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REVIEW OF BIOTECHNOLOGY IN

AGRICULTURE

HEARING

BEFORE THE

SUBCOMMITTEE ON CONSERVATION, CREDIT,

RURAL DEVELOPMENT, AND RESEARCH

OF THE

COMMITTEE ON AGRICULTURE

HOUSE OF REPRESENTATIVES

ONE HUNDRED EIGHTH CONGRESS

FIRST SESSION

JUNE 17, 2003

Serial No. 108–9

(

Printed for the use of the Committee on Agriculture

agriculture.house.gov

COMMITTEE ON AGRICULTURE

BOB GOODLATTE, Virginia, Chairman

JOHN A. BOEHNER, Ohio

Vice Chairman

RICHARD W. POMBO, California

NICK SMITH, Michigan

TERRY EVERETT, Alabama

FRANK D. LUCAS, Oklahoma

JERRY MORAN, Kansas

WILLIAM L. JENKINS, Tennessee

GIL GUTKNECHT, Minnesota

DOUG OSE, California

ROBIN HAYES, North Carolina

CHARLES W. ‘‘CHIP’’ PICKERING,

Mississippi

TIMOTHY V. JOHNSON, Illinois

TOM OSBORNE, Nebraska

MIKE PENCE, Indiana

DENNIS R. REHBERG, Montana

SAM GRAVES, Missouri

ADAM H. PUTNAM, Florida

WILLIAM J. JANKLOW, South Dakota

MAX BURNS, Georgia

JO BONNER, Alabama

MIKE ROGERS, Alabama

STEVE KING, Iowa

CHRIS CHOCOLA, Indiana

MARILYN N. MUSGRAVE, Colorado

DEVIN NUNES, California

——— ———

CHARLES W. STENHOLM, Texas,

Ranking Minority Member

COLLIN C. PETERSON, Minnesota

CALVIN M. DOOLEY, California

TIM HOLDEN, Pennsylvania

BENNIE G. THOMPSON, Mississippi

MIKE MCINTYRE, North Carolina

BOB ETHERIDGE, North Carolina

BARON P. HILL, Indiana

JOE BACA, California

RICK LARSEN, Washington

MIKE ROSS, Arkansas

ANI ́BAL ACEVEDO-VILA ́ , Puerto Rico

ED CASE, Hawaii

RODNEY ALEXANDER, Louisiana

FRANK W. BALLANCE, JR., NORTH

CAROLINA

DENNIS A. CARDOZA, California

DAVID SCOTT, Georgia

JIM MARSHALL, Georgia

EARL POMEROY, North Dakota

LEONARD L. BOSWELL, Iowa

KEN LUCAS, Kentucky

MIKE THOMPSON, California

MARK UDALL, Colorado

RICK LARSEN, Washington

LINCOLN DAVIS, Tennessee

PROFESSIONAL STAFF

WILLIAM E. O’CONNER, JR., Staff Director

KEVIN KRAMP, Chief Counsel

STEPHEN HATERIUS, Minority Staff Director

ELYSE BAUER, Communications Director

SUBCOMMITTEE ON CONSERVATION, CREDIT, RURAL DEVELOPMENT, AND RESEARCH

FRANK D. LUCAS, Oklahoma, Chairman

JERRY MORAN, Kansas

TOM OSBORNE, Nebraska

Vice Chairman

SAM GRAVES, Missouri

ADAM K. PUTNAM, Florida

MAX BURNS, Georgia

JO BONNER, Alabama

MIKE ROGERS, Alabama

STEVE KING, Iowa

——— ———

TIM HOLDEN, Pennsylvania

Ranking Minority Member

ED CASE, Hawaii

FRANK W. BALLANCE, JR., NORTH

CAROLINA

COLLIN C. PETERSON, Minnesota

CALVIN M. DOOLEY, California

BOB ETHERIDGE, North Carolina

ANI ́BAL ACEVEDO-VILA ́ , Puerto Rico

JIM MARSHALL, Georgia

MIKE MCINTYRE, North Carolina

RYAN E. WESTON, Subcommittee Staff Director

(II)

(III)

C O N T E N T S

Page

Holden, Hon. Tim, a Representative in Congress from the Commonwealth

of Pennsylvania, opening statement ................................................................... 3

Lucas, Hon. Frank, a Representative in Congress from the State of Oklahoma, opening statement .................................................................................... 1

WITNESSES

Crawford, Lester M., Deputy Commisioner, Food and Drugs, U.S. Food and

Drug Administration ............................................................................................ 6

Prepared statement .......................................................................................... 30

Hegwood, David, Special Counsel to the Secretary, U.S. Department of Agriculture ................................................................................................................... 4

Prepared statement .......................................................................................... 23

Johnson, Stephen L., Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances, U.S. Environmental Protection Agency .......... 7

Prepared statement .......................................................................................... 26

(1)

REVIEW OF BIOTECHNOLOGY IN

AGRICULTURE

TUESDAY, JUNE 17, 2003

HOUSE OF REPRESENTATIVES, SUBCOMMITTEE ON CONSERVATION, CREDIT, RURAL DEVELOPMENT, AND RESEARCH, COMMITTEE ON AGRICULTURE, Washington, DC.

The subcommittee met, pursuant to call, at 11:00 a.m., in Room

1302 of the Longworth House Office Building, Hon. Frank D. Lucas

(chairman of the subcommittee) presiding.

Present: Representatives Osborne, Putnam, Burns, Bonner, Rogers, King, Goodlatte [ex officio], Holden, Case, Ballance, Peterson,

Etheridge, Acevedo-Vila ́, and Marshall.

Staff present: Ryan Weston, subcommittee staff director; John

Goldberg, Anne Hazlett, Elizabeth Parker, Dave Ebersole, Callista

Gingrich, clerk; Elyse Bauer, Jon Hixson, Claire Folbre, Kellie Rogers, and Russell Middleton.

OPENING STATEMENT OF HON. FRANK D. LUCAS, A REPRESENTATIVE IN CONGRESS FROM THE STATE OF OKLAHOMA

Mr. LUCAS. The hearing of the Subcommittee on Conservation,

Credit, Rural Development, and Research to review biotechnology

in agriculture will come to order. And I would like to welcome to

the subcommittee’s hearing regarding biotechnology today.

I can think of few technologies that provide as much hope for the

future as biotechnology. The fact that we are able to create

healthier, environmentally friendlier, and higher yielding crops as

a result of modern biotechnology should not be taken lightly. The

process of creating desired traits through conventional breeding

has been used for centuries. The problem has been the time needed

for the trial and error necessary for conventional breeding that can

take decades, and sound results can sometimes be very elusive.

Conventional breeding is a science and, yes, an art form. Not

only do you get some of the desired traits from crossbreeding, but

you also get many traits that may not be so desirable. The fact that

modern biotechnology focuses on using the exact genes needed to

express a particular trait has allowed us to leap, literally, light

years forward and vastly expand our realm of possibilities.

I was quite surprised by some of the comments made last week

during debate on House Resolution 252. The United States’ decision to go before the World Trade Organization in an attempt to

end the European Union’s 5-year moratorium on the approval of

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new agricultural biotechnology products, which does not take away

any of the European sovereignty. Waiting for 5 years to see if the

EU would take any steps to explain their action, or should I say

inaction, has been more than fair.

It should also be made clear that farmers are embracing products

of biotechnology. Cotton, corn, and soybean farmers, in particular,

have found that biotech crops have allowed them to cut down on

input costs while maintaining, or even increasing, yields. Small

subsistence farmers in third world countries may have the most to

gain from biotechnology. Once crops that can survive local conditions or specific yield nutrition benefits are available, these farmers

will be better able to support themselves and help protect their

communities from famine.

Finally, some statements on the House floor erroneously suggested that products of biotechnology are not regulated. I find this

quite interesting that I have before me three witness from three

different agencies, all of them having a hand in regulating products

of biotechnology.

We live in a world where new developments in science have revolutionized how we live and how long we live. We can cower in fear

of science every morning when we wake up, or we can get out of

bed, turn on the electric lights, eat our breakfast foods that are

able to be stored longer and kept fresher than ever, and then get

into our car and drive to work as we all sit down in front of our

computer terminals. My point is that science is all around us. It

isn’t going away, and congress will continue to regulate science and

its innovations as it sees fit.

Biotechnology and its regulatory structure have been developed

during both Republican and Democratic administrations and Republican and Democratic Congresses. Debate over the appropriate

amount of regulation has occurred in the past and will likely continue into the future. Everyone has had their chance to impose

changes in the regulatory structure. Most importantly, we must

base our legislative decisions on sound science and not, I repeat,

not unfounded assumptions.

Today’s hearing is a great opportunity for our subcommittee. We

have asked our witnesses to explain their federal responsibilities

for regulating genetically modified foods and plants.

In 1984, the White House Office of Science and Technology Policy

published its ‘‘Coordinated Framework for Regulation of Biotechnology’’. This framework proposed that products of biotechnology would be regulated according to their characteristics

and novel features and not by their method of production. It further proposed that new biotechnology products be regulated under

the existing web of federal statutory authority and regulation.

In 1986, that same OSTP finalized the coordinated framework.

This allowed each agency to know who should be the lead agency

and to encourage coordination whenever jurisdiction overlapped.

The U.S. Department of Agriculture regulates importation, interstate movement, and environmental release of transgenic plants

that contain pest components. The Food and Drug Administration

is responsible for regulating food and feeds in the market that have

been modified through biotechnology. And the Environmental Protection Agency registers certain pesticides produced in plants prior

3

to their distribution and sale. And it also establishes pesticide tolerances in foods.

It is very tricky to navigate the details of where one agency’s jurisdiction ends and another begins; yet I believe this is very important for the subcommittee members to know the details. It is my

understanding that the administration is currently reviewing the

Coordinated Framework. If, in the future, any changes are proposed, it is imperative that we know why those changes should be

considered.

There are many topics that we will discuss today, and I hope to

keep the focus on the Coordinated Framework and time allowing

any current or future proposed rules and regulations concerning

plant-made pharmaceuticals, PMPs, plant-made industrial products, PMIPs, and plant-incorporated protectants, PIPs, to be discussed. Yes, that is a lot of acronyms.

I would note that the witnesses have also mentioned, in their

testimonies, instances when they have had to take action to ensure

the public and the environment safety. They should be commended

for taking appropriate actions, but we should strive to do all that

is possible to prevent these types of concerns from arising in the

future.

The testimony before us today does get into the details, and I

look forward to hearing from the witnesses. And with that, I turn

to the ranking member, Mr. Holden, for any opening statements he

may have.

OPENING STATEMENT OF HON. TIM HOLDEN, A REPRESENTATIVE IN CONGRESS FROM THE COMMONWEALTH OF PENNSYLVANIA

Mr. HOLDEN. Thank you, Mr. Chairman, for holding this hearing

to review biotechnology in agriculture. Hopefully, this hearing will

provide us all an opportunity to understand how USDA, FDA, and

EPA work together to ensure a safe food supply in a growing industry.

At some point in time, we have all consumed genetically modified

food. A majority of products in supermarkets have been altered in

some way. The biotechnology industry has seen rapid growth over

the past decade. Employment has doubled, revenues have tripled,

and research and development investment has quadrupled. The industry has seen many breakthroughs in revolutionized food processing, but not without debate. Farmers have contributed greatly

to the success of the industry. They have been crossbreeding varieties for centuries and have been adopting biotechnology in an effort to improve yield while increasing efficiency and competitiveness.

The agriculture industry has recognized the potential benefits,

and now we must help educate the public that we can produce safe

food if technology is allowed to advance. While the proper balance

of testing must be achieved, we must allow for innovation. We are

in a common debate with opponents calling for tighter controls and

supporters believing the necessary structure is in place.

Mr. Chairman, I look forward to the testimony that we are going

to hear today as we learn more about the biotechnology regulatory

framework.

4

Thank you, Mr. Chairman.

Mr. LUCAS. The Chair thanks the ranking member for those

opening comments, and would note that he requests that any other

Members submit their opening statements for the record so that

the witnesses may begin their testimony to ensure that we have

ample time for questions.

And with that, I would like to invite the rest of the first panel

to come to the table and join Mr. David Hegwood, Special Counsel

to the Secretary of Agriculture, U.S. Department of Agriculture. We

also have Dr. Lester M. Crawford, Deputy Commissioner for Food

and Drugs, U.S. Food and Drug Administration, and Mr. Stephen

L. Johnson, Assistant Administrator, Office of Prevention, Pesticides, and Toxic Substances, U.S. Environmental Protection Agency.

And with that, Mr. Hegwood.

STATEMENT OF DAVID HEGWOOD, SPECIAL COUNSEL TO THE

SECRETARY, U.S. DEPARTMENT OF AGRICULTURE

Mr. HEGWOOD. Thank you, Mr. Chairman, and members of the

committee, for the opportunity to be here with you this morning.

I will make a brief oral statement and ask the committee to accept

my written statement for the record.

Biotechnology is probably the most important technological development ever introduced in agriculture. It is the driver of profound changes in the global food and agriculture system. As an

early adopter and aggressive user of the technology, U.S. agriculture is experiencing the tremendous benefits as well as the complex challenges of biotechnology.

USDA has a broader role in biotechnology than any other agency

in government. Biotechnology impacts nearly every program area

within the Department, from the Agricultural Research Service to

the Foreign Agricultural Service. Our responsibility at USDA is to

foster the development of biotechnology as a tool that can improve

the food and agriculture system while, at the same time, ensuring

that it is used in a manner that ensures the health and safety of

U.S. agriculture, the American public, and the environment.

