BEFORE THE

UNITED STATES DEPARTMENT OF HEALTH AND HUMAN SERVICES

FOOD AND DRUG ADMINISTRATION

\- - - - -

PUBLIC MEETING

BIOTECHNOLOGY IN THE YEAR 2000 AND BEYOND

\- - - - -

MONDAY, DECEMBER 13, 1999

\- - - - -

The meeting was convened in the Auditorium,

Federal Building, Oakland, California, at 9:00 a.m.,

Sharon Smith Holston, Deputy Commissioner for

International and Constituent Relations, Food and Drug

Administration, presiding.

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PRESENT:

L. ROBERT LAKE

Director, Regulations and Policy

Food and Drug Administration

MELINDA PLAISIER

Associate Commissioner for Legislation

Office of Policy, Planning and Legislation

BERT MITCHELL, D.V.M.

Associate Director for Policy and Regulations

Center for Veterinary Medicine

CATHERINE COPP

Associate Chief Counsel for Foods

Office of Chief Counsel

JAMES MARYANSKI, Ph.D.

Biotechnology Coordinator

Center for Food Safety and Applied Nutrition

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A G E N D A

PAGE

WELCOME AND OPENING REMARKS 12

SHARON SMITH HOLSTON

Deputy Commissioner for International and

Constituent Relations

Food and Drug Administration

SESSION 1. 21

FDA POLICY: 1994 TO THE PRESENT

JAMES MARYANSKI, Ph.D.

Biotechnology Coordinator

Center for Food Safety and Applied Nutrition

Food and Drug Administration

SESSION 2. 45

SCIENTIFIC, SAFETY AND REGULATORY ISSUES

INTRODUCTION

SHARON SMITH HOLSTON

PANEL DISCUSSION

CALVIN O. QUALSET, Ph.D. 47

Director, Genetic Resources Conservation

Program

University of California, Davis

JOHN FAGAN, Ph.D. 51

Chairman and Chief Scientific Officer

Genetic ID

PHILIP J. REGAL, Ph.D. 57

Professor of Ecology, Evolution and Behavior

College of Biological Sciences

University of Minnesota

SUSANNE L. HUTTNER, Ph.D. 62

Director, Systemwide Biotechnology Research &

Education Program

University of California, Berkeley

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SUSAN L. HEFLE, Ph.D. 73

Research Assistant Professor and Co-Director

Food Allergy Research and Resource Program

University of Nebraska, Lincoln

R. L. BALDWIN, JR., Ph.D. 77

Sesnon Professor of Animal Science

University of California

PANEL ANSWERS FDA QUESTIONS 81

SUMMARY REMARKS

SHARON SMITH HOLSTON

SESSION 3. 118

FDA POLICY: LABELING

L. ROBERT LAKE 118

Office of Regulation and Policy

Center for Food Safety and Applied Nutrition

Food and Drug Administration

SESSION 4. 121

PUBLIC INFORMATION AND LABELING

INTRODUCTION

SHARON SMITH HOLSTON

PANEL DISCUSSION 123

THOMAS J. HOBAN, IV, Ph.D. 123

Professor, Department of Sociology and

Anthropology

North Carolina State University

ANDREW KIMBRELL 131

Executive Director

International Center for Technology Assessment

RHONA S. APPLEBAUM, Ph.D. 140

Executive Vice President

Scientific and Regulatory Affairs

National Food Processors Association

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SUSAN E. HAEGER 146

CEO and President

Citizens for Health

DIANE JOY GOODMAN 154

Farm Box Project Consulting

DAVID A. BOSSMAN 162

President/Treasurer and Chief Executive Officer

American Feed Industries Association

PANEL ANSWERS FDA QUESTIONS 167

SESSION 5. 205

SCHEDULED PUBLIC PRESENTATIONS

STATEMENT OF

MARK LIPSON 206

Policy Program Director

Organic Farming Research Foundation

DEBORAH P. DELMAR 208

University of California, Davis

Professor/Chair Sec. of Plant Biology

Speaking on behalf of

American Society of Plant Physiologists

SHARON LANINI 210

Executive Director

Monterey County Farm Bureau

MARY WANG, Ph.D. 212

Food and Drug Scientist

California Department of Health Services

Food and Drug Branch

Speaking of behalf of

California Dietetic Association

ANN M. COULSTON, MS, RD 214

Immediate Past President

American Dietetic Association

DAN STEINBERG 216

CHERISA YARKIN, Ph.D. 218

Associate Director for Economic Analysis

University of California Bio STAR Project

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MARGARET CLARK 219

Director of Legal Affairs

Oregon Tilth Certified Organic

MARK LAPPE, Ph.D. 221

Center for Ethics and Toxics

SUE MARKLAND DAY 222

President, Bay Area Bioscience Center

IRVIN J. METTLER, Ph.D. 224

Manager, Technology Acquisition and Contracts

Seminis Vegetable Seed, Inc.

PETER M. ROSSET, Ph.D. 226

Executive Director, Food First

The Institute for Food & Development Policy

BETH BURROWS 228

President/Director, The Edmonds Institute

CLAIRE CUMMINGS, ESQ. 229

KPPA Radio Reporter

PEGGY G. LEMAUX 231

UC Cooperative Extension Specialist

JAMES DIAMOND, M.D. 233

Biotechnology Task Force, Sierra Club

THERESA SELFA 235

Rural Sociologist

RICHARD L. MATTEIS 236

Executive Vice President

California Seed Association

California Grain and Feed Association

SIMON HARRIS 238

Biodemocracy Campaign

KATE BURROUGHS 241

Harmony Farm Supply

RITA MITCHELL 243

President, California Nutrition Council

University of California

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MARTINA MC GLOUGHLIN 245

Director, Biotechnology Program

University of California, Davis

PHILLIP LA ROCCA 247

President, Board of Directors

California Certified Organic Farmers

NELL NEWMAN 249

KENT J. BRADFORD 251

Director, Seed Biotechnology Center

University of California, Davis

SYLVIA DEMAREST, ESQ. 253

Demarest, Smith, Jones, Guinta & Moore, PLLC

MELODI NELSON 255

Vice President, Terra Prima, Inc.

JORGE VALLE, 257

Graduate Student

NEAL GUTTERSON, Ph.D. 258

Managing Research Director

DNA Plant Technology

ELISA ODABASHIAN 260

Senior Policy Consultant, Consumers Union

West Coast Regional Office

REBECCA SPECTOR 262

Program Coordinator

Mothers and Others for a Livable Planet

ANGELO SACERDOTE 264

ZEA SONNABEND 265

Organic Materials Review Institute

AMIGO CANTISANO 267

President, Organic Agriculture Advisers

JO ANN BAUMGARTNER 269

Neptune Farm

JOSEPH PANETTA 271

CEO/President BIOCOM

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BRUCE MARTIN 273

KATI BUEHLER 274

Director, Environmental & Regulatory Affairs

Western Crop Protection Association

ALANA SMITH 275

Harrington Investments, Inc.

ROY L. FUCHS, Ph. D. 277

Director, Regulatory Science

Monsanto

AMY BRICKER 279

Project Director, Center for Food Safety

RICHARD HEINBERG 281

New College of California

DANIEL H. JOHNSON, JR., M.D. 283

Clearview Medical Imaging

DAVE HENSON 285

Executive Director

Occidental Arts & Ecology Center

PAUL BETTENCOURT 287

California Cotton Growers Association

SKIP SPITZER 288

Chair, Santa Cruz Action Network

VERNAL GOMEZ 290

Dairyman/Farmer

ERICA PENG 292

Berkeley Food Policy Council

TERRI COMPOST 294

Gardener/Consumer

IGNACIO H. CHAPELA, Ph.D. 295

Assistant Professor

Department of Environmental Science, Policy &

Management

University of California

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PILAR M. WEISS 297

School of Public Health

University of California, Berkeley

ELLEN JEFFERDS 299

National Law Party

MARK GUY 300

CAROL B. SLOAN, R.D. 302

Nutrition & Foodservice Consultant

KATHY MANNION 304

Director of Government Affairs

Western Growers Association

MARTIN J. SPROUL, ESQ. 306

SPROUL LAW OFFICES

BOB CANNARD 307

Cannard Farms

MILTON P. GORDON 309

Professor of Biotechnology

University of Washington

ALAN MOORE 310

City of Berkeley

Butterfly Gardeners Association

SHEILA BARRY 312

Executive Officer

Alameda County Conservation District

GREGORY FRANKEL 314

Project Coordinator, The Green Link

University of California

Berkeley Food Council

NANCY EVANS 316

Communications Consultant

The Breast Cancer Fund

KARA COSBY 318

Media Relations Manager

International Food Information Council

JANET BROWN 319

Program Officer, Center for Ecoliteracy

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RON PETERSON 321

CHRIS BRINEGAR, Ph.D. 323

Professor, Molecular Biology

San Jose State University, Biotech Education &

Research Institute

WALTER EPP 325

SHIRLEY STUART 327

Retired, University of California

C. S. PRAKASH, Ph.D. 329

Professor, Tuskegee University

College of Agriculture

MAUREEN TERNUS, MS RD 330

Food and Nutrition Communications

GUY CARDINEAU, Ph.D. 332

Global Leader, R&D, Output Agriculture

Dow AgroServices

ARIELLE LEVINE 335

Department of Science Policy and Management

University of California, Berkeley

MICH B. HEIN, President 337

EPIcyte Pharmaceutical, Inc.

MIKE PHILLIPS 339

Biotechnology Industry Organization

MATTHEW METZ 341

University of California, Berkeley

KEVIN DANAHER 342

TransFair USA

MICHAEL STRAUSS 344

Innovative Marketing and Public Relations for

Agriculture, Beyond Organic

SALLY FOX 345

Cotton Breede, Fox Fibre

REBECCA KAPLAN 347

Green Party

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JOHN DUARTE 349

DUARTE FARMS

CLOSING REMARKS 350

SHARON SMITH HOLSTON

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P R O C E E D I N G S

9:05 a.m.

COMMISSIONER HOLSTON: I\'m Sharon Smith Holston,

and I\'m FDA\'s Deputy Commissioner for International and

Constituent Relations.

It\'s a pleasure to be here and to open the last

of the three public meetings on foods produced by

utilizing the tools of modern biotechnology, a process

sometimes called genetic engineering, or bio engineering,

as FDA Commissioner Dr. Jane Henney noted at an earlier

and also an extremely well-attended meeting in Chicago.

We hoped that there would be interest in this issue, but

the response to our announcement was so overwhelming that

we had to make arrangements for two additional overflow

rooms. I apologize for any inconvenience that this change

may have caused, but I am pleased that, as a result, we

can accommodate our panelists, who represent a diversity

of views; preregistered presenters, who want to contribute

to the discussion; and, of course, the press.

Before I go any further, I would like to

announce that we will also have two sign language

interpreters available today to anyone who needs them.

Susan Eadie is here with us now, standing in front of the

auditorium, and Anna Mendess will be here also.

As I just mentioned, this is FDA\'s third public

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meeting on this important and timely topic. In the first

two public meetings, in Chicago on November 18, and also

in Washington, D. C. on November 30, the participants

included 23 panelists and 140 scheduled speakers,

representing a broad spectrum of viewpoints. In addition,

there were about 100 press representatives at each

meeting. Altogether, 1,075 individuals attended the

meetings, which received rather full-press coverage.

Today, in my introductory remarks, I want to

emphasize the same points that were made by Commissioner

Henney in Chicago.

In the first place, we who work for the Food and

Drug Administration are truly pleased to have this

opportunity to listen to your views and share our

experience on this very important issue. We recognize

that this is a topic on which there are widely differing

and very strongly held views. While we at FDA wish to

listen to everyone, we also ask that all of us listen to

one another, so that the community at large can gain a

better understanding of the full range of opinions and

positions.

The second point that Dr. Henney made in Chicago

is that FDA has a long history of public health

protection. Our agency\'s origins go back to the turn of

the century, and the basic law under which we operate

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today was passed in 1938. 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 a lot of concerns about 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. In short,

throughout our history, FDA has based its regulatory

decisions on sound science, with protection of public

health as the foremost criterion. This is central to

FDA\'s mission and tradition, and it\'s a tradition that

continues with FDA\'s oversight of products developed using

modern biotechnology. A very substantial experience in

this area goes back to 1982 when FDA approved a new

insulin product, a medication that became the first

consumer product developed using modern biotechnology.

Since that time, the agency has had extensive experience

in evaluating the safety of product developed using this

new technology.

The use of the tools of biotechnology in foods

began in the mid 1980s. In 1990, FDA completed its review

of the safety of the first food ingredient developed with

the tools of biotechnology, which was caymosun, or a

rennet preparation, the milk clotting enzyme used to make

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cheese. At that time, FDA received no public comments

that addressed the safety of this ingredient. Recently,

however, questions have been raised about the safety and

labeling of foods derived from new varieties of crops

developed with the tools of modern biotechnology, and

about the effects these crops have on the environment.

Some of these questions, such as those regarding human

health and food and animal feed safety, as well as food

labeling, fall under FDA\'s authority. Other concerns, for

example, both about environmental safety and the effects

of genetic modification 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 United States

Department of Agriculture.

I want to take this opportunity to briefly

explain how FDA oversees the safety of foods developed

with the tools of biotechnology, and share with you some

of the experience that we have had in evaluating the

safety of these foods, since the first such whole food

product, the Flavr Savr Tomato, entered the market.

FDA introduced its current policy for regulating

foods developed with the tools of biotechnology in 1992,

following an extensive scientific review. In 1994, the

policy was elucidated and discussed publicly during the

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joint meeting of FDA\'s Food Advisory Committee and our

Veterinary Medicine Advisory Committee. Since then, FDA

has carried out over 40 consultations with firms involving

the safety of new varieties of foods made using the tools

of biotechnology.

In a few mintutes, you will hear from my FDA

colleagues in more detail about 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. We are convinced 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 had

been substantive, credible and appropriate.

We have now had five years of experience with

our consultation process. However, we\'re committed to

keeping FDA\'s review and regulatory processes as open and

transparent as possible. And we want to hear from you

whether we need to consider adjustments to our current

system. We want to hear your suggestions on how we might

improve our approach to safety assessment, and how we can

best provide pertinent information to the public.

Now, I want to take a minute to explain the

format and logistics for today\'s meeting.

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This morning, we will focus on issues concerning

the safety assessment of these foods, and on FDA\'s

regulatory oversight. There will be a brief overview of

our current approach to safety assessment and FDA\'s

experience in this area in the past five years. We will

then ask our invited panelists to address issues and

questions that we believe will help FDA evaluate its

current approach to safety assessment.

In the afternoon, we will focus on issues

surrounding disclosure of information to the public; and,

again, a brief presentation will be provided by a member

of FDA\'s staff, followed by a panel discussion.

Finally, we have reserved almost three hours to

hear from as many members of the audience as we possibly

can. However, we have to conclude our meeting promptly at

6:00 p.m. And because we want to give everyone a chance

to present his or her views, we\'re asking that all

presentations from the floor be limited to two minutes.

When you checked in this morning, each of you should have

received a folder with a number on it. That number

indicates the order in which public presentations will be

made.

Because we have limited time for open comments,

I would like to remind everyone that we also welcome

written comments, and that we have established a public

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docket that will display all of the information that the

agency will have received at these public meetings. The

FDA web site also provides easy access to pertinent

information on this subject and enables anyone to submit

comments electronically. The FDA internet address is:

www.FDA.gov

We\'re transcribing the three public meetings on

this topic. The transcript of each meeting will be made

available in the docket and on the internet as quickly as

possible, hopefully within 15 working days. As a matter

of fact, the Chicago transcript is up on the internet now.

Information on how to access the public docket and submit

comments is in your registration packet, as well as on

FDA\'s internet home page.

Before we begin, I want to extend special thanks

to the members of our panels for coming and sharing their

views with us and our audience, and with one another. We

have attempted to assemble panels that represent a wide

cross-section of all interested parties, and we\'ve

received much help in that selection from consumer

organizations, professional societies, trade groups and

other umbrella organizations. They have our thanks for

their cooperation.

A panelist no doubt has varied but strongly held

views and a wealth of useful information for all of us to

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consider. We trust that they will explain their position,

exchange comments, and, in general, make sure that the

issues before us are fully discussed.

I also want to join Commissioner Henney in

expressing appreciation to the FDA staff who have devoted

a great deal of time and energy to make today\'s meeting,

and all of the other meetings, possible. This includes,

in particular, our employees in the Office of Consumer

Affairs and in our Pacific Region, and in our San

Francisco District Offices. Their response to the many

logistical challenges connected with this meeting has been

particularly impressive.

As I have suggested earlier, FDA is here

primarily to listen and to ask questions. We\'re not

trying to reach any conclusion by the end of the day.

Therefore, and because we want to have time to hear the

views of others, we will not be engaging in debating any

points that may be raised.

I must also note that FDA\'s policy is the

subject of litigation, which severely limits our ability

to respond to comments. I expect today\'s discussion to be

productive and stimulating, and I look forward to our

working together.

One final logistical detail: I would like to

ask any of you in the audience who may be carrying cell

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phones or audible pagers to please turn them off so as not

to distract our speakers and the rest of the audience. So

I thank you for that.

I would now like to introduce our FDA panelists.

To my far left, L. Robert Lake, who is the

Director of our Office of Regulations and Policy, in our

Center for Food Safety and Applied Nutrition.

Seated next to me, on the left, is Melinda

Plaisier, who is our Associate Commissioner for

Legislation in our Office of Policy, Planning and

Legislation.

On my immediate right is Dr. Bert Mitchell, who

is the Associate Director for Policy and Regulations in

FDA\'s Center for Veterinary Medicine.

Seated next to Dr. Mitchell is Catherine Copp,

who is the Associate Chief Counsel for Foods in the Office

of the Chief Counsel.

At the far right, is Dr. James Maryanski, who is

the Biotechnology Cooridinator in the Center for Food

Safety and Applied Nutrition.

And now Dr. Maryanski will give his

presentation.

//

//

//

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FDA POLICY: 1994 TO THE PRESENT

JAMES MARYANSKI, Ph. D.

BIOTECHNOLOGY COORDINATOR

CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FDA

DR. MARYANSKI: Thank you, Ms. Holston. Good

morning, ladies and gentlemen.

I\'m Jim Maryanski. I have the honor this

morning of explaining to you what we do with foods that

are produced by modern biotechnology, and some of the

experiences that we\'ve had over the past several years.

We\'d like to give you a little context for the discussion

that we will be having throughout the day today.

If I might have the slides, please.

Just to sort of tell you a little bit about who

we are, the Food and Drug Administration, as many of you

know, is an agency in the Department of Health and Human

Services. And just to give you an idea of where we fit in

the scheme of things, there are other public health

agencies that make up this department, including the

National Institutes of Health and the Centers for Disease

Control and Prevention. And, so, FDA and NIH and CDC are

health-protection agencies within this larger department.

The law that FDA has responsibility for carrying

out and insuring the safety of the products that it

regulates is the Federal Food, Drug and Cosmetic Act.

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This is the law that Ms. Holston mentioned has been in

place since 1938, and provides the basis for the oversight

that FDA has for assuring the safety of foods and other

products that we regulate.

I think I will explain to you in a few minutes

just what those products are that this law covers. But I

think it\'s important to understand that this law is very

broad, covers many aspects of consumer protection, and it

is consumer protection that is our mission.

Our approach to protecting consumers is based on

the best science that is available. So our policies and

regulations are science-based policies. And we regulate

foods that are interstate commerce. We don\'t regulate

foods that are in research; but we do regulate foods that

are for sale, both imported into the U.S. and on the

market in the U.S. So it is the commercial part of the

food chain that FDA has responsibility for.

I\'d like to give you a little sense of how

products of modern biotechnology fit within the broader

federal system in the U.S., because there are a number of

agencies that have responsibilities for various aspects of

the safety of these products. Of course, FDA is

responsible for the safety of foods, and that means we are

responsible for most foods. The Department of Agriculture

has oversight over meat, poultry and egg products, in

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terms of inspecting those products. But FDA has oversight

over all the other things in the grocery store. And, so,

if you think about the diversity of the products in the

grocery store, and that includes all the substances that

are added to foods, you think about the ingredient package

labeling, all the substances that are added to foods, fall

under FDA\'s authority.

So, in terms of biotechnology products, the same

applies. Those products fall under the act just as other

products produced by other methods. There is no

difference in the way FDA exerts its oversight.

The Department of Agriculture is responsible for

many of the issues that relate to environmental concerns.

They, of course, have authority to insure that plant pests

are not introduced into agriculture, both in terms of

plants and seeds that are transported in the U.S., as well

as materials that come into the U.S.

The Environmental Protection Agency, or EPA, has

responsibility for pesticides in the food supply and, of

course, elsewhere. So, if a substance is introduced into

food that is a pesticide, EPA is responsible for assuring

its safety, for setting tolerances for its use in food, or

for exempting it from those tolerances. But all

pesticides must be registered by EPA before they\'re used

in food.

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So, now, let me give you an example of a product

produced by modern biotechnology, but falls under all

three agencies in some aspects. The BT Corn, the corn

that has been developed to produce its own pesticide

substance. That corn is a product that the company would

discuss and take through the process at USDA, for

consideration of plant pest characteristics and a number

of the environmental issues that would be associated with

that plant. They would also, of course, have to have the

pesticide as produced by that plant registered by EPA

before it could be used in food. And EPA\'s process for

registration addresses both human safety of exposure to

that pesticide and environmental issues related to the use

of that pesticide. And, of course, FDA has responsibility

for food products that are derived from that corn. So,

for example, high fructose corn syrup is a product that is

produced through the processing of corn that\'s used in

soft drinks and other products. And, of course, most of

the corn that is produced today from plants developed by

modern biotechnology is used for animal feed. So both

human food products and animal feed products fall under

FDA. As I described our policy for foods today, I will be

speaking of feeds at the same time. We consider them in

the same manner.

In the late 1980s, FDA began to receive a lot of

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questions about the use of modern biotechnology in

agriculture. At that time, as you have heard, we had

already had experience both with pharmaceutical products

and with the first food products, such as the enzyme

rennet, or caymosun, that\'s used to make cheese. But we

realized that the real large impact of biotechnology was

going to be in agriculture, and really on things that we

think of as whole foods. And, so, FDA convened a group of

scientists within the agency to look at all aspects of

this technology. And these scientists were asked to

consider all possible impacts of this technology on the

food supply. They were not given any restrictions

whatsoever in terms of the law or any other constraints in

terms of bringing the policy together. But they were

asked to look at all possible impacts on health, and then

to consider that within the framework of the Food, Drug

and Cosmetic Act.

The purpose of that exercise was so that we

could, first of all, understand the impact of this new

technology on the food supply: How would these foods be

similar, how would they be different from other foods; and

therefore, how should FDA carry out its responsibility of

public health protection? Also to answer the questions

from industry about what kind of safety testing would be

needed for these products, and what kind of regulatory

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process should be in place for these products to come to

market. In other words, would they be regulated like

other foods that are placed in the grocery store?

So the 1992 policy was intended to answer the

questions that we were receiving at the time. It was not

intended to look forward five or ten years later. We

wanted the policy to be flexible. We knew this was a new

technology. We wanted to be able to answer the questions

at the time based on the types of products that were

coming then, and leaving ourselves sufficient flexibility

so that we could adjust if there were changes in the

future. This, of course, is a policy based on the Food,

Drug and Cosmetic Act, and the policy applies to foods

derived from plants developed by all methods of plant

breeding. There are many methods. We\'re familiar with

cross-hybridization and the sexual processes of mating

plants, but breeders have many other different methods of

introducing, coaxing plants to do things that they would

like them to do that will be beneficial in agriculture and

food production.

Our conclusion was that the Food, Drug and

Cosmetic Act applies to all foods, and that all foods

should meet the same standards. So we do not have a

different standard for products of modern biotechnology.

So the policy applies to plants produced by all methods of

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plant breeding. And it applies to human foods and animal

feeds. This policy explains the regulatory framework and

the scientific approach for assessing safety for products,

such as fruits and vegetables, and cereals, and the

products that are derived from those types of plants, such

as vegetable oils and food starches.

The policy that we published in 1992 really

explained how foods have always been regulated, and how

foods that are produced by modern biotechnology can fit

within that framework. FDA has two tools that it uses

primarily to insure the safety of foods in the grocery

store. If a food would pose a health problem to

consumers, if we know something about that food, that we

know that it will be unsafe, we have very broad

enforcement authority to remove that product from the

market. That system works because, of course, companies

do not want to be in that situation, nor do their

customers, who will ask to make sure that the product is

okay with FDA before it goes to market. And, of course,

it works because FDA has very strong enforcement

authority. We, of course, can issue injunctions and

seizures against products, and we can even initiate

criminal prosecution against those who place an illegal

product on the market. So the law is a very strong law in

terms of enforcement.

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Foods are not required to undergo pre-market

approval by FDA. So new varieties of corn, for example,

or soy beans, do not necessarily \-- do not come to FDA for

approval before they go to market. But the Act places the

legal responsibility for the safety of these products on

the developer, on the purveyor of the product. And FDA\'s

job, then, is to provide the guidance to make sure that

these products are safe, to make sure that the purveyors

know what the standards are; and, of course, to remove

products from the market if they do not meet the

standards.

There is pre-market approval for substances that

are added to food that are food additives. These would

include substances such as new flavors, thickeners,

preservatives, any substance that is added to food that

isn\'t otherwise exempt from this part of the Act.

Pesticides, for example, are exempt because they are

regulated by EPA. But there\'s also a large category of

substances that we call GRAS substances, G-R-A-S,

Generally Recognized as Safe. Congress has established

this exemption because they\'re are many substances that

have been used safely in foods, such as flavors, spices,

vinegars, sugar, food processing enzymes, and so forth,

and did not intend that all of those, that type of

substance, would undergo pre-market review. But this

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gives us the tool to insure that any substance introduced

into food through modern biotechnology that is not

generally recognized as safe will be reviewed and approved

by FDA before the food goes to market. And we have said

that there are many substances introduced into food

through plant breeding, and that many of those substances

have been safely consumed. And to the extent that a

substance is introduced into food through modern

biotechnology or other means, and it\'s derived from food

where it\'s been safely consumed, we will presume that that

substance is really exempt from the Food Additive

requirement.

On the other hand, we have also said that there

are many substances that are very similar to substances

found in food, even though they come from very diverse

organisms. And to the extent that that is the case, those

substances are also considered to be, presumed to be,

GRAS. But we have the legal hook. If someone can put a

substance into food using this, or any other technology,

for which there is not a basis for us to presume that that

substance is GRAS, it will be required to undergo

pre-market review. And we\'ve published extensive guidance

for developers.

This is really the crux of the 1992 policy: to

make sure that developers know the kind of safety issues

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that should be taken into account in evaluating new

varieties for commercial food use. And it really is this

part which was new in 1992 in the sense that what we said

wasn\'t new. We think that there are practices that

breeders normally follow, but we put it down on paper so

there could be no mistake about what the standard is that

FDA expects for these products to meet. And we also set

up a consultation process to make sure that companies had

an opportunity to make sure that they knew all the steps

that need to be taken so that they could meet their legal

duty in bringing these products to market.

This was something that evolved after the

publication of the 1992 policy and our review of the first

product, the Flavr Savr Tomato. FDA conducted a full

review of that product at the request of the company.

That review was a review that lasted about three or four

years, and we worked with the company right in the

beginning, helping them design the tests. Because, in

fact, this was the first time that anyone had come to FDA

and said: Well, how do we apply modern biotechnology, or

modern science, rather, to a food? In other words, most

foods have been accepted on the basis of experience and

use. Now the question was: Well, actually, we would like

to provide some additional assurance and use modern

analytical and other methods to assure the safety of these

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foods. How will we do that?

We\'re very used to looking at the safety of

single chemicals as food additives, that are added to

food. We realized that this was a very different question

because a food is composed of many substances. And, so,

we had to think about that quite hard in terms of

developing a process to assure that this food would be

safe, as safe as other foods in the market. And we

discussed the approach that we presented in the 1992

policy with our Food Advisory Committee in 1994, which is

a committee of experts from outside of FDA and includes

academic, consumer and industry representatives. Those

committee members felt that the approach that had been

used for the Flavr Savr, and that we were proposing for

other similar products, was scientifically sound; but they

also said to us that, given the nature of the Flavr Savr

product, and other products that we were seeing at the

time, they did not, in fact, raise substantial safety

issues, and that FDA might better use its resources by

having some sort of process that was more abbreviated

where we would still have some oversight of this new

technology, but not commit the kind of resources that we

did to this full scientific review of the Flavr Savr

Tomato. And we felt that, given the nature of the

products we were seeing at the time, that was appropriate.

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We developed what we now call the \"consultation

procedures,\" and discussed those again with our Food

Advisory Committee, and our committee that assists us in

areas on veterinary medicine, such as animal feeds. And

again, the Committees felt that the consultations that we

have in place were an appropriate mechanism given the

nature of the products.

The way consultations work is: Our guidance is

there for companies to use and to consult with us on

particular scientific issues, such as evaluation of

nutritional changes, or assessment of possible

allergenicity. What we do ask companies to do is to

provide us a comprehensive summary of the information that

they have developed when they feel they have completed all

the work that they need to do. That information \-- which

usually is a hundred to several hundred pages in length \--

gives the FDA scientists an opportunity to make sure that

all safety issues have been resolved before those products

go to market. And that is the system that has been in

place since 1994, and there are about 45 products that are

now listed on our home page, where companies have

completed their food safety and nutritional assessment

discussions with FDA.

I\'d like to just give you a little bit of sense

of some of the principles that underlie our approach to

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safety assessment.

The products that we\'re seeing, of course, are

familiar food crops. They\'re corn, soy beans, potatoes,

tomatoes. They\'re not something that we\'ve never seen in

food before. And we felt that, because these are products

that have been modified, but they\'re based on conventional

crops, that the food that we have today should be the

standard. FDA should not ask developers to prove that

tomatoes are safe to eat, or that corn is safe to eat. In

fact, we know that, if one subjected many of our foods to

the kinds of extensive toxicological testing, they might

not pass because they contain many different substances

that can cause effects in food.

What we thought was important is that the food,

as the standard, should be what is used to compare the new

variety. The new variety should be looked at in terms of

what is similar, what is different about this new variety

in terms of food safety, and that we would have to use a

different approach than we normally use for single

chemical, such as food additives. We would have to look

at many different kinds of information. Plant breeders do

extensive evaluations of new varieties over a period of

time during development, and that that agronomic and the

quality characteristics that plant breeders evaluate for

individual crops is a very important process in

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determining whether a product is suitable to come to

market.

We also have some new tools. Modern

biotechnology gives the tools to develop new products. It

also gives us a way to know more about those products, to

know the identity of the genetic material, to know the

identity and the function of the proteins and other

substances that are new in food as a result of the use of

that technology. And so that that information would be

very important to the assessment of the safety of these

products.

In addition, we recommend to companies that they

take some extra steps that are not normally done in plant

breeding. That they develop information to show that, in

fact, the foods have not been changed in the ways that are

important in terms of their nutrients, and other

components of the food, the vitamins, minerals, that I

will show you in a moment. But really to assess whether

the food is, in fact, the same as what is expected in

addition to, of course, whatever change had been made in

that food.

There could be circumstances where we would

recommend that further testing be done. And I will give

you some examples. But we don\'t generally recommend that

animal tests be conducted with these foods, because the

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tests are very difficult to design, and they cannot be

done in the same way that we do for standard chemical

toxicity testing.

Maybe if I could \-- it looks a little out of

focus, but there could be situations where we would have a

new protein expressed by a gene introduced into a plant

that would be very different from the proteins that have

been safely consumed. So there would likely have to be

additional tests that would be done for that substance, or

other new chemicals that would be in the food as a result

of genetic alterations. If a new substance showed

similarity to an allergen, or to a toxin, there would have

to be additional testing to assure that that product was

safe.

To give you an example, you may have heard in

the news about a potato developed in Europe that contained

a substance called Lectin. Lectin is a substance that, as

a class, there are a number of those substances that are

very toxic. If that product were presented to FDA, there

would have to be extensive toxicity testing in order to

establish that the substance, that the potato, was

actually safe for consumers. So there can be a number of

circumstances where there would be additional testing.

These, of course, are just some examples.

I would just like to give you a sense of the

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kind of information that is being developed on products of

modern biotechnology. This is really our recommendations

for foods derived from all methods of plant breeding. But

it takes into account the change that has been made in the

plant that is the intended change that has been made, and

whether there would be any new substances introduced into

the finished food by that modification, and what would be

the identity structure and function of that substance? Is

it, of course, safe to consume? Will it present allergic

reactions to consumers? Is it a substance that is present

in food at very high levels? To date, most of the

substances, all of the substances, in fact, that have been

introduced into food have been present at very low levels.

They\'re enzymes.

Remember! FDA does not look at the pesticide

substances. EPA has oversight over those. All of the

substances that fall under FDA to date, in terms of new

substances in food, have been enzymes. They\'re present at

very low levels in the food. They\'ve been shown to be

very readily digestible and not similar to any known

toxins or allergens.

There could also be nutritional changes in the

food that would be important. This is an issue that is

particularly important in animal feed, because animals

often have a diet that consists primarily of one crop.

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And, so, a change in the nutrition of that crop can have

potential ramifications in feed use. But that, of course,

could also be true in humans, a human diet. And we have

to look at changed in nutrition with respect to the

overall diet that people consume.

In addition to the intended changes, we ask

companies to consider what unintended or unexpected

changes might occur in the plant and ultimately in the

food. It is well known, of course, that, in plant

breeding, there often are unintended or unexpected effects

that occur, and plant breeders take that into account in

terms of the observations in bringing new varieties to the

market.

But we have suggested some additional steps to

minimize the likelihood of unexpected changes. First of

all, by insuring that any inserted genetic material in the

plant is stablely inserted so that it\'s not moving around,

perturbing the chromosome.

And secondly, companies are doing extensive

analytical studies to insure that the important, or the

key components of the plant, are what is expected for

commercial varieties of that crop.

I would like to just give you briefly some

examples that we have taken from some of the information

that has been submitted to us. I\'m going to show you

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essentially composite information because there\'s quite a

bit of information that we have, but just to give some

examples of the kinds of things that are looked at in

bringing a product to market.

Typically, of course, there are many

characteristics, such as plant morphology, flower color,

time of flowering, resistance to disease, the percent of

oil and quality of protein that are observed for soy

beans. And I\'m using soy bean as an example because it\'s

one of the major crops that has been developed by modern

biotechnology. But these, of course, would be dependent

on the type of crop and where it will be grown, and the

breeder normally will do tests over several years in

several different locations and field sites in order to

assure that this plant is performing in the way that it\'s

expected to perform. These are just a few of the

characteristics that are taken into account during this

process.

There are also, of course, a number of types of

information that are accumulated during development based

on the molecular change, that is, the change using modern

biotechnology techniques. What kind of information has

been introduced into the plant and is it stable? Does the

plant reproduce from generation to generation in the

manner that would be expected? And, of course, I\'ve

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already discussed the safety of new proteins, nutrients,

anti-nutrients. Soy beans in particular, of course, are

known to cause allergic reactions in some individuals, and

companies have actually done analyses to assure that the

native, or normal, allergens that are present in soy beans

have not been increased in these new varieties. In

addition, companies also do wholesomeness studies in

feeding to animals to be sure that the animals growth, and

so forth, is typical for these new foods.

I\'m going to go through several slides fairly

quickly, but I would just like to give you a sense of the

kinds of information that companies submit to FDA as part

of a consultation. That, of course, reflects the kind of

testing that they are doing.

This shows what is called the proximate analysis

of seed, but this is carbohydrate fat protein, and these

are fiber analyses for digestibility of the seeds. And,

of course, it\'s typical to control the product of modern

biotechnology with its appropriate counterpart that is not

modified. But these values are also looked at in terms of

the range that is typical for this crop. Because various

parameters vary considerably depending on environmental

conditions, growth conditions, genetic background, and so

forth. And, so, it\'s very important to look at these

values in terms of what has been accepted commercially,

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what is typical of this crop. Analyses are done for

minerals that are typical of the crop in the same manner.

Oils, or course, is very important to insure that the

fatty acid composition, the composition of the vegetable

oil, is what is expected.

The same for the proteins where the protein will

be an important food ingredient derived from the soy bean.

These are just a few examples of the amino acid analysis

that would be done to assure that the protein quality of

the protein derived from the soy bean will be typical of

what is expected. And there are other substances that can

affect nutrition of both humans and animals that are

typical of soy beans. Analyses are also being performed

on those types of substances.

Those are just some of the kinds of information

that companies are generating to assure that these

products are as safe as other foods.

To date, there are actually a limited number,

but a growing number of crops that have been produced

through modern biotechnology. There are sugar beets,

canola, corn, cotton, potato, soy bean, flax, radicchio,

squash and tomato. These are the crops that, to date,

companies have completed food safety discussions with FDA.

So you can see that actually there are some major crops,

but it\'s also a relatively limited number of crops at this

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time.

To give you a sense of what some of the changes

are that are introduced into these crops, they\'re also

limited in terms of the types of modifications that are

being done. This is just the beginning of this

technology. And, so, many of the crops \-- in fact, the

majority \-- are herbicide tolerant; others are resistant

to insects or viruses. Some have altered ripening, such

as the modified tomatoes. And then there are other

products, such as vegetable oils, that have been modified.

We have two examples where there are completely

new products, in the sense that they\'ve been modified such

that they are not similar to their traditional

counterpart. One is a product that is a soy bean oil that

has been modified to increase one of the fatty acids

that\'s typical of soy bean, oleic acid. And that product,

that now has a very high level of oleic acid, as a result

of the genetic change, is very different than soy bean

oil. It\'s an oil that can be used for high-temperature

frying without processing before it\'s \-- soy bean oil

typically has to be processed before it can be used for

high-temperatures. So this product is a very new product.

It, of course, has a different name. It\'s called High

Oleic Soy Bean Oil.

There is a second product called Lauric Canola,

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which is a variety of canola oil in which a fatty acid

lauric acid has been introduced into the canola plant, and

that again produces a very different product. Lauric acid

is not a new substance in food. It is found in tropical

oils, such as palm oil. But the canola oil that contains

this lauric acid is very different. It\'s not a vegetable

oil that you typically think of as the bottle on the shelf

in the grocery store. This oil is used in confections and

coffee whiteners. It actually has a relatively limited

use in food.

So we have two products that are fairly

different. Most of the products, of course, are more

typical of agriculture. It\'s typical for plant breeders

to want varieties that resist insects and disease, and to

be tolerant of other agricultural conditions. In the

future, we expect to see a number of different

health-enhanced varieties. But these are the products

that we have seen to date.

I\'d also like to give you a sense of the time

period, and just what happens when companies bring these

products to market. Usually, it is typical \-- what we\'re

showing here is the time frame in months on this side

(indicating), so this is 15 months, for example; and

presubmission is what it says on the bottom. That really

is the time that companies discuss these products with FDA

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before they complete all of their safety assessment data.

And you can see that, while it varies considerably, it\'s

not unusual for companies to spend a year, or two years,

talking to FDA. Because, what typically happens is: They

come to the agency and talk to our scientists about the

kinds of test they\'re planning to do. And that gives our

scientists an opportunity to suggest different tests or

modifications of the kinds of tests. In other words, to

help them design appropriate kinds of testing. For some

products that we have seen before, often the consultations

may be very brief.

What we do tell companies we expect is for them

to consult with us, to provide us substantial information

about the testing that has been done when they have

completed it, so that we have a chance to make sure that

all the proper testing has been done. You can see this

time frame is more in the five to several months period

that FDA spends looking at the submission that the company

feels is a complete package.

When we are satisfied that the company, in our

view, based on the information we have seen, has answered

all the questions, we do provide the company with a letter

that says not very much. What the letter says is: We

don\'t have anymore questions based on what we know today.

And we remind the company that it is their continuing

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obligation to insure that these products meet all the

provisions of the Food, Drug and Cosmetic Act.

So this is the process that has been in place.

This process of consultation is described on our home

page. Currently, there are about 45 products that are

also listed there for which companies have completed this

process.

So, what do we expect? We expect that new foods

will be as safe as the foods that are in the grocery store

today. And what does that really mean? It means, of

course, that the food cannot have an unimproved food

additive in it. It must \-- that would be an illegal

product. So there cannot be a new food additive. It

cannot contain a substance that would be harmful to humans

or the food would be adulterated. FDA would have to

initiate actions to take the product off the market. It

would have to meet all the provisions of the Food, Drug

and Cosmetic Act. This is what we mean when we say that

the food must be as safe as today\'s foods that are on the

market.

Thank you for your attention.

\[Applause.\]

COMMISSIONER HOLSTON: Thank you so much, Jim,

for your presentation.

All right. We\'re a little ahead of schedule,

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which is a good thing. So, right now, we are going to

take a 15-minute break; and, then, when the break is over,

we will begin the panel discussion on the scientific, the

safety, and the regulatory issues.

It is now 10 minutes to 10:00 according to my

clock; and, so, we are going to ask that everyone return

and be back in place at 5 minutes after. Let me remind

you of something that I should have reminded about before,

and that is: There are no foods or drinks, including

water, allowed in the auditorium. So please remember that

when you return from the break.

Thank you.

\[Fifteen-minute recess.\]

SESSION 2.

SCIENTIFIC, SAFETY AND REGULATORY ISSUES

COMMISSIONER HOLSTON: Thank you very much. It

is now time for our first panel, which will discuss

scientific, safety and regulatory issues. I will ask each

panel member to give brief opening remarks, and they will

be followed by discussion among the panel members and

questions from the FDA panel.

These are the questions we have asked to be

addressed by our panelists in order to help us evaluate

our current policy:

No. 1: Has FDA\'s consultation process achieved

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its intended purpose? Based on experience to date, should

this regulatory approach sunset, continue as it is, be

made mandatory, or otherwise be revised?

No. 2: What newly emerging scientific

information related to the safety of foods derived from

bio-engineered foods is there, if any? Are there specific

tests which, if conducted on such food, would provide

increased assurance of safety for man or animals consuming

these foods?

No. 3: What types of food products derived from

bio-engineered 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?

I am pleased to introduce our first panel.

Please note that your information packet has additional

biographical information about each panelist.

Dr. Calvin Qualset is the Director of the

Genetic Resources Conservation Program, with the

University of California at Davis.

Dr. John Fagan is the Chairman and Chief

Scientific Officer with Genetic ID.

Dr. Philip Regal is a Professor of Ecology,

Evolution and Behavior with the College of Biological

Sciences at the University of Minnesota.

