> am the Legal Director for the Center for Food Safety. We are a
> nonprofit, environmental sustainable agriculture and human-health
> interest group here in Washington, D.C. We are currently serving as a
> lead attorneys in the law suit against the FDA that is awaiting a
> decision at this very time from the U.S. District Court.
>
> I am glad the public hearing now begins at 4:15 in the day. I am also
> personally affronted that I am told about how much education I need
> and then everything will be all right. Please allow me to return the
> favor and remind and reeducate the FDA on what it knows already, how
> the American public feels on this issue.
>
> In 1992, when the FDA issued its food policy, it received thousands of
> public comments. Those comments overwhelmingly told you three things:
> one, the public wants mandatory premarket safety testing; two, the
> public wants mandatory environmental review before these foods are
> commercialized; and, three, when they do come on the market, the
> public wants mandatory labeling.
>
> The FDA did not respond to those comments in any official way. In
> 1993, the FDA, again, took public comments on labeling. It received
> thousands of letters, again, from consumers saying it wants mandatory
> labeling. The FDA did not respond.
>
> In 1994, the FDA held a public conference on allergenicity. It has not
> done anything with that data. The bottom line is the FDA\'s refusal to
> act has led to our filing of a law suit. Regardless of the decision
> that comes out of that law suit, it is time for the FDA to act on what
> the public is telling it. Be a servant of the American public, not a
> slave to industry.
>
> MR. LAKE: Thank you, sir.
>
> MS. O\'LEARY: Patricia O\'Leary, just interested consumer. Food
> resulting from seeds that have been genetically altered is essentially
> no different from that resulting from traditionally bred seed is
> incompatible and inconsistent with the whole criterion of
> patentability.
>
> In order to receive a patent, the entities that have engineered the
> seed must prove that the product is significantly different and
> sufficiently transformed in order to be patented as an original
> creation. Nor are they near hybrids as they cross species barriers.
> But what is wrong with making plants tolerant to herbicides, resistant
> to insects, fungus or viruses?
>
> What is wrong with fruits and vegetables that will not ripen or bruise
> before being told? What is wrong with vaccines in bananas and high
> vitamin-A concentrations in rice and rape seed, giant salmon growing
> so fast that you can almost watch, or cows with oversized udders
> injected with recombinant growth hormone so as produce many times the
> amount of milk than non-treated cows and then highly dosed with
> antibiotics to treat their mastitis and other infections?
>
> What is wrong with envisioning future plants and animals as
> tailor-made commodities. Even if all of these benefits were actually
> achievable and safe, society would have to question the ethics, the
> democratic process, the monopolies created, the patenting of life, the
> cost to the environment, the impact on the third world and on
> biodiversity.
>
> Or we could simply ask what is wrong with food and nature as we know
> it? I am going to leave a little bit out in the interest of time. For
> the consumer, herbicide-tolerant plants pose another danger. Plants
> grown in the presence of weed killers can suffer from stress and react
> by over- or underproducing certain proteins or other substances.
>
> Glycosate-tolerant soybeans have been found to produce higher levels
> of plant estrogens when grown in the presence of that herbicide, thus
> presenting a potentially severe health risk to children. As for plants
> with built-in insecticides\--thank you.
>
> MR. LAKE: Thank you, ma\'am.
>
> DR. BARACH: Good afternoon. I am Dr. Jeffrey Barach with the National
> Food Processors Association. NFPA serves as the scientific and
> technical trade association for the \$460 billion U.S. food-processing
> industry. Today, I would like to make several comments regarding foods
> derived using modern biotechnology and to affirmatively answer these
> two questions.
>
> Number one; could the FDA voluntary consultation process be made more
> formal and transparent? Yes; we think it could. This would help with
> possible consumer safety concerns in both the U.S. and abroad. Number
> two; are criteria required to insure voluntary labeling statements are
> truthful and nonmisleading? Yes; we think well-defined criteria are
> very important to the integrity of this growing niche market.
>
> As in the past, NFPA member companies remain fully supportive of
> today\'s agricultural developments and those anticipated future
> biotech food products that will offer remarkable nutrition and health
> benefits directly to consumers.
>
> As well as the technology, we support the consultation oversight
> process for safety assessment of biotech foods. The process has worked
> and continues to work well. Could this process be made more formal and
> transparent? Yes. Although we believe the current voluntary
> consultation process is already, essentially, a mandatory one, it may
> provide added confidence to the system to make it a more formal
> process.
>
> We also strongly support the science-based FDA policy on labeling of
> biotech foods and promote the use of voluntary labeling statements
> provided that such statements are truthful, nonmisleading and disclose
> the necessary required material facts.
>
> To this end, we would recommend that when voluntary statements are
> used, such as biotech-free, three criteria should be met. These
> include quantitation, certification and putting claims in contact with
> qualifying statements.
>
> In conclusion, NFPA and its member companies strongly support the
> FDA\'s regulatory oversight of biotech foods. We believe our
> suggestions will improve the process as it develops into the next
> century.
>
> MR. LAKE: Thank you, sir.
>
> MR. STEIN: Good afternoon. I am Jeff Stein, a molecular biologist by
> training and Director of Regulatory and Government Affairs for
> Novartis Seeds in North America. Both in Chicago and here today, we
> have listened to many speakers call for the labeling of foods whose
> ingredients have been derived from crop plants that have been
> genetically modified by the tools of biotechnology.
>
> Individuals and groups that have expressed this point of view have
> stated that they wish to have access to foods that are free of the
> introduced DNA sequences, however innocuous these sequences may be, or
> they wish access to foods that are free of the expressed proteins,
> however safe they have been proven to be, or they wish access to foods
> that are free of unintended toxins or other unidentified substances
> although the scientific evidence does not support the presence nor the
> risk associated with these materials.
>
> Regardless of the reasons, their call for this choice is genuine.
> Speaking both as a consumer and a representative of Novartis seeds, I
> wholeheartedly support their desire for the option to purchase
> products lacking these attributes.
>
> Those individuals who wish to purchase foods that are free of
> ingredients derived from genetically enhanced crop plants should be
> able to do so. For members of the FDA panel, clinical quantities of
> fresh and processed food products that meet these standards are
> already available in local and specialty grocery stores across the
> nation. These products are grown and processed according to a strict
> set of rules and standards including the absence of so-called GMOs.
>
> Food product that meet these standards carry the label of \"organic.\"
> Organic and processed foods provide a choice for those consumers who
> wish to purchase products that are free from introduced DNA sequences
> and newly expressed proteins.
>
> To meet the demands of consumers who wish to purchase food free from
> these materials does not necessitate the rewriting of the \'92 food
> policy or the rewriting of current FDA labeling guidelines.
>
> MR. LAKE: Thank you, sir.
>
> MR. GOLDBERG: Good afternoon. I am Gary Goldberg, Chief Executive
> Officer of the American Corn Growers Association. This issue of
> genetically modified organisms, or GMOs, has placed the American
> farmer in the middle of a dispute between seed dealers, chemical
> companies, grain elevators, grain exporters, foreign consumers and our
> own government.
>
> While we have been told, under this current farm program, to grow more
> crops for the marketplace, the marketplace is rejecting what we grow.
> Our nation\'s farmers pride themselves on growing the safest and
> tastiest food in the world. Now our integrity is being questioned over
> the issue of GMOs and we resent being put in this position.
>
> Until we can instill confidence in the commodities we grow, foreign
> buyers will continue to reject our products and question our
> motivation. The questions over food safety will not go away simply
> because our government threatens foreign countries with trade
> sanctions. This leave our farmers with the risk of planting crops in
> the spring that may not be marketable in the fall because of growing
> consumer unrest.
>
> This uncertainty will continue until the FDA restores consumer
> confidence. Therefore, the ACGA recommends the following measures:
> one, conduct independent clinical studies on the safety of genetically
> modified foods; two, determine the consequence of cross-pollination
> and its effects on non-GMO crops, our water and our soil; and, three,
> mandate labels on all GMO foods, both domestic and foreign, to fulfill
> the consumer\'s right to know what foods they and their children eat.
>
> We recognize that biotechnology companies have made a sizeable
> investment in the research and development of GMOs. That is not our
> concern. Our concern is the investment that the American farmer makes
> in purchasing, planting, nurturing and harvesting of crops that may
> not have a readily available market.
>
> The FDA must recognize the concerns and address this problem head-on
> through testing and labeling.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> MS. MELNICK: My name is Rita Melnick and I am here as a concerned
> consumer. Genetic modification is a powerful tool. It can bring about
> great good but it can equally bring about great harm. In these early
> days of genetics, no scientist can guarantee with absolute certainty
> the outcome and ramifications of genetically modifying our food
> supply.
>
> With genetics, we are modifying the building blocks of life and, thus,
> should proceed with the utmost caution. We must remember we are
> dealing with living organisms, not inanimate objects.
>
> I am also concerned with the use of antibiotic-resistance markers for
> detecting that the GM transformation took place. With antibiotic
> resistance in humans at an all-time high, why use this type of marker?
> Why not some other type of substance to measure the change. And, once
> the change occurs, how many generations will it last?
>
> What occurs when the mutation becomes recessive? I want to know that
> the companies doing genetic modification are answering these and other
> essential questions that I am too ignorant to ask. Long-term testing
> must also be performed, but these issues may take a back seat when the
> company\'s main objective is the quest for profit.
>
> Until we know with more certainty the long-term effects of introducing
> GMOs into our food supply and our environment, I propose that the FDA
> mandate specific testing and criteria to be met for a product to be
> released on the market. I also propose that mandatory notification be
> added to the existing food label if the product contains or is
> processed with GM items.
>
> The consumer must have the right to decide whether or not to partake
> in any ongoing experiment of the long-term safety of GM foods.
>
> Thank you.
>
> MR. LAKE: Thank you, ma\'am.
>
> DR. SANTERRE: My name is Dr. Charles Santerre. I am an Associate
> Professor in the Department of Foods and Nutrition and Purdue
> University.
>
> Does the consumer have the right to know if their foods are
> bioengineered? The answer to this question is a resounding, \"Yes.\"
> The consumer has a right to know how their foods are processed,
> produced, distributed and prepared. Is the food label the proper place
> to inform the consumer?
>
> In a recent survey by the International Food Information Council, most
> Americans do not desire this information on the label. I agree that
> the label is not the most appropriate place for this information. The
> consumer would equate the fact that a food has been bioengineered with
> the importance of nutrient information that is currently on the label.
>
> The NLEA of 1990 already requires a substantial amount of information
> on the label. This information is pertinent to prevention of
> osteoporosis, as in the case of calcium content, or prevention of
> cardiovascular disease, as in the case of fat and cholesterol.
>
> To add new label information to products would only dilute the most
> relevant information that is provided on the label. Since
> bioengineered foods do not pose a significant health hazard to
> consumers, there is on reason for a labeling requirement.
>
> Consumers can be informed by brochures placed in grocery stores and by
> county-based outreach efforts such as those programs delivered to the
> USDA\'s Cooperative Extension Service.
>
> Is our food supply safer due to bioengineering? Yes; some
> bioengineered products required fewer pesticides be applied in the
> field which reduces pesticides residues in foods. Farmers growing
> bioengineered soybeans can use herbicides that don\'t contaminate
> their ground water. Insect-resistant corn has been shown to contain
> less cancer-causing mycotoxins, and the compounds produced by the bT
> corn are less toxic than other pesticides that would otherwise be used
> to control insects.
