A New Technological Era for American

Agriculture

August 1992

OTA-F-474

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Recommended Citation:

U.S. Congress, Office of Technology Assessment, A New Technological Era for American

Agriculture, OTA-F474 (Washington, DC: U.S. Government Printing Office, August 1992).

For sale by the U.S. Government Printing Office

Superientendent of Documents, Mail Stop: SSOP, Washington, DC 20402-9328

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Foreword

American agriculture is entering a new technological era that holds great promise.

Biotechnology and advanced computer systems have the potential to increase productivity,

enhance the environment, improve food safety and quality, and bolster U.S. agricultural

competitiveness.

Many of these new technologies will be available in the 1990s. But their introduction will

be under circumstances unlike any met by past technologies. Uncertainties over these new

technologies raise questions of potential impacts on food safety and the environment, and

possible economic and social costs. Nevertheless, there will be a push for some of these

technologies-biotechnology in particular—to be used commercially, adopted by industry,

and accepted by the public.

Congress requested the Office of Technology Assessment to examine emerging

technologies that may be available to American agriculture in the 1990s, their potential for

industry, and consequent policy issues. This report analyzes the technologies and related

policy issues Congress may need to resolve. The analysis includes an assessment of

adjustments industry must make to capitalize on the new technologies, the scientific and

institutional issues relevant to food safety and environmental risk and benefit, and the

implications for intellectual property rights and science policy.

The report concludes that these technologies have the potential to provide new solutions

to many agricultural problems. The challenge, however, will be whether government,

industry, and the public can strike the proper balance of direction, oversight, and use to allow

these technologies to flourish. Congress will be faced with many issues and choices as

American agriculture moves into this new era.

This OTA report for Congress is the fourth and final report in a series begun in 1990. The

study was requested by the Senate Committee on Agriculture, Nutrition, and Forestry; the

House Committee on Government Operations; and the House Committee on Agriculture. The

first report issued was Agricultural Research and Technology Transfer Policies for the 1990s,

the second report was U.S. Dairy Industry at a Crossroad: Biotechnology and Policy Choices,

and the third report was Agricultural Commodities as Industrial Raw Materials. Findings from

these reports were relevant to the issues debated for the 1990 Farm Bill.

OTA greatly appreciates contributions of the advisory groups, authors of background

papers, reviewers, and other contributors to this study who were instrumental in defining key

issues and a range of perspectives on them. Their participation does not necessarily represent

endorsement of this report, for which OTA bears sole responsibility.

- Directo r

iii
A New Technological Era for American Agriculture

OTA Project Staff

Roger C. Herdman, Assistant Director, OTA

Health and Life Sciences Division

Walter E. Parham, Program Manager

Food and Renewable Resources Program

Michael J. Phillips, Project Director

Marie Walsh, Senior Analyst

Laura R. Meagher, Senior Analyst

Kevin W. O’Connor, Senior Analyst

Lawrence R. Jones, Analyst

Laura Dye, Research Assistant

Susan Wunder, Editor

Administrative Staff

N. Ellis Lewis, Office Administrator

Nellie Hammond, Administrative Secretary

Carolyn M. Swarm, P.C. Specialist
Assessment Advisory Groups

Advisory Group on Animal Technology and Related Issues

Dale Bauman

Professor

Department of Animal Science

Cornell University

David Berkowitz

Director

Technology Transfer and Coordination Staff

Food Safety Inspection Service

U.S. Department of Agriculture

Roger Blobaum

Director of Americans for Safe Food

Center for Science in the Public Interest

Thomas T. Chen

Associate Director

Center of Marine Biotechnology

University of Maryland

Gary Cromwell

Professor

Department of Animal Science

University of Kentucky

Stanley Curtis

Professor

Department of Animal Scienc e

University of Illinois

Dennis Dykstra

Vice-President of Quality Assurance

Jack Frost Golden Plump Poultry

Terry Etherton

Professor

Department of Dairy and Animal Science

Pennsylvania State University

Don Gill

Regents Professor and Extension Animal

Nutritionist

Oklahoma State University

William Hansel

Distinguished Professor

Department of Veterinary Science

Louisiana State University

Michael Hansen

Research Associate

consumer Policy Institute

Consumers Union

Norman Harvey

Farmer

Florence, VT

Burke Healey

southern Cross Ranch

Davis, OK

Walter Hobgood

Director of Animal Nutrition and Health

Monsanto Co.

Maynard Hogberg

Head

Department of Animal Scienc e

Michigan State University

Gerald Isaacs

Chairman

Department of Agricultural Engineering

University of Florida

Daniel D. Jones

Deputy Director

Office of Agricultural Biotechnology

U.S. Department of Agriculture

James Kleibenstein

Professor

Department of Economics

Iowa State University

John Kopchick

Professor

Edison Animal Biotechnology Center

Ohio University

Edward Korwek

Partner

Hogan and Hartson

Darold McCalla

President

Granada Biosciences, Inc.

Tom McGuckin

Associate Professor

Department of Economics

New Mexico State University

Dave Meisinger

Product Manager for New Products

Pitrnan-Moore, Inc.

Jan E. Novakofski

Associate Professor

Department of Animal Scienc e

University of Illinois

B.I. Osburn

Associate Dean for Research

School of Veterinary Medicine

University of California

Dennis Powers

Director

Hopkins Marine Station

Stanford University

Rodney Preston

Professor

Department of Animal Science

Texas Tech University

Vernon Pursel

Research Leader 

Agricultural Research Service

U.S. Department of Agriculture

Allan Rahn

Professor

Department of Animal Science

Michigan State University

Caird Rexroad

Research Leader

Agricultural Research Service

U.S. Department of Agriculture

Tim Rose

Fanner

Lyons, KS

Andrew Rowan

Assistant Dean

School of Veterinary Medicine

Tufts University

Colin Scanes

Professor and Chairman

Department of Animal Science

Cook College, Rutgers University

Thomas Sporleder

Professsor

Department of Agricultural Economics and

Rural Sociology

Ohio State University

Charles Strong

Extension Biotechnology Coordinator

University of Georgia

Michael Tomaszewski

Professor/Extension Dairy Specialist

Department of Animal Science

Texas A&M University

Edward Veenhuizen

Manager of Animal Science Projects

Lilly Research Laboratiories

Eli Lilly and Co.

v
Advisory Group on Plant Technology and Related Issues

Michael Adang

Associate Professor

Department of Entomology

University of Georgia

Garren O. Benson

Professor

Department of Agronomy

Iowa State University

Norman Brown

President

FBS Systems Inc.

J.A. Browning

Professor

Department of Plant Pathology

Texas A&M University

John Burke

Research Leader

Agricultural Research Service

U.S. Department of Agriculture

Raghavan Charudattan

Professor

Department of Plant Pathology

University of Florida

Sharon K. Clark

President

Minnesota Corn Growers Assoc.

Ken Cook

Vice-President for Policy

Center for Resource Economics

James Davis

Vice-President of Development and

General Counsel

Crop Genetics International

Willard Downs

Professor

Oklahoma State University

Lynn Forster

Professor

Department of Agricultural Economics

and Rural Sociology

Ohio State Univeseity

Nicholas Frey

Product Development Manager

Specialty Plant Products Division

Pioneer Hi-Bred International

James Fuxa

Professor

Department of Entomology

Lousiana State University

Robert Hall

Associate Professor

Department of Plant Science

South Dakota State University

Chuck Hassebrook

Director

Center for Rural Affairs

Dale Hicks

Professor

Department of Agronomy and

Plant Genetics

University of Minnesota

Carol Hoffman

Research Scientist

Institute of Ecology

University of Georgia

Donald Holt

Director

Agricultural Experiment Station

University of Illinois

Marjorie Hoy

Professor

Department of Entomology

University of California

Jeffrey Ihnen

Attorney-at-Law

Venable, Baetjer, Howard, and Civiletti

George Kennedy

Professor

Department of Entomology

North Carolina State University

John C. Kirschman

President

FSC Associates

Ganesh Kishore

Research Manager

Monsanto Co.

Jerry R. Lambert

Professor

Department of Agricultural Engineering

Extension Service/USDA

Clemson University

Sue Loesch-Fries

Assistant Professor

Department of Plant Pathology

Purdue University

Gaines E. Miles

Professor

Department of Agricultural Engineering

Purdue University

Kevin Miller

Farmer

Teutopolis, IL

Kent Mix

Rancher

Larnesa, TX

Ian Munro

Director

Canadian Centre for Toxicology

Michael W. Parka

chairman

Food Research Institute

University of Wisconsin

Philip Regal

Professor

Department of Ecology and Behavioral

Biology

University of Minnesota

Jane Rissler

Director of Biotechnology

National Wildlife Federation

Douglas Schmale

Farmer

Lodgepole, NE

Allan Schmid

Professor

Department of Agricultural Economics

Michigan State University

Ronald Smith

Extension Specialist

Auburn University

Steve Sonka

Professor

Department of Agricultural Economics

University of Illinois

Kent K. Stewart

Professor

Department of Biochemistry and Nutrition

Virginia Polytechnic Institute and

State University

Nicholas D. Stone

Associate Professor

Department of Entomology

Virginia Polytechnic Institute and

State University

Christen Upper

Professor/Research Chemist

Agricultural Research Service

U.S. Department of Agriculture

Department of Plant Pathology

University of Wisconsin

Ann Vidaver

Professor

Department of Plant Pathology

University of Nebraska

William Wilson

Professor

Department of Agricultural Economics

North Dakota State University

Paul Zomer

Director of Bioherbicide Research

Mycogen Corp.
Advisory Group on Agricultural Research and Related Issues

Norman Berg (retired)

Formerly with Soil Conservation Service

U.S. Department of Agriculture

Donald Bills

Deputy Area Director for Product Quality

and Development Institute

Agricultural Research Service

U.S. Department of Agriculture

Patrick Borich

Director

Cooperative Extension Service

University of Minnesota

Lucas Calpouzos

Professor

School of Agriculture

California State University

Mary Carter

Associate Administrator

Agricultural Research Service

U.S. Department of Agriculture

Neville Clark

Former Director

Texas Agricultural Experiment Station

Texas A&M University

Arnold Denton

Senior Vice-President

Campbell soup co.

Chester T. Dickerson

Director of Agricultural Affairs

Monsanto Co.

Catherine Donnelly

Associate Director

Agriculture Experiment Station

University of Vermont

Jeanne Edwards

Past Member

National Agricultural Research and

Extension Users Advisory Board

W.P. Flatt

Dean

College of Agriculture

University of Georgia

Ray Frisbe

IPM Coordinator

Department of Entomology

Texas A&M University

Paul Genho

National Cattlemen’s Association

Deseret Ranches of Florida

Robert Heil

Director

Agricultural Experiment Station

Colorado State University

Jim Hildreth (retired)

Formerly with Farm Foundation

Vemer Hurt

Director

Agricultural and Forestry Experiment

Station

Mississippi State University

Terry Kinney (retired)

Formerly with Agricultural Research

Service

U.S. Department of Agriculture

Ronald Knutson

Professor

Department of Agricultural Economics

Agricultural and Food Policy Center

Texas A&M University

William Marshall

President

Microbial Genetics Division

Pioneer Hi-Bred International, Inc.

Roger Mitchell

Director

Agricultural Experiment Station

University of Missouri

Lucinda Noble

Director

Cooperative Extension

Cornell University

Susan Offutt

Executive Director

Board on Agriculture

National Research Council

Dave Phillips

President

National Association of County Agents

Jack Pincus

Director of Marketing

Michigan Biotechnology Institute

Dan Ragsdale

Former Research Director

National Corn Growers Association

Roy Rauschkolb

Resident Director

Maricopa Agricultural Center

University of Arizona

Alden Reine

Dean

Cooperative Agricultural Research Center

Prarie View A&M University

Grace Ellen Rice

Legislative Director

American Farm Bureau Federation

Bob Robinson

Director of Agricultural and Trade

Analysis Division

Economic Research Service

U.S. Department of Agriculture

Jerome Seibert

Economist

Department of Agricultural Economics

University of California

Keith Smith

Director of Research

American Soybean Association

William Tallent

Assistant Administrator

Agricultural Research Service

U.S. Department of Agriculture

Jim Tavares

Associate Executive Director

Board on Agriculture

National Research Council

Luther Tweeten

Anderson Chair for Agricultural Trade

Department of Agricultural Economics and

Rural Sociology

Ohio State University

Walter Walla

Director

Extension Service

University of Kentucky

Tim Wallace

Extension Economist

Department of Agricultural Economic-s

University of California

Mike Wehler

Vice President

National Pork Producers Council

John Woeste

Director

Cooperative Extension Service

University of Florida

Fred Woods

Agricultural Programs

Extension Service

U.S. Department of Agriculture

NOTE: OTA appreciates and is grateful for the valuable assistance and thoughtful critique by the advisory group members. The groups

do not, however, necessarily approve, disapprove, or endorse this report. OTA assumes full responsibility for the report and

the accuracy of its contents.

vii
Chapter 1

Overview and Summary

Photo credit: Grant Hellman, inc.
Contents

Page

ADVANCING TECHNOLOGIES FOR AGRICULTURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Biotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Advanced Computer Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

IMPACTS OF THE NEW TECHNOLOGIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Production Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Agribusiness, Farm Labor, and Rural Communities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Food Quality . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Intellectual Property Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

MAJOR FINDINGS AND OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Environmental Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Public Sector Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

3

3

6

8

9

9

10

11

11

12

12

19

27

31

Figure

Figure

1-1. Jurisdiction and Coordination of Environmental Policy for Biotechnology-Derived

Agricultural Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Tables

Table

Page

. . . . 14

Page

1-1. Estimates of Crop Yield and Animal Production Efficiency . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1-2. Projected Annual Rates of Growth (1990–2000) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

1-3. Federal Agencies Primarily Responsible for Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

1-4. Total Research Funding for State Agricultural Experiment Stations, Selected Years . . . . . . 28
Chapter 1

Overview and Summary

Technological innovation has played a significant role

in transforming American agriculture in the past and again

promises major impacts on the U.S. food production and

processing industries. The transition from horsepower to

mechanical power ( 1920– 1950) boosted the productive

capacity of agriculture even as farm labor requirements

decreased dramatically. From 1950 to 1980 agricultural

productivity rose further as chemical fertilizers, feed additives, and pesticides increased yields and helped farmers control pests and disease. Biotechnology and advanced

computer systems now are ushering American agriculture

into a new technological era. These technologies have

the potential to increase U.S. agricultural productivity

and competitiveness, enhance the environment, and improve food safety and quality.

