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S. HRG. 109–438

TO REVIEW THE BENEFITS AND FUTURE

DEVELOPMENTS IN AGRICULTURE AND

FOOD BIOTECHNOLOGY

HEARING

BEFORE THE

COMMITTEE ON AGRICULTURE, 

NUTRITION, AND FORESTRY

UNITED STATES SENATE

ONE HUNDRED NINTH CONGRESS

FIRST SESSION

JUNE 14, 2005

Printed for the use of the 

Committee on Agriculture, Nutrition, and Forestry

(

Available via the World Wide Web: http://www.agriculture.senate.gov 

COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY

SAXBY CHAMBLISS, Georgia, Chairman 

RICHARD G. LUGAR, Indiana 

THAD COCHRAN, Mississippi 

MITCH MCCONNELL, Kentucky 

PAT ROBERTS, Kansas 

JAMES M. TALENT, Missouri 

CRAIG THOMAS, Wyoming 

RICK SANTORUM, Pennsylvania 

NORM COLEMAN, Minnesota 

MICHEAL D. CRAPO, Idaho 

CHARLES E. GRASSLEY, Iowa 

TOM HARKIN, Iowa 

PATRICK J. LEAHY, Vermont 

KENT CONRAD, North Dakota 

MAX BAUCUS, Montana 

BLANCHE L. LINCOLN, Arkansas 

DEBBIE A. STABENOW, Michigan 

E. BENJAMIN NELSON, Nebraska 

MARK DAYTON, Minnesota 

KEN SALAZAR, Colorado

MARTHA SCOTT POINDEXTER, Majority Staff Director 

DAVID L. JOHNSON, Majority Chief Counsel 

STEVEN MEEKS, Majority Legislative Director 

ROBERT E. STURM, Chief Clerk 

MARK HALVERSON, Minority Staff Director 

(II) 

(III)

C O N T E N T S 

Page

HEARING(S):

To Review the Benefits and Future Developments in Agriculture and Food 

Biotechnology ........................................................................................................ 01

Tuesday June 14, 2005

STATEMENTS PRESENTED BY SENATORS 

Chambliss, Hon. Saxby, a U.S. Senator from Georgia, Chairman, Committee 

on Agriculture, Nutrition, and Forestry ............................................................. 01

Harkin, Hon. Tom, a U.S. Senator from Iowa, Ranking Member, Committee 

on Agriculture, Nutrition, and Forestry ............................................................. 16

Lugar Hon. Richard G., a U.S. Senator from Indiana .......................................... 02

WITNESSES 

Brackett, Robert E., Ph.d., Director, Center for Food Safety and Applied 

Nutrition, Food and Drug Administration, Department of Health and 

Human Services, Rockville, Maryland ............................................................... 06

Gabriel, Clifford, Director, Office of Science Coordination and Policy, U.S. 

Environmental Protection Agency, Washington, DC ........................................ 05

Greenwood, Jim, President and Chief Executive Officer, Biotechnology Industry Organization, Washington, DC ..................................................................... 18

Heck, Ron, Chairman, American Soybean Association, Perry IOWA ................. 20

Lambert, Chuck, Deputy Under Secretary, Marketing and Regulatory Programs, U.S. Department of Agriculture, Washington, DC ............................... 03

Quinn, Kenneth M., President, World Food Prize Foundation, Des Moines, 

Iowa ....................................................................................................................... 22

APPENDIX 

PREPARED STATEMENTS: 

Harkin Hon. Tom .............................................................................................. 36

Brackett, Robert E. ........................................................................................... 50

Gabriel, Clifford ................................................................................................ 44

Greenwood, Jim ................................................................................................ 70

Heck, Ron .......................................................................................................... 78

Lambert, Chuck ................................................................................................ 39

Quinn, Kenneth M ............................................................................................ 82

DOCUMENT(S) SUBMITTED FOR THE RECORD: 

Letter and Statement of the Alliance for Health Econonic and Agriculture 

Development .................................................................................................. 98

QUESTIONS AND ANSWERS SUBMITTED FOR THE RECORD: 

Harkin Hon. Tom, (Some answers were not provided) .................................. 107

(1)

TO REVIEW THE BENEFITS AND FUTURE DEVELOPMENTS IN AGRICULTURE AND FOOD 

BIOTECHNOLOGY 

TUESDAY, JUNE 14, 2005, 

U.S. SENATE,, 

COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY,, 

Washington, DC. 

The committee met, pursuant to notice, at 2 p.m., in room SR–

328A, Russell Senate Office Building, Hon. Saxby Chambliss, chairman of the committee, presiding. 

Present or submitting a statement: Senators Chambliss, Lugar, 

Harkin, and Salazar. 

STATEMENT OF HON. SAXBY CHAMBLISS, A U.S. SENATOR 

FROM GEORGIA, CHAIRMAN, COMMITTEE ON AGRICULTURE, 

NUTRITION, AND FORESTRY 

The CHAIRMAN. The hearing will come to order, and I welcome 

you this afternoon to this hearing to review the benefits and future 

developments in agriculture and food biotechnology. I appreciate 

our witnesses and our members of the public being here, as well 

as those who are listening through our website. 

This year marks the tenth anniversary of the commercialization 

of agriculture biotechnology. The dramatic adoption rate of biotechnology crops has changed U.S. and global agriculture. I know 

of no other modern technological development in agriculture that 

has had such a profound impact on farm operations and food production as biotechnology. I have heard biotechnology described as 

the single largest influence changing agriculture since the introduction of the cultivator. In my home State of Georgia alone, 94 percent of the upland cotton acres were planted this year with biotech 

varieties. Nationally, crops enhanced through biotechnology accounted for 76 percent of the cotton acres, 85 percent of the soybean acres, 45 percent of the corn acres. By all accounts, biotech 

crops have produced real gains for growers by raising incomes and 

promoting more environmentally friendly farming. 

According to a 2003 study released by the National Center for 

Food and Agriculture Policy, U.S. farmers who planted biotech 

crops earned an additional $1.9 billion over what they would have 

earned planting conventional varieties. Globally, during the 9–year 

period from 1996 to 2004, planted acreage of biotech crops increased more than 47–fold, from 4.2 million acres in 1996 to over 

200 million acres in 2004, with an increasing proportion grown by 

developing countries. 

2

The estimated global area of approved biotech crops in 2004 was 

200 million acres, up from 167 million acres in 2003. I appreciate 

that despite the strong growth and commercial success of biotech 

crops, the technology and its application elicits strong opinions 

from many sides. The American public has accepted agriculture 

and food biotechnology and has a high level of confidence in Government agencies responsible for its oversight. However, we recognize that it is important to institute science-based systems in other 

countries that do not enjoy the same level of confidence in their 

government or their regulatory systems. 

One of the purpose of this hearing is to review the current regulatory framework governing agriculture biotechnology and to learn 

about new policies that are being instituted based on the lessons 

we have learned. It is important that sound science remains the 

cornerstone of our efforts when regulating this technology. A strong 

science-and risk-based system that ensures products are safe for 

the environment and human and animal health must be the underlying premise of U.S. Government policy. 

The U.S. Government agencies responsible for oversight of agriculture biotechnology include the Department of Agriculture, the 

Environmental Protection Agency, and the Food and Drug Administration. Sound regulatory oversight of agriculture and food biotechnology ensures public confidence and is essential to present 

and future acceptance of the technology worldwide. 

I believe that protection of our food and feed supply is our highest priority, and I look forward to hearing how our regulations are 

currently working and what efforts are being made to update them. 

We will also hear about current innovations and future uses. 

Just as biotechnology is revolutionizing the medical field, its application to agriculture is no less exciting. The past 10 years focused 

on agronomic input traits that improved yields, reduced pesticide 

costs, and improved soil conservation and water quality. In addition to building on these benefits, the next 10 years promise innovations that will allow consumers to derive benefits through 

healthier foods and new crops that will help alleviate world hunger. 

We are also already developing industrial products in our crops 

that promote a cleaner environment through renewable fuels and 

biodegradable plastics. No other technology in agriculture is transforming the way our Nation farms quite like this. The testimony 

we hear today will help further explain what is being done to ensure we continue to have confidence in the technology and how future innovations will impact our daily lives. 

Now, Senator Harkin has already let us know that he is going 

to be getting here a little bit late. We will certainly allow him to 

make any comments when he does arrive. Senator Lugar, we are 

glad to have you here this afternoon. If you have any opening comments, we will be happy to hear from you at this time. 

STATEMENT OF HON. RICHARD G. LUGAR, A U.S. SENATOR 

FROM INDIANA 

Senator LUGAR. Well, Mr. Chairman, I just thank you for having 

this hearing. You have excellent witnesses, and this is very, very 

3

important, just as you have indicated. But I look forward to hearing the testimony. 

The CHAIRMAN. Great. Thank you very much. 

We have two panels this afternoon. The first panel will include 

the Honorable Chuck Lambert, Deputy Under Secretary, Marketing and Regulatory Programs, United States Department of Agriculture. Mr. Lambert we are certainly pleased to have you here. 

Dr. Clifford Gabriel Director, office of Science Coordination and 

Policy, from the Environmental Protection Agency. Dr. Gabriel, 

welcome. We are glad to have you here. 

And Dr. Robert Brackett, Director, Center for Food Safety and 

Applied Nutrition, from the Food and Drug Administration. Dr. 

Brackett, we are pleased to have you, and I cannot help but note 

that we know you are an expert because you taught at the University of Georgia, and everybody from the University of Georgia is an 

expert. 

[Laughter.] 

The CHAIRMAN. Gentlemen, we are pleased to have you here. We 

look forward to your testimony and to your responding to our questions. And, Dr. Lambert, we are going to start with you, and we 

welcome hearing your comments. 

STATEMENT OF CHUCK LAMBERT, DEPUTY UNDER SECRETARY, MARKETING AND REGULATORY PROGRAMS, U.S. 

DEPARTMENT OF AGRICULTURE, WASHINGTON, DC 

Mr. LAMBERT. Thank you, Mr. Chairman. I am pleased to be here 

to provide the committee an overview of USDA’s role in regulating 

ag biotech. I understand that my full comments will be in the 

record, so I will just try to hit the high notes here. 

Biotech is rapidly evolving, and as Federal regulators, it is critical that we keep pace with the technology. Since we began regulating biotech in 1986, we have deregulated more than 60 genetically engineered agricultural products and overseen more than 

10,000 biotech field tests. It is the responsibility of USDA to thoroughly evaluate genetically engineered organisms to verify that 

they are safe for agriculture and the environment. 

This is a responsibility that we share with the EPA and the Food 

and Drug Administration. Under the Coordinated Framework, we 

work in concert to ensure that biotech crops are safe not only for 

agriculture but also the environment. 

APHIS’ primary focus is regulating the interstate movement, importation, and field release of plants under the Plant Protection Act 

through a permitting and notification process. To a lesser degree, 

we also regulate biotech-derived veterinary biologics under the 

Virus-Serum Toxin Act. And we are currently evaluating our role 

in the regulation of genetically engineered animals and other 

pathogens and pests under the authority of the Animal Health Protection Act that was in the 2002 farm bill. 