>
> Ultimately, bioengineering may allow us to remove allergens from food
> to further decrease pesticide usage, to increase the nutritional
> content of food and to further enhance the food supply.
>
> I support the FDA\'s current strategy for\--
>
> MR. LAKE: Thank you, sir.
>
> DR. VAN BUREN: How do you do? My name is Dr. Ariane Van Buren, the
> Environmental Director for the Interfaith Center on Corporate
> Responsibility where we represent religious institutions that have
> \$100 billion in investments in the stock market.
>
> These shareholders, this year, are engaged in beginning dialogue,
> already last week and this week, with twenty-four companies involved
> in genetically engineered food. They are asking the Board of Directors
> to adopt a policy of removing genetically engineered ingredients from
> all products sold or manufactured by the company until long-term
> safety has shown that these are not harmful to humans, animals and the
> environment and, in the meantime, labeling and identifying these
> products and reporting to shareholders by August, 2000.
>
> So we ask the FDA to require that labeling and the safety testing.
>
> A January 1999 Time-CNN poll indicated that 81Êpercent of Americans
> said that genetically engineered foods should be labeled as such. The
> European Union requires labeling of genetically engineered foods
> throughout the European Union as well as Japan, New Zealand and
> Australia.
>
> The European Union additionally has suspended approval of new
> genetically engineered organisms until a new safety law for them is
> implemented in 2002. We believe that this technology involves
> significant social, economic and environmental risks. Our company
> should take a leadership position, we feel, in delaying market
> adoption of genetically engineered crops and foods until the safety
> testing has been done.
>
> Failure to do so could leave our companies financially liable should
> detrimental effects to the public health or to the environment appear
> in the future. So I just want to mention that these are
> shareholders\--
>
> MR. LAKE: Thank you, ma\'am.
>
> DR. VAN BUREN: I will leave the names of the twenty-four companies.
>
> MS. BRODY: I am Charlotte Brody. I am a registered nurse. I am the
> Organizing Director of the Center for Health, Environment and Justice.
> But I am really here today as one of those baby-boomer moms who reads
> the labels, loves the labels, and really works hard to put nutritious,
> healthy food on my family\'s table.
>
> I don\'t want to serve my children arrogance. I don\'t want to serve
> them the corporate arrogance that puts some of these foods on the
> market. I don\'t want to serve them FDA\'s arrogance.
>
> I have read the science. I have heard the testimony today. There is a
> whole lot we don\'t know. Even with all of the flag-waving about sound
> science, I think if we put the arrogance aside, it is, \"maybe yes,\"
> \"maybe no,\" \"maybe sometimes.\" Maybe we need more testing.
>
> While we are trying to work through the corporate power and while we
> are trying to work through the arrogance, I need to know what is
> genetically engineered. I need to be able to make that decision but I
> don\'t think you are really going to make it safely for me.
>
> So the least you can do is mandatory reporting and mandatory labeling.
> Thank you.
>
> MR. LAKE: Thank you, ma\'am.
>
> MS. RICE-ARNOLD: My name is Elizabeth Rice Arnold. I am Associate
> Director of the Institute of Science, Technology and Public Policy, a
> non-profit educational public-policy institute devoted to promoting
> proven solutions and programs of prevention.
>
> One of our areas of focus is sustainable agriculture. We are here
> today to underline what has been said many times before, that the
> government must reverse its position and establish stringent,
> premarket safety testing on these foods and keep them out of our
> fields and kitchens until they are scientifically proven safe for our
> environment and our families.
>
> Until those protocols are in place, federal regulations must mandate
> the clear and accurate labeling of all genetically engineered foods.
> We, again, mandate the labeling of genetically engineered foods,
> declare a moratorium on the release of genetically engineered
> organisms until the ecological impact of such organisms can be
> established.
>
> The Institute envisions a time when American farmers will farm in full
> accord with the laws of nature, fully utilizing nature\'s creativity
> to yield abundant, healthy foods while protected the environment and
> insuring a vigorous, diversified, sustainable agricultural economy.
>
> We are the time in our world\'s history where we can no longer afford
> to violate the laws of nature in our haste for progress. Please,
> mandate labeling of genetically engineered foods now.
>
> MR. LAKE: Thank you, ma\'am.
>
> DR. THOMAS HOBEN: Good afternoon. I am Thomas Hoben, Professor of
> Sociology and Food Science at North Carolina State University. I have
> spent the past ten years researching public knowledge and attitudes
> about biotechnology.
>
> Labeling questions represent one of the most complex and ambiguous
> areas of survey research. What I conclude from my own research and all
> the other surveys I have reviewed is, \"What you ask is what you
> get.\" On one hand, opinion polls indicate that a majority of
> consumers feel foods developed through biotechnology should be
> labeled.
>
> However, to put that in perspective, almost as many want to know the
> country of origin for the food and an even greater percentage feel the
> label should explain whether or not pesticides have been used. It will
> be very hard to set priorities for limited label space when everything
> is very important to everybody.
>
> A much more realistic approach to this question is to first describe
> the current FDA policy; that is, that foods will be not be labeled if
> they are unchanged. In this case, then, about three-quarters of U.S.
> consumers actually support your current policy.
>
> Answers consumers give spontaneously over the phone do not necessarily
> provide a sufficient basis for public-policy decisions. It is more
> valid to use focus groups that engage consumers in a thoughtful
> discussion. Let me quickly summarize a few of those results.
>
> We explored the case of biotech-produced chymosen to learn that
> consumers really don\'t expect a label of the food\--in this case,
> cheese\--has not been changed in some material way. In fact, that has
> been your approach.
>
> Next, we have found that consumers see much less need for labels on
> processed foods compared to whole produce items. We have also learned
> that many consumers don\'t place much value on such labeling and
> appear unwilling to pay any additional cost.
>
> Finally, most consumers are already overloaded with information and
> overwhelmed by choice when it comes to food purchases and they mainly
> use the labels right now for nutritional information. A system for
> voluntary labeling of foods not produced through biotechnology would
> provide meaningful choice to the concerned minority without imposing
> costs on or denying benefits to the majority of consumers who are
> generally quite supportive of biotech.
>
> To do this, we need a much greater commitment to education. Thank you.
>
> MR. LAKE: Thank you, sir.
>
> DR. WOO: I am Dr. Robin Woo at Georgetown Center for Food and
> Nutrition Policy. First of all, I would like to thank you all of the
> FDA. If I could have a big sign saying, \"I hired FDA,\" I would
> because I want to thank you for protecting our food and our drugs. We
> are probably all here and healthier because of you.
>
> The Georgetown campus provides the program in the Masters and Public
> Policy. Our nutrition program provides education in areas such as
> this. Today\'s meeting is very much the core of my class in public
> policy.
>
> One of my students looked at Tom Hoben\'s data on what is the most
> important factor in the acceptance of public policy, and that is
> belief and trust in government and regulators. With that in mind, I
> think you should take to heart, as I know you will, everything that
> has been said today about how to strengthen what you have already done
> well in the beginnings of your regulatory process.
>
> On another front, I think public communication is, perhaps, one of
> your weakest areas of effort. That can be improved by taking a team
> approach with your natural allies, the joint groups of USDA, FDA and
> EPA, in creating a program with those who communicate to the public,
> the educators, the press, working with them to educate the educators,
> working through AAAS and the science writers, telling them how they
> can better relay some of the efforts you are doing.
>
> Answer the press\'s questions when they are wrong, directly, quickly.
> Provide summer education programs with ADA. You heard the offer. You
> have got all those nutritionists and dieticians out there waiting to
> help you. Keep up your Internet, your 1-800 line.
>
> I think labels and more regulations will naturally happen as products
> become more consumer friendly because there will be changes.
>
> MR. LAKE: Thank you, ma\'am.
>
> DR. THOMAS: My name is Dr. John A. Thomas. I am Professor Emeritus of
> Pharmacology and Toxicology at the University of Texas Health Science
> Center at San Antonio. I have had over three decades of experience in
> various areas of toxicology and safety assessment including
> biopharmaceuticals and transgenic drugs in food.
>
> Given the brevity of my allotted time, I will use two GM prototypes,
> namely soy and corn, to illustrate my views of the safety for
> livestock and human consumption. In my professional opinion, but GM
> corn and GM soya are safe\--that is to say, safe as conventional
> foods. More importantly, these GM crops exhibit additional
> characteristics that render them even safer for human consumption.
>
> For example, GM corn contains less mycotoxins or aphlatoxins.
> Aphlatoxins have been associated with human esophageal cancer. They
> have been associated with neural-tube defects and aphlatoxins are
> hepatic carcinogens in rodents. Aphlatoxins have also been associated
> with equine leukoencephalomalacia as well as porcine pulmonary edema
> and liver toxicity. Thus, GM corn with its aflatoxin content
> represents and additional safe food characteristic.
>
> Finally, and my second example, an important advance in technology, is
> GM soy. GM soy is compositionally similar to conventional soy.
> However, GM soybeans, as has been previously mentioned, are used
> growing broad-spectrum nontoxic, nonresidual herbicides. With GM soya,
> there is no longer the need or concern about residual organochlorines
> and organophosphates.
>
> Epidemiologic studies have revealed a lower incidence of breast,
> prostate and colon cancer in individuals consuming soy products.
> Similarly, infant formulas have used soy products for over 50 years.
> GM and conventional soybeans are substantially equivalent.
>
> Healthy and wholesome foods are important for disease prevention. I
> believe GM foods fulfill this criteria. The Twenty-First Century will
> be heralded by a number of biotechnology breakthroughs including
> low-cost oral vaccines.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> MR. FUCHS: Good afternoon. My name is Roy Fuchs from Monsanto Company.
> My comments briefly address the benefits of agricultural
> biotechnology, the effectiveness of FDA\'s \'92 policy and our efforts
> to provide the public with better information on biotechnology
> products and issues.
>
> Monsanto has conducted research and development for almost twenty
> years to produce biotech products which help farmers manage insect
> pests, weeds and plant diseases more effectively. The use of these
> crops by farmers have helped reduced pesticide usage, lessen soil
> erosion through conservation tillage, improve feed and food quality
> and lower food production costs.
>
> For example, cotton farmers who chose to use bT cotton only had to
> make, on average, one to two insecticide sprays versus five to six in
> non-bT-fields. Researchers are developing products with enhanced
> nutritional traits such as healthier oils without trans-fatty acids.
> Scientists are also working to improve the productivity of feed crops
> for developing countries.
>
> FDA\'s implementation of the \'92 policy has been effective. The
> policy, itself, is science based and provides adequate guidance. It
> addresses relevant questions for new products and methods and FDA
> assures that appropriate safety questions are addressed and resolved
> during the consultation.
>
> We are committed to developing safe and nutritious crops for farmers,
> food companies and consumers. Comprehensive research studies are
> performed to evaluate the composition, nutrition and safety of each of
> these crops. We have, and will continue to seek, FDA\'s review of all
> of our biotechnology products and will address and resolve all safety
> issues before any product is sold commercially.
>
> We are committed to communicating information about our product. We
> partner with various educational groups and organizations. Our
> Internet website at www.monsanto.com provides links to hundreds of
> independent sources and provides access to over 10,000 articles and
> reports related to our products and biotechnology. Over 2 million
> visitors have accessed information on this site this year.