Many of the new technologies will be commercially

viable in the 1990s. However, they will not automatically

be put to use. Today’s public increasingly questions

whether technological change is always good or needed

and is voicing new concerns about the safety of the food

supply, the environment, and the changing structure of

agriculture. These issues as well as declining public confidence in institutions create an atmosphere in which

agricultural biotechnology may not readily be approved

for commercial use or adopted by industry. Lack of public acceptance could prevent some technologies from being

used even if they are approved by regulatory agencies.

To avoid this fate, agricultural biotechnology must meet

rigorous scientific standards of safety and efficacy. And,

institutions regulating these products must satisfy unprecedented demands for accountability.

This report focuses on the new technologies for agriculture and the related issues that policy makers most

likely will face during this decade. Part I identifies advances being made in agricultural biotechnology for crops,

animals, and food processing, and in computer technologies to improve agricultural management. Part 11 analyzes ways in which these technologies might improve

agricultural productivity and discusses certain adjustments that industry will need to make to capitalize on

this potential. Part 111 considers scientific and institutional issues relevant to environmental benefit and risk

assessment of biotechnology. Part IV focuses on food

safety and quality issues, presenting institutional, scientific, and public perspectives on these issues. Finally,

Part V analyzes some of the implications of the technologies for intellectual property rights and science

policy.

ADVANCING TECHNOLOGIES

FOR AGRICULTURE

Biotechnology

Biotechnology, broadly defined, includes any technique that uses living organisms or processes to make or

modify products, to improve plants or animals. or to

develop microorganisms for specific uses. It rests on two

powerful molecular genetic tools: recombinant deoxyribonucleic acid (rDNA); and cell fusion technologies. Using these techniques, scientists can isolate. clone, and

study the structure of an individual gene and explore the

gene’s function. Such knowledge and skills allow scientists to exercise new control over biological systems,

leading to significant improvements in agricultural plants

and animals.

Plant Technologies

Each year in the United States, weeds, insects, and

disease (as well as weather and soil conditions) significantly decrease potential crop yields and cost farmers

billions of dollars in lost revenues. New approaches to

control pests include the use of biological agents to manage pests and the application of biotechnology to produce

plants with new genetic characteristics.

Biological control of pests is the use of living natural

enemies to reduce pest populations to levels lower than

would otherwise occur. The classical (searching native

lands for control agents to pests of foreign origin) and

augmentation (periodic release of control agents to increase populations) approaches are the most commonly

used biological control tactics. To date, biological control

has been most successfully used in orchards and vegetables; efficacy in field crops has been ‘limited. Insect

and weed control using biological control agents has been

most successful; use of biological agents to control disease is lagging. Traditional selection and breeding approaches, as well as new biotechnology approaches are

being used to improve the control and range of biological

control agents. Several biocontrol agents currently are

available or could be in the next 10 years, but the field

is not sufficiently advanced to replace most pesticides in

that time.

New tissue culturing and genetic engineering tools

combined with traditional agricultural research methods

are allowing scientists to alter plants to have greater dis-

- 3 -
4 ● A New Technological Era for American Agriculture

ease, insect, and weed resistance; to withstand environmental stresses such as cold, drought, and frost; to develop

value-added products from agricultural commodities; and

to improve understanding of plant resistance and of the

interactions of plants, pests, and biological control agents

in the agro-ecosystem.

Genetic Engineering of Plants for Insect Control—

Traditional breeding programs have and will continue to

produce insect-resistant or insect-tolerant varieties of crops.

However, the tools of biotechnology can be used to selectively engineer plants for this trait. Candidate genes

must code for proteins that are stable in the plant cell

and insect midgut; have high activity against target insects; and are safe for non-target invertebrates and animals. Genes coding for trypsin inhibitors and for bacterial

Bacillus thuringiensis (Bt) toxin are two possible candidates. The gene coding for the Bt toxin has been cloned

and inserted into plants; transgenic plants producing Bt

toxins are expected to be commercially available by the

mid to late 1990s.

Genetic Engineering of Plants for Weed Control—

Improved understanding of the mechanisms of action of

herbicides is leading to the improved ability to design

herbicides effective against some plants (target weeds)

but inactive against others (nontarget weeds or crops).

The lack of naturally occurring resistance genes in crops

Photo credit: Richard Nelson, Samual Roberts Noble Foundation

Transgenic tomato plant expressing the coat protein

gene of tobacco mosaic virus (left) and control

plant (right).

limits the ability to use traditional breeding methods to

develop herbicide tolerant crops; however genetic engineering techniques can overcome these constraints. The

first herbicide tolerant crops are expected to be available

commercially by the mid 1990s.

Genetic Engineering of Plants for Disease Control—

Biotechnology is being used to elucidate the mechanisms

by which pathogenic organisms cause disease and to engineer plants with enhanced disease resistance. Genes

coding for virus coat proteins (i. e., the proteins that make

up the shell that surrounds viruses) can be genetically

engineered into plants to elicit resistance to infection by

the source virus, and in some cases to related viruses

having similar coat proteins. Several plant viral coat proteins have been transferred to plants to confer resistance.

Genetically engineered dicotyledonous plants resistant

to certain viruses are expected to be available commercially by the mid 1990s. But virus resistant monocotyledonous plants will probably not be available until the

late 1990s or early 21st century. Plants resistant to bacteria and fungi are not expected to be developed until

the end of the decade and not available commercially

until after the year 2000.

Animal Technologies

Biotechnology has the potential to improve feed efficiency, reduce losses from disease, and increase reproductive success in all sectors of the livestock industry.

Advances in growth promotants, reproductive technologies, and animal health will play a major role in enhancing the efficiency of animal agriculture and the quality

of its products.

Growth Promotants-Currently used growth promotants such as anabolic steroids and antimicrobial compounds will continue to be used in the livestock sector.

However, rDNA techniques are being used to produce

new products such as a new class of protein hormones

called somatotropins.

Porcine Somatotropin—Pigs administered porcine somatotropin (pST) for a period of 30 to 77 days show

increased average daily weight gains of approximately

10 to 20 percent, improved feed efficiency of 15 to 35

percent, decreased adipose (fat) tissue mass and lipid

formation rates of as much as 50 to 80 percent, and

concurrently increased protein deposition of as much as

50 percent without adversely affecting the quality of the

meat. Prolonged release formulations and daily injection

produced similar growth rates and feed efficiencies. PST

is currently being reviewed by Food and Drug Administration (FDA) for commercial use.
Chapter l—Overview and Summary .5

CONTROL T

Photo credit: Terry Etherton, Pennsylvania State University

Comparison of pork loins that show the effect of pigs treated with porcine somatotropin

(pST). The loin-eye area of the loin treated with pST is 8 square inches; the control is 4.5

square

Bovine Somarotropin—Bovine somatotropin (bST) is

currently undergoing FDA review for use in lactating

dairy cows to increase milk production. While individual

gains rely on the management ability of the producer,

on average, gains of about 12 percent are reasonable.

Bovine somatotropin does not alter the composition of

milk. The fat, glucose, protein, mineral, and vitamin

composition of milk fall within the range of values normally observed in milk from cows not supplemented with

bST. Bovine somatotropin decreases pregnancy rates

(proportion of cows becoming pregnant), increases days

open (days from parturition to conception), but does not

alter conception rates (services per conception). These

observed effects are similar to those occurring in highproducing cows that do not receive bST. Implications of

using bST in dairy production are discussed more thoroughly in the OTA publication U.S. Dairy Industry at a

Crossroad: Biotechnology and Policy Choices.

Reproduction Technologies—The field of animal reproduction is undergoing a scientific revolution. For example, in the cattle industry it has become possible to

induce genetically y superior females to shed large numbers

of eggs (superovulation); and to fertilize these eggs in

vitro with the sperm of genetically superior males. Each

resulting embryo can then be sexed and split to produce

multiple copies of the original embryo. Each of these

new embryos can then be frozen for later use, or transferred to a recipient cow whose reproductive cycle has

been synchronized to accept the developing embryo. The

recipient cow carries the embryo to term and gives birth

to a live calf. It may be possible in the near future to

sex the sperm rather than the embryo, and to create more

inches.

copies of each embryo than currently is possible. New

techniques being developed will make it easier to insert

new genes into the embryos to produce transgenic animals. Embryos produced by new reproductive methods

are being marketed, although as yet no transgenic animals

are available.

Transgenic Animals—The combination of new reproductive technologies with recombinant DNA technologies (the identification. isolation, and transfer of

selected genes), provides opportunities to produce transgenic animals efficiently and cost effectively, and to improve livestock quality more rapidly than could be done

with traditional breeding. Some transgenic livestock may

contain genes that improve growth characteristics or resistance to disease. These new developments also have

human medical implications. It may be feasible to produce important human pharmaceuticals in livestock.

Transgenic animals can also serve as a powerful research

tool to understand genetic and physiological functions,

and to provide a model system to study human disease.

For example, pigs display striking physiological similarities to humans and because of this, transgenic pigs

are currently being developed to serve as a model system

to understand and treat gastrointestinal cancers. Commercial availability of transgenic animals is not expected

before the year 2000.

Animal Health Technologies—improvements in animal health will lead to considerable cost savings to the

animal industry. Biotechnology rapidly is acquiring a

prominent place in veterinary medical research. New vaccines include those created by deleting or inactivating
6 ● A New Technological Era for American Agriculture

the genes in a pathogen that cause disease. The first genedeletion viral vaccine to be approved and released for

commercial use was the pseudorabies virus vaccine for

swine.

Many currently used diagnostics tests are costly, time

consuming, and labor intensive, and some still require

the use of animal assay systems. Monoclinal antibodies

and nucleic acid hybridization probes can be used to

produce simpler, easily automated, and highly sensitive

and specific diagnostic procedures. At least 15 different

rapid diagnostic tests based on monoclinal antibodies are

on the market or soon will be.

Food Processing Technologies

Historically, the food processing industry has had to

accept and adapt to heterogeneous raw materials. Biotechnology can be used to tailor food crops to meet food

processing and consumer needs. For example, new plant

tissue culture techniques can be used to produce food

flavor and coloring ingredients. These methods potentially could replace production and extraction of these

ingredients from plants.

Genetic engineering can also be used to alter food

characteristics. Genes coding for enzymes involved in

starch and lipid biosynthesis are being isolated and cloned,

enhancing the prospects of engineering plants with specific compositions of starch and oil. And, genetic engineering is being used to eliminate toxins, allergic

compounds, or off-flavor components in plants, and to

delay ripening of tomatoes.

New biotechnology products are being developed for

food manufacturing and monitoring of animal products for

food safety. For example, a genetically engineered version

of the enzyme rennet, which is normally extracted from

the forestomach of calves, has recently been approved by

FDA for use in cheese manufacturing systems. Bacteria

and yeast strains engineered to convert waste products such

as blood, bone, and milk whey into useful products could

decrease the costs associated with their disposal. For example, engineered yeast strains are capable of fermenting

the lactose in whey to value-added products, such as vitamin C, biofuels, or pharmaceuticals. Food safety monitoring will be enhanced by the development of nucleic acid

probes and monoclinal antibodies; raw materials, ingredients, and finished products can be analyzed for the presence of pathogenic organisms and chemical and biological

contaminants. Detection kits are also commercially available for monitoring several pesticides, antibiotics, and bacterial contaminants.