Today I want to focus on the Department’s regulatory role in biotechnology. Working together under the Coordinated Framework

since 1986, USDA, the FDA, and the Environmental Protection

Agency have created a robust, effective, and efficient regulatory

system for products derived from modern biotechnology. USDA’s

Animal and Plant Health Inspection Service, under the authorities

in the Plant Protection Act, regulates the interstate movement, importation, field testing, and release of bioengineered plants, insects,

and microorganisms through permitting and notification procedures. In general, APHIS’s field testing requirements for regulated

plants are designed to prevent the unintentional environmental introduction, whether by pollen movement, seed or grain commingling, or other means of any protein or trait produced in these

plants that would present a risk or potential risk to agricultural

crops or the environment.

APHIS operates a permit system for the field testing of genetically engineered crops. Companies that wish to field test such crops

must submit detailed applications to the agency with information

5

about the plant variety being tested, the purpose of the test, how

it will be conducted, and the specific confinement conditions taken

to prevent the escape of pollen, plants, or plant parts from the field

test site.

APHIS also has a streamlined permitting process called notification in place for certain types of low-risk plants. Most of the field

tests carried out in the United States are done under notification.

Compliance and enforcement are critical components of the regulatory system. All field test sites are subject to APHIS inspection.

Field test sites under permit are inspected at least once during the

current growing season. APHIS has a range of enforcement authorities up to and including civil and criminal penalties.

After successful completing the field testing stage of a new plant

variety’s development, a permit holder can petition APHIS to deregulate the biotechnology crop. In considering the petition, APHIS

carefully reviews the data submitted by the permit holder and also

weighs other pertinent scientific studies and information. APHIS

bases its deregulation decision on a determination that the plant

poses no pest risks to other crops or plants.

Once APHIS deregulates a particular product, the company must

still comply with applicable FDA or EPA requirements prior to

marketing. These requirements, coupled with APHIS’s inspections

and oversights, provide a scientifically sound regulatory scheme for

the safe field testing of bioengineered plants in the United States.

In an effort to stay ahead of potentially regulatory challenges,

the administration is also looking closely and proactively at the

rapidly developing science and how the science is being applied to

potentially new products. Some examples of our efforts include in

August 2002, the White House Office of Science and Technology

Policy published a notice in the Federal Register relating to the inadvertent and low-level presence of varieties being developed for

food or feed purposes that have not completed applicable agency review. In this Federal Register notice, APHIS proposed to update requirements for field testing of genetically engineered plants. USDA,

EPA, and FDA have received comments regarding this notice and

are in the process of developing those appropriate responses. The

White House’s Agricultural Biotechnology Working Group is looking at regulatory challenges posed by plants genetically engineered

to produce pharmaceuticals and industrial chemicals. I want to emphasize that APHIS already subjects these crops to more restrictive

confinement conditions than most genetically engineered crops.

And finally, in June 2002, APHIS established a new biotech unit

to consolidate and better coordinate its services and activities in

this area. The new unit, Biotech Regulatory Services, is responsible

for programs focusing on both plant-based and animal-based biotechnology. We plan to strengthen the BRS inspection and compliance unit, which conducted 305 inspections in 2002, and we estimate that that will double this growing season. Taking together

these steps in conjunction with the continued collaboration with

the EPA and FDA officials ensure that USDA is fully prepared to

meet the present and future regulatory challenges arising from biotechnology while allowing U.S. agriculture and the rest of the

world to realize the potential of this important technology.

6

Thank you again for the opportunity to be here today, and I look

forward to answering your questions.

Mr. LUCAS. Thank you, Mr. Hegwood.

Dr. Crawford.

STATEMENT OF LESTER M. CRAWFORD, DEPUTY COMMISSIONER FOR FOOD AND DRUGS, U.S. FOOD AND DRUG ADMINISTRATION

Dr. CRAWFORD. Thank you very much, Mr. Chairman.

I am Les Crawford, Deputy Commissioner of Food and Drugs.

Thank you for the opportunity to testify here today about how FDA

regulates genetically engineered foods, or bioengineered foods, as

we prefer to call them. FDA also regulates bioengineered drugs,

medical devices, biologicals, and veterinary products.

We are confident that the bioengineered plant foods on the market today are as safe as their conventional counterparts. Both the

General Accounting Office and the National Academy of Sciences

have issued reports agreeing with this assessment. FDA has reviewed the data on more than 50 bioengineered food products ranging from herbicide-resistant soybeans to modified canola oil, and

there is a list of these products on our website.

After 10 years of experience in this country, there is every reason

to conclude that bioengineered foods are as safe as food produced

through traditional breeding techniques. In a 1992 policy statement

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

aware of any information showing that 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 concern than foods developed by traditional plant breeding.’’ This statement was based on two separate

reports issued by the National Academy of Sciences. The 1992

statement and its scientific underpinnings still reflect the FDA’s

thinking about bioengineered foods.

Please allow me to add some perspective to the aforementioned

statements. Scientists have been improving plants by changing

their genetic makeup for years through crossbreeding 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 often can appear in addition to the desirable ones. Some of those undesirable

traits can be eliminated through additional breeding, which is time

consuming. Breeders can then further select and reproduce the offspring that have the desired traits. Many of the foods that are already common in our diet are obtained from plant varieties that

were developed using conventional genetic techniques of breeding

and selection. Hybrid corn, nectarines, which are genetically altered peaches, and tangelos, which are a genetic hybrid of a tangerine and grapefruit, are all examples of such breeding and selection.

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

7

improvement over traditional breedings. Are there risks? Any genetic modification technique, including both traditional methods

and bioengineering, could change the composition of a food in a

manner relevant to food safety. But because of the increased precision offered by bioengineering, it is our conclusion that the risk of

introducing detrimental traits is actually likely to be lessened.

Bioengineered foods and food ingredients must adhere to the

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

This means that these products must be as safe as the tradition

foods in the market. FDA has broad authority to initiate regulatory

action if a product fails to meet the requirements of the Food and

Drug Act.

FDA has established a consultative process to help companies

comply with the FD&C Act’s requirements for bioengineered foods

that they intend to market. Companies have used the consultative

process more than 50 times as they sought to introduce genetically

altered plants representing 12 different crops into the U.S. market.

We are not aware of any bioengineered plant food that is subject

to FDA’s jurisdiction and is on the market that has not been evaluated by FDA and through the current consultation process.

On January 18, 2001, FDA published a proposed rule to require

that developments of bioengineered plant varieties notify FDA of

their intention to market such products. FDA proposed that specific

information be submitted to help determine whether the foods pose

potential safety, labeling, or adulteration issues. The comment period for the proposed rule has closed, and the agency is in the process of evaluating the many comments received. The proposal has

raised policy and legal concerns and is not a public health rationale

for FDA given there is a voluntary consultation process in place

that is working well.

With respect to pharmaceutical crops, the FDA has the authority

and responsibility for regulating pharmaceuticals whether they are

manufactured in a traditional manufacturing plant or they are

manufactured in crops in the field. For crops in the field, however,

there are additional issues to be addressed related to the parts of

the plant that do not contain the pharmaceutical and the residual

crop left over after the pharmaceutical is extracted. We at FDA are

evaluating ways to help keep pharmaceutical and industrial chemical material out of food when it isn’t supposed to be there that

would be science-based and risk-based that would be enforceable

and that would not pose too high a barrier to development of these

crops.

Mr. Chairman, we thank you very much, indeed.

[The prepared statement of Dr. Crawford appears at the conclusion of the hearing.]

Mr. LUCAS. Thank you, Dr. Crawford.

Mr. Johnson.

STATEMENT OF STEPHEN L. JOHNSON, ASSISTANT ADMINISTRATOR, OFFICE OF PREVENTION, PESTICIDES, AND TOXIC

SUBSTANCES, U.S. ENVIRONMENTAL PROTECTION AGENCY

Mr. JOHNSON. Good morning, Mr. Chairman and other members

of the committee. I certainly appreciate the opportunity to be here

8

today. I would like to make a brief oral testimony and then I would

like to ask that my written statement be entered into the record.

Mr. LUCAS. So ordered.

Mr. JOHNSON. Thank you.

I am pleased to be here with my colleagues from FDA and USDA

to talk about how we regulate biotechnology in the Federal Government. The three agencies here today have a lot of experience and

insight into the regulation of biotechnology. And the administration

looks forward to working with this committee on biotechnology.

I want to stress up front that biotechnology holds tremendous

promise. It can bring better solutions to our society. And at EPA,

we believe it can provide opportunities that benefit the protection

of human health and our environment. This is important technology. As you know, the regulation of biotechnology is spread between the three agencies. We believe that the existing regulatory

system is working well and produces decisions that are scientifically sound and defensible. Our goal is to ensure that our regulatory decisions are based on rigorous scientific information, the

highest scientific standards with a high degree of transparency.

Under the Coordinated Framework, EPA regulates pesticide

products under the Federal Insecticide, Fungicide, and Rodenticide

Act, also known as FIFRA, and section 408 of the Federal Food,

Drug, and Cosmetic Act, or FFDCA. EPA also regulates biotechnology under the Toxic Substances Control Act, or TSCA.

Biotech pesticide products regulated under FIFRA and FFDCA include bioengineered microorganisms with pesticidal action as well

as products produced by plants that act within the living plant as

pesticides to protect the plant.

This latter category are called ‘‘plant-incorporated protectants’’ or

‘‘PIPs.’’ The leading example of these plant-incorporated

protectants or plants which contain genes from Bacillus

thuringiensis or simply Bt. The plant can now synthesize its own

Bt protein and ward off pests.

EPA has a long history in biotechnology in developing a comprehensive regulatory program for pesticide products. In fact, the

agency has been working with companies and individuals to regulate biotech products since the 1980s. Throughout these years, the

agency has developed robust regulatory and scientific standards for

biotechnology products going through the registration or licensing

process.

Let me briefly discuss the requirements of our registration process. First, a potential registrant typically comes in for a meeting

with our scientific staff at which time we decide upon the appropriate or product-specific data requirements. The registrant generates a wide range of data, submits it to EPA for our review. We

require scientific data in at least five categories: product characterization; toxicology, including allergenicity; non-target organism effects, particularly focused on birds, fish, and beneficial organisms;

exposure and environmental fate, including gene transfer; and resistant management. These data that are developed are then carefully reviewed by agency scientists. If any concerns or questions

arise in any one of the categories of tests described, a higher tier

of testing is required to allow EPA to more thoroughly evaluate the

potential risks.

9

Also, given the scientific nature of our regulatory decisions, EPA

routinely consults with our scientific advisory panel, an outside

panel of experts, as well as the USDA and FDA and others to ensure that the science supporting our regulatory decisions is sound.

The agency carefully evaluates the available data and the product

labeling to determine if the available information meets the established scientific and regulatory standards. Our standard is to ensure that the product can be used safely and will not cause any

harm to people or the environment. Our average time to review

and reach a decision on a new plant-incorporated protectant is between 24 and 30 months. Currently, EPA has registered 11 separate products, biotech products, the crops that have included potatoes, cotton, field corn, sweet corn, and popcorn.

EPA also administers regulatory oversight over commercial introduction of new microorganisms and significant new uses of existing

microorganisms under the authority of the Toxic Substances Control Act. This law gives EPA the authority to take any action on

‘‘chemical substances’’ that may present an unreasonable risk of injury to health or the environment.

In conclusion, I would like to thank you for allowing EPA to

share our experience with biotechnology. The agency’s biotechnology program is based on five important principles: sound

science, transparency in decision making, consistency and fairness,

collaboration with our regulatory partners, and building public

trust, all of which help to ensure environmental and human health

protection is achieved. Given our intellectual and scientific investment in regulating biotechnology, the agency stands ready, working

with our partners at USDA and FDA, to meet the future challenges

necessary to safeguard this technology for the future.

I would now be happy to answer any questions that you may

have. Thank you.

[The prepared statment of Mr. Johnson appears at the conclusion

of teh hearing.]

Mr. LUCAS. Thank you, Mr. Johnson.

Clearly, the administration places a significant importance on agriculture and food biotechnology by the recent actions in filing the

case against the moratorium on new biotech crops by our friends

in the European Union. I guess what I would like for you to do for

a moment is, perhaps starting with you, Mr. Hegwood, whether it

is to pick out some product that successfully made its way through

the process like soybeans or any product, explain for the committee

what the process would be and how the three entities work together in a concise fashion. I have a biotech company, and I want

to develop a new product, and I assume I come see you first.

Mr. HEGWOOD. Yes, sir, Mr. Chairman. The USDA has what

could be termed the ‘‘gatekeeper’’ role. We are the first stop for any

company that would want to come in and conduct a field trial. We

would have a consultation with the company, talk about the data

requirements. If they wanted to do field testing, we would come to

an agreement on the specific requirements, confinement requirements for the field testing, look at the purpose for the field test,

the purpose for the product, and look at the genetic sequencing.

And then, depending on the type of product, we would also have

discussions with EPA and FDA about requirements that we would

10

have to make our requirements consistent with what EPA and

FDA would require to meet their objectives.

Mr. LUCAS. So in that first stage, I would come to you. I would

have to have a plan of action. I would have to justify what I was

endeavoring to do, discuss the genetics. I would have to have a

plan for how to control the endeavor. And at that point, if I pass

muster, I would proceed to the next step, and depending on the

product, then I would turn to your friends here, and they

would——

Dr. CRAWFORD. If it is a food, a bioengineered product intended

to be a food, they would come to FDA after the APHIS pass-off, and

we would have a consultation with them in terms of what we needed with respect to data. They would share with us their research

plan. We would critique it and then there would be a follow-up consultation once they had completed these studies. And we would

evaluate that and then advise the company of the suitability of

product for inclusion into the U.S. food supply. There may be more

consultations in between the first one and the second one, depending on the kind of product.