>
> Thank you for this opportunity to make comments.
>
> MR. LAKE: Thank you, sir.
>
> DR. TOZZI: Good evening. I am Jim Tozzi with Federal Focus, a
> non-profit institute. If FDA decides to change its current policies,
> the resulting proposed regulation is going to be subject to the
> Paperwork Reduction Act. Under the Paperwork Reduction Act, it is the
> Office of Management and Budget, not the FDA, who makes the final
> decision on the proposed rule.
>
> One of the most important decisions that OMB will make with FDA\'s
> advice, of course, is whether the labeling requirements have practical
> utility. The determination of practical utility must be based on a
> sufficient record to withstand potential review. It is for that reason
> the Paper Act was applied to labeling, to be sure that sound science
> exudes and goes over passion.
>
> For this reason, Federal Focus will be having a symposium on biotech
> October 24 at Georgetown University Conference Center. In doing so, we
> are going to look at the existing system which you which, on
> preliminary reviews, looks like it is working well, but not real well,
> the difference being transparency.
>
> We think that if you would have these meetings and publicize the role
> of your sister agencies, the EPA and USDA, and have them, in presence,
> on the panel would help. We will give some recommendations for that.
>
> We are going to look at three options; claims-based labeling, identity
> preservation and FDA-mandated labeling. To address the
> comprehensiveness of the system, we are going to look at maintaining
> the current regulatory GM or GM-specific review process, premarket
> review process.
>
> Our report will be on the web and we ask for all people who attended
> this to give us their view through our website which is fedfocus.org.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> MS. WITTENBERG: My name is Margaret Wittenberg. I am the Vice
> President of Governmental and Public Affairs for Whole Foods Market,
> Incorporated, the world\'s largest retailer of natural and organic
> foods. In addition to the name Whole Foods Market, our stores are
> doing business as Fresh Fields, Bread and Circus, Bread of Life, in
> Florida, Well Spring Grocery and Merchant of Vino. At the end of our
> 1999 fiscal year, we had sales of \$1.6 billion.
>
> With any new technology, it is the responsibility of society to
> understand the technology and make sure appropriate safeguards are in
> place. Regarding agriculture biotechnology, the majority of our
> customers are very concerned, asking questions that should have been
> explored and answered in an objective manner before products from it
> arrived in the marketplace.
>
> The genetic modification of our food supply is a very complex issue
> that truly requires input from all stakeholders in the process, as we
> are having the opportunity to do today. Accordingly, Whole Foods
> Market urges the FDA to reconsider its decision not to require
> labeling of foods that contain genetically modified ingredients.
>
> Your policy in 1992 concerning new plant varieties stated that no
> special labeling is needed for foods that you perceive at no different
> than conventionally bred food in nutrition or in requirements for
> storage and handling. However, we question whether this evaluation of
> substantial equivalence truly constitutes sound science.
>
> The term that is often bandied about is what those in favor of
> agricultural biotechnology support and those that question it don\'t.
> Judging a food primarily on the amount of macro- and micronutrients is
> not enough to explore risk and insure safety that are best evaluated
> through toxological, biological and immunological testing.
>
> Relying on the FDA\'s apparent definition of substantial equivalence
> is wishful thinking without adequate grounds on which to judge whether
> a product has short- or long-term safety or not.
>
> Science doesn\'t exist in a vacuum. Food choices are also based on an
> individual\'s religious, ethical, social or even personal decision of
> foods he wants to eat or the technologies he wants to support.
>
> MR. LAKE: Thank you, ma\'am.
>
> MR. ANDERSON: Thank you for the opportunity to be here today. My name
> is Tony Anderson. I am a soybean and corn farmer from Mt. Sterling,
> Ohio. In addition, I serve as First Vice President of the American
> Soybean Association, an organization that represents 32,000 producer
> members on national policy issues important to all U.S. soybean
> farmers.
>
> My brother and I have farmed in partnership for the last eighteen
> years. Both of us graduated from the Ohio State University with a
> degree in agriculture. Furthermore, I participate in a continuing
> education program for safe pesticide application. My brother and I,
> like fellow soybean producers, have worked hard to establish the
> quality reputation that soybeans enjoy with consumers in the U.S. and
> around the world.
>
> If there were any legitimate basis for questioning the safety of
> varieties derived through biotechnology for animal or human
> consumption or to the environment, we would be among the first to
> raise concerns. Like the consumers we serve, farmers have full
> confidence in the FDA as well as USDA and EPA to make these
> determinations.
>
> The complete absence of sound scientific evidence to support false and
> misleading claims about the safety of biotech products gives everyone
> of us reason to support this new technology. It is a tool for
> producing safer, more nutritious crops more efficiently and more
> abundantly.
>
> The American Soybean Association fully supports the current process
> through which FDA reviews applications for commercial introduction of
> biotech products. However, if replacing this voluntary process with
> mandatory approval would strength the FDA\'s ability to reassure
> consumers regarding the safety of these products, we would endorse
> such a change.
>
> We believe the critics of this new technology do not adequately
> consider the very real benefits of agricultural biotechnology brings
> to the environment. While we have great strides in reducing toxicity
> and usage of pesticides in recent years, I hope that our friends in
> the environmental community can see that the future of biotech
> innovations will allow us to improve even more.
>
> One of the greatest benefits of biotech crops is our potential to slow
> the clearing of rain forests and other nonagricultural lands in
> developing countries. By increasing yields rather than expanding
> global acreage, we can find the solution to feeding an additional
> 2Êbillion people by the Year 2035.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> MS. TAKISE: Thank you very much for the opportunity to participate in
> this meeting. I came from Japan for this meeting. My name is Kaori
> Takise, a member of Japan\'s Offspring Fund.
>
> In April, 1996, the U.S. began the widespread planting of GM foods
> before Japan had developed standards. Therefore the Japanese
> government had to make rushed guidelines and accepted the import of GM
> foods. Most
>
> Japanese consumers, however, did not accept GM foods. The Yomiuri
> newspaper conducted a survey and found more than 80 percent consumers
> did not accept them.
>
> In spite of this, we are unable to make our own choices about GM foods
> even after starting of labeling in April 2001. On November 29, the
> Ministry of Agriculture, Forestry and Fisheries proposed the labeling
> law that food industries can label \"segregated\" even when food
> contains large amounts of GM foods.
>
> Due to pressure from the U.S., the Japanese government made such
> mutilate proposal on labeling. The Japanese consumers are furious
> about this proposal. Therefore, if the U.S. ignores the Japanese
> consumer preferences and exports agricultural products without
> identifying GM foods, the Japanese will stop buying American products.
>
> For the sake of consumers, we believe that labeling of GM products is
> essential. We believe that many American consumers also agree with our
> opinion. In order to respect consumers\' rights, we ask you to
> institute the strict labeling and separating of GM foods.
>
> Thank you very much.
>
> MR. LAKE: Thank you, ma\'am.
>
> MS. SMITH: My name is Sandy Smith. I am from York County,
> Pennsylvania. I am speaking for Pennsylvania Environmental Network,
> Pennsylvania for Responsible Agriculture, Sludgebusters and York
> Greens. I have already handed in a petition with 1500 names and have
> promised the people that I would hand over the message, the message
> being it is unbelievable that in a country of so many freedoms, the
> American people are forced to buy and eat food that is genetically
> engineered and grown in a soup of toxic chemicals without even a
> warning label.
>
> Not only is the FDA not looking out for the welfare of the people,
> they are not looking out for the American farmer as he looses
> competitiveness in the world market by allowing his food to be grown.
>
> We, the undersigned, demand labeled foods.
>
> Thank you very much.
>
> MR. LAKE: Thank you, ma\'am.
>
> MS. PORTER: Good afternoon. My name is Leah Porter. I am the Executive
> Director of the American Crop Protection Association\'s Biotechnology
> Committee. ACPA members represents major manufacturers, formulators
> and distributors of crop protection and pest-control products
> including biotechnology products with crop production and protection
> characteristics.
>
> We applaud the FDA for holding these public meetings to explain its
> policy and relate its experience regarding the safety evaluation of
> food products derived via biotechnology. ACPA member companies firmly
> support and open and informed dialogue on how to reconcile technical
> advances with human and environment protection.
>
> ACPA supports those presentations that express support of plant
> biotechnology and the coordinated regulatory framework that fully
> examines food safety risks and concerns. However, I would like to
> address a comment from earlier today, a statement that there is an
> utter absence of direct consumer benefit from current crops derived
> via biotechnology.
>
> A recent press release highlighted research that indicates lower
> mycotoxin concentrations in insect-resistant corn hybrids commonly
> referred to as bT corn. The presence of mycotoxins can be directly
> related to insect damage in crops. Additionally, mycotoxins, notably
> fumonisin, can be fatal to livestock and is a probable human
> carcinogen.
>
> Lower mycotoxin concentrations which result in lower livestock and
> human health threats clearly represent the direct consumer benefit.
> ACPA urges that the current debate surrounding the safety of plant
> biotechnology be based on thorough risk and benefit assessment.
>
> Given the solid record of the U.S. regulatory system in insuring food
> safety, we are confident that future decisions will adequately protect
> human health and the environment.
>
> Thank you.
>
> MR. LAKE: Thank you, ma\'am.
>
> MR. LEMIENX: Hi. My name is Joe Lemienx. I am a healthfood store
> owner. The first thing I would like to say is that I would really
> prefer to get my food from God the way it is provided and not from
> scientists. I am opposed to genetically engineered foods on both
> ethical and religious grounds and I would like to see them removed
> from the marketplace until they are proven safe for human consumption
> and pose no danger to the environment.
>
> I do not believe that this proof exists. Labeling is better than
> nothing, but removal from the marketplace is what I would like to see.
> Even Former President Jimmy Carter, a supporter of some GE research,
> has spoken out for a moratorium on genetically engineered foods until
> they can be proven safe.
>
> Second, I would like to say that I believe that the FDA policies in
> regard to food safety show a total disregard for human and
> environmental safety and support the reckless behavior of chemical
> companies and their political supporters.
>
> Again and again, choices are being made for corporate profits at the
> expense of public safety and health. Instead of supporting sustainable
> agriculture that respects and nurtures the earth, you continue to
> support measures that rely on chemical solutions, that destroy the
> soil of this country, pollute our waterways and fill our plates with
> poison chemical pesticides.
>
> And now you bring us \"Frankenfoods.\" Genetically engineered foods
> also pose a threat to the healthiest food on this planet, organic
> foods. Because of the possibility of pollen drift, organic foods can
> be compromised and destroyed by this experiment.
>
> I have spoken to companies who provide food to the health industry who
> are unable to guarantee that their products are GMO free because of
> the possibility of cross-contamination from GMO fields.
>
> Recently, you were asked to provide corridors between organic fields
> and GMO fields and I understand that you refused. Your reasoning, I
> believe, was that there was no need for this since GMO foods are no
> different than organic foods. I do not believe this and I do not
> choose to be a part of this experiment.
>
> I resent the fact that you will not safeguard organic foods from this
> misguided experiment.
>
> MR. LAKE: Thank you, sir.
>
> MR. MENCHEY: My name is Steve Menchey. I am here on behalf of the
> National Cotton Council. The National Cotton Council does have a
> vested interest in food safety. Some of our products go into certain
> food and feed products. Our interest is great enough that we come to
> this meeting in support of a sound and reliable food-safety regulatory
> system.