In the last 3 years, the program has made a number of changes 

to address the latest advances in biotech. We created the Biotech 

Regulatory Services, or BRS, in June of 2002. Cindy Smith, here 

behind me, is the Deputy Administrator for BRS, as is John Turner. 

4

APHIS’ field testing requirements for regulated plants are designed to prevent the unintentional environmental introduction, either through pollen movement or seed or grain commingling or 

other means, of a protein produced in these plants that could 

present a potential risk to agricultural crops or the environment. 

Anyone who wants to field test such crops must submit a permit 

for applications and inform us of the confinement conditions to prevent the escape of pollen, plants, et cetera. 

I would add that we are committed to ensuring that State interests are fully considered in the field test permit and notifications, 

and before any product can be field tested, we address and work 

with the State officials to address their concerns to ensure that the 

tests can be conducted safely. And the agency has never approved 

a field test permit over the objections of our State counterparts. 

Regarding pharmaceuticals and industrials, although there has 

been much attention given to these in reality, the hype exceeds reality. We have approved about 90 permits for field tests out of the 

total 10,000 field tests. But this is a growth area, and we have 

modified and imposed stringent confinement measures with increased isolation distances and fallow zones and other measures to 

assure that there is no commingling of these pharmaceuticals and 

industrials with commercial production. 

The Biotech Regulatory Services established a new Compliance 

and Enforcement Unit to ensure further adherence to permit conditions, and inspectors conduct at least five inspections during the 

growing seasons and another two inspections in the year following 

the growing season in the case of industrials and pharmaceuticals. 

As I have indicated, we are seeing a lot of change in the biotech 

industry, and we recognize the need to modify. In January of 2004, 

we announced plans to renew and strengthen our current biotech 

regulations. We are currently conducting an Environmental Impact 

Statement to evaluate our regulations, and we are looking toward 

moving away from the current notification and permit process to 

more of a science-based evaluation or a tier-based evaluation where 

the products that we know and are most familiar with would receive the least regulation; those new and unknown products we 

would subject to further scrutiny and closer evaluation prior to release. We are anticipating that that EIS would be published sometime this fall or early winter. It will be out for notice and comment 

and will invite a wide range of public comments. We have worked 

with our counterparts here and obviously will keep the folks here 

on the Hill posted as well. 

So we are continuing to work on communication and outreach. 

We are working closely with our sister agencies at FDA and EPA, 

and we are confident that we are ready for the future of agricultural biotech. 

So thank you again for the opportunity to be here, and I look forward to answering any questions. Thank you. 

[The prepared statement of Mr. Lambert can be found in the appendix on page 39.] 

The CHAIRMAN. Dr. Lambert, thank you very much. 

Dr. Gabriel. 

5

STATEMENT OF CLIFFORD GABRIEL, DIRECTOR, OFFICE OF 

SCIENCE COORDINATION AND POLICY, U.S. ENVIRONMENTAL PROTECTION AGENCY, WASHINGTON, DC 

Mr. GABRIEL. Thank you very much. Good afternoon, Mr. Chairman, Senator Lugar. I am pleased to be here before you today to 

discuss EPA’s role in the administration and regulation of agricultural biotechnology. I welcome the opportunity to participate along 

with my colleagues from FDA and USDA to explain what the agency is going in this area. 

The agency believes that biotechnology has great potential to reduce our reliance on some older, more risky chemicals and to lower 

worker and ecological risk. Regulation of these products is designed 

to manage and mitigate any risk posed by these products to ensure 

protection of public health and the environment. 

Under the Coordinated Framework for the regulation of biotechnology products, the responsibility for oversight is shared by 

three Federal agencies: the USDA, EPA, and FDA. Efforts in this 

administration have been aimed at strengthening the coordination 

among these agencies. 

Under the Coordinated Framework, products of biotechnology are 

regulated under existing statutes in a manner similar to the regulatory approach used for products developed through other techniques. EPA currently uses three statutes to regulate certain classes of biotechnology products. Products of biotechnology that are intended for use as pesticides would be regulated by EPA under the 

Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, and 

sections of the Federal Food, Drug, and Cosmetic Act that address 

pesticide residues for food and feed. Under the Toxic Substances 

Control Act, or TSCA, EPA reviews novel microorganisms that are 

products of biotechnology. 

Because TSCA specifically excludes pesticides, foods, feeds, and 

pharmaceuticals, this biotechnology program sees few products 

with agricultural applications. The one exception to date is nitrogen-fixing bacteria, for example, for increased alfalfa or soybean 

yield. 

Under FIFRA, regulated products include genetically engineered 

microbial pesticides, as well as pesticides produced by plants that 

act within the living plant to protect it from pests. The most wellknown agricultural biotechnology products are crops engineered to 

contain highly specific insecticidal proteins derived from the bacterium Bacillus thuringiensis, or simply Bt. Such pesticidal substances produced and used in living plants along with the genetic 

material to produce these substances are called plant-incorporated 

protectants, or PIPs. 

EPA has built numerous opportunities for transparency into its 

review procedures. EPA’s Biopesticides Pollution Prevention Division has been working with companies and individuals developing 

PIPs since the mid–1980’s. EPA has held numerous public meetings with scientific experts and with interested stakeholders, and 

EPA makes data submitted concerning human health and the environment available for review through a public docket. Every new 

PIP is announced in the Federal Register with an invitation for 

public comment. 

6

For the PIPs EPA has registered to date, we review data in five 

categories. Those are product characterization, toxicology, non-target organism effects, exposure and environmental fate, and resistance management. 

One of the challenges that lie ahead is formalizing data requirements and testing guidelines specific to PIPs. Currently these requirements are determined on a case-by-case basis by EPA scientists. Currently, EPA has 12 active registered PIP products. A 

list of those is attached to my written testimony. Eleven of these 

products are Bt proteins, and crops include potatoes, cotton, field 

corn, sweet corn, and popcorn. 

Mr. Chairman, we at EPA think that these are promising times 

for advancing better, lower-risk solutions to pest control needs. We 

believe that these products have great potential, but we are not 

simply accepting industry claims as to their safety. We are proceeding cautiously to ensure the protection of our citizens and the 

environment while at the same time recognizing the potential benefits. 

In closing, I would like to emphasize that EPA’s biotechnology 

program is based on five important principles. Those are sound 

science, transparency in decisionmaking, consistent and fairness, 

collaboration with regulatory partners, and building public trust. 

EPA believes that our regulatory system is based on the most rigorous scientific information available, and is credible, defensible, 

and will serve to protect the environment and public health as we 

address the challenges associated with biotechnology in the future. 

Thank you for the invitation to appear before your committee 

this afternoon, and I will be happy to answer any questions you 

may have. 

[The prepared statement of Mr. Gabriel can be found in the appendix on page 44.] 

The CHAIRMAN. Thank you very much. 

Dr. Brackett. 

STATEMENT OF ROBERT E. BRACKETT, PH.D., DIRECTOR, CENTER FOR FOOD SAFETY AND APPLIED NUTRITION, FOOD 

AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH 

AND HUMAN SERVICES, ROCKVILLE, MARYLAND 

Mr. BRACKETT. Good afternoon, Mr. Chairman and Senator 

Lugar. I am Robert Brackett, Director of the Center for Food Safety 

and Applied Nutrition at the Food and Drug Administration, and 

I would like to thank you for the opportunity to testify today about 

how FDA regulates genetically engineered foods, or bioengineered 

foods, as we like to call them, and I am pleased to be here today 

with my colleagues from USDA and EPA. 

FDA is the Federal agency that regulates everything we eat except for meat, poultry, and egg products, which are regulated by 

our partners at USDA. FDA’s Center for Veterinary Medicine oversees animal feed and products used to improve the health and productivity of animals. My shop, the Center for Food Safety and Applied Nutrition, oversees the rest, including plant-derived bioengineered food. FDA is confident that the bioengineered foods on the 

market today are as safe as their conventional counterparts. Both 

7

the Government Accountability Office and the National Academy of 

Sciences have issued reports agreeing with this assessment. 

For years, scientists have been improving plants by changing 

their genetic makeup through cross-breeding and hybridization in 

which two related plants are cross-fertilized and the resulting offspring have characteristics of both parent plants. In the breeding 

process, however, many undesirable traits can often appear in addition to the desirable ones. Some of these undesirable traits can be 

eliminated through additional breeding, but this is time-consuming. 

Breeders can then further select and reproduce the offspring that 

have the desired traits. 

All of our major food crops have been extensively genetically 

modified through conventional breeding and continue to be improved through various breeding methods. Breeders have also developed new food varieties through breeding. Nectarines, for example, are genetically altered peaches, and tangelos are a genetic hybrid of the tangerine and grapefruit. Today, by inserting one or 

more genes into a plant, scientists are able to produce a plant with 

new, advantageous characteristics but with greater precision. The 

new techniques give scientists the ability to isolate genes and introduce new traits into foods without simultaneously introducing undesirable traits. This is an important improvement over the traditional breeding methods. Bioengineering expands the range of new 

proteins and other substances that can be introduced into plants, 

and this is of enormous utility to breeders. 

Are there risks? Any genetic modification technique, including 

both traditional breeding methods and bioengineering, could 

change the composition of a food in a manner relative to food safety. But because of the increased precision offered by bioengineering, the risk of inadvertently introducing detrimental 

traits is actually less likely to occur with bioengineering. 

The agencies have well-established procedures for establishing 

the safety of such new substances. In a 1992 policy statement on 

bioengineered foods, FDA announced that the agency was ‘‘not 

aware of any information showing that the foods derived by these 

new methods differ from other foods in any meaningful or material 

way, or that as a class, foods developed by the new techniques 

present any different or greater safety concerns than foods developed by traditional plant breeding.’’ The 1992 statement and its 

scientific underpinnings still reflect FDA’s thinking about bioengineered foods. 

Bioengineered foods and food ingredients must adhere to the 

same standards of safety under the Federal Food, Drug, and Cosmetic Act that apply to their conventionally bred counterparts. This 

means that these products must be as safe as traditional foods on 

the market. FDA has broad authority to initiate regulatory action 

if the product fails to meet the requirements of the FD&C Act. 

FDA has established a consultative process to help companies comply with FD&C Act requirements for bioengineered foods that they 

do intend to market. Companies have used this consultative process more than 60 times as they sought to introduce genetically altered plants representing 16 different crops into the U.S. market, 

and there is a list of these products on our website. 

8

We are confident that the bioengineered foods that have been 

subject to the consultations with FDA over the past 10 years are 

no different in terms of safety than their conventional counterparts. FDA is participating in the interagency Agricultural Biotechnology Working Group, which includes the Office of Science 

and Technology Policy, EPA, USDA, and others. FDA, in cooperation with the working group, will continue its oversight of new and 

emerging food biotechnology products and will be vigilant in ensuring the safety and integrity of the food supply. 

I thank you again for the opportunity to address these issues, 

and I am happy to answer any questions that you might have. 

[The prepared statement of Mr. Brackett can be found in the appendix on page 50.] 

The CHAIRMAN. Thank you very much. 

Let me address this to all three of you. One of the challenges for 

the Federal Government is to ensure all three agencies responsible 

for the regulatory oversight of agricultural biotechnology are communicating effectively and are coordinating action together. While 

each has distinct and separate authorities, if any one agency is not 

working with the others, oversight is compromised. Public confidence in the safety and integrity of the food supply will diminish, 

compromising the agricultural sector and food export markets. 