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Dr. Susanne Huttner is Director of the

Systemwide Biotechnology Research and Resource Program,

with the University of California at Berkeley.

Dr. R. L. Baldwin is the Sesnon Professor of

Animal Science, with the University of California, and I

don\'t have \-- excuse me, one moment. I apologize.

Dr. Susan L. Hefle is a Research Assistant

Professor and Co-Director of the Food Allergy Research and

Resource Program at the University of Nebraska, Lincoln.

Thank you very much to all of our panelists, and

now I would like to invite Dr. Qualset to open the first

panel.

Dr. Qualset.

DR. QUALSET: Thank you very much.

I want to first congratulate FDA for having the

courage and energy to carry out such discussions as we\'re

having here, and they\'ve had in Chicago and Washington, D.

C. I think it\'s very important that the science community

and the public all have a chance to talk about these

issues in a common forum. And it\'s important that the

regulatory agencies be aware of all of the issues.

I\'d like just to say one thing about

terminology. This discussion is dealing with

bio-engineering, and is not quite the same as genetic

engineering; but I think I\'d like to focus this a little

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bit more on the genetic side. In other words, that seems

to be the interest here, which is that genes that are

being discussed and the gene products that are produced,

and how those might affect food products.

So, bio-engineering, of course, is a very old

field and it involves modifications of biological

materials after harvest. And I think that the genetic

engineering part we think of as beginning with the

introduction of genes into plants that will be used and

expressed in products.

The first think I think I want to say is that

all organisms are genetically modified. We have common

genes, or conserved genes, through all of the living

things, and many, many genes are very common in plants and

animals and microbes. So we\'re, at first instance,

dealing with the continuum of life, that we\'re talking

about genes that are very similar and that there\'s no

mystery there about DNA in the sequences of nucleotides in

the DNA that produce, that make up genes, which, in turn,

direct the synthesis of protein. So gene conservation and

genetic modification is a fundamental principle that we

need to remember.

I\'d like to say something to illustrate a little

more about the continuation continuum that we\'re working

with. The plants and animals that we use as food products

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are derived from wild species. They were domesticated

through a series of processes done by early farmers and

protofarmers. These resulted in dramatic changes from

wild species to the domestic species, in terms of their

genetics. But, remarkably, we can identify the

progenitors of many of the important species.

The modern farmers have taken those materials

developed by the early farmers and selected and modified

them to suit their needs. Thus, we find different types

of materials within the plants, such as wheat being grown

in Turkey looks different from wheat grown in Canada or

Russia. So we have these changes in genetics of materials

that has been an ongoing process.

It was about in the 1700 and 1800s that people

began to be more involved in selection and modifying

plants more systematically to suit their needs. They

worked within land races, which were the early lab types.

Then, in the 1900s, and late 1800s,

hybridization was discovered as a possible way to

introduce recombination of genes. And, again, with this

process, you can select recombinant types that represent

new things and they would be adapted to use. So the

hybridization and selection process was going on, and is

still going on, but has been the dominant procedure in the

1900s.

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After the Second War, when more was known about

mutation and mutigenesis, mutations and induced mutations

by radiation and chemicals, was used as breeding process

to change the genetic material in plants without

recombining through hybridization. So we had an era of

interest in mutation breeding during that period and some

300 or 400 different crop cultivars were developed by

induced mutations.

It\'s the modern era that we need to talk about.

Molecular breeding has become known as the issue of taking

DNA from an organism and studying the genes and isolating

parts of the gene, or all of the gene, and making sure

that gene transferable by putting it into a vector. So

we\'re know dealing with relatively highly defined genes

that are transferred to crop plants that are being used in

so-called genetically modified organisms. The safety

issue of those genes needs to be considered not for how

they were produced and how the traits were introduced, but

what are the genes doing within the plant, and what are

the genes doing, what do the genes do and produce in a

food product.

So the issue of the process, using recombinant

DNA, is not the issue. The issue is what does the gene do

and how does it perform, and is there any inherent risks

involved if we have introduced a new gene to a plant.

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This is an issue of the safety. This is the safety issue,

and I think any discussions about regulating the process,

and all, are misguided and that we must continue to look

at the products that are produced and how safe they are.

This issue of process, for example, how we do

that, the FDA has established, I think, the model for

development of an oversight process. Their consultation

program is working. It is very comprehensive and it

places the responsibility on the developers and others to

make sure that the products they\'re proposing are safe for

the environment.

So those are the few points that I think we

should talk about some more later, but I think my time is

up.

COMMISSIONER HOLSTON: Thank you, Dr. Qualset.

Dr. Fagan.

DR. FAGAN: Thank you for this opportunity. I

really appreciate it.

I think that what I\'d like to cover is really

not to focus on the arguments regarding safety. I think

you\'ve all heard those by this meeting. You\'ve heard

those from a number of people. I\'d like to focus really

on another technical issue that\'s critical to responding

to the existing situation here in the U.S. And that is

the feasibility, the technical feasibility of segregation

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and labeling and traceability of these products.

Just one comment on the safety is that really

the same database of information is at the hands of those

who think these things are safe, that need experts to say

these are very safe, and the experts who say they\'re not.

So it really doesn\'t come down to the science, but the

personal perspective of the individual who is making that

evaluation at this point.

There is the key point, though, that there is no

consensus on the issue of the safety of these things.

There\'s wide range of views on this, and quite

conflicting, as you\'ve experienced in the last three

meetings. And it seems to me that, in the lack of clear

consensus and in light of the fact that this is a highly

novel approach to modifying foods, it makes sense to have

very open introduction of these things. There needs to be

transparency so that consumers can come to terms with

these things on their on own ground, instead of wondering

what\'s out there. And this is critical to, I think, the

implementation of these, that there be choice. That there

be also more rigorous safety testing just, for no other

reason, than to confirm the beliefs of the scientists who

think these things are safe.

And third, in the same way, there needs to be

stronger assessment of environmental impact, for at least

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some period, so that we can really be confident of the

beliefs on that level.

But how to respond to the concerns of consumers?

One thing is certain, namely, that, by providing

transparency, we will be able to deal with this in a more

open and effective way, and deal with this in a way that\'s

going to serve consumers better. What I would like to do

is look at how to provide transparency.

First of all, labeling of genetically engineered

crops or foods, all the way through the food chain, is not

some hypothetical theme. It\'s the reality in most of the

industrialized world. If you look to Europe, you see that

this is the case in virtually every country. There\'s a

law that requires engineered foods to be labeled, and it\'s

successfully operating. The same way in Japan and in

south \-- in Australia and New Zealand, there are laws in

place. In other areas around the world, laws are coming

into being. So it\'s happening. So it can be done.

In terms of the technical feasibility, there are

three things to consider. One is the ability to

segregate; the second is the ability to monitor, which is

testing; and the third is the ability to actually have a

traceability system that allows this process to be

verified. And, as it exists now, all of those are in

place around the world.

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We have considerable experience in the testing

area. And what we find is that the methods that we use

are common to testing methods that are being in more than

40 laboratories across Europe. The methodology has been

verified by the European Commission as being effective.

Similarly, in Japan, there are a score of labs that are

doing this kind of testing. So the feasibility is there

and it\'s really part of the market system at this point.

In fact, American food industry is already testing,

segregating and delivering non-GM, verified non-GM, and

verified genetically modified products to Europe and

Japan. In order for them to export, at this point, they

have to do it. So it isn\'t a question of can it be done;

it\'s a question of whether we choose to do this in America

in the same way that we\'re doing for consumers in other

areas of the world. So it\'s a very feasible thing on that

level.

Going on to the key thing here in traceability,

identity preservation systems are the norm in organic

agriculture. They\'re also what is really put in place by

the biotech agricultural systems in order to segregate the

value-added products that are going to be coming down the

pike right now. There are already some biotech products

being segregated in this way. And, of course, this is

being done now for genetically \-- for nongenetically

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modified things for export around the world. It can be

done here.

The common approach is to establish a threshold.

This is the basis of law in Norway, throughout the EU, in

Switzerland, in Australia, Japan, all of these places,

set a threshold. Testing verifies that a product is above

or below that threshold. The testing works very

effectively. I won\'t have time to go into that, but it

is.

There is one critical point here; and that is:

Generally, the thresholds have been in the 1 to 2 percent

range. These are thresholds that are not satisfying to

consumers. And consumers across Europe, for instance, are

now pressuring for lower thresholds in the more, in the

range of 0.1 percent. Just last week, the European

Parliament made an announcement that they will reconsider

legislation in this area looking to lowering the

thresholds and making the system more stringent.

So I encourage us, here in American, to really

look to the future and establish a program that\'s going to

serve consumers.

Second, look to the future to a program that

will serve the food industry. What has happened in Europe

is that, because legislation laid far behind the

implementation of the technology and the needs of

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consumers, the food industry was caught between a rock and

a hard place. If they had had government support,

regulatory support, to allow them more effectively to

deliver what they needed to deliver to consumers, there

would have been hundreds of millions of dollars saved, and

it would have saved a lot of, you know, ulcers and this

sort of thing, as well.

So a more rigorous program that serves both the

consumers and the food industry is a thing that\'s critical

here. And, really, having worked with the food industry

in this testing area, it has become so clear to me that

the industry has been in a very difficult position because

lack of, because of lack of regulation and guidance from

government regarding segregation, testing, labeling, these

sorts of things. If you put something in place long-term,

it will facilitate commerce around the world in this area.

And it will bring America up to the international standard

with regard to this issue, which is the standard requiring

labeling, requiring segregation, and serving the consumer

in a way that hasn\'t been done here in a manner that is

more transparent.

Thank you very much.

COMMISSIONER HOLSTON: Thank you, Dr. Fagan.

\[Applause.\]

Dr. Regal.

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DR. REGAL: Thank you very much for the

opportunity to explain why I believe that the mandatory

testing and labeling of genetically engineered foods is

necessary. And also the opportunity to explain why, after

15 years of trying to work with government agencies, I\'ve

recently joined the lawsuit to ask the courts to require

mandatory labeling and testing of genetically engineered

foods. It was not an easy decision for me.

I began studying this issue back in 1984. I

organized the first conference that brought together

molecular biologists and leading ecologists and government

scientists, and we held it at Cold Spring Harbor. We had

to Nobel prize winners there, and so on and so forth. And

after that, I organized conferences for the Environmental

Protection Agency, for the National Science Foundation,

for the American Association for the Advancement of

Science, for the Ecological Society of America. I\'ve been

to dozens of other conferences on bio safety, and I\'ve

published key papers in these areas.

President Reagan\'s head of the Basic Sciences

Coordinating Committee, David Kingsbury, asked me to

continue my work and to continue to publish and try to

inform scientists about the various risks. After

Kingsbury left his position, the effort to have in-depth

studies of the risks petered away in Washington, D. C.

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Basically, there was no continuity on that.

So I\'d like to say that, what I\'ve seen since

then, and, well, actually, to some extent, even before

that, is a tendency to try to minimize the risks, and to

try to deal with the incredible problems that genetic

engineering presents with slogans and simplifications.

And we\'ve seen an effort, by industry, to get into the

official documents very vague terms, scientifically vague

terms, like familiarity, substantial equivalence, and the

notion that genetically engineered organisms are not

different in their purposes from traditional breeding, and

don\'t present any additional sorts of problems.

What I\'ve seen in this process of simplification

is the industry, and its supporters, painting themselves

into a corner. If you don\'t, if you oversimplify these

problems, you give the impression that you don\'t know what

they are; and, then, the public is not going to trust you

to be screening thoroughly. And other scientists, such as

myself, are not going to trust the genetic engineers to be

screening thoroughly. You would not trust a doctor who

says that there side effects are all a bunch of nonsense,

or whatever. You know, if you can\'t speak intelligently

about side effects, you shouldn\'t trust that doctor. But

that\'s what we\'re getting. We\'re getting a lot rhetoric

that there are no particular dangers here.

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I\'ll just give you a few comments.

I consulted for a company that was putting the

genes for spider venom and scorpion venom into corn and

potatoes and soy beans, and so on and so forth. I think I

talked them out of it. But, you know, they had really

convinced themselves that, just because these venoms were

not toxic to mammals, that they didn\'t present any special

problems. And I think I talked them out of it for

scientific reasons, because there are all sorts of other

problems that need to be considered and not just public

relations. But they had really \-- this rhetoric had

worked at their minds and they spent several million

dollars doing this, and it was probably a very big

mistake.

This is \-- you\'ve heard a lot of science, I

assume, in the previous panels; but maybe I can just

quickly point out that we\'ve already had surprises. Some

remarkable things are happening with this new technology.

Some of them have been in the newspaper and will be

familiar to people. You know, it was a surprise that the

pollen from genetically engineered plants was more

powerful, by 20 to 1, than the pollen from normal plants

in pollinating. There was a competitive advantage. No

one expected that. That was a surprise.

It was a surprise to the people at Pioneer

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Hybrid that the one gene from Brazil Nut would carry the

allergen to soy beans. They didn\'t expect that. They had

to destroy a lot of soy beans. They found out about that

very late.

It was a surprise that the Klebsiella bacteria

that was genetically engineered and they found out that it

turned wheat into slime. It killed the plants. No one

expected that. They were at the verge of releasing it and

they had to do other sorts of tests, by luck, more or

less.

We know about all sorts of really odd side

effects in genetically engineered organisms. You\'ve

genetically engineered growth hormones into rats and the

growth hormones produced all sort of brain tissue, but not

the hypothalamus or the pituitary. There are patented

transgenic salmon out there right now that are producing

growth hormones not in their brains like other vertebrates

do, but in their livers. I\'m not saying that\'s dangerous.

But you don\'t expect these sorts of things with normal

breeding. There\'s some radical changes.

Now I\'ve discussed why the processes are

different in my scientific publications, and some of them

are out there. And we could sit down and, you know, with

a blackboard and I could go through some of these reasons.

But the point is that there are still surprises. It\'s not

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\-- the traditional breeders would not be used to. I think

it was \-- whether or not the Monarch is endangered, it\'s a

surprise that toxins are produced by pollen, you know.

And it\'s very interesting that the different BT types of

corn are producing different levels of this toxin. There

are things out there that \-- this is still an experimental

technique.

Well, in the case of foods, of course, what

we\'re concerned about is that some of these surprises may

end up with changing biochemical pathways. These are

delicately balanced biochemical pathways.

You might \-- a lot of the examples I\'ve just

given you, you would look at it, and you might say: Well,

this salmon, or this plant looks just like any other

plant; but, when you get into it, there are weird things

going on with its biology. So we need, we need this

testing.

Again, I want to stress the fact that the

rhetoric, the basic rhetoric, is dangerous. When we say

things about it being no different from traditional

breeding, it makes the public and the scientific community

doubt that the people who are dealing with it know how to

deal with it. It\'s really clear to me, as a university

scientist, when I talk with genetic engineers, when I talk

with molecular biologists, they cannot talk knowledgeably

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about the risks. That\'s not part of their training. You

can look at their textbook. Their textbooks do not

include \-- they tell them how to build these things; but

they don\'t have chapters about safety that are meaningful.

They\'re very, very thin.

So there\'s nothing in their training, there\'s

nothing in their public comments, and there\'s nothing in

their conversation that suggests that there\'s a community

of people being built out there who are well prepared to

deal with these risks. And, so, I \-- it\'s part of their

culture, I suppose you might say, to try to minimize an

impression that there are risks, and they\'ve talked

themselves into that. And I think, if pressure doesn\'t

come from the government, that that will continue, and I

think it\'s going to continue a very unstable situation. I

don\'t want to see that. Genetic engineering for the rest

of our lives, and I just don\'t want to see the present

situation continue.

COMMISSIONER HOLSTON: Thank you, Dr. Regal.

\[Applause.\]

Dr. Huttner.

DR. HUTTNER: Thank you very much for inviting

me today, and thank you especially for bringing this

meeting to California and the Bay Area. To allow our

remarkably diverse community to address this issue is

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important. I think you\'ll know, if you visit our

restaurants and our local fresh markets here in the Bay

Area, food, small farms, and organic farms are an

important part of our culture. It\'s important that people

have an opportunity to discuss these kinds of issues so

that they can make decisions. So thank you for coming

here to the Bay Area.

As Director of the Systemwide Biotechnology

Program at the University of California, I have a couple

of jobs. One is, quite frankly, to promote research in

molecular biology, and a good portion of that is in

agriculture, plant sciences and understanding better the

relationship between plants and diseases and pests.

Another important part of my role, though, is to

promote research and communication on issues related to

the impact of biotechnology in the public arena. And in

that context, I\'ve had the pleasure of working with food

leaders in the Bay Area, several years ago, discussing

just this issue about the time when the BST controversy

was really hitting the headlines. What I\'ve learned from

that is that most people in the Bay Area, who are

concerned about biotechnology, have very sound concerns

related to their professional and personal interest in

food safety. And, so, I thank you for allowing them to

talk about this; but, most importantly, to recognize that

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we\'re facing a serious information gap.

The views about biotechnology becomes so

polarized that people are simply trying to sort it out and

are left without sound information to make decisions.

There\'s a huge role for the Food and Drug Administration

to play in that context. I wanted to emphasize that at

the very outset, before I address the questions.

Your first question was about whether or not the

consultation process achieved its intended purpose. And,

in my view, it has. It will continue to do so, and I

encourage you to continue it as it\'s currently structured

and implemented.

What is important about the current structure is

that it lays out, in the 1992 policy statement, a

scientifically sound and transparent set of guidelines for

food producers. It enables them to understand the key

issues of food safety that they have to address and how to

go about addressing it. I think the decision phase is

particularly important, and I encourage anyone who hasn\'t

looked at it on the FDA web site to do so.

The other thing that\'s very important about the

1992 policy statement is that it built the appropriate

historical context. It\'s looking at all genetic

modification techniques. It acknowledges the fact that

all the food that we eat is genetically modified. In

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fact, all the food we\'ve eaten all our lives, that our

parents have eaten and our grandparents have eaten, and so

on, it\'s all been genetically modified just by various

kinds of techniques.

So, when you\'re judging the risks associated

with genetic modification, you have to consider it in the

context of what we know about other kinds of genetic

modifications that have been made in food, and what kinds

of risks where involved with them, and what kinds of

benefits were involved with them.

If I could have the first slide.

In California, we\'re all used to seeing, during

the summer, semi-truckloads of red, ripe tomatoes. But I

think many consumers would be surprised to find out that

our modern tomato is derived from an ancient predecessor

that was a tiny berry. In fact, it was quite toxic, very

bitter. It took literally hundreds of years of selective

breeding that is genetic modification that we have the

modern tomato.

The same thing \-- next slide \-- for modern corn.

I\'m sure many people don\'t know that modern corn is

derived from a very fragile grass. It was only through

selective breeding, originally by indigenous people, like

Native Americans, that have brought us the kinds of corn

that we have today, with increased numbers of kernels and

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large kernel size. This is the kinds of genetic

modification that\'s going on in virtually all aspects of

our food supply. It\'s occurred gradually over hundreds of

years. Eventually, plant breeders and scientists came to

understand the molecular basis for this kind of

improvement in plants, and they\'ve been able to take

advantage of it better.

Many people also don\'t understand that genetic

modification is actually a cornerstone of organic farming.

Through genetic enhancement of a plant\'s ability to

withstand pests and disease, you can reduce the implicit

chemical pesticide. Without genetic modification, it

would be very hard to have organic farming.

Even with this broad range of genetic

modification techniques that have been widely used, what

we all know from our personal experience is that the

American food supply is remarkably safe. Yet, today\'s

biotechnology message, which really fall on a continuum

with these older, more familiar methods, are getting an

enormous amount of attention these days. It\'s unfortunate

that they\'re being painted in such stark and contrasting

terms. It makes them seem very new and unfamiliar when,

in fact, when you look at the products that are

development in research laboratories across the United

States, the R&D is quite familiar. They\'re approaching

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the same kinds of goals that plant breeders have

traditionally approached in trying to enhance the

production, the quality, of the plant that\'s going to be

used in farming, or the nutritional characteristic of the

food that\'s going to be introduced into the marketplace.

There are two major differences, though, with

the new techniques. One is precision, and the other is

flexibility. Precision in the sense that you can make

changes one gene at a time, compared to traditional

breeding techniques that randomly intermix hundreds of

thousands of genes from each of two parent plants.

Flexibility in the sense that you can utilize genes

anywhere you find them in nature. Those are the two

issues that really bear our attention when we consider the

FDA\'s approach to food safety.

I\'d like to bring to your attention that the

scientific community has been looking at the nature of

risks associated with products made with these new genetic

techniques. More than a decade ago, the National

Academies of Science, then two years later the National

Research Council, convened panels that came to the

conclusion that the risks associated with products of the

new genetic techniques are essentially the same kinds of

risks associated with products of older genetic

techniques. That\'s not to say that the products of the

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new genetic techniques are inherently safer. What it

means is that the risks are similar, and, so, we can

manage them using the same kinds of food-safety systems

that we\'ve used for foods that were produced using more

traditional methods, more familiar methods. That\'s the

foundation on which the Food and Drug Administration\'s

policy is built, and it\'s a scientifically sound

foundation.

I do not believe that the consultation process

should be made mandatory, for two reasons: (1) is

diminishing returns; and (2) is cost. Because there has

been no evidence of unique risks stemming from genetically

engineered organisms or foods, and because these risks

have been judged the same as those involved in other

genetically modified products, and they can be managed

using our existing system, there can be no incremental

benefits to the public for any additional regulatory

requirement.

In addition, we have to consider that regulatory

requirements do add cost to the development of food. Cost

is particularly important to small businesses in

California, to farmers who grow small acreage crops, and

the consumers who are poor. So, for those reasons, I

don\'t recommend making this process mandatory. It\'s

working very well the way it is right now, and you have a

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good deal of information that\'s available and will

continue to be made available by companies.

The second question that you addressed was:

What newly emerging scientific information related to the

safety of foods derived from genetic engineered plants?

Is there any?

Well, I consulted with the Centers for Disease

Control, and I couldn\'t find any evidence of anybody being

made sick by having eaten a genetically engineered

product, or a product containing substances from

genetically engineered plants. Now that\'s important

because the answer has very broad exposure in the U.S.

food supply. Literally millions of people have eaten the

products of genetic engineering over the last decade, or

so, and there isn\'t a single instance of someone being

made sick by these products.

In addition, the U.S. Department of Agriculture

has undertaken extensive analysis of more than 5,000 field

trials of genetically engineered plants. This is

available on the web, if you\'re interested, at the USDA

web site. They have the data they\'ve collected. The

problem is it\'s difficult to read, even if you\'re a

scientist. Something has to be done to make that more

accessible to the public.

In addition, the European Union has invested

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more than 40 million Euros in biosafety assessments, both

on environmental questions and on food safety questions.

And in none of this research have any unusual problems or

risks been uncovered. Taken altogether, and added to our

experience with literally billions of genetically

engineered organisms used in biomedical research and in

the biopharmaceutical industry, that sets a very high

standard for judging safety issues of biotechnology, and

it lends strong support to the FDA approach.

Now what FDA has done, with that as background,

is said: What are the most important issues for food

safety? And they say there\'s four things, and they make

amino acid a lot of sense: Allergenicity; toxicity;

changing nutrients or fats in the food; and \-- this one is

specifically related to the flexibility of the new genetic

techniques \-- the introduction of substances that are new

to the food supply that\'s something that we don\'t have a

history of safe use for in the food supply. In that case,

it\'s going to be treated very rigorously by the agency, as

if it was a chemical food additive, and subject it to

pre-market regulations, as Dr. Maryanski described.

That\'s a sensible approach to food safety. It addresses

the common issue that are important to all of us as

consumers. And, at the same time, it doesn\'t add

additional burdens that could in any way distance people

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from the benefits of our new knowledge in the genetics of

plants and food.

The third question is more open-ended, and

that\'s: What types of new products are going to be coming

forward? What kinds of new plants are going to be made?

Well, the fact is, the National Science

Foundation has launched a major initiative called the

Plant Genome Initiative. It\'s going to, over the next

several years, identify a very large number of important

genes in plants. And, as we gain that information, we\'re

going to be in a better position to engineer the metabolic

systems of plants to increase their ability to withstand

pests and disease and to make them more nutritious. So

the number of new products that are going to come out will

expand rapidly as our knowledge grows. But I don\'t

anticipate that you\'re going to see many new and entirely

novel products that they would introduce new kinds of

risks. But it\'s worth asking the question repeatedly as

new products are coming forward.

The most important role, as I said at the

beginning, for the Food and Drug Administration is not in

regulating risk that people could perceive as being real;

but, instead, recognizing that people know very little

about the fact that genetics plays an important part in

the food supply, and always has. And they deserve to

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understand better how genetic modification has been

overseen to insure that the food supply is safe, even

though the Food and Drug Administration has never

regulated it, ever. They also need to understand better

the biosafety work that has been done both in the United

States and in Europe, and other countries.

Now I, for one, being from the academic

community and the scientific community, am willing to

admit that we\'ve done a lousy job of making this clear to

consumers. We need to work better at that. We need to

make this simpler to understand. These assessments should

not be so opaque that only other scientists can understand

them.

In addition, I think it\'s important that the FDA

acknowledge the important role that other layers of

oversight, outside the government, have played in insuring

the safety of our food supply. In fact, there are

standard practices that have been applied by food

manufacturers and plant breeders for decades, that have

participated in a very meaningful way in insuring safety.

And finally, anyone who read the New York Times

saw that article on functional foods. As we move into an

era of functional foods, consumers are going to be

increasingly presented all sorts of claims, health claims,

about what kinds of health benefits these functional foods

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can provide to them. They\'re going to need much more

information about the role of food ingredients in health,

not just in nutrition, but making them better able to ward

of cancer and heart disease and other important diseases.

This is just an incredibly important time in the

life sciences. I think we need to continue the kinds of

dialogue that your opening up here and through this

series, and recognize the public has a right to know.

But, at the same time, we have to be cautious not to

pursue public opinion as the basis for public policy; but,

instead, address risk, given the best scientific attention

we can and explain it.

COMMISSIONER HOLSTON: Thank you very much, Dr.

Huttner.

\[Applause.\]

Dr. Hefle.

DR. HEFLE: Again, thank you very much for the

opportunity to come and speak today.

I\'m a food toxicologist, and my research areas

are in the interest food allergies and sensitivities and

naturally occurring toxicants in foods. I want to talk

specifically about the safety assessment that\'s currently

done for genetically modified foods.

In my opinion, genetically modified foods are

safe for consumption by anybody and all people. These

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foods are thoroughly tested by the developers using

appropriate and adequate methods to address safety

concerns. The current FDA consultation process insures

that genetically modified foods are appropriately tested.

The process has been used by every developer, for every

case, even though it is not mandatory. I think this will

continue. The process has worked and worked with success.

Now a few comments in particular.

The methods used to assess toxicological

concerns of genetically engineered foods are appropriate

and adequate. These methods are the same ones that have

served us very well for many years for food toxicological

concerns, such as testing of preservatives and sweeteners.

Toxicological tests targeted to the novel

protein are most appropriate, and those are the ones that

are currently used. Not for whole foods, for example.

Whole food testing is not warranted, is not feasible, and

would be wasteful in terms of laboratory animal resources.

In addition, the inadequacies of single-food animal diets

can cloud the interpretation of results.

Now a few comments about the methods used to

address concerns about allergenicity. The current methods

are appropriate and adequate for addressing concerns about

the transfer of known allergens and also possible new

allergenic commodities. If the novel protein is derived

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from a known allergen, it must be assessed for

allergenicity. The developers are keenly aware of the

obligations to do this assessment and would conduct

appropriate and adequate tests in this situation. My

personal experience with developers is that they are very

acutely aware of the toxicological and allergenicity risks

associated with genetically modified organisms, and do

everything in their power to assure safety.

For example, such was the case of the Brazil Nut

protein cloned in the soy beans. Because of the testing

that was done to assess allergenic concerns, the product

development and plans to market were dropped. Plainly and

simply, the system worked. That product, though destined

only for animal feed, was not allowed into the

marketplace.

The assessment of novel proteins of unknown

allergenic history is also preformed using appropriate and

adequate methods. To date, all genetically modified

products are of this type and rigorous testing for

possible allergenic concerns has been performed to assure

that these novel proteins are quickly digested and bear no

resemblance to any known allergen, whether it be food,

drug, venom, or inhalant. There are millions of proteins

in food, but only a few hundred of which are allergens.

Given the low expression level of novel proteins in most

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genetically engineered crops, this makes the risk of any

of these novel protein becoming allergens exceedingly

small.

There is no history of increased allergenicity

of traditionally bred crops, and we expect therefore none

was genetically modified crops. It is my opinion that

there is a much greater allergenic risk with traditional

breeding methods, rather than the precise method of

genetic modification. In fact, as Dr. Huttner said, we

have seen no untoward allergenic or toxicologic, for that

matter, responses to the genetically modified foods that

are on the market.

It is neither practical nor feasible for FDA to

perform toxicological and allergenicity testing. This

responsibility and obligation should remain with the

developers. The process in place now is adequate, but

needs to be dynamic. As our base of knowledge expands,

and as we know more, the assessment scheme should

encompass and select new pertinent information. For

examples: If validated animal models for allergenicity

become available, they should be considered for possible

exclusion in the assessment scheme. Further discussions

should be encouraged and developed.

Thank you.

COMMISSIONER HOLSTON: Thank you very much, Dr.

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Hefle.

\[Applause.\]

And our last panelist, Dr. Baldwin.

DR. BALDWIN: Thank you very much for allowing

me, on behalf of the Federation of Animal Science

Societies, to present a couple of observations.

A bit about myself: I work at the University of

California at Davis in the Department of Animal Science.

I do a lot of work \-- I\'m basically a nutritionist. I do

a lot of work on digestive physiology and metabolism of

animals.

The Federation of Animal Science Society is a

professional organization made up of approximately 10,000

scientists in academia, government and industry. This

society exists to serve society through the improvement of

all aspects of food animal production. FASS represents

the combined memberships of the American Dairy Science

Association, the American Association of Animal Science,

and the Poultry Science Association. I will comment on

behalf of FASS on newly emerging scientific information

related to the safety of feeds and animal products derived

from genetically modified crops.

It\'s been estimated that the supply of food

required to adequately meet human nutritional needs over

the next 40 years is quantitatively equal to the amount of

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food previously produced throughout the entire history of

humankind. This poses a daunting challenge to agriculture

for several reasons:

First, virtually all land suitable for

cultivation worldwide, exclusive of environmental

constraints, is currently being farmed. Thus, the only

feasible means of feeding the world population is

development of new technologies that enhance food

production and including the production of livestock

products, which add to the total supply of high-quality

human food.

Genetic modification of crops used by livestock

has been conducted for many years, as mentioned by

previous speakers. The livestock feed supply is increased

markedly over the past 40 years because of new plant

varieties and high yielding hybrids were developed.

Recently, crops used in livestock production

have been improved using biotechnology. These products

are emerging in the marketplace. Both conventional and

biotechnology techniques have benefitted agriculture.

Corn grain, corn sileage, corn stover and soy beans from

genetically modified crops commonly fed to livestock have

been compared with conventional feeds to determine effects

on feed composition, digestibility and animal responses.

Chickens, sheep, beef cattle and dairy cattle have been

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used in this research.

Data collected clearly indicates that the

chemical composition of genetically modified and

conventional feeds are substantially equivalent and are

within the normal range of values reported in the

literature. These data indicate that intakes,

digestibilities, nutrients absorbed, growth, milk

production, milk composition and the health of livestock

fed genetically modified and conventional food are

equivalent.

The digestive processes in all livestock break

down the nutritional components of feeds, reducing

proteins to amino acids and DNA to nucleic acids. The

latter are then excreted. In fact, extensive data show

that livestock afford considerable protection for the

human food supply by degrading, detoxifying, or otherwise

discriminating against potential toxicants in foods.

Examples of this include Strontium 90, microtoxins,

phosphorous-based pesticides and undesirable proteins in

feeds. Because components of feeds are broken down into

smaller components during digestion, novel plant proteins

have not been detected in milk and would not be expected

in either meat or eggs. Available data and our

understanding of nutrient digestion, absorption and

metabolism indicate that genetically modified feeds are

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safe for livestock to consume. In addition, the food

products from livestock consuming these feeds are safe and

often may be safer for human consumption than unaltered

feeds, from animals fed unaltered feeds. This will be a

benefit to the nutrition and wellbeing of the world

population, especially to children in developing

countries.

FASS strongly recommends that the scientific

basis of the consultation process for acceptance of

genetically modified feeds for livestock be continued.

FASS endorses the use of biotechnology techniques to

improve agricultural plants and animal products. FASS

believes the agricultural biotechnology has the capability

to improve the supply of livestock feeds and healthful

animal and plant products, and thereby help meet the

nutritional needs of the world\'s population.

Just in closing, I\'d like to thank you again for

the opportunity to provide this testimony. I think it\'s

very important to note that we have the safest food supply

that humankind has ever witnesses. Moreover, we live in a

time when the greatest proportion of our population ever

has the luxury of dying of old age diseases. I think this

speaks volumes about the effectiveness of the agencies

responsible for assuring the safety and wholesomeness of

our food.

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If we can be of further assistance in the

future, feel free to call upon us. Thank you.

COMMISSIONER HOLSTON: Thank you, Dr. Baldwin.

\[Applause.\]

COMMISSIONER HOLSTON: I\'d like to thank all of

our panelists for their statements. And now I am going to

open the rest of this session to our FDA panel to pose

questions to our panelists. You may direct your questions

to any of them, as individuals, or to the entire panel.

Who would like to like to begin? Bob.

MR. LAKE: I would like to address this

question, I guess, basically to Dr. Regal. Although, if

anyone else wants to respond to it, that\'s okay, too.

I heard you express a lot of concern about

unexpected effects. I guess one of the questions I have

is to what extent are you concerned about those

bioengineered crops that are currently in the marketplace

versus to what extent are you worried about what might

happen in the future? If you could sort of elaborate on

that a little bit \...

DR. REGAL: You know, I have some concerns about

the present crops, but I\'m mostly concerned about the

future. Because the techniques are getting more and more

powerful and people are getting more and more ambitious.

They\'re putting more \-- you know, this is only the first

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generation of corn, and they\'ll take those same strains of

corn and engineer them over and over. Every time the

insects evolve resistance to the BT, they\'ll put something

else in, and then something else, and then something else.

And, so, we\'re going to see continual modification of

these and they\'ll be more ambitious putting in whole

segments of genes.

But I am concerned about the present food

supply. I\'m concerned about some of the, some of the

comments that I\'ve heard here.

You know, we\'ve been told that all of these

foods are thoroughly tested. And then we also have been

told that it would be too expensive to test all foods.

Now there\'s a contradiction there somewhere, it seems to

me. If they\'re all being thoroughly tested, then why is

it too expensive to do it?

We\'ve also heard that no one has been injured by

the presently genetically engineered foods. Well, how

could we possibly be know that if they\'re not labeled? I

mean, people are getting allergies and dying and getting

sick all the time. And if you don\'t know what you\'re

eating, there\'s no way to trace that. There\'s no way that

epidemiologists can work with that.

In the case of the L-Tryptophane, those batches

that showed danko produced could be traced, and so the

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problem could be stopped. But as things are presently,

there\'s no way an epidemiologist could ever give the kinds

of answers that we would like to have so that we could, we

can improve the process of genetic engineering into the

future.

Is that helpful?

MR. LAKE: Yes, it is. Thank you. I just

wondered if any of the other panelists wanted to comment

in particular about the existing food, as opposed to what

we might see in the future?

Co ahead.

DR. FAGAN: It seems to me that the problem of

traceability is a critical thing. Without that, there\'s

no way to \-- it would have to be an acutely toxic effect

to be able to identify a problem, or link a problem, to

one of the genetically modified crops that\'s in the

marketplace right now. When you\'ve got a product that

contains 5 percent soy, you may not see that for some

period of time, or it may be something you eat that you

don\'t even notice is in the product under normal

conditions, reading labels, and that sort of thing. So

there needs to be better traceability this way.

DR. HUTTNER: On the issue of whether or not the

foods should be thoroughly tested, I think one of the

perplexing problems is that the appropriate baseline is

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all food. It\'s food produced by other kinds of genetic

methods. And the fact is, because these foods have not

historically been tested for their safety, we lack that

baseline. And it\'s going to be fairly expensive to

develop it. If you decide to go in that route, that is

the data that you\'re going to have to collect. The

corollary to that is that moving in that direction would

definitely lead us to a profound difference in the way we

oversee food safety and the role of the federal government

in that. I think you need to take that into

consideration.

DR. HEFLE: I\'d like to make a comment to Dr.

Regal\'s comment on food allergies. We are not seeing the

prevalence of food allergies increasing at all, and there

are ways of determining it. For example, if a genetically

modified crop was suddenly responsible for a lot of

allergic reactions, there are ways of figuring that out.

We can figure that out. So that would be traceable.

DR. REGAL: I know you don\'t want a debate, but

I would like to point out that I have seen information

from England that the allergies to sooy beans have

increased 50 percent. And, you know, the article, the

editorial, in the New England Journal of Medicine that

warned about allergies in genetically engineered foods,

following the Brazil Nut episode, suggested it\'s not going

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to be as easy to test for some of these things as you\'re

indicating. So I think this worth a deeper discussion.

COMMISSIONER HOLSTON: And we would like to have

that discussion \--

DR. FAGAN: It should be pointed out \--

COMMISSIONER HOLSTON: \-- but not here.

\[Laughter.\]

DR. FAGAN: Can I just, can I just make one

fairly relevant point here?

COMMISSIONER HOLSTON: All right.

DR. FAGAN: That is that, as was pointed out

earlier, it should be possible to detect all these

allergens based on the regulations that the FDA now has.

But, in fact, if you look at the system, there\'s a huge

loophole as it now exists. It says that, if a novel

protein from a known allergen is used, or a gene from a

new allergen, if such a thing is used, it must be \-- you

must test for allergenicity. But if there is no history

of safe \-- history of use as a food, we have no evidence

as to whether it\'s allergenic or not. And according to

the current guidelines that you give to developers, they

actually are not required to assess that. Therefore, I

would say, since a large proportion of the genes that are

being put into foods today are from plants, or from

organisms that are not part of the food supply, we, in

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fact, have no way of assessing and no regulatory impetus

to assess the allergenicity of these things. This is a

big gap in whether it\'s mandatory or voluntary, as it now

is. At least that gap should be filled.

COMMISSIONER HOLSTON: Thank you. Panelists?

COMMISSIONER PLAISIER: I have a question.

COMMISSIONER HOLSTON: Melinda.

COMMISSIONER PLAISIER: This is for Dr. Baldwin.

Dr. Baldwin, I heard you say that animals fed

genetically modified feed may actually be safer for human

consumption than food animals not fed genetically modified

feed. Could you comment a little more about that, please?

DR. BALDWIN: Yeah. What I was, what I had on

my mind at that, on that issues, was: I worked for some

time on crops contaminated with microtoxins, apple toxins,

and the like. And insect damage causes a mold growth in

these, you know, in corn and cotton. And the microtoxins

that these molds make are, indeed, deadly materials. It

was my thought that, if the corn plant is protecting

itself, for example, and a corn bore infestation was

reduced, the mold growth would be reduced; and, as a

result, the danger of microtoxins would be reduced.

MS. COPP: I\'d like to direct this question to

Drs. Fagan and Regal.

One thing that the agency is engaged in, not

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only in this arena but others, is evaluating risk. And in

order to evaluate risk, we need to identify the things

presenting the risk. Now, Dr. Fagan, if I listened

correctly, you stated in your opening remarks that you

believe there\'s no consensus on safety. Which, at least

to me, suggests that there are scientists who believe

there are risks with food developed using this technology.

And I think, Dr. Regal, your \-- the underlying sense of

your presentation is that you also believe there are

risks.

I wonder if each of you could be more specific

about the particular risks are so that we could use that

to then evaluate whether appropriate questions are being

asked? So I really want to hear a little more

particularization of the risks presented by the use of

this technology to develop foods.

DR. REGAL: Well, some of the, some of the

questions that I have, that I\'ve raised about risk, and

would like to see answered, go back many years. The most

obvious one, I\'ve already mentioned; and that is: If you

disrupt biochemical pathways, can you produce new novel,

toxic compounds? And, of course, you can. I mean, they

evolve and plants are little biochemical factories that

are producing all sorts of nasty things to protect

themselves from viruses and fungi and insects, and so on.

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We pick the plants that have toxic compounds that are

toxic to insects and not to us, but those pathways can be

changed so that some of them are toxic to us. And we want

to make sure that that sort of toxicity doesn\'t occur.

I had a concern, for a long time, that vectors

were being developed, called \"enhanced vectors,\" that can

go into any kind of tissue because there are species

limitations for the vectors that are being used in many

cases. And those clearly could have carcinogenic

properties if they got into the human \-\-- into animals or

humans. So I think there should be limits placed on the

use of enhanced vectors.

Another problem I raised a long time ago was:

Genetically engineered plants are going to be used for

nonfoods. They\'ll be used to clone drugs and industrial

chemicals, and the pollen will blow into other fields.

And we are seeing that now. Of course, the pollen blows a

lot farther than the agronomists thought it would, or that

the genetic engineers thought it would. And you could

blow some nasty things into a corn field and we\'d end up

eating it, simply by contamination. So I asked for a

review of the seed purity standards 10 years ago, and I

was told it would be taken care of. It has not been taken

care of.

We\'ve talked about \-\-- I mean, I\'m sure you\'ve

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heard already about antibiotic resistance markers and

promoters that mutate, and that sort of thing. I think

actually some of the, some of the concerns that I have

have come up in the documents from FDA scientists

themselves that have been revealed during the discovery

process and the trial. So if you were to look at, if you

were to look at those court documents, you\'d find a lot of

the same concerns that I have some of your scientists also

had.

Well, let\'s see, I could \-- you know, we could

sit down and talk about it, if you like, but that\'s a

partial list, and, of course, allergies.

DR. FAGAN: Just to add a little bit to what Dr.

Regal has said, one of the points that Dr. Huttner brought

up was that the major \-- that risks associated with

genetic engineering are the same kinds of risks; and,

therefore, we don\'t have to do anything different than we

do with other foods. This is actually not a science-based

statement; this is a legalistic statement. It\'s based \--

it\'s really operating on the basis of precedent and not

science.

Yes, it\'s true. Allergens, toxins reduce

nutritional value, happen through other approaches, as

well. But, in fact, the processes of genetic engineering

are what we have to look at. And what we see is that the

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processes of genetic engineering in fact are more likely

to create unexpected, unintended side effects than the

conventional approaches. And this is because you\'re using

approaches that, in fact, disrupt the existing genome in a

random way. You have insertional mutagenesis every time

you put a piece of DNA into these things.