Mr. LUCAS. But just because I came first to USDA and then potentially to Food and Drug with a concept, an idea, doesn’t necessarily mean that either entity would grant approval? But if I convinced both entities, then potentially, our friends at EPA would be

a factor?

Mr. JOHNSON. Well, again, in the EPA’s case, if the initial consultation with the Department of Agriculture was that it was going

to be pesticidal, for example the Bt was going to be inserted into

a particular plant, and they wanted to claim the pesticidal property, then after the initial consultation with the Department of Agriculture, then they would come to EPA. And then we would have

a consultation and then sit down and describe the specific data requirements. And we are looking at both the potential environmental effects as well as the potential human health effects.

It is EPA’s responsibility for pesticides to not only look at the environment but also to determine whether, in fact, this particular

pesticidal gene would be safe in food. And that authority comes

from the Federal Food, Drug, and Cosmetic Act, similar to the way

a chemical pesticide is. Again, we evaluate a chemical pesticide for

both its effects on the environment as well as potential human

health in the food. And then we would either establish a tolerance,

that is the maximum allowable of the particular material, or an exemption from tolerance saying that it was safe and it was not necessary to set a level.

Mr. LUCAS. Fascinating. Having to clear all three entities depending on the nature of the product. One last question on this

first round: are you confident, each of you, in the way your agencies work together? Are you confident that every opportunity is

being utilized to work among agencies and among the rest of the

Federal Government? Do you believe that the Framework now provides a sufficiently restrictive and very methodical process? Any or

all.

Mr. JOHNSON. Mr. Chairman, I think, first, we, at EPA, believe

that the Coordinated Framework has, and continues to, serve us

very well and that the working relationship across the three agenVerDate 11-SEP-98 13:16 Jul 18, 2003 Jkt 083355 PO 00000 Frm 00013 Fmt 6633 Sfmt 6633 F:\DOCS\1089 HAGRI PsN: HAGRI
11

cies is very, very strong. And but as you are probably well aware,

we are continuing to look at the Coordinated Framework. And if

there are needed improvements, then we will make those recommendations. But certainly, for EPA’s perspective, it has and continues to serve us very well.

Dr. CRAWFORD. FDA is also confident in the Coordinated Framework, and we believe that relations between EPA and USDA in

this regard are very, very good, indeed. And the system, in fact, is

working.

Mr. HEGWOOD. I would just reinforce my colleagues. We have absolute confidence in the system as it exists. And the Coordinated

Framework has been tested time and again, and we believe it provides adequate, effective regulatory framework for these products.

And of course, we always need to make sure that we are keeping

up with the technology, and we are doing that.

Mr. LUCAS. Thank you, gentlemen, for your insights.

I turn to the ranking member, Mr. Holden, for any questions he

might have.

Mr. HOLDEN. All right. Thank you, Mr. Chairman, and I thank

the panelists for their testimony.

My question on coordination has been answered, but my next

question has to do with the resources. And I would ask each of our

panelists: do you believe that your agency has the adequate resources and funding to approve new bioengineered agriculture

products in a timely manner and perform the best possible oversight of these products?

Mr. HEGWOOD. We believe we have adequate resources to do

what we need to do now. One of the things that we are doing is

looking ahead, trying to gauge where the technology is going and

what impact that is going to have on USDA’s resource requirements. We have recently established an advisory committee on biotechnology for the Secretary, and this is specifically one of the

issues that they will be looking at. So we do anticipate that in the

future we will have to address the issue of resources, but we believe we are able to do what we need to do with the resources we

have got now.

Mr. HOLDEN. Dr. Crawford.

Dr. CRAWFORD. FDA, likewise, believes we have adequate resources. I agree with Mr. Hegwood that we have to stay ahead of

the research that is being developed, the new products that are

coming. So it requires an exquisitely productive relationship with

USDA’s regulatory apparatus as well as its research apparatus, but

also such entities in the government as EPA and the National Institutes of Health. And it is necessary for us to work very carefully

with them and also with the industry to know what is coming. Our

first responsibility is public health, but we also don’t want to array

ourselves in such a way that we impede either the research or the

development of the industry. And at the present time, we think we

are able to keep up, and we also believe that we do know what is

being developed and what is coming, and I think we can do an adequate job of dealing with it from a regulatory and public health

perspective.

Mr. HOLDEN. Mr. Johnson.

Mr. JOHNSON. Thank you, Mr. Holden.

12

We, too, believe that we have adequate resources to review the

license applications that we receive. We are also very much aware

of both the importance of the technology as well as what we see

on the horizon. And again, we believe we have adequate resources,

of course, as the technology continues to grow and expand, then we

will have to revisit the resource issue.

Mr. HOLDEN. Thank you.

One last question, Mr. Chairman, for Dr. Crawford. We know

that other countries are developing and growing products derived

from biotechnology.

Dr. CRAWFORD. Yes.

Mr. HOLDEN. What authority exists for the FDA to monitor, enforce, and require safety assessments for potential biotech imports?

Dr. CRAWFORD. The products that are coming into the country

from other countries also require the same kind of evaluation. If

these products are coming from countries that we have regular

trading agreements with, we have to be assured that the product

is either approved in this country and is being brought in from another country or if it is bioengineered, we need to have an analysis.

So we would follow the same exact concerns and same exact process for imported products as we would for domestically produced

products.

Mr. HOLDEN. Thank you, Dr. Crawford. And thank you to our

panelists, and I would yield back, Mr. Chairman.

Mr. LUCAS. Thank you, Mr. Holden.

The gentleman from Alabama, Mr. Bonner.

Mr. BONNER. Thank you, Mr. Chairman.

Dr. Crawford, listening to your testimony about food safety and

realizing that this stretches a little bit away from the subject of

biotechnology. I would like to take advantage at this opportunity

to ask you a question. I come from the Gulf Coast, south Alabama,

where we have had a number of shrimpers in my District that have

been adversely affected by the importation of shrimp that contained chloramphenicol. It has not only devastated the shrimpers,

but it has had a rippling effect throughout the economy with regard to the people who supply the shrimp boats, build the shrimp

boats, the banks that loan the money, and other things as well.

And I was wondering, can you tell me what, if anything, FDA has

done to determine whether the introduction of chloramphenicol into

the American diet has had any negative impact with regard to the

importation of the shrimp that are coming into our country.

Dr. CRAWFORD. Well, thank you. I used to feast on those shrimp

and oysters from the vantagepoint of Demopolis, Alabama, a little

further north. And that is why I grew up to be a strong, healthy

American, also. Chloramphenicol does not belong in the food supply

at all. As you know, USDA and FDA have worked very hard to

keep it out. FDA has had some notable episodes in its history, particularly in the early 1980s, the illegal use of chloramphenicol by

livestock producers and have clamped down, eliminated. We have

done the same thing with importations of seafood products and also

honey. We have developed new, more sensitive tests to deal with

it. We have also met with the Chinese Government and others that

can help us with this process, since most of those products, as you

know, came from that part of the world. And we believe we have

13

made great progress. We think we just about have eliminated any

threat to the American food supply. However, we will continue to

monitor the food supply in all aspects, not just shrimp, not just

honey, but also various other things that we think would be subject. And we will be testing as well as monitoring, and that is going

to give us the satisfaction that this does not enter our food supply,

because chloramphenicol has no business being in any food that is

consumed at any level.

Mr. BONNER. Thank you, Mr. Chairman.

Mr. LUCAS. Thank you. The Chair turns to the gentleman from

Georgia, Mr. Marshall.

Mr. MARSHALL. Thank you, Mr. Chairman.

I must admit that I suffer from a great deal of ignorance about

this subject matter, and I don’t worry about what I eat. I just trust

you guys to make sure that what I eat is appropriate. Mr. Chairman, I don’t know how the panel was chosen today. I am a lawyer

who is used to sitting in on arguments where people disagree with

one another, and it seems like the three of you pretty much agree

with one another. And Mr. Chairman, I suppose it would be helpful

to me to have a debate on these subjects, if that can be arranged

at some point in the future.And I guess my question to any of the

panelists would be who are the naysayers here, besides the French?

They don’t count in my book right now. But who are the nay-sayers, the folks with some credibility who think that either biotechnology generally is very threatening to us or that the process

we go through in regulating biotechnology is inadequate?

Dr. CRAWFORD. Yes. Thank you for the question. I think in the

scientific and medical community worldwide, there is little disagreement. I think when bioengineering first came on the market,

if you will, in the 1980s, as we evaluated what the prospects were

and what the safety factors were, we asked the National Academy

of Sciences here in the U.S. to do a couple of reports. And they concluded two things that have turned out to be true now that we

have had 10 years of consuming these products. The first was that

there is no inherent reason that bioengineered foods would be unsafe. And then the second thing is that because the technology is

so sensitive and precise, there is every reason to expect that they

might even be safer. And so I think that remains to be what the

consensus of opinion is in the scientific community.

There are some trade issues with biotech foods, but I don’t think

they are science based.

Mr. JOHNSON. Yes, Mr. Marshall. Among the comments that we

have heard of some of the issues related to biotech, in addition to

what Dr. Crawford has mentioned, deal with the environmental

issues. One of them being gene drift, can the genes from a bioengineered plant drift to a non-engineered plant or to a weed, for example? Issues of resistance, could insects become resistant to the particular bioengineered material faster or in a worse way than insects to a conventional chemical?

And then there have been some issues that have come up related

to specific issues, animals or insects, such as the Monarch butterfly. In each of those instances, for example, the Monarch butterfly,

we required an extensive amount of data and testing. We actually

had a public scientific workshop to address, and in fact, no, there

14

aren’t any effects associated with the use of Bt corn or Bt cotton

with the Monarch butterfly.

With regard to insect resistance as well as gene drift, we actually

have in place management plans to manage it so that we won’t

have the kind of gene drift that could occur. Or in the case of resistance, we want to ensure that this technology lasts for a long

time, and frankly, so do the growers. So do the companies, everyone wants it to last for a long time. So we have in place, in the

case of pesticidal products, plans in place to make sure that the

technology will last and insect resistance will not occur.

Mr. MARSHALL. Just as a brief follow-up, if I had to pick one organization or publication or expert to go to to listen to a little bit

of naysaying here, what organization, publication, or expert would

either of you consider to be, you know, reasonable or credible? You

know, there are lots of nuts out there that I don’t want to waste

my time with, and so can you identify somebody or entity or publication that is sort of credible and sort of a naysayer?

Dr. CRAWFORD. What we can do is provide a little bibliography

and rank it. For recent reports on this, there have been three or

four that are very good that present, you know, the possible reasons for the trade disputes and some assertions that some of these

are science-based. And you know, they deconstruct it in a neutral

way. We actually can supply you, I think, with those reports, and

we will do that within 10 days’ time, of course.

Mr. MARSHALL. Thank you very much. Thank you, Mr. Chairman.

Mr. LUCAS. And the Chair wishes to reassure the gentleman

from Georgia that there will be all perspectives. The view of this

is a beginning of a series of hearings on biotechnology so as to

bring the members of the subcommittee and Congress up to date

as to where we stand, the procedures, and the processes we go

through. And then we will broaden our base and look at it from all

perspectives, but building this well of knowledge. So that we have

an understanding of some of the very complex procedures these

gentlemen or agencies go through would seem to be the foundationbuilding part of the program. But we will have lots of fun before

this is over, I assure you.

I will now turn to the gentleman, Mr. King.

Mr. KING. Thank you, Mr. Chairman.

And I have a broad question, and I would direct it to Mr. Johnson, who I happened to notice referenced the future in the horizon,

so you are my designee for clairvoyance this morning. And just several parts to the same question, and I would really ask all of your

attention to this is that looking at what is going on in the world

and the resistance that is there in the European Union and the resistance there among some of the environmental groups. If you just

fast forward in your mind a generation or so, and just say if politics

and logic lost this public relations contest here between GMO products and the more organic version that they are promoting in other

parts of the world. Can you envision a world 25 years from now

that doesn’t include GMO products? And if you can, then what

would the impact be on nutrition, health, and population?

Mr. JOHNSON. Well, let me turn to my crystal ball and see, at

least hazard a response. Certainly, as having been involved with

15

this technology for most of its life, and certainly as I look forward

I really don’t see a world that is void of this technology. I think

that this technology has established its roots in a number of areas

from whether it be drugs or cosmetics or in our case, pesticides or

other kinds of uses. So as I look to the future, I see that the technology will be there. And I think one of the driving reasons for that

is really the benefit.

And let me just talk about it from a human health environmental standpoint for a moment. In the case of Bt cotton or in the

case of the newly registered Bt corn rootworm insecticide, what we

see in the case of the Bt corn rootworm insecticide is a reduction

of about seven and a half or eight million acres of insecticidal treatment or use of chemicals, and in fact, some fairly harsh. They

work. If used properly, they don’t present a risk to human health

or the environment, but nonetheless, what we see is a significant

reduction in that use. In the case of Bt cotton, again, we see a significant reduction in classical chemical use. And what does that

mean? Well, certainly for workers who are handling the material,

it is safer. Certainly from an environmental standpoint, there is

less environmental loading. And certainly from a food safety standpoint, you are replacing a protein that is readily digested, just like

other proteins, from a chemical. And so I think with the kind of

benefits that we are seeing now and the kind of benefits that this

technology holds for the future, I see the world embracing this

technology, I would certainly hope sooner rather than later.