Can you please explain the procedure—and I would like for each 

one of you to briefly do this—for coordinating among your respective agencies to ensure that biotechnology policy issues are being 

address in a consistent and coordinated and efficient manner? 

Specifically, can you walk through your individual roles related 

to the approval of Roundup Ready soybeans and how the agencies 

have worked together to address regulatory issues that have arisen? 

And how is the administration coordinating to assure appropriate 

oversight on future products that may or may not be intended for 

introduction into the food supply? 

Dr. Lambert, would you start us off, please? 

Mr. LAMBERT. Thank you, Mr. Chairman. There is a coordinated 

process. The Office of Science and Technology Policy coordinators 

the interagency process to make sure that we are all three on the 

same page, especially on big decisions. There are monthly calls 

among the three agencies, and we confer on scientific issues at the 

staff level on a routine basis. 

At USDA, our primary role, first, we would control the importation or the interstate movement of the proposed event. We would 

handle the notification or permitting and notification process for 

the confined field releases and field tests of the event, and to make 

sure that that event is confined from the commercial product. As 

more information becomes available, then we would go through the 

deregulation process. We would evaluate the scientific data to 

make sure it is as safe as traditionally bred varieties or counterparts. Then any proposal to deregulate would be published in the 

Federal Register for notice and comment to allow for broad-based 

input into that proposal to deregulate that event. 

The CHAIRMAN. Dr. Gabriel? 

9

Mr. GABRIEL. I am afraid as this goes down the panel, you will 

be hearing some of the same things since we are a coordinated 

group. 

The CHAIRMAN. I hope so. 

[Laughter.] 

Mr. GABRIEL. Actually, 5 months ago I was at the Office of 

Science and Technology Policy at the White House and was the 

principal staff person responsible for coordinating the Ag Biotech 

Working Group, so I have a lot of experience with managing that 

structure. But as Dr. Lambert said, there is a higher policy level 

working group that includes OSTP, OMB, all the relevant agencies, 

including State Department, Department of Interior, basically all 

agencies that have an interest in either regulating or basically 

marketing the product overseas or domestically. 

This group has worked very well. Usually the way it works is an 

issue would surface, whether it is, say, something to do with, pharmaceuticals from plants, there would be a smaller working group, 

usually consisting of the technical experts. The regulatory agencies 

would get together, develop proposals, bring them to the larger 

working group for further discussion with basically clearance 

through that process, and then the agencies would go back and sort 

of work on implementing whatever agreement was reached through 

that working group process. 

There are also opportunities to coordinate up and down the 

chain. There are technical-level discussions with folks that actually 

have the deep science experience, trying to make sure that the programs are coordinated, so that happens as well. 

In terms of Roundup Ready soybeans, that is an area where EPA 

would be responsible for looking at the herbicide application as a 

new use to the product. You are not looking at a PIP, as I mentioned in my testimony. This is not a plant-incorporated protectant. 

But it is a potential new use for a herbicide, and we would look 

at all the ramifications of expanding the label for a new herbicide 

on soybeans. 

The CHAIRMAN. Dr. Brackett? 

Mr. BRACKETT. Well, Mr. Chairman, I, too, am going to emphasize how closely we do coordinate things, but in addition to the 

higher-level coordination that Dr. Gabriel just mentioned, it is important to point out that the working-level scientists are in pretty 

much constant communications between the three agencies on any 

new issues that are arising. So even though it may not necessarily 

on the surface appear to be the responsibility of one agency, we all 

know about it. 

With respect to FDA’s role, we are responsible for making sure 

that any introduced proteins that are a result of biotechnology are, 

in fact, safe. So, in particular, we will look at any potential toxicity 

or allergenicity effects of a particular protein, and then on the final 

product, for instance, in the Roundup Ready soybeans, to make 

sure that there are not any unintended consequences that would 

have affected, for instance, the nutritional status of that product as 

well. And so our role goes to affirming the safety of those products 

together with what USDA and what EPA have done. 

The CHAIRMAN. Does there come a point in time—and I use the 

example of the Roundup Ready soybeans because of its more recent 

10

action. But is there a point in time when the three of you or at 

least a representative from all three agencies sit down and sort of 

digest what is going on in other agencies relevant to a product like 

that so you make sure that everything that needs to be covered has 

been covered? 

Mr. LAMBERT. I would say yes, we do that on a routine basis. 

The CHAIRMAN. OK. Dr. Brackett, the FDA first published policy 

regarding the voluntary premarket consultation for new bioengineered food in 1992. With the acceleration of new biotechnology 

food product commercialization during the 1990’s, consumer groups 

and foreign export partners began expressing concern that the FDA 

policy is voluntary and have urged a mandatory system be put in 

place to review bioengineered food products before they are marketed. 

In January of 2001, FDA proposed a rule for the premarket notification of bioengineered foods. The proposed PBEN establishes a 

mandatory procedure for the submission and review for bioengineered food. I have been informed that FDA has delayed finalizing 

that proposed rule. 

Can you please provide us with the agency’s current thinking on 

the finalizing of this rule? 

Mr. BRACKETT. Yes, Mr. Chairman. When we proposed that rule, 

that was earlier in the consultative process. In the intervening 

years, we have found that the consultation process has worked so 

well that actually trying to finalize that rule was actually put to 

a lower priority, and we are focusing on the consultative process at 

this time. 

The CHAIRMAN. OK. Senator Lugar? 

Senator LUGAR. Well, thank you very much, Mr. Chairman. I appreciate your organization of the hearing with each of these agencies, ask the question you have just asked, and that is, are they 

visiting with each other, are they coordinating policies, and they 

have responded that they are—in fact, in preparation for the hearing, I suspect have made sure everybody is on track because this 

has been a regular and appropriate line of questioning in these 

hearings over the years on biotech. 

The integrity of the products really depends upon the efficiency 

and efficacy of the agencies that are represented here, plus others 

you may identify. And that is extremely important as we talk about 

biotech to the rest of the world. And this hearing is important, once 

again, to establish the integrity of the process, that users of biotech 

products in this country not only are safe but, as we will hear from 

the distinguished additional panel, have resulted in extraordinary 

gains in income for American farmers as well as for those abroad, 

as well as extraordinary changes in yield which have made life-saving differences, especially in other countries. 

All of those things would be very dramatic as they were, but if 

you taking a chance in the process, why, the downside would be obvious, too; that in return for the money and for the life-saving, you 

also are putting at risk in products that are deficient people who 

are also involved in farming and production. 

I make that point because throughout the years in these hearings, we have been trying to explore why there is such resistance 

11

in Europe. I don’t center entirely the criticism there, but this has 

been a major bone of contention. 

As one of the witnesses in the second panel points out in testimony, it says, ‘‘Even in Europe, things are happening.’’ Quite apart 

from other continents where a lot of things are happening. We have 

had Dr. Borlaug before the committee several times, and we appreciate and hope that he gets well now because his contribution, just 

as has been suggested, has been magnificent in terms of life-saving. 

Some have suggested that he has been responsible really for the 

longevity of more people on this Earth than any other one individual through the breakthroughs, first of all, in the Mexico 

projects and the Philippines and moving through India and now 

into Africa. And this is exciting work. 

But I mention the second panel. They will speak for themselves 

because their testimony is truly thoughtful and informative. Many 

people of common sense have reasoned, if all of this is true, if literally you are going to be saving hundreds of thousands of lives, 

why the resistance? And so it is important we do our homework 

back here so there is no academic reason whatsoever for anyone in 

Europe, Asia, or anywhere else to question the safety and efficacy 

of the products that are involved in biotech. 

So this is useful, I think, as a benchmark always to just check 

our own findings, our own regulatory procedure to make sure it as 

sound as you have testified. 

Now, having said that, let me ask: Do the regulatory agencies in 

any way get into the diplomacy of the spreading of the good word 

or the good products? In other words, if, in fact, there are the income gains that are evident from biotech, plus the fact that people, 

because the yields are higher and because the crops work better in 

various other climates, manage to change really the quality of life, 

I suspect it is not your portfolio to advertise these effects. But, on 

the other hand, this is such good news that it would be hard for 

you to suppress it. 

I am just curious. At what point does either the marketing or the 

diplomacy of these situations become a part of your responsibilities, 

or do you stick strictly to the regulatory functions to make certain 

as the products come through? Can you describe even more, in 

other words, your mission as you perceive it? 

Mr. LAMBERT. We do from a standpoint of communication and 

outreach talk about the regulatory process, the safeguards that we 

have in place, the additional measures that we have taken, share 

our experiences and changes in the regulatory process. So through 

communication and outreach, not only domestically but to our trading partners, I think we foster that climate where the technology——

Senator LUGAR. Do you visit with regulators from other countries? Are they interested in what you are doing? 

Mr. LAMBERT. We do, and through the Codex, there is a working 

group that is working on biotechnology as well. 

Mr. GABRIEL. There are multiple international fora for us to 

interact with our counterparts. There is the Codex, as was just 

mentioned. There is also the Organization for Economic Cooperation and Development, OECD, a lot of good interaction there, especially with our European colleagues, and others. We have fora in 

12

Asia, a lot of bilateral interactions. So, you know, the opportunities 

are many and we certainly try to take advantage of all those opportunities. 

I think probably the very best way for us to instill confidence in 

the consuming public, I think, is by sticking to the science, by having a transparent process that puts the cards on the table and people can see how we are making our decisions. And as long as we 

can do that, I think that takes us a long way to making the kind 

of inroads into the pockets of skepticism, perhaps, that you mentioned in your comments. 

Senator LUGAR. Do you have any interaction with the World 

Food Program of the United Nations? I ask this because essentially 

this is a group of people that are really on the forefront of trying 

to stop starvation. And I know from my own visits with some of 

these people that they have been frustrated often in Africa because 

some statespersons there have gotten word from Europeans that 

these biotech situations are unsafe and are likely to cause great 

harm to the ecosystems of their countries. This is why I am a bit 

curious whether there is any interaction with those people. 

Mr. LAMBERT. Not that I am aware of, Senator. 

Mr. GABRIEL. Same here. 

Senator LUGAR. Thank you, Mr. Chairman. 

The CHAIRMAN. That is interesting that you raise that issue, 

Dick, because I was sitting here thinking about this hearing this 

morning, and as we move toward going to Hong Kong for the WTO 

Round in December, certainly we are going to have a lot of formal 

discussions. But what I have found is that a lot of the information 

that you get comes more from the informal discussions than the 

formal. 

So I think we probably want to coordinate with you folks maybe 

a sit-down before that. There is a large delegation from this committee going. We ought to sit down with you all to glean from you 

what you have learned from your counterparts, so when we talk 

with our counterparts across the table in Hong Kong, it would be 

very beneficial to know kind of their thought process so we can 

hopefully remove some of these impediments and answer some of 

these arguments that they have got or that we will hear about. 

Senator Salazar? 

Senator SALAZAR. Thank you very much, Chairman Chambliss, 

for holding this hearing on this very important subject. 