>
> The National Cotton Council supports the current system of FDA review
> of food and feed products derived from genetically enhanced crop
> varieties. We believe that the process, developed in 1992, is sound
> and adequate to address any concern about the safety of biotechnology.
> We also feel the system is flexible enough to deal with future
> technologies that will be developed.
>
> The National Cotton Council supports FDA\'s policy that mandates
> labels only when information provides useful information pertaining to
> food nutrients, health or safety. To require special labels because of
> political, marketing or emotional reasons is not appropriate.
>
> The mere presence of such labels unnecessarily implies health and
> safety concerns. To mandate label information referring to specific
> technology used to impart plant traits into food crops would be an
> unnecessary, unreasonable and unmanageable regulation that has no
> bearing on the mission of the FDA.
>
> Under the current system, there are no demands for labeling of, for
> example, tomatoes that have been developed through conventional
> breeding to have nematode or fusarium-wilt resistance. The reason, of
> course, is that the food constituents of these varieties are
> considered to materially equivalent to varieties not containing those
> characteristics, although the resistant varieties will have different
> genes and different proteins than the conventional varieties.
>
> Similarly, we believe that same rationale should apply to foods from
> plants that have been enhanced through biotechnology, that labeling
> should be required only if foods are shown to be substantially
> different, not simply because of the type of technology used in the
> development.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> MR. JOHNSON: My name is Eric Johnson. Labeling must be mandatory. That
> is my position. Here is why? Substantially equivalent and generally
> recognized as safe are claims that simply are not supported by the
> facts. I would refer you to the memos made available as a result of
> the Alliance of Biointegrity law suite. You can find them on their
> website, although many of you may have your own file copies already.
>
> It looks an awful lot like the process of easy approval for transgenic
> foods is driven more by political influence than by science-based
> concern for human health or the environment. Add to this the shoddy
> environmental assessment work done with respect to transgenic
> virus-resistant summer squash and with respect to butterfly- and
> moth-killing transgenic bT crops, and the regulatory framework for
> assessing transgenic crops and foods looks incredibly weak.
>
> Yet the FDA refuses, to this point, to mandate labeling so that
> consumers can choose to be cautious when their government won\'t be.
> This has to change. We need mandatory labeling of all products that
> contain transgenic ingredients.
>
> MR. LAKE: Thank you, sir.
>
> MS. McCULLUM: My name is Christy McCullum. I am a doctoral candidate
> at Cornell University. This statement has been prepared by Rodney
> Leonard, Executive Director of Community Nutrition Institute and
> myself representing the Institute for Agriculture and Trade Policy,
> Defenders of Wildlife and CNI.
>
> In 1992, FDA introduced substantial equivalence as a regulatory device
> to permit genetically modified ingredients to be substituted in foods
> for conventional ingredients. This concept\'s validity as a basis for
> public-health policy is now being questioned.
>
> Consumers in Europe, Japan, Korea and elsewhere do not accept the
> concept of substantial equivalence and, therefore, will not accept
> foods with genetically modified ingredients. Furthermore, European
> governments are requiring labeling on all foods with genetically
> modified ingredients.
>
> The uproar in Europe and elsewhere over current U.S. regulatory policy
> has caused substantial losses of export markets for U.S. foods and
> food commodities. Thus, mandatory labeling of all foods containing GM
> ingredients is needed to prevent further damage to U.S. farmers.
>
> The current practice and risk assessment defined by FDA as a
> precautionary approach evaluates harm on a case-by-case basis. This
> approach is based on a process of linear analysis and reductionism.
>
> Instead, the FDA needs to adopt a precautionary principle as its
> guiding safeguard in public health. The precautionary principle is
> based on nonlinear analysis. Risks occur in complex systems from
> feedback, looping and other nonlinear conditions. Harm in these
> systems is inherently uncertain, unpredictable and can be examined
> only through nonlinear analysis.
>
> We invite FDA to insure public participation in how to avoid future
> errors starting with citizen panels and hearings on the precautionary
> principle as a regulatory framework for a new FDA.
>
> Thank you.
>
> MR. LAKE: Thank you, ma\'am.
>
> MR. ABBOTT: Good afternoon. My name is David Abbott. I am Past
> President of Purina Mills, Incorporated, St. Louis, Missouri. I
> currently serve as Chairman of the American Feed Industry Association.
>
> Food safety and consumer confidence are top priorities for my company
> as well as the feed industry. We support sound science-based
> food-production systems. We support government regulations that
> protect public health and also enhance food production. We strongly
> oppose any regulation based upon theoretical risk.
>
> The use of genetically enhanced ingredients in human and animal foods
> is rife for benefit analysis. The promises of biotechnology are
> well-known. Most risks associated with the science are largely
> speculative. The great benefits of biotechnology must not be lost
> because of relatively minor concerns.
>
> We have excellent systems in place and working to protect the safety
> of our food. FDA\'s feed-additive approval guidelines provide for
> removal of unknown allergens that may evolve. New test methods are
> becoming widely available.
>
> The voluntary industry-agency consultations are successful. To mandate
> consultations would waste federal and private funds, manpower and
> time. AFIA strongly supports the current federal labeling policy.
> There is no logical reason to label based upon a process or a
> production practice if the information is of no value to the consumer.
>
> We must educate consumers about the technology that will transform and
> insure the safety of their food. FDA can\'t be the industry\'s
> cheerleader but it can explain the success of its consultation and
> review system that assures the continued safe use of genetically
> enhanced foods and feeds.
>
> Consumers need facts, not fairy tales or horror stories.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> DR. HAEGLEN: I am John Haeglen, nuclear physicist and presidential
> candidate for American\'s fastest growing political party, the Natural
> Law Party.
>
> As a scientist, I am deeply concerned about the genetic manipulation
> of food. I am concerned about the health and environmental risks of
> this radical technology which manipulates life at its foundation. The
> possibility of unanticipated allergic and toxic reactions is already
> well documented.
>
> Even the FDA\'s own staff scientists have warned of \"the possibility
> of high concentrations of plant toxicants in these experimental
> foods.\" And, of course, the environmental risks from these
> experimental crops are incalculable from the gene pollution that
> results from breaking down genetic barriers put in place by natures.
>
> Yet, our government has helped slip these foods onto our grocery-store
> shelves without safety testing and with no labeling. As a nuclear
> physicist, I have seen, first-hand, the results of the hasty
> commercialization of nuclear technologies that have threatened mankind
> with extinction.
>
> I am similarly concerned that short-term financial interests of a few
> biotech firms are guarding the commercialization of these equally
> dangerous genetic technologies. Genetically engineered crops have not
> fulfilled their promises of higher yields or environmental benefits.
>
> Since molecular biologists are, themselves, deeply divided about the
> safety of these foods, there is no scientific basis for the
> government\'s assurances that the risks are minimal. That is why I
> have helped draft legislation calling for mandatory labeling and
> safety testing.
>
> That is why thousands of Natural Law Party candidates across the
> country will challenge their incumbents on televised debates as to
> where they stand on this crucial labeling legislation. It is time our
> government fulfilled its responsibility to put the safety of the
> American people first instead of serving as apologists to the biotech
> industry.
>
> MR. LAKE: Thank you, sir.
>
> MR. GREEN: Hi. My name is Joey Green. I am an intern organic farmer. I
> just came back from a six-month hiatus in Austria. I can tell you that
> the Europeans will not accept this technology.
>
> I look around this room today and I feel like I am not at a public
> comment hearing, I am at a lobbyist hearing. It is all suits. It is
> all money. It is all special interests. I am really appalled at this
> entire seminar.
>
> I have been hearing all day there are no studies. There is a Cornell
> study, the Monarch butterfly study. There is a study by Dr. Putzai
> with the rats and the transgenic potatoes. There is a study that is
> going on in Norway by Dr. Terje Traavik documenting horizontal gene
> transfer which we are not talking about here today. It is available in
> English, if you want to read it.
>
> Green lacewings and other beneficial insects are dying in a Swiss
> report. At NYU, they did a study and they found out that bT toxins
> don\'t deteriorate in two or three or four or five days. Sometimes,
> they stay in the soil for eight months killing all kinds of microbial
> and beneficial insects.
>
> This information I have heard today here is just disheartening. We
> have been bought. Calvin Coolidge was right. The business of
> government is business and that is what is going on in this room
> today, and that is what is going on in America.
>
> Let me tell you something; Europe is not going to accept this and,
> eventually, Europe\'s will, Europe\'s political momentum, is going to
> sweep over this country and this stuff is going to be gone. I don\'t
> want it labeled. I want this stuff out of here.
>
> MR. LAKE: Thank you, sir.
>
> MS. ARNOLD: My name is Charlotte Arnold and I am Policy Director with
> the International Center for Technology Assessment. While labeling is
> an important issue, the larger issue is that these foods have not been
> proven safe. The agency has a legal duty not to allow genetically
> engineered foods onto the market without safety testing.
>
> FDA bureaucrats say that genetically engineered foods are
> substantially equivalent to conventionally produced foods. But agency
> scientists disagree saying that genetic engineering creates new
> proteins that must be safety tested. FDA bureaucrats say that
> genetically engineered ingredients are generally recognized as safe,
> but FDA scientists say these foods pose health threats.
>
> These include: toxicity, by increasing levels of existing toxicants
> and creating new toxicants; allergic reactions, by creating new
> allergens and synthesizing existing allergens; antibiotic
> resistance\--people who eat genetically engineered foods may become
> more susceptible to bacterial infections; cancer\--genetically
> engineered hormones may increase the risk of breast cancer, colon
> cancer and prostate cancer.
>
> Immune suppression\--tests linking genetically engineered foods to
> immune suppression have been validated by peer review. All of the
> scientific evidence reinforces that these foods are not safe. Labeling
> is not a panacea. You have a legal duty to insure that genetically
> engineered foods are safe before they are put on the market.
>
> FDA should be protecting consumers and not big business.
>
> MR. LAKE: Thank you, ma\'am.
>
> DR. HANSEN: Hi. My name is Michael Hansen from Consumer\'s Union, the
> publisher of Consumer Reports. We urge FDA to require mandatory safety
> assessments and mandatory labeling of all genetically engineered foods
> in order to assure safety. One reason is allergenicity. Becky
> Goldburg, this morning, talked about allergenicity.
>
> We agree with what she said. Pioneer did the right thing. However,
> there will be companies that do not act as responsibly as Pioneer did.
> Consider the Delcon Shield IUD, the Shiley heart valve, asbestos and
> PCBs. FDA must develop a detailed mandatory protocol for assessing
> allergens.
>
> Common known allergens present a new and unnecessary risk in the food
> supply and should be prohibited. Genetic engineering can also
> introduce new toxins or increase natural toxins that are already
> present in plants. Internal FDA memos recently made public show that
> when the FDA was developing its current industry self-regulatory
> proposals, staff from the Center for Veterinary Medicine recommended
> FDA review of all genetically engineered foods for potential toxicity
> problems, but they were overruled.
>
> The FDA says there is a vanishingly small risk that
> antibiotic-resistance marker genes in genetically engineered food will
> be transferred to disease-causing bacteria. However, other experts,
> including the British Medical Association, recommend a ban on the use
> of these genes in GE foods, as does Consumers Union.