Mr. KING. And should the world not embrace this technology,

would you concede that the impact on the nutrition health and population, it would limit the population of the earth and we wouldn’t

be able to sustain the requirement to feed the population that is

growing?

Mr. JOHNSON. Well, I think that certainly it could have that kind

of an impact, although very difficult, you know, to predict at the

moment.

Mr. KING. Then it is difficult to predict, but this is, I think, a hypothetical question and I offer anyone to answer. And that is that

if we can sit here in this panel and foresee and realize the very

beneficial nature of GMO products and the essential nature of it

that in order to provide the quantity and the quality of the food

that we will need in the future, the people who are in opposition,

does anyone want to speculate on what they envision the future to

look like if they get their way?

Dr. CRAWFORD. I don’t know what motivates them, but what I

see is a world where there would be more hunger. Some time between 2020 and 2050, as you know, we are going to have 2 billion

more people. There is hunger today. There will certainly be more

without bioengineering food crops, also as a possibility of having

geographical problems like redrawing the maps, because as deserts

increase, we need crops that can grow in desert type conditions, as

humidity increases, whatever happens with the changing weather

patterns, which we know will be coming. If we had the flexibility

that we have with biotechnology, we can perhaps meet that. And

it is still possible in this world to have something like the potato

famine of the mid-19th century. If biotechnology is allowed to continue, and it must be in my view, then we will have the capability

16

to deal with something like that, if not overnight, within a few

days rather than the 20 or 30 years it might take to rebreed Irish

potatoes or perhaps yams in Africa, rice in other areas of the world.

Much of the world now depends on a staple crop for 50 percent or

two-thirds of its nutrition.

The other thing, as we learn more about nutrition, finally, I

think we would have more nutritional diseases without this. Once

you understand nutrition, you have got to get, as you know, a nutrient-dense diet in order to take advantage of that. It is also possible we can modify. If things turn out to be the case like lycopene,

which is in tomatoes preventing prostate cancer, for example, it can

be included in some sentinel foods and improve that situation with

bioengineering. I can not help but conclude that nutritional diseases of all sorts will be diminished.

Mr. KING. Thank you very much. Thank you, Mr. Chairman.

Mr. LUCAS. The gentleman’s time has expired.

The Chair turns to the gentleman from North Carolina.

Mr. BALLANCE. Thank you, Mr. Chairman.

I am sort of like Mr. Marshall in this area, but I know there is

some skepticism in the community and in America and around the

world. And Dr. Crawford, I believe, gave testimony that you are not

aware of any bioengineered plant food that is subject to FDA jurisdiction that is on the market that has not been evaluated by FDA

through the current consultation process. In other words, although

the current pre-market clearance process for biotech products is

voluntary, the companies have always submitted to it. Is that the

case?

Dr. CRAWFORD. Yes, we believe that to be the case. And we are

not aware of any company that has not done that. I mean, I don’t

think it would be in anyone’s best interest for that to happen. I

don’t think it is going to happen. If it does and the product posed

some threat to the American people, then we can use the full force

of our authority to protect the food supply to take advantage of

that situation and interdict it from the market. And we wouldn’t

hesitate to do that. We would go to the American people and tell

them, you know, the product isn’t approved. It holds some threats

to their health, and don’t eat it.

Mr. BALLANCE. And of course the natural question that comes to

mind is if that is the case, why has not FDA pressed ahead with

this proposed rule to require that the pre-market clearance become

mandatory?

Dr. CRAWFORD. We have a proposed rule, as you may know, that

is on the books. We received comments on that rule. It was proposed a little over 2 years ago. We received 115,000 comments on

it to date, and we are evaluating those. However, since the current

system is working so well and since there is no public health reason to impose the mandatory requirement, it is not a high priority

for FDA to finalize this rule at this point.

Mr. BALLANCE. Well, I started out with the idea that there is

skepticism and would not a mandatory system silence those skeptics?

Dr. CRAWFORD. Well, I don’t believe it would change. I mean, you

know, I am not an expert in that particular area. But I don’t believe it would change any minds, because if this system is working

17

and if we have been consuming these kinds of products for 10 years

without any adverse events, including no recalls, whereas in the

traditional food supply we have had adverse events, and we have

had multiple recalls. If there is skepticism, I don’t think this would

be the answer to it.

Mr. BALLANCE. All right. Thank you, Mr. Chairman.

Mr. LUCAS. Thank you.

And the Chair turns to the distinguished chairman of the full

committee who has been able to participate with us today. Any

questions you might have, Mr. Chairman?

The CHAIRMAN. Thank you, Mr. Chairman. I first want to thank

you for holding this hearing and continuing to press this committee’s interests in biotechnology. This is a very, very important aspect of the future of American agriculture and I would argue the

future of world agriculture and the ability to feed the world. I

would follow-up on the comments, I think, of Mr. Johnson regarding the wide acceptance of biotechnology and safety, its advisability

in the scientific community and the medical community not just in

the United States, but around the world.

Earlier this year, I had the opportunity to meet with scientists

at a biotechnology research facility in Belgium. And while they

would not want to be on the record sharing with their political representatives the views that they hold, they did share them with

me, and that is one of great frustration that ignorance and emotions and, in some instances, hysteria have rule in Europe and in

some other parts of the world in this area. And it is clear that that

frustration is holding back their ability to solve a great many problems that they had some very unique and novel ways of doing it.

And instead, their talents have been channeled into the area of determining how to detect genetically modified organisms in products

that might be shipped to them by the United States and elsewhere

in the world as they get ready to enact a solution to the challenge

that we have made to their moratorium, the solution being a labeling and traceability requirement that may be more onerous than

the current ban, because it will make it more difficult to export

non-GMO products. And we have consistently maintained our desire not to force anybody to eat anything that they don’t want to

eat but to simply have the opportunity to put these products on the

shelves in Europe and elsewhere around the world and let them

sell themselves for their environmental benefits, their nutritional

benefits, in some instances, the longevity of the product, the taste

quality of the product, and others as well as the cost will very well,

I think, dictate the future course if we do get a fair shot there. I

think the best thing we can do to continue to press ahead with that

is to continue to do the work that all of you do to make sure that

the American public, which has widely accepted and used these

products very safely, I would note, for many, many years, that that

confidence remains high and that we bring new products to the

market as they are ready to be brought to the market, but continue

to have an open process that people can review and see the data

that is available, the studies that have been done. And with the assistance of responsible news media organizations, get the word out

that these products are not only safe, but they are extremely beneficial in a wide variety of ways.

18

I would like to follow-up on the question asked by the gentleman

from North Carolina to Dr. Crawford in a question to Mr. Hegwood.

As a result of the response that we got there, I wonder, we understand that the FDA has recently published a notice in the Federal

Register indicating that a decision on issuing a final rule on premarket notification would not be made for at least the next 12

months. As part of USDA’s regulatory review, is it feasible for the

Animal, Plant, and Health Inspection Service to formalize a consultation process with the Food and Drug Administration to ensure

that the FDA is notified of the availability of an agricultural biotechnology product prior to its entry into commercial markets?

Mr. HEGWOOD. Well, we have a system now for ensuring that we

have early discussions with both EPA and FDA at the field trial

stage. Whether we would take that a step further, as I believe you

are suggesting, is something we could certainly look at in the context of the ongoing review we are having of our regulatory system

within the interagency process. It may be a way that we could address that issue.

The CHAIRMAN. Well, thank you. Would you review that suggestion, which is not mine alone, but others have put that forward as

well, and let the committee know whether you think that that is

something that you could pursue with FDA to help advance this

process?

Mr. HEGWOOD. Yes, sir. We will do that.

The CHAIRMAN. Thank you very much. I appreciate it.

Mr. Chairman, I ask note that we had a little opportunity to advance information about biotechnology going on just as your hearing was beginning with a delegation from Brazil. And that is why

I was late getting to the hearing, that came to join us and speak

with us specifically about this issue. They have quite an interesting

conflict in Brazil. They are using our biotechnology products, in

some instances without paying the royalties on them, I would note,

while at the same time they have laws banning the use of those

products in Brazil and have, because they have now produced over

a billion acres of, in particular, soybeans, created a temporary moratorium on the imposition of their law so this current year’s crop

can get into play in the world market notwithstanding their own

laws and concerns about the issue. And we shared with them our

concerns about that policy, but also our appreciation for their coming here to learn more about this issue and about biotechnology.

And I think we are taking the right steps to build more consensus

with that major exporting country. And I think since we have been

joined by Argentina and Canada and Australia and a number of

other countries in pursuing this issue with the World Trade Organization, the signs are increasingly positive that the major exporting countries will ultimately join us on this issue and that way I

think make it far more economically attractive to create and market these products. And that hopefully will hold.

So I thank the chairman for allowing me to participate today.

Mr. LUCAS. Thank you, Mr. Chairman.

And now the Chair turns to Mr. Case.

Mr. CASE. With that announcement, I will start.

First of all, I just want to endorse the chairman’s comments,

thanking the subcommittee Chair for this hearing, and the series

19

of hearings promised. I think this is an issue that the more we talk

about it, the better it will be for everybody. I also want to thank

the subcommittee Chair for his response to my colleague from

Macon’s request for the opinion of the other side, because I certainly think that that is valuable for us to listen to people that do

have concerns with the testimony that was given. And I think as

we do that, we are going to get to the bottom of this. I am not sure

we have gotten there. But I certainly, as one Member, want to get

to the bottom of what are the realistic risks, if any. And what can

we do about them and what is really an opposition for reasons

other than legitimate concerns over plant or animal safety, for example, just basic issues of trade? I think as we listen to others, we

will be able to isolate those issues.

Let me just say that I think, if I am understanding the issues

correctly, we have really got two issues and two government responses. The first has to do with human health, the health of humans because they are consuming bioengineered foods or drugs

manufactured by bioengineering.

The second is environmental and plant health. Let me focus on

the latter, because looking at it through the lens of my own District, as most of us start to do, the opposition that I hear in my

District tends to be more focused on is bioengineering going to

upset the balance of the environment, which is a particularly sensitive issue in a place like Hawaii that has the highest percentage

of endangered plant species in the world, as I recall, and where we

have specialty crops that have gone through a very long history of

their own kind of bioengineering to get themselves to a perspective

of being able to produce what we want. Coffee is the perfect example in Hawaii. There are about 100-plus years worth of making coffee, and the coffee farmers are scared that the introduction into

Hawaii of bioengineering research in other crops, not in coffee, but

in other crops is somehow going to crossover and interfere with the

coffee crop. And the same thing could be said about other crops in

other areas.

So I think my question is more to APHIS than anybody else, Mr.

Hegwood. The permits that you ask for, that you require, they are

not optional like FDA, right? They are mandatory, the field testing

and deregulation permits? Well, first, I want to get a sense of why

are those permits not so much approved as rejected? And what are

the risks that are presented by those that you try to stop by those

permits and that you do stop? And what are the practices that

somebody asks you to approve by permitting that you say no to?

First of all, let us just start. How many of those permits are actually disapproved? What percentage, just in round figures? Is it like,

you know, 50 percent or 1 percent or less than 1 percent or what?

Mr. HEGWOOD. OK. About 8 percent are disapproved.

Mr. CASE. And why are they disapproved? Are there categories

of reasons where it is just pretty obvious that the risk exists that

the permit is designed to protect against?

Mr. HEGWOOD. I think, in many cases, they are disapproved because confinement procedures are not adequate.

Mr. CASE. I am sorry, confinement?

Mr. HEGWOOD. Confinement procedures to prevent——

20

Mr. CASE. So isolation of the bioengineering crop from the general environment?

Mr. HEGWOOD. That is right. The primary risk that we are concerned about is out-crossing. It is pollen flow in some form. And

so——

Mr. CASE. Within a crop or cross-crops or do you just not worry

about the cross-crop thing?

Mr. HEGWOOD. We do worry about cross-crop contamination, so

we would look at that as well as out-crossing from one corn field

into another or cross-contamination as well into other crops. And

so if the confinement procedures do not meet our standards, and

those standards are developed on a product by product basis in consultation with the state regulatory officials, then we will not approve the permit.

Mr. CASE. Now is there another significant category of reasons

to deny a permit, or is it pretty much all cross-crop confinement

procedures? For example, are there certain crops that you are just

not going to put next to other crops, period or——

Mr. HEGWOOD. That is a consideration. And as we move into the

next generation of products, such as plant-made pharmaceuticals or

industrials, that becomes even more of a consideration.

Mr. CASE. OK. One final question because I am about to run out

of time. I don’t understand the enforcement mechanisms. Is it a

self-enforcing thing? I noticed you had testimony along the lines of

a particular situation that came about and there was a consent decree and there was a $250,000 fine. And I have no idea whether

that is, you know, reasonably related to the crime, if I can put it

that way, but do you actually go out and enforce these permits or

are they self-enforcing and when there is a violation, then there is

an enforcement procedure? Is there a regulatory aspect to this that

APHIS goes out and says, ‘‘Hey, are you complying with these permits?’’ And do you think that is adequate or resource-wise for the

prevention of the risk?

Mr. HEGWOOD. We inspect every field test permit site at least

once a year. And in the case of pharmaceuticals and industrials,

much more frequently than that. And we also do follow-up visits

in the succeeding years to make sure that, for example in the case

of corn, that there are no volunteer plants growing in a field test

site from the previous year. So we have very rigorous enforcement

requirements, and we consider that an integral part of the regulatory process.

Mr. CASE. Thank you very much.

Mr. LUCAS. The gentleman’s time is expired.

The gentleman from Nebraska, Mr. Osborne.