I want to follow up just on the question from Senator Lugar, regarding what we do to try to get more into these pockets of skepticism that we face in other countries. My question is whether or 

not we are doing enough and whether there are more specific 

things that we ought to be doing here in America, including out of 

this Congress. For many of us on this committee, we very much 

want to open up markets in other places of the world for our agricultural products, whether that be in Japan or South Korea or 

China. We are always working on that agenda to try to provide 

new opportunities to sell our agricultural products. Yet, when you 

hear about the skepticism that we find in Europe as well as in 

other places around the world with respect to our biotech products, 

it just raises the same question for me in my mind that Senator 

Lugar asked: What more can we do to try to get rid of some of the 

13

skepticism? We have gotten rid of it, I think, here in this country 

pretty well, but we still face it so clearly in Europe and other 

places. 

So are there things that we ought to be doing as a Congress to 

try to address that issue? 

Mr. LAMBERT. From my viewpoint, it is just continue dialog and 

discussion, Senator. We have explained to the U.N. about the safety of genetically engineered products with respect to food aid to Africa and tried to have broader understanding there. I have been in 

some APEC forums. There are many Asian countries that have 

biotech developments in channel, but for whatever reason have 

been able to commercialize those. And we have seen in China they 

are beginning to bring many of those onlines, and I think possibly 

as China goes, so may go the rest of Asia. But we are beginning 

to see, I think, reduced resistance in some of these regions, where 

there is a growing awareness of the importance of adopting this 

technology for a variety of reasons. 

Mr. GABRIEL. One of the components in a lot of these discussions 

is the whole area of capacity building. A lot of developing countries 

are reluctant to take on some of these products if they don’t have 

their own, you know, in-house ability to make these safety assessments for themselves. They don’t want to be seen as accepting a 

rubber stamp from any other country. It is important that they 

have their own capabilities. And we certainly are looking at the 

possibility, not so much the EPA but certainly across the Government, on ways to improve our capacity building, ways to target the 

resources that we have to help countries develop their own regulatory apparatus, making sure that they are comfortable with the 

products. So that’s another important part of the puzzle there. 

Senator SALAZAR. I would just make a suggestion. Most of us will 

have meetings, as I have within the last week, with the Ambassador from China to the United States, the Director from Taiwan, 

the Ambassador to the United States, to talk about trade in these 

countries. I think for us to have a set of talking points in terms 

of how those countries could have confidence in the bioengineered 

products coming from this country is something that would be helpful to us as we try to be good Ambassadors for the work that you 

do. 

A question just for Dr. Brackett. I understand that we do not 

have legislation to address this issue. For us this hearing is simply 

a hearing to learn more about what is going on and to see whether 

or not there are any issues that we ought to be concerned about. 

I noted in your testimony, on page 6 you talk about the authorities 

of the FDA. You talked about how the authority of the FDA gives 

you the power to remove food from the market if the food poses a 

risk to public health. My question to you is: Has that power ever 

been exercised on the part of the FDA? Or have we never had a 

product that has essentially triggered the use of that authority on 

the part of the FDA? 

Mr. BRACKETT. For bioengineered products specifically? 

Senator SALAZAR. Yes. 

Mr. BRACKETT. No, we have never had to exercise that. It has all 

been safe. 

Senator SALAZAR. Thank you very much. 

14

The CHAIRMAN. Thank you. 

Gentlemen, recently Syngenta notified all three agencies that 

seed distributed by the company contained an event known as 

Bt10, which had not undergone full regulatory clearance. APHIS 

has since completed its investigation, and FDA released a statement regarding its presence in food and feed. Last week, Syngenta 

announced it has applied to the FDA for marketing approval. 

For all three of you, how have all three agencies coordinated on 

the Bt10 issue, particularly on the investigation and how you came 

to the conclusions on safety? And to Dr. Brackett, how long should 

the process take to complete the review of Syngenta’s packet? And 

in your opinion, does this incident highlight the need for a more 

comprehensive adventitious presence policy that identified an appropriate level of safety for intermittent, low levels of products in 

development that have not completed all regulatory reviews? 

Mr. BRACKETT. We did just receive a packet from Syngenta to 

evaluate that. Based on our initial consultations with the other 

agencies, we realize this is probably an instance where the gene 

product itself was safe because it is similar to one that was—or it 

is the same protein that was approved before. 

With the current full packet that we have received, we have 

moved that to the very top of our evaluations, and so we are going 

to be moving forward with that as quickly as we can. We will not 

know exactly how long it will take until we actually get into the 

materials and see how much or what of the materials are there 

that we might need. 

With respect to the second part of your question, this does not 

necessarily, we do not think, say anything against the current policy for early protein review. That policy or that guidance is meant, 

very early in the research and development stage for companies 

who anticipate they might have a product going into commercial 

food production, to meet with FDA early and often to sort of get 

an idea of what problems we might see down the line. In this case, 

we would likely not have seen any problems there. 

So with respect to any other sort of adventitious presence, this 

was a laboratory error, basically, one in which the sample was 

never meant to get out into the commercial supply. And so that is 

something that the guidelines were really not meant to address. 

The CHAIRMAN. How about as far as the coordination between all 

three agencies relative to the safety issue on Bt10? 

Mr. GABRIEL. The agencies have worked very closely on this, as 

you might imagine. Since Syngenta came to the three agencies at 

the end of last year, probably not a week goes by that there is not 

some conference call, face-to-face, or some other interaction between all the agencies that are involved in this topic. 

In terms of how the agencies worked to determine the safety of 

the product, very early on we requested information from Syngenta 

about the nature of the genetic construct within Bt10. And based 

on sequence information, based on other information that Syngenta 

was able to provide, EPA scientists primarily were able to confirm 

that the proteins that are expressed in Bt10 are, in fact, the same 

proteins that are expressed in another biotechnology product, Bt11, 

which has an exemption from the requirements of tolerance. Therefore, we are able to determine that should Bt10 be found in feed 

15

or food, the existing exemption from the requirements of tolerance 

would apply; therefore, those products would not be considered 

adulterated. So that was basically the thought process that we 

went through. 

In terms of the investigation, we were able to work very closely, 

EPA with USDA, and I am sure we will hear from USDA on their 

process. But to the extent that we work together, under different 

statutes, different requirements, it could not be exactly on the 

same track. In fact, EPA’s investigation is still open. We are still 

in, I believe, the final stages of that. But the agency has worked 

very closely together, shared resources, shared information. And, 

again, it was a fairly seamless operation. 

One of the things that we have been talking about doing—and 

we will be doing that very soon—is looking basically at lessons 

learned. Even though the process worked very well in our estimation, we think that there probably are places that we could 

make this process more efficient, improve the types of interchanges 

that we had to have to deal with something like this. 

Mr. LAMBERT. USDA APHIS used the following framework to 

evaluate whether there were safety issues involved with Bt10: The 

first question we asked was how similar is this corn line to lines 

that have been deregulated and deemed to be safe. And the fact is 

that this is the exact same protein that is deregulated in Bt11. 

And we asked then is there any reason to believe that these 

genes or gene products could pose safety risks if they were produced in other corn lines, and the answer is no, because they are 

already deregulated in some other corn lines. 

Is the undefined cultivation of Bt10 likely to present any plant 

risks or would this become considered a weedy species? And, again, 

the answer was no. 

And are there ways which this corn could be likely to cause direct or indirect damage to other plants? And, again, the answer 

was no. 

So we did have daily, in some instances, interagency meetings 

and calls. The general coordination and communication was very 

good, and, in fact, this was, I think, the first time that EPA and 

USDA conducted a joint environmental investigation or a joint investigation of this event. 

Regarding adventitious presence, we do support addressing that, 

and that is one issue I failed to bring up when I was discussing 

the EIS, the Environmental Impact Statement. We plan to come 

with the need for establishing thresholds for adventitious presence. 

Whether that would have helped in this case given that it was a 

laboratory issue I think is open for discussion. But we have at 

APHIS conducted an internal evaluation of how we handled this 

and important things to learn. And one of the things as we go into 

the interagency discussion and process that we intend to bring to 

the table is that in other areas we have used the incident command 

system—in Veterinary Services, Plant Protection Quarantine, Forest Service, and other governmentwide agencies—to understand 

and we probably did not really understand how complex this issue 

is, so recommending to our fellow agencies that we work and plan 

to coordinate and work through an incident command system. As 

16

we move on future issues, this is something that at least might 

warrant consideration. 

The CHAIRMAN. Thank you. 

Senator Harkin? 

STATEMENT OF HON. TOM HARKIN, A U.S. SENATOR FROM 

IOWA 

Senator HARKIN. Mr. Chairman, thank you very much, first of 

all, for having this hearing. 

I have just a couple of opening comments. I just wanted to welcome two prominent Iowans who will be on the next panel, they 

are, Ambassador Ken Quinn, who is president of the World Food 

Prize Foundation; and Mr. Ron Heck, who is Chair of the American 

Soybean Association. I will have more to say about those two and 

about the World Food Prize Foundation when their panel comes up. 

I will just ask that my opening statement be made a part of the 

record. 

The CHAIRMAN. Without objection. 

Senator HARKIN. Thank you, Mr. Chairman. 

[The prepared statement of Senator Harkin can be found in the 

appendix on page 36.] 

Senator HARKIN. There is a lot of talk about the controversial aspects of recombinant DNA, but I think we have to keep in mind, 

as I tell people a lot, that biotech has been with us a long time. 

This is not something new, whether it is hybridization or whether 

it is—I always say you go back to whenever it was in history that 

people first used yeast to make their bread rise, thath was biotech. 

And so we have been using it for a long time. 

But in the case now where we are looking at recombinant DNA 

and we are sort of collapsing timeframes here in many cases, we 

have to be, I think, pretty cautious in how we proceed. We have 

a set of regulations basically in place that were there for conventionally produced and conventionally bred precursors to some of 

these. Now, the fundamental question we need to ask is whether 

those regulations are sufficient for the new challenges that are 

arising. Again, I say that sometimes we have to proceed with some 

caution and to make sure that we have wise regulations. That is 

why I liked the last question that our chairman asked about the 

coordination that is being done. 

I would also say at the outset that we need to focus more on research, Mr. Chairman. In the 2002 farm bill, we put in there a goal 

of doubling agricultural research over 5 years, but 3 years later, 

viryually none with inflation, we have only had an increase of 4.3 

percent. And with all of the problems that confront us in terms of 

global hunger, food safety, biotech and using biotech not only for 

food but for energy and other things, it would seem to me that this 

is where a dollar of investment pays off greatly. 

Having made those statements, there is one question I wanted 

to ask this panel, and it has to do with the regulatory scheme that 

we have now. FDA currently has a premarket consultation process 

whereby biotech seed companies submit all safety data related to 

the product. They discuss safety considerations with the FDA before the product is marketed. If FDA has questions about the safety 

17

data, the company may be asked to conduct additional studies to 

provide more detailed answers. 

Now, this process is voluntary, and although it is voluntary, all 

bioengineered products, I understand, have undergone this consultative process. And no biotech food product has been commercialized 

without FDA’s evaluation of their safety data. So, Dr. Brackett, my 

question is: Does an independent company or FDA conduct studies 

on the safety of the products at hand, or does FDA rely solely on 

the company-provided data? 