Advanced Computer Technologies

Since the industrial revolution, agricultural systems

have intensified, and agricultural productivity has increased significantly along with farm size. Labor-saving

devices on farms have increased output per worker several fold, and advances in understanding and application

of biological principles have boosted agricultural yields

significantly. With increased production, however, farm

management becomes correspondingly more challenging

and complex. In general, methods for making management decisions have failed to meet this challenge. As a

Photo credit: Calgene, Inc

Tomatoes with genes that delay ripening (left) and control (right) 3 weeks after harvest.
Chapter 1—Overview and Summary ● 7

result, many decisions are ‘‘uninformed’ and many agricultural systems poorly managed.

The application of advanced computer technologies to

agricultural management can help remedy this situation.

Improved access to information will allow farmers to

monitor progress more effectively and to determine suboptimal performance. For example, close monitoring of

animal performance will allow early detection of diseases

and can help reduce stress in animals.

Overall, advanced computer technologies can provide

managers with the ability to systematically determine the

best decision rather than arrive at decisions in an ad hoc

fashion. Optimal decision making requires a holistic view

of a farm enterprise, factors that affect it, and probable

consequences of management decisions. Thus, a farmer

deciding whether to plant a specific crop on a specific

field should weigh the profitability of the crop as well

as overall farm needs (e. g., nutrition requirements if it

is an animal enterprise). The decision will impact land

sustainability and the need to use certain pest-control

strategies.

By-and-large, computers have had little impact on production agriculture to date. Predictions that every farmer

would own a computer by 1990 have not come true. Few

farmers have computers and those that do use them primarily for book keeping and general calculations (e. g.,

ration balancing).

The largest impact of computers in American agriculture has been in support industries. Using computer

networks and tracking systems, equipment dealers can

provide faster service, and feed dealers are better able

to manage feed inventories. Most of these advances have

come from directly adopting general business software

with little or no input from the agricultural academic

community.

The primary agricultural application of advanced computer technology by the mid - 1990s will be ad hoc expert

systems (i.e., computer programs that use knowledge to

solve well-defined problems). Problem diagnosis expert

systems currently are under development, and farmers

will have a cadre of these systems at their disposal to

diagnose diseases and to evaluate production performance. These systems generally will not be integrated

with one another and each will consider only one aspect

of a problem. Integrated systems that solve production

problems while considering economic consequences will

not become available until the later part of the decade.

The primary use of expert systems within the next 5

years may be by agribusiness which will be able to leFarmer and consultant examine data from COMAX

(COtton Management eXpert) computer program.

verage the cost of adopting these technologies across a

number of farms. Using expert systems to increase service to farmers may change the role of some professionals. For example, expert systems can help veterinarians

take an epidemiological approach to solving problems.

It will also allow some diversification in services provided. For example, animal nutritionists may be more

likely to become involved in consulting for the crop program when aided by an expert system.

Computer-based sensors will be used on a limited basis

to collect real-time data for expert systems. The primary

use of sensors will be for monitoring weather and field

conditions for crop management. Expert systems will

help farmers interpret these data and suggest appropriate

management strategies such as irrigation, fertilization,

or pesticide treatment.

Another technology likely to see application by the

mid- 1990s is full-text retrieval systems. It will be possible for farmers and Extension personnel to have a CDROM with all of the latest publications at their fingertips.

Using a full-text retrieval system, they will be able to

retrieve pertinent information that will help them improve

their decisions. For example, when a farm experiences

a corn mycotoxin problem, the owner-operator can access

an information base to find relevant literature.

Robots for highly specialized, labor-intensive tasks

will begin to be applied to agriculture in the late 1990s.

This would include robot transplanting of seedlings, pork

carcass sectioning, and harvesting of fruits and vegeta-
8 ● A New Technological Era for American Agriculture

Photo credit: Gerald Isaacs, University of Florida

An experimental fruit picking robot uses a machine

sensor and a computer to locate individual fruit for

detachment. Approximately 3 seconds per fruit

‘are required.

bles. Robots for milking cows, however, may reach commercial application by the mid-1990s.

IMPACTS OF THE NEW

TECHNOLOGIES

The new era of biotechnology and advanced computer

technologies will be faster paced than previous technological eras. A more rapid pace of technological change

will be fostered by major changes in public policy regarding technology. One of the most important changes

was the granting of property rights for new plant varieties, new life forms, and computer software. Patent

rights were extended to new plant varieties by the enactment of the Plant Variety Protection Act of 1970. This

was followed in 1980 by the U.S. Supreme Court ruling

in Diamond vs. Chakrabarty’ that investors in new microorganisms, whose inventions otherwise met the legal

requirements for obtaining a patent, could not be denied

a patent solely because the innovation was alive. This

decision opened the door to patent a broad range of potential new products of the biotechnology era. Capping

this series of policy changes was the amendment to the

Copyright Act in 1980 that made explicit provisions for

computer programs as (literary) works of authorship.

In previous technological eras most technologies were

capital intensive and substituted for labor and land. Many

emerging biotechnologies will substitute for conventional

purchased inputs. For example, biopesticides will replace

some chemical pesticides in plant insect control, biotechnology-improved animal disease vaccines likewise

will replace some existing vaccines. On the other hand,

some biotechnologies will compliment existing technologies. An example is the genetic transformation of plants

to incorporate desired traits. In this case, conventional

plant breeding will still be required for incorporation of

biotechnology-induced traits into commercial lines, for

continued plant improvement selection, and for seed multiplication. In addition, for the foreseeable future, chemical fertilizers will remain important in crop production.

As with past technological eras, successful adoption

of specific biotechnology innovations will result in additional profits for some, at least the early adopters. As

in the past, increased profits will result mainly from

reductions in real production costs per unit of output.

This, in turn, can increase productivity and the competitive position of U.S. agriculture.

As with past technological innovation, biotechnology

is expected to be supply-increasing in the aggregate. The

implications, however, can be quite different for different

farms. Late adopters of the new technology, for example,

will be faced with lower product prices. This is because

early adopters have already reduced their production costs,

enjoyed increased profits in their period of initial adoption, and are ready to respond to the next wave of technological innovation. Increased supplies are generally

associated with lower prices. Consequently, nonadopters

often have higher costs while facing lower prices for their

products.

Successful use of technologies of this new era most

likely will require changes in the production process and

may require a higher quality of management. This may

mean increased human as well as monetary capital. Less

educated farmers with limited capital resources may find

it difficult to implement the new technology successfully.

Thus, the new technologies may widen the gap between

capital-limited and capital-rich farm operators.

Many advancing technologies are approaching commercialization. In crop agriculture, biotechnology research has advanced at a much faster rate than anticipated

just a few years ago, and transgenic crops are currently

undergoing field trials. in animal agriculture, vaccines

and diagnostics are on the market or will be soon. Growth

promotants are going through the regulatory process. Reproduction technologies are advancing at a rapid pace

and cloned embryos are currently being marketed. Transgenics are still in the future but considerable strides are

being made in the use of livestock to produce high value

pharmaceuticals. These technologies and others will impact agriculture in a number of ways.
Chapter 1—Overview and Summay) ● 9

Table l-l—Estimates of Crop Yield and Animal Production Efficiency by 2000

Less new Most likely More new

Actual technology technology technology

1990 2000 2000 2000

Crops

Corn—bu/acre . . . . . . . . . . . . . . . . . . . . . . . . . .

Cotton-lb/acre . . . . . . . . . . . . . . . . . . . . . . . . .

Soybeans—bu/acre . . . . . . . . . . . . . . . . . . . . . .

Wheat—bu/acre . . . . . . . . . . . . . . . . . . . . ., ., ,

Beef

Lbs meat/lb feed . . . . . . . . . . . . . . . . . . . . . . . .

Calves/100 cows . . . . . . . . . . . . . . . . . . . ... , .

Dairy

Lbs milk/lb feed . . . . . . . . . . . . . . . . . . . . . . . . .

Lbs milk/cow/year . . . . . . . . . . . . . . . . . . . . . . .

Poultry

Lbs meat/lb feed . . . . . . . . . . . . . . . . . . . . . . . .

Eggs/layer/year . . . . . . . . . . . . . . . . . . . . . . . . . .

Swine

Lbs meat/lb feed . . . . . . . . . . . . . . . . . . . . . . . .

Pigs/sow/year . . . . . . . . . . . . . . . . . . . . . . . . . . .

116.2

600.0

32.4

34.8

113.8

NA

32.6

37.7

128.5

708.0

33.7

42.6

141.6

NA

36.4

53.8

0.143

90.0

0.146

93.750

0.154

96,221

0.169

102.455

1.010

14,200.0

1.030

17,247.200

1.050

19,191.600

1.057

20,498.800

0.370

250,0

0.373

250.500

0.389

258.0

0.428

273.125

0.154

13.900

0.174

14.420

0.181

15.750

0.196

17.791

NOTE: OTA expresses its appreciatio nto Yao-chi Lu

in deriving the estimates for this table,

NA = Not available.

SOURCE: Office of Technology Assessment, 1992,

and Phil Coiling, Agriculture Research Service, U.S. Department of Agriculture, for their assistance

Table l-2—Projected Annual Rates

(1990-2000)

of Growth agriculture is in milk production. Since 1960, the annual

rate of growth has been about 2.0 to 2.5 percent. OTA’s

1985 projection (24,200 pounds of milk per cow by year

2000) was higher than its current one (19,200 pounds of

milk per cow by year 2000). A major reason for this

change is the slowness to market of bovine somatotropin.

In 1985, bST was predicted to be commercially available

in 1987. BST had yet to be approved by the Food and

Drug Administration as of early 1992.

Less new Most likely More new

technology technology technology

Corn

Cotton

Soybeans

Wheat

Beef

Lbs meat/feed

Calves/cow. . .

Dairy

Lbs milk/feed .

Milk/cow/year.

Poultry

Lbs meat/feed

Eggs/lay/year.

Swine

Lbs meat/feed

Pigs/sow/year.

– 0.210/0

NA

0.06

0.80

1.000%

1.66

0.39

2.02

1.97%

NA

1.16

4.36

0.21

0.41

0.74

0.67

1.67

1.30

. . . . . .

. . . . . . Efficiencies in crop production will about match historical trends or climb slightly, and for the most part will

exceed OTA’s 1985 projections. This, in part, reflects

the movement of many of the new technologies from the

laboratory to the field at a much quicker pace than thought

possible in the mid- 1980s. Even though rates of growth

may accelerate during the 1990s, the absolute quantity

of yields will, for the most part, be lower than projected

in the mid- 1980s. This is due, in part, to the fact that

many of the early biotechnology inputs will be substitutes

for chemical inputs and, hence, the absolute gain in efficiency will in many cases be negligible. Yields are

expected to improve in the latter part of the decade as

more is learned about the genetic make up of plants.

0.20

1.94

0.39

3.01

0.46

3.67

. . . . . .

. . . . . .

0.08

0.02

0.51

0.32

1.46

0.89

. . . . . .

. . . . . .

1.22

0.37

1.62

1.25

2.41

2.47

. . . . . .

. . . . . .

NOTE: OTA expresses its appreciation to Yao-chi Lu and Phil Coiling,

Agriculture Research Service, U.S. Department of Agriculture, for their

assistance in deriving the estimates for this table.

NA = Not available.

SOURCE: Office of Technology Assessment, 1992.

Production Measures

Agribusiness, Farm Labor, and Rural

Communities The advance of agricultural biotechnology will play

an important role in increasing agricultural productivity

at about the historical rate of the last two decades. (See

tables 1- I and 1-2. ) The most dramatic increase in animal

Historically, the commodity-oriented agribusiness sector has been driven by economic forces to produce at
.

10 ● A New Technological Era for American Agriculture

maximum efficiency and to maintain low costs. This has

resulted in a system that is effective at converting undifferentiated commodities into low-cost food. Today this

sector is undergoing change inspired, in part, by the

evolution of more demanding and differentiated food

consumers. in response, retailer strategies have emerged

that focus on improving service to the consumer. information technology has facilitated the shift of marketing

efforts toward the discovery of consumer preferences.

To respond to a more consumer-oriented environment,

input suppliers may need to explore how information

technology can facilitate the coordination of activities

needed to assure particular attributes. Information technologies in the future may facilitate new business strategies by providing improved information flows and by

facilitating coordination of production and marketing activities.

To date, input suppliers have experienced more consequences of the new technologies than any other part

of the agricultural industry. In anticipation of biotechnology-enhanced seed, chemical and seed input industries have transformed structurally. Multinational chemical

and pharmaceutical companies have acquired almost all

the major seed companies. Concentration of input industries increases the potential for monopoly power, hence

the potential for exploiting farmers in their purchase of

improved inputs.

The trend toward vertical integration in agriculture and

toward proprietary production processes could result in

a captive market for some biotechnology products. For

example, a genetically engineered seed might be produced by a large, vertically integrated chemical-seed

company with specified inputs such as fertilizer, pesticides, and herbicides produced only by that company.