Mr. OSBORNE. Thank you, Mr. Chairman.

Just a very short question. It may take a while to answer. But

there has been quite a bit of discussion about a new variety of

biotech wheat. I wondered if you could inform us as to what the

different agencies have been doing, how far we are away from some

type of approval and what is going on with this particular issue?

This is a question for, really, all of you.

Mr. HEGWOOD. We have received an application for a biotech

wheat variety, I believe it was this past fall, that we first received

the application. We have been reviewing it. The first review we

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make is for the adequacy of the data that is presented and have

we responded to the company? So we are in the process now of preparing to respond to the company as to whether their data is adequate to proceed with deregulation. And once we have adequate

data to support a decision, only then would we be in a position to

make a determination to deregulate the product. But at this point,

we have not informed the company. We have not made a determination of whether we have the adequate data. And we will be

doing that very shortly, but I think we are not looking at an immediate decision. I don’t think there is any expectation that there

would be a decision on deregulation for the next planting season.

Dr. CRAWFORD. Well, the FDA obviously follows APHIS’s lead,

USDA’s lead. And we have also been informed of the crop. We

would be in an evaluation mood, but it would not be until APHIS

reaches its determination before we finally inform the company

about the marketability.

Mr. JOHNSON. And likewise from an EPA perspective. Although

in EPA’s case, we are additionally concerned about what pesticides

that may or may not be able to be used on the particular crop. And

so we need to look at the pesticide product itself, the chemical

itself, and to make sure that we wouldn’t have any unintended consequences associated with the chemical use on the particular genetically engineered. But we are in the same position as USDA and

FDA.

Mr. OSBORNE. It seems to me that sometimes when we are dealing with biotech, there are really two issues. One is the science,

and then second is public perception. And if you get one out of it

or the other, it seems like you have a problem. Particularly, it is

the science is ahead of the perception issue.

And just a general question again. Do you gentlemen have any

thoughts as to how to prevent some of the issues that we had with

Star Link and other issues where we were not really very well coordinated in how the whole topic was handled?

Mr. JOHNSON. I can certainly start, Mr. Osborne. On the case of

Star Link, certainly starting from the beginning that the way the

pesticide law is constructed, it actually allows for the so-called split

registration, in other words to allow a pesticide, whether it is a

chemical or a product of biotechnology in the StarLink case, to be

used on and get into animal feed but then not to be allowed to be

used into human feed, if you will. In the case of Star Link, the company availed itself of that ability of the law. Certainly our experience with the Star Link situation showed that even though it is legally able to be done, as a policy matter, we are not granting a

split registration for the very reasons that we saw in Star Link.

I think the important thing to note about Star Link, a number

of people view it as a failure of the system. In fact, I view it as

a great success of the system, because the U.S. Department of Agriculture and the Food and Drug Administration and the EPA quickly stepped in to take control and actually manage the whole Star

Link situation to get it out of the food supply. And so when we became aware of a problem in the case of Star Link, we took swift

action, which was costly, fortunately, with the company’s cooperation to deal with. And certainly as we consider future products, as

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I said, we are not granting split registrations in the case of Star

Link.

Dr. CRAWFORD. Yes, I agree. I think it was a success, from FDA’s

point of view, and the fact that there won’t be split registrations

will help us in the future. The key to it is always good communication between the three agencies that are represented here. And I

believe we have that. And so I think we can learn some things from

Star Link and some of these other episodes, but for the most part,

what we learned is that the system works.

Mr. OSBORNE. Thank you, Mr. Chairman.

Mr. LUCAS. Thank you, Mr. Osborne.

One last question from the Chair. Could you expand for a moment on how the agencies are working together to expand APHIS’s

rule on plant-made pharmaceuticals to make it applicable also to

the plant-made industrial products?

Mr. HEGWOOD. We have recently issued new guidance to the industry for field testing requirements for plant-made pharmaceuticals. We are in the process of developing an interim rule for

notifications. Many of the industrial products are currently done

under notification procedures rather than permitting procedures.

And so the interim rule that we are working on would shift the

field testing requirements for industrials to the permitting system

so that we would have greater control over the field tests.

Dr. CRAWFORD. Yes, we also are evaluating with APHIS the procedures that would be used. We think that our system, you know,

is active and also is sufficient to deal with this particular new industry. We would want to regulate it from a public health point of

view so that it poses no risk or minimal risk to the population. But

also, we would want to see in place regulations and procedures that

would not unfairly disadvantage this industry, because we believe

that this is a good modality in the future for producing pharmaceuticals and other products.

Mr. JOHNSON. Mr. Chairman, the same applies for EPA. In our

case, instead of the pharmaceuticals, we are now seeing the development of industrial products, industrial chemicals, enzymes, and

other kinds of materials. And so likewise, we are working with the

Department of Agriculture and Food and Drug Administration to

make sure that we have got a coordinated framework that ensures

public health and environmental protection and at the same time

doesn’t inhibit a good technology and innovation.

Mr. LUCAS. The Chair has no further questions. Are there any

other questions from any other member of the panel? Seeing none,

the Chair wishes to thank the gentlemen for your insightful comments and to note that without objection, the record of today’s

hearing will remain open for 10 days to receive additional material

and supplemental written responses from witnesses to any question posed by a member of the panel.

This hearing of the Subcommittee on Conservation, Credit, Rural

Development, and Research is adjourned. And the Chair wishes to

note that in approximately 5 minutes, the subcommittee will reconvene for a markup on House Resolution 1907.

[Whereupon, at 12:15 p.m., the subcommittee adjourned.]

[Material submitted for inclusion in the record follows:]

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STATEMENT OF DAVID HEGWOOD

Thank you for the opportunity to be here today. I am pleased to provide the subcommittee with an overview of the Department of Agriculture’s role in the regulation of products derived through biotechnology.

The advances made in recent years in this field have shown us quite clearly that

biotechnology has the potential to improve existing products and create new ones

capable of benefiting the environment, agriculture, human health, and the U.S.

economy. In some cases, however, the advances made by researchers and biotechnology companies have also brought forth challenging new questions for regulators and a range of important concerns expressed by citizens, industry groups, and

other stakeholders.

For these reasons, the Federal Government is playing an active role in ensuring

that these new products are safely developed and field-tested. This is critical for reassuring industry, consumers, and other groups—both here in the United States

and, increasingly, abroad—that biotechnology derived crops, animal vaccines, and

other products will not harm agriculture, the environment, or human health. Consistent with the Coordinated Framework (51 FR 233302, June 26, 1986), USDA is

working with the Environmental Protection Agency (EPA) and the Food and Drug

Administration (FDA) to make sure that the United States continues to lead the

world in the safe development and commercialization of genetically enhanced agricultural products.

REGULATORY OVERVIEW

For its part in this coordinated effort, USDA’s Animal and Plant Health Inspection Service (APHIS), under the Plant Protection Act, regulates the interstate movement, importation, and field-testing and release of bioengineered plants, insects and

microorganisms through permitting and notification procedures. APHIS’ efforts help

to ensure that transgenic plants and organisms do not have unwanted effects on

U.S. agricultural health or the environment.

In other areas, APHIS regulates biotechnology derived veterinary biologics under

the Virus-Serum-Toxin Act. The Agency is also evaluating its role in the regulation

of genetically engineered animals, pathogens, and pests under the authority of the

Animal Health Protection Act (AHPA), which was passed as part of the 2002 farm

bill. The AHPA enables APHIS to address any pest or disease risk posed to livestock, and we continue to coordinate with other agencies, including FDA and EPA,

that share regulatory responsibility in this new arena.

In general, APHIS’ field testing requirements for - regulated plants are designed

to prevent the unintentional environmental introduction, whether by pollen movement, seed or grain commingling, or other means, of any protein or trait produced

in these plants that would present a risk or potential risk to agricultural crops or

the environment. APHIS has a permit system for the field-testing of genetically engineered crops on a case-by-case basis. Companies that wish to field test such crops

must submit applications, with information about the plant variety being tested, the

purpose of the test, how it will be conducted, and the specific confinement conditions

taken to prevent the escape of pollen, plants, or plant parts from the field test site

and prevent persistence in the environment. Applicants must meet or exceed the

basic requirements for planting, pollination control, and the harvesting and shipping

processes set by APHIS. These basic requirements are specific to each plant variety,

and we continually evaluate them to ensure that the latest scientific evidence is

taken into account. After reviewing the information contained in the permit application, we may require that applicants modify their proposals to include additional

conditions.

APHIS also has a streamlined permitting process, called notification, in place.

Most of the field tests carried out in the United States are done under notification.

The notification process expedites approvals for field-testing for certain types of low

risk plants that APHIS has considerable experience in regulating. Under the notification procedure, the regulated article to be field-tested must be a plant, and the

genetic modifications to that plant must meet established eligibility criteria. When

APHIS receives a notification, it is typically reviewed within 10 to 30 days, forwarded to State officials for further review, and then returned to the applicant as

either acknowledged or denied.

I want to emphasize again that APHIS is committed to ensuring that State interests are fully considered and accommodated in the Agency’s biotechnology field test

permit application and approval processes. Before any field test can be undertaken

in a given State, APHIS officials provide permit information pertaining to the proposed field test to their counterparts in that State for review and concurrence. If

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a particular State has concerns about the confinement measures described in the

documentation, APHIS works with that State to address the outstanding concerns

and add any additional conditions the State deems necessary to ensure that the

field test can be conducted safely.

We believe that these customized field testing requirements, when fully met by

permit holders, are capable of confining these plants to test sites. To encourage and

enforce compliance with these requirements, all field test sites are subject to APHIS

inspection. Field test sites under permit are inspected at least once during the growing season to confirm that the permit holder is meeting all the conditions specified

in the field test permit. Should an APHIS inspector find that a permit holder is not

complying in full with the permit requirements, APHIS would require the holder to

come back into compliance with the permit requirements and, depending on the severity of the problems, the Agency could also initiate an investigation and possible

enforcement procedures.

After successfully completing the field-testing stage of a new plant variety’s development, a permit holder can petition APHIS to deregulate the biotechnology crop.

In support of this petition, the permit holder must submit further information on

the results of the field-testing, in addition to information attesting that the plant

poses no risk to agricultural crops or the environment. In considering the petition,

APHIS carefully reviews the data submitted by the permit holder, and also weighs

other pertinent scientific studies and information. When APHIS deregulates a biotechnology-derived plant, it does so because the plant poses no pest risk to other

crops or plants. The deregulation process requires that APHIS publish a Federal

Register notice thereby making the decisions documents available to the public.

Once APHIS deregulates a particular biotechnology product, the company must still

comply with applicable FDA or EPA requirements prior to marketing. In addition,

APHIS can bring a product back under regulation at any time if the Agency becomes aware of evidence indicating that the product may pose some sort of plant

pest risk.

The administration, through the NEC’s Agricultural Biotechnology Working

Group, is addressing regulatory challenges posed by rapidly developing science and

how this science is being applied to potentially new products. For example, in August 2002, the White House’s Office of Science and Technology Policy (OSTP) published a notice in the Federal Register relating to the inadvertent and low-level

presence of varieties being developed for food and feed purposes that have not completed applicable agency review. In this Federal Register notice, APHIS proposed to

update requirements for field-testing of genetically engineered plants. The USDA,

EPA, and FDA have received comments regarding the Federal Register notice and

are in the process of developing appropriate responses. The Working Group is now

looking at regulatory challenges posed by plants genetically engineered to produce

pharmaceuticals and industrial chemicals.

To further coordinate regulatory efforts, as well as increase the transparency of

the decision-making process, APHIS is working with EPA, FDA, and several other

involved Federal agencies on the creation of a unified government website regarding

new biotechnology products. Once operational, this website will allow stakeholders

and other interested parties to view basic information on the products and, when

appropriate, what determinations have been made by Federal regulators. The

website is currently in the final stages of development and should be launched later

this year.

USDA RESEARCH INITIATIVES

USDA has two major research initiatives with regard to biotechnology risk assessment and risk mitigation. The longer running program is the Biotechnology Risk Assessment Competitive Grants Program (BRACGP), established in 1992 to comply

with language in the 1990 farm bill. The BRACGP has played a central role in identifying potential risks involved in the development and release of certain bioengineered products. Funding for these grants typically extends for 2 to 3 years.

The second research initiative is housed within USDA’s Agricultural Research

Service (ARS), and is designed to complement the BRACGP. In general, ARS provides funding for research on biotechnology risk assessment and risk mitigation, enabling the collection of data over longer periods of time. Officials with APHIS, EPA,

and the FDA benefit from receiving such comprehensive, unbiased data from ARS,

and can use this information to make adjustments to existing regulations or other

field test requirements. The ARS peer review process ensures that the research

projects undergo intensive scrutiny.

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PHARMACEUTICAL PLANTS

APHIS subjects pharmaceutical crops to more restrictive confinement conditions

than most genetically engineered crops. Due to the relative newness of this field of

biotechnology, APHIS takes a proactive approach to regulating field tests of socalled pharma crops. Again, working closely with FDA and EPA, APHIS officials

monitor new scientific developments and review its regulations to ensure that the

Agency’s requirements are appropriately targeted to address any relevant agricultural, food safety, and environmental risks associated with pharma crops.

APHIS and FDA share responsibility for regulating pharmaceuticals produced in

plants, from the field-testing stage through the final approval of a pharmaceutical

product. APHIS believes its customized field testing requirements for pharma crops,

when fully met by permit holders, coupled with the Agency’s increased inspections

and oversight, provide a solid basis for the safe field testing of pharmaceutical

plants in the United States.