Second, has there ever been a case where FDA does not approve 

of a company’s safety data and rejects the company’s request to 

market a product? 

Mr. BRACKETT. With respect to the first part—could you repeat 

the first part again? 

Senator HARKIN. The first part is: Does an independent company 

or does FDA itself conduct studies on the safety of the products at 

hand, or do you just rely upon the studies provided by the company 

that is trying to market this product? 

Mr. BRACKETT. We would rely on the packet provided by the company and look at a very broad base. First of all, the most important 

thing is the gene product itself and the safety of that product, and 

the main problems one would see would either be potential toxicity 

from that product or allergenicity. So that we could tell based on 

what the company submitted to us and based on our experience 

with those gene products, whether they were likely to be. 

In a broader issue——

Senator HARKIN. Wait a minute. You ask the companies if they 

would like to have further studies done? Is that what you are saying? 

Mr. BRACKETT. We would ask them for more data in some cases, 

yes. 

Senator HARKIN. If you want to, you would ask them for more 

data. 

Mr. BRACKETT. Right. 

Senator HARKIN. But there is no other independent company that 

would examine this. 

Mr. BRACKETT. No, there are no others. 

Senator HARKIN. Well, then, the second part is: Has there ever 

been a case where the FDA does not approve of a company’s safety 

data and rejects the company’s request to market a product? Has 

there ever been a case? 

Mr. BRACKETT. There have been cases, yes. 

Senator HARKIN. And could you supply those for us? 

Mr. BRACKETT. Yes, we would be happy to provide them for you. 

Senator HARKIN. I would like to take a look at those myself. 

Now, my last question. What are the arguments for or against 

making this consultative process—which is voluntary now, making 

it mandatory? 

Mr. BRACKETT. Well, the case is—of course, if it is mandatory, it 

has a bit more clout. But the case against it, actually, is that the 

voluntary process has worked very, very well. We cannot really find 

a way to—there are always ways to improve it, but there are no 

major flaws. And, really, as a practical matter, the reason that the 

products have not been commercialized is that the consultative 

18

process, the letter that the company gets from FDA has enough 

clout with the customers of that product that a company who does 

not go through the consultative process would not even be able to 

market, no one would really want their product unless they could 

be assured that it had gone through an investigation or an evaluation. 

Senator HARKIN. Thank you very much, Dr. Brackett. 

That is all I have, Mr. Chairman. 

The CHAIRMAN. Gentlemen, thank you all very much. We appreciate your being here and appreciate very much your testimony and 

your input. 

The CHAIRMAN. Our second panel will consist of a long-time good 

friend of mine, former House colleague, the Honorable Jim Greenwood, who is now the Chief Executive Officer, Biotechnology Industry Organization; Mr. Ron Heck, Chairman of the American Soybean Association; Ambassador Kenneth Quinn, President of the 

World Food Prize Foundation. 

Gentlemen, welcome. We are pleased to have you here, and we 

look forward to your testimony. 

Mr. Greenwood, I will have to tell you that one of the advantages 

of being a former Member during the quiet period is that you get 

discriminated against. We have to ask you to stand and let’s put 

you under oath. Would you raise your right hand, please? Do you 

swear or affirm that the testimony you are about to provide is the 

truth, the whole truth, and nothing but the truth, so help you God? 

Mr. GREENWOOD. I do. 

The CHAIRMAN. Thank you very much. 

Gentlemen, again, we welcome you here to discuss this critically 

important issue, and particularly as to what is going on out there 

outside the Government sector. And, Jim, we will start with you, 

and, Mr. Heck and Ambassador Quinn, we will come that way. So 

we look forward to your comments. 

STATEMENT OF JIM GREENWOOD, PRESIDENT AND CHIEF EXECUTIVE OFFICER, BIOTECHNOLOGY INDUSTRY ORGANIZATION, WASHINGTON, DC 

Mr. GREENWOOD. Well, thank you, Mr. Chairman. It is the first 

time I have been on that end of the swearing-in process. I have 

been on the other end many a time, and it feels a little different. 

But I thank you, Mr. Chairman, for holding this hearing, and I 

welcome the opportunity to testify before Senator Harkin and Senator Lugar as well. 

My name is Jim Greenwood. I am the President of the Biotechnology Industry Organization, otherwise known as BIO. Our 

membership includes over 1,100 member companies and research 

institutions in North America and around the world. These members are actively involved in research and development of new 

medicines, foods, and industrial products to benefit the lives of people and the environment. 

I would to thank Senator Saxby Chambliss for the opportunity 

to be with you today. 

The industry celebrates two important milestones this year: first, 

the tenth anniversary of commercialized biotech crop plantings; 

and, second, the planting of the one billionth acre of biotech crops. 

19

Agricultural biotechnology is the most rapidly adopted technology 

in the history of food production. Its widespread use demonstrates 

a shift from chemically based agriculture to biologically based agriculture. 

According to the International Service for the Acquisition of AgriBiotech Applications, in 2004, 8.25 million farmers in 17 countries 

planted biotechnology crops, 90 percent of whom were in developing 

countries. 

In the United States, in 2004, 85——

The CHAIRMAN. Jim, excuse me. Would you state that again, 

those numbers? 

Mr. GREENWOOD. In 2004, for the first time, biotech—excuse me. 

Let me say that again. According to the International Service for 

the Acquisition of Agri-Biotech Applications, in 2004, 8.25 million 

farmers in 17 countries planted biotechnology crops, 90 percent of 

whom—that is, the farmers—were in developing countries. 

In 2004, for the first time, biotech crops acreage in developing 

countries grew faster than in developed countries. In the United 

States in 2004, 85 percent of soybeans, 76 percent of cotton, and 

45 percent of corn were biotechnology crops. We expect these gains 

to continue. By 2010, ISAAA projects that up to 15 million farmers 

will grow biotech crops on more than 370 million acres in as many 

as 30 countries. Biotechnology enables farmers to reduce input 

costs and improve yields. It is also used to increase the health of 

farm animals, enabling the production of safer and more nutritious 

meat, milk, and eggs. 

Pest-resistant and herbicide-tolerant biotechnology crops reduce 

the need for ag chemicals. Biotechnology crops have been attributed to reduction of ag chemicals by significant amounts, increasing farmers’ incomes by $1.9 billion per year and boosting crop 

yields by 5.3 billion pounds. 

Benefits to the farmer also translate into benefits to the environment. Growing more food on less land reduces the need to clear forested lands to create more farmland. This will be increasingly important as global population grows. Reducing the number of times 

farmers spray chemicals also reduces the consumption of fuel and 

greenhouse gas emissions. Further, the reduction in the need to 

plow to control weeds leads to better conservation of soil and water 

and decreases soil erosion and ag chemical runoff. 

The development and subsequent adoption of this technology 

could not have been possible without a strong regulatory system to 

ensure the safe use of these products for both human health and 

for the environment. We recognize that strong regulatory systems 

are essential to consumer confidence, and we work closely with the 

U.S. Department of Agriculture, the Food and Drug Administration, and the Environmental Protection Agency, all of whom play 

important roles in providing science-based assessments of our products. We recognize that this dependence on a strong regulatory system will only increase as we move to the development of what is 

often referred to as second-generation biotechnology products. 

While research and development in agronomic traits like the 

ones discussed above will continue, significant research is under 

way in the second generation of products which will address a wide 

range of societal concerns. 

20

Biotechnology offers great promise to provide more nutritious 

foods. Researchers are working to create oils with reduced levels of 

harmful trans fat and saturated fats. Foods are in development 

which will have higher levels of nutrients, protein, and essential 

amino acids, as well as extended shelf life. And we can look forward to foods that are allergenic to certain segments of the population today being non-allergenic in the future because of the use 

of biotechnology in food production. 

Another promising avenue of research is the development of 

plant-made pharmaceuticals, which will allow companies to manufacture novel biologics and therapeutics in plant cell systems. The 

technology has the potential to reduce the costs of producing pharmaceuticals to enable increased access to life-saving drugs. 

In closing, biotechnology has a long track record for using innovative techniques to solve long-standing problems. Our industry is 

investing heavily in research and development which will provide 

products which will promote human, animal, and environmental 

health. 

Thank you for giving us the opportunity to provide this information to you today, and I will try to answer any questions that you 

may have. 

[The prepared statement of Mr. Greenwood can be found in the 

appendix on page 70.] 

The CHAIRMAN. Thank you very much. 

Mr. Heck, welcome. 

STATEMENT OF RON HECK, CHAIRMAN, AMERICAN SOYBEAN 

ASSOCIATION, PERRY IOWA 

Mr. HECK. Good afternoon, Mr. Chairman. I believe you will find 

our remarks to be very consistent with your opening remarks earlier this morning. 

I am Ron Heck, a soybean and corn farmer from Perry, Iowa. I 

serve as Chairman of the American Soybean Association, and I am 

appearing today on behalf of the American Farm Bureau Federation, the National Corn Growers Association, and the National Cotton Council, as well as ASA. We thank you for the opportunity to 

testify before the committee. 

2005 marks the tenth anniversary of the introduction of biotech 

crops for commercial production. Our organizations recently recognized the planting of the billionth acre of biotech-enhanced agricultural crops. Since 1996, and in each successive year, American agriculture has been the world leader in the adoption of agricultural 

biotechnology. In 2004, the United States accounted for half of the 

world’s total planting of biotech crops. U.S. plantings of the three 

major biotech crops continue to expand. For example, in 2004, 86 

percent of total soybean plantings were modified to be herbicide-resistant, up from 81 percent in 2003; 76 percent of the upland cotton 

plantings were biotech cotton, up from 73 percent in 2003; and 46 

percent of corn plantings were biotech corn, up from 40 percent in 

2003. 

American farmers have seized the opportunity offered by biotechnology to improve their production efficiency. They recognize 

that the adoption of new technologies is essential in maintaining 

a competitive advantage for U.S. agricultural exports. The benefits 

21

of biotech crops include lower pesticide usage, decreased soil erosion, increased yields, disease resistance, and fuel savings. The future of this technology is bright: new biotech plant varieties are 

being developed that will produce crops within enhanced nutrient 

and health profiles, as well as crops tolerant to drought, salty soil, 

cold, and disease. 

Crop biotechnology has led to reduced tillage practices, saving 1 

billion tons of topsoil annually, reducing by 309 million gallons the 

amount of fuels used by farmers, and decreasing greenhouse gas 

emissions by 1 billion pounds. Biotechnology has decreased pesticide applications by 46 million pounds and is saving U.S. consumers $3.5 billion a year in water treatment and management 

costs. 

While the United States is the world leader in the production of 

agricultural crops enhanced through biotechnology, other countries 

are also expanding their biotech crop production. In 2004, global 

biotech crop acreage increased by 20 percent to a total of 200 million acres—the ninth consecutive year of double-digit growth. The 

global value of total crop production from biotech crops in 2003 was 

estimated at $44 billion. 

Market development for these crops is dependent on public policy 

that does three things: maintains an unbiased, science-based regulatory system that inspires consumer confidence; two, works to ensure market access for biotech crops and products domestically and 

internationally; and, three, creates an environment conducive to 

the development of new biotech crop varieties. I would like to 

elaborate on each of these three points. 