We heard, earlier, that you\'re putting in one

gene; and, therefore, it\'s not a problem. But the problem

underlying that is that that\'s not a surgically precise

process. You\'re putting it randomly into the genome.

Second of all, we don\'t know how that gene, once it\'s been

put in, is going to interact with the other genes, and how

the product is going to interact with the other

biochemicals, biomolecules of that organism.

So there are levels and levels of complexity,

interactions, unpredictability that no one, even with a

Ph.D. and 30 years of experience in plant science and

molecular biology, could be able to predict the outcomes

of those things. Without the ability to predict the

outcomes, we need to have a program for assessing the

outcomes in terms of safety. And that\'s not \-- that\'s

what is not in place now. We\'re saying: It looks like a

tomato; it smells like a tomato, and it\'s been made

through changing genetics. We\'ve been changing genetics

forever; and, therefore, there\'s nothing new here and we

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don\'t have to do anything other than look at and see that

it\'s a tomato. Look at gross things like how much

carbohydrate, how much fat is there.

Now, what if that tomato had a toxin gene, a

metabolic pathway induced unexpectedly due to the

introduction of a gene? There are tens of thousands of

metabolites that are produced in any tomato. And we

wouldn\'t have any idea which one of those has been altered

in its levels, which gene was altered, therefore giving

rise to that altered thing. And without knowing what it

is, we can\'t do the kinds of chemical tests,

chemically-based tests, that are now recommended by the

FDA. We can\'t choose which test to do. And the basic

principle in science is that you find what you\'re looking

for. If you don\'t do an assay for the toxin, or other

problem that\'s there, you can\'t detect it. Therefore,

what we need is to use biological testing systems,

long-term, short-term. Not only animal, if we need to do

that, but also human. Because, in fact, there are no

animal models that are appropriate and effective for

assessing allergenicity. There is not such a model, and

there\'s no chemical model that could be used. Therefore,

the only way we can assess the allergenicity of a novel

product of this sort is by doing human testing. If we

haven\'t\' done that, we haven\'t assured ourselves that

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novel allergens aren\'t present.

Now, let\'s look, just for a minute, at one

example of how this can happen.

The work that was done in the UK with potatoes,

a lectin gene was put into potatoes. Before that gene was

selected for use, years of research had been done showing

that, when you isolate that protein, that lectin, from its

natural source, it\'s not toxic to human beings.

Therefore, there should be no problem when you put it into

a potato. And we were working with a food that was not,

quote, \"toxic\" in an acute sense, either. So what they

did was to put a gene, a \"safe gene,\" into a safe food,

and they came up with a product that was, in fact,

hazardous to rats and, we assume, probably hazardous to

human beings, too.

So this illustrates that there\'s room in the

system for unpredicted side effects to come up. Given the

existence of those, how can we do anything other than do

testing that\'s broad enough to assess the full range of

unpredictable side effects? And, really, the only way to

cast a broad enough net to do that is to do biological

testing, where you\'re using the organism itself, and it\'s

biological processes as the detection system for these

things.

These are challenging experiments to do. They

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take longer than to do a lab test. But without that, we

are not protecting the American people. And because

what\'s done here in the U.S. is, in fact, legislated as

being the norm other places \-- what I mean by this is: In

many smaller countries they say: If the FDA has said this

is okay, the USFDA, then we\'re not going to do testing.

So, when you do testing here, you\'re testing for a large

portion of the world, developing countries that can\'t

afford to do this for themselves. We have a huge

responsibility here.

Thank you.

\[Applause.\]

MS. COPP: I just wondered whether any of the

other panelists \-- I did direct the question to the two

gentlemen \-- any of the other panelists wanted to respond?

Okay, Dr. Qualset, please.

DR. QUALSET: Thank you.

Sounds like we\'re engaged in biological warfare.

What I think we have to think about is that we are

producing products, the developers are producing, directed

towards solving some problem or making an improvement to

our food chain. And I think that the matter of testing

can be taken to an extreme, and you will never, never,

never rule out that there isn\'t another molecule in there

that you don\'t know about. And I think that baseline

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approach, as to our current status of food safety with a

particular product, needs to be the baseline and adjudge

our new products against that.

And I think that this matter of testing and

segregation issues need to be discussed. Let me give you

an example:

Wheat is a self-pollinating crop, grown widely

in the United States and throughout the world, and

arguable the most important food plant we have. It has

serious problems with diseases, one of which is leaf rust.

There\'s a gene called LR-31, which is a very good gene for

resistance to leaf rust. We can breed it into the

varieties easily. But what we need to do is isolate that

gene and be able to put it into varieties at will. In

other words, to combine it with other genes.

So, what I\'m saying is: We bred leaf-rust

resistant wheat with LR-31; and, if we now introduced that

gene to other varieties of wheat, we now have a

genetically modified organism, according to the discussion

here. And now we have to go through testing, ad nauseum,

to see that the gene has contributed anything new or

different. We have many ways to test the comparison of

the transgenic and the nontransgenic type of

LR-31-carrying plants, and we can verify that that is

going to be \-- not going to be an issue.

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So I think that the speakers downplayed the

value of the testing that we have now. I do think that

there is the baseline. The unpredictable things, I think

that, if someone has a trait that\'s going into the, into

the plant, that is really unknown to us there will be

sufficient, many more, tests done. More feeding trials

done, biological tests. We use flour beetles, for

example, to look at wheat flour quality where, if the

flower beetles die on eating wheat flour, why we got a

problem, right? Okay?

So we have plenty of, a lot of, opportunities

for testing. And I do think that we\'ll all go hungry

pretty soon if we\'re going to wait for every last possible

test to be conducted on any modified crop. And I haven\'t

heard yet that there\'s anything serious about any possible

problem with the current genetically modified crops. I

haven\'t heard an example that there\'s a problem. The

lectin in the potato, I think the research on that was

judged by scientists as a faulty research, for example. I

think that needs to be relooked at.

So I\'m just saying that we can\'t throw out the

baby with the bath water here. We got potential for a

great improvement in crops.

Just one more example. How many of you know

someone who can\'t eat wheat gluten, or wheat products,

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wheat flour? Any of you know people that are sealiac

(phonetic)?

\[No response.\]

That\'s the problem. That\'s a very important

crop, and we can\'t \-- a lot of people can\'t eat wheat.

They can\'t eat the gluten. Wouldn\'t it be good if we

could knock those genes out of that wheat so everybody

could have that wheat. Same with milk, and so forth. So

I think we\'ve got to look for the positives here. I\'m

confident on the testing, that we can develop sufficient

testing. Risk benefit, that\'s what we have to look at.

If the risk is very low, and the benefits very high, go

for it.

Thank you.

\[Applause.\]

COMMISSIONER HOLSTON: Thank you. Jim.

DR. MARYANSKI: Well, I think that I\'d like to

hear a little bit more about how one might explore these

unknown effects, in the sense that \-- I recall hearing a

lecture by Paul Berg a number of years ago, who, of

course, is a Nobel Prize Laureate. He was talking about

how the genome is very plastic. That the genes and

segments of genes move in the chromosome in a way that was

never thought to be the case. At one time, we thought

that chromosomes were this sort of string of beads that

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kind of stayed in one place unless there was a mutation.

And, of course, it was through the work of Dr. McClintock

in corn that are called transposons \-- or, in laymen\'s

language, jumping beans \-- were discovered.

I guess what I\'m sort of getting at is: What do

we know from plant breeding about changes and

rearrangements that occur in the chromosome during various

methods of genetic alteration? Do we see, are there

always cases where it\'s only the same gene? Or, when new

traits are brought in, do we see changes in the genome

that really represent, in some cases, new DNA, and,

therefore, newly expressed proteins? Is this very

different in terms, in kind, than what we see with

recombinant DNA techniques where there are, of course,

genes that come from different organisms introduced?

I guess I\'m somewhat confused in terms of what

really happens in plants? Because this is something that

we\'ve really thought about a lot in trying to understand

just how do the new techniques compare with the changes

that occur through other methods of breeding.

DR. QUALSET: Those new traits, new genes, genes

producing new traits, they may be done, as you pointed

out, at random within the genome. We don\'t know exactly

where they\'re going to be incorporated. But what we do do

is study the expression of that gene. And if it\'s

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expressed, then we know we have the gene incorporated into

the plant. Then we do several generations of testing. In

other words, self-pollinating, growing the progeny, and

growing the progeny, and what we need to find out, then,

is that trait stable. Is it reoccurring as predicted

every generation? And if it is, then it doesn\'t make any

difference, really, how it got there. And it also says

that it is not moving around. Because, if it\'s moving

around in the genome, we would have instability. We\'d

have altered segregation ratios, and there would be ways

to discover that.

So the first criteria are expression, and then

stability of expression through many plant generations.

And I think that\'s where we get the confidence that the

trait is working as planned.

Does somebody else want to \--

DR. REGAL: You know, there can be some

fundamental differences, and not all of them are going to

lead to safety problems. But it\'s important, I think, if

we\'re going to have a scientific discussion, to keep in

mind that there can be some fundamental differences. For

one thing, you\'re normally limited in plant breeding to

hybridization between members of the \-- where the whole

genetic network is familiar within a species, or within a

closely related species, closely related genera. And, so,

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there\'s some sort of coadaptation of these genes. That

involves things like regulatory systems that keep

everything in homeostasis. And when you take genes from

outside, there\'s the possibility of adding totally,

totally unfamiliar traffic, biochemical traffic, to the,

to the new organism. Some of that may not be recognized.

They may not recognize, oh, this is something that needs

to be regulated because it\'s so, it\'s so foreign.

So that\'s one thing. And, again, you know,

incorporating spider venom genes is obviously very

different from the sorts of things that normally have been

done.

Another difference is: We can only breed traits

that vary in a Mendelian fashion, or heterozygous traits.

And I use an example from mammals, because they are more

familiar to most of us.

You can breed for height and color and hair

texture and ear shape, and so on. You can\'t breed people

that have six eyes, or that have long backbones like

snakes, and so on and so forth. A great deal of the

genetics of an organism, a lot of the basic biology, are

fixed. They\'re genetic, but they\'re fixed and you can\'t

get your hands on that with traditional breeding. You can

mess it up with mutations, but you can\'t get your hands on

it. Now, with genetic engineering, there\'s the

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possibility of going in to fundamental parts of the genome

that normally have normally been closed off to us and

altering those. And we have so little experience with

that, virtually none, that this is possibly one reason

that it seems like we\'re dealing with the unknown in many

of these bizarre cases like, like the salmon that are

expressing growth hormones in their livers. You couldn\'t

breed that, I don\'t think. Well, nobody has tried,

but \...

Another way in which they\'re different is that

traditional breeding generally involves trading off

characteristics. In other words, you got to trade off

some wild-type traits in order to get some new traits in.

Because there are only so many sites on the chromosome

where genes can sit. And, generally, when you do that,

you weaken the plant because you\'re trading off the wild

traits. And, so, corn is not going to compete with wild

relative, for example. With genetic engineering, you can

keep some very potent biological systems in place and

still add new traits. Then the question is: How can

those be disturbed? So that\'s another difference. It\'s

pretty fundamental.

Another difference is that, normally in

breeding, you\'re not introducing these vectors. In some

cases, it could be enhanced. You\'re not introducing these

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markers, which could be \-- which could confer antibiotic

resistance. And you\'re not introducing new types of

promoters, which could have their own effects, as well.

So there are, there are several big differences

there. And I think that has to be our starting point

instead of just saying, well, it\'s just like moving genes

around.

You know, I\'m going to take another example that

maybe is easy to relate to. You could say, well, we\'ve

been moving mail around; we\'ve been moving information

around for years. But the internet produces new types,

new ways, of moving information around. It\'s going to

change society. You can say we\'ve been moving money

around for years, but it depends on how you move the money

around. If you\'re moving the money around electronically

with computers, it can be very different from an armored

car, or normal banking procedures. And, if you\'re moving

money around in campaign contributions, reading in the New

York Times Sunday, moving money around in campaign

contributions can be very different from moving it around

in ways that help people to build houses. So it depends

an awful lot on the context.

MS. COPP: Dr. Huttner.

DR. HUTTNER: What\'s clear, scientifically, is

when you move genes around, whether between sexually

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compatible species, or unrelated species, once they\'re in

the new cell, they\'re subjected to the same biochemical

processes of genetics that they had been when they were in

the original donor cell. There\'s no difference there.

And, in fact, plant breeders have, for a very long time,

encountered unexpected and unwanted outcomes using

traditional breeding techniques. Often metabolic

processes were introduced that they didn\'t want, or they

disrupted metabolic processes that they did want. What

Professor Qualset said, very clearly, is that, through

that experience, they\'ve developed extensive systems to

evaluate these plants over time and to eliminate those

that have traits, or metabolic changes, that are not

beneficial. That same system can be applied to the new

genetically engineered plant.

In addition to that, the Food and Drug

Administration\'s 1992 Policy has added another safeguard.

And that\'s if you introduce something into a food that

does not have a history of safe use, it\'s going to be very

stringently regulated as if it was a chemical food

additive. That\'s important to recognize. It\'s not as if

we have no safeguards for dealing with these novel kinds

of combinations that can be made.

COMMISSIONER HOLSTON: Is there anyone on the

panel that would like to respond?

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DR. QUALSET: Yes.

COMMISSIONER HOLSTON: Dr. Qualset.

DR. QUALSET: One quick comment basically

supporting what Susanne has said. That the hypothetical

and real situations, that Dr. Regal points out, those are

the first steps. You see those at the first step in the

laboratory where you see unusual biochemistry, for

example, or morphology. Those aren\'t the things that are

going out to the public. Those are the first steps. We

only take things further and further when they have what

seems to be useful and meeting our targeted goals. So we

will never understand all the biology of mutant forms and

gross things that happen.

I\'m saying we have to remember we\'re moving out

to the consumer. We\'re moving from the lab to testing out

in the field, and we\'re only working with those things

that seem to be beneficial. If there is serious

disruption in the physiology and metabolism, that will be

known, be shown, as a defect. And we will find it, then,

as low yielding, or some defect, and it will disgarded.

When I was breeding wheat plants, we grew

100,000 lines a year. We saved four or five that really

made it. You know, so we\'re in traditional breeding there

is a huge amount of selection for those that don\'t meet up

to the standards. So there\'s just another angle.

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COMMISSIONER HOLSTON: Dr. Fagan.

DR. FAGAN: Just a couple comments.

Dr. Qualset just said that, if there is a

serious disruption, you\'ll know it. My question to him

is: How? Are you going to use X-ray vision, or \-- what?

You can\'t tell if a new toxin has been generated.

Another point that I think needs to be corrected

scientifically is that Dr. Huttner said that, when you put

\-- once you get a gene in, it\'s going to be subjected to

the same biochemical processes that were there in the

original organism. Now that\'s completely inaccurate

because even different cells in an organism will have

different regulatory proteins that interact with the gene

so that that gene, present in a liver cell, will function

very differently from a brain cell. Similarly, you take a

gene from agrobacterium, and you put it into a soy bean

plant, and the regulatory proteins that are present are

going to be a completely different spectrum. There\'s no

way to predict what kinds of interactions will be there.

A sequence that might have no regulatory function in the

agrobacterium might happen to be present in that gene when

it\'s put into soy, and there could be a protein present

that could interact with it to cause something completely

unexpected: rearrangements, increased, decreased

expression, a whole range of things.

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I spent 20 years doing that kind of work. I

know the range of unpredictability that can come up when

you put a new gene in a new genetic background. It

happens everyday.

DR. QUALSET: But, still, at the end, you don\'t

keep the thing that isn\'t working.

DR. FAGAN: The question is: How do you know if

it\'s working or not.

COMMISSIONER HOLSTON: Okay.

DR. FAGAN: You can look at see if it grows

faster, or if it\'s resistant to \--

COMMISSIONER HOLSTON: I\'m afraid I\'m going to

have to stop the debate.

DR. FAGAN: How would you know if you haven\'t

done the test.

COMMISSIONER HOLSTON: Are there other members

of the panel who have questions? Dr. Mitchell.

DR. MITCHELL: Yes. It\'s the same line of

questioning. I\'d like to ask Dr. Regal if he could

characterize tests, or a series of tests, that would

satisfy the concerns that you\'re describing. We heard Dr.

Fagan describe one that sounds a lot like the testing

model for industrial chemicals. What do you have in mind?

DR. REGAL: You know, really, it wouldn\'t be my

field. That\'s a highly technical field, how you test

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toxicologically, and so on. What I want to see are

scientists who can discuss these issues in depth, and who

are not simply defending the industry, who are aware of

what the problems are, and who are working on \--

\[Applause.\]

COMMISSIONER HOLSTON: Excuse me. Could we

please allow the speaker to speak.

DR. REGAL: I want to see a literature that

moves forward, that discusses these and moves forward,

instead of, you know, trying to whitewash things. I want

to see research programs that we all are involved in

working out and push us toward better and better tests.

That\'s what I want to see. I\'m not \-- I can\'t give you a

quick answer about this test or that test. These things,

they require a lot of thought and discussion.

COMMISSIONER HOLSTON: Panelists?

DR. MARYANSKI: I guess one of the things I

wonder about is how we will \-- you know, we are always

looking for ways to improve the kind of testing the

companies do. In fact, I suspect the companies would like

that, too.

It\'s a little puzzling when we think about these

unexpected effects, or long-term effects, in terms of

food. If we think about what are the effects that are

generated by simply consuming a particular food over the

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course of one\'s lifetime, what do we know about that?

In other words, for any of the testing that we

do, we have to have something to compare. And, so, when

we start asking the questions about familiarity with

proteins, or toxins in the food, or vitamins, we have to

have some baseline. And I think that I wonder about how

we will be able to understand information that is

generated and be able to interpret it given what our

current state of knowledge is about foods generally and

effects on, for example, the nervous system, immune

system, and so forth, of any particular food. How we will

we \-- what kind of ways are there to approach that?

DR. FAGAN: I could get us started.

Let\'s \-- I think what you\'re getting at, Dr.

Maryanski, is the challenges of evaluating foods when we

don\'t really have existing paradigms for doing the tests.

The early studies, with the Flavr Savr Tomato, and some of

these things, tried to use classical toxicological

approaches, where you give very large doses to accelerate

the appearance of harmful effects. But because, with

foods, you have such a range of products there, or of

materials there, you ended up with toxicological effects

from things other than the elements in the food that you

were interested in. So, obviously, we can\'t use the

classical toxicological approach. But there are

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approaches that can be developed, and this is the kind of

research that Dr. Regal was talking about, that we need to

develop these models.

Let me suggest a model that might work.

The GMOs that are developed here in the U.S. are

going all over the world. When genetically modified cry9C

containing protein, corn, goes to South Africa, it won\'t

be just a little part of the people\'s diet. When it goes

into Soweto or into Alexander, or some of these other

townships, it will be the major portion of the people\'s

diet. That means 80 to 90 percent of the diet will be

corn. That\'s how it is in those places. They\'re

essentially on a mono diet: 80 percent of the diet is

corn. Now, they get a little veggies and a little other

things with it, but that\'s what they eat.

Why not set up a model where we take that as a

worse-case scenario, and let\'s feed people these materials

for a period of time, where, you know, they still have 20,

15 - 20 percent of their diet to cover the protein, the

vitamins, the other things that they need so there won\'t

be malnutrition problems; but, yet, they\'ll have a higher

level of exposure to the material of interest. Put them

on that diet for awhile. Have to pay them quite a lot to

do that, I think. But you would learn some things. And

we then could really stand behind our claim that, if it\'s

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been tested by the U.S. Food and Drug Administration, and

okay-ed by them, it\'s safe for South Africa, and it\'s safe

for Indonesia, and it\'s safe for the Philippines. That

would be a start.

COMMISSIONER HOLSTON: Are there any other

responses from the panel?

\[No response.\]

All right. Melinda.

COMMISSIONER PLAISIER: One of the things I

think it seems we\'ve have heard in some of the other

forums, and I also heard this morning, was a need for

greater transparency and information to consumers and the

general public. And I\'d like to direct this, first, to

Dr. Huttner, and, then, of course, anyone else who would

like to respond.

One of the points I heard you make, Dr. Huttner,

was that we have real polarization of views on this issue;

and, then, in between, we\'ve got an information gap. And

I heard you also say that FDA has an important role that

we can play. I\'d like you to talk in the context of

safety. I mean, obviously, this is a question relevant to

the labeling, which we\'ll be doing late this afternoon,

but in the context of safety review, what role do you

think the FDA has to play? How can we help fill that gap?

What do you think we can do?

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DR. HUTTNER: The most important thing is to

help people overcome the sense that this technology and

these products are unlike anything that they\'ve ever seen

before; and, so, they have no means, through their own

experience, to judge safety issues. So, as has often been

characterized in the press, their being used as guinea

pigs, or at least they feel like their being used as

guinea pigs. We have to empower them to be able to

consider these issues of genetic modification of food.

And the first step is to help them understand that genetic

modification of food has had a very long history, and that

each of us does have a good deal of experience with

genetically modified foods.

We also need to explain to them what roles

non-government organizations have played, especially in

the private sector, in determining the safety of products

before they get to the marketplace; and, then, what role

the federal agencies have in enforcing the Food, Drug and

Cosmetic Act should a food safety problem arise. I think

that that\'s important fundamental information that they

need before they start to address biotechnology foods.

Now this is something that\'s not going to be a

simple undertaking for the Food and Drug Administration.

But I encourage you to take it seriously because as

Gaskell, et al, found in their paper that was published in

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Science Magazine in July, this past summer, that was

looking at the attitudes of American and European

consumers, U.S. consumers have remarkably confidence in

your agency. You\'re in a position of influence. I think

that it\'s a wonderful opportunity for you to provide

information to them, sound and accurate information on the

issues.

Now, after telling you that I think it\'s your

job, I\'ll say that we\'re willing and happy at the

University of California to help you in any way that we

can. We have a number of outstanding biotechnology

programs that have, at their core, public education

efforts. One in particular is at UC-Davis, run by Martina

McGloughlin, who is here today. Another is overseen by

Peggy Lemaux, who is the cooperative extension specialist

for biotechnology in California and has access to all the

farm advisers and home economists in the entire state of

California, and can provide you an excellent model for

communication to people out in communities, who are

influential and trusted and excellent communicators, to

allow you to get tremendous amplification. So we\'d like

to work with you.

We also have organizations that interface with

the private sector, like the Bay Area Bio Science Center.

Dr. Sue Markland Day is here today. All of these

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organizations in California could help you develop a model

for communication. We could help you to work with the

community, as we have in the past, to try to understand

what they\'re information needs are so we just don\'t send

things out and assume that it answers their questions.

First, we ask them first what they want; and, then, try to

best address those issues. Then, maybe after testing the

water out here, you might have a model that you could use

nationally.

\[Applause.\]

COMMISSIONER HOLSTON: Do we have anymore

questions from our panel here?

MR. LAKE: I have one more.

COMMISSIONER HOLSTON: All right.

MR. LAKE: I\'d like to address a question to Dr.

Hefle.

One of the consistent concerns that we heard in

the hearing to this point really is about the potential

for unexpected allergens. So I\'d like to probe your

expertise a little bit in that area.

One of the concerns that we\'ve heard is that

there is the potential for something that is not now a

known allergen to show up, you know, in some future

product that might cause allergies. Do you have any

thoughts on anything that we could or should do in the

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future that might lessen the likelihood of that?

DR. HEFLE: I think, right now, we\'re doing the

best we can do. Everyday, we eat new foods that our

bodies haven\'t seen before, especially with this \-- the

food producers exporting to the world, we\'re eating foods

we never ate before. Early in the \'80s, before we

imported a lot of kiwis, or grew them ourselves in the

United States, there were no reports of allergy in the

literature in the United States to kiwi. But we imported

it and started eating it and, sure enough, people became

allergic to kiwi. Now, should we regulate kiwi like we

regulate genetically modified organisms? So we\'re eating

new proteins everyday.

I think the assessment that\'s in place for

proteins that have no allergenic history is appropriate

and the best we can do right now with the knowledge that

we have. We\'re learning new things everyday. The

developers do do giant comparisons of these proteins that

they\'re using with any known toxin or allergen that\'s in

the literature to date, up to date. They\'re updating

these everyday. And we do the digestibility studies,

also.

Now I think that\'s the best we can do right now.

It\'s very difficult to assess something that\'s going to

become an allergen. We just don\'t know until it does.

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People are very individualistic. You may have an allergy

and someone else doesn\'t. There\'s a lot of issues there.

So I think, right now, I don\'t know of any

technology that would help us, or any testing that would

help us, additionally predict these things. If a

validated animal model would become available \-- and there

is promising research along these lines \-- it must be a

validated animal model, however, that would assist in the

prediction of possible allergenicity. That\'s the only

technology that I\'m aware now that holds promise for

helping with that issue.

I am still confident in that, I mean, all of the

crops, right now, have no allergenic concerns with them.

These were novel proteins that do not have allergenic

history. I think that speaks for itself right there. We

have no increased allergy concerns.

COMMISSIONER HOLSTON: Dr. Regal.

DR. REGAL: Can I make a comment? This is

obviously a really difficult problem. But I just want to

make a comment.

I\'m not comfortable with comparing these

genetically engineered organisms to kiwis. If you\'ve ever

struggles with allergies yourself, you know, you find a

food that you can eat, and you find \-- you know that you

can avoid other things. So suppose you\'ve found that you

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can eat corn, you know. Well, you\'d never suspect, if

suddenly you\'re allergic to corn, one batch of corn and

not another batch, you can\'t control yourself. You can\'t

control your life anymore. And that\'s very different from

finding that some exotic fruit from China is something

you\'re allergic to it because it\'s basically hidden in the

food, a food that you thought was perfectly safe before.

And, so, imagine the agony a person would go through, who

has allergies, trying to figure out what the source of

their problem is.

So I\'m not quite comfortable with that problem.

But I, you know, it\'s a difficult issue, and maybe they

are \-- you know, they\'re working at it.

COMMISSIONER HOLSTON: Thank you.

Any other panelist? Jim.

DR. MARYANSKI: Thank you, Sharon.

I\'d just like to follow-up because, with the

example of kiwi, of course, you\'re eating a fruit. You

got a whole food there. You\'re essentially exposed to a

lot of protein. I know that, you know, there isn\'t hard

and fast rules we can make about food allergy in any area.

But it seems to me there might be a difference between the

kinds of foods that are being produced where, at this

point of the technology, the substance is an enzyme. It

is present at very low levels of the food.

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I would just like to hear from Dr. Hefle, and

others, whether in fact that is something that the

experts, who are knowledgeable about food allergies, think

that\'s something that\'s important or not important?

DR. HEFLE: Yeah. We think that exposure levels

are important. There are threshold levels for food

allergens. Unfortunately, we don\'t know what those

numbers are. We know that it\'s not zero, that there is

subclinical \-- someone can eat something and there\'s a

subclinical thresholds.

So expression level is very important, and it\'s

my understanding that most of the products on the market

today have very low levels of expressed protein in them,

or the proteins are expressed in a different part of the

plant than is actually eaten by the consumer. So exposure

level is something that\'s important. Exposure levels,

when people become allergic to foods, they\'re usually

exposed at very high levels for a significant amount of

time. That\'s for the classic food allergies, like peanut

and soy bean, and things like that.

So expression levels are important to us. We do

look at that. These are expressed right now in the

products we have at very low levels. I would not

anticipate that they would cause a problem at the levels

that are produced now.

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COMMISSIONER HOLSTON: I\'m looking at my panel,

and I\'m seeing if anyone has any other questions?

\[No response.\]

If not, I would like to say, first of all, this

first session has been as stimulating as we had hoped it

would be. And I want to thank all of our invited

panelists for your very thoughtful comments. These are

certainly not easy issues, but the Food and Drug

Administration very much appreciates the input that we\'ve

heard this morning, as we try to grapple with these issues

from this point forward. We had hoped to hear a variety

of views and you certainly didn\'t disappoint us in that

regard. And we are going to consider your views with the

ones that we also heard in Chicago and the ones we heard

in Washington, D. C., and, with the other information that

is going to be submitted for the public docket.

We are now going to break for lunch. After

lunch, we will be discussing labeling and other issues.

We have an hour for lunch; but, since we\'re just about

five minutes early, we will stick to our original

schedule, and that is: We will reconvene and start the

next part of our session promptly at 1:00 o\'clock.

Thank you very much.

(Whereupon, at 11:55 a.m., the meeting was

adjourned, to reconvene at 1:00 p.m.)

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A F T E R N O O N S E S S I O N

1:00 p.m.

COMMISSIONER HOLSTON: All right, everybody. We

are at the time for starting the next part of our program.

I want to thank those of you who are here for returning

promptly so that we can get underway and have as much time

as possible for the presentations later on in the

afternoon.

To begin this session, Bob Lake, who heads our

Office of Regulations and Policy, for the Center for Food

Safety and Applied Nutrition, is going to describe FDA\'s

current policy on labeling and public information related

to bioengineered food.

Bob.

SESSION 3

FDA POLICY: LABELING

MR. LAKE: I will not take nearly as long as my

colleague this morning. He had to be more thorough

because he had more technical stuff to do, and I just

wanted to show two slides, actually.

One of the things that Dr. Maryanski didn\'t

mention this morning, that he asked me to mention right up

front, is that all of the information that we receive on

safety is publicly available information. It\'s available

under the Freedom of Information Act. We are thinking

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about making it available in a more user-friendly sort of

way.

That\'s part of what we\'ll be talking about,

hopefully, in this afternoon\'s session, which is: Making

information available, either through labeling or other

means. Part of that is how, you know, input from you on

how FDA can processes more transparent, and make the

information that we have more readily available.

The issue of food labeling, which we know is a

topic of great interest to many of you, and many others,

is like safety, governed by the Food, Drug and Cosmetic

Act. The Act basically says that labels on foods, label

statements, cannot be misleading, cannot be either false

or misleading. So that\'s the overall guiding principle.

Now the Act does require a number of different

kinds of additional information, by statute and by

regulation, including ingredient statements, the

nutritional labeling panel that we implemented at the

beginning of this decade.

Also, a very basic thing that has always been

required on the label of a food is its common or usual

name. Simply, you know, put, it\'s, you know, identifying

what the food is. And that actually gets into one element

of existing labeling policy.

As Dr. Maryanski pointed out this morning, foods

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that have been modified to the point that it is really no

longer appropriate to call them by their traditional name

can be required to bear a modified name to identify those

foods. And the modified soy that he mentioned is such a

food. We\'ve done that a couple of times with regard to

the identity statement. And that\'s one component of

existing FDA labeling policy.

The Act also permits FDA to make other

requirements if there is a fact, a material fact. Well,

the material fact has to be either related to other

representations on the food label, or consequences of use.

And it\'s really this area of consequences of use that is

the part that is perhaps of greatest focus in the

discussions we\'re having here.

Also, the thing I would emphasize, the statute

does permit voluntary labeling, determined by those who do

the labels, so long as the information is truthful and not

misleading.

Next slide, please.

Now the other thing that we would like to hear

something about today is not just labeling, but other

means of making information available to the public. The

World Wide Web, 1-800 numbers, are a couple of ideas that

have come to mind. But we also would be interested if

anyone has other possible suggestions about ways of making

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information available. And, of course, these are not

mutually exclusive. They can be used in combination, but

we would be interested in thoughts either from our panel

or from the speakers we have this afternoon on that.

So, with that, I\'m going to stop and we\'ll get

on with this afternoon\'s panel.

Thank you very much.

\[Applause.\]

COMMISSIONER HOLSTON: Okay. Thank you very

much, Bob.

SESSION 4

PUBLIC INFORMATION AND LABELING

COMMISSIONER HOLSTON: I will now turn the floor

over to our panel on Public Information and Labeling.

Again, I will ask each member of the panel to give brief

opening remarks, and then discussion will follow among the

panel members, with questions from our FDA panel.

First, let me review the questions that we have

presented to our second panel:

No. 1 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 applies? Have these

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policies, regarding the labeling of these foods, served

the public?

No. 2 Should additional information be made

available to the public about foods derived from

bioengineered plants? If so, what information? Who

should be responsible for communicating such information?

No. 3 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?

I would know like to introduce the panelists for

our second discussion.

Dr. Thomas Hoban is a professor with the

Department of Sociology and Anthropology at North Carolina

State University.

Andrew Kimbrell is the Executive Director of the

International Center for Technology Assessment.

Dr. Rhona Applebaum is Executive Vice President,

Scientific and Regulatory Affairs, for the National Food

Processors Association.

Susan Haeger is the Chief Executive Officer and

President of Citizens for Health.

Diane Joy Goodman is with the Farm Box Project

Consulting Group.

And David Bossman is the President/Treasurer and

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Chief Executive Officer with the American Feed Industries

Association.

So, without further ado, I would now like to

invite Dr. Hoban to open to open this panel.

Dr. Hoban, please.

PANEL DISCUSSION

DR. HOBAN: Well, thank you very much. Is this

mic \-- it sounds like it\'s on. Very good.

Well, I am Thomas Hoban, as you heard, and I\'ve

been studying the consumer perceptions, consumer

knowledge, about biotechnology for the past decade. And I

want to commend the FDA for holding these meetings. I was

fortunate to have a chance to give a short, two-minute

presentation in Washington, and glad you\'ve invited me

back to hear a longer version of it.

Well, as you\'re certainly aware \-- and all you

had to do was to go outside and take a look \-- supporters

and critics of biotechnology are really clamoring to draw

attention to their positions. The consumer, however,

should be your most important consideration.

Those who claim to speak for the consumers

sometimes may not, in fact, will be serving in their true

interest. Because, despite rhetoric claiming the

consumers want all products of biotechnology labeled,

research really reveals some different consumer views on

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this particular topic.

To talk about labeling issues briefly, labeling

questions on surveys are very complex and very ambiguous.

What I conclude from my own research and all the other

surveys that I\'ve reviewed is that how questions are asked

directly effects how consumers respond. Let me highlight

this complexity with two basic examples:

On one hand, opinion polls do indicate that a

majority of consumers feel foods developed through

biotechnology should be labeled. However, almost as many

want to know the country of origin for the food. In fact,

an even much larger percentage feel that food labels

should explain which pesticides were used in the

production of the food. So it\'s very hard to set

priorities for limited label space when everything is very

important to everybody.

A more realistic approach to take is to provide

a meaningful context to elicit consumer views. In

research that I developed with the Interantional Food

Information Council, also known as IFIC, a question

described the current FDA policy, which was, in fact, not

the to label foods developed through biotechnology that

are basically identical to traditional foods. We\'d

explained the cases in which they would be labeled. And,

in fact, when that survey was done three times over the

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last two years, consistently find approximately

three-quarters of the U.S. consumer say they support the

current FDA policy. So, clearly, it\'s a little bit

different, probably 180 degrees different, from some of

the other surveys.

Well, as a survey specialist, somebody who has

been doing this for over 15 years, I hate to admit it, but

sometimes we do ask people to answer questions

spontaneously over the phone when they\'ve not thought

much, if at all, about the topic. So such results, as

telephone surveys alone, do not provide a sufficient basis

for important public policy decisions. It\'s much more

valid to use focus groups, or other techniques, that tend

to engage consumers in much more thoughtful dialogue.

Let me quickly emphasize and summarize some of

the findings from focus groups that I\'ve done myself for

USDA, as well as others, that I witnessed and reviewed.

One of the first things we learn is that the

consumers really expect the label only if the food has

been changed in some significant way. We explore that

example with the case of the widely used cheese

ingredient, which was mentioned this morning, caymosin,

developed through biotechnology, which, as you know, has

been in cheese production for almost a decade.

Most of the consumers we interviewed felt there

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was no need for special labels, since, in fact, the cheese

was no different in taste, nutrition, or safety. And, in

fact, if you look at the cheese packages that are

available there is no special designation of it being from

products of biotechnology.

The other thing we found that was quite

important is that consumers see much less need for labels

on processed foods then they do on the fresh food or

vegetable. We used tomatoes as an example here, and

people would say that the Flavr Savr Tomato \-- that was

the model we used \-- would be probably beneficial to know

about, because they perceived there to be some beneficial

difference to it. But few even recognized that food

processors typically blend together different tomato

varieties to get the desired taste of consistency for

ketchup, or for frozen pizza. In fact, most consumers we

talked to did not particularly care how the ingredients in

processed foods were developed.

The next point we found was that most consumers

do not want to pay higher costs for food in order to have

the testing, or to keep the commodity segregated, as we

heard about this morning.

So care must be taken with any initiative about

labeling because cost will ultimately be involved, and

would ultimately be passed on to consumers, which would

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also impose difficulties, logistically, on all parts of

the food-value chain from the farm to the table.

But, finally, I think, more importantly, when we

look at what consumers mainly use labels for \-- and this

research has been reviewed by USDA and a number of others

\-- we find that people mainly look at labels for fat

content, sugar content, salt content. Those items that

are of most concern to them from a health, from a

nutritional standpoint. That was the basis for your food

facts labels, and so on. So I think you\'ve got a good

precedent there.

Many consumers, in fact, expressed a lot of

frustration with conflicting information that they read in

the media and elsewhere. They seem overwhelmed almost by

the variety of food already available. Most consumers, in

light of this, tells us their scarcest resource is time,

and complex labeling, related to biotechnology, would

significantly increase the time and mental energy that a

consumer must spend shopping for food.

Well, over the past decade, my research, as well

as a lot of that conducted by others, have found a clear

majority of U.S. consumers are quite positive and remain

quite positive about biotechnology.

We also recognize, though, that a number of

people have unanswered questions. So one effective way to

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allow for informed choice would be to have a system of

voluntary labeling for foods not produced through

biotechnology. In that case, if the demand is real, the

market will become viable, as it seems to be happening now

with organic foods. In fact, it\'s, I think, a very good

position to put biotech-free foods in the category with

organic foods. In this case, a meaningful choice can be

provided to concerned consumers without imposing cost on

or denying benefits to the majority of consumers who

remain positive about biotechnology.

We clearly need more directed research to

determine what consumers truly expect and need on a food

label. It will also be vitally important to test

alternative wording, to look at the placement of the

information, to find out that it\'s truthful and not

misleading.

I do want to address the second point that the

committee is interested in hearing about, and that\'s the

education and information issues.

One way or another, education is vital for

consumer choice; but labeling is not the same thing as

education. Consumers truly want and they truly deserve

more information about biotechnology. In fact, without a

major commitment to education, any form of labeling

initiative will likely do nothing but confuse and alarm

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most consumers. So let me quickly outline an effective

education program.

One of the first questions you want to know is

what the consumers want to know. We\'ve done this in many

focus groups and surveys over the years. One of the first

things they\'re interested in learning about is why is

biotechnology being used? What are the benefits? What\'s

in it for the consumer?

Next, they want an assurance that the products

have been certified as safe by an agency, such as your

own.

Finally, they\'re genuinely curious about it.

They really don\'t understand much about it and would like

to learn more about the topic.

Well, who should provide them with this

information? Any educational program would require an

ongoing partnership among government, industry, consumer

groups, universities, and others. U.S. consumers have

consistently told us that their greatest trust in

information is from third-party groups, university

scientists, and even your own agency. The nation\'s

land-grant universities, I might put out, and cooperative

extension programs are also ready and eager to help in

this educational effort.

Finally, how should we provide consumers with

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the information they want about biotechnology? Toll free

numbers, internet sites hosted by third parties, those are

all viable alternatives, good ideas, as would be in-store

brochures, and so on. In fact, the FDA, or another group,

should maintain an information clearing house that

describes the products of biotechnology that have been

approved, including where those ingredients might be

found.

A quick final point here is as the FDA

considered the complex issues associated with

biotechnology, please keep in mind the real consumer

interest when it comes to food. Again, surveys that have

been done over the past 20 years have consistently shown

that consumers want their food to be tasty, affordable,

safe, nutritious and convenient, in that order. How seeds

and other ingredients are produced is very, very low on

the list, if it even appears at all, and will likely not

be an issue for the vast majority of consumers. Providing

the variety of safe and affordable food that the U.S.

consumers have come to expect, while feeding a world

population, will require ongoing development and adoption

of new technologies. The continued application of

science-based regulation will insure safety and real

benefits for consumers.

So I conclude that maintaining the current

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policy of FDA is in the best interest of the majority of

U.S. consumers.

Thank you very much.

COMMISSIONER HOLSTON: Thank you, Dr. Hoban.

\[Applause.\]

Now, Mr. Kimbrell.

MR. KIMBRELL: Thank you very much.

I am director of the International Center for

Technology Assessment, as well as the Center for Food

Safety, and one of the counsels of record for the lawsuit

that was filed against the FDA in May 1998 demanding the

testing and labeling of genetically engineered foods.

And, by the way, which is currently pending. Final

briefing was over in July. FDA inviting me here shows a

welcome and refreshing masochistic tendency on the part of

the agency, and I respect that.

I think, at first, I have to note, with all due

respect to Ms. Holston and Dr. Maryanski, that a very

crucial element to public information was missing from

this morning\'s otherwise interesting presentation, which

is: This is not the first time that the public has been

asked about how it feels about the testing and labeling of

genetically engineered foods. As a matter of fact, when

the 1992 policy was first published in the Federal

Register Notice, comment was solicited. Thousands of

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people responded. Many of the scientists you\'ve heard

from today, and in the other two meetings, responded.

Nobel Prize Laureates, health professionals, consumers by

the thousands.

The results \-- and these are FDA\'s results, not

mine; this is something we got through discovery in the

lawsuit \-- 80 percent, 80 percent, favored labeling and

safety testing; 2 percent, 2 percent, favored the FDA

policy. Two percent. Not surprisingly, and in my view in

gross violation of the Administrative Procedure Act, the

FDA never responded, never responded at all to those

comments. Never responded. No public information went

out. FDA decided to do what it had to do in private.

In 1993, the beginning of the Clinton

Administration, another federal notice went out asking for

comments very much like the questions we\'re being asked

today, all these years later. Thousands of us bothered to

comment, again, the scientists, professionals, many of

whom you\'ve heard in the last 3 meetings. Once again,

absolute silence from the FDA. No response whatsoever.

So I find it alarming and I find it scandalous

that we find ourselves here, all these years later, now

that these foods are being consumed by millions of

Americans, ten of millions of acres being planted by these

foods, and we can still have a session, like we had this

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morning, where there is basic scientific conflict I think

on both sides, probably well-reasoned and in good faith,

on whether this food is even safe. Because of the refusal

of FDA in timely fashion to obey the law and respond to

the public, that food has been released on the public.