>
> We commend the agency for its policy of mandatory review of
> genetically engineered fish and animals as new animal drugs. We urge
> FDA to be consistent and to adopt a similar review for engineered
> plants. In sum, current FDA policy is fundamentally flawed because it
> trusts that the industry, domestic and foreign, will do the proper
> safety assessments in testing to insure safety.
>
> But, to assure safety, the public needs FDA to require review and
> labeling of all genetically engineered foods.
>
> MR. LAKE:
>
> MR. LAKE: Thank you, sir.
>
> DR. VIDAVER: I am Ann Vidaver commenting on behalf of the American
> Society for Microbiology. The ASM commends FDA and concurs that its
> policy on bioengineered foods provides safe foods, that the policy is
> scientifically warranted and is reasonable and appropriate.
>
> There are clear potential benefits to consumers for products such as
> naturally decaffeinated coffee, mycotoxin-free corn and allergen-free
> peanuts. Some of the benefits of biotechnology, including improving
> our food supply, can be seen on an ASM-sponsored PBS program Creators
> of the Future to be shown tonight on public T.V. at 8:00Êp.m.
>
> The products of bioengineering, their composition, nutrient value and
> safety should be the focus of FDA and not the process by which they
> are made. Specifically, first, ASM believes the FDA process is sound
> and has provided safe products. Mandatory consultation by marketers
> may be prudent and reassuring to the public.
>
> Second, the ASM is not aware of new safety information issues or tests
> for bioengineered foods different than for foods currently tested
> according to FDA guidelines. Third, future food products derived from
> bioengineered plants include foods with altered composition in oils,
> vitamins, antioxidants and minerals, an allergen decrease or removal.
>
> Safety issues raised by these foods are no different in kind than
> those that have been developed over nearly a century of testing.
> Regarding public information, the ASM believes labeling should be
> based on significant alterations in the composition of food rather
> than process.
>
> Secondly, the ASM supports science education efforts. The FDA, USDA
> and EPA should coordinate providing information on policies and
> practices about bioengineered foods relative to non-engineered foods.
>
> Lastly, additional information can be made available through 800
> numbers, websites, leaflets and various media. The American Society
> for Microbiology has a full statement available.
>
> MR. LAKE: Thank you, ma\'am.
>
> MR. JACOBSON: Hello. My name is Andrew Jacobson. I am the President of
> the Natural Food Division of the Hain Food Group. We are the largest
> supplier of natural and organic foods to the organic products
> industry.
>
> Obviously, food safety is the number-one concern of all of us here.
> For the sake of our comment, though, we would like to deal with the
> segregation of raw materials. As a supplier and a manufacturer, we
> would like to have the ability to buy non-GMO or GMO raw materials and
> process them into finished goods as we see fit.
>
> We also would like to start the process and ask FDA to support
> regulation for that which will evolve into a mandatory labeling
> requirement. We feel that consumers should have the right to know what
> is in their products. Labels should be representative of the
> ingredients that are on them.
>
> It is difficult today to get clean or good-lineage products. We go to
> extensive testing. We try to use the best ingredients but, again, we
> are not here to argue the science. We just would like to get the
> segregation of the raw materials while the debate goes on before it
> becomes harder and harder to separate the materials that have been put
> together.
>
> Thank you for your time.
>
> MR. LAKE: Thank you, sir.
>
> MR. YODER: Good afternoon. My name is Fred Yoder. I grow corn,
> soybeans and wheat in Plains City, Ohio and am currently serving as a
> member of the Board of Directors of the National Corngrowers
> Association representing more than 30,000 farmers nationwide.
>
> As you may know, approximately one-third of this country\'s 72.6
> million acres of corn were planted in the biotech this past year.
> Consequently, corn farmers have a tremendous stake in this new
> technology. Farmers are very adept in dealing with the every-day
> uncertainties of the business. However, it is excessive to expect
> farmers to deal with the recent issues emerging around the issue of
> biotechnology.
>
> Simply, this country\'s producers now worry if there will even be a
> market for the crop they are going to produce. I have grown both corn
> and soybeans in biotech the last two years. I am very comfortable with
> both the science and the safety behind this technology. However, my
> confidence in the products and my stewardship of the technology will
> not insure consumer confidence in the science.
>
> The food safety determinations of the FDA are critically important in
> this process. It is imperative that the scientific assurances of
> safety come from the FDA and other trusted regulators. The National
> Corngrowers Association feels that the current science-based
> regulations and processes being used by the FDA is vitally important
> to assuring consumers of the safety of these products.
>
> It has become clear that there are consumer concerns. These concerns
> step from a lack of understanding of both the technology and the
> process of approval. To insure the marketability of both biotech corn
> and to insure our markets, the food products must not only be safe,
> but the consumer must be assured that they are safe, also.
>
> This role, the one of educating consumers, in one of the critical ones
> and one that must be played by the FDA and its team of experts. We
> join the FDA in the hopes that these hearings lead to greater
> confidence for everyone. It is only with greater awareness and
> confidence that these technologies can advance in all sectors and lead
> to more opportunity for both consumers and producers.
>
> Thank you very much.
>
> MR. LAKE: Thank you, sir.
>
> MR. MEDLEY: Good afternoon. My name is Terry Medley. I have
> responsibility for biotech regulatory affairs at Dupont Nutrition and
> Health. I am delighted to be here speaking today on behalf of Dupont.
> Dupont is a science company dedicated to delivering science-based
> solutions that make a difference in people\'s lives.
>
> I would like to echo the comments of Director Levitt this morning that
> we must do a better job of engaging, listening to and addressing the
> questions, even demands, of all stakeholders in this global debate.
> Listening implies engagement and respect that requires initiative,
> patience and the willingness to build relationships that will provide
> a point of view and perspective that may the counter to our own.
>
> This is one reason I am happy to be here today. Dupont concurs with
> and compliments FDA on this initiate to hold public meetings to
> discuss the agency\'s oversight of foods arrived through
> biotechnology. This type of regulatory transparency and solicitation
> of public input is critical.
>
> We must support and adhere, and we support and adhere, to the
> transparent and the comprehensive oversight system of the U.S.
> government in regulating this technology. We believe the U.S.
> regulatory framework has provided American with an abundant, safe and
> affordable food supply.
>
> FDA\'s statement on policies derived through new plant varieties
> provides Dupont with guidance oversight necessary to insure that we
> produce safe products. We are committed to insuring safe and
> high-quality supply to the world\'s consumers.
>
> We urge the FDA to continue their efforts to communicate their role in
> overseeing how new food and feeds are introduced into the marketplace
> in order for consumers to maintain confidence in that process as well.
>
> Promises of biotechnology are great. As with all new technologies,
> people want it done safely, ethically and responsibly. We want the
> same.
>
> MR. LAKE: Thank you, sir.
>
> MR. DEBUS: My name is Tim Debus with the United Fresh Fruit and
> Vegetable Association. We represent the interests of producers and
> distributors of fresh produce. We believe that mandatory labeling of
> food should be reserved to communicate health information that
> consumers must know, not interesting information that some consumers
> might want to know.
>
> We also believe in a consumer\'s right to know. Everyone has the right
> to ask grocery stores and food manufacturers anything about their
> product. If you cannot get an answer to your satisfaction, then buy it
> from someone who can answer you. That is consumer choice in a free
> market and it does not require mandatory labeling.
>
> Most Americans are not aware that eating at least five servings of
> fruits and vegetables each day improves health. If labeling is
> intended to provide consumers will useful information for their
> health, then shouldn\'t our priority be to inform the public about
> nutritious eating habits rather than to segregate safe and equivalent
> foods derived from biotechnology.
>
> Instead of labeling for nucleotides, DNA and genetic transformation,
> consumer health would be better served by labeling for antioxidants,
> phytochemicals and five servings a day. The benefit of labeling
> unchanged foods should be viewed as inconsequential compared to the
> value of informing consumers about the real public-health risk from
> poor nutrition.
>
> We believe FDA\'s current regulations and labeling policy on
> biotechnology provide the necessary oversight to balance the timely
> access to new technology and the affirmation of safe food. We support
> FDA\'s commitment to consumer safety and confidence, the reasonable
> policies based on knowledge and experience.
>
> We applaud FDA for the courage to continue to do what is right. Let us
> maintain an open and constructive dialogue on biotechnology but let us
> be mindful of our priority to provide labeling on topics that matter
> most to consumers, useful information for their health.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> DR. JAMES: My name is Clive James, Chairman of ISAAA, a not-for-profit
> organization based at Cornell University. Global acreage of
> genetically modified crops increased from 5 million acres in \'96 to
> 100 million acres in \'99. The top four countries are the U.S.,
> Argentina, Canada and China with the U.S. grown 72 percent of global
> acreage and China assigned a very high priority to biotechnology.
>
> Global food security is a formidable challenge. In the next 50 years,
> we must at least double crop production on the same area of land.
> Conventional technology alone will not allow us to double food
> production. A combined strategy of conventional technology and
> biotechnology offers the best probability of success.
>
> The most compelling for biotechnology is its potential contribution to
> global food security and the alleviation of hunger in the third world
> where 840Êmillion people suffer from malnutrition today. ISAAA is a
> not-for-profit organization established to alleviate hunger in the
> Third World by facilitating the safe and responsible transfer of crop
> biotech applications.
>
> U.S. organizations are featured prominently in ISAAA projects by
> generously donating technologies and training young scientists from
> the Third World. The U.S. is a world leader in crop biotechnology. It
> is important that the U.S. maintain this commitment to GM crops.
>
> In the absence of continued U.S. leadership, developing countries
> would be denied the opportunity to source U.S. technologies in their
> quest for food security and condemn up to a billion people in the
> Third World to unnecessary and unacceptable suffering from
> malnutrition, hunger and poverty.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> DR. TOLIN: My name is Sue Tolin. I am representing the American
> Phytopathological Society as a member of their National Plant
> Pathology Board. The 5,000 members of APS study diseases of plants
> worldwide. We view biotechnology and genetic engineering as an
> additional and an essential tool in our constant battle to protect
> plants from harmful microorganisms and produce a safe and sustainable
> food supply.
>
> APS believes the FDA consultation process has achieved its intended
> purpose by initiating a science-based review of recognizable risks;
> namely, toxicity, allergenicity and nutritional composition. These
> were the traits that could be started with in this review.
>
> The FDA process should be continued but be flexible and reactive to
> new scientific issues. A sunset might be considered for specific cases
> of familiarity with specific crops and traits. The FDA should make
> their decisions in an open and transparent manner and focus on the
> safety of food products.
>
> We urge, also, cooperating with USDA, EPA as well as plant sciences in
> the research community. We know of no specific test that could be used
> exclusively to provide greater assurance that food products from
> bioengineered plants are safe to consume.
>
> The APS recognizes the many potential benefits of engineered crops and
> is particularly interested in crops engineered to resist plant
> pathogens that are now currently reaching the market. We realize that
> some new issues may arise from the genetic constructs that are used
> but we will quite willingly cooperate with FDA in the dialogue.
>
> We believe that the policy of requiring labeling only for significant
> changes should be maintained and we urge that any label be informative
> and complete.
>
> Thank you.
>
> MR. LAKE: Thank you, ma\'am.
>
> MS. DAVIS: Good afternoon, or should I say evening. I am Susan Davis.
> I am a registered dietician speaking on behalf of myself. I am from
> the great state of Maine and delighted to be in Washington.