First, the U.S. regulatory system does not require any specific labeling or traceability for biotech crops and ingredients that have 

been determined to be substantially equivalent in safety and nutrition to conventional crops. This science-based regulatory approach 

should continue. 

Some countries have adopted or are considering regulatory regimes that stigmatize biotech crops by requiring mandatory labeling and traceability of foods containing ingredients derived from 

biotech commodities. These policies have the effect of nullifying the 

regulatory system in place. 

Unfortunately, countries with mandatory labeling and 

traceability laws for biotech commodities are trying to internationalize their systems by pushing for adoption of similar requirements 

by the Codex Alimentarius Commission. The U.S. Government 

must continue its efforts to prevent adoption of non-science-based 

and discriminatory standards on a worldwide basis. 

Two, regarding market access, it is critical to ensure open access 

to world markets for the products of biotechnology. The European 

Union’s current approach to require the labeling and traceability of 

food and feed derived from biotech commodities is inconsistent with 

its own risk assessments and also inconsistent with the widespread 

practice by the EU’s own food industry, where they use biotech-derived processing aids in the product of food products that are not 

then required to be labeled. 

Our organizations, along with 17 other major U.S. ag organizations, have requested that the U.S. Government file a WTO complaint against the European Union challenging non-scientific barVerDate 0ct 09 2002 13:35 Jun 22, 2006 Jkt 000000 PO 00000 Frm 00025 Fmt 6633 Sfmt 6633 C:\DOCS\22645.TXT TOSHD PsN: LAVERN
22

riers to market access for biotech-derived crops. We also support 

the current WTO case against the EU’s moratorium on approvals 

of new biotech varieties. 

Third, it is important that we foster an environment conducive 

to innovation and the adoption of new technologies. Government 

and private sector research centers must be assured that the 

United States is working to ensure that there will be a market, domestically and internationally, for approved products derived from 

biotechnology. 

In developing countries, adoption of suitable biotechnology traits 

has the potential to deliver increased efficiency in ag production, a 

driver of economic growth. Biotechnology is an important tool for 

tackling world hunger. 

In conclusion, American agriculture has enthusiastically embraced the benefits that biotechnology provides in enhancing production efficiency and the competitiveness of U.S. agricultural commodities on world markets. As we recognize this tenth year of commercial biotech production, we look forward to continuing our work 

with Congress to support this important agenda. U.S. farm organizations are committed to ensure broader acceptance of these products internationally and continued consumer confidence at home. 

We will work with Congress and the administration to address unnecessary trade barriers implemented by other countries for biotech 

commodities. 

Thank you for the opportunity to testify, Mr. Chairman. 

[The prepared statement of Mr. Heck can be found in the appendix on page 78.] 

The CHAIRMAN. Thank you, Mr. Heck. 

Ambassador Quinn, welcome. 

STATEMENT OF AMBASSADOR KENNETH M. QUINN, PRESIDENT, WORLD FOOD PRIZE FOUNDATION, DES MOINES, 

IOWA 

Ambassador Quinn. Thank you very much, Mr. Chairman. I 

wanted to say at the outset that we do not know each other, but 

I was part of an Iowa-Georgia initiative to increase exports in 1979, 

and I visited the University of Georgia and had dinner at the wonderful President’s House, the antebellum home there, and so I hope 

that gives me at least a little credibility and——

The CHAIRMAN. That qualifies you as an expert. 

[Laughter.] 

The CHAIRMAN. You went to heaven while you were in Athens. 

Ambassador Quinn. It certainly felt like that. Thank you very 

much, Mr. Chairman. 

Dr. Borlaug asked me to convey his greetings to you, his apologies that he could not be here today, and his hope that you would 

understand his medical necessity keeping him away. I may seem 

like a strange substitute for him being a political science major 

who worked in the State Department for 32 years, but he and I 

had the same experience of working in poor villages, and we saw 

and learned the lesson that the things that can uplift people out 

of poverty were the same things that uplifted our own country, 

whether it is in Iowa or Indiana or Georgia. It was rural roads and 

agricultural technology, particularly that which came from our land 

23

grant and agricultural colleges. And so he and I are kind of soul 

mates and kindred spirits on this subject, and that is why I am so 

pleased to be the President of the World Food Prize, where our 

mission is to inspire similar kinds of breakthrough achievements. 

Dr. Borlaug created the World Food Prize to be the Nobel Prize 

for food and agriculture. He went to the Nobel Committee and tried 

to convince them to create one, and they turned him away—nicely, 

of course, since he was a Nobel Peace Prize winner. So he went out 

and started one on his own—The World Food Prize— and for the 

last 19 years, every October on or around World Food Day, we give 

a quarter-million-dollar prize to an individual who has made a 

breakthrough achievement. 

We also hold a symposium with speakers talking about cutting 

edge issues in food and technology. Senator Lugar, I know that before I was President, you were there. Thank you so much for that. 

Senator Harkin has also been at many of our events. Then we have 

a Youth Institute. We get 100 high school kids and 100 high school 

teachers, and we throw them in the room with all these laureates 

and experts. And it is amazing what rubs off and the inspiration 

for careers in food and technology and biological sciences come out 

of that experience. 

Dr. Borlaug created the World Food Prize to inspire those 

achievements necessary to feed the world in the 21st century. And 

if he were here today, he would tell you that it took 10,000 years 

to expand world food production to its current levels of over 5 billion tons a year. But by 2025, the world will nearly have to double 

that current production just to feed the growing world population. 

And there are only two ways to do it: Either we grow more food 

on the land that is in production now; or we will have got to cut 

down more forests, jungles, or bring fragile land into production 

with all the environmental consequences that entails. 

And so the World Food Price seeks to reach out and inspire and 

to touch and urge those people working in this field to find ways, 

not only through biotechnology but certainly including biotechnology, to increase productivity, reduce the use of pesticides, 

increase the nutritional content of food. Malnutrition, of course, affects people both in developed countries and underdeveloped countries. We tend to think of it just of hunger and poverty, but it also 

involves obesity. And so our leading companies now are looking at 

how can food be changed to make it more nutritional and more 

healthful. And our symposium this October will highlight that, 

whether it is through the school lunch programs that Catherine 

Bertini,our 2003 laureate was advocating, or promoting similar 

programs of Senator Dole and Senator McGovern. We were one of 

the first to have a symposium on the importance of food in Africa 

in countering HIV/AIDS or highlighting the work of golden rice and 

its promise. 

Also, the World Food Prize wants to promote conservation, conservation tillage, reduced soil erosion, and ways to resist plant disease. Dr. Borlaug’s dream is someday a scientist will find a way to 

take from rice that gene that allows it to be immune to rust disease 

and plant it into soybeans or corn others to stave off those kinds 

of diseases. He also stresses that biotechnology can help plants better deal with cold and heat and arid conditions, or reduce the time 

24

for breakthrough achievements. It took 70 years to figure out from 

beginning to end, how can you put more lysine and tryptophan into 

corn to make it more nutritious and healthy. It finally, has two 

World Food Prize. But if biotech procedures had been used, that 

time could have been cut in half or more. Of course, as Dr. Borlous 

said, we are running out of time for making these kind of advances 

in bringing food and medicine closer together. 

One of the lessons I learned as an American ambassador and as 

a young diplomat in the Mekong Delta in Vietnam during the war 

was that biotechnology can also be a crucial weapon in countering 

terrorism. The only time America has ever totally destroyed a terrorist organization was in Cambodia, the Khmer Rouge. More than 

200,000 Vietnamese troops could not get the job done the 10 years 

that they were there. But we put in place an effort—we built roads 

into every Khmer Rouge base area, and we brought with it new agricultural technology and education and human rights, all the 

things that followed just as they did in our country going down the 

road into our small towns. In 9 years, the Khmer Rouge went from 

25,000 people who controlled two-thirds of the country to the last 

general surrendering and the organization being obliterated. And it 

was the roads and new agricultural technology that did the job. 

Mr. Chairman, Dr. Borlaug would tell you that the things we 

need to do in the future are: promote the primacy of science; support our land grant colleges and institutions with more money for 

research; and also make visas more readily available for foreign 

students. I was with a group of 300 officials last night from all the 

agricultural and land grant colleges. What they talked about were 

how visas and lack of funding were cutting back their institution’s, 

the ones that produced the individuals who in the last 60 years led 

the greatest period in agricultural achievement and hunger reduction the world has ever seen. We have 24, if you count Dr. Borlaug, 

World Foof Prize laureates who were in the forefront of that effort, 

the greatest achievers during the greatest period achievment. Fifteen of these Laureates, including those from abroad came from 

America’s land grant colleges and agricultural institutions. Dr. 

Borlaug would also tell you that we need an event that can bring 

everybody together from around the world. We are trying to create 

that with our World Food Prize symposium. We want to have the 

single most significant observance of World Food Day anywhere 

around the world, and that is what we are seeking to build. With 

the support of Senator Harkin, we also are working to have a Norman Borlaug Hall of Laureates, which would serve as the pantheon 

of these heros. Just as the Nobel Laureates are honored in Stockholm and in Oslo, there ought to be a place to honor the heros of 

Agriculture, and it ought to be in the heart of America where the 

greatest agricultural achievements have come, so that people can 

come and visit there. 

This October 13th we have our Laureate ceremony in our Iowa 

State capitol. There will be more life-saving achievement gathered 

at that place than at any other place around the world. Indeed, it 

will feature Dr. Borlaug, and I guess if he were there alone, you 

could say that as well, along with all of the other laureates. We 

will have people from 62 countries. We will have 100 people who 

are from other countries who are with the Iowa and Nebraska Corn 

25

Promotion Boards and the biotech seminar. We take these foreing 

officials all around the State. We will also have people from the 

U.S. soybean organizations who will be there as well. And we are 

enormously pleased to work with them. 

I apologize for running over time, Mr. Chairman. Thank you. 

[The prepared statement of Ambassador Quinn can be viewed in 

the appendix on page 82.] 

The CHAIRMAN. You are very inspirational, Ambassador, and you 

are certainly welcome to whatever time you need to talk about the 

great things that you are doing. Thank you very much. 

Ambassador Quinn. Thank you. 

The CHAIRMAN. Mr. Heck, I want to ask you a question that is 

somewhat related to biotech but somewhat related to the 2005 

farm year. This issue of rust and soybeans, what kind of apprehension has been raised and anxiety has been developing among farmers across America relative to this issue this year? And where do 

you think we are headed short term? 

Mr. HECK. Well, there is great apprehension. Rust left untreated 

will devour 80 percent of our yields. However, on the other hand, 

with proper warning systems and proper preparation, the damage 

can be limited to mostly the financial damage caused by the necessity to spray the fungicides. 

Certainly we are in for a few years of being very nervous about 

our soybean crop all throughout the country. It may well get to 

Iowa this year. It may not. We do not really know. That depends 

on the weather. Certainly it is already in Georgia, and it is certainly a problem there already and will be every year because of 

the over-wintering problem. 

We would like to have a biotech solution for that. We know that 

is at least several years away, and in the meantime, we have to 

use fungicides. But the only real answer to totally protect ourselves 

would have to be within the plant itself. 

The CHAIRMAN. I have heard from some of my farmers that there 

is conversation and thought about the fact that kudzu actually attracts that rust. I hope that is the case. Maybe we will finally find 

some good use for kudzu. 