And the anger you see outside, FDA has no one to blame but

themselves, for the actions that they did.

Now Dr. Huttner, and others, have talked about

the regulatory regime at FDA that will insure safety.

That people\'s concerns about labeling are unfounded. I

think it\'s very important to understand what FDA\'s real

position is. This is their position in court on exactly

what we have with genetic engineering. What do we have?

We have a regulation. Do we have something that is

binding? Is it going to insure anything? I will quote

directly. This is FDA\'a direct position \-- all right? \--

that they wrote in their brief before a federal court.

\"The 1992 policy statement creates no binding

norms of any kind, nor does it make any

dispositive scientific findings.\"

No binding norms, no dispositive scientific

findings of any sort. So this is extraordinary that we

find ourselves in this hearing, this discussion \-- I

should say; it\'s not a formal hearing, not pursuant to any

Federal Register Notice this time. All these years later,

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what we have regulating genetically engineered food is a

nonbinding policy that has made no scientific findings of

any sort.

So, please, I don\'t want to hear about a policy

based on sound science. I don\'t want to hear about a

policy based on sound regulation when this agency has gone

before a federal court and stated that there is no binding

regulations and that there are no dispositive scientific

findings.

Now as to the issue of labeling. Labeling is

actually \-- and I thought it was well summarized by \-- is

it Dr. Lake? I don\'t want to mis \--

MR. LAKE: Mr. Lake.

MR. KIMBRELL: Mr. Lake, okay, I thought

actually had summarized it quite well. The issue here is:

Are the changes that genetic engineering accomplishes in

food, are they material? All right? This is the key

legal issue. Material fact is defined in the legislative

history as what a reasonable person would expect to know

about the food that they are purchasing. What a

reasonable person would expect to know. All right?

The FDA, Dr. Maryanski, have decided that all

those 80 percent, and all the polls \-- and with all due

respect to Dr. Hoban, I think we\'re getting 95 percent of

polls saying that they want the foods labeled; that\'s what

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the people want \-- they are saying that\'s unreasonable

because these foods are essentially the same. All right?

The substantial equivalence. Why would you want to label

something that\'s the same? That\'s the argument, right?

Well, in our discovery, we found that that was

not the view of the scientists, nor even the compliance

officer that reported back to Dr. Maryanski when he

submitted the 1992 policy for their approval. I\'m going

to quote directly from Linda Call, the FDA\'s Office for

Compliance. Ms. Call is obviously a very witty woman. I

won\'t include all of the jibes that she threw back at Dr.

Maryanski, but there are some here that are legally

extremely important. She said:

\"I believe in at least two situation, relative

to this policy, it is trying to fit a square

peg into a round hole. The first square peg

into a round hole is the document that is

trying to force an ultimate conclusion that

there is no difference between foods modified

by genetic engineering and foods modified by

traditional breeding practices. The processes

of genetic engineering are different and

according to the technical experts in this

agency (the FDA) they lead to different risks.\"

This is the compliance officer at the FDA. It\'s

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not emotional consumers, and this is not people on

demonstration. This is the compliance officer, the person

whose job it is to make sure that this policy complies

with the law. And who is she citing? The technical

experts in the agency. So when we\'re talking about sound

science, let\'s remember there\'s the FDA\'s own technical

expert that said these foods are different, they present

different risks, and they are not substantial equivalents.

So, once you get rid of this charade of substantial

equivalence, as exposed by FDA\'s own scientist, then we

get into what does, what does constitute a material fact?

It was said at the beginning of this

presentation that there has to be a significant change to

the food. Incorrect, not part of the law, not part of

FDA\'s regulations. In its regulation requiring the

labeling of irradiated foods, FDA said if there is

sufficient public demand, that even nonsignificant, even

nonsignificant, organoleptic \-- that is, material changes

to the food \-- should require labeling. And, indeed, that

was their holding with irradiated foods.

So you have two very basic categories. You have

performance characteristics and you have changes in

flavor, taste, texture. Now, if you look through the

gamut of genetically engineered foods \-- and I thought Dr.

Maryansky did a very good job of this earlier today; he

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described exactly what performance characteristics were

changed, right? \-- we\'ve got tomatoes that ripen later \--

right? \-- a whole group of them. We\'ve got herbicide-

resistant crops. We\'ve got BT crops performance

characteristics both in the field. And, by the way, BT

potatoes, for example, there\'s less solids in them. These

Flavr Savr Tomato, they claim that there\'s flavor changes.

If you do what I\'ve done and look at the patents

for everyone of these foods, there are only two open in

saying we\'re different, we\'re novel. We\'re creating

things that are absolutely impossible through traditional

breeding. So the processes we\'re using should be

patentable, and they have been, and the foods themselves

should be patentable, and they are.

Now, if FDA does not agree with that, perhaps it

should join others and file suit with the Patent Office to

rescind all of the patents on these foods. If they are

not truly novel, if the processes do not bring in

substantive changes, then they should not be patented, and

their patents are invalid, or would be invalid.

Finally, I think it\'s important to say that the

very nature of genetic engineering, according to FDA\'s own

scientist, creates important issues that require labeling.

In the response by the Division of Food, Chemistry and

Technology to Dr. Maryanski \-- who was aware of this,

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again, in 1992 \-- this is what they said, and it\'s very

important: \"The insertion \...\" \-- remember before about

that insertion \-- right? \-- that Dr. Regal and Dr. Fagan,

and others talked about, and Dr. Huttner, that there\'s the

insertion of the gene, this mutagenesis of insertion?

This is what they\'re talking about:

\"The insertion of DNA into the plant genome may

result in various desirable or undesirable

changes.\"

All right? And they stated what these

undesirable effects could be.

\"These undesirable effects, such as increased

levels of naturally occurring toxicants,

appearances of new, not previously identified

toxicants, increased capability of

concentrating toxic substances from the

environment, pesticides or heavy metals, and

undesirable alterations in the levels of

nutrients may escape breeders attention,

unless genetically engineered plants are

evaluated specifically for these changes.\"

Toxicants, new toxicants, unknown toxicants \--

right? \-- just what they were talking about today.

\"Such evaluations should be performed on a

case-by-case basis. That is every

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transformance should be evaluated before it

enters the market. Unrecognized toxic

substances may unexpectedly occur in

transgenic plants.\"

So they recommend long-term toxicological tests

and they recommend that these be labeled.

So that\'s what the scientists, that\'s the sound

science inside the agency. That\'s what they said. What

happened between sound science? They\'re different, they

contain risks, and significant performance changes. And

the policy and why that was kept quiet from the public for

7 years? These are questions I cannot answer right now.

But if you\'re going to be talking about public

information, clearly, there\'s a huge gap between what the

scientists have said, a huge gap with what the agency has

said, and what actually occurred. And I don\'t think

there\'s any discussion about the labeling of genetically

engineered foods. The law absolutely requires it. These

are material changes, performance changes. The public, by

a tremendous majority, wants these. And for 7 years, this

agency, with no scientific basis, by their own admission,

and no binding regulation, has deprived millions of

Americans of the right to choose. And that is regulatory

disgrace.

\[Applause.\]

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COMMISSIONER HOLSTON: Thank you, Mr. Kimbrell.

Dr. Applebaum.

DR. APPLEBAUM: Good afternoon.

My name is Rhona Applebaum, and I serve as

executive vice president for Scientific and Regulatory

Affairs for the National Food Processors Association. Our

trade association serves as a scientific and technical

trade association for the food processing industry, and

our primary focus is on \--

COMMISSIONER HOLSTON: Excuse me, Dr. Applebaum.

He says you\'re speaking too fast.

DR. APPLEBAUM: I\'m sorry.

COMMISSIONER HOLSTON: Would you slow down just

a little bit.

DR. APPLEBAUM: I apologize. Okay.

And our principle focus is on issues related to

food science and food safety, and we appreciate very much

this opportunity to present our views.

I\'m going to cover two principle issues, very

quickly, on the safety and then the remaining, my

remaining remarks will focus on why I\'m here on the panel

today, and that\'s on labeling. First on the safety.

Consumers have a right to expect that all foods

on the market are safe to eat, whether those foods are

produced through traditional or conventional agriculture,

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or the use of modern biotechnology. Food safety concerns

related to biotech-derived foods should be considered and

addressed no differently than other foods, with the common

goal of continuing to insure the safest food supply

possible.

In the case of biotech foods, the primary

oversight for safety of the food, quote, unquote, \"to eat\"

is through a consultation process with the FDA, a process

NFPA supports. Why do we support this process? Because

the process for overseeing the safety of food developed

through biotechnology is, with due respect to my colleague

on the panel, science-based, built on the principles of

risk assessment, and it works. It has worked, and it

works well. This is NFPA\'s view.

With that said, while we know that every biotech

company has submitted to this consultation process prior

to the marketing of new products from engineered plants,

the consultation process is voluntary. And this fact has

caused questions to be raised as to whether this is the

best approach to maintain consumer confidence.

Could this prior-to-market process be made more

formal and more transparent using already established

procedures, established for other FDA regulated food

products, and thereby insure, to the extent possible, that

consumer confidence \-- something very important to the

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food industry \-- is maintained?

Yes, it could.

NFPA has some specific ideas to improve the

formality and transparency of this consultation process.

First, we believe there needs to be a mandatory food

safety consultation. FDA should require that biotech

companies consult with them prior to introducing a biotech

food into the market. We believe this step would boost

public confidence in the safety review, a process, as we

heard this morning from Dr. Maryanski, that is thorough,

rigorous and scientifically based.

Second, at the conclusion of the consultation

process, at a specified time before the food is introduced

into interstate commerce, the biotech company should file

with FDA summary documentation to support the

determination of safety for the biotech food. And this

documentation should be made publicly available. NFPA

believes it is important for the summary information to be

publicly available so that anyone interested can examine

it, and so the general public can develop a high level, a

higher level, of understanding, a higher level of

confidence, and a higher level of comfort regarding the

safety of biotech foods.

We therefore agree with what Dr. Huttner stated

earlier this morning, that there is a serious information

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gap. But we also agree with Dr. Regal, that rhetoric is

dangerous. To correct this serious information gap, we

need factual information in order to prevent the fears,

the fears that rhetoric produces. So to the extent that

we would like to see hyperbole and hypothetical risks

diminished, we do need factual information, we do need to

close this serious information gap.

Concerns over information that is trade secret,

or otherwise confidential commercial information, this has

already been addressed appropriately in FDA\'s general

regulations.

Now for labeling.

NFPA, and its member companies, strongly support

the current FDA policy on labeling requirements for

biotech foods. We believe it is essential that mandatory

labeling be reserved for information that is material,

that is information that goes to the safety, to health,

the composition or the nutritional value of the food.

NFPA further supports the use of voluntary

labeling of foods to indicate the presence or the absence

of bioengineered ingredients. NFPA has long supported

voluntary label statements provided such statements are

truthful, non-misleading, and disclose the necessary

material facts. Such label statements could include

biotech-free, or similar terminology, or contains biotech

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ingredients.

In order to support any voluntary statements,

NFPA believes that three criteria are necessary. First, a

quantitatively-based threshold should be established

especially for any, quote-unquote, \"free claim.\" Such a

threshold should be strict, but technologically feasible.

Just as a fat-free claim does not mean absolute zero fat

content, the threshold for biotech-free does not have to

be set at absolute zero. A reasonable threshold is

probably some small percentage. In this matter, consumers

understanding, in qualitative, of the meaning of \"free\"

needs to be given some consideration. The industry and

consumers could and should assist FDA in such efforts.

Second, every claim needs to be substantiated.

For a biotech-free claim, the ability to substantiate

identity preservation and other trace-back procedures

would be vital components. Provisions could be made on

the enforcement side for processors that make claims to

provide substantiation to FDA upon written request, just

like the substantiation provisions in the recent soy

protein coronary heart disease health claim provisions

that NFPA strongly advocated. In other words, FDA has the

authority to require substantiation.

Finally, most biotech-related claims will need

supplementary statements that place the claim in its

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proper context. NFPA believes supplementary statements

are absolutely necessary to prevent such claims from being

misleading. NFPA believes that FDA\'s policy regarding

claims on milk from cows treated with RBST served as the

best model. In that policy, FDA made clear that

supplemental statements must include a representation that

no significant difference has been shown between milk

treated from cows and milk from untreated cows. In a

similar vein, for a biotech-free claim, a supplemental

statement should note that there are no significant

differences between biotech-derived and biotech-free

versions of the same food \-- the food, not the plant. No

significant difference has been shown between biotech-free

and biotech-derived products, or no significant health or

safety differences have been shown between biotech-free

and biotech-derived products are two possible accompanying

statements that may be considered.

NFPA and its members companies believe strongly

in the regulatory process FDA applies in assessing the

safety of biotech foods. It is a science-based process

built on the principles of risk assessment. And we urge

FDA to continue its strong science-based focus on placing

their resources on real safety issues, not hypothetical

risks. Only two questions require answers:

1\. Could the review process be made more formal

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and transparent? We believe, yes; it can and it should

be.

2\. Are criteria required to insure voluntary

label statements are truthful and non-misleading? Again,

our position is yes.

Today, NFPA has advanced some ideas to help

reach those answers. The government should require no

more and consumers deserve no less.

Thank you for the opportunity to comment.

COMMISSIONER HOLSTON: Thank you, Dr. Applebaum.

\[Applause.\]

Ms. Haeger.

MS. HAEGER: Thank you.

I\'m Susan Haeger, with Citizens for Health. We

are a consumer advocacy group that has chapters in all 50

states, volunteer chapters nationwide, of individuals who

are concerned about natural health issues. Our work and

our mission is to insure consumer access, information and

choice for natural health care products and therapies.

We have come to this issue because our

constituency has had tremendous questions about the

presence of genetically engineered materials in their

food. And through our investigation and discussion with

scientists, what we have seen is that genetic engineering

is a method of altering or making new organisms through

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techniques that change the molecular or cell biology of

the plant by means that are not possible in nature. And I

think this has been a highly contested definition of GE

foods, and we hear, on the one side, that it\'s just an

extension of traditional breeding practices; and, on the

other side, that, in fact, there are material changes.

And, yet, there is no program in place to fully answer

this question for the consumers that have the concern.

We have many scientific studies being done,

which show that there are probable causes of concern in

both health and environmental areas. And, yet, many of

those emerging scientific studies are being set aside

because, supposedly, they are not thorough enough, or

they\'re not complete enough. But I think they raise flags

that consumers expect the FDA to be looking seriously at

and answering, and not simply setting aside.

We have had a growing numbers of consumers and

natural product retailers contacting us about the

prevalence of genetically engineered material in the food

supply. And I have seen that, week by week, this issue

has gained more attention as FDA has done an excellent job

of opening up this public discussion that these questions

are increasing.

The growth of preventative health care,

including the use of dietary supplements, the

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establishment of the National Center for Complimentary

Alternative Medicine, the USDA\'s recent decision to

respond to public objections to its originally proposed

organic standards, are examples of how consumers create

market trends and resulting social changes that can change

public policy. But the American public cannot make

choices about genetically engineered foods without it

being labeled. And this segment of the public, which is

voting with its dollars, must be taken into account as

this debate is going forward. I think it\'s very important

to understand that consumers are making decisions about

the products they buy based on the way on which those

products are produced. We have now a healthy living

marketplace, which is estimated at \$230 billion, that is

the segment of the public which is concerned about organic

food, natural food, natural dyes, environmentally

sensitive building, making certain that the products that

they\'re buying represent healthy living, both for

themselves and for the planet which they inhabit. These

consumer concerns should not be set aside.

We are committed to providing consumer choice

and pursuing mandatory labeling of genetically engineered

foods because we believe that the debate in the scientific

community that is going today shows that there is a

technical difference, there is a genetic difference, and

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there is a difference in the scope of the impact of these

foods. And, when we talk about bridging the information

gap, I think the FDA will do both itself, as an agency, a

disservice and the American public a disservice by simply

putting forward the views of the biotech industry and not

seriously considering the concerns that have been raised

by experts and by scientists outside of the industry

itself.

We have also heard a lot about how consumers

really don\'t have to have labeling unless there is some

significant change shown to the product while the

scientific debate is going on about whether or not there

are changes. The easiest way to address it is to simply

label it, for people to make a decision for themselves.

And I think that the putting of the information on the

label tends to reduce people\'s fears and people\'s risks.

As we try to bridge this information gap, as Dr.

Applebaum has said, I think it\'s very important that we

provide a way for the individuals who are concerned not

bear the complete burden. I mean, what we\'re talking

about now is if there is only voluntary labeling, there\'s

only a voluntary information process, then the individuals

who are concerned about this are the ones who are going to

have to bear the burden. I think it should be borne by

those who have developed these technologies and not by

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those who are now put at-risk.

Since FDA does not require mandatory labeling,

consumers don\'t have adequate knowledge to make informed

choices. And I think especially the fact that there is no

mandatory pre-market safety testing, and that these foods

are generally considered to be generally regarded as safe

or GRAS, there is enough scientific debate going on that

the agency needs to look closely at whether or not, in

fact, these foods can be considered GRAS simply on the

basis of getting voluntary submitted information from the

companies that are developing them.

Some biotech supporters are advocating making

the process of consultation mandatory, as Dr. Applebaum

has said. We don\'t believe that measure goes far enough

because the initiation and depth of the process to

determine whether a genetically engineered food is GRAS

depends on the discretion of the biotechnology companies,

whose products are involved. Products can be marketed now

whether or not FDA reviews the submitted information, and

we believe that the agency needs to be taking an

independent view of the information which has been \-- is

being put forward.

Additionally, I think there are concerns that

have been raised by our members about the regulatory

structure for genetically engineered foods being

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fragmented. And I think this is something that FDA needs

to look closely at. The USDA approved the release of

genetically engineered plants into the environment and

approves crops for production. FDA oversees food safety

but not pesticides expressed in food, and the EPA

regulates pesticides expressed through genetic engineering

but not food. So there is a lack, from the public\'s

perspective, of complete agency coordination and looking

at the effects that these foods have. For instance: Corn

that is genetically engineered contains a BT pesticide.

It\'s commercially sold as a food product without

pre-market mandatory, independent pre-market safety

testing, even though no food product containing BT has

ever been ingested by humans before.

We\'re seriously concerned about the flaws in

FDA\'s pre-market screening and labeling processes and the

fragmented regulatory structure; and, therefore, we have

become involved and are supporting the mandatory labeling

legislation, which has been put forward in Congress. I

think the agency has an opportunity to address these

issues and to avoid this type of movement that\'s going to

take place in the public, and cause a lack of confidence

in the agency\'s regulation of the food supply, by clearly

addressing the need for the labeling and also for the

mandatory pre-market safety testing.

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We\'re also concerned about the rapid

proliferation of largely unregulated genetically

engineered crops, as they pose a risk for organics. There

has been a 23 percent growth in the organic market every

year. It\'s going to \-- it\'s estimated to hit \$10 billion

by the year 2000. And the polluting of organic crops is

of tremendous concern. It\'s virtually impossible for

farmers, whose fields are near genetically engineered

crops, to insure that their crops are free of genetically

engineered material. This is especially true with corn.

It\'s a wind-pollinated crop. And economically, this has

been having impact. We found Terra Prima, for instance, a

certified organic producer, had to destroy 87,000 bags of

chips that tested positive for genetically modified

organisms and they could not be sold as organic. This is

something that the organic community is grappling with.

And, yet, no one, when these products came to market,

looked at the impact that they could have on the organic

community, on the agriculture system that organic is

engaged in, and I think those questions should be answered

before these crops are allowed to proliferate.

We find that natural food sales are the fastest

growing segment of the retail market. And the new science

on the health and environmental implications of

genetically engineered foods that is emerging shows that

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there are mounting concerns about disrupting the

ecosystems that may cause damage to the soil and other

plant and animal species. However, FDA\'s policies on

genetically engineered food, despite scientific and

consumer concerns, have allowed the introduction of these

genetically engineered foods and crops to proceed and to

out pace the science. And this morning\'s panel, and the

scientific panels you\'ve had in Washington and in Chicago,

show that there are many scientists who do not agree that

there are no significant health and environmental

concerns.

Supporters of biotechnology contend that genetic

engineering is simply an extension of traditional

breeding. FDA scientists that we have heard from, and Mr.

Kimbrell, have disagreed with that. It\'s in the public

record. I think it\'s very important that, as this

information comes to light and the public begins to review

it, the agency clearly respond and give an explanation as

to why these issues have not been addressed before and why

the public comments that\'s been in before have not been

addressed.

So, again, I think that, from our perspective,

it\'s very important that there be mandatory labeling, that

there is an opportunity for consumers to make a choice,

and that there be mandatory pre-market safety testing that

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is not simply company initiated and is looked at

independently by the agency. I would suggest that, as a

means of addressing these concerns, there have been

precedent, such as the FDA Council on Food Safety, and the

Keystone Project that was developed some years ago around

food labeling questions, that brought industry, academics,

scientists, consumers and the agency together to discuss

the concerns and to develop a policy for addressing

labeling. And I think that that would be very productive

because there is tremendous perspective in the public that

the agency has made all of these decisions in consultation

with industry without communication to the public directly

and without dialogue.

Thank you.

COMMISSIONER HOLSTON: Thank you.

\[Applause.\]

Ms. Goodman.

MS. GOODMAN: My name is Diane Joy Goodman, and

I\'m a consultant to the organic agriculture and food

processing industry. And I\'d like to thank the FDA for

inviting me to speak here today.

I\'ve been involved with food, which is the focus

of my personal, professional and public life for over 25

years, the last 10 exclusively in the organic industry. I

have run restaurants, I\'ve marketed fresh produce at large

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distribution terminals, as well as farmers\' markets. I\'ve

live on farms and I\'ve worked in the field. Currently,

I\'m the chairman of the California Organic Food Advisory

Board of the California Department of Food and

Agriculture. And I sit on task forces, with the National

Organic Standards Board.

As a consultant, I advise entering and existing

businesses, particularly in the areas of government

affairs, marketing and communication. My clients come to

me to learn how government and industry regulations will

impact their production and marketing practices, and how

best to educate themselves, their companies, their

suppliers, and their customers about the organic industry

\-- especially about what sets them apart from conventional

agriculture and processing.

My comments today are going to focus on the

needs of the organic industry and the public\'s expectation

of the organic label, and why labeling at all product

levels, from seed to supermarket, is necessary to the

organic industry.

The National Organic Standards Board, the NOSB,

established by the Federal Organic Food Production Act of

1990, defines organic production as \-- and I quote part of

this \-- \"\... the use of materials and practices that

enhance the ecological balance of natural systems.\" The

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NOSB has further recommended that genetically engineered

organisms, and their derivatives, be prohibited in organic

production and handling systems. USDA Secretary Dan

Glickman stated, in response to the overwhelming, 280,000

public comments to the first proposed rule for the

National Organic Program that, and I quote, \"Biotechnology

does not fit current organic practices, nor meet current

consumer expectations about organics, as the comments made

clear.\"

The organic industry is based on the premise

that food can be raised and produced in the manner that

replicates nature. Genetic engineering, specifically the

technology of recombinant DNA, the movement of genetic

material from one species into the genetic code of an

unrelated species, would never occur in nature. It is not

comparable to hybridization and traditional breeding

practices. The transference of genetic traits between

species, not varieties but species, does not occur in

nature. Organic farming has never needed genetic

modification, and I cannot see that it ever will need it.

The National Organic Standards Board, as well as

the 44 public and private organic certification agencies

currently operating in this country, have determined that

this technology is a synthetic process. And synthetic

processes and products are only permitted in organic

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agriculture and food processing if they meet strict human

health, environmental and toxicological criteria. Even

then, their use in the field is limited by application

rates and necessity, as documented by soil and plant

tissue testing.

In organic food manufacturing, ingredients

produced by synthetic process may only be included in no

more than 5 percent of the ingredients of a product, and

that is only if all criteria have been met and absolutely

no other alternative exists.

Organic food generated over \$5 billion in sales

in 1998. The industry has grown at the rate of over 20

percent annually for the last 10 years, compared to

conventional grocery growth of rates of only 3 to 5

percent. American consumers are more aware than ever

before of the choices available to them in the

marketplace. Health, wellness, environmental conscience

are now deciding factors in the shopping habits of a

growing number of consumers. And many of these people are

choosing organic food because they can trust the label to

represent food that is grown and processed without the use

of materials that may be harmful to the soil, to the

water, to the air, to plants, animals, to their own or

their family\'s health.

On the farm, organic practices offer a new set

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of tools to today\'s farmer looking for ways to reduce

chemical use in the field, and generally return of 20

percent, or better, premium in the market over

conventionally raised crops. Over and over in

conversations with long-time conventional farmers. who

have incorporated organic practices into part of their

operations, we hear the same success stories about the

decreasing pest pressure, both disease and insects. The

success is always attributed to the increased health of

the soil and, of course, to the resourcefulness of the

farmer.

Without labeling of genetically engineered

agricultural and food products, a potential liability is

created for the organic industry, who has made the public

commitment to keep organically grown food free of

genetically modified organisms. Without labeling, this

promise is becoming more difficult to keep. As far back

at the seed, organic farmers need to know that they seed

they buy is not genetically engineered, or that it does

not contain traits environmentally transferred to it.

Organic farmers need to know that livestock feed contains

no cotton seed meal that comes from genetically engineered

BT cotton. Organic manufacturers need to know that the

enzymes used in cheese making contain no caymosin. And

the organic customer needs to know that the soy milk, for

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their infants, don\'t come from Roundup Ready Soy Beans.

Without labeling, GMOs may make their way into the organic

food chain and violate the public trust it has taken 20

years to build.

The chain of responsibility must start at the

genetic souce. Right now, the organic industry is

struggling to determine policy about how to test for the

presence of GMOs in minor ingredients, in manure use for

compost, and in additives to livestock feed and vaccines.

The certification agencies are baffled at how to manage

genetic drift from pollen from BT corn that may be carried

over miles when traditionally sufficient zones have never

exceeded 25 feet. I believe the responsibility of proof

is misplaced on the organic industry, and that it presents

undue obstacles for the potentially stunning opportunity

of growth the organic industry has in the future for

farmers and for the public.

Manufacturers who market genetically engineered

products must be willing to inform their customers about

the unique technology that went into production. If these

products are proven to be safe over time, and with

long-term testing and development to insure environmental,

as well as public safety, it\'s certainly possible that

they will. And after determining that safety is as

important as recovery of the financial investment gone

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into bringing these products to market, labeling will be

enthusiastically and willingly used by the products\'

manufacturers.

Genetically engineered food and its production

are still in trial phases, as is demonstrated by the

numerous new scientific revelations about its effect.

Every few weeks, a new study is published about these new

discoveries and the potential effect, whether it be on

Monarch Butterflies, to transference of pest resistance to

the soil, or to Brazil Nut allergies in soy beans.

The pharmaceutical industry, in the

pharmaceutical industry, a new drug is offered in trials

to patients that may benefit from it. But those people

choose to participate in the trial, and it takes place in

closed environments. Drugs are developed in laboratories

and used by people that make that choice.

Seeds, on the other hand, are planted outdoors

and released into the environment. Food produced by those

seeds is currently being eaten by people who don\'t know

they are participating in a trial. They don\'t have the

choice. Choice in the marketplace has always been an

essential element of American culture. Those people who

want to eat only kosher food look for kosher labels.

Vegetarians read labels to make sure there is no chicken

stock in their minestrone. And people with peanut

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allergies read candy bar labels to stay alive. People who

want a drop a few pounds look for fat content. Isn\'t this

the reason we have nutritional labeling information? The

organic consumer seeks out the organic label the same way,

and is entitled to trust what that label has come to

represent.

In specific response to the questions put

forward in the Federal Register Notice, of October 25,

1991, requesting information regarding labeling of

genetically engineered food, yes; the current FDA policy

should be modified to address environmental safety, as

well as food safety. The name of the food should be a new

name that clearly states it is the product of genetic

engineering. And, no; these policies have not served the

public well or wouldn\'t even be here.

Furthermore, labels should clearly state in

language similar to that recommended in legislation

recently introduced into the House of Representatives by

Congressman Dennis Kasinich of Ohio, and I guote:

\"United States Government Notice. This product

contains a genetically engineered material, or

was produced with genetically engineered

material.\"

To close. In response to the question of how to

make information available to the public, yes; you do use

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the internet and food information phone lines and food

labels. The larger question is what information to make

available.

I think the information needs to be broader than

about promotion and marketing, and it needs to be more

than about its safety. It needs to be about its potential

unknown risks. Yes, please do it. Also use other means.

Use longer environmental-criteria-based testing. Use

greater percautions in protecting the health of the

public. Respect the American consumer\'s right to be

informed and make marketplace choices. Be transparent, be

honest, and please be as concerned about this as I am.

Thank you.

COMMISSIONER HOLSTON: Thank you.

\[Applause.\]

Dr. Bossman.

MR. BOSSMAN: I\'ll keep it brief, and not

doctor.

My name is David Bossman, and I\'m president of

the American Feed Industries Association in Arlington,

Virginia. AFIA is the national trade association

representing the manufacturers and more than 75 percent of

the commercial livestock, poultry and pet food sold

annually in the United States. Our industry is the single

largest purchaser of grain, oil, seeds and byproducts in

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the U.S. Nearly 65 percent of the nation\'s corn, and

almost all of its soy bean mean are used in the feed

industry.

We all have to very proud of what we\'re doing

here today and that we\'re a part of the United States

where we can discuss, demonstrate, debate and litigate an

issue that carries so much passion from all sides.

I\'ve attended all three of the FDA public

hearings on biotechnology and am aware of the

controversies surrounding not only the use of

biotechnology, but the debate over whether the product

should be mandatorially labled if they contain ingredients

derived from biotechnology. I certainly don\'t have to

remind the agency that standards for determining federal

labeling on any regulated product must be based on science

and not on public opinion polls.

AFIA supports FDA\'s current labeling policy and

opposed blanket mandatory labeling. If genetically

modified feed ingredients, and products which contain

them, are not materially different from the conventional

counterparts, if they\'re just as safe, of equal quality,

and have the same functional characteristics, then

mandatory labeling is not justified.

We view reasonable labeling regulation as

critical to enhancing consumer confidence in the food they

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buy. However, to be consumer-friendly, labeling must,

above all, provide useful information for the purchasing

decision. Requiring labeling in the case of material

differences between genetically engineered and

conventional products makes sense. It makes sense to

label if there is a demonstrated safety risk. It makes

sense to label if we are effectively creating a new plant

variety. It makes no sense to label based on a production

method when there is no material difference between the

conventional and the genetically engineered foods or feed,

since such arbitrary labeling really provides no benefit

to the consumer.

FDA has resisted such labeling requirements

demonstrated in the original BST approval. Avoiding this

policy will also keep the \-- will be keeping the agency\'s

longstanding policy against regulating based on

theoretical risks.

Voluntary labeling means the marketplace, not

the government, who will determine what foods consumers \--

what information consumers value when it comes to

genetically engineered foods or feed. Labeling is one of

the many ways that impart knowledge. All the means that

you mentioned, the 800 number, the internet, and product

production, are all appropriate and necessary.

From a food safety perspective, FDA policy on

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biotechnology must not only insure that the information

provided on the label is accurate and valuable, but that

the product inside the package is safe. Food safety and

consumer confidence is the top priority of the feed

industry. There can be no higher goal for industry or for

government.

Our industry supports sound-science-based

production systems. We support balanced government

regulation that fulfills the agency\'s mandate to protect

public health and a benefit to the food production. The

two goals are not mutually exclusive. We strongly oppose

regulation based on theoretical risk.

The consultation system, initiated as part of

the agency\'s 1992 policy, under which companies

voluntarily share with FDA information about the safety

and nutritional labeling, appears to be successful.

However, we do support a move to formalize those

requirements of those consultations and make that more

transparent.

The industry\'s priority and the government\'s

mandate to insure the food supply is safe is paramount.

Only compelling science can be used on the basis for

regulation of biotechnology. The promises of

biotechnology are known and achievable. The risks are

easily managed because they are minor.

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Also important is the need to educate consumers

about that technology and how it will transform the food

production. Consumers need to hear the story of

technology, its promises, it\'s limits. Consumers need

facts not horror stories. They need to hear from the

government and they need to hear from it industry.

We in the U.S. and most of Europe are part of

the earth\'s wealthy and well-fed few. Five billion of the

six billion people in this world are less fortunate. In

the next 40 years, we must produce as much food that has

already been produced in the history of the world.

Because we born here in the United States are clearly

apart of that lucky gene club that has all the food we

need, we have a responsibility. We have a responsibility

to use all the available technology to produce an abundant

and wholesome food supply, not just for us, but for the

world.

We understand FDA\'s role is not to be an

industry cheerleader. However, the agency must publicly

explain the effectiveness of your regulatory process that

assures continued safety of biotech-developed foods and

feed ingredients.

Thank you.

COMMISSIONER HOLSTON: Thank you very much.

\[Applause.\]

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PANEL ANSWERS FDA QUESTIONS

COMMISSIONER HOLSTON: All right. Thank you all

very much for your comments. And we are now going to turn

this part of the program over to the FDA panel to pose

questions to you, either individually or to the entire

group.

So, I\'m going to ask who would like to be the

first? All right. Melinda Plaisier.

COMMISSIONER PLAISIER: This is really to

everyone. I\'m still trying to sort of get my arms around

this broader issue. I\'ve heard a lot of things today.

This morning I heard that we have a gap, a lack of

information, that we need to better educate and provide

information to consumers. That we need to continue to

uncover the science of this new technology. And then I

hear from this panel a call for labeling.

What I\'m trying to figure out and what I\'d like

to hear from you is: How do you filter this down? How do

you decide what information to provide consumers? What

information would you envision going on the label? As we

heard this morning, you know, tomatoes started as a

bitter berry, and corn came from a grass. How would you

label that? What kind of information do you think is

important to provide consumers, and how would you go about

doing that?

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MS. GOODMAN: I think that, to start with, I

think FDA would need to be willing to give both sides of

the story on the label. That may mean putting something

on the label about the genes that have been included.

That the product has been genetically modified, and here\'s

how it\'s been modified. This particular gene has been

inserted into the genetic code of this particular product.

This gene comes from something else. Of course, it

couldn\'t be this wordy, but the gene comes from something

that is not corn; it comes from a bacteria. And, then, to

present what you know about its safety, and some form of

disclaimer that you may not know at all. And I think that

that would be at least a starting point in your thinking.

MR. KIMBRELL: I\'d like to comment on that.

There\'s a \-- you know, whenever I speak about this \-- and

I\'m sure this is true for people on the panel and people

at the FDA \-- one of the confusions people say: Well,

wait a minute! If it\'s not safe, then we should certainly

label it. All we know that this is not the issue. As was

explained earlier this morning, in the 1992 policy, FDA

said that these were probably food additives, all these

genes and promoters and antibiotic marker systems; but

that they were going to give them GRAS. They were going to

say that they were generally recognized as safe. That

would require scientific defenders. That\'s one issue.

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Okay?

It\'s my view that giving a blanket

generally-recognized-as-safe to an entire class of foods,

rather than the individual way it\'s handled generally in

the additive things. Grossly negligent, but that\'s one

issue. We don\'t label unsafe foods. We take them off the

shelves. They\'re adulterated. They don\'t belong there.

Once a food, and once we were to have mandatory

toxicological testing of genetically engineered foods, and

many were to be, I\'m sure would prove probably safe, then

the issue of labeling comes in. Then is there something

material about those foods that consumers have the right

know? The reasonable consumer would have the right to

know if their peformance changed, longer shelf life, more

viscosity, a difference in an oil or fatty composition,

many of the things we\'ve already discussed. And in

virtually every food that I have seen so far, there is at

least some organoleptic change and/or some performance

changes, which is what the law requires if the agency also

believes that the public wants that kind of labeling \--

and, clearly, it does.

So I think it\'s helpful to make a dichotomy

between the safety issues and the GRAS issue, and the

labeling issue. First, we got to decide if they\'re safe.

First, there has to be tests. Then, if they\'re safe, then

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those who want to be more precautionary, who have

religous/ethical objections, who may be allergenic and

sensitive, then they have the right to know what\'s in

those foods. Two separate issues that need to be dealt

with separately.

DR. APPLEBAUM: I have just a couple of points.

In regards to the statement by Mr. Kimbrell, as it

relates, you know, not being allowed to have safe, unsafe

foods on the, on the market, just because, you know,

whether or not they carry a label or not, we only wish

that were the case. We have an incident, or an issue,

here in the United States with raw juice being sold and

not, and carrying a warning label on that. There\'s a

perfect example of a label for an unsafe product, but

that\'s a different issue. But I want to make that point

so Mr. Kimbrell wasn\'t, was made \-- it was clear to Mr.

Kimbrell that there is an example of that on, in the

marketplace.

On a different issue, and the question to your

point, Ms. Plaisier, as it relates to the issue you

raised. It gets down to what are you talking about. Are

you asking whether it\'s mandatory or voluntary? Let\'s use

that tomato as an example.

The early tomato being a toxic berry, and

today\'s tomato being, you know, a red, very nutritious

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product. Let\'s just say that that early berry didn\'t

contain a toxin, but it contained a particular nutrient,

and the nutrient, today, through modern biotechnology, was

increased. So let\'s just say that toxicant is now a, a

very beneficial antioxidant, and the tomato, produced

today through modern biotechnology, that the antioxidant

was increased. It\'s that increased level of that

antioxidant that should be labeled, and that\'s FDA\'s

policy as it stands. And for that, we applaud that.

Because you are providing material information. You are

providing information that has to do with health,

nutrition and composition. And that is material.

As for whether or not to provide that

information voluntarily, yes; that information can today

be provided voluntarily, as long as it\'s truthful and

non-misleading. You have to be very careful, as the legal

shows, as to what constitutes misleading and what is,

indeed, truthful.

On a different issue, again, it has been raised

in terms of taste organoleptic differences. When it comes

to mandatory labeling and the statute reads that mandatory

labeling revolves \-- I\'ll leave it at that \-- material

fact. Material fact, by statute, has to be, is and has to

be, consequence-based information. You have to have some

type of a common denominator, or a denominator that is at

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least objective. If you move to a paradigm where you have

a value or preference-based information, there will be no

end to that type of information that will be required on

the product label, or desired on the product label. Were

consumer interest alone sufficient to mandate information

on a product label, there would be no end to that type of

information. Right now, we\'re focused on a process, a

production method. There is materiality associated with

that process or the production method, unless there is a

significant change in the food. And what we have seen

today, in terms of the science that has been presented,

there is no discernible impact to the food that can be

identified. There\'s a lot of hypotheses. There\'s a lot

of hype, you know, theories abounding; but there is no

discernible impact.

So, in order to make your job easier, our job

easier, not only as representatives of industry, but also

as consumers, you have to have some common denominators

that are objective in order to make the issue as easy as

possible. If not, when you\'re dealing with value and

preference-based information, that\'s where the market

steps in.

Mention has been made to niche markets for

kosher and organic. Consumers have made an impact in

terms of those three niche markets. The same can be true

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for GM-free and biotech-free, but it should be voluntary.

It should not be mandated by the government. Government

has no business in marketing and mandating certain market

segments.

Thank you.

DR. HOBAN: I\'d like to just build on what was

just said there already, and kind of come back to sort of

some different rationale for labeling, which have been

used over the years.

I think the approach of FDA have been one of

sort of need to know, if you will. You will put

information on there that there is some need for that

consumer to know. And then we\'ll get into the whole area

that Rhona just talked about of the want to know. Things

we would like to know about our food. Then you might also

imagine a lot of cases in the future where there will be

the want to market, or want to sell the food, based on

some enhanced characteristics and desirable traits being

added in all these new next-generation biotech products.

But I do think it comes back to, when it\'s the

want-to-know situation, and where you said there\'s almost

an unlimited amount of things that people would want to

know about their food. And that was the point I made from

the USDA survey we did a few years back, when we asked for

15 minutes worth of question on biotechnology. Went ahead

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and said: Now tell me if each of the following types of

information would be very important, somewhat important,

or not important to you to have on a food label. And we

did, in fact, find 85 percent said it would be important

to know if biotech was on the label; 95 percent wanted to

know what pesticides were used; 93 percent wanted to know

the type and amount of fat, the food additives, the

radiation. Those four all came in above biotech. The

other thing that came in was 81 percent wanting to know

the country of origin. So I do feel like, if we had

asked, did you want to know if it\'s produced in an

environmentally sound manner, you\'d get 95 percent. I

mean, there\'s a lot of things consumers would want to know

about their food.

Now I thought it was very interesting, the

comments about the organic industry right now. Because I

would imagine, if I was in the organic industry, I would

see this whole issue as one of the greatest boons to the

business imaginable because of the fact that, for those

consumers who want to know and want to avoid the products

of modern biotechnology, I think this is an incredibly

efficient and effective niche for that to happen. And,

if there\'s been a growth rate of 23 percent, hey!, this

may cause an even greater increase in consumers\' desire to

avoid certain products because they want to know, as she

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was saying, the food is produced along a number of

desirable characteristics.

So, I guess that\'s where we\'re thinking that, if

there was a way that this could be described for people,

and you could put the products side by side in the store

and let an actual test be done \-- and there were those

done, if you think back a few years, in England, back

before, when there was still a consumer choice allowed in

England.

There was actually a tomato paste produced and

sold through Safeway Stores, and others, that was labeled

as a product of modern biotechnology. Then it went on to

explain how that resulted in less wastage of the tomato,

and things. It gave a little benefit statement. Then the

clincher was, it was a couple cents less a can and it

outsold the other tomato pastes very, very quickly. Now

that was, of course, pre all the publicity that\'s been

going on in the UK.

I think you\'d find the same case here. It\'d be

nice to see a true market test, where there would be a

GM-free product on the shelves right, next to one that\'s

already, you know, produced through conventional means,

and see, you know, given the differential costs that might

be associated. As I understand, organic does cost a bit

more. You know, see if the consumer will pay for it or

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not, rather than seeing this proliferation. If you go to

the average supermarket, where now you may have 50 or 60

different kinds \-- and I used spaghetti sauce as an

example. You\'ve got it with basil, you got it with

garlic. You\'ve got all these different kinds of choices

for the consumer right now. If you were to then double

those, so that some could be GM-free and some would not,

in the average supermarket, I think what you\'d end up with

is them saying: Well, gosh! We\'re going to only have

room for 60, so we\'re going to scrap 30 of the ones we

already have anyhow.