Where product quality is influenced strongly by biotechnologies (i. e., pork by pST); and where highly specialized new markets are formed (i. e., for pharmaceuticals),

increased incentives for production-marketing links via

contracting and other forms of vertical integration can

be expected.

The advancing biotechnology and information technologies generally will shift labor from farming as has

been true of past technologies. Newly emerging technologies will displace less farm labor than mechanization, but the farm labor force will have to be substantially

more skilled than in the past. For example, a key requirement of the new information technology will be

computer literacy. Programs to support skill upgrading

of the farm labor force will be needed to capture fully

the potential benefits of the new technologies.

Photo credit: Grant Heilman, Inc.

Production of lean meat with porcine somatotropin (pST)

will give meat packers a strong incentive to vertically

integrate or contract with farmers. Economic pressures

will be strong for most swine producers to adopt pST or

exit the industry.

The emergence of biotechnology and computer technologies will most likely spur on the decline of many

small farms and agriculturally dependent rural communities. Moreover, increased demand by many farmers for

one-stop shopping centers for farm supplies—including

those involving biotechnologies and information technologies—may reduce the viability of business enterprises in smaller communities. These enterprises will

need to diversify into nonfarm-related economic activities if they are to remain economically viable.

Management

The new technologies will demand greater attention to

management issues than have technologies in the past.

For crop agriculture, in particular, a systems approach

to the use of genetically engineered plants and biocontrol

technologies will be needed. Concern about pest resistance to technologies that control pests is reaching a high

level. Many chemical technologies are ineffective today

because of pest adaptation caused by poor management

strategies. As products from biotechnology are used to

control pests, management strategies for delaying or pos-
Chapter l—Overview and Summary ● ll

sibly avoiding pest adaptation need to be identified. Evidence exists already that insects are quite capable of

adapting to Bt, one of today’s most popular genetically

engineered protein toxins. At present, there is some information to establish general guidelines about the judicious use of engineered crops with insect and pathogen

resistance and herbicide tolerance. However, to establish

more detailed guidelines will entail generating a body of

empirical knowledge relevant to these products. And, an

effective educational program designed to bring these

results to the agricultural industry and the public is needed.

For animal agriculture research results clearly show

the extent of response achieved from technology depends

heavily on the management capability of the producer.

Use of somatotropins, for example, may require altering

the animals’ diets. Administration of somatotropin to

lactating cows may require extending the reproductive

cycle.

As important as these management issues are, a more

pressing issue is that of animal welfare—with or without

biotechnology as a complicating factor. Much of the success in increased productivity in agriculture has been the

result of lowered costs through the use of confinement

systems—which some have coined factory farming. The

question from an animal welfare perspective is whether

we have gone too far.

The impact of biotechnology on animal well-being is

perhaps the most challenging issue genetic engineering

raises. The technology is most likely impact neutral in

that one could use biotechnology to enhance animal wellbeing as well as compromise it. Clearly, biotechnology’s

impact depends on what is done and its effect. If it is

used judiciously to benefit humans and animals, with

foreseeable risks controlled, and the welfare of animals

kept in mind, it is morally defensible

great benefit.

Food Quality

Information about food quality can be

and can provide

provided through

labeling, brand names, price, and grades. Food grades

are used to classify products according to certain quality

characteristics and are established by the U.S. Department of Agriculture (USDA). In particular, they sort a

group of foods with heterogeneous characteristics into

lots of more uniform characteristics. Biotechnology will

challenge the relevance of grades since this new technology is capable of producing products of uniform high

quality. For example, as discussed above, pST reduces

backfat thickness and increases protein deposition in hogs,

resulting in a final product that is more desirable to a

health conscious society. Current USDA grading criteria

based, in large part, on backfat thickness and degree of

marbling will not be relevant since there will be little. if

any, difference from animal to animal in these characteristics in products produced with the new technology,

For a grading system to be useful, new grading criteria

will be needed. What these new criteria should be and

how they will be measured are open to question. An

argument can be made for providing quality information

via labels to consumers and dispensing with USDA grades

for most, if not all, agricultural products.

Intellectual Property Rights

Intellectual property protection is one of the most important incentives for the commercial development of

biotechnology- and computer-related processes and products. Patents and other forms of intellectual property

(plant breeders’ rights, trademarks) provide this protection. Patents may be issued in the United States for microorganisms, plants, and nonhuman animals. U.S. patent

law is the most inventor-friendly statute in the world: if

Congress takes no action regarding patentable subject

matter, broad protection for inventions created by biotechnology will continue. The Patent and Trademark Office (PTO) issued its first patent on an animal in 1988.

No further patents have been issued since, and the backlog of applications at PTO now numbers at least 160.

Since the status of patent applications is, by law, confidential, no way exists to determine when or if the patent

office will issue subsequent animal patents; or whether

such patents will have agricultural applications. Congress, through its oversight responsibilities, may require

PTO to explain the present status of any such patent

applications.

Rapid technological advances in computer software is

challenging the intellectual property laws in the United

States and internationally. Copyright law offers straightforward remedies for the literal copying of program code,

although enforcement remains a problem. Functional aspects of computer programs pose difficult questions for

application of copyright. The protection of software-related inventions by patent is a fairly recent development

and is controversial. PTO faces considerable challenges

in examining applications for computer-related inventions. An incomplete data base of “prior art” for computer-related inventions makes it difficult for examiners

to judge whether an application describes a “novel”

invention. Improving the database of ‘‘prior art’ is one

important means of improving the quality of the examination but will be difficult because so much of what
12 ● A New Technological Era for American Agriculture

constitutes ‘‘prior art’ has been in the form of products,

not literature or issued patents.

MAJOR FINDINGS AND OPTIONS

For any new technology, it is important to weigh the

potential benefits against the risks and possible costs of

its widespread adoption. Biotechnology-related risk assessment focuses on the planned introduction of genetically modified organisms into the environment

(environmental safety) and on the consumption of products derived from biotechnology (food safety).

In many ways this is a difficult time for a new technology to emerge. Negative experiences with nuclear and

chemical industries have made the American public wary

of new technologies, and confidence in institutions has

eroded. For these reasons, and because the consequences

of environmental introductions of genetically modified

organisms cannot be predicted with certainty, biotechnology has been subjected to extensive, apprehensive

scrutiny and regulatory oversight. Many institutions will

choose to “go the extra mile” to ensure public confidence as some policy issues are resolved. In making

policy decisions it remains important, nonetheless, to

distinguish clearly between the technical basis for assessment and regulation of technology-related risks, and

what might or might not be done as an extra step to

maintain public confidence. Balancing safety and institutional credibility against economic competitiveness will

be a skill much in demand throughout the decade.

Environmental Safety

Findings

Adequacy of a Knowledge Base for Risk Assessment

Analysis-After several years of experience with planned

introductions, a consensus is growing among scientists

that the risks of planned introductions of genetically modified organisms into the environment can, for the most

part, be assessed with available analytical capabilities.

Although risk assessment is itself a relatively young field,

the capacity to identify and weigh risks and benefits in

a structured and analytical way has matured rapidly in

recent years. Based on experience with other technologically oriented issues such as pollution and its control

and food safety, risk assessment as a field has generated

principles and methodologies that can be adapted for

planned introductions of recombinant-DNA modified organisms in the environment.

The fields of community ecology, population biology,

population genetics, evolutionary theory, and agricultural sciences as well as others have contributed to our

current understanding of the ecology of planned introductions. Decades of research in life history dynamics,

competition, characteristics of colonizing species or disturbed habitats, disease resistance, and gene flow have

provided a basis for risk assessment of planned introductions. Thus, while it is impossible to assess the exact

consequences of any specific planned introduction, the

fact remains that ecological understanding combined with

risk assessment methodologies make it possible to analyze the potential risk of each introduction before it is

allowed to take place.

Adequacy of a Knowledge Base for Science-Based,

Risk-Based Regulations-Reports of the National Research Council, the Ecological Society of America, and

the Scope document of the Office of Science and Technology Policy (OSTP) and the Council on Competitiveness all advocate science-based and risk-based regulations

of biotechnology applications. The implementation of

such regulations draws on the ability of regulators to

conduct adequate risk assessments, which in turn rests

on the knowledge base and technical capabilities discussed above.

Regulatory oversight rests with Federal agencies, with

varying degrees of involvement by state regulatory personnel. USDA’s Animal and Plant Health Inspection Service (APHIS) has taken the lead in designing a process

for the evaluation of possible risks and benefits when a

specific planned introduction of a genetically engineered

plant is proposed. Technical information to be provided

by an applicant is clearly defined, so that a thorough,

science-based risk assessment can be performed. Technical personnel in fields such as genetics and ecology

have joined the staff of APHIS’s Biotechnology, Biologics, and Environment Program (BBEP), to ensure vigorous assessments. State regulatory personnel are drawn

into the process so that they can provide additional technical information specific to local habitats and add an

additional perspective.

The Environmental Protection Agency’s (EPA) Office

of Pesticide Programs (OPP) has extended its review

processes under the Federal Insecticide Fungicide and

Rodenticide Act (FIFRA) to planned introductions of

microbial pesticides; it also cooperates with USDA-APHIS

in reviewing proposals for introduction of pest-resistant

plants. EPA’s Office of Toxic Substances (OTS) has

recently published draft regulations to cover planned introductions of genetically modified microorganisms; significant controversy exists as to whether these regulations

are indeed science- and risk-based, or whether they sim-
Chapter l—Overview and Summary .13

ply single out biotechnology for attention because it is

biotechnology. The final status of these regulations, as

well as their implementation processes, is not yet known.

State agencies have yet to be pulled into EPA regulatory

processes to the extent accomplished by USDA.

Extent That Regulations Are Product-Based—Reports of the National Research Council and the Ecological

Society of America stated that the techniques of biotechnology are not themselves inherently risky or unmanageable. In line with these findings, the early

Coordinated Framework, the document that established

responsibilities of Federal agencies that regulate biotechnology derived products, and the principles put forth

by OSTP and the Council on Competitiveness recommend that biotechnology not be regulated as a process.

Rather, a central tenet for biotechnology regulation is

that the various products of biotechnology should be regulated, just as are products of other technologies.

The product/process distinction has generated a great

deal of controversy in the past. However, as the experience base with biotechnology has grown, the premise

of judging each product on its own basis rather than

automatically implementing special regulations, has gained

wide acceptance. The extent to which this premise has

been implemented, however, varies among agencies.

Though its focus is on plant pests, USDA-APHIS has

been able to include along with other organisms under

its purview any vector,vector agent, donor organism,

recipient organism,or any other organism or product

produced through genetic engineering if it can be defined

as a pest. This product-selective approach makes it possible for regulated articles to become exempted from

special review as evidence indicates their safety.

Under FIFRA, EPA-OPP also has applied an existing

mandate to products of biotechnology, specifically plants

engineered to produce compounds aiding them in resisting pests. By pulling these ‘‘pesticidal plants’ under the

rubric of its oversight for pesticides, EPA-OPP seems in

one sense to be focusing on the product rather than the

process by which it was generated. However, a question

exists as to whether or not *‘pesticides’ is the appropriate

category into which to place these particular products,

especially since naturally occurring plants produce some

anti-insect compounds (see next section). To assume authority over plants genetically modified to be resistant to

pests, EPA-OPP seems to have chosen to look only at

plants that have gone through a biotechnology process,

leaving naturally-occurring pest-resistant plants alone.

Under the Toxic Substances Control Act (TSCA), EPAOTS has promulgated draft regulations for oversight of

microorganisms that do not fall under other authority.

However, under these draft regulations, essentially all

microorganisms other than those modified through biotechnology techniques are automatically exempted from

review, whereas those modified through biotechnology

techniques are labeled “new” and therefore subject to

regulation. When the only products subjected to special

review are biotechnology products, a question arises as

to whether or not the regulations are contradicting the

scope principles by focusing on process. The draft regulations under TSCA have been charged by some with

automatically and unfairly assigning a special riskiness

to organisms modified through biotechnology, while exempting organisms that are known to be potentially dangerous but not produced through a biotechnology process.

This discrepancy, and perhaps its final resolution, underscores a central tenet of regulation—that regulation

should be based on scientifically determined risk.

Appropriate Review Authority for Plants Genetically

Modified for Pest Resistance—Under the Coordinated

Framework (figure l-l), which established the responsibilities of Federal agencies with regard to biotechnology, EPA-OPP took on authority for plants into which

genes coding for compounds toxic to insects had been

introduced. The premise was that these were special

“pesticidal plants” that presented risks to the environment, food, and human health similar to traditional chemical pesticides applied externally in large volumes to plants.

This premise is questioned for several reasons. Compounds toxic to insects that are part of plant tissue do

not cause pesticide run-off and other such environmental

problems (so long as they are alive); they are distinctly

localized. Furthermore, most of the compounds are not

complex, like many synthetic compounds, and may well

be more readily biodegradable.