[Laughter.] 

The CHAIRMAN. Congressman Greenwood, you note in your testimony global adoption rates for biotech crops and the rapid rise in 

planted acres, especially in developing countries. It is fascinating 

to hear those numbers. That is why I asked you to repeat that to 

make sure I understood exactly what you were saying. You also 

note that food and fiber production will need to double in order to 

keep pace with population growth by 2025. 

What do you see as the biggest challenges and impediments regarding biotech crop development and acceptance, both domestically and internationally? 

Mr. GREENWOOD. Mr. Chairman, I think it is mythology and misunderstanding. Biotechnology has been around, as has been noted, 

for some time now, and Americans have been eating biotech products for a very long time. And there really is no evidence whatsoever of a safety concern, and yet in some quarters the resistance 

is pretty strenuous. 

26

If you look at the European resistance, which is not universal but 

it is intense in some quarters, I think we have to consider that 

there are multiple agendas at work. First off, the Europeans have 

had some tough times with regard to the credibility of their food 

safety organizations, with mad cow disease and so forth, so they 

are perhaps in some regards more skeptical there than we are. 

One has to consider the green politics in Europe, which is party 

politics that is very different than it is here and how that affects 

the decisionmaking. 

I think there is a fair amount of protectionism, frankly, that 

plays into this issue as well. There is some anti-U.S. sentiment. 

There is some anti-capitalist sentiment. 

But when you go to the issue of the Third World, I think it might 

lend some—the notion as to how this resistance may ultimately 

dissipate, and that is, as long as the world sees this as a U.S. phenomenon with U.S. products entering European markets, those 

sentiments that I have just addressed will persist. But the more 

the world sees this as an issue for developing countries to help lift 

poor farmers from poverty so that they can educate their children 

and live in higher standards, so that they can feed their people 

with more levels of protein so that they can overcome issues like 

Vitamin A deficiency from rice, I think particularly in Europe, 

where there is a great deal of sympathy and empathy with the 

Third World, perhaps that part of the world will begin to view biotechnology more favorably. 

But we have a big responsibility to act constantly at the highest 

standards of ethics, to have the best regulatory regime in the world 

so that we can set the standard. 

The CHAIRMAN. Senator Harkin? 

Senator HARKIN. Just following up on that, I remember when we 

met several years ago with the President of the European Union, 

Romano Prodi. The problem was that they did not have in place 

an FDA type of an organization for the European Union, and they 

were going to set that up. I believe they have established an agency. 

Mr. GREENWOOD. I believe they have. It is not a mirror image 

of ours, and I don’t think it has the credibility and the rigor of 

ours. 

Senator HARKIN. Does it even have the authority that ours does? 

Does it cut across national lines? 

Mr. GREENWOOD. It does not have—individual nations can still 

stop approval. 

Senator HARKIN. That was a big problem before, and it is still 

a problem over there, that they have not set up the type of an 

agency, and they said they were going to try to set up one that 

would mirror our own FDA. But to the best of my knowledge, that 

still has not happened. 

Mr. GREENWOOD. They have some distance to travel in that regard, Senator. 

Senator HARKIN. I think that is right. 

Mr. Heck, I just wanted to ask you briefly—and then I wanted 

to ask Ken Quinn a question—about the soybean rust coming in. 

I may have missed the answer to Chairman Chambliss’ question, 

27

but is there some thought that with biotech we can actually do 

something about this? 

Mr. HECK. Yes, we have talked——

Senator HARKIN. What is the latest you have heard about it? 

Mr. HECK. We have talked about it extensively for a number of 

years, and the two alternatives are a solution through the seed, 

through the plant itself, where it becomes resistant to rust, or fungicides. Fungicides are expensive and there is a difficulty of application. And you still have loss of yields with a fungicide, so that 

is a stop-gap measure that we will be using for a number of years, 

and I hate to say it, but, you know, rather than leave it open, like 

5 years or 10 years before we have a solution through the seed 

with biotechnology, where the plant itself is resistant to rust. First 

you have to find the proper genetics and then transfer it into soybeans and then transfer it into commercially adopted varieties. 

Senator HARKIN. So again, in terms of the immediacy of the soybean rust, it probably might not be helpful right away. 

Mr. HECK. It certainly will not be helpful right away. It will be 

at least a period of a handful of years. 

Senator HARKIN. Sometime down the road. 

Ambassador Quinn, thank you for being here. Thanks for a very 

passionate statement about the need for us to be more aggressive 

in our whole research agenda and, in fact, being the promoter of 

a worldwide effort to bring scientists and others together to really 

solve this problem of feeding the additional people that are going 

to be on this planet in the next 20, 30 years, without resorting to 

cutting down all the forests and depleting all the water and other 

resources. 

A big question that comes up on biotech is that a lot of poor people around the world, a lot of the smaller farmers who want to 

grow crops that will yield more, yield better, be more disease resistant, pest resistant, that type of thing, there is a fear that some of 

these farmers may save the seed, and if they save the seed, two 

things happen: one, obviously is a market loss for the producers of 

seed who have invested in the genetus; second, it may destroy or 

replace some of the indigenous heirloom type varieties that might 

be there that might be lost forever. 

I don’t know that much about it to talk any more than that, but 

I hear that a lot, and I am just wondering if your foundation is 

looking at that and asking scientists and others about how we 

might deal with of those hurdles. 

Ambassador Quinn. Yes, absolutely, we are. Last year, one of our 

laureates was Dr. Monty Jones, the first African scientist from 

south of the Sahara to win such a prize, probably the highest scientific honor ever accorded to a scientist from Africa south of the 

Sahara. And Dr. Jones, working with conventional methods, figured out how he could marry Asian rice and African rice. The 

Asian rice, you know, it just yields incredibly. And you have got the 

African rice, which is tough and it has learned how to survive in 

these tough soils and incredible heat and arid conditions. It stays 

alive, but it cannot produce much. 

Dr. Jones went into the seed banks which had been preserved by 

his research center, despite the fact that there were terrible wars 

going on around them in Cote d’Ivoire, they had to pick up and 

28

move to Ghana with the seed banks. But they had preserved a 

great, great many, in fact thousands of ancient African seeds. A 

crucial thing to do. Dr. Jones went back in there and found some 

of these oldest African seeds and brought them out and had an arranged marriage with the Asian rice. Now when they take these 

new seeds out to the fields, they can get—if they put enough fertilizer on it, they can get 150–percent increases in yields. It has incredible potential for what can be done to feed West Africa. 

But it is crucial. It is crucial to save those seeds and not let them 

be obliterated. Dr. Jones example is as much one to other scientists 

in Africa as it is to what can be done for farmers. And so it is exactly the kind of thing, the World Food Prize seeks to do: to find 

somebody who needs to be honored somebody who needs to be 

brought before the world. And the example of what he has done 

needs to be shared so that his work can be the model to be followed. 

Senator HARKIN. Mr. Chairman, the World Food Prize Foundation, as Ambassador Quinn has talked about, gives this award 

every year. It is the brain child of Dr. Borlaug. It has been said 

that he saved more human lives than any single person in the history of the world because of his Green Revolution that he had developed, a farm kid from Cresco, Iowa. As you can see, we are very 

proud of him. 

The history of the prize involves going to the Nobel committee to 

try to get them to establish a prize like this, But, no, they had 

their set-up and that is it, they were not going to add a new prize. 

John Ruan and his family have stepped to the forefront to fund the 

World Food Prize. It is an incredible gathering of scientists every 

year at the awarding of this prize. 

Now, not too many Americans know about it, but I tell you, you 

go to Africa, you go to Southeast Asia, and they know about it. I 

mean, this is a big deal to them. Food is so crucial to them. We 

Americans may not think that much about food. It is cheap and so 

plentiful in America. Go to the local grocery store and the shelves 

are stocked, and you can buy whatever you want at a very cheap 

price. In these countries where food is just in a delicate balance all 

the time, it is so crucial to them. So the World Food Prize is a momentous thing, and the fact that it is America that is doing it and 

leading the charge is something that strengthens our leadership in 

so many parts of the world. 

I wanted to add that little editorial comment on the World Food 

Prize and thank you for your leadership, Ambassador. 

Ambassador Quinn. Thank you, Senator. 

Senator HARKIN. And the Ruan family and Norman Borlaug. I 

am sorry he could not be here. Al is 91 years old, and I tell you, 

he would outpace us any day of the week. He is very energetic and 

travels all over the world. Why I thought it would be appropriate, 

to have Ambassador Zuinn here at this hearing on biotechnology is 

because what the World Food Prize Foundation is about is really 

getting the best minds in the world to figure out how we can both 

save the planet ecologically and how we are going to feed these additional 3 billion people coming along. When you see what they 

have already done and what some of these scientists have done and 

you think about the promise of biotechnology and what it can do 

29

in terms of genetically engineering plants to be more drought resistant, for example, to save water, to hold it when they need it instead of just evaporating it off, to be able to even use brackish 

water for growing. I have wondered why is it that there are certain 

plants that can grow in sea water, the most popular being 

mangroves, for example. Coconut palms, I don’t know how many 

people know this, tolerate sea water. You can grow them with sea 

water. How can they do that and we cannot do it with soybeans 

or corn or rice? 

Well, just think of all of the parts of the world where they have 

bad water or brackish water, coastal plains. If we can do that kind 

of genetic engineering, my goodness, what we could do to increase 

the production of edible crops and food supplies around the world. 

That promise is out there, and that is what is down the road that 

we can do, and that is why I feel so strongly about supporting biotechnology, making sure we have the regulatory structure to reassure people that it is safe, to make sure that we have the processes 

to go through and everything, but to really push ahead on this. 

Otherwise, we are going to have a big problem here not only in 

America but globally. I just want to make those comments and, 

again, to thank all of the witnesses and especially Ambassador 

Quinn and all that you have done for the World Food Prize Foundation. These two marry together, what we are trying to do 

through the World Food Prize and what we are trying to do 

through biotech and leading the world in that area, too. 

So thank you very much, Mr. Chairman, for letting me editorialize. 

Ambassador Quinn. May I add just one comment? 

Senator HARKIN. Sure. 

Ambassador Quinn. In 2002, we had our symposium on global 

water insecurity, and we brought several Israeli water engineers 

and water experts. We had a Palestinian water expert. We had one 

from Egypt. We had somebody from the World Bank who works in 

arid conditions in Syria and researchers from the UAE and others 

working exactly, Senator Harkin, on what you ere talking about. 

How can you use biotechnology to take brackish water and to have 

productive plants that can survive in that kind of situation? And 

we see it not only about feeding people, but it is about building 

peace. 

You know, the other great legacy of Dr. Borlaug is that he went 

to India and Pakistan when they were virtually at war with each 

other in the middle 1960’s, one of the few people who could go back 

and forth, and he dealt with the top leaders and convinced them 

to change their whole approach to agriculture. But it saved, you 

know, hundreds and hundreds of millions of people from famine, 

starvation, and death. And that is another part of what food can 

be in the World Food Prize. It ought to be this is a place where 

you can bring people together, whether it is Israelis and Palestinians, people from other parts of the Middle East, and because they 

are talking about food and alleviating human suffering, it can be 

a place where they can come together, put those other differences 

aside, and work together on this. 