So I think these kind of issues have to be

decided as compared to having a whole different

alternative channel of products available for that

consumer who wants to know, wants to avoid \-- and that\'s

what we\'re having here: not who wants to seek out, but

wants to avoid, just like people want to avoid pesticides,

want to avoid other kinds of things. I think that just

makes it more market oriented sense and will still give

the consumers \-- again, in the surveys we\'ve done, we find

that people generally aren\'t as concerned about this as

they are other issues, like pesticides, fat content, and

things like that \-- in that market an opportunity to work.

COMMISSIONER HOLSTON: Ms. Haeger.

MS. HAEGER: I wanted to comment on several

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things that have been said.

Dr. Applebaum talked about the fact that their

voluntary labeling is a solution because, then,

individuals can decide whether or not they wanted to

inform the public about what\'s in the product, and that

RBST was used as an example. RBST was finally allowed to

be labeled after a 7-year lawsuit. The original

regulation, by the FDA, did not allow manufacturers of

dairy products to label their products. It originally had

to be fought in a court of law whether or not that label

could go on products, telling consumers that it was free

of RBST. And, yet, the final label that came out that\'s

telling consumers where people can say that it has RBST,

it tells them that it\'s no different than any milk that\'s

produced with RBST; but it fails to tell consumers that

there\'s good, sound science out there that shows that

there\'s increased incidence of mastitis in cows. So what

kind of a really and truly informed decision is the

consumer getting to make in that particular instance?

I think, also, when we talk about niche markets

and organic and kosher, et cetera, and the fact that this

allows consumers to make a decision, I think it goes much

\-- in this particular instance, it\'s very difficult.

Because, as we\'ve discussed in organic alone, there is

contamination and there is cross-pollination. There are

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other issues in transportation and contamination of other

materials with genetically-changed material, which then

changes the organic material. And until those kinds of

issues can be addressed \-- for instance, until all of the

ingredients and byproducts are segregated and a

manufacturer can know whether or not they\'re buying a

non-GMO-produced product, they can\'t label it non-GMO.

In the market today, it\'s very difficult. We

see a proliferation now of marketing claims being made

because people that it is a market advantage to say it\'s

non-GMO. But there\'s no standard there, and there\'s, in

many cases, companies that I know that very much want to

deliver non-GMO products to their customers but can\'t do

it because they\'re having such a difficult time finding

out if their original supply is GMO or non-GMO.

We know, today, that genetically engineered corn

is being processed into corn syrup, and because it doesn\'t

test for having genetic modification DNA in it, because

the DNA is so mutilated in the processing, it\'s being

shipped over to Europe and being sold as non-GMO corn

syrup when, in fact, it\'s derived from genetically

engineered corn. These are the kinds of things that

manufacturers and suppliers are confronting in the

marketplace, and it\'s very difficult, then, to bring a

product to market that consumers can make a choice about,

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unless the agency is requiring those products to be

segregated and to be labeled.

Mr. Hoban talked about there\'s a lots that

consumers want to know. And I think that, in this

particular instance, consumers want to know because the

debate over whether or not there is material change in

these products and the types of impacts that have in the

long term in the environment and on human health have not

yet been resolved, and while those questions are open

consumers want to be able to make a choice about whether

or not they consume them. So I don\'t think the burden

should be put on manufacturers to develop products that

are non-GMO. Let those who are investing the dollars in

developing genetically modified products indicate to

consumers that that\'s what they are, and then let

consumers choose.

It fundamentally comes down to the fact that you

can do focus groups, and you can have consumers standing

there in the aisle looking at a non-GMO or GMO product;

but, if they don\'t understand, in the first place, what

the issue is, they\'re not going to be able to make a good

decision. And I think that\'s why we\'re seeing in America

today, now, that the issue is growing through the process

of these hearings, because people are getting themselves

educated. It\'s the process that\'s going on. It\'s while

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this process is going on, I think it\'s very important to

include everyone who is impacted by it in the dialogue.

I think it fundamentally comes down to the fact

that these products have been made GRAS, and there\'s a lot

of questions outside of the biotech industry, and outside

of the FDA, that people feel aren\'t resolved; and,

therefore, the product should not be being considered as

GRAS right off the bat.

COMMISSIONER HOLSTON: Thank you. Bob.

MR. LAKE: I would like to ask a question that

follows up on some of the discussion we\'ve just had. But,

before I do that, I need to correct an omission.

For some inexplicable reason, I failed to point

out in my little discussion up front that, under existing

FDA policy, we would require the labeling of an unexpected

allergen, should it shows up in a food. I just failed,

failed to say that explicitly.

Coming back to some of the discussion we were

just having, I heard concerns about the need for FDA to

set standards. I\'ve heard concerns about contamination,

and even, you know, among organic growers who are trying

to stay away from genetically engineered organisms.

I guess one of the questions, you know, that I

would like to ask of this group, and I would like each

panelist to answer it \-- I\'ve asked it in the two previous

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meetings, as well \-- what would be your thoughts on what

the appropriate standard would be for genetically

modified-free on a food label, taking into consideration

the fact that there is apparently a growing amount of

unavoidable contamination?

Let me just start down at this end of the table,

and I would like to hear from each of you.

DR. HOBAN: Well, certainly, one of the lessons

that has been learned in pollution control \-- which we\'ve

done a wonderful job of over the last 25/30 years \--

certainly more could have been done. But it often \-- you

can get out the first 95 percent of the pollution for a

certain amount of money; and, then, getting that final

percent, that 5 percent out, is going to cost you as much

money as the first 95 percent, and some.

So I would think we do need to set the standard

at some point, and I don\'t have the number, a magic

number, out of the air that would be, I would say, cost

effective to the standpoint that it would still give a

consumer a sense that it was free of any GM materials;

but, in a sense, didn\'t drive the prices through the roof

by being unrealistically stringent and making sure there

was like 0.01 percent. I think the number that\'s been

thrown around is 2 to 3 percent, something along those

lines.

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I would say FDA goes back and looks at some of

your other tolerance settings. You know, you got

tolerances for certain things. We don\'t need to get a lot

into the insect parts, and things like that. But there

are certain things in food that, if they\'re below a

certain below a certain level, they\'re not required to be

put on the label, and they\'re not required to be discussed

in any particular manner. So there\'s certain tolerances

for metals, et cetera. Not to put these in the same

category as biotech, but I\'m just saying, in fact, we

can\'t achieve zero. There\'s no such thing.

I think the other thing that\'s important to talk

about in this whole debate, which we missed, is that there

is no zero risk to anything, either. Everything we do,

everything we eat, contains some sort of risk. So I think

at that point, you need to just use your best available

science and find something in consultation with consumers,

with the industry, that\'s going to have to carry out the

law.

Then I would again come back to something like

the case of caymosin, where you\'ve already decided, and

the marketplace has already accepted the fact that that\'s

been a genetically engineered product that\'s been on the

market for for 8 or 9 years now, and we\'re not going to go

\-- we\'re going to go back and require that to be in some

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way labeled differently.

MR. KIMBRELL: That\'s a very good question and a

very difficult one, and I know the organic community is

working on that question. It\'s one they\'re going to have

to resolve.

Just a quick comment before, when Ms. Applebaum

correctly said that there are products out there that are

not labeled, but are adulterated. And I think you

mentioned the E. coli.

DR. APPLEBAUM: Orange Juice.

MR. KIMBRELL: They are labeled but adulterated.

You mentioned the E.coli, apple juice. That\'s very true.

As a matter of fact, one of my lawsuits against the Center

for Food Safety recently was against the USDA for not

having mandatory cooking instructions on beef because of

the E.coli contamination. And we said it is mis-branded.

That beef is mis-branded because you\'re selling it without

saying how it has to be cooked in order to make it

healthy, to make it worthy of the brand that it currently

has. We won that lawsuit. It\'s on the label that you can

see.

So I certainly support you, and I agree with

you, that federal agencies sometimes guilt of not having

the right labels on, and that we need to remain ever

vigilant to make sure that they do the job so that public

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safety and health is protected.

I think on the genetic pollution issue, we have

a very complicated, speaking as an administrative attorney

\-- admittedly, some people think of some of the lowest

forms of life on earth; but I think the work is

interesting \-- this is a major problem that you brought

up. Absolutely important problem. I\'m not sure FDA is

the major agency that has to deal with it. We know that

EPA and USDA actually have better jurisdiction on this.

But the problem with the entire environmental movement \--

which many of us have been struggling for \-- is that it is

based on a chemical pollution paradigm. All right?

Chemical pollution is a contamination model of pollution.

You put poisons in the water, you put poisons in the air,

you put poisons in the food, and we want to get rid of

those toxics \-- right? It\'s a contamination model.

We\'re dealing here with biological pollution.

Biological pollution is a disease model of pollution. You

have pollution by a living organism, or by genetic

components of a living organism. And one of the great

difficulties we\'ve had, and the reason this has been so

litigious and such a difficult area, is that all of our

environmental laws, Clean Water Act, Clean Air Act, the

whole acronym bit, are based on chemical pollution. And

despite the best efforts of people of then-Representative

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Gore and Senator Bacchus and Bob Castenmeyer, and many,

many fine legislators throughout the years, we\'ve never

been able to pass a singly law on biological pollution,

never, over the last 15 years that they\'ve been trying,

these fine legislators, because of the pressure from the

biotech industry. So we don\'t have any laws on the

biotech industries.

So what happens? We have to take all of these

issues and try and shove them back into regulatory

agencies \-- which, even despite my occasional rhetoric, I

have some sympathy for \-- who then have to regulate these

biological pollution issues under chemical pollution

statutes. So you have these weird things like where you

have to view an entire plant as a pesticide. Or USDA will

have to view a whole plant as a plant pest. These very

anomalies. Well, you have to do that because of the

resistance to a really good law on biological pollution

that we desperately require if we\'re going to deal with

this problem.

I recently had a meeting with Secretary

Glickman. He said that his major concern here is the

liability issue, regardless of the tolerance level that is

set up. Whether it\'s 0.1, as some have requested, or more

than that, you\'re going to have a biological pollution

issue. And he feels that the government has significant

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liability in this. Because, if they allow a genetically

engineered crop out there, there will be the inevitable

genetic drift, this biological pollution, that the

government will be liable. And he, at that point, was

suggesting actually self-insurance by the government to

try and avoid this problem.

Once again, it\'s in your own 1992 policy. The

chickens are coming home to roost. I hope that\'s not a

double-entendre.

The biological pollution issue \-- which,

unfortunately, the biotech industry has been able to stop

reasonable and important legislation going through \-- is

now reaching the point where it\'s going to have tremendous

liability for the industry, and potentially for the

government. It\'s long past due that we address this

question, long past due.

\[Applause.\]

DR. APPLEBAUM: Your issues, Mr. Lake, in

regards to what type of criteria to use, in our comments,

we identified three criteria, that there needs to be some

type of a threshold. If you\'re looking for a number at

this point in time, we don\'t have a specific number. The

numbers are all across the board. Sometimes, from the EU,

it\'s 1 percent. Sometimes you hear a tenth of 1 percent.

Some people try to throw out zero. We know zero is

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technologically unfeasible. You just won\'t be able to do

it.

At the same time, I think there are \-- there\'s

some work that needs to be done. The number is not just

going to pop out of the hat. There\'s going to have to be

some studies done to assess what that, what is technically

feasible from the potential for cross-contact, or the

issue of drift. So there isn\'t a number that we can

identify, I can identify, for you today. I think it\'s

something that\'s going to take a little bit more, more

research to get a hold on.

As it relates \-- and this is an issue that I

want to get back to Ms. Haeger. We, too, do not agree

that something should be identified as GM-free just

because you can\'t find it. If that were the case, we

would only put the one criterian for GM-free, that it be a

threshold, and either you meet that or you don\'t. You do

have to have substantiation. You do have to have identity

preservation and other trace-back to make sure that, if

you\'re dealing with a corn syrup, that corn syrup was not

derived from BT corn. To do anything else but would be

misleading to the consumer, and you can\'t do that. And

last but not least, of course, you have to have the

accompanying statements. Because, in today\'s environment,

there is a warning associated with biotech not due from a

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scientific perspective. It is a fear that has been

generated due to a gap in the information. And to

require, or to allow for a GM-free, or contains GM type

label, without the accompanying statement, would just be a

disservice to the consumer. It would not be providing

them with the information they need to have a balance

assessment of what that, that truly does infer.

MS. HAEGER: This relates to your question about

a GM-free label. I agree that threshold levels are really

difficult to identify. Certainly the current testing

methodologies that are available will test down to

one-tenth of 1 percent. Most things, except for processed

ingredients, can be tested for that. However, as we see,

because of the difficulty with processed ingredients, in

many cases, people are being misled. I think, therefore,

the only competent way to do it is to see the shelf

tracking system that has similar system to the

certification that\'s done for organic.

I think, also, the established threshold for

genetically engineered foods must apply to individual

ingredients and not to the overall product only. I think

that\'s very important. I think consumers who are

concerned about avoiding genetically modified organisms in

their food want to know that on an ingredient basis,

versus on a general overall product basis.

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And I think that the processes that are

developed for pre-market safety testing and for handling

liability issues are critical to this whole concern of

creating a GM-free label. Because, as we\'ve heard about

in organic \-- and I think the organic community is only

beginning now to identify all of the issues for which

they\'ve been impacted \-- is that we have all of these

genetically engineered crops that have been planted, and,

over the 4 years that there\'s been such a large

proliferation, it\'s only now that we\'re figuring out what

it\'s impact is on the organic community. There could be

other impacts that we\'re going to be figuring out two or

three years from now that have \-- that causes more serious

concern; and, therefore, I think that the liability issue

and the pre-market safety testing issues are going to have

to be addressed.

I also go back again to this point, which I\'ve

made several times, but which I think is very important,

is that, when we talk about a GM-free label, I think it\'s

\-- at this moment, we\'re encouraging companies to develop

foods that are free of genetically modified organisms. We

don\'t think you can have a GM-free label. We actually

think that\'s a misleading label because you can\'t get

GM-free at this point. You can get to a certain

threshold.

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But I think that, again, the burden of dealing

with this labeling, and informing the consumers when these

products are present, should be on the foods that are

genetically modified and not on creating this whole new

niche market now.

Natural health consumers, those who, you know,

who are buying in natural food stores and natural products

in traditional supermarkets, these people want to know

whether or not the food is genetically modified. And

we\'re talking now about having to create alternate system

to organic, which is now going to be a non-GMO system.

MS. GOODMAN: I\'d like to respond to your

question. As was stated earlier on the panel, the range

of tolerances that are being considered by the organic

industry right now have not been formulated. They are in

discussion. The Organic Trade Association has a task

force that\'s looking at trying to determine tolerances

that are acceptable to the organic industry. And the

numbers of the EU of 1 percent, down to testing ability of

one-tenth of 1 percent, are all being considered, and

everywhere in between.

It brings up whole plethora of issues and the

minutiae becomes overwhelming of how far detailed do we

want to go, as an industry, to trace back where can

contamination occur. And, then, the question arises: Are

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all products evaluated at the same level? Will there be

varying levels and varying tolerances for different uses

and different products?

The bigger question, for the organic industry,

is the cost of all of this testing. Right now, it is the

industry to bear the burden of proving the proof of the

truth of their label, that, in fact, there are no

genetically engineered organisms in organic products. The

organic industry is essentially looking for the needle in

the haystack, and it\'s exceptionally costly. Were

manufacturers to put this information on their labels at

all levels of the product chain, we\'d only be bearing the

cost of labeling, which eliminates the mystery, as well.

And I really can\'t help but have this prompt this question

to me: If the confidence is there in the safety of these

products, why is there so much objection to labeling?

\[Applause.\]

MR. BOSSMAN: Obviously, if this was an easy

answer, it would have been made quite some time ago. In

the grain feed industry, for instance, the tolerance level

for foreign material is 3 percent. That\'s the starting

number. Now, as we just heard, there probably needs to be

multiple levels, and it would make some sense to have

multiple levels. If you have fresh produce, for instance,

where people are consuming it right off the vine, that

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probably should have a different tolerance level, or a

different labeling level, if you will, than something that

has been processed. You can expand that to something that

has been further processed more than once, because the

levels would continue to drop.

As Dr. Baldwin said this morning, when you pass

products through livestock, it\'s an incredibly good

screening process, if you will, to take out anything that

humans can\'t eat or wouldn\'t want to eat, or may feel that

it\'s not safe to eat; but the meat, the eggs and the milk

that they get is certainly wholesome.

So there\'s a huge gap, I think, and, clearly,

it\'s one of those that you\'re struggling with. Is it

proper to just label it GMO of GMO-free? I\'m not sure

that that\'s even proper. I suspect, in an year or so, we

will come back and the debate will be how do the companies

that develop the products that want to label, because of

the attributes that they gain out of the technology, how

are they allowed to label those products? Whatever you do

now certainly has to pass that test, as well.

If we use terms like \"uses less pesticide,\" or

\"produces less waste,\" they are very user-friendly terms,

and, clearly, they are apart of all of this. The

biotechnology firms aren\'t making these products just for

the sake of making these products. There is a need out

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there that are satisfying. And I think we sometimes lose

sight of that.

Are there risks? Yes, but none of them as great

as what they are when we jump in our car and drive home

tonight.

COMMISSIONER HOLSTON: Thank you.

Panelists?

MS. COPP: I\'d like to ask a question as a

follow-on to Mr. Lake\'s question. He assumed in his

question, I believe, that FDA would set the standard, if

they were such a standard for GMO-free, or whatever the

label might be. I\'d like the panelists to address whether

there are other organizations that could also, independent

of the agency, set a standard. What are your thoughts on

that?

DR. HOBAN: I\'d just might throw in one concept

that would be very important. It probably ought to be an

international standard at some point, given the fact that

the commerce does take place. I know you\'re all involved

with Codex, and things like that. I would imagine that

any standard that would and could be set ought to be in

harmony. Because that\'s much of the difficult we\'re

running into right now, which is: The depth of the ocean

between here and Europe.

MR. KIMBRELL: I think this problem is actually

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rather easily solved, as Diane and Susan have suggested,

simply by putting the burden where legally it belongs,

which on those who are introducing genetically engineered

foods into the market to label. That\'s what the law

requires.

And I respectfully disagree with Mr. Hoban.

This is not like country of origin, or as FDA official

once said, like scab labor or union labor picking your

fruit. That was an irresponsible statement to make to the

press, which they did.

I have \-- I mean, I don\'t want to go and bore

the audience with a list, but you all know these. I can

go down to the Calgene Flavr Savr Tomato, the DNA Plant

Technology ripening tomato, all the way to AgrEvo\'s

tolerant corn. Each one of these \-- and by the way,

unlike the mild produced from BST, each one of these has

novel material changes, performance characteristic

changes, and organoleptic changes. That is texture, by

the way, shelf life, nutrient values, which have already

been determined to be requiring labeling, mandatory

labeling, by FDA. All right? Each one of these foods is

patented for that purpose.

So I think the whole discussion of voluntary

labeling is both legally incoherent and also tremendously

unjust to companies who are not trying to bring these

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changes into the food system, and you\'re asking them to do

this, to actually try to find another body that might find

a label that find a label that would be suitable for them.

It\'s easy: Follow the law. Label these material changes.

Have the companies that are introducing this food in the

market, mandatory labeling. Very easy. It\'s your

solution.

\[Applause.\]

MS. COPP: Excuse me, Dr. Applebaum. I\'ve been

asked to restate my question. My question is: If you

assume that there will be voluntary labeling of GMO-type,

free-type labeling, and that there needs to be a standard,

which I believe your organization has stated is the case,

who, besides FDA, could perform the function of setting

that standard?

DR. APPLEBAUM: And, again, I think that\'s an

excellent question. Also, it even goes further in terms

of establishing, perhaps \-- it might already be

established \-- a body to assess whether or not they\'re

meeting those criteria, once those criteria are set.

I think, in terms of a body of this nature, it

needs to be all stakeholders, not just the industry. Even

though the industry is very keen on allowing opportunity

to police itself. We know that raises a lot of issues,

you know, with that type of a statement. So we would like

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to see something where all stakeholders a part of the

panel, or part of a council, if you will, consumers,

industry, academics, government, to the extent that

government could participate on such a panel, to have

these criteria established. Where the facts are presented

in terms of what the reality is, and identify, again,

going with the threshold, going with the substantiation,

as well as the accompanying statements.

Now, once those criteria are set, we can\'t

expect FDA to provide resources to determine whether or

not those criteria are being met. They have a greater job

in the enforcement.

So, in terms of looking at what\'s currently

available as a prototype, as a paradigm, the National

Advertising Council, for example, seems to work very well

as it relates to identifying whether or not advertising is

meeting \-- quote-unquote \-- \"the letter of the law.\" If

it isn\'t, it\'s sent over to the FTC. These are all ideas

that we, I think, would welcome the opportunity to

brainstorm further with FDA on, as well as others, who are

interested in advancing this issue, as opposed to just

seeing it shelved for not particular benefit to humankind.

Thank you.

MS. HAEGER: I simply want to comment that it

concerns me that the agency might consider, in light of

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the comments which have been made in the three panels,

including today\'s thus far, and other comments which have

been submitted and the questions which have been raised,

the idea of putting forward voluntary labeling before

these other issues around whether or not these products

are, in fact, GRAS, and whether or not, in fact, the

consultation process should not be a process of simply

getting information from industry, but should be a process

of looking at the information provided and independently

evaluating it, and determining if there\'s other criteria.

I mean, I heard on the science panel this morning, and

from other scientists that have presented previously, that

there is still a big debate in the scientific community as

to whether or not these products cause a concern in health

and environmental implications.

And, so, I think to simply set up a voluntary

labeling system at this juncture is not going to serve the

public. Because, for those people \-- and I\'m one of those

people who wants to know whether or not I\'m eating

genetically modified organism in my food. I have no

guarantee that, when I purchase food, that I\'m fully

informed. Or else I am going to have to search out those

foods which have gone through this process and have been

voluntarily labeled, and I may or may not be able find

them when I need them.

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So, I think that there\'s some fundamental issues

that have been brought up through these hearings that need

to be addressed by the agency before any voluntary

labeling or simply making the current consultation process

from voluntary to mandatory should be considered.

COMMISSIONER HOLSTON: Before you comment, I

would just like to say that we want to make certain that

we have adequate time for our oral presentations. So

we\'re getting very close to the end of this part of the

program.

Let me just ask my panel, who else has a

question that they would like to raise? Jim, Bert. Okay.

I just need to gauge how much time we have left.

Please go on.

MS. GOODMAN: I\'ll be very quick. I\'m a

creative thinker, and I always think very positively.

And, when I hear this question, I start thinking: Okay.

Who else could be involved in this process? Well, USDA

should be involved in the process, and EPA should be

involved in the process. And then I realize that this

process is going to open up a Pandora\'s Box, but

essentially it\'s the wrong box.

I think GMO-free standards is looking at the

situation that needs to be addressed in a convoluted way.

If you go towards GMO-free labeling, then you\'re going to

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need regulations. And after regulations, you\'re going to

need enforcement. And enforcement is going to require

testing. And enforcement is going require penalties. And

my question that that would promote would be: Will the

government be funding the cost, the cost of an entity

meeting those standards? Would this become a marketing

program that would be subsidized by the government so that

you could say your product is GMO-free? And I think it\'s

really the wrong box.

I think it needs to go back to the manufacturer

taking the liability and saying, yes; these things are in

our products. And, if the belief is there that they are

okay, and they are safe, then they can do their own

marketing and let the market decide whether or not they

want to purchase them.

\[Applause.\]

MR. BOSSMAN: There are a lot of groups that

would certainly help with the labeling; but, ultimately,

it\'s going to come down to FDA, EPA and USDA, or the

government approving, if you will, those labels. Clearly,

there\'s going to be lawsuits that follow, on one side or

the other, and it\'s got to come down to the government

approving the labels. But you can have a lot of help in

having people help you build them.

COMMISSIONER HOLSTON: Thank you very much.

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And the last question from the FDA panel will

come from Dr. Bert Mitchell.

DR. MITCHELL: Just a quick question, then, for

Dr. Hoban. To the extent that you can here, and

preferably I think for the docket, would you elaborate on

the distinction you introduced there between education and

labeling, as far as the consumer is concerned?

MR. BOSSMAN: Well, very good.

Certainly, there is a distinction. Our feeling

is that any kind of labeling, if you want to make an

informed choice, you need to know what a term on the label

would mean. So if you look now at the nutrition facts

label, people get a lot of information on fat content,

salt content. Often, if their physician \-- they, in other

words, have a reason to care about that issue to start

with. And the education they gain is often sought out as

a result of some of us being a bit overweight and thinking

we should avoid fat, some of us being hypertensive and

want to avoid salt. So we actually go and seek out

information actively.

What we found with this particular issue of

biotechnology is almost the vast majority of things that

people have heard so far have come from the mass media.

They\'ve heard a strory on the news. They\'ve heard a

little bit about it. They really haven\'t delved to deeply

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into the issue. I\'m talking, again, about the 70 percent

of the people that would probably be relatively uninformed

about this, compared to many of you in the room.

So, certainly, as you get more interested in an

issue, you seek out information. You seek out all sides

of the issue. You\'re willing to spend the time and the

mental energy to learn the nuances of these issues, learn

the details of the technology.

All I\'m saying is that, for a lot of people

right now, who have very busy lives, and their most

important problem right now is lack of time, they are

selective in their perception of information. When they

hear about a story, they would like to maybe follow up on

it, learn a little bit more, they would go to a source of

information that they would trust. Increasingly, it might

be on the internet, it might be an 800 number to a food

manufacturer; or, it may, in fact, be to a government

agency. They may try to learn a little bit more about it.

But the information seeking, I just tell you

now, on an issue like this, for a lot of people in this

country, is not going to be very sustained, and it\'s not

going to be very deep. In many ways, they\'re looking to

an organization like yours to tell them, in fact, that you

thought long and hard about the issue, that you made some

tough decisions and some tough choices on these questions.

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But when it does come to education, I think,

clearly, all sides ought to be involved. I\'m on a very

high-level committee right now of the land grant

university system. The land grant system in every state

has a college and has an extension office in every county.

And, in fact, there are many initiatives underway already,

through the land grant system, to get information out to

the leaders, to citizens, to consumers, to farmers, who

are kind of being forgotten in this whole particular round

of discussion so far. But, in fact, I think education has

to give a variety of information, has to have it out there

so that a person that\'s initially interested would then be

able to get it. I don\'t think there\'s going to be any

amount of push of information out there that is going to

get an uninterested person interested in the issue. But,

as they become interested, they want to turn somewhere

they can trust, and, for some people it will be the

organic store. They\'ll go in there and find the

information.

So it has to be widely available. It has to be

openly debated, but have to start with the premise that

not everybody is going to care a whole lot about this

issue, or as deeply, or as passionately as many of us do.

So we have to, in some way, not overload people. Because

that\'s the other thing I think some of you may experience:

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information overload. And this, in fact, issue can get

easily lost among all the other things \-- much as like

what happened in Seattle.

There\'s an interesting analogy for you there.

This was the No. 1 issue for many of you in this room,

probably, going into WTO meetings. But as the average

citizen watched the news, it didn\'t come on the radar

screen very much. So that wasn\'t an education event.

That was maybe a protest event, and other things. I think

education is a whole lifelong process of people gaining

some context, gaining some insight into an issue when they

are interested.

MR. KIMBRELL: I have a very brief comment to

that. First of all, I couldn\'t disagree with you more on

the WTO. I think the American public finally realized

that we have a political issue, not an economic one. And

I think that\'s going to create a tremendous democratic

discussion in this country over the WTO, long overdue. So

I disagree with you about that.

But I think the irradiation issue is a very good

precedent for this agency. There is clearly lots of \--

talk about a passionate issue. If you were to have a

panel on that, you\'d probably get as much as passion as

you see here. People feel very passionate that

irradiation is either \-- can be an extreme health hazard,

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or is no health hazard at all. Okay?

There\'s going to be both those sides getting

information out. The biotechnology industry has a lot

more money than the rest of us, and they\'re getting all

their information out all the time. We do the best we

can, as well. That\'s still going to happen. But that is

no excuse this agency not obeying the law. You obey the

law on irradiation. You ordered, correctly, the labeling

of irradiated whole foods. You had a label. You came to

terms with the label. That\'s the way this agency should

behave. Not the way it\'s behaved with genetically

engineered foods. That is, as I said, a regulatory

scandal.

COMMISSIONER HOLSTON: Unfortunately, we are out

of time for this part of the agenda. But before we turn

to the section of the program where we are going to hear

oral presentations from the members of the audience, I

would like to thank, very much, the members of the panel.

Not only those who are on the stage at the moment, but

those who presented earlier this morning. We have heard

very thoughtful discussions from each and every one of

you. We certainly are going to consider all of the

comments that we\'ve heard, both this morning and this

afternoon. I expect that we will be hearing a lot more

from the audience after we take our break, and we will

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also be looking at the comments that go to the docket.

But let just say, once more, how much we

appreciate the time and effort that went into your

presentation and thank you again very much.

We are now going to take a 15-minute break.

We\'re running a little bit behind schedule. We will start

promptly at five minutes after 3:00.

\[Applause.\]

\[Fifteen-minute recess.\]

COMMISSIONER HOLSTON: Could we have your

attention, please.

SCHEDULED PUBLIC PRESENTATIONS

COMMISSIONER HOLSTON: During this part of the

meeting, we are going to hear from those who have

requested time to address the meeting. And, as I

mentioned this morning, we received a very large number of

requests to speak at this meeting, and we want to

accommodate all of them. However, our time is quite

limited. We do have a feed going to San Francisco. We

must end promptly at 6:00 p.m. And, therefore, we\'re

asking each speaker to bear with us, and, as a courtesy to

everyone else who wants to make comments, respect the

two-minute time limit we have to place on the remarks of

each participant.

But, as I also emphasized this morning, we

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encourage every one to submit full written comments to the

FDA docket, whose address is in your information folder.

This docket will remain open through January 13, 2000.

Also, the speakers will have an opportunity to

address the meeting in the order in which they arrived

this morning, and they received a folder with a number

that lists their position.

Bob Lake is going to moderate this portion of

the meeting. Please, when you come forward, would you

state your name and the organization, if any, which you

represent. Thank you.

Bob.

MR. LAKE: Just one other thing. We do have a

timekeeper over here. On the podium there, when you

start, the green light will come on. At the halfway mark

of one minute, the yellow light will come on; and, when

the two minutes is over, the red light will start to

flash, and I will thank you and ask the next speaker.

Again, we will maintain a steady line of speakers so that

we don\'t have time between speakers.

With that, let\'s get started. Go ahead sir.

STATEMENT OF

MARK LIPSON, POLICY PROGRAM DIRECTOR

ORGANIC FARMING RESEARCH FOUNDATION

MR. LIPSON: Thank you, Madame Deputy,

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panelists. My name is Mark Lipson. I\'m with the Organic

Farming Research Foundation. My remarks are with a title

borrowed from our computer system: System Failure, Abort,

and Retry.

OFRS is not categorically opposed to every use

of bioengineered in agriculture, but the Federal

Government has fundamentally failed to provide an adequate

regulatory regime for transgenic foods. The division of

responsibilities among FDA, EPA, and the USDA assures that

there is no comprehensive oversight governing transgenic

organisms released into the environment and the food

supply. The environmental agricultural food safety and

food security issues cannot be considered in isolation

from each other, and sound public policy has not been and

cannot be formulated in this fragmented system.

As a consequence of this policy failure, nobody

ultimately is in-charge except the biotech industry

itself, and perhaps some its university subsidiaries.

Unless and until a new system is put in place, a

moratorium on all transgenic food and agricultural

applications should be imposed.

Regarding the six specific issues posed for this

meeting, FDA\'s consultation process has failed to assure

public safety and it has helped to undermine confidence in

the products of U.S. agriculture. You should be scrapped

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immediately.

New information related to the safety of

bioengineered foods include the emerging knowledge, an

awareness of ignorance about the effects of transgenic

plants in the agricultural environment and livestock

physiology.

No. 3, the powerful and uncertain qualities of

current and planned transgenic food events demand a

complete overhaul of the government\'s approach to food

safety testing and oversight.

No. 4, FDA\'s labeling policy has failed to serve

the public interest. It is imposing unacceptable costs

and risks on the farmers and manufacturers \--

MR. LAKE: Thank you.

MR. LIPSON: \-- who don\'t want anything to do

with transgenic foods.

Thank you.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

DEBORAH P. DELMER, PROFESSOR/CHAIR,

SECTION OF PLANT BIOLOGY, UNIVERSITY OF CALIFORNIA, DAVIS

SPEAKING ON BEHALF OF

THE AMERICAN SOCIETY OF PLANT PHYSIOLOGISTS

DR. DELMER: Thank you. My name is Deborah

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Delmer, and I\'m a professor and chair of the Section of

Plant Biology, at the University of California at Davis.

I\'m speaking \-- my comments are on behalf of myself, as a

plant scientist, and also on behalf of the American

Society of Plant Physiologists, which is a nonprofit

society of 5,000 plant scientists, who have elected me to

be their president this year.

So, in only two minutes, one cannot make much of

a point. I only want to make one point, from the point of

view of scientists. Many of the procedures that were used

to generate bioengineered plants were developed by

scientists like myself and my colleagues within the

society. And, so, we use these techniques daily in our

own laboratories. We understand what vectors are, what

promoters are. We understand the mechanisms involved.

And, understanding those things, the vast majority of the

members of our society believe that there\'s nothing

fundamentally unsafe about the directed targeting of a

specific gene into a plant. And it is, in fact, a more

directed process, as we\'ve heard today, than many of the

conventional breeding processes in which many genes are

introduced at one time.

Now, lacking time to really defend that issue

here, I will only finish by saying that many of us plant

scientists realize, now, that the information gap is

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serious, the issues are very complex, and we can\'t begin

to explain our point of view with sound bites. So, we

urge the press and concerned organizations to draw upon

us, FDA as well, because we do understand the issues

involved, at least in the development of the technology.

We\'d be happy to participate in more in-depth dialogue to

help solve the information gap.

Thank you.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

SHARON LANINI

EXECUTIVE DIRECTOR

MONTEREY COUNTY FARM BUREAU

MS. LANINI: Good afternoon. My name is Sharon

Lanini. I\'m the executive director of the Monterey County

Farm Bureau and a third generation California farmer. I\'m

also a graduate of the University of California at Davis

in the biological sciences.

I\'d like to address the basic questions of this

hearing today: The validity of FDA\'s current policy, as

it relates to agricultural biotech, and the labeling

issue.

My answer to these basic questions is that I

believe that the current FDA policy is science-based and

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sound, and has worked very well for the last 5 years.

Therefore, it has protected the fundamental safety and

nutritional quality of our food and feed products to all

end consumers.

As to the question of public information on

biotech, adding mandatory biotech labels to ag products

would, at best, be innocuous and generally ignored by the

consumers; and, at worst, would actually mislead consumers

and confuse the entire issue. Which, paradoxically, is

what mandated labeling is supposedly trying to prevent.

Mandatory labeling is a bad idea.

Information about biotech can and should be made

more accessible to all interested parties. There are a

variety of ways that this can be done: through consumer

web links, hot phone lines, outreach by credible

university scientists, nutritionists, supplying

information throughout the food, fiber and feed chain.

The bottom line is: The United States currently

provides a strong safety net for agricultural biotech

products. Biotechnology and its ag products can literally

provide tremendous potential to enhance the quality of

life globally, with improved nutritional characteristics,

decreased environmental impact that literally saves lives.

The government regulators at FDA, USDA and EPA, who all

have regulatory authority over biotech products, must

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continue to communicate and coordinate their efforts and

help agriculture promote the development of new biotech \--

MR. LAKE: Thank you, ma\'am.

MS. LANINI: \-- tools for our nation\'s most

important industry, agriculture.

Thank you.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

MARY WANG, Ph.D.

FOOD AND DRUG SCIENTIST, FOOD AND DRUG BRANCH

CALIFORNIA DEPARTMENT OF HEALTH SERVICES

SPEAKING ON BEHALF OF

ASSOCIATION OF FOOD AND DRUG OFFICIALS

DR. WANG: Good afternoon. I am Dr. Mary Wang,

representing AFDO, the Association of Food and Drug

Officials.

AFDO is nonprofit professional association

consisting of state, federal and local regulatory

officials. For 103 years, AFDO has actively promoted

uniformity and cooperation within the regulatory arena.

We appreciate this opportunity to present our comments.

AFDO has supported FDA\'s 1992 policy guide. It

applies to all developers of new plant foods where the

safety must be based on individual product

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characteristics, rather than the development methods. The

policy guide has, since then, served as the industry\'s

gold standard. If maintaining consumer confidence in food

safety, oversight requires it, AFDO would support an

agency requirement for pre-market notification. AFDO does

not believe that a pre-market approval process is

necessary. And, with limited resources, additional

requirements in regulatory and enforcement activities must

only be in priority areas of consumer safety.

A food label must be truthful and not

misleading. When there is a safety concern, all food

labels must address that concern on an individual product

basis. When there is no identified safety concern about

bioengineered foods, as a class, special labeling is

unnecessary and should not be required. Further, requiring

special class labeling would place additional enforcement

burdens on state regulatory agencies without added health

protection.

AFDO urges the FDA to carefully consider other

options to better inform the consumers. FDA should

conduct a scientific study, one that is similar to the

consumer survey, that\'s acceptance and use of nutrition

labeling to determine whether new special labeling

regulations would benefit consumer health and safety.

Lastly \--

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MR. LAKE: Thank you, ma\'am.

DR. WANG: Thank you.

STATEMENT OF

ANN M. COULSTON, M.S., R.D.

IMMEDIATE PAST PRESIDENT OF AMERICAN DIETETIC ASSOCIATION

SPEAKING ON BEHALF OF

CALIFORNIA DIETETIC ASSOCIATION

MS. COULSTON: Thank you. Good afternoon.

My name is Ann Coulston, and today I represent

the California Dietetic Association, an affiliate of the

American Dietetic Association. It\'s a group of 7,000

dedicated dietetic professionals.

We are advocates for the safe and nutritious

food of all. We know that the public needs accurate and

clear information regarding engineered food. At the same

time, however, we appreciate that not everything is known

about the hazards, if any, of these products to the

consumers or the environment.

For some time now, those who promote genetically

modified crops, and those who oppose them, have squared

off in a highly public struggle. But these individuals,

and often unyielding perspectives on biotechnology, can

mislead the public and professionals.

The Food and Drug Administration must take an

active role in educating American consumers by dispelling

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biotechnology myths on both sides of the debate. We must

recognize that the biotechnology revolution is only in its

infancy. A few genetically modified crops and foods that

exist now are mere novelties compared to what will be

available to consumers in the imminent futute. The walk

through the supermarket of tomorrow will be a thrilling

experience for those equipped to embrace and understand

these new products; but, for those who are unprepared for

and unfamiliar with the language of biotechnology, it will

be an alien and alienating experience.

As nutritionists, we believe that we are in an

excellent position to contribute to FDA\'s effort in

informing consumers about the potential benefits and risks

of foods and food products derived from biotechnology.

Members of the American and the California Dietetic

Association meet the consumer daily in schools, hospitals,

clinics, supermarkets, community settings, and through the

media.

We believe the U.S. consumers, accustomed to a

system that has served them well, have been patient as the

information on biotechnology comes together and has been

available to them. It is now time to act. This complex

issue requires a coordinated approach \--

MR. LAKE: Thank you, thank you, ma\'am.

MS. COULSTON: \-- directed by the FDA.

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\[Applause.\]

MR. LAKE: Go ahead.

STATEMENT OF

DAN STEINBERG

MR. STEINBERG: Hi! My name is Dan Steinberg.

I live in San Francisco. I don\'t represent any particular

organization, but am a member of the Organic Consumers

Association.

According to the FDA policy of substantial

equivalence, if a genetically engineered food is

chemically similar to its conventional counterpart, it is

assumed to be safe for prolonged and widespread public

consumption. This policy is not supported by empirical

research, is obviously preferential to the biotech

industry, and directly contradicts the advice of FDA

scientists.

Significantly, the FDA has lied to the public

about information it has regarding the safety of

genetically engineered foods. In it\'s official statement

of policy on genetically engineered foods, the FDA states:

\"The agency is not aware of any information

showing that foods derived by these methods

differ from other foods in any meaningful or

uniform way, or that, as a class, foods

developed by the new techniques present any

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different or greater safety concern than foods

developed by traditional plant breeding.\"

The legality of the FDA policy on genetically

engineered foods is based on this lie. Internal FDA memos

disclose that several FDA scientists absolutely did not

agree with this assessment. For example: Dr. Linda Call,

at the FDA, stated in a memo to Dr. Maryanski, quote:

\"The processes of genetic engineering and

traditional breeding are different; and,

according to the technical experts in the

agency, they lead to different risks. There

is no data that addresses the relative

magnitude of the risks.\"

Dr. Call also went on to state that the agency

was, quote, \"\...putting a square peg in a round hole\" by

trying to force an ultimate conclusion there is no

difference between foods modified by genetic engineering

and foods modified by traditional breeding practices.

Although the FDA and the biotech industry claim

biotech foods have been extensively tested for safety, the

tests to which they refer are not empirical animal tests

or epidemiologically studies of humans. They are not

safety tests. They are simply chemical assays that do not

provide evidence of safety, per se. They are provide

measurements of the concentrations of a selected list of

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chemicals. Nobody has ever shown that safety of

genetically engineered foods, or any other foods, can be

assured by limited chemical assays.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

CHERISA YARKIN, Ph.D.

ASSOCIATE DIRECTOR OF ECONOMIC ANALYSIS

UNIVERSITY OF CALIFORNIA BIO STAR PROJECT

DR. YARKIN: Hello. I\'m Dr. Cherisa Yarkin.

I\'m with the University of California Biotechnology

Program.

From an economic \-- I\'m an economist, and, from

an economic standpoint, I would say that the FDA\'s focus

on product, rather than process, is absolutely

appropriate. In that way, you give plant breeders,

farmers, and others, an incentive to focus on what we care

about, in this instance, which is food safety. And you

don\'t constrain a priori the techniques that they use to

achieve that goal. That means that they can take

advantage of the advances in scientific knowledge and

technology over time.

Suppose you were to regulate the process of

modern biotechnology. Plant breeders would continue to

develop new cultivars, as needed, in agriculture. They

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would just be constrained to use other ways of developing

these traits, which could include, as we\'ve heard,

chemical mutagenesis, irradiation, cross-breeding with

wild relatives, none of which we have found scientific

evidence is any safer either from a food-safety standpoint

or environmentally.

The costs here are not only the direct costs of

regulation there, for they\'re the opportunity costs. What

are we foregoing by choosing to propose to focus

regulatory attention on modern biotechnology and not

continue this FDA current view of looking at food products

and considering any modification technique?