Another key argument with the premise of singling

out plants genetically modified for enhanced resistance

to pests is that all plants have natural pest resistance

characteristics. Selection pressures over evolutionary time

have favored the spread of genes in natural populations

that code for characteristics unattractive or harmful to

insects. Making a distinction between genetically modified plants and natural plants that are pest resistant,

calling the former ‘‘pesticidal plants’ and the latter simply ‘‘plants’ is in fact arbitrary, not science-based. If

the “pesticidal plant” premise is disallowed, an argument then exists that EPA-OPP is not automatically the

best home for regulatory review of such plants.
Figure I-l —Jurisdiction and Coordination of Environmental Policy for Biotechnology-Derived Agricultural Products.a

I President I

Biotechology sciene

National Enviromental coordinating Committee (Bscc),

Policy Act (NEPA) now Biotechnology Research

I Subcommittee (BRS)

I

coordinated framework

Scope document

united states Department

of Agriculture (USDA)

Animal and Food office of

Plant Heatlh safety and Agricultural 

Inspection Inspection Biotechnology/

Service Agricultural Assessment

(APHIS) (FSIS) Biotechnology Program

Research (NBIAP)

Advisory

Committee

(OAB/ABRAC)

,

,

I I I

USDA statutes EPA statues FDA statues

- Plant Pest Act - FederaI Insecticide, Fungicide, - Food, Drug, and Cosmetic Act (FDCA)

- Plant Quarantine Act and Rodenticide Act (FIFRA)

- Noxious Weed Act - Toxic Substances Control Act (TSCA)

- Virus-Serum-Toxin Act

- Federal Meat Inspection Ad

- Poultry Products Inspection Act

aOSTP, the Council on Competitiveness, and OMB do not have direct oversight over the Federal agencies; the connections shown here are those of

influence through law, key policy documents, or review.

SOURCE: Office of Technology Assessment, 1992.
Chapter l—Overview* and Summary ● 15

Finally, EPA-OPP has in the past dealt with chemicals

and, to a small but growing extent, microorganisms.

These are the areas of staff expertise, for the most part,

not plant ecology. The latter is the strength of USDAAPHIS. In fact, USDA-APHIS currently takes the lead

in assessing applications for field trials of plants genetically modified for enhanced pest resistance. In consultation with EPA-OPP personnel, USDA plant scientists

employ their plant expertise and their established review

system toward this end. Although companies and universities have moved ahead and conducted tests, the unclarified status of OPP’s approach to large-scale

commercialization worries these parties as well as State

governments. Treating all crop plants as pesticides would

take an immense toll in State government time and personnel; yet States cannot plan because they have not as

yet received guidance from EPA as to what is coming.

Appropriateness of TSCA for Biological Commercialization- Can or should a law written for chemicals,

specifically TSCA, be used to cover living organisms’?

Essentially, this is happening as the traditional role of

“gap filler” played by TSCA is applied to planned introductions of microorganisms used for purposes other

than as pesticides. Approval for the introduction of microorganisms rests on determination that they will not

harm human health or the environment. Microorganisms

themselves are not toxic; neither are they likely to be

applied in the volumes typical of chemical applications.

Instead of persisting as do many synthetic chemical compounds, living organisms are eminently biodegradable.

However, because they can potentially reproduce themselves and spread in the environment, their use brings

up concerns different from those aroused by chemicals.

TSCA could be stretched to cover microorganisms.

However, biologically trained staff will have to be given

the authority to develop the procedures and requirements

of the office. Managers will have to acknowledge the

differences between microorganisms and chemicals, and

back up their biologically trained staff accordingly, when

different treatments are devised. Paradigmatic shifts in

management policy need to occur if EPA is appropriately

to adapt to living organisms those laws, premises, and

procedures originally designed for chemicals. EPA’s ability

to evidence such flexibility is questioned.

Managing Risks of Large-Scale Introductions—As

agricultural biotechnology moves toward commercialization and large-scale planned introductions, the combination of several approaches can maximize benefits and

minimize risk. Technically sound implementation of science-based regulations are critical to risk management,

as are technically competent regulatory personnel. In addition, specific scientific and agronomic methods are

needed to manage risks of particular planned introductions. Examples are methods to reduce the chances for

horizontal gene transfer or to diminish the survival potential of any non target recipient of an introduced gene.

Scientists are exploring ways in which the gene of interest, or supplementary genes transferred along with it,

can be designed to constrain the potential for transfer (a

kind of internal, genetic “containment” system).

Agronomic methods can also be used to manage identified risks. For example, physical or spatial barriers could

be put in place between a field of genetically modified

crop plants and the adjacent field or surrounding natural

vegetation. While this sort of barrier would probably not

be necessary in most cases, in particular cases where

gene flow was of concern (perhaps for canola), this could

be useful. Other mechanisms could be used as well, such

as surrounding a field of genetically modified plants with

barriers of a “trapping” species that attracts any pollinators that might otherwise carry genes from one of the

modified crop plants to other plants. The actual need for

such ‘‘separations’—whether spatial, or temporal—can

be determined by assessing the risk of gene flow or of

establishment of genetically modified organisms.

Photo credit: Grant Heilman, Inc.

A traditional approach to isolation of plants is to spatially

separate desired plants from other plants. Similar

guidelines for spatial separation have been applied to

transgenic plants as well.
.

16 ● A New Technological Era for American Agriculture

Risks of Genetically Modified Plants or Microorganisms Becoming Pests—Any novel organism potentially

represents some level of risk to the environment, whether

that organism is naturally occurring or genetically modified. However, the likelihood of a genetically modified

plant or microorganism actually becoming a pest is relatively low. The long history of agriculture shows that

current crops are not likely to become established as

weeds. Long established mechanisms for containment in

agricultural systems have been highly successful in the

United States. Furthermore, recombinant-DNA modified

organisms, unlike wild, naturally occurring organisms,

are designed to exist only in a specific environmental

regime—the nurturing surroundings of a cultivated field.

Microorganisms modified for agricultural purposes are

constrained somewhat like plants, although they are not

so dependent on cultivation for continued survival. However, the extensive agricultural experience with microorganisms has not resulted in a pest problem. To become

a pest, an agricultural plant or microorganism has to exist

independently of cultivation—outside the planted field.

Several steps are necessary to its success; each one, from

dispersal to the production of viable, competitive offspring, is not likely to occur.

Potential for Gene Transfer or Cross-Hybridization

Between Genetically Modified Plants and Wild PlantsCross-hybridization, the crossing of two plants of different species to produce fertile offspring, is a rare phenomenon. While gene transfer between individuals of the

same species is straightforward, gene transfer between

different species is not; their genetic compositions are

usually sufficiently different that they do not line up and

match well for the key molecular and cellular events of

reproduction. Even if a transferred gene were involved

in such a cross, it would be cast onto an ‘‘alien’ genetic

background—its expression could be problematic.

Most crop species in the United States do not have

indigenous weedy relatives with which they could crosshybridize. Canola is the only major crop for which related

weedy species exist in the United States. The possibility

of cross-hybridization is greater in other countries, where

crop species and related weedy species do coexist. Developing countries, in particular are the centers of origin

for many crop species. As it exports agricultural biotechnology capabilities, the United States has at least a

moral responsibility to provide advice to developing

countries as to the management of risk from cross-hybridization.

Options

1. The tools of biotechnology offer great potential

to American agriculture; regulatory treatment of agricultural products derived with such tools will play

a dominant role in any related gains or losses in economic competitiveness. Science-and risk-based regulation of products can help ensure safety while not

impeding the economy.

. Congress could directFederal regulatory agencies

to make science-based, risk-based regulation of biotechnology products (not process) a unifying policy across

agencies.

This would be a clear message to the executive branch

that Congress expects a unified approach across Federal

agencies based on the product not on the process of

biotechnology. Communication through interagency groups

would help to ensure a common approach based on scientifically determined product risk. This approach can

help protect health and environment and, at the same

time, should generate a comprehensive, workable regulatory apparatus for incorporating the tools of biotechnology into American agriculture. However, EPA will

need to address their shortage of technical staff needed

to conduct technical risk-based reviews.

No scientific evidence exists to justify Congress directing agencies to review and regulate biotechnology as

a process, rather than the products produced by it. Nevertheless, EPA-OTS has been accused of regulating the

process of biotechnology, not the products, in its proposed rules. If agencies were to ignore the use of risk

assessment of products and automatically penalize any

efforts made using biotechnology, several impacts would

likely occur. Industries and universities probably would

‘‘agency -shop,’ orienting their efforts toward the agency

with the clearest analytical assessment of science-based

risks—that agency will be the least arbitrary and the most

predictable, an approach certainly favored by industry.

The agency regulating biotechnology as a process sends

out an obvious negative message to industry and perhaps

an equally important, if more subtle, message to the

public. Regulations based on the assumption that biotechnology is inherently unpredictable and highly risky

can lead to reverse public reactions and political pressures

that may be detrimental to the economic competitiveness

of American agriculture.

2. Enhanced pest resistance in crops is one of the

most promising applications of new biotechnology tools.

Obstacles to its development could send a negative

message to agribusiness, slowing its incorporation of
Chapter 1—Overview and Summary* .17

biotechnology as a mechanism fostering increased

economic competitiveness.

. Congress could keep the oversight authority for plants

genetically modified, for enhanced pest resistance under

EPA Office of Pesticide Programs (OPP), but direct

EPA to strengthen OPP.

If oversight of “pesticidal plants” introduced at a largescale is to be handled effectively by OPP. several changes

would need to occur. Technical staff with plant expertise

would need to augment current staff; definitions would

have to be clarified, given that some naturally occurring

plants contain more "pesticidal compounds’” than will

the products of biotechnology: communication with Statelevel implementors would need to be improved immediately; and a clear approach would have to be articulated

so that the public, industry and academia would know

where the agency stands and how it will implement its

policy.

. Congress could direct USDA-APHIS to regulate large -

scale introducation of plants genetically modified for enhanced pest resistance.

Since USDA-APHIS-BBEP has taken the lead for field

tests of plants genetically modified for enhanced pest

resistance, APHIS could handle large-scale introductions. This has the advantages of centralizing plant oversight and making effective use of an already well

functioning technical staff and organizational unit. The

chief disadvantage would be a disruption in the original

Coordinated Framework, which ascribed authority to EPAOPP.

. Congress could direct EPA to work with USDA to

develop a similar model of operation and to report on

progress to Congress within a specified period of time

(e.g. , 6 months).

Despite disadvantages of ‘forcing’ two very different

offices to work closely together, this has the advantage

of allowing USDA to handle any risk concerns related

to planned introductions, while allowing EPA to continue

to handle food-safety concerns related to ‘‘pesticidal’

toxins in the food supply. USDA has established a strong

track record for taking the lead in field tests of pestresistant plants.

3. TSCA is a statute explicitly designed to regulate

activity “for commercial purposes. ” Academic research, therefore, has been exempt from TSCA oversight. The proposed draft rules for microorganisms,

however, greatly expand the regulatory “net.” One

rationale for including academic research is that

sometimes universities engage in technology transfer

or patent filing, or receive research funds from companies. Obviously, the effects of microorganisms being

placed in the environment by a university scientist are

no different from the effects of those same microorganisms being placed in the environment by an industry scientist. Concern exists, however, that the

draft rules could have a negative impact on academic

research.

● Congress could allow the proposed ru1e to stand,

placing the same requirements on academic research as

on industrial research.

Subjecting universities to the requirements placed upon

companies seems contrary to the Congressional intent

behind TSCA. It could have significant negative impacts

on university research. Faced with the added bureaucracy

and high costs entailed by this rule, the majority of university researchers might deliberately avoid planned introductions of genetically modified organisms. This would

leave industry in charge of an area of research that could

continue to benefit from broad, objective, openly published study. Such a situation would inhibit the production of new knowledge for use in future risk assessments.

However, it is an arbitrary decision to exclude universities automatically from oversight—the release of organisms that pose a risk should be regulated regardless

of who conducts the release.

. Congress could direct EPA to develope an oversight

mechanism for planned introductions as an alternative

to the proposed TSCA rule.

Universities could make use of their already existing

system of oversight committees and institutional biosafety officers to regulate biotechnology field trials ‘‘in

house’. Just as the Institutional Biosafety Committees

(IBCS) review laboratory research involving recombinant DNA, they could review proposals for planned

introductions. It would entail education of laboratoryoriented personnel as to the ecological considerations

of field release, as well as possible expansion of committee membership to include appropriate disciplines.

Serving on an IBC is a time-consuming effort for university personnel. Many feel that there are already too

many university committees on which they must serve.

Use of IBCS to provide oversight is a possible tradeoff for the university between being able to conduct

this research or not.

. Congress could direct EPA-OTS to develop special

procedures to minimize or eliminate any unwarranted

regulatory burden on universities, to ensure that public

research continues in this area, and to report to Congress

 on the method selected and its results.
18 ● A New Technological Era for American Agriculture

This option would still hold public scientists accountable but would be aimed at lessening the regulatory burden if the appropriate procedure is used. Several possible

procedures exist. One possibility would be that the agency

funding the research would have the responsibility for

monitoring and reviewing the work. As part of the funding contract, the principal investigator would agree to

follow EPA guidelines on management and to contact

EPA if the need arose. This makes it possible for the

funding agency to monitor the project and enforce regulations through the distribution of funds.

