[Senate Hearing 109-438]
[From the U.S. Government Publishing Office]



                                                        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

                                 _____

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                             WASHINGTON: 2006        
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           COMMITTEE ON AGRICULTURE, NUTRITION, AND FORESTRY



                   SAXBY CHAMBLISS, Georgia, Chairman

RICHARD G. LUGAR, Indiana            TOM HARKIN, Iowa
THAD COCHRAN, Mississippi            PATRICK J. LEAHY, Vermont
MITCH McCONNELL, Kentucky            KENT CONRAD, North Dakota
PAT ROBERTS, Kansas                  MAX BAUCUS, Montana
JAMES M. TALENT, Missouri            BLANCHE L. LINCOLN, Arkansas
CRAIG THOMAS, Wyoming                DEBBIE A. STABENOW, Michigan
RICK SANTORUM, Pennsylvania          E. BENJAMIN NELSON, Nebraska
NORM COLEMAN, Minnesota              MARK DAYTON, Minnesota
MICHEAL D. CRAPO, Idaho              KEN SALAZAR, Colorado
CHARLES E. GRASSLEY, Iowa

            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)





                            C O N T E N T S

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                                                                   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


 
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.
    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 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.
    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.

  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 well-known 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.
    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 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.
    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?
    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 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 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 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 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.
    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 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 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 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 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. 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 Agri-Biotech 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.
    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 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 barriers 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 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 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 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.
    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, 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 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 
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?
    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 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.
    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 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.
    [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

                             June 14, 2005



      
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                         QUESTIONS AND ANSWERS

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