We run the risk of a longer time relying on

older methods. So chemical pesticides, for example, will

be around perhaps longer if you force plant breeders to

forego modern biotechnology as a means to find plant

resistance for our agricultural crops.

I want to address, very briefly, the labeling

issue \--

MR. LAKE: Thank you, ma\'am.

DR. YARKIN: I\'m sorry. Thank you.

STATEMENT OF

MARGARET CLARK, DIRECTOR OF LEGAL SERVICES

OREGON TILTH CERTIFIED ORGANIC

MS. CLARK: Good afternoon. I\'m Margaret Clark.

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I\'m the director of Legal Services for Oregon Tilth

Certified Organic. I was a retailer for a number of

years. I\'m also the chairman of the Task Force on GMOs

for the Organic Trade Association.

Oregon Tilth certifies over 300 organic farms

and 325 processors in the United States and around the

world.

We believe strongly, with the rest of the

organic industry, that consumers have a right to make

informed food choices. The organically grown label tells

consumers that food is produced in compliance with the

Federal Organic Food Production Act of 1990. GMOs do not

meet the criteria set out in that act. No organic

certifier has ever allowed them. A large number of

consumers want to buy food produced without GMOs, as

evidenced by the 20 percent increase in our industry

yearly.

Not requiring labeling of GMO foods creates a

situation where consumers can only make that choice by

purchasing organic. Organic production requires identity

preservation, as you\'ve heard, or what we call organic

integrity, by segregating organic crops from conventional,

and protecing them from contaminants. For organic

purposes, GMOs are contaminants.

Some recent testing of organic crops have shown

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contamination by GMOs, probably from pollen drift in corn,

or storage with soy. This has resulted in substantial

economic losses. Organic farmers bear considerable

additional costs to prove that they don\'t use chemicals.

GMOs should be labeled and the costs of labeling

should be placed on those who use them.

MR. LAKE: Thank you.

MS. CLARK: Organic farmers shouldn\'t have to do

this.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

MR. LAKE: Go ahead.

STATEMENT OF

DR. MARK LAPPE

CENTER FOR ETHICS AND TOXICS

DR. LAPPE: My name is Mark Lappe. I direct the

Center for Ethics and Toxics. In another capacity, I\'m a

consultant to you, at the FDA, and your medical devices

division.

Now I\'m not talking to you in any official

capacity, but I would like to talk to you an offer the

advice that I\'m frequently asked to give to that division

about ethical issues relating to genetic engineering, and

the posture that the agency has taken on the issue of

labeling.

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Specifically, the FDA has unfortunately treated

the issue with benign neglect. It\'s going to catch up

with. There is a groundswell of public opinion, much of

which you\'ve seen in your hearings, which you\'ve

generously given over the last three sessions. This issue

is real. The public\'s concerns are bona fide.

There are studies, as you will see, that are

beginning to demonstrate subtle differences between

genetically engineered and conventional crops. I\'ve

submitted to the panel such a study for your review.

As a public health advocate, though, I have to

say that I\'ve questioned the adequacy of the testing that

you\'ve undertaken. I don\'t see that you\'ve tackled this

issue with the kind of agression it needs. When we filed

the Freedom of Information Act request to get all of the

BT studies in your files, there were none. Perhaps

they\'re at the EPA. They belong in your files. Ingestion

of potentially contaminated food is squarely within your

domain. Thank you.

\[Applause.\]

MR. LAKE: Thank you, sir.

STATEMENT OF

SUE MARKLAND DAY

PRESIDENT, BAY AREA BIOSCIENCE CENTER

MS. MARKLAND DAY: Good afternoon. I\'m Sue

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Markland Day, the president of the Bay Area Bioscience

Center, and a former staffer to the House of

Representatives Agriculture Committee. I was a specialist

in family farms and initiated the first Organic Farming

Act.

The Bay Area Bioscience Center is a 9-year-old,

independent nonprofit, headquartered in San Francisco..

The BABC\'s mission is to strengthen Northern California\'s

climate for bioscience research, development and

commercialization through public education outreach. Our

region is home to more than 120,000 professionals, not

including those in education, medical care, who rely on

life sciences for their livelihood.

As to the question of labeling, the consumer

certainly has a right to know what is in his or her food.

Replacing the words \"genetically engineered,\" \"genetically

modified,\" of \"bioengineered\" on a label does not provide

content information. Just labeling of food, as to its

development process, does not inform the consumer that a

grain, fruit, or vegetable has improved nutritional

values, such as contains 100 percent of one daily

allowance of Vitamin A, or is grown without the use of

chemical pesticides.

Labeling for content may make sense. But

labeling for process technology will not make food

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labeling \-- will make food labeling incomprehensible and

misleading. Consumers have a right to understand the

content of food, but modification to the seed, or

otherwise, whether genetically altered or not, is not the

key. Nutrition and safety is. Labeling of food, if

genetically modified at all, does not inform the consumer

that FDA considers the food product and that the USDA, EPA

review for safety and ecological impact was acceptable.

This is the type of information I, for one, would find

most useful.

In conclusion, food product labels can provide

an excellent opportunity to inform the public about food

content and the role of FDA, USDA, and EPA in food safety.

Improved nutritional content is another already modified

by FDA as appropriate for labeling.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

IRVIN J. METTLER, Ph.D.

MANGER, TECHNOLOGY ACQUISITION AND CONTRACTS

SEMINIS VEGETABLE SEED, INC.

DR. METTLER: Good afternoon. My name is Irvin

Mettler, and I\'m representing Seminis Vegetable Seed

Company.

Seminis Vegetable Seed Company is a leading

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vegetable seed company active in worldwide markets. We

produce over 60 different crop species, and over 2,000

different varieties of seeds in our market.

As a seed company, we basically sell genetics or

new combinations of genes, and are committed to providing

our growers with improved agronomic characteristics, such

as insect, disease, stress and increased yield; and, for

the consumer, improved quality traits, such as color,

taste and nutrition.

Currently, using what can be called classical

breeding methods, each year we release hundreds of new

varieties of vegetable crops for sale. Each of these have

hundreds, perhaps maybe even thousands, of new

combinations of genes. And many of these also have new

organoleptic properties, nutritional qualities, et cetera,

which some this afternoon mentioned may require labeling.

Based on our experiences, the existing FDA guidelines have

been transparent, effective, and have functioned to assure

the safety of our food supply.

On a final note, I would just like to relate my

own personal experience observing the safety of

genetically modified corn plants that have been engineered

to be resistant to insects, using the BT gene. In 1995, I

visited a field trial in Northern Iowa, where the

conventional corn was compared against the BT corn. This

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was a year of high insect pressure; and, when we went down

the row of conventional corn, every ear had been chewed,

the kernels had been damaged. Even worse, had been

infected \--

MR. LAKE: Thank you, sir.

STATEMENT OF

PETER M. ROSSETT, Ph.D.

EXECUTIVE DIRECTOR, FOOD FIRST

THE INSTITUTE FOR FOOD & DEVELOPMENT POLICY

DR. ROSSET: My name is Peter Rosset. I have a

Ph.D. in biology from the University of Michigan. I\'m the

executive director of the Institute for Food & Development

Policy.

I have submitted written comments, which I will

not read, but which are titled: \"Ten Reasons Why

Biotechnology Will Not Insure Food Security, Protect the

Environment, or Reduce Poverty.\" They summarize

scientific research, put together by our institute,

basically rebutting the two principle public relations

claims of the industry, as to why we need these foods and

these crops so rapidly, which are, (1) that they will help

feed the hungry; and (2) protect the environment. We show

quite conclusively that both of these claims rest on false

assumptions.

However, since there is limited time, what I

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would do is: If there are any members of the media who

would like a copy of the written statement, I have them

available. Therefore, as I said before, I will not read

them. Instead, I would like to take the minute remaining

to me to make two comments.

The first is addressed to those of you who have

read the New York Times in the last few days. In that

sense, I would like to state, for the record, that I have

not been paid by Monsanto, or any public relations firm

retained by any biotechnology company to appear here. Nor

have my transportation or meals been paid by any

biotechnology company. And I think it\'s important to

state that up front.

The second point I\'d like to make is about the

nature of public hearings. Allowing only 1 hour and 50

minutes at the end of a long day, after most of the media

have left, for the public to speak, makes a mockery of our

democratic process, and a mockery of the phrase \"public

hearings.\" I think the FDA \--

\[Applause.\]

\-- has the democratic duty to engage in a real

discourse, a real discourse, with members of the public.

Thank you.

\[Applause.\]

MR. LAKE: Thank you, sir.

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//

STATEMENT OF

BETH BURROWS

PRESIDENT/DIRECTOR, THE EDMUNDS INSTITUTE

MS. BURROWS: I\'m Beth Burrows, president and

director of The Edmunds Institute, a public interest,

nonprofit organization, dedicated to research and

education about environment and technology.

This year, I attended biosafety discussions in

Cartegena, Columbia; Vienna, Austria; New Delhi, India;

Burlington, Vermont; Bryansk, Russia; and Seattle,

Washington, to name a few of the venues. And I think it

is safe to tell you what you must undoubtedly already

know, notably that people the world over are concerned

about the safety of genetically engineered food. They do

not believe you, and they will avoid, by any means

necessary, to avoid having such food shoved down their

throats. I advise you to read their lips.

In answer to the question of whether FDA

policies have served the public, I, as representative of

my Institute, can only say: No, no, very sadly, no; they

have not.

The policies, that have put unlabeled

genetically engineered food that has not been stringently

and independently tested onto the world\'s plates, are

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policies that have led to a loss of confidence in the

quality and safety of our food and the agricultures that

produce it. To a loss of confidence in FDA\'s willingness

to regulate. To a loss of confidence in FDA\'s

independence and integrity. To a loss of confidence in

FDA\'s ability to differentiate absence of evidence of

hazard from absence of evidence of looking for hazards.

To a loss of confidence in FDA\'s ability to trace future

public health problems back to novel foods that have been

allowed onto our marketplaces unlabeled. To a loss of

confidence in FDA\'s ability to serve the common good in

the face of encumbering a promising industry. To a loss

of confidence in FDA\'s ability to understand that,

although science may inform the decision making, it should

not be the sole decision maker. And finally, to a loss of

confidence in FDA\'s ability to understand what is meant by

genuine public dialogue, or how to conduct a respectful

public hearing.

Thank you.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

CLAIRE CUMMINGS, ESQ.

KPFA RADIO REPORTER

MS. CUMMINGS: My name is Claire Cummings. I\'m

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here representing just myself.

I have about 30 years experience in agriculture

and food. I used to be a USDA attorney and a former

special assistant U.S. Attorney, and I\'m here mostly in my

capacity as a journalist covering food and farming issues,

to talk about the question of how your communicating with

the public. You\'ve made it really difficult to attend

this hearing and to speak to you, and I think that speaks

for itself in many ways. It\'s been really difficult for a

lot of people to be here.

I think one of the reasons I used to be a part

of the Federal Government was because I really believed in

public service. I want to appeal to that part of

yourselves that also may believe in public service, and to

understand that the proper role of the government is to

stand between the merchants of greed, like Monsanto, and a

trusting public. If you\'re feeling that you have trouble

communicating with the public, it\'s because you\'re not

acting with integrity in these issues. You\'re acting as

if, you\'re acting as if you\'re interested in the public,

instead of acting in the public interest.

I also want to say that my other personal view

is that there are moral implications to biotechnology, and

I want to represent that. I gave a sermon recently here

in Oakland on the moral implications of genetic

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engineering called the \"Comodification of the Sacred,\"

which is what I think we\'re having, we\'re dealing with

here. And I don\'t think I\'m alone in holding that 6

billion years of evolution, that species line that\'s being

violated by recombinant DNA technology is a violation of

something sacred. And I would like to invoke that, as

well.

I think the public deserved to be respected in

their feelings on these issues. Thank you.

\[Applause.\]

MR. LAKE: Thank you, ma\'am.

STATEMENT OF

PEGGY G. LEMAUX

UC COOPERATIVE EXTENSION SPECIALIST

MS. LEMAUX: My name is Peggy Lemaux. I\'m a

cooperative extension specialist at the University of

California. Although professionally, I represent an

important public institution, I also grew up on a farm, am

a consumer and a mother. I\'m concerned about the nature

and the safety of our food.

Since the 1970s, I\'ve been engaged in the fields

of classical genetics and genetic engineering. As such, I

think I\'m able to evaluate the scientific risks involved

in the use of these new technologies. Most individuals

don\'t have this background. I don\'t have the background

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to evaluate the vagaries of the stock market.

Because many individuals aren\'t able to evaluate

the new food products being developed with classical and

modern genetic technologies, regulatory agencies have that

responsibility. They must make decisions about risk based

on sound science. Scientists have the responsibility to

provide adequate, additional, independent assessments of

risk through carefully controlled, peer-reviewed studies.

As consumers, we can then use that information to help us

make decisions about out own personal safety, which we

define as acceptable risk.

In the popular press, many articles discussing

foods developed through biotechnology have focused on

possible or imagined risks. Should these foods developed

using the new genetic technologies be labeled? For food

safety reasons, as a practicing scientist, I\'d say no. The

foods developed using the new tools are not zero risk, but

they\'re not inherently more risky than foods developed

through classical genetics. For consumer choice reasons,

again, I would say no. U.S. consumers look to food labels

to provide information on the composition and attributes

of foods, not to the details of agricultural or

manufacturing processes used to produce it.

Labeling a fresh fruit or vegetable would be

fairly simple, although it really wouldn\'t provide the

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consumer with much information. With a processed food,

like ketchup, which might contain 6 different varieties,

each with its own new gene, labeling becomes complicated.

As a scientist, I know what would be required to monitor

that ketchup for those genes. I personally can\'t support

a system that would raise the price of food significantly

for everyone.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

JAMES DIAMOND, M.D.

BIOTECHNOLOGY TASK FORCE, SIERRA CLUB

DR. DIAMOND: Hello. I\'m Jim Diamond,

representing Sierra Club, our nation\'s largest grass roots

conservation group. I\'m a pediatrician.

I\'ve admired the work of the FDA in regulating

drugs. Transgenic agriculture has gone from zero to 80

million acres in 5 years. This is astonishing. Like all

new technologies, it involves risks, some foreseeable,

others not. We could draw parallels to the introduction

of the automobile. Car crashes were foreseeable, smog

wasn\'t. We speak, of course, about foreseeable risks, but

unknown risks are very important, also. A reminder that

decisions based on sound science can be wrong. We need

some humility. We need to know that our knowledge base is

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always changing and a caution is the key element of

judgment.

Two minutes isn\'t enough. Speaking as a

consumer, I\'d like to know what I\'m buying and eating.

Speaking as a physician, I know that they\'re public health

risks involved in having pesticides and

antibiotic-resistant genes engineered into our food.

Speaking as an environmentalist, I know that taking genes

from one species and putting them into different, entirely

different, species is not substantially equivalent to

anything we\'ve ever done before.

The agency\'s position that the public has

nothing to worry about isn\'t science. Science calls

things by name and takes a good hard look. The Sierra

Club is asking for just that, clear labels, so we know

what we\'re dealing with. Good science, not all done by

industry and not protected by trade secrecy provisions.

We call for informative labels, such as: This corn

contains a bacterial gene coating for an insectidial

antitoxin. Human health effects are unknown.

On behalf of the Sierra Club, thank you very

much.

MR. KIMBRELL: Thank you, sir.

\[Applause.\]

//

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//

STATEMENT OF

THERESA SELFA

RURAL SOCIOLOGIST

MS. SELFA: Hi! My name is Theresa Selfa, and

I\'m here just as a consumer.

I would like to express my concern that foods,

which contain GMOs need to be labeled. As a conscientious

consumer, a mother, and a rural sociologist, who works on

food, agriculture and community development issues in the

U.S., as well as in developing countries, I would like to

have this information so that I can make choices about the

food I eat. I\'m concerned that GMO foods have not been

sufficiently tested to determine both human and

environmental effects.

I am concerned that genetically engineered foods

are being promoted by the same few corporations, which now

completely dominate the food industry. This consolidation

has not only created power for monopolies, but has also

been linked to economic declines in the farm economy,

particularly for small farmers.

Finally, while these corporations are promoting

genetically engineered as an essential solution to world

hunger, I see just the opposite. Right now, farmers in

Washington State, which is where I live, and across the

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U.S., are suffering from an overproduction crisis, leading

to low prices. Many are going out of business. Farmers

can\'t even cover their costs of production, and the

numbers of hungry people in the U.S. and around the world

are increasing. So this obviously is not a production

problem, but a distribution problem. And I don\'t see how

giving increased power to a few corporations will do

anything to solve this problem.

Thank you.

\[Applause.\]

MR. LAKE: Thank you, ma\'am.

STATEMENT OF

RICHARD L. MATTEIS

EXECUTIVE VICE PRESIDENT, CALIFORNIA SEED ASSOCIATION

CALIFORNIA GRAIN AND FEED ASSOCIATION

MR. MATTEIS: I\'m Richard Matteis. I\'m the

executive vice president of the California Seed

Association and the California Grain and Feed Association.

I wear both hats.

I\'d like to commend the FDA for holding this

meeting here today, and the process I think is working

well. We do support the current regulatory program, as

is. It\'s clear from the testimony today that there\'s many

benefits from the production of foods through

biotechnology.

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With regard to the consultation process, we

support the voluntary process that is in place now, and

feel that it is working. That is evidenced by the fact

that there is not one shread of evidence of any single

food safety problem occurring from the use of

biotechnology to produce foods; and, therefore, it is

working.

We see companies involved in producing seed

which have been selecting for traits for hundreds of

years. They\'ve used various means to do that:

cross-breeding, hybridization, and now this newest

technology, biotechnology. Some years hence there may be

some other techniques that we use to do that. But I can

assure you that the companies involved are intent on

producing a product that is safe.

Let\'s not confuse the fact, either, that the

seeds that are produced through biotechnology are not the

ultimate foods. Those are a different thing. We heard a

smoke-screen argument about things being patented,

therefore they\'re different. The process may be

different, the seed may be different; but the end food

product is substantially equivalent.

With regard to labeling, we are opposed to

mandatory labeling of these products. We feel, as there

are consumer benefits that are promoted, other than the

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production benefits we have now, that those companies

selling those products will want to clearly get that

information to the public so that they can take advantage

of that intended market. The market will drive that

issue.

Just pointing on my Grain and Feed hat for a

second, we have spent millions of dollars in this state

alone to protect our milk supply, and other food products,

from contamination by aflatoxin. There is very real

evidence that, through this technology, we\'re going to be

able to reduce the microtoxins that occur in our feed

products.

I think FDA does have a role to play in

providing information to the public so that there not

confused.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

SIMON HARRIS

BIODEMOCRACY CAMPAIGN

MR. HARRIS: HI! My name is Simon Harris. I\'m

speaking on behalf of Biodemocracy.

I don\'t really have any comments, but I would

like to propose a few questions to the panel.

How can a federal agency be simultaneously

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responsible for regulating and promoting a technology,

genetic engineering, which has the potential to devastate

ecosystems, cause massive public health epidemics, and

ruin the livelihoods of farmers in rural communities

worldwide?

Why are you holding these hearings in 1999, a

year in which tens of thousands \-- sorry \-- tens of

millions of acres GE crops are planted, instead of five

years ago before the first genetically engineered foods,

diary products derived from Monsanto\'s genetically

engineered bovine growth hormone were surreptitiously

slipped into our food supply?

Global agriculture now produces a 50 percent

surplus in terms of global food needs, so why should we

believe that the alleged yield increases of genetically

engineered crops will do anything to address the problems

of food distribution and poor people\'s access to food?

How can these genetically engineered crops feed

the hungry people of Asia, Africa, and Latin America when

most of them are fed to livestock to support the developed

world\'s insatiable appetite for meat products?

How can you consider the insertion of a fish

gene into a tomato, or human genes into pigs, to be

substantially equivalent to selecting plants each year

which grow taller or bear more fruit than their

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counterparts?

How can we believe that a company like Monsanto,

who makes the world\'s largest selling herbicide, is

actually interested in reducing chemical use by farmers?

Why are FDA\'s officials time and time again

found to have financial conflict of interest with the

very companies whose products they\'re approving?

Why are the results of independent scientists

discounted as inaccurate while the findings of those on

agribusiness payrolls, like today\'s demonstration by he

so-called Coalition of Concerned Scientists, considered to

be unquestionable scientific fact?

Why should a few companies, whose abysmal past

track records concerning the environment, human health and

corporate accountability be allowed to control the world\'s

seed and food supply?

I would like to conclude by asking my first

question again: How can a federal agency be

simultaneously responsible for both regulating and

promoting a technology, genetic engineering, which has the

potential to devastate ecosystems, cause massive public

health epidemics \--

MR. LAKE: Thank you, sir.

MR. HARRIS: \-- and ruin the livelihoods of the

farmers and communities worldwide?

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\[Applause.\]

MR. LAKE: Go ahead.

STATEMENT OF

KATE BURROUGHS

HARMONY FARM SUPPLY

MS. BURROUGHS: Hi! My name is Kate Burroughs.

I\'m co-owner of Harmony Farm Supply. Thank you for

holding the public hearing to take input regarding

genetically engineered food.

As a consumer, I demand the right to choose what

kind of food I am eating. At a bare minimum, the FDA must

make it mandatory immediately that all foods that contain

any GE, GMO ingredients be clearly labeled, regardless of

whether it is a major or minor ingredient. As part of my

moral and spiritual beliefs, it is critical that I not eat

bioengineered foods as currently available in the

marketplace.

The current products of the bioengineers break

two of Ghandi\'s seven deadly sins: Commerce without

morality, and science without humanity. How dare FDA

determine GE foods are comparable to non-bioengineered

foods when there have been no long-term feeding studies

done on any GE crops. The short-term studies show there

can be increased allergens in GE foods, that antibiotic

resistant marker genes were routinely used in GE crops and

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increase the risks humans becoming resistant to

antibiotics. And some GE crops, like GE potatoes, have

been shown to be poisonous to mammals, resulting in vital

organ damage and immune system damage.

There is also the issue of food quality and

nutrition in GE foods. Several studies show reduced

nutritional value in GE foods. I refuse to be a guinea

pig or lower my standard of eating so the bioengineers can

recoup their billions of dollars of investment.

FDA must require stringent pre-market animal and

human studies to ascertain whether new allergens of toxins

are present in genetically engineered foods. Voluntary

compliance is not enough. Bioengineers are the same

companies that brought dioxin-contaminated Agent Orange

herbicide and other environmental disasters. They don\'t

exactly have a sterling track record for voluntarily

removing unsafe products from the marketplace. The

overall problem is a lack of respect for the complexity of

life and food webs.

As a certified organic farmer, I am furious that

GE crops are being allowed to genetically pollute other

crops being grown within wind distance of GE crops. The

potential for the creation of superweeds and superbugs is

imminent, and I don\'t see EPA or FDA making any attempts

to stop it. Do the right thing and make GE products

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labeled.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

RITA MITCHELL, PRESIDENT

CALIFORNIA NUTRITION COUNCIL

UNIVERSITY OF CALIFORNIA

MS. MITCHELL: My name is Rita Mitchell. I am a

registered dietitian and president of the California

Nutrition Council, a nonprofit organization of nutrition

professionals. CNC members have expertise in influencing

nutrition policy in California, and in communicating

nutrition information to the public.

Few issues in recent years have sparked more

interest or passion than bioengineered foods. CNC

acknowledges that some consumers are concerned about the

safety of bioengineered foods. We encourage consumers to

study the issues carefully and consider sound science when

making food decisions. We believe that consumers have a

right to information so they can make informed choices.

New plant production and processing techniques

have provided society with tools to alleviate pressing

problems in human health and environmental stewardship.

Food biotechnology has the ability to provide benefits for

both consumers and producers. For example: It has helped

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enhance the quality, shelf life, nutritional value and

variety of foods available.

CNC encourages FDA\'s continued commitment to

insure the safety and regulatory concerns that are

addressed in the production and marketing of bioengineered

foods. We support current regulatory policy, which

requires labeling when new products are significantly

different in safety or nutritional quality.

CNC members believe the communication and public

education about the use of bioengineering is critical. We

encourage the media and others who provide information to

consumers to do so in a responsible manner. Present facts

supported by sound science, rather than emotion.

Communicate potential benefits, as well as potential

risks. Address consumer concerns.

We encourage the FDA to fund educational

outreach, as well as consumer research on beliefs,

attitudes and behaviors. CNC supports scientific research

on appropriate uses of biotechnology, and encourages

consumers to educate themselves on all aspects of this

topic.

We applaud the FDA for providing this

opportunity to speak out publicly. Thank you for your

attention..

MR. LAKE: Thank you, ma\'am.

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STATEMENT OF

MARTINA MC GLOUGHLIN

DIRECTOR, BIOTECHNOLOGY PROGRAMS

UNIVERSITY OF CALIFORNIA, DAVIS

MS. MC GLOUGHLIN: My name is Martina

McGloughlin. I\'m the director of the Biotechnology

Program at UC at Davis. I grew up on a small farm, and

I\'m not paid by any company to be here today.

I believe the regulatory oversight, above all,

needs to be science based. An august group of scientists

and the National Research Council determined that, as

molecular methods are more specific, users of these

methods will be more certain about the traits they

introduce into plants. Greater certainty means greater

precision and safety. The subtly altered products are now

placed and are being put through more thorough testing

than any conventional food ever has been subjected to.

Many scientists who worked in the past on crop

improvements, using much less precise methods of crop

breeding, mutation-induced breeding, a wide species cross,

did no go through the same type of scrutiny or inquiry.

Ironically, many of our daily staples would be

banned if subjected to today\'s rigorous standards.

Potatoes and tomatoes contain toxic glycoalcolides

(phonetic); kidney beans contain physohemogluten

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(phonetic) which are poisonous if undercooked. Organic

growers use copper sulfate and animal feces, yet none of

these are labeled.

Comments by Dr. Regal on misinformation should

apply to himself on unexpected effects. Salmon growth

hormone is expressed in the liver because it is under

control of the metallitinen (phonetic) promoter, which is

expressed on the liver, so the surprise would be if it

wasn\'t expressed there. On BT pollen, truckloads of

information was provided to the FDA before the Cornell

Study. There was nothing new there, except that forced

feeding Monarchs is not \-- is still less hazardous than

using traditional chemicals. However, evolving

technologies, including transformation will eliminate

pollen expression, removing not only Monarch hazards, but

also gene flow of concern to organic growers.

Site specific targeting will address Dr. Fagan\'s

concern or random integration, which, by the way, also is

caused using traditional methods. Although, I suspect Dr.

Fagan\'s real concern is creating a market for his company.

The only conclusive scientific point \--

\[Applause.\]

I\'m sorry.

The only conclusive scientific point that Dr.

Putze\'s (phonetic) study on lectins and potatoes proved

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was that rats do not like eating raw potatoes. Scientists

\--

MR. LAKE: Thank, thank, thank you, ma\'am.

\[Applause.\]

STATEMENT OF

PHILLIP LA ROCCA

PRESIDENT, BOARD OF DIRECTORS

CALIFORNIA CERTIFIED ORGANIC FARMERS

MR. LA ROCCA: Excuse me, I\'m losing my voice.

My name is Phillip LaRocca \--

MR. LAKE: If I may ask the audience, we are

very squeezed for time. And, you know, I would like the

next speaker to be able to go ahead and get started;

otherwise, we won\'t finish. Thank you for your \...

Go ahead.

MR. LA ROCCA: My name is Phillip LaRocca. I\'ve

been in the organic industry for 30 years. I farm 200

acres of certified organic wine grapes. Have a certified

organic winery, and I have 350 head of sheep under

certification. I am the president of the Board of

Directors for the California Certified Organic Farmers.

Thank you for this opportunity to speak here.

I would just like to mention, in terms of

labeling, that, as a certified organic grower, we are

forced to label our products. There hasn\'t been any

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controversy over the detrimental effects of organic

growing to the environment, to the healthy individual;

yet, we are forced to do it. It just seems ironic to me

that we have countries objecting to GMO products that they

don\'t have to label.

Also, in regards to labeling, most of our 1,100

farmers and processors are proud to put the CCF seal on

the label. It allows the consumer to make that decision

if they want to buy something that has been grown

organically or not. We saw, in the case of the bovine

growth hormone, not only did they not want to label that,

but they passed a law saying that people that weren\'t

using it couldn\'t label it. That shows fear, not pride.

In terms of sound science, my family has been

farming for years. I remember 40 years ago, when they

were told sound science gave them DDT, and there was

nothing to worry about DDT. Forty years later, we\'re

still seeing residue of DDT in our soil. We also are

still seeing the effects that it had on the environment.

We never had to use bees to pollinate; now we do.

Also, in terms of \-- and this is a touchy one

here \-- in terms of biological pollution, I actually make

a warning to you: The USDA received 265,000 citizens

telling the government that they did not want GMOs in

organic agriculture. If this happens, watch out. We are

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a \$6 billion industry. You will be affecting the

livelihood of a lot of people in that industry. In

California and throughout the country, it is against the

law to breathe second-hand smoke. We don\'t want our

organic crops polluted by GMO materials.

Thank you very much.

\[Applause.\]

MR. LAKE: Thank you, sir.

STATEMENT OF

NELL NEWMAN

FOUNDER, NEWMAN\'S OWN ORGANICS

DIVISION OF NEWMAN\'S OWN

MS. NEWMAN: My name is Nell Newman, and I\'m the

founder of Newman\'s Own Organic, a division of Newman\'s

Own. Our division has grown tenfold in 7 years. We\'ll

gross approximately \$8 million this year. It has a line

of products which range from 80 to 100 percent organic.

Due to time constraints, I will limit my

comments today to question 1, in section A: Has the FDA\'s

consultation practice achieved its intended purpose of

resolving all safety and regulatory issues?

No, it has not. Because it did not address the

effect of biotech on the safety of the nation\'s organic

food supply.

Over the past year, the extensive planting of

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GMO crops in the U.S. has become the bane of my existence

and threatens my livelihood in the organic food industry.

Our customers expect that products meet the national

organic standards, which does not allow GMOs. The

potential contamination of organic crops has created a

nightmare for those of us trying to insure the integrity

of our organic ingredients. We are now having to consider

the cost of testing all of our ingredients, which could

potentially be contaminated at some point in the growing

or manufacturing process.

For a company which donated all of its profits

to charity, it means that I\'m now wasting my charity

dollars trying to figure out whether or not Monsanto has

cross-contaminated any of my raw ingredients. This year,

one of my corn growers spent over \$16,000 testing for GMOs

to insure that her crop had not been cross-pollinated.

So, if you broaden your scope of the definition

of safety, you see that the FDA\'s consultation process has

not protected the safety of organic farmers.

I believe that testing and labeling is

unfortunately now going to be a necessity. I also believe

that a complete moritorium is needed to evaluate all the

concerns you\'ve heard here today. My question to the FDA

is: In the coming years, what safe haven will I have to

plant my organic corn crops in, and who will cover the

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liability and losses that are bound to occur?

Thank you.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

KENT J. BRADFORD, DIRECTOR

SEED BIOTECHNOLGY CENTER

UNIVERSITY OF CALIFORNIA, DAVIS

MR. BRADFORD: My name is Kent J. Bradford. I\'m

a professor of Vegetable Crops and director of the Seed

Biotechnology Center at the University of California at

Davis. As a plant biologist, I\'d like to address a couple

of the issues that I\'ve heard today.

We\'ve heard that it\'s a violation of the sacred

to mix species. I\'d like to say that every single tomato

plant that\'s grown commercially in California \-- and we

grow about 95 percent of the processing tomatoes that

everyone eats in their pizzas and tomato sauce, a very

large fraction of the fresh market tomatoes \-- everyone of

those carries genes that have been transferred from other

species. If we did not have those disease resistant genes

that have been transferred from those species, we would

not be growing any of those tomatoes in California. I

would venture to say that likely, even the organic

growers, who are growing tomatoes in this state, are using

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varieties that contain those genes. They\'ve been

transferred by nonrecombinant DNA techniques, but they are

still transferred from other species.

A couple of other issues that I\'d like to just

mention.

I heard today about the pollen contamination of

organic crops. I\'d just like to mention that the use of

biotechnology has not increased contamination; that is:

It has not made pollen fly farther or grain handling

procedures be any different than they were before. All

it\'s allowed us to know is the level of contamination that

must already be there from nonorganic adjacent crops, or

other types of crops. The only difference is that we can

now find it because you can test for the DNA and you know

that you have a contaminant. So I believe if the

contamination is the real issue, then, we need \-- and the

real concern is the label of being pure, and therefore,

not contaminated with anything that\'s not organic, the

issue is still there, and it\'s not being created by

biotechnology. It\'s just been able to be discovered by

biotechnology.

The last thing I\'d say is that I think that we

don\'t now label, require labeling on the final product,

just indicate the variety from which it was produced. And

I don\'t believe that we should in the future. I think

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that the FDA\'s current guidelines are rational, they\'re

science-based, they\'re safe and they\'re effective. I urge

the agency to maintain its current position with respect

to food labeling.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

SYLVIA DEMAREST, ESQ.

DEMAREST, SMITH, JONES, GUINTA & MOORE

MS. DEMAREST: Good afternoon. My name is

Sylvia Demarest. I\'m an attorney in private practice in

Dallas, Texas. I appear before this panel as a private

citizen.

A recent poll by a public relations firm found

that 62 percent of Americans were unaware that genetically

modified foods were already being marketed. More shocking

are the figures showing the extensive penetration of the

food supply, including the presence of GMO organisms in 60

to 80 percent of all processed foods. This has occurred

without the knowledge or the consent of the American

people. Surveys have shown that 80 to 90 percent of all

Americans support the labeling of genetically modified

organisms. Yet, these foods are not labeled and industry

is opposed to labeling.

So, who then can vouchsafe the safety of the

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American food supply? The biotech companies deny that

they should have to guarantee the safety of biotech food.

One company, Monsanto, stated: \"Our interest is in

selling as much of it as possible. Assuring its safety is

the FDA\'s job.\" Yet, the FDA has certainly not served as

a regulator on this issue. Instead, the FDA has allowed

itself to become seriously compromised by its relationship

with the biotech industry.

What has emerged is a sophisticated circle game,

where the regulatory ball is passed from the FDA to the

EPA to the USDA without any agency assuming final

responsibility. All that the FDA requires is voluntary

consultation. This process is fundamentally flawed and it

violates the Food, Drug and Cosmetic Act. This Act

incorporates the precautionary principle. Meaning that

food additives are presumed unsafe until proven safe.

These additives have never been tested, much less proven

safe.

Further, there is no scientific consensus

supporting the FDA\'s regulatory approach even among FDA

scientists. Surely this is not acceptable. The FDA

claims to be the nation\'s foremost consumer protection

agency. Is this true?

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

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STATEMENT OF

MELODI NELSON

VICE PRESIDENT, TERRA PRIMA, INC.

MS. NELSON: Good afternoon. Thank you for this

opportunity to be heard.

I\'m Melodi Nelson, coowner of a small business

in Hudson, Wisconsin. We export certified organic

agricultural commodities to Japan, as well as a line of

certified organic tortilla chips to Europe.

In December of 1998, we were forced to issue a

recall of over 87,000 bags of organic tortilla chips that

were discovered to have been made with organic corn that

was accidentally contaminated by wind-borne pollen from

neighboring genetically modified corn. This recall, as

well as the continued loss of the sales, for my company,

had been a financial disaster.

There are many reasons to be skeptical of the

so-called benefits of this technology, not the least of

which, in many regards, to genetically modified life

forms, is: Once mistakes are made, it may not be possible

to ever undo these mistakes.

But I\'ve traveled from Wisconsin to talk about

choice, the choice of all of us in the organic industry

have made. Whether we\'re farmers, retailers, commodity

brokers, or consumers, we have made the choice to raise,

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eat and support organic sustainable agriculture. This

does not include genetically modified organisms. We have

the right to make this decision. We have the right to not

have our farms contaminated and our livelihoods taken away

from us. We have the right to know what we choose to eat

and feed our children. We have the right and obligation

to be skeptical. What is at stake is the safety and the

security of our food source around the world.

There are currently no regulations for labeling,

no way to trace health effects, no way to protect

consumers, as well as their right to make informed

decisions. There\'s no required testing to show that these

organisms are safe. No rigorous, no independent study, no

comprehensive testing requirement. No one can tell us

what the consequences of releasing these genetically

modified organisms in nature will be. I believe the risks

far outweigh any unproven potential benefits.

I would request that all government agencies

rescind the registration and the use of genetically

modified organisms in agriculture production.

Thank you.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

//

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STATEMENT OF

JORGE VALLE, GRADUATE STUDENT

MR. VALLE: Hello! My name is Jorge Valle. I\'m

a consumer. I represent only myself and my family, and I

don\'t have any special affiliations.

To start with, the idea of modified food is not

natural. A strawberry, for example, were not meant to

have fish or other strange types of genes in them. In

addition, just because scientists haven\'t yet found any

harm in GMOs doesn\'t mean there are neutral to our health,

with no side effects.

In the past, scientists also thought all the

technological inventions were great. What happens to the

environment, CFCs, for example. Until after a few decades

of widespread use have passed when it was discovered that

they were, in fact, very harmful.

The point is: We just don\'t know, for sure, if

GMOs are harmless or harmful. Either way, nature did not

make such strange mixtures of genes and was probably for a

reason.

Lastly, even if some people don\'t mind eating

it, neither I nor my family should be forced upon GMOs.

Consumers should be given the choice of whether eating

GMOs or not. Genetically modified food products should be

clearly labeled as millions of consumers also in the

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European Union are demanding.

I don\'t see why I should be forced to eat

cabbage with scorpion genes. I just want a choice. So,

please, just give me a choice.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

DR. NEAL GUTTERSON

MANAGING DIRECTOR OF RESEARCH,

DNA PLANT TECHNOLOGY CORPORATION

DR. GUTTERSON: Good afternoon. My name is Neal

Gutterson. I\'m the managing director of research at DNA

Plant Technology Corporation, located right here in

Oakland, California.

On behalf of my company, I\'d like to offer the

following comments:

First, from a standpoint of insuring safety of

the food supply, we support fully your 1992 statement of

policy regulating foods produced using biotechnology. We

urge you to continue with this policy, which is

appropriately science and safety based, not processed

based. The scientific risk assessment principles endorsed

by the National Academy of Sciences, and other world

experts, provide a solid foundation guiding us in the

development of food products.

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We utilize the consultation process established

in 1992 to assure the safety of a long shelf life tomato

variety developed to reduce shipping and post-harvest

damage, thereby providing a better product for the

consumer. Your staff reviewed our package of information

on the nature of the genetic modification, relevant

nutrients, and the levels of naturally occurring

toxicants, which demonstrated that this

biotechnology-derived tomato variety is substantially

equivalent to other commercial tomato varieties.

We have recently returned from another

consultation in which we provided FDA staff with

information on products in a very early stage of

development. We believe this process works well to insure

the safety of our country\'s food supply.

Second, we believe that consumer confidence in

the FDA and the regulatory process that governs

biotechnology-derived foods is essential to the continued

adoption of this extraordinarily useful, and eventually

vital technology.

DNAP, both individually and together with our

industry colleagues, has urged you and other federal

regulatory agencies to better explain your role in

assuring food safety. Education, as to the process you

employ, is truly the key. We see these public sessions as

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one clear example of your commitment to assuring that the

public\'s confidence in this food supply parallels the

safety of the food supply itself. We urge you to continue

in this outreach to the public.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

ELISA ODABASHIAN

SENIOR POLICY CONSULTANT, CONSUMERS UNION

WEST COAST REGIONAL OFFICE

MS. ODABASHIAN: MY name is Elisa Odabashian.

I\'m with Consumers Union, a nonprofit publisher of

Consumer Reports Magazine.

Consumers Union has long maintained that

consumers have a right to know what goes into the foods

their buying and eating. We urge the FDA to require both

safety testing and labeling on genetically engineered

foods.

While to date there has been little scientific

evidence that genetically engineered foods presently on

the market are unsafe, this does not mean that the FDA and

industry can say, with impunity, that biotech foods are

absolutely safe. There is still much to be learned about

the long-term impact of genetically modified foods on

human health and the environment.

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A good example of this is the use of synthetic

bovine growth hormone, or RBGH, in the production of milk,

on which human health tests have never been done. Not

only does the drug cause numerous health problems to cows,

thereby requiring intense use of antibiotics, which can

lead to increased resistance in farm-borne bacteria that

affects humans; but a number of international scientific

bodies have called for further research on the impact of

RBGH on humans. And the drug is banned in both Canada and

the European Union.

The recent demonstrations in Seattle at the

World Trade Organization Meeting is a seering example of

how it never pays to keep information from the public, nor

to turn a deaf ear to consumers\' expressed desires, and

unwillingness by government and industry to label

genetically engineered foods is born of fear, not of

confidence. Fear that, if consumers were fully informed,

they would draw incorrect conclusions and spend their

money on products not containing GE-modified organisms.

In a democracy, it is fundamentally not the

place of government or industry to dictate what

information consumers should or should not be given, or to

determine in advance how consumers will interpret that

information. The only way to inspire consumer confidence

in genetically engineered foods is through full

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disclosure. In other words, through mandatory labeling.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

REBECCA SPECTOR, PROGRAM COORDINATOR

MOTHERS & OTHERS FOR A LIVABLE PLANET

MS. SPECTOR: My name is Rebecca Spector, and

I\'m program coordinator for Mothers & Others for a Livable

Planet, here in San Francisco.

Mothers & Others is a national nonprofit

consumer education and advocacy organization, with over

30,000 nationwide. Our mission is to promote consumer

choices that are safe and sustainable for current and

future generations. One of our primary goals is to

educate consumers about safe and sustainable food and

production practices, and increase consumer access to

these foods.

We\'ve come a long way in working toward these

goals, as the tremendous demand for organic and natural

foods has increased exponentially over recent years.

Consumers not only want safe and sustainable foods, but

they also have the right to adequately tested and labeled

food, including those that have been genetically

engineered.

The introduction of genetically engineered foods

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into the environment and our supermarkets has been very

rapid. GE foods are being introduced without thorough

testing of long-term impacts on human health and the

environment. Some preliminary tests on GE crops show

reasons for concern and further testing. We should invoke

the precautionary principle and hold back on introduction

of these new technologies until they are better

understood. As the November 26 issue of the journal

Science points out:

\"The evidence so far hasn\'t pinpointed any

specific problems, but also can\'t dispel the

doubts. Further testing could help dispel any

doubts.\"

We know from experience with pesticides that

once hazards enter the ecosystem and our bodies, they are

nearly impossible to eliminate and can result to harm to

human and environmental health for generations. DTT, for

example, is still found in human breast milk, as well as

the fat of other mammals. It would be unwise to repeat

our mistakes and allow an inadequately tested technology

to proliferate on our farms and in our foods without proof

of their safety.