Another approach is to streamline the application for

public researchers. For example, an abstract of a grant

proposal could be required to contain specific information

that would be sufficient to trigger important questions

that arise about the project from EPA. Another possibility

would be for EPA to set aside a budget for reimbursement

of costs incurred in filing an application. However, even

if a cost-savings mechanism is developed, a bureaucracyminimizing mechanism will also be necessary if Congress

desires to encourage public researchers and their home

institutions to conduct the objective research that will

contribute further to our knowledge base.

, Congress could amend TSCA to exclude universities

or to provide alternative means to regulate academic

research.

An argument can be made for including academic researchers. Obviously, genetically modified organisms released into the environment by a public researcher have

the same effect as the same organism placed into the

environment by an industry scientist. On the other hand,

concern exists about the legal precedent that could be set

by extending TSCA’s scope to noncommercial research

and that it could have a negative impact on research. An

application fee for a single field trial costs between

$180,000 and $600,000. Even the lower cost is more

than most universities or research grants are able to cover.

Even though companies have personnel and a budget to

cope with regulatory processes, universities for the most

part do not have regulatory policy offices or the budget

for filing applications. However, if universities and industry worked together, industry would benefit by not

having universities file applications. Congress could make

its intent for universities clear by stating it in legislative

language through TSCA.

4. As large-scale planned introductions become imminent, companies are looking to the regulatory agencies for guidance as to how to proceed. Clear guidance

is critical to commercial development of agricultural

biotechnology.

. Congress could direct EPA-OPP and OTS to clarify

their regulatory approaches to large-scale introductions

and report back to Congress on their approaches within

u specified period of time.

Interagency work groups, as well as the leadership of

EPA, can orient efforts toward assisting EPA staff in

clarifying the regulatory guidelines. A flexible approach

seems appropriate. Clarifying regulatory guidelines would

be particularly helpful to agribusiness working with

“pesticidal plants” or microorganisms other than microbial pesticides. USDA-APHIS-BBEP could provide model

mechanisms for clear communication of requirements,

use of input from outside the agency, addition of technologically-trained personnel, and creation of an effective structure as well as clarification of direction.

. Congress could direct EPA to continue on its present

course.

This is basically a status quo option. It would mean a

continuation of the lack of clarity of regulatory policy

for potential applicants at the large-scale stage. This lack

of predictability could have a negative impact on industry. The absence of applications to EPA-OTS for environmental releases under TSCA over the last year illustrates

industries’ response to lack of predictability in the regulatory arena. It also undermines public confidence in

the ability of regulatory agencies to regulate biotechnology.

. Congress could conduct over-sight hearings of EPA

and USDA regarding regulatory policy for large-scale

release.

Oversight hearings could assist the agencies to develop

policy to meet congressional intent for regulating these

products even though the regulatory agencies have stated

that current laws are sufficient for regulation of products

derived from biotechnology. This could help clarify differences in laws written primarily for chemicals instead

of genetically modified organisms.

5. Institutions handling new technology must win

public confidence and be responsive to public concerns. A balance between maintaining the public interest and ensuring industry competitiveness must be

achieved.

. Congress could direct EPA and USDA to emphasize:

1) increased input of public participation into their Systems; 2) an open process; 3) scientifically sound procedures communicated clearly to other scientists; and 4)

follow-up on appropriate cases.
Chapter l—Overview and Summary .19

Most systems can be made sounder when external input is factored into decisions. External advisory committees, hearings, and informal workshops are examples

of mechanisms by which Federal agencies can obtain

such input. EPA-OPP for example, cosponsored workshops on transgenic plants to gain scientific advice as

they deliberated their approach to “pesticidal plants”

and has used its scientific advisory board in deliberations

over TSCA draft rules. USDA-APHIS has held a variety

of conferences and workshops on planned introductions,

stressing public input and State officials’ input. In fact,

USDA-APHIS has made State input an integral part of

its review process; EPA could wisely adopt this approach

in OPP and OTS.

By developing scientifically sound procedures for determining data needs and communicating them clearly,

an agency can build an accessible database and contribute

to and benefit from the input of the scientific community.

USDA’s Agricultural Research Service is complementing the work of APHIS by building a database on field

tests.

Parties concerned about a new technology want to

know that potentially problematic cases are being subjected to close follow up. While USDA and EPA can

and do impose monitoring requirements on field tests,

both agencies could benefit from implementing more extensive follow upon specific cases that might prove troublesome (perhaps by monitoring indicators identified for

a Possible worst-case scenario). This is, of course, time

consuming. However, if implemented, it should be used

in a rigorous manner, so that undue burdens are not

placed on straightforward cases, yet so the public feels

secure in the knowledge that problematic cases will be

tracked after introduction.

. Congress could require regulatory

velop explicit plans for building public

report those plans to Congress.

agencies to deconfidence and

This option would give agencies maximum flexibility.

It would allow for the evolution of regulation based on

the experience of the agency. Moreover, this approach

would allow for a solution to be developed within the

agency as opposed to it being imposed on the agency

from outside. Reporting the plan to Congress would allow the public to express its opinion and to exert pressure

on the agency to change those parts of the plan found to

be unacceptable. On the other hand, this process is time

consuming for the agencies and Congress. With the large

demands on Congress, some members probably would

be concerned that it was not the best use of their time.

. If regulatory agencies fail to maintain public confidence, new Law(s) or congressional oversight could be

established to satisfy the public demand for account ability.

This option is relatively drastic and could have several

disadvantages. Managing a system from the outside invites logistical and other difficulties. Moreover, the tendency with this approach would be to “freeze” procedures

at a particular moment. This could hamstring the natural

and positive evolution of regulation, such as the gradual

extraction of generic principles from case-by-case reviews. More generally, this approach would be more in

the nature of imposed management rather than a solution

developed within the agencies, and as such, its own credibility may be weakened. However, it is an option that

could ensure accountability to the public if regulatory

agencies are incapable of doing so themselves.

Food Safety

Biotechnology is not so different from previous agricultural technologies as to raise novel scientific issues

concerning the safety of foods. What is substantially

different, however, is the climate in which this new class

of technologies is being introduced. Society in general

is more skeptical of the need for new technologies. Scientific illiteracy combined with a lack of knowledge about

agriculture and biology leads some people to misunderstand how and why these technologies will be used. Society is also skeptical of how new technologies are

developed and regulated. Scandals involving institutions

that develop and regulate these technologies have shaken

the public’s confidence in the ability of these institutions

to carry out their activities responsibly. Public confidence

will sink further if the public feels that food safety standards are too lax, are fraught with scientific uncertainty,

or are not adequately enforced.

In addition, uncertainty exists within industries as to

how new food technologies will be regulated (table 1-

3). FDA policy has been a long time in the making for

biotechnology-derived products. EPA has yet to establish

guidelines on data requirements to establish residue tolerances for pesticidal plants, and USDA’s Food Safety

and Inspection Service (FSIS) has not established guidelines concerning transgenic animals. Genetically engineered products, plants in particular, are approaching

commercialization at a faster rate than was anticipated

even 5 years ago. These agencies no longer have the

luxury of long time frames in which to articulate policy.

An end to the uncertainty over how these products will

be regulated is needed. Additionally, general need exists
20 ● A New Technological Era for American Agriculture

Table 1-3—Federal Agencies Primarily Responsible for Food Safety

Agency Principal statutory authority Responsibilities

Food and Drug Administration Federal Food, Drug, and Cosmetic Act Safety/quality/effectiveness of animal

feeds and drugs, and all foods except

meat and poultry

USDA-Food Safety and Inspection Service Federal Meat Inspection Act and the Safety/wholesomeness/accurate labelFederal Poultry Products ing of meat and poultry products

Inspection Act

USDA-Agricultural Marketing Service Egg Products Inspection Act Safety/quality of egg products and shell

eggs

Environmental Protection Agency Federal Insecticide, Fungicide, Safety of pesticide products

Rodenticide Act

Federal Food, Drug, and Cosmetic Act Pesticide residue tolerance in food/

feeds

National Marine Fisheries Service and Agricultural Marketing Act Voluntary seafood inspection

Food and Drug Administration

SOURCE: Office of Technology Assessment, 1992.

to regain public confidence in the regulatory agencies

responsible for determining the safety of new biotechnology products.

Findings

Establishment of Federal Regulations and Guidelines Concerning Biotechnology FoodProducts—in the

first half of the 1980s, it was anticipated that animal

biotechnologies would be developed more quickly than

plant biotechnologies because more was known about

animal physiology than plant physiology. However, several scientific breakthroughs have speeded progress toward transgenic plants and some are now in various stages

of field testing. As transgenic plants approach commercialization, scientific guidelines for assessing their safety

will be needed. Further delay in establishing Federal

regulations and guidelines could cause a competitive disadvantage to industry, as well as continue to undermine

public confidence in the ability of regulatory agencies to

establish a clear policy concerning biotechnology.

FDA is now wrestling with the question of whether to

classify all, none, or some transgenic plants as food additives and to require a food additive petition for these

foods. In May 1992, FDA published a preliminary proposal regarding the regulation of new varieties of genetically modified crops. This policy states that FDA is

concerned with the characteristics of the food product

and not with the method used to produce the product.

Thus, new genetically modified crop varieties will not

automatically be required to obtain a food additive regulation. New varieties that do not contain new toxicants,

elevated levels of inherent toxicants, altered nutrient

composition or bioavailability, or enhanced allergenic

potential may be regarded as not significantly different

from conventionally produced new varieties that are generally regarded as safe. These varieties could be marketed

without premarket oversight by FDA. The adulteration

clauses of the Federal Food, Drug, and Cosmetic Act

could be used to remove these varieties from the market

if FDA disagrees with a firm’s safety evaluation. Varieties that contain substances (either gene expression products or unintended products) that differ significantly in

structure, function, and composition from substances

currently contained in foods may be required to obtain

a food additive regulation.

The lack of a priori oversight of some new varieties,

however, may still leave considerable uncertainties in the

minds of the public, at least for the first generation of

products developed. Public confidence in the process

may still require at least a minimum review of the product

prior to commercial release. Such review may consist of

notifying FDA of the development of a transgenic crop

and provision of a minimum level of data so that FDA

can make a determination as to whether a food additive

petition will be needed. Such a notification process could

be open to the public so that any significant concerns

can be identified. Additionally, public interest groups

have expressed opposition to the policy and have threatened legal action to prevent its implementation. The policy is currently open to public comment, and could be

subject to revision. Congress may yet be required to

intervene in the development of food biotechnology regulations if differences cannot be resolved in a timely

fashion. If such action is needed, several options are

available to Congress.

Public Confidence in the Decision making Process—

One method of enhancing public confidence in the regulatory process is to make that process open and accessible and to increase public participation in the process.

Opponents of increased public input in regulatory decisionmaking processes argue that citizens lack the training

needed to understand complicated scientific and technical
Chapter l—Overview and Summary .21

issues, and as such their participation only delays the

agency’s decisionmaking without offering any offsetting

benefits. Critics also fear that public representatives may

act in emotional and irrational ways and make unreasonable demands. Those who support increased public

input argue that such input is invaluable in establishing

the legitimacy of regulatory decisions. Indications also

exist that public participation can increase the comprehensiveness of agency decisions by encouraging the

agencies to focus on a wider range of issues and values

than they normally would. Lastly, it is hard to justify no

public participation in regulatory processes in a democratic society.

The public will not make the regulatory decisions—

that is the responsibility of the State and Federal agencies

whose statutory authority requires them to ensure a safe

and wholesome food supply. However, public confidence that these agencies are fulfilling their responsibilities will be enhanced if there are mechanisms available

for public questions and concerns to be heard and addressed prior to decisionmaking by the regulatory agency.

At present, public input into the regulatory process consists of notification and comment procedures and participation on advisory committees.

Recent revelations that companies have withheld negative research results from regulating agencies have also

undermined public confidence and raised serious questions about the process used in making safety assessments. Currently, manufacturers of technology submitted

to the regulating agency for approval also perform the

safety assessment following guidelines established by the

agency. This situation creates potential conflicts of interest. Most companies are honest, but given the current

climate of public skepticism, the appearance of impropriety may be sufficient to prevent consumer acceptance

of a new technology. Given the lack of public understanding about biotechnology, doubts about the validity

of the safety data used to make regulatory decisions for

this new class of products could be substantial. There

may be merit in considering a safety assessment process

that includes independent testing of products.

Tradeoffs Between Industry Competitiveness and Society’s Right to be Informed About Health and Safety

issues—Public interest groups argue that industry claims

too much scientific data as confidential business information (CBI) when submitting a new technology for agency

approval, thereby limiting the amount of health and safety

data available to the public. On the other hand, industry

feels that there is too little protection of proprietary data

by Federal regulatory agencies. Achieving the proper

balance between protecting proprietary rights and disclosing health and safety data to the public is a delicate

undertaking.