On March 10, 2003, APHIS published a notice in the Federal Register indicating

new measures prescribed by the Agency that apply to the field-testing of pharmaceutical plants, starting with the current 2003 growing season. Included are requirements for mandatory recordkeeping; increased buffer zone distances around field

trials; dedicated equipment and mandatory training for field personnel; and, as

mentioned earlier, increased frequency of field inspections conducted by Agency officials. The comment period on the notice just closed on May 9, and we have begun

to review all the comments we received.

In addition to administering regulations regarding bioengineered plants, APHIS

has also worked with the FDA to develop a draft guidance document for companies

that use such plants in the production of biopharmaceuticals. Among other things,

the document provides companies with guidance in addressing environmental issues

such as containment during field-testing, and other human health and safety issues.

The document includes an outline of plans to conduct formal environmental analyses of pharmaceutical crops when commercial production is near. The public comment period for this document closed on March 7, 2003. APHIS and FDA are currently reviewing the comments received.

PRODIGENE, INC.

The situation involving violations at ProdiGene, Inc.’s field test sites highlighted

the effectiveness of APHIS’ routine compliance inspection procedures, demonstrating

that the Federal oversight system can detect potential problems and respond swiftly

and appropriately to safeguard U.S. agriculture and the domestic food supply.

Last fall, at sites in Nebraska and Iowa, APHIS found volunteer corn plants that

were descendants of the previous year’s cornfield tests. The presence of these volunteer plants was a violation of ProdiGene’s permit conditions. APHIS, in cooperation

with FDA and the State of Nebraska, took appropriate action to keep the product

in the warehouse and out of the food supply. In addition, APHIS signed a consent

decision with ProdiGene. The consent decision included a considerable monetary

penalty, in addition to new requirements that ProdiGene will need to follow during

field tests of its bioengineered crops. APHIS will also be monitoring ProdiGene’s future field tests very closely and will take further action if necessary.

BIOTECHNOLOGY REGULATORY SERVICES (BRS)

In June 2002, APHIS established a new biotechnology unit to consolidate and better coordinate its services and activities in this area. The new unit, Biotechnology

Regulatory Services (BRS), is responsible for programs focusing on both plant-based

and animal-based biotechnology.

By consolidating policy and operations into one unit, APHIS is able to bring greater focus to its domestic and international policy coordination and development and

its risk assessment, permitting, and compliance activities. The creation of BRS also

allows APHIS to communicate more consistently to State regulators and our other

stakeholders and ensures that USDA continues to develop appropriate regulatory

policies to address emerging biotechnological issues and challenges.

We plan to strengthen BRS’ inspection and compliance unit. As mentioned above,

since the ProdiGene, Inc. incidents, APHIS has increased its oversight of field tests

involving plants engineered to produce pharmaceutical and industrial products. We

conducted 305 inspections in 2002 and we estimate that the Agency will about double that number of inspections during this growing season. APHIS will also significantly increase the number, quality and rigor of audits it conducts of permit holder

records.

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As one of its first initiatives, BRS has established an Office of Science to ensure

the continued enhancement and credibility of APHIS’ biotechnology regulatory program. Working with the regulatory and policy staffs, this office will help to funnel

the latest scientific information into policy, regulation, and risk-assessment efforts.

We expect that personnel with the Office of Science will also form strong working

relationships with their colleagues in academe and the private sector, providing current information for APHIS decision makers and ensuring Agency personnel are

using the most up-to-date information, protocols and assessment procedures.

Finally, BRS officials are responding to recommendations made in reports issued

in 2000 and 2002 by National Academy of Science (NAS) review panels. As requested in the 2002 farm bill, APHIS, along with FDA and EPA, is preparing a report summarizing our current biotechnology regulatory programs and the potential

directions these programs may take in the future. Consistent with several recommendations made by the NAS review panels, APHIS officials are continuing with

steps to improve the Agency’s risk assessment process, in addition to all of the safeguards built into the biotechnology regulatory program.

Thank you again for the opportunity to be here today.

STATEMENT OF STEPHEN L. JOHNSON

Good morning, Mr. Chairman and members of the subcommittee. I am pleased to

appear before you today to discuss the Environmental Protection Agency’s (EPA)

role in the assessment and regulation of products produced through biotechnology.

I welcome the opportunity to participate on this panel and explain what the Agency

is doing to regulate biotechnology products. We are working closely with our partner

agencies, the U.S. Department of Agriculture (USDA) and the Food and Drug Administration (FDA) to ensure that crop plants created using biotechnology, and food

from such plants, are safe to both people and the environment.

Biotechnology holds great promise. For example, it can reduce our reliance on

some older, potentially more risky pesticides, while also reducing potential risks to

farm workers and the environment. Given these and other potential benefits, the

Agency is committed to ensuring that our regulatory decisions are based on rigorous

scientific information, the highest scientific standards, with a high degree of transparency to ensure our decisions are available to the public for understanding and

oversight. By following these principles, our program ensures the protection of public health and the environment, while promoting consumer confidence in our regulatory decisions. Biotechnology is a rapidly evolving field, and requires that the Federal Government’s regulatory program similarly advance to ensure the continued

protection human health and the environment. The Agency believes that regulated

biotechnology products are safe, provided they are used according to the approved

labeling. Given our intellectual and scientific investment in regulating biotechnology, the Agency stands ready to meet the future challenges.

COORDINATED FEDERAL FRAMEWORK

In the early 1980’s, companies began to apply the techniques of bioengineering to

agriculture for eventual commercial use. Also at this time, the Federal Government

began to evaluate its options for regulating products created using biotechnology. In

1986, the Federal Government released a document entitled: ‘‘Coordinated Framework for Regulation of Biotechnology’’ which laid out the broad approach to regulating biotechnology products. In summary, the products of biotechnology would be regulated under existing statutes and in a manner similar to the regulatory approach

used for products not produced through this technology.

The Framework established an approach to regulating the products of this new

technology based on the characteristics of the products and the specific use of the

product, not the process used to create it. Rather than seek new legislative authority, the Federal Government concluded that it could appropriately regulate these

products using existing laws, but also recognized that, in some cases, new regulations would be needed. Thus, products that are intended to be used as pesticides

are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)

and the Federal Food, Drug and Cosmetic Act (FFDCA). Also, under the Toxic Substances Control Act (TSCA), EPA reviews bioengineered microbes and the substances they produce when the genes come from a different type of microbe. The

Framework has been reaffirmed by several administrations, including the current

one, and current efforts are aimed to make the coordination between EPA, FDA, and

USDA even stronger, while ensuring a comprehensive and seamless regulatory system.

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STATUTORY FRAMEWORK

Under the Framework, EPA regulates products under FIFRA and section 408 of

the FFDCA; this includes bioengineered (and naturally occurring) microorganisms

with pesticidal action as well as products produced by plants that act within the

living plant as pesticides to protect the plant. Any remaining residues of these pesticides are regulated under FIFRA and the FFDCA. The products produced by

plants which are intended to act as pesticides, along with the genetic material necessary to produce these substances, are called plant- incorporated protectants or

PIPs.

EPA proposed two different sets of rules for these two different types of products.

In 1992, the Agency proposed rules tailoring the experimental use regulations for

microbial pesticides. EPA finalized rules dealing with field testing of microbial pesticides in 1994. Similarly, EPA proposed an approach to PIPs in 1994, and major

portion of these regulations were finalized in 2001. These rules formalized regulatory procedures for plants bioengineered to exhibit pesticidal traits. PIPs created

through conventional breeding were exempted from regulation. A National Academy

of Sciences study in 2000 urged, after examining the existing knowledge, EPA to

reconsider some of the PIP exemptions originally proposed in 1994. In 2001, EPA

asked for additional public comment on these specific exemptions and the NAS analysis. EPA is currently considering comments received, the NAS analysis, and the

record on the scientific merit and potential risks associated with granting these exemptions.

THE BIOTECHNOLOGY PROCESS

To fully understand our regulatory approach to PIPs, some basic information on

biotechnology may be helpful. EPA’s jurisdiction under FIFRA is limited to pesticides. For example, the sale of a plant that has been bioengineered to resist insect

damage would be subject to FIFRA, whereas a plant engineered to resist drought

would not. Such products come under our authority because the substance produced

by the plant is intended to function as a pesticide by affecting a pest. In this latter

instance, a substance produced by the drought resistant plant may result in, for example, deeper roots to enable the plant to access more water reserves. This bioengineered plant would be subject to USDA authorities, and any food or feed obtained

or produced from such a plant would be subject to FDA authorities.

Up until the last quarter of the twentieth century, growers have relied on plant

breeders to provide them with hardier and more disease-resistant crop varieties.

This is done primarily through plant breeding and transferring pollen from one variety of crop to the flower of another variety, or mating a crop plant with a wild or

related plant to produce offspring with the desired trait. It is the way that we got

bigger roses and more robust tomatoes.

In the early 1980’s, scientists began to move single genes selectively through biotechnology techniques. The transfer of desired traits could now be accomplished

more broadly and more rapidly. Science is at the point now where genes can be

moved between unrelated species. In the case of PIPs, scientists alter plants to

produce pesticidal substances from any source, for example, from another plant, a

bacterium or virus, etc. The most well known example is the bacterium Bacillus

thuringiensis, or simply Bt. This bacterium, when sprayed on plants, is toxic to certain types of pest insects that feed on the plant. Through the process of biotechnology, scientists can remove the genes that produce the toxic protein from the

bacterium and place them in, for example, a corn plant. The corn plant can now

synthesize its own Bt protein and ward off pests on its own. No external spraying

for the target pest is necessary.

EPA’S REGISTRATION REQUIREMENTS AND PROCESS FOR PIPS

EPA has been working with companies and individuals since the early–80’s in developing a regulatory approach for pesticide related biotechnology products. In developing our approach, EPA has held numerous public meetings with extramural

panels of scientific experts; e.g., the Agency’s Biotechnology Science Advisory Committee, the FIFRA Scientific Advisory Panel, the Office of Pesticide Programs’ Pesticide Program Dialogue Committee, and with interested stakeholders at a number

of public hearings and workshops throughout the country. Through this process, the

Agency has developed robust regulatory and scientific standards for biotechnology

products going through the registration process.

Specifically, a potential registrant typically comes in for a meeting with our scientific staff, at which time we decide upon the appropriate data requirements to

support the Experimental Use Permit (EUP), the tolerance or tolerance exemption,

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for the full commercial approval and registration. The studies done under the EUP

are used to obtain the data necessary to support the application for the full registration. Once the Agency receives a complete package for a new PIP active ingredient,

it typically takes about 18 months for the Agency to review the data and reach a

registration decision.

For the PIPs products EPA has registered to date, we review data in five categories: product characterization, toxicology, non-target organism effects, and exposure and environmental fate, and resistance management. Product characterization

includes reviewing the source of the gene and how the gene is expressed in a living

organism, the nature of the pesticidal substance produced, modifications to the introduced trait as compared to that trait in nature, and the biology of the recipient

plant. For toxicology, an acute oral toxicity test of the pesticidal substances on laboratory animals is required. At times, it has not been possible to make enough of

the substance for testing purposes in the plant itself so EPA has allowed the exact

same protein to be produced by bacteria and used for the testing.

It should be noted that to date, all of the PIPs reviewed by EPA are protein based.

For protein based PIPs, EPA requires a digestibility test where the amount of time

it takes for the protein to break down in gastric and intestinal fluids is determined.

This information is relevant to a determination of the potential of the protein to be

toxic or an allergen. EPA and FDA are working together on this issue. Currently,

for an allergenicity assessment, EPA requires digestibility test, tests for heat stability, and a comparison of the structure of the protein to the structures of known food

allergens.

For ecological effects, EPA examines the exposure and toxicity of the PIPs to nontarget organisms, such as wildlife and beneficial insects. These tests are unique to

the crop and pests involved. For example, during the review of the Bt- potato, a test

of potential effects of the introduced protein to lady beetles was conducted and

showed that there were no adverse effects to these predators of the pesky Colorado

potato beetles. For Bt-corn, tests were conducted on the potential effects on fish because field corn may be manufactured into commercial fish food. No effects were observed in the tests. Currently, monitoring of potentially affected organisms in fields

planted with PIPs is also required. EPA also can evaluate the degradation rates of

the proteins in soil and plant residues. If any concerns or questions arise from the

testing, a second or higher tier of testing is required to allow EPA to more thoroughly evaluate the potential risks. EPA routinely consults with our Scientific Advisory Panel, the USDA, the FDA and others as we carefully evaluate the scientific

and regulatory issues.

Currently, EPA has registered 11 separate PIP products. Ten of these products

are for a Bt protein. The crops have included: potatoes, cotton, field corn, sweet

corn, and popcorn. There have also been Experimental Use Permits issued for Bt

tomatoes and Bt soybeans. The Agency has also established tolerance exemptions

for pesticidal proteins from viruses that have been moved to plants like watermelon,

cucumber, potato, and papaya. In 1998, EPA registered a PIP based on the potato

leaf roll virus (PLRV) and a Bt protein. The Bt protein and the PLRV protein were

combined to provide virus and insect protection.

In 2001, EPA completed a reassessment of all of the existing Bt registrations, to

make sure that all uses were up to current regulatory and scientific standards. All

stakeholders were encouraged to participate and the Scientific Advisory Panel was

convened to peer review EPA’s scientific findings. As a result, those Bt products that

were reregistered were supported by the latest scientific data requirements and are

being used under updated and more stringent regulatory conditions.

Recently EPA has approved two new products that should help farmers reduce reliance on chemical pesticides. The first product is a new version of Bt cotton with

an additional pesticidal protein that is expected to improve resistance management.