>
> Basically what I do is translate science into useful information for
> consumers so they can make informed food choices. Today, it seems like
> I spend an awful lot of time clearing up consumer confusion. The
> current debate among consumer groups who oppose biotech foods,
> researchers and companies who are involved in this technology is
> bringing consumer confusion to a new level.
>
> The \"he says, she says\" arguments currently embellished in the press
> don\'t serve the public. I encourage an effective, comprehensive
> consumer-education campaign using a balanced approach based on sound
> science. Labeling of all biotech foods won\'t accomplish this. It will
> further confuse consumers.
>
> It is an oversimplified approach to a complex technology that only
> education can help solve. All foods containing biotech ingredients are
> not alike. Again, this will just further confuse consumers.
>
> In addition, most consumers are confident in the oversight that is
> provided by the current regulatory agencies. I would like to support
> the current FDA labeling laws that identify those foods that are
> substantially different or contain allergens. Those who wish to avoid
> biotech foods can do so by choosing organic foods, which are plentiful
> throughout the United States.
>
> I would also like to comment that the biotech foods that are currently
> available do have a tremendous benefit to the consumer. These are in
> the area of the environment. Any technology that reduces herbicides,
> pesticides, fungicides should be applauded.
>
> Thank you very much.
>
> MR. LAKE: Thank you, ma\'am.
>
> MR. GRAY: Good afternoon. My name is Robert Gray. I am representing
> the Organic Trade Association. The FDA should label foods containing
> genetically engineered organisms or their products because Americans
> want to know what we eat and we have a right to that knowledge.
>
> There are a variety of concerns about our food. Some people want food
> that is grown in an ecologically healthy way, others food that is
> prepared according to religious principles and still others food that
> does not contain animal products.
>
> As proper scientific studies began to be made, those that are both
> longitudinal and objective, we will learn more about both the health
> and ecological effects of this infant and radially different
> technology. But we must act in the meantime.
>
> The public interest lies in more knowledge, not less. The businesses
> creating genetically engineered product are free to make their claims
> but these claims cannot be taken as proof of anything. Any unintended
> side effects of these new organisms must be discovered and obviated.
>
> Until a full, independent testing program is completed, the public
> interest is not served by denying the public the choice of eating
> non-genetically engineered food. This is especially important for the
> organic industry. We have taken great care to offer our customers a
> quality product without the use of synthetic processing materials or
> ingredients.
>
> Now we are faced with not only the problem with contamination in the
> field, more fundamentally, even the inability to choose
> non-genetically engineered minor ingredients because they are not
> labeled. The burden of labeling should not be on the producer of
> conventional or organic food. They are not the ones introducing this
> new technology.
>
> The burden should be on the companies seeking to market these new
> products. Our consumers eat \$5 billion worth of organic food annually
> and have already made the choice of what they want to eat.
>
> Thank you very much.
>
> MR. LAKE: Thank you, sir.
>
> DR. DONALDSON: Hello. I am Robert Donaldson. I am a plant scientist
> and Professor and Chair of the Department of Biological Sciences at
> George Washington University. My remarks or provided on behalf of
> myself and the American Society of Plant Physiologists, a non-profit
> society of 5,000 plant scientists.
>
> We feel that the safety record of the FDA in this area demonstrates
> that the agency is meeting its goal to assure the safety of foods
> modified using biotechnological techniques. We believe that the use of
> biotechnology to transfer one or a few known genes can be safer and
> more predictable than traditional breeding techniques which transfer
> hundreds of sometimes unknown and sometimes harmful genes.
>
> Some of the most spectacular benefits of plant biotechnology will
> offer to consumers will be the development of more nutritional and
> safer foods. Food allergens in wheat and milk products are being
> eliminated in the laboratory by researchers using biotechnology.
> Biotechnology is being used to develop high-quality protein corn to
> battle protein deficiencies in people\'s diets. Rice with higher
> levels of Vitamin A and higher amounts of usable iron are being
> developed using biotechnology.
>
> Research using biotechnology to enhance the levels of Vitamin E and
> other vitamins in food crops could help prevent heart disease,
> Alzheimer\'s and cancers. Genetically engineered offers powerful tools
> to improve the nutritional content of food crops and, therefore,
> improve the health of millions of people worldwide.
>
> Plant scientists are modifying plants for use as vaccines that may
> prevent deadly illnesses such as diarrhea, cholera, hepatitis B and
> malaria. Clearly, plant biotechnology offers profound benefits to
> people worldwide and I feel that we owe the world our technology.
>
> The FDA should continue to vigorously regulate modified products in
> all food for their safety.
>
> MR. LAKE: Thank you, sir.
>
> MR. SCHMIDT: I am Dave Schmidt with the International Food Information
> Council. The vast majority of Americans support the current FDA
> labeling policy for foods produced through biotechnology. Surveys
> commissioned by the International Food Information Council and
> conducted by the Worthlin Group from March, 1997 to October, 1999
> indicate two-thirds to three-quarters of consumers find the policy
> rational when it is explained to them.
>
> Further research conducted among both Canadian and U.S. consumers
> finds that most terms and jargon that have been proposed for biotech
> labels worldwide would not be understood and would provide unwarranted
> negative connotations.
>
> We should do everything we can to provide as much information as
> possible to consumers who want that information. In fact, in our
> October survey, four out of five consumers agree it would be better to
> provide such information off the label on websites, brochures and
> telephone hot lines from credible government health professional or
> academic sources.
>
> Precious food-label real estate should be reserved for vital health
> and safety information, not for social statements. Regulators
> throughout the world, as well as American consumers, are looking to
> the FDA to maintain its science-based \"food safety first\" rational
> food-labeling policy.
>
> In order for consumers from Boston to Beijing to realize the full
> promise of agricultural biotechnology, it is important for FDA to
> provide steady leadership and resist the cries to remove science and
> safety as the foundation of food biotech regulation.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> MS. FRANCES: Good evening. My name is Valerie Frances and I am
> speaking to you as a citizen. I have worked nearly fifteen years as a
> public-health nutritionist working in hunger, community food security
> and sustainable agriculture. Fundamentally, I am here before you
> because I feel betrayed as a citizen by the U.S. government and the
> major biotech companies.
>
> I am grateful that these public hearings are being held but I truly
> wonder whether anything substantive will come from them. It seems to
> me that we are embarking on a dangerous path from which we cannot
> return and the government is making a grave error in judgment by not
> exercising more prudence.
>
> Given the history of repeated assurances by the government and
> corporations and a long list of technologies such as pesticides,
> antibiotics or RbGH that were all declared safe based on research and
> then to find out, a few years later, that crucial evidence was not
> evaluated properly or even suppressed and now are shown to be unsafe.
>
> I have come to have little or not confidence in the government\'s
> ability to exercise sound judgment in these matters on its own. The
> bottom line is that we don\'t need genetic engineering. This path
> primarily benefits those who are reaping the profits. I do not
> appreciate being treated as a guinea pig. It doesn\'t help farmers. I
> believe genetic engineering violates nature and am deeply concerned
> that we have no way of cleaning up any unintended environmental
> catastrophes.
>
> In addition, I feel using hungry people to justify the use of GMOs to
> increase the profits of a few biotech companies is emotional
> blackmail. Yes; I want to see mandatory premarket testing. And, yes; I
> want mandatory labeling. But what I really want is for us, as a
> country, to embrace the vision of sustainable agriculture and
> community food security.
>
> Instead of channeling vast resources trying to prove the safety of a
> questionable technology, let\'s take the higher road and support
> on-the-farm community and market-based research and education towards
> broadly beneficial and life-affirming practices from the microscopic
> to the human community level.
>
> MR. LAKE: Thank you, ma\'am.
>
> MR. FREESE: My name is Bill Freese. Remember the time when electricity
> was going to be too cheap to meter, back in the 50\'s when federal
> officials assured us that nuclear energy was safe, cheap and, above
> all, inevitable?
>
> Something similar is going on today with genetic engineering. Like the
> Atomic Energy Commission of the 50\'s, the FDA has taken on the
> contradictory roles of booster and regulator of a dangerous new
> technology. Like the government boosters of nuclear energy then, FDA
> officials presume absolute knowledge they don\'t have and treat
> critics with barely concealed arrogance and contempt irrationally
> convinced that the only possible future is a genetically engineered
> one.
>
> For many in the FDA, genetic engineering appears to be more religion
> than science. How else can one explain the FDA\'s mystical dogma of
> substantial equivalence. This is the notion that a novel life form
> created by gene splicing to unrelated species is equivalent to its
> natural precursor.
>
> Why is it that such a novel creation can be patented as a new
> invention but is, nevertheless, deemed the same as its parent for
> regulatory purposes. Could this be to spare its corporate creator the
> time and expense of thorough testing to insure its safety?
>
> This suspicion is born out by the FDA\'s outrageous approval of
> Monsanto\'s bovine growth hormone, a drug banned in Canada and the EU.
> Three former Monsanto employees or contractors were hired by the FDA
> to rush BGH through the approval process, a clear case of corruption.
>
> The FDA fired Richard Burroughs, its point man on BGH, for insisting
> on adequate safety testing because he care more about protecting human
> health than corporate profits. The made rush to exploit nuclear energy
> has caused untold suffering and left a toxic legacy for future
> generations.
>
> Genetic pollution could have comparable, irreversible effects. I urge
> the FDA to institute thorough and mandatory premarket safety testing
> and labeling of all new GE foods.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> DR. WOOTON: I am Dr. Percy Wooton from Richmond, Virginia. I served as
> President of the American Medical Association in 1997 and 1998. As a
> Past President of the American Medical Association and as an internist
> who specializes in cardiovascular disease and as a physician who has
> seen thousands of patients in Virginia and the D.C. area, I know
> humanity stands to inherit tremendous value from biotechnology.
>
> Biotechnology creates tools. In my career, I have seen it give
> physicians the ability to save lives through the advent of drugs and
> medical devices which did not exist ten, twenty and thirty years ago.
> Currently, food biotechnology is a tool that helps farms get more
> crops off an acre of land than they did five years ago.
>
> It also lets them use less fertilizer and less pesticides. These tools
> benefit the environment, our food supply and every consumer concerned
> with healthful food production. In time, food biotechnology may
> enhance a physician\'s ability to use food to improve a patient\'s
> health.
>
> Very soon, food manufacturers will stock shelves with cooking oils
> containing less-saturated fats as well as vegetables and fruits
> enriched with antioxidants. These benefits will help people to control
> their weight and expedite their ability to recover from illnesses.
>
> If we abandon this technology because of what might go wrong, these
> valuable tools will never make it into the hands of physicians or
> their patients. I am here today because I believe in the spirit of the
> AMA\'s position which encourages physicians to be public spokespersons
> for technologies that they feel will benefit the public.
>
> My endorsement of biotechnology is built on my faith in the FDA\'s
> existing review process. I know they have established a system for
> evaluating foods produced through biotechnology that has served us
> well and I support its continence.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> DR. MESSING: My name is Joachim Messing. I amÊProfessor at Rutgers
> University and quite familiar with plant biotechnology and I will
> speak here on behalf of myself and my opinion, listening all day to
> the panels and the different comments that have been made. You see I
> have no written statement because many of the things that I could have
> written down have been said.