Disclosure practices are regulated by the Trade Secrets

Act and the Freedom of Information Act. The Trade

Secrets Act of 1982 subjects government employees to

criminal penalties for the disclosure of proprietary data

unless authorized by law. The Freedom of Information

Act (FOIA) of 1982 permits agencies to protect trade

secrets and commercial and financial information that is

confidential. Both laws seek to protect information that

would be of commercial value to a firm’s competitor.

However, a congressional order mandates that EPA and

FDA release some types of scientific data in certain circumstances.

The FDA has restrictive CBI policies. Although Congress has mandated that health and safety testing data for

new drugs can be released after another manufacturer

becomes eligible to sell the drug unless extraordinary

circumstances are shown, little data are actually released.

This is in part because FDA defines extraordinary circumstances to include any claim that the data are CBI,

such as a claim that it could be used by competitors in

foreign countries.

While FDA usually does not release safety data, it did

in the case of bovine somatotropin (bST). For the first

time in FDA history, FDA published an article in a peer

reviewed scientific journal detailing how FDA reached

its conclusion that bST was safe for human consumption.

Specific safety data were presented. Additionally, the

National Institutes of Health (NIH) and FDA hosted a

scientific meeting with public participation to discuss

food safety concerns of bST. FDA has also published an

article explaining why FDA granted GRAS status to the

genetically engineered enzyme chymosin. Thus, FDA

has shown that it is possible to release such information

when it is in the public interest.

FIFRA protects CBI, but allows release of health and

safety testing data for registered pesticides. Also, data

concerning production, distribution, sale, or inventories

of a pesticide maybe released in connection with a public

proceeding if disclosure is in the public interest. Thus,

FIFRA permits the release of health and safety data after

the decision is made but not during the process.

After notification of a food additive or pesticide registration petition has been published, under FOIA, requests for safety data can be made. However, sometimes

it is not possible for agencies to determine whether or

not information is CBI in the time allotted to them to

make a regulatory decision. Attempts to mitigate these
22 ● A New Technological Era for American Agriculture

problems include requesting that companies restrict their

CBI claims and that they justify their claims of confidentiality at the time they submit a petition.

Decisions to disclose CBI focus on whether or not

such disclosure will be harmful to the company. No attempt is made to weigh this harm against the public’s

right to be informed about health and safety issues that

might affect them. Other countries, most notably Canada,

have taken the approach that disclosure of health data is

authorized if it is in the public interest as it relates to

public health, public safety, or protection of the environment and if it clearly outweighs in importance the

financial loss to the competitive position of a company

or person.

Enforcement of Regulations-Research indicates that

a significant factor in public lack of confidence in regulatory agencies is concern that regulations are not adequately enforced. For example, although Federal law

bars sale of produce with pesticide residues above Federal

tolerances, recent studies show that consumers are willing to pay for labels assuring them that these tolerances

are in fact not exceeded. If the public is to regain trust

in regulatory agencies, enforcement of regulations will

need to be improved.

This will be difficult as biotechnology becomes a new

focus of public concern and a new arena of regulatory

responsibility. The regulatory agencies do not have the

resources to increase enforcement activities significantly.

A recent General Accounting Office study found that the

regulatory agencies involved in food safety had fewer

staff, less funding and a larger workload in 1989 than in

1980. Available resources already are being stretched,

and must be spread even thinner to develop new multiresidue assay procedures and sampling methodologies for

tracking genetically modified organisms. A new approach to food safety assessment must be developed as

well. Traditional approaches to safety assessments of

food additives are inappropriate for the assessment of

whole foods because large enough quantities of the food

cannot be fed to test animals without invalidating the

results of the test. New assay and testing methods applicable to genetically modified foods will thus be needed,

and this will require additional agency resources.

Labeling—Many consumers have expressed a desire

that food products developed with biotechnology be so

labeled. However, while consumers express a desire to

have accurate and verifiable labels, many of them are

not willing to pay much for those labels. For example,

approximately one-third of consumers do not seem willPhoto Credit: U.S. Department of Agriculture,

Agricultural Research Service

Chemist evaluates a screening assay for residues. New

analytical methodology will need to be developed for

biotechnology-derived foods.

ing to pay anything for labels; another 5 to 10 percent

of consumers seem willing to pay as much as 50 percent

higher food prices for labels. Most consumers seem willing to pay 5 to 10 percent more for labels. Clearly a

labeling proposal that is expensive will not be popular

with most consumers.

FDA has stated in its preliminary policy that generic

labeling of biotechnology food products will not be required but selected products may require labeling. Such

products include those for which nutritional composition

has been altered or potential allergens introduced.

International Coordination—The United States annually imports billions of dollars worth of food products,

many from countries that also use biotechnology in their

food industries. If U.S. food safety regulations concerning biotechnology substantially differ from other countries’ regulations, difficulties could arise. U.S. producers

will likely beat a competitive disadvantage if U.S. policy
Chapter 1—Overview and Summary ● 23

is substantially stricter than that of other countries. Enforcement will be difficult—no generic methods exist to

detect genetic modification. Reliance on the word of

other countries that their products contain no biotechnology-derived constituents may or may not be acceptable. If U.S. regulations are substantially less stringent

than those of other countries, then the U.S. agricultural

export market could suffer. Agricultural commodities are

a major export of the United States. Thus, international

coordination will be paramount. Preliminary FDA policy

is consistent with international organizations’ working

papers and reports on food safety assessment procedures

for genetically modified organisms.

Options

1. FDA and EPA no longer can delay the development of final regulations and guidelines because

transgenic plants are approaching commercialization.

FDA has the choice of requiring a food additive petition for all, some, or no transgenic plants.

. Congress could monitor the development of regulations and conduct oversight hearings of FDA and EPA

to determine why final regulations and guidelines do not

exist and to have them report back to Congress with

recommendations in these areas within a specfied period

of time.

This would be a strong signal to the executive branch

that Congress is concerned about the delay in providing

guidance to the private sector for these new technologies.

An oversight hearing would provide the agencies with

an opportunity to explain their rationale and concerns in

establishing regulations for these new products and allow

Congress the opportunity to provide guidance and direction to the agencies.

Congress and the Executive Branch through EPA,

FDA, and USDA have a number of options for regulating transgenic organisms. The following part of

Section 1 illustrates options available.

. Congress or FDA could establish categorical exclusions to the requirement of a food additive regulation for

certain transgenic organisms and require a case-by-case

approach for the remaining products.

Essentially, this is the policy chosen by FDA. Transgenic organisms that involve gene products that are widely

present in the current food supply, and do not introduce

new toxicants, elevate levels of existing toxicants, alter

the composition or bioavailability of nutrients, or transfer

allergenic components, and that use safe marker and promoter sequences can be excluded from the need for a

food additive regulation. These products do not introduce

new food compounds into the food supply and they have

no unintended effects. Therefore, FDA states that they

can be classified as GRAS because they are equivalent

to traditional new varieties that historically have been

given GRAS status. Only products that contain components that are significantly different in structure, function, and composition may be required to obtain a food

additive regulation on a case-by-case basis. This option

is a risk based option that requires extensive safety testing

for products that are not normally found in the food

supply, and less testing for products that contain substances already widely consumed. It places responsibility

for the initial food safety assessment with industry. Lack

of FDA oversight, especially for the first generation of

biotechnology-derived food products, may raise public

concerns. A number of public interest groups have indicated their opposition to this policy.

. Option: Congress or FDA could establish a policy

similar to the preliminary policy articulated by FDA,

and include a formal notification procedure.

Such a policy would require the establishment of a

system for notifying FDA when a new transgenic crop

is marketed. As currently outlined, FDA policy allows

firms to determine if a new variety contains components

that are already widely consumed. Thus, firms can make

a determination about the GRAS status of new biotechnology products without consulting FDA. In the beginning, it is quite likely that most firms will consult FDA

prior to marketing a new biotechnology-derived variety,

but they are not required to do so. This situation is likely

to create considerable apprehension among the public.

Thus, a formal system of notification may be desirable.

The notification process could include safety data

the company used to determine that the product was

GRAS. Such data includes the identity of the host and

donor organisms, information on the genetic construct,

and information on the physiology of the gene product.

Additional information required could include compositional data. A comparison of nutrient and toxic

component levels in transgenic and counterpart traditional crops could be included, as well as data on allergens. This type of information will be available in

the development of transgenic organisms and is required for a company to make its determination of the

regulatory status of the product. Thus, requiring this

information to be on record with FDA should not present undue burdens on industry. However, requiring

FDA to review and act on this information for all transgenic crops will place a strain on the agency’s re-
24 ● A New Technological Era for American Agriculture

sources. Most likely FDA will need additional resources

to implement this policy.

The notification process could be open to the public

so that they can raise concerns and issues regarding transgenic organisms. It may also be useful for FDA to use

an advisory committee to comment on the data presented.

If an advisory committee is used, representatives from

the public could be included along with technical representatives.

Such a policy might be effective for the safety assessment of the first biotechnology food products developed. It would allow FDA to provide at least minimal

oversight over all biotechnology food products, assure

the public that scientific information is available, and

thus, might alleviate some public concern. In the short

run, such a policy may appear to result in unnecessary

regulation of these products. However, it may be the

price industry must pay to have their products accepted

by the public, at least in the initial stages of commercializing biotechnology food products.

. Congress or FDA could require a food additive

petition for all transgenic crops.

This policy would force all transgenic food products

to undergo a premarket safety approval process. It would

only be based on a risk assumed to be inherent in the

process of genetic engineering, an assumption not supported by scientific data. This policy would likely delay

commercialization of transgenic crops already being developed and possibly could inhibit the development of

additional transgenic crops. On the other hand, this policy would not be inconsistent with a broad interpretation

of the food additive definition. And it probably would

soothe some consumer fears and uncertainties about these

products.

. Congress or FDA could establish some categorical

exclusions of transgenic food products from the requirement of a food additive petition, and could require all

other biotechnology products to meet the requirements

of a food additive petition.

Once again categorical exclusions might include transgenic crops that do not contain components that are significantly different from those currently present in the

food supply and for which unsafe, unintended components have not been introduced. This policy would be

more risk based than requiring all transgenic organisms

to meet the rigors of a food-additive petition, because

transgenic organisms that are essentially the same as

products that have historically been viewed as safe would

not be required to undergo premarket approval. This policy would ease some of the burden on industry. There

may still be public apprehension with respect to those

products that have been excluded.

Ž Congress or FDA could establish a policy in which

the gene expression product is classified as a food additive if the same traditionally processed product would

have been classified as such. It could exclude from the

food additive definition gene products that would not

have been classified as a food additive if produced by

traditional means.

Gene products that might be excluded as food additives

are those that would code for agronomic functions such

as drought resistance. This policy is based more on the

intended use of the gene product rather than any safety

risk that the gene product may pose, but would be consistent with how FDA has historically interpreted the food

additive amendment. It would, however, be difficult to

justify on scientific grounds.

. Congress or FDA could establish a policy that the

requirement for a food additive petition for transgenic

organisms be determined on u case-by-case basis for

each transgenic organism.

Such a policy would allow FDA to provide oversight

of all biotechnology products. This would provide the

public with an assurance that all transgenic organisms

would be reviewed by FDA. However, continuation of

this type of policy indefinitely could overwhelm FDA,

since the number of products that could be developed is

large. At some point, FDA will likely need to categorize

some products as GRAS, just as it does with chemical

additives.

. Congress or EPA could establish guidelines for the

safety evaluation required to establish pesticide tolerances for whole plants.

Currently, EPA does have guidelines for transgenic

pesticidal microorganisms, but has yet to establish such

guidelines for whole plants. Transgenic plants producing

pesticidal compounds, such as Bt producing plants, are

completing small-scale field trials. Guidance from EPA

for dealing with such plants no longer can be delayed.

Establishment of safety guidelines will require a new

assessment paradigm (discussed later). Additionally. because States, FDA, and USDA enforce pesticide tolerances, EPA needs to work closely with appropriate agencies

in establishing tolerances. EPA’s work with States needs

improvement in this area. Only recently has EPA even

begun to compile a list of contact persons in State agencies. This ignoring of States could easily lead to State

laws that are incompatible with Federal regulations, or
to gaps in State authority or expertise to carry out Federal

regulations. Congressional hearings and oversight may

be necessary if EPA does not improve this situation.

. Congress or USDA -FSIS could establish guidelines

concerning transgenic animals.

USDA-FSIS plans to release guidelines in the near future

concerning the slaughter of experimental animals in which

gene transfer attempts failed. Guidelines concerning the

slaughter of transgenic livestock are still in early draft form.

Of particular interest will be guidelines concerning the

slaughter and potential food use of transgenic animals that

produce pharmaceuticals. FSIS and FDA have established

a joint committee to deal with issues that jointly affect the

two agencies. Careful monitoring of how successful this

committee is may be required.