Consumers have the right to know what\'s in their

food and how it is produced. Consumers also have the

right to expect government agencies and businesses to

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adequately test the impact of food ingredients on human

health and the environment before they are introduced into

farms and into the marketplace.

Thank you.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

ANGELO SACERDOTE

MR. SACERDOTE: Good afternoon. My name is

Angelo Sacerdote. I have a production company called

Wholesome Goodness Production, and I\'m working on a

documentary on the subject. I\'m speaking today as a

concerned citizen.

From the beginning, the thrust of FDA policy has

been to foster the growth of the U.S. biotech industry,

rather than to critically examine this radical new

technology. We have been hearing the biotech industry

applaud the FDA\'s science-based policy, the FDA\'s policy

regarding substantially altered crops should be

substantially equivalent to their conventionally bred

counterparts, and also claims that these foods are

generally regarded as safe by most scientists. Even

scientists within the FDA dispute these claims. The fact

is there is no consensus among scientists regarding the

safety of this food.

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When it is time to patent these organisms are

novel and unique. When the issue of safety and labeling

arises, industry maintains they\'re no different from

conventional food. Numerous surveys have been done which

clearly show that people don\'t want to eat genetically

engineered food. The biotech industry\'s business plans

could never have succeeded had their been labeling laws

and informed consumers.

We have labeling laws for irradiated foods,

which don\'t require the labeling of mere ingredients. I

fear some similar manipulation would take place around

genetic engineering labeling laws. There should be a

moratorium on all genetically engineered crops. We

shouldn\'t have to be unwilling, unwitting participants in

this uncontrolled experiment.

In America, we are told we have the freedom to

choose; yet, the FDA has taken away our fundamental right

to choose whether or not to eat genetically engineered

food.

Thank you.

MR. LAKE: Thank you, sir.

STATEMENT OF

ZEA SONNABEND

ORGANIC MATERIALS REVIEW INSTITUTE

MS. SONNABEND: Hi! My name is Zea Sonnabend.

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I\'m with the Organic Materials Review Institute, a

nonrpofit group which works on policy for inputs on

ingredients for organic crop production and processed

foods. Our 29 subscribing certification organizations and

state program represent over 6,500 certified organic

producers and food processors.

As you\'ve heard already, the organic food

industry has a commitment to not allow genetically

engineered organisms, or their derivatives, into our food.

Those of us who serve that industry are faced with a huge

challenge of determining which ingredients in processing

aids may come from a GMO source. Even those ingredients

that are present in small amounts are in widespread use

and very important in organic food processing.

We\'re in favor of labeling, both primary and

incidental ingredients and processing aids, as well as all

seeds and the products of crops produced from those seeds.

We feel that much more thorough study is needed of the

whole system involved in agriculture and food production

before these products should be just allowed everywhere in

our food supply.

At a minimum, the following groups of

ingredients should be labeled if they contain the products

of bioengineered: Enzymes, amino acids, cultures of all

micro organisms from yeast to bacteria, starches made from

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genetically engineered crops, gums, citric acids,

sweeteners, oils, vitamins, and weigh and dairy

derivatives.

Finally, I\'m a consumer who is so highly

allergic to soy beans and peanuts that my life would be

threatened by eating the smallest amount. I am highly

dependent on reading food labels to stay alive. I could

not tolerate a gene from a soy bean being bred into a crop

that was not labeled on a product. Therefore, my life is

in your hands on this issues.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

AMIGO CANTISANO

ORGANIC AGRICULTURE ADVISORS

MR. CANTISANO: I\'m Amigo Cantisano, and I\'m

president of Organic Ag Advisors. I\'m an organic farmer

for 25 years and organic farming advisor to 160 farmers,

producing more than 200,000 acres of a wide variety of

organic and transitional crops.

I am here today to strongly protest the use of

genetic engineering in agriculture, especially its

negative effects on organic farming. Scientific research

has already shown that BT-engineered crops can have severe

negative impacts on beneficial insects, such as lady bugs

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and lace wings. These organisms are very important to

organic farmers. Reductions on their life span will

threaten our crops.

BT-enhanced crops take extremely long periods to

breakdown in the soil, causing significant soil ecological

changes. The microbial activity of the soil is crucial to

organic farming. BT has been successfully used by organic

farmers as a nontoxic pest control for more than 30 years.

However, due to continued exposure to the BT toxin in GMO

crops, insects have rapidly developed resistance to this

useful bacteria. This has already happened in the

southern U.S. wherever BT cotton has been extensively

planted. We will soon lose the effectiveness of BT, one

of the most important pest control used on organic farms.

The widespread use of bovine growth hormone in

the dairy industry results in RBGH residues in the dairy

manure, some of which is being used by organic farmers to

make compost. Contamination of composting feed stocks by

GMO crops raises economic and ecological concerns for

organic farmers and consumers.

We demand the outright ban of all currently

allowed GE crops, a 3-year moratorium on the release of

anymore genetically engineered plants, and mandatory,

full-disclosure labeling for all crops and products

containing GMOs. The FDA must act immediately to protect

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the integrity of the food system and minimize

contamination of organic and other farms. Thorough

long-term, independent scientific studies of the health

and ecological effects of GMO crops must be completed

before anymore GMO crops are allowed in agriculture.

Organic farming can provide high quality and

high yields, which meets the needs of our society.

Thank you.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

JO ANN BAUMGARTNER

NEPTUNE FARMS

MS. BAUMGARTNER: My name is Jo Ann Baumgartner,

and I\'m half owner of Neptune Farms.

I\'ve farmed organically on the California

Central Coast for 15 years. My customers have always

expected the highest integrity from our products. The

drift from unregulated GE crops is causing genetic

pollution. Organic and conventional non-GE farmers should

not have to suffer to accommodate these Frankenstein

foods.

Not only should GE products be labeled on the

shelf, but they should also be labeled in the field, so

that non-GE growers will know if we should think twice

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before we plant a corn crop next to our neighbors.

The other aspect I want to address is bovine

growth hormone issues.

BGH increases milk production at the expense of

animals and our health. Cows are more likely to have

infections; and, therefore, require more antibiotics.

IDF-1, a product formed in the BGH milk, has been linked

to higher rates of cancer. What is really astounding is

that, if the producer, who is giving a daily shot to one

of his cows does not realize that this animal has quit

producing, the hormone will act as growth promoter and the

cow will grow to twice its size. What do you think the

producer does with this animal? It ends up as hamburger.

BGH promotes unhealthy, unregulated and inhumane

practices. Testing should be done on all BGH dairy cows

destined to be slaughtered and eaten, and BGH milk and

meat should be labeled.

We demand integrity from you, our government

officials. Don\'t tell us GE crops are the same as our

historically grown foods. We know they are not.

Thank you.

\[Applause.\]

MR. LAKE: Thank you, ma\'am.

//

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STATEMENT OF

JOSEPH PANETTA

CEO/PRESIDENT BIOCOM

MR. PANETTA: Good afternoon, ladies and

gentlemen. MY name is Joe Panetta. I\'m president and CEO

of BIOCOM, San Diego, a regional association in Southern

California, representing some 350 companies engaged in the

application of biotechnology in agriculture, life

sciences, medical devices and pharmaceuticals.

I\'m also the former chairman of the

Biotechnology Committee at the American Crop Protection

Association in which I represented my former company,

Micogen. At Micogen, I was responsible for leading the

regulatory affairs program. And at Micogen, we received

the first approvals of BT corn in the United States and

other countries around the world.

I\'ve had the opportunity to work on six

continents, with regulatory officials in the approval of

BT corn. I can assure you that the fact that we have

stronger support in this country, in the surveys that are

done of the public on biotechnology, that are testimony to

the fact that the FDA has been open, not just in holding

these hearings, but holding public comment periods in

1992, with the publication of your policy on novel foods,

and going all the way back to 1986 in the publication of

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the coordinated framework for biotechnology.

Both BIOCOM and ACPA believe that the FDA\'s

current regulatory framework regarding crops improved

through biotechnology provide adequate and appropriate

protection for consumers for the following reasons:

It\'s based on scientific fact, rather than on

science fiction.

It\'s concerned with the nature of the product

and not the process by which the product was first

produced.

It recognizes that genetic techniques of today

are not something holding new, but a logical extension of

centuries old, incremental progressions of agricultural

technology.

It\'s cognizant of the reality and not the

supposition that genetic techniques being utilized today

in agriculture are more precise; and, thus, more

predictable than the predominant techniques of 20 or 30

years ago.

It focuses on benefitting the consumer, rather

than rewarding those who can merely the most noise.

It\'s generally accepted by the broad scientific

community that, in terms of safety of the consumer, foods

improved through biotechnology are no different than other

foods produced through so-called traditional methods.

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MR. LAKE: Thank you, sir.

STATEMENT OF

BRUCE MARTIN

MR. MARTIN: My name is Bruce Martin.

Part of my education, health education, is to

encourage them to eat healthy foods, preferably organic.

But this population, a lot of them have limited income,

are on SSI. Preparing food, sometimes they\'re limited

physically, too. They have to prepared foods at the

store, convenience foods, which are presently not labeled

as to the substances.

This morning\'s seminar, he showed a graphic

showing that the majority of the present GMOs that are on

the, that are being produced, are patented for resistance

to herbicides and pesticides. There\'s been numerous

studies showing that these are leftover. There are

residues in fruits, vegetables that can be washed out.

This population, with the compromised immune systems, are

very sensitive to any chemicals in their food.

I\'m urging that there will be, there should be,

labeling for this population that is at high-risk for the

increased amount of residues in the food because of

genetic modification.

Thank you.

MR. KIMBRELL: Thank you, sir.

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STATEMENT OF

KATI BUEHLER

DIRECTOR, ENVIRONMENTAL & REGULATORY AFFAIRS

WESTERN CROP PROTECTION ASSOCIATION

MS. BUEHLER: Good afternoon. I\'m Kati Buehler,

with the Western Crop Protection Association in

Sacramento. My comments will focus on three of the public

information issues posed in the Federal Register Notice.

No. 1. FDA\'s consultation process. WCPA

supports the regulatory framework provided by the USDA,

EPA, and FDA, and believes it fully examines food safety

risks and concerns. We also have confidence in the

systems ability to evolve as scientific advancements are

achieved.

No. 2. FDA\'s current labeling policy. WPCA

strongly supports FDA\'s existing science-based labeling

policy. This means we support the labeling of

genetically-improved foods, whether it\'s a significant

compositional change, where the food is nutritionally

different from its traditional counterpart, or where a

potential allergen has been introduced. The FDA labeling

policy also allows for voluntary labeling statements that

are truthful and not misleading.

No. 3. Providing additional information.

Through focus groups and telephone surveys, consumers are

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telling the U.S. food industry that they are able to

obtain information about food biotechnology from the news

media, internet, food companies and academic experts.

These sources can provide far more useful information than

just labeling. In fact, a new survey from the

International Food Informational Council found that 81

percent of American consumers agree that it would be

better for food manufacturers, the government, health

professionals, and others, to provide more details through

toll free phone numbers, brochures and web sites.

However, much more can be done to provide information to

the public.

We urge the FDA to increase public outreach

efforts with more attention paid specifically on

familiarizing consumers with the regulatory system

currently in place.

Thank you very much.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

ALANA SMITH

DIRECTOR, RESEARCH AND DEVELOPMENT

HARRINGTON INVESMENTS, INC.

MS. SMITH: My name is Alana Smith. I\'m the

director of Research and Development at Harrington

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Investments. We\'re a registered investment advisors,

managing \$130 million.

We have a fiduciary responsibility, and we are

concerned with the potential legal and financial liability

of the companies that manufacture, distribute, or use

genetically engineered ingredients.

Unfortunately, the FDA, and other U.S.

regulatory agencies, have failed the American public by

not requiring comprehensive, prerelease safety testing;

or, at the very minimum, requiring companies to label

GMOs. This leaves food safety in question, and food,

seed, and agricultural chemical companies, grocery stores

and Federal Government legally and financially liable for

health, safety and environmental effects that may result

from premature release of GMOs.

The burden of proof should be on the agencies of

the government to prove, beyond a reasonable doubt, that

food products released to the public for consumption meet

maximum health and safety standards that are safe for the

environment and the human consumption. Currently, the

public must prove that a product endangers the public

safety before the government acts to remove the product

from the stores\' shelves.

On October 27, Harrington Investments filed a

shareholder resolution with seven companies: Coca Cola,

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Pepsi, General Mills, Quaker Oats, Sara Lee, Proctor &

Gamble, McDonalds. We co-filed with Monsanto and DuPont.

We\'ve asked that they remove genetically modified

ingredients until further long-term safety testing can be

shown that these products are safe for human and animal

consumption, and the environment. We also asked that, in

the interim, these companies label the products as such.

Our clients are not alone. There are many other

concerns. Shareholders, stakeholders, environmental

groups that are currently in dialogue with corporate

management to protect the public from potential dangers of

these foods. This is not enough. We call upon the FDA to

act immediately.

Thank you.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

DR. ROY L. FUCHS

DIRECTOR OF REGULATORY SCIENCE

MONSANTO CO.

DR. FUCHS: Good afternoon. I\'m Roy Fuchs, from

Monsanto.

I\'ve been responsible for the food, feed and

environmental safety of Monsanto\'s plant biotechnology

products for the past 10 years. I\'ll briefly address an

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important topic, which was raised during the FDA meeting

in Washington, D. C.

A panelist questioned whether the plant biotech

products on the market met FDA\'s food safety standard of

reasonable certainty of no harm. Plant biotech products,

which have completed FDA\'s consultation process, have

clearly met this well established food safety standard.

Monsanto has established that our biotech

products are compositionally and nutritionally equivalent

to the parental varieties from which these products were

derived, and show that the proteins expressed for the

introduced DNA are safe for humans, animals and the

environment. The food safety assessment for these

products is based on extensive testing following the

guidance provided by FDA, by key international food safety

organizations, which include the World Health

Organization, the United Nation\'s Food and Agricultural

Organization, International Life Sciences Institute, and

by regulatory agencies around the world. For example:

Over 1,800 analyses were conducted with Round-Up Ready Soy

Beans to establish their safety.

The proteins produced from the inserted DNA have

a long history of safe use. For example: The BT family

of proteins, which confer insect protection, were

subjected to extensive short- and long-term toxicology

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testing prior to their approval for use in microbial BT

products. These products have been used safely

commercially for almost 40 years. The protein used to

confer tolerance to Round-Up herbicide is a member of a

protein family which occurs in every plant, every

bacterium, and every yeast, all of which have been

consumed safely for centuries. In addition, detailed

safety studies were conducted with each of these proteins

to confirm their safety.

The conclusion that Round-Up Ready soy beans are

as safe and nutritious as other soy beans has been

confirmed by regulatory approvals in Europe, Canada,

Japan, Switzerland, Argentina, and numerous countries

around the world. As a developer of these products, we\'re

committed to insuring their safety.

MR. LAKE: Thank you, sir.

DR. FUCHS: Thank you.

\[Applause.\]

STATEMENT OF

AMY BRICKER

PROJECT DIRECTOR, CENTER FOR FOOD SAFETY

MS. BRICKER: Hi! My name is Amy Bricker. I\'m

a project director at the Center for Food Safety.

I\'d like to thank the FDA for inviting us to

give our feelings on genetically engineered foods today.

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However, the FDA is already keenly aware of the public\'s

interest and views on this issue.

In 1992, the agency received thousands of public

comments on the 1992 food policy. In 1993, it also

received thousands of letters during a comment period

specifically concerning the labeling issue. Again, in

1994, the FDA heard public input at a scientific

conference on allergens and genetically engineered foods.

And most recently, as the FDA is well aware, over 275,000

members of the public commented on these issues to the

USDA during it\'s proposed national organic rulemaking.

During all of these comment periods, the public

overwhelmingly supported three things:

1\. Mandatory premarket safety testing of

genetically engineered foods;

2\. Mandatory environmental review of these

foods; and

3\. Mandatory labeling.

Despite recognition of these public sentiments,

the FDA has refused even to respond to these comments. As

as a result of the FDA continued refusal to acknowledge

public concerns on this issue, our organization was

compelled to file a lawsuit against the FDA. This lawsuit

is consistent with the public\'s comments and also

establishes the FDA\'s legal requirements to take action

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under the Federal Food, Drug and Cosmetic Act.

It is unfortunate that the FDA has forced the

public to litigate on a matter of such critical importance

and consumer concern. A decision on this lawsuit could be

handed down by the United States District Court, for the

District of Columbia, by the end of this year. Regardless

of this decision coming forward from the court, it is

about time for the FDA to start acting like a servant of

the American public and not a slave of the industry.

Thank you.

\[Applause.\]

MR. KIMBRELL: Thank you, ma\'am.

MR. HEINBERG: I\'m Richard Heinberg, a core

faculty member at New College of California, where I teach

courses on ecology and human culture.

I\'m also a journalist. Three years ago, a

publisher contracted me to research and write a book on

the moral impact of biotechnology. My research led me to

conclusions critical of both the biotech industry and the

FDA. The dispute about biotech foods is often portrayed

as good science, versus public hysteria. What I learned

dramatically contradicts that view.

Recently, peer-reviewed journals have published

showing damaging health and environmental effects from

genetically engineered crops, as well as reductions in

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nutritional quality. These findings should surprise no

one. Because the new technology is inherently risky.

Indeed, my research led me to conclude that the hazards

are so novel and great that the requirements for the

testing of genetically engineered foods should be far more

rigorous than those for standard pharmaceuticals or

chemical food additives. Instead, in defiance of its own

scientists\' warnings in memos \-- initially suppressed but

now available on the internet \-- the FDA has required

little or no testing, not even the labeling of genetically

modified foods. Many ethicists I interviewed regard this

not just as a failure of the FDA\'s mandate to protect

American citizens, but as an outrage against democracy

itself.

If anyone believes biotech foods are safe, I

would not prevent them from eating them. But that

millions should be caused to eat poorly tested genetically

engineered foods without their knowledge or consent is

unconscionable. Perhaps conflicts of interest involving

agency officials are to blame.

In any case, history may not look kindly on the

FDA\'s failure in this instance to offer adequate

protection to the American people when it could have done

much more. I urge you to begin to reverse this perilous

course of inaction by requiring the labeling of all

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genetically engineered foods and food ingredients.

Thank you.

\[Applause.\]

MR. LAKE: Thank you, sir.

STATEMENT OF

DANIEL H. JOHNSON, JR., M.D.

CLEARVIEW MEDICAL IMAGING

DR. JOHNSON: Good afternoon, and thank you very

much for giving me the opportunity to speak and share my

thoughts on food biotechnology.

My name is Daniel Johnson. I\'m a practicing

physician in a high-tech specialty, in a suburb of New

Orleans, Louisiana. I\'m a former president of both the

American Medical Association and the World Medical

Association.

I\'m pleased to be here today with a physician

travel grant from the International Food Information

Council. But I\'m speaking as an individual who has become

very interested in the subject before you. My interest

derives from the fact that, every day in my practice, I

use biotechnology to do what I consider almost miraculous

things to deliver care to ordinary people.

The developments that I use in my practice would

never have possible if we had not recognized that the

benefits of biotechnology outweigh the risks \-- and the

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risks are there. And food biotechnology is simply the

application of biotechnology in food production. And it,

too, may have risks.

In my view, the FDA\'s role is to manage that

risk. But I suggest that the benefits far outweigh those

risks. In time, food biotechnology may enhance a

physician\'s ability to use food to improve a patient\'s

health. But if we abandon this technology because of what

might go wrong, these valuable tools will never make it

into the hands of physicians and their patients.

I know that safety is a tremendous concern to

those who are not as enthusiastic about science and

technology as I am. But my endorsement of biotechnology

is built on my faith in the FDA\'s existing review process.

I believe it has served us well and will continue to do

so.

I\'d like to just close by making the observation

that I disagree with the comments that some have made that

this is not an open and fair process. On the contrary,

I\'ve had the opportunity to have been engaged in public

discourse for many, many years now. I think this is an

extraordinary opportunity for you to listen to a very

diverse group of comments. The panels you had today were

very balanced. The comments you\'ve heard today I found

very fascinating and across the whole spectrum of input.

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I comment you for holding this hearing.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

DAVE HENSON, EXECUTIVE DIRECTOR

OCCIDENTAL ARTS & ECOLOGY CENTER

MR. HENSON: Greetings! My name is Dave Henson.

I\'m the executive director of the Occidental Arts &

Ecology Center up in Sonoma County. We\'re an organic farm

research and education center. We focus on biodiversity

and food crop seeds.

I\'m a citizen, first; a consumer, sometimes.

That\'s important, because it\'s a democratic process. It\'s

not about consumers and corporations. This is the first

step in a better democratic discussion. Thank you for

holding it.

I hope you all had a chance at lunch to see the

spontaneous outbreak of democracy that occurred outside.

Many, many hundreds of people could not be in here because

this room size was the limit, and these amazingly tiny

seats were aggravating to sit in all day. I encourage

you, at the next democratic discussion, to have a big hall

and invite everybody to listen. Because there could have

been a lot of learning on all sides.

\[Applause.\]

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On this question of material differences and

substantial equivalence in GE products, transpecies

genetic engineering is a quantum leap in breeding

technologies, with no scale equivalent in natural

evolution. Let\'s be clear: It\'s disingenuous, at best,

to suggest, as some of the corporate operatives and Ms.

Huttner insisted on, that transpecies transferred genes is

the same as traditional plant breeding. It is not. It

insults our intelligence.

Others have spoken well on many issues. I want

to address context, for a second.

We are an agrarian species. A hundred thousand

years of agriculture have given birth to civilization.

Modern food crops are the results of collective invention

and conscious selection of millions of farmers all over

the world. This co-evolved relationship between culivator

and cultivar is deeply sacred and should invoke great

humility on the part of you all and us when we imagine

changing it forever. And changing to genetic engineering

is forever. We cannot go back.

It\'s the height of arrogance of the so-called

life science corporations and the U.S. Government to seek

to patent, privatize and commodify and lease back to the

world\'s farmers the collective commonwealth of our

ancestors. I beg you to take this seriously and think

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deeply. This moment in history is a big one, and we\'re

not \-- it\'s going to be remembered in history as the time

we decided.

Thank you.

\[Applause.\]

MR. LAKE: Thank you, sir.

STATEMENT OF

PAUL BETTENCOURT

COTTON GROWER

MR. BETTENCOURT: Good afternoon. My name is

Paul Bettencourt. I\'m a cotton grower from Fresno County,

down in the San Joaquin Valley. Thanks for coming out to

California.

In 1999, we planted our first biotech cotton. I

planted BT cotton, 12 sacks of it, just to see how it

worked, and it works great. You could see down to the row

where our BT cotton was, separate from our other cotton.

And, you know, farmers are hammered about being, you know,

careful for the environment. Here, I had a product that

saved me at least two applications of pesticide for the

same amount of bug control, and we\'re getting criticized

for it. You know, that part of it, I don\'t quite

understand.

As a farmer, you know, I am committed absolutely

to consumers and the environment, and that\'s why I like

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the BT cotton, for the environment. I understand the

concerns of the consumers. Nothing that I do, as a

farmer, is above question.

As to the question of whether I\'m beholden to

Monsanto, those guys are a pain in the neck to work with

on this seed. You don\'t know how many hoops you got to

jump through to get a couple sacks of seed.

I\'d like to leave you with a question: Why

should we change the current regulations because they

work? What we have here is not an additive to the crop,

but we have a new varieties.

Philosophically, you\'re being asked to perform

an impossibility. You can\'t prove a negative if we take

this to the extreme. My concern is that tools that will

help me, as a farmer, care for the environment and be

productive will be taken away by playing on people\'s fears

needlessly. I urge the FDA to maintain its current

policy.

Thank you very much.

\[Applause.\]

MR. LAKE: Thank you, sir.

STATEMENT OF

SKIP SPITZER, CHAIR

SANTA CRUZ ACTION NETWORK

MR. SPITZER: Good afternoon. I\'m Skip Spitzer.

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I\'m the chair of SCAN, the Santa Cruz Action Network. For

about 20 years, SCAN has been in the business of helping

consumers organize and participate in environmental and

public health issues.

I appreciate the dilemma the FDA faces. I can

see, internally, you\'re addressing the issue of agency

performance and statutory compliance. I can see the

obvious context of limited resources that you have to work

with. And I can see you\'re emphasis on cooperation with

so-called stakeholders, many of whom have very different

perspectives.

One source of crystal-clear direction you can

rely on, however, is your own mission statement, as

updated by the FDA Modernization Act. Regarding food, the

FDA mission used quite definitive language, quote:

\"Protect the public health by insuring that foods are

safe.\" It does not use the language of reasonable

assurance, as in the case of, for example, devices

intended for human use. This suggest an extremely high

bar in terms of acceptable risk. Insure that it is safe.

At the same time, it is clear that there\'s no

scientific consensus on the safety of of GE foods.

Furthermore, there are no compelling, competing interests

here, such as the need to bring medications quickly to

market in the case of pharmaceuticals. There\'s certainly

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nothing in the FDA mission to elevate developers

profitability concerns with insuring safety of food.

I therefore submit that FDA\'s GE food labeling

policy should be modified to reflect the highest

precautionary regulatory approach as directed by its

mission. Insure that our food is safe by requiring

rigorous per-product, premarket testing; or, at the very

minimum, require appropriate labeling. This is what U.S.

consumers are beginning to organize themselves to demand.

Thank you.

MR. LAKE: Thank you, sir.

STATEMENT OF

VERNAL GOMES

DAIRYMAN/FARMER

MR. GOMES: Ladies and gentlemen, I am a dairy

farmer, and I am row-crop farmer from the south San

Joaquin Valley of California. My brother and I have

continued in partnership on our family farm, which was

started in 1940 by my father who immigrated to this

country. Our operation is located in Tulare, California.

We have approximately 2,000 dairy animals, and we grow

about 8,000 ton of corn to feed those animals.

My first reaction to the term \"biotech seed\" was

not without suspicion. I can understand the feelings of

people who react in opposition to such terms \-- especially

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when it comes to effecting our food chain. I, nor anyone

else, wants to endanger the basic livelihood on this

planet. However, I can only say to those who are

skeptical: Please take the time to research and

understand this wonderful, new and exciting technology,

what it\'s all about.

I have planted biotech corn seed on our ranch,

and I found it to be one of the most exciting new

developments in agriculture. Weed control has always been

an age-old problem for farmers and agriculturalists.

With biotech seeds, we have been able to control the vast

array of problem weeds in our crops, the damage to

production which lessened the quality. Biotech crops

continue to grow while surrounding competitive weeds die

once the field has been sprayed only once with an

herbicide. Because of this, we\'ve been able to eliminate

several conventional sprayings of herbicides on the same

crop. Because of biotechnology, we can eliminate pest

control sprayings, also.

What a wonderful, wonderful science this is.

What a combination. Eliminating herbicide sprayings and

insect sprayings, at the same time killing unwanted weeds

that damages the quality of our crops.

Less farming expense has been realized in our

operation because of biotech seeds. Because weed control

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has been made easier, we have started to eliminate some of

the traditional farming practices that we\'ve always done

in the past.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

ERICA PENG

BERKELEY FOOD POLICY COUNCIL

MS. PENG: Hi! Erica Peng from the Berkeley

Food Policy Council.

I visited a school garden recently. Proudly and

prominently displayed in the very center front was a large

banner made by students in the kindergarten through fifth

grade. On that banner was a list of the principles that

they believed important to learn and practice: Respect,

patience, understanding, cooperation, honesty,

stewardship, sustainability, relationships and laughter.

I invite you to ask yourselves, as members of the FDA and

as individuals, and I want to look in your eyes as fellow

people as I ask you these questions:

Are you exercising these principles to the best

of your ability as individuals? I believe that, if you

are, you will be exercising them as members of the FDA.

What has happened to these principles to learn

and live by, as recognized by our elementary school

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students?

Would students feel that you are qualified to

teach and lead and to be a model for them? And have these

principles been exercised in the way that GE foods have

been silently introduced into our food supply?

I am disturbed, I am disappointed. I\'m not

surprised, given the revolving door between industry, the

USDA, and FDA, but I am appalled and I am offended at the

failure to adequately inform the American public with

accessible, non-industry information and resources prior

to the release of GMOs in the environment and the food

supply.

Perhaps you personally didn\'t have access to the

information, which points to how you, too, are victims, as

we all are, in this process driven by and for industry

profits. It is unacceptable that, while debate ensues

about appropriate animal testing models, about labeling,

about the science, we are losing sight of the central

issue, which is our individual rights to know and approve

of our food which has been supplanted by industry profits.

Growing numbers of people are not satisfied with the way

you are fulfilling your role, or not fulfilling your role.

On behalf of the Berkeley Food Policy Council, I

want to present two resolutions approved by the Berkeley

City Council and the Berkeley School, the Board of

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Education \--

MR. LAKE: Thank you, ma\'am.

MS. PENG: \-- in support of federal legislation

to ban GE food and products.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

TERRI COMPOST

GARDENER/CONSUMER

MS. COMPOST: Hi! My name is Terri Compost, and

I am an eater. And I will try to represent the hundreds

of people who are outside and who could be at this public

hearing had the doors been opened.

We want to know, we want to know the effects of

genetically altered food on our bodies and the environment

before it is commercially grown, before we eat it. This

technology is new, it is radical, it will change

evolution. We urge caution. It\'a taken a long time to

get here. We can take our time from here. We need a

public assessment of the risks involved. It needs to be

tested thoroughly and independently.

I\'m sure you\'re aware of the millions of dollars

that the industry is putting into convincing you that this

is safe, and convincing the public this is safe. In fact,

there must be a considerable amount of industry money in

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the pockets of people in this very room \-- hopefully not

yours.

With all our collective scientific brain power,

we really know very little about the intricacies of

genetics, about our \-- the human body, about ecology. The

current FDA policy of not labeling makes tracking any

health problem from genetically modified food virtually

untraceable. Convenient for companies trying to avoid

liability; devastating for the health of the public. We

have a right to know.

The broken promises of the Green Revolution need

historical review. A decision to allow industry to guide

biotech could create rather than solve world food

tragedies. Please listen to the public. Your ruling will

have effects on many generations. We need moratorium

until proven safe and immediate labeling of all

genetically engineered products.

Thank you. Please take your job seriously.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

IGNACIO H, CHAPELA, Ph.D. ASSISTANT PROFESSOR,

DEPARTMENT OF ENVIRONMENTAL SCIENCE, POLICY & MANAGEMENT

UNIVERSITY OF CALIFORNIA.

DR. CHAPELA: My name is Ignacio Chapella. I am

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assistant professor of Ecology at the University of

California, Berkeley.

After 20 years of professional life, dedicated

to the study of the unseen world of microbes, the base of

our sustenance and survival, I must attest to a very

primitive understanding of the consequences of the recent

manipulations of plant, animal and microbial life in the

new agriculture biotechnologies. We know enough only to

know that the new genetic engineering methods have

definite and potentially enormous risks to the

environment. It is in the nature of those manipulations

that the changes we introduce into the environment cannot

be contained or recalled, as could perhaps be the case for

nuclear or chemical pollution. Genetic engineering, in

this sense, is perniciously promiscuous and deeply

disruptive in the environment.

I believe that an enlightened modern

understanding of human health recognizes that the

connection between environmental and human health is

intrinsic and it\'s inexorable. I have seen a lot of

evidence that we are working with an outdated regulatory

system that hasn\'t even started to ask the first questions

about these connections and the risks. Denying or

dismissing those and other risks can only be the result of

ignorance, neglect or willful misrepresentation. And I am

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alarmed that some of my colleagues have chosen not to

represent those risks to the public for the sake of their

benefit, or their peace of mind.

Many of my colleagues are being forced to strike

false agreements with the life sciences companies to allow

them access to funds that they consider necessary for

their professional survival. These scientists, ladies and

gentlemen, my colleagues, your experts, are compromised by

these direct links to these companies that have, as their

only credo, profit.

I believe that we must not continue with the

deployment of these enormously risky applications of

wonderful technologies while the gatekeepers of the public

interest, the regulatory agencies, the universities, are

held hostage by profit interests.

MR. LAKE: Thank you, sir.

DR. CHAPELA: Thank you very much.

\[Applause.\]

STATEMENT OF

PILAR M. WEISS

MS. WEISS: My name is Pilar Weiss. I\'m a

graduate student at the School of Public Health at

UC-Berkeley.

Our discussions today have repeatedly referred

to an acceptable and complete amount of safety testing for

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GMOs. This claim is incredibly suspect. Testing has been

grossly inadequate in light of its disregard for the

precautionary principle. The testing deemed acceptable

does not address the long-term effects of this new

technology. This is an especially serious issue in light

of the many unexplored exposure pathways GMOs have to

human health. This includes chronic, long-term exposure

to GMOs as they become more and more pervasive in our food

supply, as well as secondary and tertiary exposure via

processed foods and GMO-fed livestock.

The scientific community cannot forget lessons

we have learned from previous instances when caution

concerning long-term effects was not considered. In

California, I remind you of the repercussions of the use

of the pesticide DBCP and the gas additives MTBE. In both

cases, rapid approval based on short-term risk assessment

has left us in a situation where are scrambling to solve

wide-based health and ecological problems.

The FDA has the responsibility to uphold the

precautionary principle with GMO\'s entrance into our food

supply. If not, we are in danger of irreversible damage

to human health and the ecosystem. A moratorium on GMOs

must be called until long-term testing has been assessed.

\[Applause.\]

MR. KIMBRELL: Thank you, ma\'am.

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//

STATEMENT OF

ELLEN JEFFERDS

NATURAL LAW PARTY

MS. JEFFERDS: My name is Ellen Jefferds, and

I\'m running for Congress this next year, here in this

Ninth Congressional District, with the Natural Law Party.

I find it astounding that genetic engineering

proponents claim they have no substantial evidence that GE

food and food products could be potentially dangerous. In

1989, 37 people died, 1,500 were partially paralyzed,

5,000 were temporarily disabled when they ingested

tryptophan, which has been produced with the aid of

genetically engineered bacteria. Unexpected chemical

reactions produce novel toxins in the tryptophan, toxins

which would have passed the current substantially

equivalent tests, and also tests designed to detect all

known toxins.

My husband\'s cousin was one of those who

suffered paralysis, a woman in her mid-thirties. Jeannie

lost most of her motor functions. Despite undergoing

years of intensive daily physical therapy, she still has

limited small motor abilities and has lost many years of

active living. The settlement of a class action lawsuit

against the manufacturer did not alleviate her pain and

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suffering as she battled to regain basic human

functioning.

You might say that one such toxic incident was

extremely regretable. But the FDA\'s continued effort to

deny the dangers of genetic engineering is more than

regrettable. It is, in fact, negligent. A mass disaster

could happen again. The FDA\'s blind, pro-GE stance

reveals that our government is more interested in

promoting corporate profit than in protecting the American

people.

The minimum response of the FDA should be

mandatory labeling of all GE-engineered food products;

and, better still, would be a moratorium on allowing GE

products on the market until stricter safety standards and

testing are put into place.

Thank you.

\[Applause.\]

MR. LAKE: Thank you, ma\'am.

STATEMENT OF

MARK GUY

MR. GUY: Hi! My name is Mark Guy. I represent

a large number of activists who were not allowed to

participate in your public hearing today.

I would like to begin my comments by saying

that, like all bureaucracies, the FDA is made up of many

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individuals. I would like to think those of you within

the FDA, who have stood against the current policies of

this agency, who have shown by your actions and attitudes

that you value principles above propaganda, science above

ignorance, and the public good above corporate profits.

Please understand that my coming remarks to the

agency are not directed at you. And thank you for your

continued effort on our behalf.

Two recently published epidemiological studies

in Europe have found a statistically significant risk from

Round-Up exposure for hairy cell leukemia and non-Hodgkin

lymphoma. In a polled analysis that is about to be

published, this risk is large. Because of FDA\'s policies

of secrecy, the public has absolutely no way to protect

itself from surprises, such as this, should this finding

prove to pose a danger to the food supply. I propose that

we label these crops \"Round up ready for cancer crops.\"

The FDA has gone out of its way to hide the

truth from us; and, then, to use our ignorance to gloat

that we do not care. Seattle has proved that attitude to

be a lie. We are willing to face beatings, gasings, false

arrests, and all manner of police brutality to let you

know that your policies will not stand. The chemical

industry and the shareholders of Monsanto can be damned.

I saw nothing in the Food Quality Production Act that

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requires the FDA to protect the profits of Monsanto or Dow

or the rest.

This is not about democracy; it\'s not about

science. It\'s not about feeding the planet. This is

about the almighty dollar, and the raw power money has to

subvert even the highest levels of government to the will

of corporate boardrooms. Some things are in order,

however. Thank you for being so blatant in your groveling

subservience to the chemical industry \--

MR. LAKE: Thank you, sir.

MR. GUY: \-- that you\'ve finally woken a vast

public outrage that will only continue to grow.

MR. LAKE: Thank you.

\[Applause.\]

STATEMENT OF

CAROL B. SLOAN

NUTRITION AND FOOD SERVICE CONSULTANT

MS. SLOAN: Good afternoon. I\'m Carol Berg

Sloan. I\'m a registered dietitian and a member of the

American and the California Dietetic Association. I have

a nutrition consulting service and work primarily in the

area of food safety. I consult with restaurants and

health care facilities and conduct over 300 food service

safety inspections every year.

My experience consulting in food service

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departments indicates that food service employees are

mainly concerned with the model food code, and that food

products meet the general sanitation requirements of the

California Retail Food Facilities Law. Not whether or not

a food is genetically engineered.

What issues are of greatest concern in food

service? Prevention of cross-contamination, prevention of

food-borne illness, and also more education is needed in

the food handling techniques. More time and effort should

be spent in this area instead of whether or not we should

use foods that are bioengineered.

Consumers also want nutritious food that is

tasty, convenient and affordable. If a technology is

available which will help reduce the use of pesticides,

offer plant disease protection, reduce the use of

fungicides, is environmentally friendly and will improve

the quality, nutrient content and productivity of the food

supply, why not embrace and support it, for what is more

precious than a nation\'s food supply?

The FDA continues to regulate the safety of our

food supply and top priority has always been that new

genetically engineered products are safe to the

environment and to animal and human health.

Allergenic proteins should not be a concern, for

they\'re rigorously tested by the EPA and the FDA. The

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process of determining allergenicity and other safety

issues of a new food are similar to those that

pharmaceutical companies must undergo for approval of a

new drug. Concerned consumers should seek balance

coverage based on sound science because of the emotion and

skewed logic that often accompanies new technology.

As a registered dietitian and a parent, I am

very excited about the future of biotechnology for my

profession and for the future of all consumers.

Thank you very much.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

KATHY MANNION

DIRECTOR OF GOVERNMENT AFFAIRS

WESTERN GROWERS ASSOCIATION

MS. MANNION: Good afternoon. I\'m Kathy

Mannion. I\'m the director of Government Affairs for the

Western Growers Association. WGA members grow, pack and

ship fresh produce in California, in Arizona. I\'ve

submitted more extensive comments. I\'ll just make a few

points at this time.

WGA supports the current FDA science-based

labeling policy with respect to food, or food ingredients,

derived through biotechnology. This policy provides that

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products of food biotechnology are subject to the same FDA

labeling and safety policies applied to all foods in the

U.S. marketplace.

WGA supports the FDA labeling policy which

allows for voluntary labeling statements that are truthful

and not misleading. This labeling policy provides the

framework for consumer choice. It is our belief that

labeling of food products will occur in response to

consumer preference and as a result of competition in the

marketplace. If there is an identified market for food

products produced without biotechnology and customers

willing to pay a premium, labeling of food so produced

will quickly follow.

As it relates to mandatory labeling of foods and

food ingredients produced with biotechnology, WGA believes

that such a requirement would not serve the public

interest. Instead, WGA believes that mandatory labeling

would suggest a health risk where there is none; thus,

misleading consumers about the safety of these foods.

Agricultural biotechnology has the potential to

provide significant benefits to both the consumer and the

agricultural industry. As previously mentioned, WGA

represents the fresh produce industry. Value-added

innovations to meet consumer demands in recent years

include packaged salads, baby carrots, mixed vegetables

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ready for stir frying, sliced mushrooms, and so forth.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

MARTIN J. SPROUL, ESQ.

SPROUL LAW OFFICES

MR. SPROUL: Good afternoon. My name is Martin

Sproul, and I\'m here today as an attorney, private

citizen; and also as a Natural Law Party candidate for

U.S. Congress in the Seventh Congressional District.

Genetic engineering has not only breached

species barriers, it has also blurred conceptual and

regulatory categories, weakening the regulatory mission.

When the FDA decided that food developed through

engineering was not different from food developed by other

breeding methods, that decision was political, not

scientific. The decision prejudged and biased

consideration of the issues. It imposed a false paradigm.

When before in history have we witnessed foods

rapidly morphing into drugs? Biotech has engineered more

addictive tobacco and opium and plans more nutraceuticals.

We are losing the distinction between food and

drug. The public has the right, and should have the

easily exercisable means to choose to consume foods that

is natures subtle combinations and balances of nutrients

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with confidence that they are not surreptitious

drug-delivery systems, or that patchwork brainchildren of

folks in labs.

Functional public policy must be expressed in

language that corresponds to natural categories of the

human mind. Though technocrats may question the

scientific basis for distinctions between free and unfree

acts, between torts and crimes, between natural and

engineered, between foods and drugs. Such definite

categories have long proved useful and beneficial in

regulating human conduct. Bad government begins with

distortion of words and corruption of meaning.

I just have one comment I\'d like to add. The

biotech industry here today has shown astounding cynicism

and hypocrisy insuring the attack on Dr. Fagan, for having

a business. As Dr. Cantelera (sic) pointed out, many Cal

professors have become partisan cheerleaders of the

biotech industry. So much for researcher objectivity.

It\'s a shame.

MR. LAKE: Thank you, sir.

STATEMENT OF

BOB CANNARD

CANNARD FARMS

MR. CANNARD: Bob Cannard, Cannard Farms, an

organic farm.

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Until the pollens of these modified crops can be

controlled from drift, this is the death knell of any

organic industry in the nation. It doesn\'t matter what

levels you talk about as being premissible, they\'ll soon

be exceeded.