>
> My major concern is about this forum, that it doesn\'t really help the
> public the understand the background of the science. Recently, when I
> was in Europe, I encountered a survey where people answered questions
> where they would say, \"only genetically altered tomatoes have
> genes.\" And, \"If you eat genetically altered foods, your own genes
> get changed.\"
>
> I think what is very important is that the forum has to be followed up
> in coordination with the USDA to have a more direct program in public
> education where the public is really educated in the basics of the
> science that is behind this new technology.
>
> Thank you very much.
>
> MR. LAKE: Thank you, sir.
>
> MR. RIDDLE: Hello. My name is Jim Riddle, a Founding President of the
> Independent Organic Inspectors Association. To refuse to label GMO
> products fuels the perception that the biotech industry has something
> to hide. Transgenic mutations do not occur in nature.
>
> GMO products are unique and can be patented. They are not
> substantially equivalent. Transgenic crops have never been part of the
> food chain or the human diet. They must be recalled. Research shows
> that milk from cows treated with RBST contains elevated levels of
> insulin-like growth factor, IgF1. Elevated levels of IgF1 in humans
> has been linked to increased incidence in breast, prostate and colon
> cancer.
>
> Milk from RBST-treated cows is not substantially equivalent.
> Syndicated columnist Alan Guebert recently reported that cows in South
> Dakota, when given a choice between conventional corn fodder and bT
> corn fodder refused to eat the bT corn fodder. This same phenomenon
> has been reported to me by numerous organic inspectors. It seems even
> though the bT corn fodder is not labeled, cows know that it is not
> substantially equivalent.
>
> Research in Great Britain shows that incidences of allergic reactions
> to soy foods have increased at the same time that GMO soybeans have
> been introduced. Sound science shows that GMOs pose numerous
> environmental threats including cross pollination with wild relatives
> to create superweeds, long-term alterations to soil ecology, negative
> impacts on non-target species and development of pesticide- resistant
> pests.
>
> There is scandalous collusion between the biotech industry and the
> crossover to the regulators that must be investigated before you can
> move forward with a clear conscience. This technology must be tracked,
> labeled in the short term and phased out in the long term.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> MR. BETZ: My name is Fred Betz. As a scientist with the Environmental
> Protection Agency from 1976 to 1993, I was directly involved in the
> development and implementation of the coordinated framework for the
> regulation of biotechnology that was published in June of 1986. During
> that time, I had the opportunity to work with FDA staff as well as
> their critics on the review and approval of biotechnology products
> subject to FDA and EPA regulations.
>
> Since then, I have been a regulatory consultant advising developers of
> biotechnology products on regulatory matters. It is from that
> perspective and body of experience that I conclude that FDA has set
> forth a scientifically sound and credible scheme for the regulation of
> foods derived from genetically engineered crops.
>
> The FDA\'s regulatory of bioengineered foods is founded in a strong
> statute, the Federal Food, Drug and Cosmetic Act. This statute has
> helped insure that the U.S. food supply is among the world\'s safest,
> irrespective of how the food has been produced.
>
> FDA\'s 1992 policy embodies an important guiding principle of
> regulatory science and public policy. This principle is that the level
> of regulation should be commensurate with the potential risks posed by
> the use of the product. With this in mind, FDA has established an
> appropriate, balanced, science-based regulatory scheme to oversee the
> introduction of new plant varieties developed through biotechnology.
>
> However, this policy does not stand alone. Rather, it is just one tool
> within a strong regulatory framework. Under FFDCA, FDA can seize and
> stop sale of any food considered to be unsafe, can require labeling of
> foods as necessary and can require that a food additive clearance be
> established.
>
> In conclusion, I believe that FDA\'s regulatory scheme has performed
> well. By all available standards for judgment, the scheme has helped
> protect public health and insured the continued safety in the
> nation\'s food supply.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> MR. COUNCELL: My name is Phil Councell, Jr. I am a grain and vegetable
> farmer and I currently serve as President of the Maryland Grain
> Producers Association. I appreciate the opportunity to discuss
> biotechnology from a farmer\'s perspective.
>
> Maryland farmers have accepted genetically enhanced crops. In 1999, up
> to 65 percent of the soybeans and over 35 percent of the corn grown
> uses this technology. We have confidence that USDA, EPA and FDA\'s
> review and approval process for these genetically enhanced crops means
> they are safe.
>
> But having farmers believe that these products are safe is not the
> issue. It is extremely important to farmers that the consumers of our
> products know that they are safe. FDA needs to do whatever is
> necessary to maintain consumer confidence.
>
> Not only are biotech crops safe; they are beneficial to the
> environment. These crops are as close to organic farming as production
> agriculture can come while maintaining reasonable yields to feed a
> growing population. My surprise is that the environmental community
> has not insisted on expanding the use of this new technology.
>
> My final point, as you must realize, is that any regulatory changes
> made today may impact the farmer\'s ability to market his crop for the
> next three years. As a commercial seed grower, the seed that I plant
> in the spring of 2000 will continue in the production cycle and
> markets through the fall of 2002.
>
> As you make your decisions in the upcoming months, I urge that you
> develop standards to maintain consumer confidence, make decisions that
> consider the agricultural production cycle and that you make your
> decisions based on science and not emotion.
>
> Important issues regarding labeling; I can segregate crops but I
> cannot guarantee zero tolerance due to equipment contamination,
> handling contamination and cross pollination. I support voluntary
> labeling and invite the decision makers within the FDA to come to my
> farm and see, firsthand, the benefits and concerns we have about
> biotech.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> MR. HUTCHISON: Hello. My name is Robert Hutchison. I am a grain,
> vegetable and hog farmer from Cordova, Maryland and a member of the
> Maryland Grain Producers Utilization Board.
>
> As a Board, we seek to expand our markets in many ways and believe
> that biotechnology is an important tool in accomplishing this goal. We
> can use biotechnology to harness the energy of the sun in many unique
> ways. We can produce crops for more specialized markets and for
> improved environmental protection.
>
> The marketing opportunities are endless. However, to move forward,
> biotechnology research must be encouraged. Future products offer an
> abundance of opportunities for farmers to maximize the production of
> renewable resources from our productive soils.
>
> I would like to emphasize the importance of this decision you make now
> by providing you with an interesting quote from the early 1900s. And I
> quote; \"We have recently advanced our knowledge of genetics to a
> point where we can manipulate life in a way never intended by nature.
> We must proceed with the utmost caution in the application of this
> newfound knowledge.\"
>
> This statement was made in 1906 by a critic of the work of a
> California-based geneticist, Luther Burbank, who was carrying out
> research on hybridization. Crop hybrids were introduced to the United
> States in 1920s. Had we stifled this important research of the early
> 1900s, we may still be producing twenty-six bushel average corn yields
> as opposed to the one-hundred-and-thirty bushels of today.
>
> We cannot suppress progress through fear and emotion. We must move
> forward with adequate research and testing. The American farmer will
> grow what our customers request. We can revert to standard varieties
> of a few years ago, if that is necessary. But that decision should not
> be based on unfounded consumer fears.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> DR. MONRO: Good evening. My name is Doug Monroe. I am the President of
> the Calvert Institute for Policy Research which is a public-policy
> organization in Baltimore, Maryland that believes that policy should
> be based on rationality and not hysteria.
>
> As everyone in this room is well aware, at least ought to be well
> aware, artificially engineered food stuffs have been consumed for
> centuries either as the result of selective cross breeding or, more
> recently, the result of genetic engineering, and no one is known to
> have died as the result of this.
>
> Quite the reverse; biotech improvements to fruits and vegetables have
> been a blessing. We have created a food supply that is the envy of the
> world, as we all know; safe, wholesome and cheap.
>
> So my point is really as simple as it is cliched. \"If it ain\'t
> broke, don\'t fix it.\" Labeling is no small matter. This is, perhaps,
> something that has been overlooked this evening. If anyone doubts the
> potential impact of labels, consider the repeated demands for bigger
> and evermore damning health warnings on cigarettes and alcohol.
>
> Labels frighten people. That is the whole point. Labels on biotech
> foods will have the same result. For what point? Scientist after
> scientist from the National Academy of Scientists, National Research
> Council and the FDA, itself, have declared biotech foods to be safe.
>
> If biotech foods are subjected to labeling, as others have said before
> me, this may very well create a backlash against them, against what
> has been ruled a safe food source. What will happen is very simple.
> Increased use of pesticides, which will result in another hearing this
> time next year with the same crowd who have been outside demanding
> similar taxpayer-funded hearings as this, or the alternative is
> supermarkets\' increased reliance on organic foods which sounds fine
> until you think it through.
>
> Undo bioengineering and you undo progress on disease-resistant crops,
> high-yield crops and so on which means, in the long run, the public\'s
> increased consumption of macaroni and cheese instead of produce, and
> that is something no government agency should be a part of and I beg
> you not to be a part of it, too.
>
> Thanks a lot.
>
> MR. LAKE: Thank you, sir.
>
> DR. GRAHAM: My name is John Graham. I am Professor of Policy and
> Decision Sciences at the Harvard School of Public Health and Director
> of the Harvard Center for Risk Analysis. Today, I would like to
> discuss the role of the so-called precautionary principle and FDA\'s
> policy toward bioengineered foods.
>
> We have heard today there may be unknown health and safety risk
> associated with bioengineered foods and that regulators should apply
> some version of the precautionary principle to protect the public from
> these unknown risks. A stringent version of the precautionary
> principle that we have heard today is that FDA should not approve any
> bioengineered food until it has been proven completely safe with
> long-term testing.
>
> In evaluating whether such an application of the precautionary
> principle would be reasonable, I would urge the FDA to consider the
> following thought experiment which I often pose to my students in
> public health. Imagine it is 1850 in the United States. Which of the
> following technological advances would have satisfied this particular
> version of the precautionary principle; electricity, the
> internal-combustion engine, pasteurization, computers, chlorination of
> drinking water, plastics and the Internet?
>
> Although each of these technologies did, and, indeed, still do, pose
> unknown health and safety risks to the American population, I think we
> should be skeptical of any formulation of the precautionary principle
> that FDA would implement that would have halted or substantially
> slowed the development of these technologies.
>
> On the other hand, if a more nuanced version of the precautionary
> principle, one that allows for a balancing of risk and benefits and
> some risk taking for the purposes of the technological advance can be
> formulated, it certainly deserves serious scrutiny.
>
> I also want to set the record straight that there is, in fact, no
> \"the\" precautionary principle. There are, in fact, a variety of them
> in different international treaties, with different burdens of proof
> and different formulations.
>
> Thank you very much.
>
> MR. LAKE: Thank you, sir.
>
> MS. MELCAREK: I am Hillary Melcarek with the National Coalition
> against the Misuse of Pesticides, a national membership organization
> founded in 1981 to provide the public with information on pesticide
> hazards and save our pest-management strategies.
>
> The public experience with synthetic pesticides since their
> introduction in mainstream agriculture in the 1940s raises important
> questions that ought to be considered as new technologies are
> introduced in food production and pest management.
>
> The chemicalization of agriculture has led to increased insect and
> weed resistance, no improvement in the percentage of crop loss due to
> disease and infestation, contamination of ground water, adverse
> impacts associated with chemical drift as well as harmful human health
> and environmental effects.
>
> None of this was known to regulatory agencies when the technology was
> introduced and marketed as a new revolutionary way to feed the world.