It should control more insect pests than the previously-registered Bt cotton product.

The second is the first Bt corn product to control the most important corn pest—

the corn root worm. We estimate that this product can reduce chemical insecticide

use by 7.5 million acre treatments in the first 3 years of its registration.

OTHER CHALLENGES

EPA believes that these are promising times for advancing better, lower risk solutions to pest control needs. We believe that these products have great potential.

However, the Agency is proceeding cautiously to ensure protection to all citizens and

to our environment. At this juncture, I would like to turn the discussion to some

of the other issues that have been raised and what EPA is doing to address them.

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THE MONARCH BUTTERFLY

Back in 1999, the Monarch butterfly made headlines when researchers at Cornell

University determined that immature Monarchs might be susceptible to pollen from

some Bt corn plants. As a result of this information, EPA required registrants of

Bt corn to undertake exhaustive and comprehensive studies to determine the toxicity and exposure of immature Monarch butterflies to Bt corn products. The results

of these studies, which were published in the Proceedings of the National Academy

of Sciences, have shown that none of the existing registrations have any effects on

Monarch butterfly populations.

STARLINK CORN

When StarLink corn was registered in 1998, the data concerning the digestibility

of the protein was insufficient to make a complete assessment on the potential for

the protein to be a potential food allergen. EPA registered StarLink with restrictions

designed to keep it out of the human food supply (such as allowing sales only to

animal feed and industrial processors, and requiring buffer zones between nonStarLink corn). Despite these restrictions, the protein from StarLink corn was discovered in human food (taco shells). As a result EPA, FDA, and USDA worked closely together to both divert all corn containing the protein to non- human food uses

and to ensure that corn seed for growers would be StarLink-free. Additionally, an

assessment on the potential reports of allergenicity in people was conducted in cooperation with the Centers for Disease Control and Prevention (CDC). No incidents

of allergenicity have been confirmed from the CDC investigations. The registration

for StarLink corn has been cancelled. EPA meets regularly with FDA and USDA

to monitor the success of the containment program for StarLink, and determine if

any changes are necessary in the testing program for corn being used in dry milling.

In order to assure that the StarLink situation does not occur again, EPA has instituted a policy of not approving registrations that are restricted to animal and industrial uses in crops people use for food.

INSECT RESISTANCE MANAGEMENT

The Agency has placed specific requirements on pesticide manufacturers to prolong the life of Bt pesticides, and delay the development of insect resistance. EPA’s

strategy to address insect resistance is threefold: (1) closely monitor and if resistance is detected, take immediate steps to mitigate any future potential for resistance development in the field, (2) implement restrictions to prevent resistance, and

(3) continue research on the best techniques to prevent resistence.

EPA’S OTHER BIOTECHNOLOGY REGULATORY PROGRAMS

EPA also administers regulatory oversight over the commercial introduction of

new microorganisms and the significant new uses of existing microorganisms under

the authority of The Toxic Substances Control Act, also known as TSCA. This law

gives EPA the authority to take action on ‘‘chemical substances’’ which may present

an unreasonable risk of injury to health or the environment. TSCA’s jurisdiction

generally covers all new and existing chemical substances, except for certain products, including: pesticides, tobacco products, certain nuclear material, food, food additives, drugs, and cosmetics.

Under this framework, EPA has established procedures for the regulation of

microorganisms that are products of biotechnology as ‘‘new chemical substances.’’

The rule is designed to ensure that EPA can adequately identify and regulate potential risk associated with microbial products of biotechnology without unnecessarily

hampering this important technology.

Under section 5 of TSCA, if a person wishes to commercialize a new microorganism, or plans to introduce such microorganisms into the environment for commercial research purposes, EPA requires a notification at least 90 days prior to commercialization and the submission of certain information. EPA reviews the information

to determine whether the intended activity may present an unreasonable risk to

health or the environment. Decisions on what action to take for each submission are

based upon reviews by a multi-disciplinary team of scientists. This process determines if a new microorganism, when used under certain conditions, would not pose

any unreasonable risk to public health or the environment.

Types of microorganisms that fall under TSCA are ones that are used in the production of industrial or specialty enzymes, e.g., detergent formulation, processing

aid in the pulp and paper industry. These microorganisms are generally produced

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ronment include ones used in bioremediation, biosensors or agriculture applications,

such as nitrogen-fixing bacteria for increased yield in alfalfa or soybean production.

Because TSCA specifically excludes pesticides and food, this program has few notifications with agriculture applications.

INTERNATIONAL ACTIVITIES

Biotechnology also holds great global promise, and the Federal Government is actively engaged in a wide array of international activities. Specifically, EPA participated as part of the U.S. delegation to the Codex task force to develop guidelines

and principles for assessing foods derived from biotechnology. This international effort by regulators and scientists sets forth a set of principles and guidelines any

country can use to assess these products.

EPA is also working on several international fronts in an effort to share data and

foster collaborative relationships in various regulatory and scientific issues regarding biotechnology. EPA, in conjunction with USDA and FDA, was instrumental is

establishing two workgroups with the Organization for Economic Cooperation and

Development. These groups provide information useful to EPA as it performs risk

assessments on products of modern biotechnology. EPA, along with other Federal

agencies, has been developing a workable implementation of the Cartegena Protocol

on Biosafety with the involved parties. We have also been involved in standard setting activities under the International Plant Protection Convention. In addition,

EPA has been active in many bilateral exchanges of information and expertise. For

example, we receive numerous international visitors a year who come to learn about

our regulatory process. Some of these visitors are building their own regulatory

structures and find our information valuable. Others come just to understand our

risk assessment process so they can be more assured about eating foods derived

from biotechnology and produced in the United States. We have also worked with

U.S. Agency for International Development to provide information on how our regulatory process participates in ensuring the safety of domestically grown grain both

for the public and recipients of USAID’s food aid programs. All of these activities

have been valuable to ensure the U.S. remains a recognized leader in regulating biotechnology products.

Thank you for allowing EPA to share its experience with biotechnology. The Agency’s biotechnology program is based on five important principles: sound science,

transparency in decision making, consistency and fairness, collaboration with regulatory partners, and building public trust. EPA believes that the regulatory system

is based on the most rigorous scientific information available, is credible, is defensible, and will serve to protect the environment and public health, and can evolve

to meet the important challenges that lie ahead. It is important that all parties

work together to ensure the proper oversight and management of biotechnology so

its considerable potential can be fully realized.

Thank you for the invitation to appear before your subcommittee. I will be happy

to answer any questions you may have.

STATEMENT OF LESTER M. CRAWFORD

Mr. Chairman and members of the subcommittee, I am Lester Crawford, Deputy

Commissioner of Food and Drugs. Thank you for the opportunity to testify today on

the regulatory program of the Food and Drug Administration (FDA or the Agency)

for foods derived from plants using the tools of biotechnology, also known as genetically engineered, or bioengineered, foods.

BACKGROUND

Within FDA, the Center for Food Safety and Applied Nutrition (CFSAN) oversees

bioengineered plant products and ingredients intended for human consumption. Our

Center for Veterinary Medicine (CVM) oversees bioengineered plant products used

as animal feed or as an ingredient in animal feed, as well as bioengineered products

used to improve the health or productivity of animals. My testimony this morning

focuses on bioengineered plant products.

We believe it is very important for the public to understand how FDA is regulating the new bioengineered foods being introduced into the marketplace and to have

confidence in that process. Therefore, I appreciate this opportunity to describe our

policies and procedures.

First, let me state that FDA is confident that the bioengineered foods on the U.S.

market today are as safe as their conventional counterparts. This conclusion was

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echoed in both a 2002 General Accounting Office report and a report published in

2000 by the National Resource Council of the National Academy of Sciences (NAS).

The NAS report stated, ‘‘The committee is not aware of any evidence that foods on

the market are unsafe to eat as a result of genetic modification.’’

Let me also clarify that in the Federal Food, Drug, and Cosmetic (FD&C) Act,

food is defined as food for man or other animal. So, when I talk about food, it also

encompasses animal feed unless stated otherwise. FDA has reviewed the data on

more than 50 bioengineered food products, ranging from herbicide resistant soybeans to a modified canola oil. To date, the evidence shows that these foods are as

safe as their conventional counterparts.

In a 1992 policy statement on bioengineered foods, FDA announced that the Agency was ‘‘not aware of any information showing that 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

concern than foods developed by traditional plant breeding.’’ This 1992 statement

and its scientific underpinnings still reflect FDA’s thinking about bioengineered

foods.

CROSSBREEDING, HYBRIDIZATION, AND BIOENGINEERING

Scientists have been improving plants by changing their genetic makeup since the

late 1800’s. Typically, this has been accomplished 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 often can appear in addition to the desirable ones. Some

of those undesirable traits can be eliminated through additional breeding, which is

time-consuming. Breeders can then further select and reproduce the offspring that

have the desired traits. Many of the foods that are already common in our diet are

obtained from plant varieties that were developed using conventional genetic techniques of breeding and selection. Hybrid corn, nectarines (which are genetically altered peaches), and tangelos (which are a genetic hybrid of a tangerine and grapefruit) are all examples of such breeding and selection.

Today, by inserting one or more genes into a plant, scientists are able to produce

a plant with new, advantageous characteristics. The new gene splicing techniques

are being used to achieve many of the same goals and improvements that plant

breeders historically have sought through conventional methods. Today’s techniques

can be used with greater precision and allow for more complete characterization

and, therefore, greater predictability, of the qualities of the new variety. They give

scientists the ability to isolate genes and introduce new traits into foods without simultaneously introducing undesirable traits. This is an important improvement over

traditional breeding. Any genetic modification technique, including both traditional

methods and bioengineering, could change the composition of a food in a manner

relevant to food safety. But because of the increased precision offered by the bioengineered methods, the risk of introducing detrimental traits is actually likely to be

reduced.

FDA has found no evidence to indicate that ordinary plant deoxyribonucleic acid

(DNA) or the DNA inserted into plants using bioengineering presents food safety

problems. The small amounts of the newly expressed proteins are unlikely to change

dramatically the safety profile of the plant as well. If safety concerns should arise,

however, they would most likely fall into one of three broad categories: allergens,

toxins, or anti-nutrients. FDA has extensive experience in evaluating the safety of

such substances in food.

As to potential allergens, foods normally contain many thousands of different proteins. While the majority of proteins do not cause allergic reactions, virtually all

known human allergens are proteins. Since genetic engineering can introduce a new

protein into a food plant, it is possible that this technique could introduce a previously unknown allergen into the food supply or could introduce a known allergen

into a ‘‘new’’ food. FDA’s guidelines help developers to identify this issue and address any concern prior to marketing.

A second possible problem is the introduction of toxins into the food crop. It is

possible that a new protein, as introduced into a crop as a result of the genetic

modification, could cause toxicity. A third possible issue is the introduction of antinutrients, such as molecules like phytic acid that binds essential dietary minerals

such as phosphorus.

Finally, use of genetic engineering techniques could result in unintended alterations in the amounts of substances normally found in a food -- for example, a reduction of Vitamin C or an increase in the concentration of a naturally occurring

toxicant in the plant food.

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It is important to note that the kinds of food safety testing typically conducted

by developers of a bioengineered food crop to ensure that their foods meet all applicable requirements of the FD&C Act address these potential concerns. In the event

that something unexpected does occur, this testing provides a way to detect such

changes at the developmental stage and defer marketing until any concern is resolved.

LEGAL AND REGULATORY BACKGROUND

The overall federal regulatory structure for biotechnology products, known as the

Coordinated Framework, was adopted by federal agencies in 1986 (51 FR 23302,

June 26, 1986). Under the Coordinated Framework, FDA regulates bioengineered

plant food in conjunction with the United States Department of Agriculture (USDA)

and the Environmental Protection Agency (EPA). FDA has authority under the

FD&C Act to ensure the safety of all domestic and imported foods for man or other

animals in the United States market. The exceptions to this are meat, poultry and

certain egg products, which are regulated by USDA. The safety of animal drug residues in meat and poultry, however, is regulated by FDA’s CVM. Pesticides, including those bioengineered into a food crop, are regulated primarily by EPA, which reviews safety and sets tolerances (or establishes exemption from tolerance) for pesticides. FDA enforces the pesticide tolerances set by EPA. USDA’s Animal & Plant

Health Inspection Service (APHIS) oversees the agricultural and environmental

safety of planting and field testing of bioengineered plants.

Bioengineered foods and food ingredients must adhere to the same standards of

safety under the FD&C Act that apply to their conventionally-bred counterparts.

This means that these products must be as safe as the traditional foods in the market. FDA has broad authority to initiate regulatory action if a product fails to meet

the requirements of the FD&C Act.

FDA relies primarily on two sections of the FD&C Act to ensure the safety of

foods and food ingredients that are produced using biotechnology:

(1) The adulteration provisions of section 402(a)(1). Under this postmarket authority, FDA has the power to remove a food from the market (or sanction those marketing the food) if the food poses a risk to public health. It is important to note that

the FD&C Act places a legal duty on developers to ensure that the foods they market to consumers are safe and comply with all legal requirements.

(2) The food additive provisions in section 409. Under this section, a substance

that is intentionally added to food is a food additive, unless the substance is generally recognized as safe (GRAS) or is otherwise exempt (e.g., a pesticide, the safety

of which is overseen by EPA). Unapproved food additives are subject to the adulteration provisions in 402 (a)(2)(c) of the FD&C Act.