The crops on your list of \-- radicchio, reaching

into the small vegetables, the chicoria family, the

radicchio, can be cross-pollinated to endives and

escarole, and all of the other small, very important,

nutritionally important, healthfully important winter

greens, the bitter winter greens of the Cichorium group,

will soon be taken from us as organic farmers. Whether

it\'s 3 years or whether it\'s 5 years, all various small

crops. Right now, we\'re working with corn and soy beans,

and wheat, the big ones; but as we allow, as we allow

patenting to continue, soon, all various small crops, all

the way down to the table beet and carrot, will be

patented. Genetic material will be introduced to them,

their pollens will drift to the seed stocks. We will no

longer have traditional food stocks available to us. It\'s

very easy to do. It\'s extremely difficult to clean things

up.

Now this is my position, my work. To try to

slow this down, it\'s been in trying to sponsor a petition

drive to get a measure on the ballot in California to

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require food labeling, www.calrighttono. This is work you

should be doing.

Thank you.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

MILTON P. GORDON

PROFESSOR OF BIOCHEMISTRY

UNIVERSITY OF WASHINGTON

DR. GORDON: Good afternoon. I appreciate the

opportunity to talk to you.

I\'m Milton Gordon. I\'m a professor of

biochemistry, microbiology and ecological sciences at the

University of Washington. I\'m also a member of the

Science Board for the Center of Molecular Biology in

Lahore, Pakistan. So I have some experience with

third-world countries and their problems.

I feel rather lonely and sad here because I

think I\'m a minority of one. But the point I want to

make, in the limited time, is that there is not a clean

distinction between man-made genetic engineering and what

happens in nature. I don\'t understand, but for 13 or 14

years, there have been manuscripts in the press, from four

different laboratories, in Italy, France, Japan and the

United States, which show that solinacious plants, many of

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them already contain genes from agrobacterium, the

organism that is used in genetic engineering. This

occurred maybe 10 to 40 million years ago, as we can tell

by the change in the DNA sequence. But the gene has been

preserved so much that, if it\'s put back into a mutant

bacterium, it will function. So you have a gene here

which will function in the plants and in the bacteria.

I think that\'s the best fact that we\'ve heard

this afternoon about genetic engineering. It\'s done in

four laboratories.

Now there are some papers which have only done

in one laboratory, which indicate that there also are

agrobacterium in carrots and radish. Now supposing this

true, does that mean that we have to label all the carrots

and radishes in the grocery stores? What about all the

other foods? They\'ve not been tested, to the best of my

knowledge. Do other foods, like oranges, turnips, celery

\--

MR. LAKE: Thank you, sir.

DR. GORDON: That\'s it? Thank you.

STATEMENT OF

ALAN MOORE

CITY OF BERKELEY BUTTERFLY GARDENERS ASSOCIATION

MS. MOORE: My name is Alan Moore and I\'m here

representing the position of the Butterfly Gardeners

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Association, the Patch Adams Peace and Justice Center, the

Mendocino Coast Environmental Center, the Bay Area

Citizens Circle, the Global Renaissance Alliance as a

group.

There was a recent Time Magazine article on the

World Trade Organization in Seattle called \"Butterfly

Defenders.\" Our group includes David Brower, John

McConnell, Julia Butterfly, Neal Donald Wolf, Patch Adams,

Dr. Helen Caldicott, Rabbi Michael Lerner, and over 2000

other organizations and individuals.

Our government has been far too lax in approving

and failing to regulate a whole array of so-called

technological improvements that are namely focused on

improving the health of big corporations, rather than the

health and welfare of the American public. Such practices

has tainted our food, meat, poultry and milk supply with

antibiotics, growth hormones, and a whole host of

recombinant genetic materials, whose health effects and

consequences were mainly ignored, but are becoming

increasingly understood.

While we may have allowed you to pollute and

poison our food supply in the past, there is no way to

imagine that the American public will acquiesce when these

same technologies threaten butterflies.

When genetically altered crops, such as BT corn,

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were shown recently at a Cornell study to kill Monarch

Butterfly caterpillars, it created a worldwide uproar that

stopped the exportation of these transgenic seeds to the

European Union and other countries. The deep rooted of

love of butterflies that raised the consciousness of the

world to realize the dangers that these multinational

corporations were threatening us with.

Dr. Chip Taylor, at the University of Kansas

Etymology Department, and director of Monarch Watch, a

group dedicated to the conservation of the Monarchs, was

cited as saying that the new corn and soy bean crops have

the potential to raise hell with Monarchs.

MR. LAKE: Thank you, sir.

MR. MOORE: That\'s it. When we allow these

corporations and regulatory agencies, who are supposed to

protect us \--

MR. LAKE: Sir, your tow minutes is up. Thank

you.

STATEMENT OF

SHEILA BARRY, EXECUTIVE DIRECTOR

ALAMEDA COUNTY RESOURCE CONSERVATION DISTRICT

MS. BARRY: I\'m Sheila Barry. I serve as the

executive officer for the Alameda County Resource

Conservation District. This district works with private

land owners promoting soil and water conservation.

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Today, I want to make a statement regarding the

importance of biotechnology, including genetic

engineering, in providing solutions for conservation of

our soil, land, air, water, wildlife and people.

We have enormous challenges ahead of us in

conserving our natural resources. Most notably, we have

conflicting desires and needs in regards to the production

of our food and conservation of our resources. These

conflicts are evident with just a quick glimpse at any

newspaper: (1), we have a growing population that

demanding cheap, high-quality, safe food; (2) people

generally want less pesticide and herbicide used in the

production of their food; some are even willing and able

to pay for it; and (3) urban growth and public policy are

forcing food to be grown on less land.

For example: The Silicon Valley, just south of

us, used to be known as the Valley of Hearts Delights,

when, instead of software and semiconductor companies, and

houses, the valley was covered with orchards.

In terms of public policy, policies like the

Endangered Species Act, Cal Fed Open Space Protection

Programs are taking lands our of agriculture production.

So how can we continue to meet the public\'s conflicting

demands? In short, how can we produce more food on less

land with less chemicals?

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We are wise to look towards biotechnology for a

solution. And as with any new technology, we must

proceed with caution. I want to encourage you to

continue to take every step to insure that the public is

thoughtfully informed. We must be thoughtful and

responsible, for wouldn\'t it be an irony if in our zeal to

protect our environment and our children\'s children from

unknown risk associated with GE foods they starved to

death.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

GREGORY FRANKEL, PROJECT COORDINATOR

THE GREEN LINK, UNIVERSITY OF CALIFORNIA, BERKELEY

BERKELEY FOOD POLICY COUNCIL

MR. FRANKEL: Hello! My name is Gregory

Frankel. I\'m the project coordinator for a project called

\"The Green Link,\" which is funded by the California

Department of Pesticide Regulation to provide education on

ecologically based pest management. It\'s run through the

University of California at Berkeley.

I want to commend you all on having open panel

discussions, and well-rounded discussions. I hope it\'s

not a smoke screen. I hope you take it all to light.

I just want to say, right off the bat, that I

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support labeling of products that contain genetically

modified organisms. I\'m having trouble figuring out why

the GE corporations are so concerned with this. To echo

earlier remarks, if they\'re so proud of their product, I

don\'t understand why they\'re concerned about the labeling

issues and the incremental costs that would be associated

with that. It seems like there\'s a significant amount of

fear behind their opposition to it. And many of them are

supporting the 1992 study that you all put out. Except

that, the bottom line, most of the research that has been

done on this issue has been done since then. So to refer

back to the 1992 findings of scientific evidence seems

like it\'s a little outdated, since it\'s been such a new

topic of discussion.

Another point that I was having trouble coming

to grips with was that Dr. Maryanski said earlier that

it\'s the goal of the FDA to be concerned with not only the

human health risks, but also the ecological risks. But he

went through the discussion of the testing and criteria

that EPA goes through on the consultation, it talked a lot

about nutritional testing, allergy testing and toxin

testing; but it didn\'t really have any \-- didn\'t show any

discussion of the testing criteria on ecological risks.

Also, it seems like a lot of people, farmers

especially, are talking about the benefits that pesticide

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reduction has come with these GE products. But, in the

long-term, this benefits \--

MR. LAKE: Thank you, sir.

STATEMENT OF

NANCY EVANS

COMMUNICATIONS CONSULTANT

THE BREAST CANCER FUND

MS. EVANS: My name is Nancy Evans. I\'m a

health science writer, an environmentalist, a mother, a

grandmother, and a woman living with breast cancer.

I\'m deeply concerned about bioengineered foods,

and I am angry about the disinformation the biotech

industry is force feeding the American people. They

promote bioengineered foods as the only hope for feeding

the world. It seems to me, however, that bioengineered

foods were developed to feed the coffers of transnational

corporations.

Our food supply is already contaminated by

hormones in milk and meat, by antibiotics in poultry, and

by pesticides on produce. The FDA has permitted this

contamination, so it isn\'t surprising that the so-called

life science corporations are not required to show

independent scientific evidence that GMOs pose no risk to

human health or to the environment. What will it take to

get FDA to protect our food supply from corporate control

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and contamination?

GMOs are stealth ingredients in cereals, snack

foods, infant formula, pancake mix and pet food. Will

these stealth ingredients further fuel the cancer epidemic

in America? We don\'t know. Will they produce

life-threatening allergic reactions in the 5 million

American children who suffer from asthma? We don\'t know.

The majority of GMOs have been developed to

withstand higher levels of pesticide spraying or to

produce their own insecticides. Will these foods endanger

more children\'s health than already compromised? We don\'t

know.

If Americans knew the potential risks of

bioengineered foods, they would not buy them. That\'s why

industry doesn\'t want labeling, but labeling is only a

first step. We need to halt the production of

bioengineered foods until scientific evidence shows them

to be safe for us and for the environment.

The 20th Century has been characterized by three

developments of great political importance: The growth of

democracy; the growth of corporate power; and the growth

of propaganda as a means of protecting corporate power

against democracy.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

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STATEMENT OF

KARA COSBY

MEDIA RELATIONS MANAGER

INTERNATIONAL FOOD INFORMATION COUNCIL

MS. COSBY: Hello. I\'m Kara Cosby with the

International Food Information Council.

It\'s important that we all provide as much

credible information as possible to all consumers who want

that information. FDA does play a critical role in

communicating information about the safety of food

biotechnology to the general public.

Consumer attitudinal research conducted by IFIC,

and other organizations, indicate that the most credible

sources for food safety and nutrition communication are

health professional organizations, physicians, dietitians,

academic scientists, farmers, and government agencies,

such as the FDA and CDC. Priorities for information

dissemination should be consistent with both national

goals for food safety education, and the relative health

risks to the general public. In this regard, it is

important that we not let perceived risks, absent of any

evidence of actual risk from agriculture biotechnology,

distort the important Presidential Food Safety Initiative

targeted to actual risks from microbrial pathogens in our

food supply. We should not minimize legitimate questions

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or concerns about food biotechnology. Yet, we should not

be driven by opinion that we know is less than informed.

Our consumer surveys have consistently shown

that consumers with the highest level of education have

been most likely to support food biotechnology. When

consumers have solid science-based information, they make

the right decisions. A majority of consumers support the

benefits of food biotechnology when they are clearly

explained.

We look forward to working with the FDA and our

partners in the health professional and academic

communities to provide accurate and comprehensive

information that will help consumers make informed food

choices.

Thank you.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

JANET BROWN, PROGRAM OFFICER

CENTER FOR ECOLITERACY

MS. BROWN: My name is Janet Brown, and I\'m a

program officer at the Center for Ecoliteracy, for food

systems and liaison to the Food Systems Project in

Berkeley, recently designated one of four pilot projects

of the USDA, for linking farms to schools. I\'m the

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founder and chair of the Marin Food Policy Council and a

California certified organic farmer.

I bring with me a resolution adopted by Berkeley

City Council on December 7, supporting the establishment

of federal regulation to ban growing, disseminating and

marketing products genetically engineered until they have

been proven safe for human consumption.

In addition, I\'ve a resolution from the Berkeley

Board of Education adopted on December 1, supporting the

ban and calling for implementation of a transparent system

of assessment that requires a demonstration of reasonable

certainty of the benefits which greatly exceed the cost,

and a shift of the burden of proof and cost to the

manufacturer.

These may be the first resolutions of their kind

in the United States, but you and I both know they\'re not

the last.

From the Marin Food Policy Council, we take this

opportunity to register our strong concern regarding the

permissive atmosphere which allows an essentially

unregulated and disturbingly disintegrated science of

genetic engineering to operate in the absence of liability

constraints. Genetic engineering is at odds with the

sustainable agriculture. It seeks to intervene in the

natural process to undermine and move against the great

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forces of ecology, choosing, instead, to gamble on the

short-term cleverness of human ingenuity over faith in the

infallibility of nature. At this time, many concerned

citizens of the United States are uniting with citizens

from countries all over the world in questioning whether

this technology can be allowed to go forward in the face

of mounting doubt, danger and opposition.

Were the Food and Drug Administration to employ

precautionary principle, rather than the risk management

model \--

MR. LAKE: Thank you, ma\'am.

STATEMENT OF

RON PETERSON

MR. PETERSON: I appreciate the opportunity to

speak, although I think it\'s much too belated. I speak

for my family, the Peterson Family, and the hundreds

outside not given entrance, and millions worldwide not

given voice.

My family relies on organically grown crops for

our nutrition and health. Our source of sustenance is

being threatened by cross-contamination, genetic drift

from GE crops. We demand that the poisoning of our food

source cease immediately.

We demand an immediate 5-year moratorium on GE

foods, and demand long-term mandatory independent testing.

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We do not trust the current, all-to-cozy, revolving door

Monsanto-FDA tandem. We demand that we first determine

the safety of GE, GMO foods by long-term independent

testing; and only then label those Frankenfoods. We

demand that all GE, GMO foods be pulled from market

shelves immediately until proven safe.

We believe that GE, GMO methodologies are

responsible for decreased nutrition, superweeds,

biological pollution, dying Monarchs, increased chemical

use, allergies and antibiotics resistance, and

compromising BT use by organic farmers.

My family is being robbed of nutritional

supplements, such as Vitamin E, because of soy-based GMO

contamination. We will not be the guinea pigs for greed

driven corporate pirates.

We join with our brothers and sisters in Europe,

Japan, and many other countries in rejecting these

untested Frankenfoods. FDA, do your job and protect your

citizens. Your own scientists warned of dangerous toxins

in GE foods. They were significant health risks. Do your

job now and listen to your own scientists, scientists not

bought and paid for by the self-serving, greed-driven

motives of Monsanto and its coconspirators..

Thank you.

MR. LAKE: Thank you, sir.

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\[Applause.\]

STATEMENT OF

CHRIS BRINEGAR, PH.D.

PROFESSOR, MICROBIOLOGY

DIRECTOR, BIOTECHNOLOGY EDUCATION AND RESEARCH INSTITUTE

SAN JOSE STATE UNIVERSITY

DR. BRINEGAR: Hi! My name is Chris Brinegar.

I\'m director of Biotechnology Education and Research

Institute at San Jose State University. I\'m also a

professor of Botany and Molecular Biology there, too.

I\'ve have a Masters Degree in Food Science and

Ph.D. in Crop Physiology, and three years experience at an

agricultural biotechnology company. And as a professor,

I\'ve taught molecular biology for 13 years, and I\'ve

directed our Biotechnology Institute for the past 5 years.

So, speaking from almost 25 years of experience,

I truly believe that biotechnology has the potential to

improve the world\'s food supply, but not the way it\'s been

applied so far. Today, my biggest fear is that the

public\'s perception of bioengineered foods has been

poisoned by regulatory agencies and companies and by their

refusal to educate the public on this issue. This

educational void has been filled largely by British

tabloid journalism, which has led to the current backlash

against genetically modified organisms.

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In 1996, I saw that the FDA was doing nothing to

educate consumers on this issue. So, over the next two

years, I gave more than 20 lectures, all over the country,

with the goal of informing people about bioengineered

foods. At least 90 percent of all the people I talked to

didn\'t know that they\'d already eaten products from

bioengineered crops, and they were ticked off that they

were not told about it regardless of how they felt on the

issue. People want to know what their food is

bioengineered for the same reasons they want to know

whether a food is kosher, organic, or vegetarian, or

whether their tuna is dolphin free, or if running shoes

have been made in third-world sweat shops. What one eats

or buys is often an extension of what one believes. And

just as some people believe that eating animals is morally

wrong, other people may believe that swapping genes

between the kingdoms of life is morally wrong. And they

should not be forced to unknowingly eat transgenic

products.

My specific advice is this: Label all

bioengineered foods by putting an asterisk next to the

affected ingredient \--

MR. LAKE: Thank you, sir.

DR. BRINEGAR: Damn that was a fast ttwo

minutes.

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\[Laughter.\]

Well, then, you won\'t get my specific

recommendation.

MR. LAKE: You can submit it for the record.

STATEMENT OF

WALTER EPP

MR. EPP: If you think this is a scientific

issue, you are missing the point completely. Under

capitalism, you get the reward if you assume the risk.

Under socialism, the public gets both the reward and risk.

When industry gets the reward and the public gets the

risk, we have a prescription for disaster. Without

consequences, there\'s nothing to keep actors responsible.

Tampering with the genetic fabric of life is a completely

different order of risk.

Toxic chemicals and radioactive elements

disintegrate over time, so there\'s a limit to the total

damage. Mutant genes could spread and reproduce forever

with no limit to the damage. We\'re talking about

unprecedented types of recklessness.

Freedom is the ability to make choices. If

there\'s no labeling, there\'s no choice. If there\'s no

choice, there\'s no freedom. To call this a free market is

a fraud. It\'s a rigged market.

We will know the FDA is doing its job when it

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does the following: All studies regarding to health and

environmental consequences are published on the internet,

with funding sources and employment histories disclosed.

Any company that keeps anything secret is prohibited from

selling. For the public to make informed decisions, it

must have free access to all information. No product

approvals based on data produced by people affiliated with

the producer or other conflict of interest.

Require full liability from industry for all

damage from genetic engineering. Since damage could

exceed the ability of companies to pay, this will require

posting a bond. Since the damage from self-reproducing

genes could last a million years, the size of this bond

would be spectacular. If companies, and their CEOs, do

not accept liability without possibility of bankruptcy,

then they do not believe the benefits are worth the risk,

so why should we?

This criterion is more relevant than a hundred

foot pile of scientific studies. Anything less than these

terms is an astronomical subsidy.

An industry poll shows 93 percent public support

for labeling. The timing and procedures of this meeting

maximized convenience for corporations and maximized

inconvenience to the public. If the FDA continues to

serve corporate interests and subvert the public

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interests, it renounces its claim to legitimate authority

and leaves it to the public to figure out some other way

to regain control. In a democracy, the public decides by

criteria of its chosing.

MR. LAKE: Thank you, sir.

MR. EPP: \-- scientific or not.

STATEMENT OF

SHIRLEY STUART

RETIRED, UNIVERSITY OF CALIFORNIA

MS. STUART: My name is Shirley Stuart. I\'m

speaking today as a consumer.

The mandate of the FDA seems to have been turned

180 degrees. The FDA is supposed to stand between us and

the avarice of big business. Monsanto, Norvartis, and the

other agri-giants, have developed GMO products not out of

an altruistic wish to feed the world, but to make money.

Plants are being irrevocably changed. Many of the

resulting products have not been tested. And, yet, you\'re

asking us to eat them without our knowledge.

The focus of some of the panel members here

seems to be not to answer questions, but how to get us to

stop asking them. The FDA has simply accepted biotech

industry assurances that their products pose no threat to

our health. They\'re being considered as no different from

ordinary foods, so no special testing has been required.

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Some scientists are concerned that the enhanced

or souped-up promoters used to insert foreign genes into

cells may cause cancer. Questions that bacterial

resistance to antibiotics may be made worse by mark

routines, used in the splicing process, have also been

raised. Some experts have suggested that old diseases may

acquire new characteristics and new diseases may be

created as a result of these processes.

To say that gene splicing is only an extension

of traditional agricultural practices is ludicrous.

Cross-species genetic combinations could never occur

without this process. How, for instance, would a gene

from a flounder get into a tomato?

I am opposed to genetic modification of food;

but, if it\'s going to be done, the products must be

labeled. I don\'t want to eat tomatoes with fish genes,

and I don\'t want to eat corn and potatoes that have

bacteria and virus genes spliced into them. The rest of

the world has been saying, \"No,\" and we in America have

the right to say \"No,\" too.

Thank you.

\[Applause.\]

MR. LAKE: Thank you, ma\'am.

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STATEMENT OF

C. S. PRAKASH, Ph.D.

PROFESSOR, COLLEGE OF AGRICULTURE

TUSKEGEE UNIVERSITY

DR. PRAKASH: My name is C. S. Prakash, and I\'m

from Tuskegee University.

My research is in developing nutritionally new

crop plants, and I work specifically on peanut. Much of

my work also involves training of many scientists in

developing countries. And I am from a developing country

myself, from India.

As a plant breeders, and also as a molecular

biologist, I have been fortunate to know how some of these

products are developed and how agriculture has evolved.

And my belief is that risk is necessarily a function of

the nature of the product and not necessarily the process

in which it was developed.

I have heard a lot of mention of precautionary

principle mentioned here, and our being \-- the audience

here warning you about some of the risks involved. And I

just wanted to say that, if you were to invoke the

precautionary principle, if you were to be sitting here

about a hundred or two hundred years ago and asked the

same types of questions of all of the critics of

biotechnology about the safety of the GM foods, in this

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country you would be eating cranberries, blueberries and

artichoke. Because every other crop has been introduced

from somewhere else. And every other crop you can ask

the same questions, whether it is potatoes, or soy bean,

or corn, and you could come up with some risk factor to

prevent the use of those crops here. And the same goes

with the traditionally improved crop plants for which even

a small chromosome segment that is introduced from a wild

potato introduces nearly 1,000 genes for just one gene

that we are trying to introduce, and for which we have no

knowledge what those genes do.

And, again, what happens today here, the

positions that you\'ve taken, FDA, here, has really a

cascading effect on the rest of the world, especially in

developing countries. And, you know, at the end of this

century, the technology will still have the prospect of

about a billion people who earn less than one dollar a

day, and who go hungry everyday. And biotechnology may

not be the proper technology \--

MR. LAKE: Thank you, sir.

DR. PRAKASH: Thank you.

STATEMENT OF

MAUREEN TERNUS, M.S., R.D.

FOOD AND NUTRITION COMMUNICATIONS

MS. TERNUS: My name is Maureen Ternus. I\'m a

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registered dietitian with a nutrition communications

consulting practice here in the Bay Area. I work closely

with public and health professionals.

One area of my business includes manning a

nutrition hot line. And, ironically, I get very few

questions regarding biotechnology. Most consumers are

more concerned about the safety of the food supply and

pesticides, in particular. One of the greatest benefits

of plant biotechnology is the reduction in the use of

pesticides and insecticides.

From a health standpoint, biotechnology can help

improve the food supply by making foods more nutritious.

For example: Using this technology, we can add protein to

foods in developing countries with high rates of

malnutrition. Other opportunities include the production

of grains, fruits and vegetables with more vitamins and

minerals. In fact, many developing countries are already

benefiting from newly-developed high-Vitamin A rice.

The position of the American Dietetic

Association, which represents 70,000 registered

dietitians, is that biotechnology has the potential to be

useful in enhancing the quality and nutritional value in

the variety of food available for human consumption. This

is especially important when you consider the fact that

the world\'s population is expected to double in the next

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40 to 50 years, increasing food production needs by 250

percent. Plant biotechnology can help meet increased

global food and fiber demands while promoting sustainable

farming methods.

As with any new technology, lack of credible

information can result in questions and concerns. Instead

of spending so much time and money debating whether or not

to use biotechnology, more resources should be spent on

educating the public. Most consumers are so removed from

the farm these days that few understand the process by

which produce, for example, gets the field into the

supermarket, much less how this new technology works.

As a health professional, I feel biotechnology

is an important tool in providing numerous health and

environmental benefits.

Thank you.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF GUY A. CARDINEAU, Ph.D.

GLOBAL LEADER, RESEARCH AND DEVELOPMENT,

OUTPUT AGRICULTURE, DOW AGROSCIENCES

DR. CARDINEAU: Good afternoon.

My name is Guy Cardineau, and I\'m currently

global leader for Output Agriculture R&D, at Dow

AgroSciences in San Diego. For over 16 years, I\'ve worked

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in the field of ag biotechnology, and have been fortunate

to have been involved in the exploration of the tremendous

opportunities that new plant varieties offer us in

addressing environmental, nutritional, and other problems

worldwide.

I\'m here today to stress the commitment of Dow

AgroSciences to thorough and continuous testing of all new

plant varieties that we develop. We begin assessing

potential toxicity, allergenicity and environmental safety

concerns as soon as the desired traits or genes are

identified. We continue environmental and human health

safety testing as the gene is transferred to seed and

planted in the field. The resulting new plant varieties

are evaluated against their traditional plant variety

throughout the period of trait integration to assess the

effect of the modification. All collected data is

submitted to FDA, EPA, and USDA, as appropriate, which

form a coordinated framework for regulatory review. We

may conduct additional tests depending on our assessments

or from evaluations that these agencies make about our

submitted data.

While these new products are derived from

proteins that appear in nature and human and animal

toxicities are not expected, we recognize they must

nevertheless be investigated with both traditional and

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emerging risk assessment methods. The agencies are

prodigious in these reviews and work to anticipate real

problems that might occur in any situation. We believe

the coordinated framework of review allows for numerous

eyes, from various perspectives, to examine the safety and

health data on allergenicity and toxicity and

environmental impact.

I\'d like to conclude with four points:

First, we support the coordinated agency

framework. It\'s appropriate and effective in the

oversight of biotech products.

Secondly, Dow AgroSciences takes product

stewardship very, very seriously. Our company is working

to employ the most modern risk assessment methods to

evaluate the new wave of novel products.

Lastly, we expected this wonderful science will

permit us to use plants to produce novel products that

will play important roles in medicine, fuel production,

farming, food and fiber production, and to benefit the

environment.

Thank you, for your time.

MR. LAKE: Thank you, sir.

\[Applause.\]

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STATEMENT OF

ARIELLE LEVINE, GRADUATE STUDENT

COLLEGE OF NATURAL RESOURCES

UNIVERSITY OF CALIFORNIA, BERKELEY

MS. LEVINE: My name is Arielle Levine, and I\'m

here to speak as a concerned graduate student from the

University of California, Berkeley, College of Natural

Resources.

Last year, my college signed a research

agreement with Novartis, a major agricultural biotech

corporation. This alliance sparked tremendous debate

about issues surrounding biotechnology and the future

direction of reseach at our university. A good deal of

funding at Berkeley, \$25 million, in fact, is directed

towards developing biotechnology. However, little to no

funding is directed towards questioning biotechnology or

developing sustainable alternatives, such as organic

agriculture or integrated pest management.

A few large agro business companies have created

pressures to get new products on the market as quickly as

possible, before we know their possible ecological,

economic and health ramifications. Research on genetic

engineering is very one-sides, and little is known about

the potential dangers of biotechnology to our society.

As we heard this morning, there is little

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scientific consensus. In fact, there were Berkeley

faculty and students rallying outside the building today

both in support of and against biotechnology. If so much

controversy can be found in a major university, like

Berkeley, it is clear that we can not yet wholeheartedly

embrace biotechnology in all of its implications.

I, and the students for responsible research at

UC-Berkeley, advocate taking a precautionary approach

towards genetically engineered foods, and recommend that,

first, more research needs to be conducted on the

potential negative effects of GE foods. Looking at the

potential benefits is already very well funded by large

corporations. But there are sparse funds available to look

at the potential hazards, or to develop sustainable

alternatives.

Second, the FDA should mandate industry labeling

of GE foods. The public\'s concerns are valid and they

have the right to make an informed choice about the food

they consume. If these foods are as safe as their

advocates say they are, they should have no problem with

the public\'s right to know. We believe that this

precautionary approach is the only responsible approach

for the FDA to take, given the paucity of research being

conducted and how little is known about the potential

hazards og GE foods.

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Thanks.

MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

MICH B. HEIN, PRESIDENT

EPLCYTE PHARMACEUTICAL, INC.

MR. HEIN: My name is Mich Hein. I\'m the

president of EPlycyte Pharmaceutical, a small

biotechnology company in San Diego, California, which is

based on using transgenic plants to produce pharmaceutical

proteins.

I\'d like to thank the FDA for this opportunity

for all of us to meet here, and to commend you on your

endurance for this day, and for the two meetings.

We produce pharmaceuticals in plants because

plants are the most efficient producers of protein on the

planet. There isn\'t any question about that. It\'s the

reason it\'s the basis for our food supply. It\'s also the

basis of our economy. You\'ve already instituted protocols

for labeling for nutrition, and we, as an industry and as

a company, support the 1992 FDA protocol for science-based

material labeling of products.

We believe that the ability to produce proteins

in plants, for pharmaceutical purposes, will also \-- would

somebody please shut that off?

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We believe that the evolution of this technology

will lead to a blurring of the lines between

pharmaceuticals and plants. And I think Dr. Johnson

alluded to that earlier. Our health is very much tied to

our food supply.

I\'d like, in closing, to make this single point:

That there is a lot of fear and a lot ignorance out there,

and a lot of that is justified. Because we don\'t know

what we\'re getting into in many cases. However, we need

facts and we need information in order to eliminate that

fear and ignorance. And I would echo Dr. Gordon\'s

surprise and his dismay in that many of the

representations here, based on the miscegnation of genes

amongst organisms, has a very clear precedent, that there

are many, many genes that have been transferred between

kingdoms and amongst organisms that have been done so

without the help of human hands. In fact, it\'s the

ability of us to recognize that, that has allowed us to

make many of the transgenic organisms and plants that we

have made.

Thank you.

MR. LAKE: Thank you, sir.

\[Applause.\]

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STATEMENT OF

MIKE PHILLIPS, EXECUTIVE DIRECTOR

FOOD AND AGRICULTURAL, BIOTECHNOLGOY INDUSTRY

ORGANIZATION

MR. PHILLIPS: I\'m Mike Phillips, with the \--

I\'m the executive director for Food and Agriculture, for

the Biotechnology Industry Organization. I thank you for

allowing us to make comments today.

BIO represents over 850 biotechnology companies

and academic institutions. FDA is to be commended for its

1992 policy and the way it has been implemented. There is

really no issue with regard to food safety in the food

derived from crops improved through biotechnology. And

even the activists, who take the time to read and

understand FDA\'s policy, also recognize the food safety is

a nonissue.

BIO supports the consumer right to have

information that allows them to make informed choices

regarding the foods that they eat. FDA\'s 1992 policy for

biotechnology foods and ingredients provides consumers

with everything the activists have asked for, except the

ability to sow confusion and mislead consumers with

government blessing. Choice is provided. If a consumer

wants to buy food not derived from enhanced crops, they

can buy organic and also pay the higher cost. If they

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want accurate and reliable information on health and

nutrition, that is mandated by law. If they want to know

if their personal preferences in regard to genetic

modification has been met, companies are free to meet

those preferences provided there is sufficient consumer

demand.

We agree with FDA\'s implementation of the 1992

policy that requires labeling for significant changes,

including nutrients or the introduction of allergens, and,

specifically, that the common and usual name for the

ingredient should identify the change. The Food, Drug and

Cosmetic Act allows food producers to provide choice

through voluntary label statements as long as labels are

truthful and not misleading. If food companies were to

pursue voluntary labeling, FDA would need to be an

integral part of establishing uniform guidelines or

criteria to insure that consumers could relay on labeling

for factual and accurate information.

Changing policy to require special labeling for

foods derived from biotechnology could impact

significantly consumers perception of the safety of these

foods and undermine the confidence consumers presently

have in the information for which they look to food

labels.

MR. LAKE: Thank you, sir.

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\[Applause.\]

STATEMENT OF

MATTHEW METZ

UNIVERSITY OF CALIFORNIA, BERKELEY

MR. METZ: My name is Matthew Metz. I\'m a

doctoral student in the UC-Berkeley Plant Biology

Department.

First of all, I do not have an agenda fueled by

disgruntled feelings of disenfranchisement from the

scientific community. No protest rallier fed me lunch, or

ego stroking today. I\'m part of a coalition of concerned

scientists interested in public having the capability of

making informed consumer choices. These choices should

not be warped by techophobia coming from one end of this

melodrama, nor the deprivation of information that seems

to be evolving from the other end. Every melodrama needs

a villain, and I think that this debate over the

technology should really avoid being thrust into such a

position.

One other item.

Nothing is absolutely safe, and I think that the

insistence on proving absolute safety in the food product

is merely a filibuster against its reaching the market at

all. Labels will occur, driven by market demand.

Mandatory labeling will not be necessary, nor does it seem

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to be the mandate of the FDA. However, it will seem to be

very critical for the FDA to play a strong role in

governing how these labels are worded and on what products

they\'re placed. The FDA has a history of regulating food,

drug and cosmetics so that they are not \-- they do not

prevent consumer misconception.

During the second panel discussion, food

irradiation was mentioned. European markets have long

benefited from the increased safety, shelf life, plus

reduced storage costs of this technology. The U.S.

markets have not benefited from this technology in any

substantial way, partly because the labeling standards did

not promote understanding of the technological benefits

and appeared to be cautionary versus informative.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

KEVIN DANAHER, Ph.D.

PRESIDENT, BOARD OF DIRECTORS, TRANSFAIR USA

MR. DANAHER: Good evening. My name is Kevin

Danaher. I got my Ph.D. from the University of

California. I\'m president of the Board of Directors of

TransFair USA, which is the fair trade labeling

organization for the United States, part of FLO, Fair

Trade Labeling Organizations International, the largest

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international network of fair trade labeling

organizations.

I want to put this in the largest historical

context I can. It took centuries to achieve the

separation of church and state. We are now in the middle

of a struggle to separate corporations and the state in

order to have real democracy. So the question is not

about science or technology. It\'s about who rules. Is it

the citizens or is it the corporations?

America was the first nation to establish the

principle that sovereignty, which means open political

authority, resides in We, The People. And we are a beacon

to democratic movements around the world because of that

founding of our country. Abe Lincoln, in the Gettysburg

Address, referred to government of the people, by the

people, for the people. He didn\'t say of the

corporations, by the corporations, for the corporations.

In fact, corporations and profit maximization does not

appear in the Constitution, the Declaration of

Independence, or any of our founding documents.

So the question is: Are the people sovereign

citizens who should rule, or are we guinea pigs to the

latest round of corporate technology?

I apologize if this sounds condescending, but

the FDA\'s central responsibility, in my mind, is to

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protect the citizen taxpayers, not to protect corporate

profits. So the recommendations of TransFair USA, Global

Exchange, and many other activists organizations, is: We

need more democracy. As many speakers on both sides of

this has said, we need the facts to get out. Let\'s open

up the process. Let\'s have public debate. Let\'s go on

Night Line, let\'s go out in all the media, and debate the

issue and may the best argument win. And we need labeling

information so the citizens can make informed decisions

about the kind of commodities they want to purchase.

Thank you very much.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

MICHAEL STRAUSS

INNOVATIVE MARKETING AND PUBLIC RELATIONS FOR AGRICULTURE,

BEYOND ORGANIC

MR. STRAUSS: Hi! Mu name is Michael Strauss.

I\'m a public relations consultant and the former marketing

director of our family farm, the first organic dairy farm

in the Western United States. I\'m not here in any

official capacity, for the family or the dairy.

FDA labeling on RVST placed an unfair economic

burden on dairy processors, who choose not to use it, by

not requiring mandatory labeling for those who do. I

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know. I\'ve run into that repeatedly in my previous work.

The apparent revolving door policy, which

allowed RVST labeling regulations to be developed by a

person who was formerly, and is currently now, a Monsanto

employee, raises significant credibility issues. When all

is said and done, this process is built on trust. Until

conflict-of-interest issues can be fully resolved, until

trust can be restored, the public, all of our right to

know, must be honored. Mandatory labeling, by

manufacturers using GMO ingredients, is merely the first

step to restoring the public trust.

Thank you.

MR. LAKE: Thank you, sir.

\[Applause.\]

STATEMENT OF

SALLY FOX

COTTON BREEDER, FOX FIBER

MS. FOX: Good afternoon. My name is Sally Fox.

I am a traditional cotton breeder. I breed cotton that

grows in color, and I grow it organically. It\'s name is

Fox Fiber, not Frankenfiber.

I want nothing \-- I am beyond belief, aggravated

and shocked by the people who hold Ph.D.s, who, in this

room today, have told people that genetic engineering is

simply the next step beyond plant breeding.

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I want to, if I only say one thing to you today,

I want you to know that there is no resemblance whatsoever

between real, traditional plant breeding, that has brought

us all the food and fiber that created the civilization

that we enjoy or dislike \-- depending on our views \-- but

it has all been brought to us by traditional plant

breeders. And this anomaly, this current craze that has

taken over the scientific community, the quote \"scientific

community,\" in the United States is the most treacherous

threat to real science in our society that I believe we

have ever come across.

I know we only have two minutes, so I will \-- I

had brought lots of data that I\'ve analyzed in terms of

the BT crops, the crops that are producing the BT toxin.

I\'ve looked at the evidence that was supplied to the EPA,

and I find it equally lacking in logic. Nothing was

actually tested with the true plant \-- well, not nothing

\-- very few tests were actually conducted with the actual

toxin that\'s expressed by the plant. All the

registrations and the exemption from tolerance testing

that the EPA gave the BT plants were based on the natural

bacteria from which it came. I used to be, my day job

before I could afford to be an independent plant breeder,

was as a fermentation microbologist and later as a quality

control supervisor at \--

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MR. LAKE: Thank you, ma\'am.

\[Applause.\]

STATEMENT OF

REBECCA KAPLAN

GREEN PARTY

MS. KAPLAN: Good afternoon. Thank you for your

time and your attention. I know it\'s getting late.

My name is Rebecca Kaplan. First, I\'d like to

convey the Green Party, which has recently calling for a

moratorium on genetically engineered food until such time

as full, complete, safety testing is completed. And

regardless of the results of any safety testing, is

calling for labeling of all genetically modified

organisms.

Some points about what\'s going on.

I\'ve heard a lot of people talk about how

they\'re excited about genetically modified organisms, how

they find them useful in specific applications. None of

that justifies at all why we should me made to eat them

without our consent. These people that are excited about

them and they want them, let them buy them. But to not

have them be labeled violates every core principle of

democracy.

It also violates every free market principle

going back to Adam Smith, which is premised upon people

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making informed choices of their own free will about what

they do and don\'t want. Even those who think that

genetically engineered foods are great should not oppose

their being labeled. If they thought they were great,

they would promote them being labeled and tell people that

they\'re great, and let people know where to find them.

Additionally, I think there is a lack of taking

into account the big picture. Even if one specific

organism doesn\'t have a proven health impact, people

should have the right to follow their personal, ethical or

religious beliefs. Right now, there is no kosher

labeling, or labeling for other dietary requirements on

raw fruits and vegetables that are in the supermarket.

Now that there is genetic engineering, we\'re going to have

to assume that it\'s all not kosher. To prohibit people

from being able to practice their religious and ethical

beliefs is unacceptable in a multicultural society.

Finally, this cannot be undone. The United

States did not phase out lead in paint until years after

Europe did, even though it was proven to be dangerous,

because they were beholden to the corporate profits. And

I imagine many of you know how difficult lead abatement

is.

MR. LAKE: Thank you, ma\'am.

MS. KAPLAN: It\'s nothing compared to trying to

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abate genetically engineered organism in the wild.

Thank you.

MR. LAKE: Thank you.

STATEMENT OF

JOHN DUARTE

DUARTE NURSERY

MR. DUARTE: Hello. I\'m John Duarte, from

Duarte Nursery and Dry Feed Laboratories and Duarte

Farming, from Modesto, California.

Duarte Nursery is our main company. It produces

grape vines and apple trees and almond trees for growers

throughout California. We\'re probably the largest

permanent crop nursery in the nation.

I go out and talk to growers. We\'ve got

ambition of one day developing genetically modified

apples, genetically modified almonds, and genetically

modified grapes to answer the needs of many of our growers

we work with. And it\'s going to be a long process. If

it\'s difficult to deliver these technologies in field

crops, and allocate resources towards crops that have

millions, or hundreds of millions of acres that can be

sold genetically modified technology to, you can imagine

the difficulty in finding the investment capital or

wherewithal to deliver these crops, these technologies,

into the crops we deal with, so that the farmers who grow

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apples, who just lost two of their major crops protection

tools, VIA, the FQPA regulations this last year, who are

now wondering how they are going to keep the coddling moth

out of their apples. In the future, I\'m sure grape

growers will be wondering how they\'re going to keep

insects out of their grapes, the leaf rollers, the lead

folders, and other insects and disease problems they face.

This can answered well through biotechnology. But it\'s

only through a stable, predictable, and effective

regulatory framework that these crops will ever attract

the capital that will help deliver these technologies into

those crops, the crops that I work with, the crops that

the growers tell me: That would be great. Can you do it?

When can I have it? Because they know what\'s coming down

the pike in terms of pesticides and fungicides in their

crop production programs, and it doesn\'t look good without

these technologies.

So, I\'ll ask you, as you answer the needs of

those who need more information, of those who want a more

open process, do it; but please keep that predicability

there that\'s going to let me attract the capital to a

10-year development program.

MR. LAKE: Thank you, sir.

\[Applause.\]

MR. LAKE: This is the last of our scheduled

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speakers.

CLOSING REMARKS

COMMISSIONER HOLSTON: Well, we\'ve come to the

end of a very long day, but I have to say, for myself, and

I\'m certain for my colleagues here on the panel, it has

been a very productive and a very informative day. We\'ve

heard a wide spectrum of opinions, perspectives,

viewpoints on this issue. I think, for every point that

was raised on one hand, someone has given the opposite

perspective on that same point. Probably the only thing

we heard, with any consistency, is that consumers need

education. We need to do some a better job of informing

people about what this technology is and what is going on.

I want to thank all of you for taking the time

to be with us. We want you to remember that we do have a

written, an open, docket, and that you have until January

13 to submit comments to that docket. We also urge you to

continue to watch the FDA home page on the internet for

further information about this subject and all the

developments that we anticipate in the future.

Again, thank you very much for your attention

and good night.

\[Applause.\]

(Whereupon, at 5:55 p.m., the meeting was

concluded.)

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C E R T I F I C A T E

I hereby certify that this is the transcript of the

proceedings held before the

FOOD AND DRUG ADMINISTRATION

on Monday, December 13, 1999,

and that this is a full and correct transcription of the

proceedings.

James W. Higgins, CVR

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