> GMOs bring with them questions that parallel and, in many ways, far
> surpass those that have been raised with pesticides.
>
> If we have learned anything from our regulatory missteps in the
> pesticide arena, we have learned that there are uncertainties and
> unanswered questions resulting in hazards and efficacy problems.
>
> As this technology increasingly fails us, we now see many of the same
> companies that produced and promoted pesticides shifting to the
> biotechnology industry telling the public that this is a safer way.
>
> We urge FDA to immediately require labeling of genetically engineered
> food, commodities and processed food containing GE ingredients and
> additionally require thorough mandatory premarket human and
> environment safety reviews of these products.
>
> Thank you.
>
> MR. LAKE: Thank you, ma\'am.
>
> MS. FERRERA: I have attended an FDA-NIH dental conference on the 4th
> of November, 1999 at NIH. The Commissioner of the FDA stated she
> wanted open and frequent communication with industry when developing a
> new product.
>
> I want to know where does the consumer fit with genetically engineered
> food? Where is the frequent and open communication with the consumer
> when developing genetically engineered food. I find the industry and
> the FDA to be arrogant and condescending to the consumer.
>
> The genetically engineered food is not safe and it should be banned
> immediately.
>
> Thank you.
>
> MR. LAKE: Thank you, ma\'am.
>
> DR. SCHONBACH: My name is Mark Schonbach. I am a small-scale vegetable
> grower, crop scientist. I am speaking on behalf of the Virginia
> Association for Biological Farming. I ask the FDA to mandate clear and
> prominent labeling of all genetically engineered foods sold within the
> United States.
>
> This includes any foods which contain one or more ingredients derived
> from genetically engineered organisms. Such foods need to carry a
> label on their package that includes the words \"genetically
> engineered\" or \"genetically modified\" or a symbol which clearly
> expresses this so that citizens can make an informed choice as to
> whether or not to consume genetically engineered foods.
>
> This is true for several reasons. First, we have a reasonable
> expectation to know what we are eating. In a recent article in the
> journal Nature, Dr. Eric Millstone, Eric Brunner and Sue Mayer pointed
> out that genetically engineered foods are not substantially equivalent
> to conventional foods.
>
> Genetically modified foods have been substantially altered in their
> biochemical and nutritional composition. The potential health effects
> of these alterations are thus far largely untested and unknown.
>
> Second, there are preliminary findings that indicate GE foods may pose
> substantial health hazards, as we have heard earlier this evening. I
> will not go into those in detail.
>
> Third, some U.S. citizens adhere to religious practices or ethical
> codes that forbid them to eat foods of animal origins or foods that
> have been genetically engineered. Failure to provide the information
> through clear labeling makes it much more difficult for such citizens
> to be sure that the food they are buying meets the requirements of
> their religious codes.
>
> This could constitute an infringement of their constitutionally
> guaranteed freedom of religion. Fourth, many genetically engineered
> crops, particularly those containing the bacterial gene for bT toxin
> and those engineered for herbicide resistance pose significant
> environmental hazards.
>
> Citizens have the freedom to choose not to buy products whose
> manufacturer or use is harmful to the environment such as strong
> household chemicals. Thus, it is only logical that we should have the
> freedom to choose not to consume foods from genetically engineered
> crops that pose environment risks.
>
> Thank you.
>
> MR. LAKE: Thank you, sir.
>
> MS. WELD: Hi. My name is Amory Weld. I am from New York City. I am not
> comfortable being a public speaker but I feel strongly enough about
> this issue that I am willing to do this, and I apologize for however
> garbled my message is.
>
> I am here as an individual and as a concerned citizen, as an informed
> consumer and as an aunt to ten nieces and nephews. My friend, Guy
> Watson, is to blame for my being involved with this issue. Guy Watson
> has the largest organic farm in England. The English government made
> the mistake of planting genetically engineered maize across the river
> from his sweet corn, thereby threatening the organic certification of
> his crop.
>
> They awakened a sleeping activist. He said to me, \"You Yanks are
> responsible for most of the genetically engineered foods out there.
> You, Amory, should get up and do something about this.\" And he was
> absolutely right; eating organic is not enough.
>
> So I contacted Laura Ticciati, who is the head of the Mothers for
> Natural Law which is based in Fairfield, Iowa and have since taken her
> petition to the Green Market in Union Square of New York City. The
> petition calls for the mandatory labeling of genetically engineered
> crops and a five-year moratorium until there has been long-term
> testing.
>
> There is a marked difference in public response between now and a year
> ago when I started. A year ago, it was hard to get people to stop and
> talk to me and now people line up to sign the petition. I wanted to
> stand here and say, \"Don\'t underestimate the American consumer.\"
>
> A movement is growing here. All kinds of people have stopped to sign.
> By that, I mean all ages, all races and all backgrounds. I am not just
> preaching to the converted there. People want more information and
> what they ask for, more than anything, is a list of the genetically
> engineered foods that exist now.
>
> MR. LAKE: Thank you, ma\'am. For a non-public speaker, you did just
> fine.
>
> MS. BEANY: My name is Diane Beany. I am an organic and ecological
> advocate. I am also an avid label reader. I am one of those people who
> don\'t want to eat any products including animal genes, insect genes,
> virus or bacterial genes in any of my food. So labeling is a very,
> very important issue to me.
>
> I am a little shaken up because, coming in here\--I am generally a
> peaceful person, but they searched my bags, like, four times. I had to
> empty my pockets twice. They confiscated my lunch. I don\'t know
> whether to be complimented or insulted.
>
> Being here, I can\'t help but think back to testifying at the USDA
> hearings on the National Organic Program at Rutgers in New Jersey and
> what a powerful experience that was and the passionate outpouring that
> people had who were defending ecological organic ways of growing food.
>
> I am hearing some of those voices here but I am also hearing a lot of
> vested interests protecting the bottom line, wanting to keep Americans
> in the dark about knowing about what is in our food supply. I am very
> concerned about the FDA\'s very selective view of science, saying that
> people who have questions about this biotechnology are anti-science
> when there are a lot of very crucial scientific questions and a lot of
> ecological knowledge that is being swept aside in terms of their
> interests.
>
> There are so many problems with these crops that I couldn\'t even go
> into them. Generally, there is pollen drift to the organic farmers,
> the antibiotic markers that are fed to animals that are given large
> amounts of antibiotics and the antibiotic resistance problems.
>
> To determine their seed technology which, to me, is the just the
> ultimate to having seeds that are genetically engineered to poison
> themselves is just like the height of moral bankruptcy to me. I demand
> that the FDA should protect the democratic rights of the American
> people and not abdicate it in favor of the chemical pharmaceutical
> agribusiness giants.
>
> Thank you.
>
> MR. LAKE: Thank you, ma\'am.
>
> MR. HIGGINS: I am Yan-Chu Higgins. I hail from the great state of
> Iowa. I would like to say that if we think that transparency is the
> key to Indonesia\'s recovery, then I don\'t understand why we can\'t
> have transparency as it relates to our own food choices.
>
> We also need to have a little bit more transparency at the level of
> the FDA and of these much vaunted agencies that have told us that
> biogenetically engineered is safe. I am not buying it. I understand
> that these people have interests. I understand that the individuals
> with great credentials would tell us this, that and the other because
> they are getting paid.
>
> Now, that is fine and dandy because that is what they are paid to do.
> At the consumer level, we simply want to have the food that we want,
> that we can choose to have. That is not a big problem. Sure; maybe the
> labeling is going to scare a few people. Maybe it is going to actually
> facilitate their own learning about the process.
>
> Now, you guys are sitting up there and these people have come in here
> and said this, that and the other about how it is safe and that they
> know all of it. But I don\'t understand how you can actually change an
> organism at the genetic level and then claim that it is the same
> thing, that physiologically, when it enters your body, the way your
> body absorbs those nutrients or those aberrant nutrients is the same
> thing.
>
> You cannot play god. Do you believe in god? Do you really? The hubris.
> This is really very serious, very serious.
>
> MR. LAKE: Thank you, sir.
>
> MS. NEED: My name is Theresa Need. I am the Director of the Farmworker
> Health and Safety Institute. It is a unique consortium of three
> community-based farmworker organizations that work with migrant
> farmworkers along the East Coast, the U.S.-Mexico border, the
> Caribbean and in Mexico.
>
> I think it is very symbolic that I am one of the last presented
> speakers here because farmworkers are on the last rung of the ladder
> in our food system due to lack of political power and clout.
>
> Farmworkers are also on the front line of our food production and,
> therefore, at the greatest risk of coming into contact with pesticides
> and residues as they plant, tend to and harvest the food that we eat.
> Now farmworkers have another environment threat to their health;
> genetically modified food.
>
> Once again, they, along with farmers and community members, are the
> guinea pigs for this biotechnology. Here are some facts. A new study
> of Ohio crop pickers and handlers found that bT can provoke
> immunological changes and that long-term exposure might cause asthma
> or other serious allergic reactions in the infected persons.
>
> Farmworkers already have higher rates than the national average of
> parasitic infections and tuberculosis. This will further compromise
> their immune systems and health. Most GE crops are designed to be
> resistant to specific herbicides. Since herbicide-resistant GE crops
> lead to greater herbicide use, exposures to higher levels of
> herbicides, like glycosate, can lead to greater risk of cancer.
>
> Also, GE is affecting farmworkers in their home countries,
> Approximately 94 percent of farmworkers come from Mexico and GE is the
> biggest threat to their biodiversity where there are 25,000 native
> varieties. Therefore, we feel that there should be suspension of all
> GE technology until independent and comprehensive studies have been
> conducted on the health, environmental and economic impacts, and
> studies need to be conducted based on the precautionary principle.
>
> We must assume that GE foods are not safe instead of the current
> concept of substantial equivalence. In addition, protection for
> farmworkers and farmers who are already currently working with GE
> crops need to be protected so they are not at greater risk.
>
> Thank you.
>
> MR. LAKE: Thank you, ma\'am.
>
> Let me ask, is there anyone on the speakers list who has not yet had
> an opportunity to come to the podium?
>
> Mr. Levitt?
>
> **Closing Remarks**
>
> MR. LEVITT: That brings us to the end of our proceedings today. Let
> me, before we close, add or repeat a few thank you\'s. First, is to
> all of you who came today and shared your information with us; to my
> colleagues on the FDA panel for patiently listening and probing
> questions to the panelists we had up here.
>
> I also want to thank a few people who never get thanked, people like
> the people that are transcribing for us. Even though you are getting
> paid, you have worked hard today; the people on the FDA staff who
> prepare the room, organize the speakers, people who came in from the
> field and so forth. A lot of people worked hard to make this meeting
> come off I think as officially as it did. I think it did transpire
> very officially.
>
> A few reminders. We do have our public docket open. You can submit
> written comments in addition, whether or not you have spoken orally.
> Again, we have our third meeting in Oakland, California on December 13
> for people, really, who were not able to make the first two. We are
> really trying to allow different people to come to each of the
> meetings, as much as possible.
>
> But, with that, we clearly got a lot of information that was presented
> today. As I said at the beginning, we are very much in a listening
> mode but we also hope that people are listening to each other and that
> everybody came away from today\'s meeting having a little more to
> think about maybe than when we all came in.
>
> So, again, thank you very much. This tends today\'s session.
>
> \[Whereupon, at 6:15 p.m., the meeting was adjourned.\]
>
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