The FD&C Act requires premarket approval of any food additive, regardless of the

technique used to add it to food. Thus, substances introduced into food are either

(1) new food additives that require premarket approval by FDA or (2) GRAS, and

are therefore exempt from the requirement for premarket review. Generally, foods

such as fruits, vegetables, and grains are not subject to premarket approval because

they have been safely consumed over many years. Other than the food additive system, there are no premarket approval requirements for foods generally.

In 1992, recognizing that bioengineered products were on the horizon, FDA published a policy explaining how existing legal requirements would apply to products

developed using the tools of biotechnology (57 FR 22984; May 29,1992; ‘‘Statement

of Policy: Foods Derived from New Plant Varieties’’). The 1992 policy was designed

to answer questions about these products and to assist developers prior to marketing to meet their legal duty to provide safe and wholesome foods to consumers. The

basic principle of the 1992 policy is that the traits and characteristics of the foods

should be the focus of safety assessment for all new varieties of food crops, no matter which techniques are used to develop them.

Under FDA policy, a substance that would be a food additive if it were added during traditional food manufacturing is also treated as a food additive if it is introduced into food through bioengineering of a food crop. Our authority under section

409 permits us to require premarket approval of any food additive and, thus, to require premarket approval of any substance intentionally introduced via bioengineering that is not generally recognized as safe.

Examples of substances intentionally introduced into food that would be reviewed

as food additives include those that have unusual chemical functions, have unknown

toxicity, or would be new major dietary components of the food. For example, a

novel sweetener bioengineered into food would likely require premarket approval. In

our experience with bioengineered food to date, however, we have reviewed only one

substance under the food additive provisions, an enzyme produced by an antibiotic

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resistance gene, and we granted approval as a food additive. In general, substances

intentionally added to or modified in food via biotechnology to date have been proteins and fats that are, with respect to safety, similar to other proteins and fats that

are commonly and safely consumed in the diet and, thus, are presumptively GRAS.

Therefore, they have not needed to go through the food additive approval process.

In 1994, following the 1992 policy, FDA conducted a comprehensive scientific review for the first bioengineered product planned for introduction into the market.

FDA reviewed Calgene’s data on the Flavr SavrTM tomato and the use of the

kanamycin resistance marker gene. Calgene submitted food additive petitions for

the enzyme product of the marker gene for use in food and feed. We subsequently

approved the petitions. FDA also held a public meeting of our Food Advisory Committee to examine applicability of the 1992 policy to products such as the Flavr

SavrTM tomato. The Advisory Committee members agreed with FDA that the scientific approach presented in the 1992 policy was sound and that questions regarding the Flavr SavrTM had been addressed. The Advisory Committee members also

suggested that we provide an expedited decision process for the marketing of bioengineered foods that do not raise substantive scientific issues.

In response, FDA established a consultative process to help companies comply

with the FD&C Act’s requirements for bioengineered foods that they intend to market. The results of our consultation are public information and are available on our

website. Since the consultation process was created, companies have used the consultative process more than 50 times as they sought to introduce genetically altered

plants representing more than ten different crops into the U.S. market. We are not

aware of any bioengineered plant food that is subject to FDA’s jurisdiction and is

on the market that has not been evaluated by FDA through the current consultation

process.

Typically, the consultation begins early in the product development stage, before

it is ready for market. Company scientists and other officials meet with FDA scientists to describe the product they are developing. In response, the Agency advises

the company on what tests would be appropriate for the company to assess the safety of the new food. After the studies are completed, the data and information on

the safety and nutritional assessment are provided to FDA for review. The Agency

evaluates the information for all of the known hazards and also for potential unintended effects on plant composition and nutritional properties, since plants may undergo changes other than those intended by the breeders. For example, FDA scientists are looking to assure that the newly expressed compounds are safe for food

consumption, there are no allergens new to the food, no increased levels of natural

toxicants, and no reduction of important nutrients. They are also looking to see

whether the food has been changed in any substantive way such that the food would

need to be specially labeled to reveal the nature of the change to consumers.

Some examples of the information reviewed by FDA include: The name of the food

and the crop from which it is derived;

• The uses of the food, including both human food and animal feed uses;

• The sources, identities, and functions of introduced genetic material and its stability in the plant;

• The purpose or intended technical effect of the modification and its expected effect on the composition or characteristic properties of the food or feed;

• The identity and function of any new products encoded by the introduced genetic

material, including an estimate of its concentration;

• A comparison of the composition or characteristics of the bioengineered food to

that of food derived from the parental variety or other commonly consumed varieties

with special emphasis on important nutrients, anti-nutrients, and toxicants that

occur naturally in the food;

• Information on whether the genetic modification altered the potential for the

bioengineered food to induce an allergic response; and,

• Other information relevant to the safety and nutritional assessment of the bioengineered food.

If a plant developer used a gene from a source whose food is commonly allergenic,

FDA would presume that the modified food may be allergenic. The developer, however, is allowed the opportunity to demonstrate that such food would not cause allergic reactions in persons allergic to food from the source.

If FDA scientists have questions about the safety data, the company may, for example, provide more detailed answers or conduct additional studies. Our experience

has been that no bioengineered product has gone on the market until FDA’s questions about the safety of the product have been answered.

On January 18, 2001, FDA published a proposed rule to require that developers

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er the foods pose potential safety, labeling, or adulteration issues. The comment period for the proposed rule has closed and the Agency is in the process of evaluating

the more than 100,000 comments received. The proposal has raised policy and legal

concerns and is not a pressing public health priority for FDA, given that there is

a voluntary consultation process in place that is working well.

LABELING

Section 403 of the FD&C Act sets labeling requirements for all foods. All foods,

whether derived using bioengineering or not, are subject to these labeling requirements.Under section 403(a)(1) of the FD&C Act, a food is misbranded if its labeling

is false or misleading in any particular way. Section 201(n) of the FD&C Act provides additional guidance on how labeling may be misleading. It states that labeling

is misleading if it fails to reveal all facts that are ‘‘material in light of such representations (made or suggested in the labeling) or material with respect to consequences which may result from the use of the article to which the labeling or advertising relates under the conditions of use prescribed in the labeling or advertising

thereof or under such conditions of use as are customary or usual.’’

While the legislative history of section 201(n) contains little discussion of the word

‘‘material,’’ there is precedent to guide the Agency in its decision regarding whether

information on a food is in fact material within the meaning of 201(n). Historically,

the Agency has generally limited the scope of the materiality concept to information

about the attributes of the food itself. FDA has required special labeling on the basis

of it being ‘‘material’’ information in cases where the absence of such information

may: (1) pose special health or environmental risks (e.g., warning statement on certain protein diet products); (2) mislead the consumer in light of other statements

made on the label (e.g., requirement for quantitative nutrient information when certain nutrient content claims are made about a product); or (3) in cases where a consumer may assume that a food, because of its similarity to another food, has nutritional, organoleptic (i.e., affects taste, color, odor, or feel), or functional characteristics of the food it resembles when in fact it does not (e.g., reduced fat margarine

not suitable for frying).

FDA does not require labeling to indicate whether or not a food or food ingredient

is a bioengineered product, just as it does not require labeling to indicate which conventional breeding technique was used in developing a food plant. Rather, any significant differences in the food itself have to be disclosed in labeling. If genetic modifications materially change the composition of a food product, these changes must

be reflected in the food’s labeling. This would include its nutritional content (for example, more oleic acid, or greater amino acid or lysine content) or requirements for

storage, preparation, or cooking, which might impact the food’s safety characteristics

or nutritional qualities. For example, one soybean variety was modified to alter the

levels of oleic acid in the beans. Because the oil from this soybean is significantly

different when compared to conventional soybean oil, we advised the company to

adopt a new name for that oil, a name that reflects the intended change. If a bioengineered food were to contain an allergen not previously found in that food, information about the presence of the allergen would be material as to the potential consequences of consumption of the food. If FDA determined that labeling would be sufficient to enable the food to be safely marketed, the Agency would require that the

food be labeled to indicate the presence of the allergen.

FDA has received comments suggesting that foods developed through modern biotechnology should bear a label informing consumers that the food was produced

using bioengineering. We have given careful consideration to these comments. However, we do not have data or other information to form a basis for concluding that

the fact that a food (or its ingredients) was produced using bioengineering is material within the meaning of 201(n) and therefore, constitutes information that must

be disclosed as part of a bioengineered product’s labeling. Hence, we believe that

we have neither a scientific nor a legal basis to require such labeling. We have developed, however, draft guidance for those who wish voluntarily to label either the

presence or absence of bioengineered food in food products. Comments to the draft

guidance, which was issued in January 2001, are under review.

OFFICE OF SCIENCE AND TECHNOLOGY POLICY (OSTP) INITIATIVE

In August 2002, the Executive Office of the President, OSTP published a Notice

in the Federal Register (67 FR 50578) which proposed coordinated actions by FDA,

EPA, and USDA aimed at strengthening controls over field trials to address the potential of material from field trials inadvertently getting into food or feed.

FDA’s task is to publish draft guidance for comment on procedures to address the

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teins from biotechnology-derived crops under development for food or feed use but

that have not gone through FDA’s premarket consultation process. Under this guidance, FDA would encourage sponsors (domestic and foreign) to submit protein safety

information once field testing reached a stage of development such that there could

be concerns that new non-pesticidal proteins produced in the field-tested plants

might be found in food or feed. FDA’s focus would be on proteins new to such plants,

because FDA believes that at the low levels expected from such material, any food

or feed safety concerns would be limited to the potential that a new protein could

cause an allergic reaction in some people or could be a toxin. FDA would still anticipate that developers would conduct a complete consultation with FDA prior to marketing food or feed from the plant, consistent with current practices. The draft FDA

guidance on this matter is under development at CFSAN.

PHARMACEUTICAL CROPS

FDA has the authority and responsibility for regulating pharmaceuticals, whether

they are manufactured in a traditional manufacturing plant or they are manufactured in crops in the field. For crops in the field, however, there are additional

issues to be addressed, including issues involving the parts of the plant that do not

contain the pharmaceutical and the residual crop left over after a pharmaceutical

is extracted. The White House National Economic Council and OSTP are coordinating a working group, including FDA, USDA, and EPA, with the cooperation of agencies concerned with international affairs and international trade, to look at this

issue. Specifically, the group is working to clarify authorities for regulating genetically engineered crops, whether they are potential food crops, pharmaceutical crops,

or industrial chemical crops, and to make sure there are no gaps in protecting

human health and the environment. We are evaluating ways to help keep pharmaceutical and industrial chemical material out of food when it isn’t supposed to be

there, that would be science- and risk-based, that would be enforceable, that would

not pose too high a barrier to development of these products, and that would be

complementary with the APHIS regulatory scheme.

In September 2002, FDA and USDA published Draft Guidance for Industry on the

use of bioengineered plants or plant materials to produce biological products, including medical devices, new animal drugs, and veterinary biologics. This draft guidance

outlines the important scientific questions and information that should be addressed

to FDA by those who are using bioengineered plants to produce medical or veterinary products. The comment period closed on February 7, 2003, and the approximately 600 comments received are under review.

PRODIGENE

In October 2002, commercial soybeans were harvested in Nebraska that contained

a small number of immature bioengineered volunteer corn plants. The biotechnology

firm, ProdiGene, had engineered the corn to produce pharmaceutical material. The

harvested soybeans were subsequently commingled with approximately 500,000

bushels of other harvested soybeans. FDA, USDA, and the State of Nebraska made

sure that the entire lot of soybeans was secured in a warehouse. ProdiGene agreed

to buy back the lot of soybeans for disposal under government supervision.

Although the amount of genetically engineered material commingled with such a

large amount of soybeans was very small and FDA was confident that there was

no health risk, the material should not have been present in the soybeans. FDA,

USDA and the State of Nebraska have ensured that these soybeans will not enter

the human or animal food supply.

In the wake of the Nebraska incident, ProdiGene signed a settlement agreement

requiring them to apply more stringent controls to any bioengineered plant it grows

to produce a pharmaceutical product. FDA and USDA will continue to work closely

together to enforce current safeguards covering research in bioengineered food crops.

OTHER ACTIVITIES

FDA has made a commitment to ensuring that consumers have access to information about new bioengineered food products in a timely fashion and has made more

information about these foods available on FDA’s website.

To ensure that FDA has the best scientific advice on issues related to bioengineered foods, we have added experts in this field to our foods and veterinary medicine advisory committees and created a Food Biotechnology Subcommittee of the

Food Advisory Committee.

In addition, NAS has formed a standing committee on Agricultural Biotechnology,

Health and the Environment. FDA, USDA, and EPA are currently sponsoring a

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study by this committee on assessing the potential for unintended effects of genetically engineered foods and how to assess their impact on human health.

FDA has actively participated in the work with the Codex Ad Hoc Intergovernmental Task Force on Foods Derived from Biotechnology. The work of this task force

is especially important because it has developed principles and guidelines for the

evaluation of the safety of bioengineered foods internationally. This year the Codex

Alimentarius Commission is expected to adopt principles for risk analysis and

guidelines for safety assessment that will, when adopted, become international

standards for ensuring the safety of genetically engineered foods. FDA has provided

international leadership in this committee to develop harmonized policies for assessing the safety of bioengineered foods. The Codex guidelines are consistent with the

way FDA approaches the evaluation of the safety of bioengineered foods.

FDA is also actively participating as a member of the Organization for Economic

Co-operation and Development’s Task Force for the Safety of Novel Foods and

Feeds. This task force is in the process of writing scientific/technical consensus documents aimed at compiling current information that is important in food and feed

safety assessment. These consensus documents serve as references to Codex and

regulatory bodies.

Mr. Chairman, FDA, in cooperation with EPA and USDA, 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. I am happy to answer any questions you might have.

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