The CHAIRMAN. Senator Lugar? 

30

Senator LUGAR. Mr. Chairman, I would like to follow on Senator 

Harkin’s questioning. This is sort of a good session in a way for 

personal counseling. I have got three parts on my farm, about 200 

acres of hardwood trees, 200 acres in soybeans, and 200 acres in 

corn. On the tree front, the ash bore has been giving problems in 

Michigan. It is approaching Indiana. And at Purdue, with money 

really provided by the Congress in terms of agricultural research 

and trees, why, they believe that they are going to mount a defense 

against the ash bore, which will capture the bore or at least eradicate the problem before it gets to Indianapolis. It is moving rapidly 

in that direction. So this is somewhat reassuring. But I am not so 

reassured about soybean rust. 

Now, here we are talking about several years, and what other 

farmers—and, Mr. Heck, you are right in the middle of this and 

have been for years in your own life, but are contemplating is 

should we change our planting situation a little heavier in corn or 

heavier in something else other than beans, and are sort of in the 

whirlwind of this. It is not reassuring that somehow or other the 

Lord will provide ingenuity. You know, just picking up on Ambassador Quinn’s thought, maybe if the World Prize were devoted at 

this point as a high profile for the person that solves the soybean 

rust problem, we might find somewhere on this Earth—and that is 

the beauty we are talking about today. It is not just American ingenuity, but somebody who has done at least some basic work with 

regard to that problem that might contribute to a much more rapid 

solution. Because if, in fact, the soybean rust problem is as fierce 

as has been suggested—and it could well be—this is going to alter 

American agriculture very significantly for several years while we 

are working our way through the various permutations of the research. 

I don’t know that there is any such place on Earth or anybody 

who has ever thought of the problem, but they must have. Soybean 

rust has been around for a while. It has not bothered us. But, nevertheless, somebody somewhere may know something. And so I just 

highlight, the virtue of the hearing, again, is that we started correctly with our parochial concerns. Are we doing our homework in 

terms of regulation? Is the integrity of the process working? Are we 

talking to each other? Well, we found we are, and admirably so. 

So if we can go to the rest of the world with not only clean hands 

but even beyond that the idealism of this process, but then from 

the rest of the world, we need to extract some solutions that may 

be tremendously helpful here. The prize may be helpful in highlighting, as you pointed out. But so may be the American Soybean 

Association or others who may have some allies out there in the 

world who have done this sort of thing before. 

The reason I am excited about the hearing is that not only do 

we have sort of a first panel that established the ground rules, but 

the second panel, we are really thinking big. It is so big that it is 

sort of beyond our comprehension. When Senator Harkin mentions—and you do, I think, Ambassador Quinn—that maybe as 

many as a billion lives were saved because of the Green Revolution, 

this is so far beyond comprehension. We have hearings day by day 

in which we lament the fact that tens of persons are being killed 

in combat, that other persons are at risk of being killed perhaps 

31

from some terror disaster in the United States. And horrible as 

these things may be, we are talking tens, hundreds, at the worst 

maybe thousands of people that might be involved. But a billion is 

almost beyond our comprehension. 

This is the enormity of the subject matter here, and, furthermore, as you pointed out, if something does not happen within the 

next 50 years to feed 3 billion more people that are prophesied to 

be a part of our world, either we will have had the growth in 

yields, and safely so, or we will have chopped down a good part of 

the rest of the rain forests with ecological consequences for humanity for the rest of time that are incalculable. So the stakes are extremely high in terms of what is occurring here. 

I liked Congressman Greenwood’s point that even as we are 

thinking very, very big about the world, just in a parochial sense 

back home here soybean farmers had $1.2 billion more net income 

last year, 2004, because of the subject matter we are talking about. 

There are very few things we do in farm bills that could have an 

increase of that amount of money, 200–some million for corn farmers, and ditto for cotton farmers, and what have you, adding up to 

1.9, I think you calculated. This is big money now, not in the hereafter or collectively historically. These are for real farmers who are 

out there farming now and who are utilizing these biotech methods, and hopefully hoping for more to come, as well as prevention 

of soybean rust, altering the scheme. 

What I am wondering from any of you, is there any hope that 

somebody has done something in soybean rust, just to take that 

topical example, that may accelerate the process here? Because if 

so, this would be great news to a lot of farmers who are very anxious, including myself, about the whole process. If not, then we 

need to try to think through why will it take several years, sort of 

explain the process of science. And there are a lot of reasons. It 

takes time to grow whatever it is in terms of you have the ideal 

plant to check out whether it does have all the qualifications. But 

any reassurance at all on soybean rust or any of the rest of this? 

Mr. HECK. Well, there has been a great of activity on it, and the 

U.S. Government has been very helpful on some of the activity in 

the land grant college/university system. Virtually all the known 

soybean varieties and types have been screened for rust resistance. 

It seems to me like that was a number like 20,000 different kinds. 

A few genes of resistance were identified, again, with the help of 

private industry, the University of Illinois, the Ag Research Service. Those genes are being placed in soybean varieties and seeing 

how they react. 

I think you can be assured that everyone in the soybean world 

knows that this is the biggest one, the biggest one there ever was, 

and there is an enormous financial prize for the company that can 

come up with a solution through the seed. There is a great deal 

being done, and we would be happy to discuss with you in detail 

some other avenues that could be explored with congressional funding with extra pushes, because there are areas that could be done 

where a relatively small investment of a few million dollars could 

make billions of dollars of difference in the damage control and 

save many, many lives by solving this problem sooner rather than 

later. It does just take time, though. 

32

Senator LUGAR. Mr. Chairman, I just would be prompted to say 

this might be very well worthwhile of the committee or the staff’s 

time to explore what these means are, what kind of investment you 

are talking about. You mentioned land grant colleges and some private firms, and that is the genius of the American system, both of 

these. But this is so urgent, this is probably something that needs 

to be hopped on if you have ideas and so forth. And I hope that 

you will share them with the chairman and with the committee because these could be action steps for us. 

Mr. HECK. We would be happy to do that. 

Mr. GREENWOOD. May I comment? 

Senator LUGAR. Sure. 

Mr. GREENWOOD. Far be it from me to talk more about soybeans 

than the soybean guy, but in the category of thinking big, Senator, 

today is the first day in 6 months that I stepped foot in the Capitol, 

and I admit that when I did, I looked up at the dome and I had 

a moment of wondering whether I made the right step in leaving 

the Congress. The reason that I know that I did is because I believe that biotechnology will be and is now the most transformational human endeavor in our history. It will dramatically 

change our health care system, our food supply, and our environment like nothing else has before, because it is giving us the tools 

to look into the secrets of life and use them with our God-given 

brains to the benefit of our fellow humans. 

On the food side, we have heard here many times today a fixed 

amount of arable soil, a growing population, and the potential devastating consequences of that. There is much that can be done on 

the yield side to make plants more productive and more nutritious. 

But if you look at where the margin is, it is on what it is that destroys plants. It is on the diseases. It is on the insects. It is on the 

drought. It is on the other climatic conditions. And these are precisely the areas where biotechnology is offering tremendous hope 

because we can find out what it is that makes plants, agricultural 

plants, susceptible to this damage, find out what genetic materials 

and proteins exist to resist that and make them stronger, and reduce the loss. And if we can reduce the loss in agriculture around 

the world, therein lies tremendous hope for mankind. 

Ambassador Quinn. And there is the promise of looking at rice 

and seeing if you can find, what it is about the genomic makeup 

of rice that prevents it from getting rust disease. We had last year 

as our co-winner of our prize a man named Yuan Longping, a very 

simple man from Hunan Province in China who is, I think, without 

doubt the single greatest rice producer and expert in all history, because he developed hybrid rice. And he has rice that is producing 

such incredible yields of grain, it is almost beyond comprehension. 

And I have been at some of the biotech labs that are working on 

rice, the Chinese Academy of Agricultural science. We brought the 

leading genetic engineer from China to our symposium in the year 

2000. And in all of that, there may be a remarkable opportunity 

here for a U.S.-Chinese interaction on this problem of rust disease 

that could be of great benefit to both counties. 

Senator LUGAR. Well, Mr. Chairman, I thank you again for the 

hearing. I am a true believer in the situation. Getting back to my 

trees, out on our farm there is a small acreage that is fenced off 

33

by Purdue, and they are grafting year by year onto these specimen 

trees, whether they are black walnut or oak or ash or what have 

you, they are trying to find the genomes of the very best oak tree 

that ever happened and is resistant to disease, but likewise has 

growth possibilities and fewer infirmities. It is an exciting process 

to watch. My agreement with them is not to touch their trees for 

15 years or so, so I am, of course, going to abstain from touching 

them. I am just watching them. 

Ambassador Quinn. When I was in China, we were given a briefing about oak disease, and with maps and overlays of where this 

kind of oak rot is located —rot that just causes the oak trees to 

suddenly collapse without any warning. And it was—it actually 

was showing on the map—you will be happy to hear, Senator, that 

the center of this disease was going to be in Des Moines and not 

in Indianapolis. And it looked from the map that it was pretty close 

to my backyard. So I left with great trepidation, but not knowing 

quite what to do. 

Senator LUGAR. Thank you. 

Mr. GREENWOOD. Mr. Chairman, if I can end with a commercial, 

June 19th through 22nd is BIO 2005 in Philadelphia; 18,000 people 

will come and learn what is new in biotechnology. And the Senators and all their staffs are welcome to come. It is quite a fascinating opportunity. 

The CHAIRMAN. Well, thank you, and we will make sure that 

some of our folk from here are there. This is a fascinating subject, 

and I cannot tell you how much we appreciate both panels being 

here. We could stay here all afternoon and dialog about what the 

future of agriculture and what the future of food production is 

going to be and how that translates into solving problems relative 

to world hunger and any number of other issues. I just cannot tell 

you how fascinating it is to me personally. 

But we do appreciate your being here. Thank you for your testimony and your input here. The record will remain open for 5 days 

for any additional comments. 

Ambassador Quinn. Could I leave one final thought about Dr. 

Borlaug, Mr. Chairman? 

The CHAIRMAN. Certainly. 

Ambassador Quinn. That is that his powers go beyond biotechnology. His desire in life was to play second base for the Chicago Cubs. 

[Laughter.] 

Ambassador Quinn. Last year, on June the 9th, he was invited 

to Fenway Park to throw out the first pitch. And while some may 

think that the trades that sent Garciaparra away or brought Schilling there is what got the Red Sox their first world championship, 

I believe it was Dr. Borlaug’s visit there. Finally, the curse of Babe 

Ruth was confronted with another Babe Ruth, the Babe Ruth of 

food production. I think Dr. Breaus drove it out and exorcised that 

demon and let the Red Sox win. 

Now, those who are not Red Sox fans may not be so happy with 

him, but I just wanted to share that. 

The CHAIRMAN. That sounds like pretty good reasoning. 

[Laughter.] 

The CHAIRMAN. Thank you very much. 

34

[Whereupon, at 3:57 p.m., the committee was adjourned.] 

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A P P E N D I X

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DOCUMENTS SUBMITTED FOR THE RECORD

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QUESTIONS AND ANSWERS

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