2. Public confidence in the regulatory process needs

to be enhanced. Making the regulatory process open

and accessible to the public and above reproach is a

key factor in providing trust and confidence in the

decisionmaking process.

. Congress could direct agencies (FDA, USDA) to

establish mechanisms to allow for increased public participation and to report their results to Congress within

1 year.

This option sends a clear message to the agencies that

Congress is concerned about the public’s view of regulatory agencies and that the public should be more involved in the decisionmaking process. It gives maximum

flexibility to the agencies to determine the method of

incorporating the public’s input.

A number of mechanisms are available. For example,

Federal agencies could establish criteria by which local

agencies can be notified any time significant risk or unique

questions arise that are pertinent to them. Agencies may

wish to adopt a procedure similar to that used by FIFRA,

i.e., notification of petitions received, and if public interest warrants, an informal hearing. Increasing public

participation will require increased resources and risk

politicizing decisions, but could also enhance public confidence in the regulatory process. It might cost less in

the long run.

. Congress could direct the agencies to crease the

use of advisory committees for decisions involving biotechnology and to change the composition of their membership to increase the number of nontechnical public

representatives.

For FDA, advisory committees could help establish

GRAS and the minimum information needed for food

additive applications of genetically engineered whole foods.

These committees could be used as a first screening

mechanism to see if a food additive petition is actually

needed. Public meetings help assure the scientific validity

of the process. EPA might also use advisory committees

to establish tolerances for genetically engineered plants

with pesticidal properties. This might be helpful since

in-house expertise to handle this responsibility seems to

be lacking. Advisory committees might also prove useful

to USDA in establishing a policy on transgenic animals.

The credibility of any advisory committee will be enhanced if it includes public representatives.

FDA may need to consider granting current nonvoting

members of its advisory committees the right of full

voting membership. And they may need to expand the

list of technical fields beyond MDs from which experts

are drawn.

Use of advisory committees presents some logistical

problems and requires additional resources, but provides

expertise that currently may be missing. Additionally,

the possibility that non-technical representatives will pursue political agendas and unnecessarily delay committee

decisions exists. However, used properly, such representatives can focus the attention of the committee on

issues that might otherwise be overlooked and provide

legitimacy to committee decisions.

● Congress could direct the agencies (EPA, FDA,

USDA ) to change the notification procedures for advisory

committee meetings.

The standard method of notification for advisory committee meetings involves publication in the Federal Register. Few members of the public know what the Federal

Register is, much less read it regularly. Also, notices

published are written by and for those individuals knowledgeable in the field and, thus, the general public might

not be clear as to what the issue is. Additionally, most

meetings are held in Washington, DC. Agencies could

have committees convene in different cities and publish

announcements, other then the Federal Register, that are

more likely to be noticed by a wider public. Such activities are likely to be more expensive than current ones,

however, but make the decision-making process more

accessible to the public.

. Congress may wish to appoint a task force to study

the role of independent safety testing of biotechnology

products.

Independent testing is unlikely to be popular with industry, however, a growing perception exists that companies are withholding negative data and that the safety

297-937 0 - 92 - 2 OL 3
26. A New Technological Era for American Agriculture

review conducted by regulatory agencies is made without

accurate and complete data. Enhanced authority to subpoena data by regulatory agencies, most notably FDA,

could be useful. Additionally, it may be worthwhile to

consider establishing independent testing of products.

FDA, for example, rather than companies could choose

outside investigators to perform selected safety assessments, and these contractors could report results directly

to FDA rather than the companies. A study to consider

the broad range of implications of such a change would

be warranted before implementation.

3. Public interest groups argue that industry claims

too much scientific data as confidential business information (CBI), and that this restricts the amount

of health and safety data available to the public. Industry argues that there is too little protection of proprietary data and that this situation adversely affects

their competitive position. Achieving the proper balance between protecting proprietary rights and disclosing health and safety data to the public is a delicate

endeavor.

● congress could encourage FDA to publish more

scientific review articles and hold public meetings in

cases that generate public interest.

Clearly it is possible for FDA to release considerable

health and safety information to the public as it has done

for bST. The public controversy surrounding this product

apparently outweighed any competitive disadvantage

presented to the firms producing bST. Such a policy

might prove useful in responding to public concerns about

other biotechnology products and potentially could enhance the accountability and credibility of FDA decisions.

. Congress could conduct oversight to provide increased guidance to regulatory agencies attempting to

encourage firms to reduce CM voluntarily.

Congress could monitor whether health and safety data

are being made available as products approach commercialization or if firms withdraw their voluntary cooperation and claim more data as CBI. If firms increase CBI

claims, Congress could direct Federal agencies to require

firms to justify CBI claims when a petition is submitted

rather than waiting until a FOIA request is made. Currently, firms realize that it takes regulators longer to

determine the validity of CBI claims than the time allotted

to make regulatory decisions. This could encourage some

firms to make CBI claims of data that in fact are not

confidential.

Congress could also direct agencies to facilitate reconsideration of a decision if CBI data are released after

a regulatory decision is made and causes public concern.

Currently, firms can avoid public disclosure of data during the regulatory process simply by claiming confidentiality and know that the regulatory decision will not be

reconsidered. If the decision is allowed to be reconsidered, firms may reduce their CBI claims.

Industry will oppose increased disclosure of safety data

because it will erode their competitive position, On the

other hand, with the current climate of public skepticism

of new technologies and regulatory agencies, increased

industry accountability and public disclosure of safety

data may be required of business.

. Congress could liberalize the CBI policy.

Congress could direct FDA to release data it is currently authorized to release but generally does not. Congress could consider adopting a regulatory policy similar

to that used in Canada which would weigh any harm to

the company against the public’s right to be informed

about safety concerns. Current policy considers only the

harm to firms. As a last resort, Congress could force the

disclosure of health and safety data. Once again the potential harm to the competitive position of companies

must be weighed against the public’s right to be aware

of potential safety risks and to regain public confidence

in the regulatory process. Industry probably will object

to an easing of CBI policy. Public support, on the other

hand, may be equally strong for disclosure.

4. Genetically modified foods will require a new

paradigm for food safety evaluations. Changes in data

needs, assay procedures, and sampling methodologies

will be required.

. Congress could fund the development of new analytical methodologies and assay procedures through the

National Institutes of Health (NIH).

New analytical methods for whole food assessments

must be developed if FDA is to determine the safety of

genetically modified crops, and to monitor foods once

they are marketed commercially. NIH, in coordination

with FDA, could provide funding to develop food analytical technologies, These new technologies and assessment procedures would be useful in determining the

safety of genetically engineered foods and could also

enhance research programs such as the designer foods

project (a component of cancer research) and nutritional

programs.
Chapter l—Overview and Summary ● 27

. Congress could provide funds to NIH for the development of databases detailing the normal range of

nutritional and toxic components of food.

Major nutrients and toxic substances in food have been

identified, but additional information is needed to assess

these food components, such as the quantities at which

they normally are present in foods and their chronic impacts on humans. Assessment of such information will

be needed to determine whether genetically modified foods

present greater safety risks than do foods currently consumed.

. Congress could direct FDA and EPA to request that

assay procedures developed by firms to detect additives

be readily adaptable for use under field conditions.

Currently, when firms submit a food additive petition

or a pesticide registration, they are required to provide

an assay method to detect residues or additives in food.

Generally, the method provided applies to a single residue and requires sophisticated instrumentation for identification and quantification. Agencies might require

multiresidue assay methods that are more readily usable

under field conditions than they are today. The residues

would have to have some similar characteristics for a

multiresidue technology to work. Development of such

assay methods may create technical difficulties and are

likely to create added costs for industry. However, they

would improve monitoring and enforcement activities of

regulatory agencies, an issue of particular importance to

the public.

5. Surveys clearly show that consumers desire additional information about the foods they consume.

Labeling is a method to provide this information, especially for those concerned about foods produced

from biotechnology.

. Congress could mandate that all food products containing constituents derived from biotechnology be so

labeled.

This would satisfy the desire of the public to be able

to identify foods derived using biotechnology. But it

probably would be expensive to provide labels and difficult to verify label information. No generic means exists

today to identify whether a food constituent, such as a

kernel of corn that will be ground into meal, has been

genetically engineered or not, and it is unlikely that such

a method can be developed. Consequently, genetically

modified products would have to be kept segregated

throughout the market to be able to assure the public as

to whether their food contains such products or not. This

is not now the case for many bulk commodities, such as

grains, and entirely new marketing structures would need

to be developed. Increased vertical integration of agricultural industries would likely occur. And, significant

government resources would be needed to enforce mandatory labeling and the added expense would be passed

along to consumers. Thus, guaranteeing that a product

does not contain any products derived from biotechnology could become expensive. Based on current research,

it is not clear that consumers would be willing to pay

that added expense.

. Congress, through research and extension agencies,

could encourage niche markets to be established to satisfy the concerns of those willing to pay higher prices

for labeled food signifying that it does not contain genetically engineered food.

An alternative to passing the high cost of verification

along to all consumers is to establish a higher priced

niche market for biotechnology-free foods that would

satisfy needs of some consumers. Such a market would

be similar to the current organically produced food market. Organic produce is higher priced than traditionally

grown produce but provides an alternative product to

consumers who are willing and able to pay higher food

prices. Recent legislation has been enacted to help resolve some problems involved with organic produce such

as a lack of a standard definition, grower certification

and oversight procedures. Such a policy might also work

for biotechnology-free food products, and would have

the advantage of passing the extra costs along only to

consumers willing to bear them.

Public Sector Research

It is becoming increasingly difficult for the land-grant

system to carry out its historic mission. In addition to

the increasingly specialized nature of the research conducted, pressures from outside the system are building.

Changing political support, resource base, and institutional frameworks combined with the development of

revolutionary new technologies will put pressure on the

land-grant system to change dramatically.

Historically, political support for the agricultural research system has come from the farm and rural population. For this reason, agricultural research has focused

heavily on increasing the productivity of agriculture.

However, this traditional base of support has been steadily

eroding, and urban groups have put pressure on the system to shift research priorities to such areas as water

quality, human nutrition, food safety, and sustainable

agriculture.
.—

28 ● A New Technological Era for American Agriculture

The development of biotechnology and advanced computer technologies has the potential to revolutionize the

way in which agricultural research is conducted, and to

provide powerful tools to help address social problems.

The scientists who conduct research using these technologies will need a thorough grounding in the basic

disciplines that underlie them. Today only a small proportion of academic agricultural scientists have this background. Moreover, for advanced computer technology

research to reach its potential, it will need to be identified

as a research priority and universities must be encouraged

to develop a promotion and tenure system that recognizes

more than a publication record for research accomplishments. In addition, multidisciplinary teams involving basic

computer sciences, systems design, and traditional agricultural sciences need to be encouraged. To this end,

development of nationally recognized centers of excellence, similar to those developed for biotechnology, need

to be considered.

In general, agricultural research is underfunded. Estimates of the social rate of return to public-sector agricultural research investments range from 35 to 145

percent, indicating a significant underinvestment in this

type of activity by the public sector.

There has also been a slight, but potentially significant

shift in the source of funding for agricultural research at

land-grant universities (table 1-4). The States, which provide the majority of the funding for research at these

universities, have been constrained in spending by the

recession of the early 1990s. Few States have increased

funds for research and many have cut funding in this

area. USDA funding, the second largest single contributor to agricultural research, has remained basically stagnant, barely keeping up with inflation.

Funding from the private sector for university research,

on the other hand, has been increasing in the form of

industry-supported research, and from the sale of products by universities. Currently, these sources of income

represent about 13 percent of the total funding for agricultural research, but have increased by 60 percent since

1982. The product sales category is a potentially lucrative

source of funding for universities. Legal and institutional

changes have made it easier for universities to capitalize

on their research, since now they can retain title to any

federally funded technology the university develops. Incentives to privatize the benefits of university innovation

could shift the university further toward private funds,

especially if public funds do not keep pace with increased

needs.

Changing clientele, funding bases, technologies, and

institutional structures will create new demands on the

land-grant system. Decisions need to be made on how

land-grant universities can best serve society in this new

era.

Findings

The Uniqueness of Land-Grant Universities—Landgrant universities differ from other universities in their

legislated mission to address research on the problems

of society. Some argue that the land-grant system has,

in part, already abandoned its mission, as agricultural

researchers increasingly work for disciplinary laurels rather

than society’s benefit. Others argue that the system deTable 1-4—Total Research Funding for State Agricultural Experiment Stations, Selected Yearsa

(in millions of dollars)

USDA Other Product

Year USDAb

competitive Federald Statee

Industry sales Otherf Total

1982 . . . . . . . . . . . . . . . . . 161.3 5.5 77.8 522.2 57.0 58.5 70.0 952.3

1984 . . . . . , . . . . . . . . . . . 174.9 6.1 81.7 591.4 64.1 61.3 79.8 1,059.3

1986 . . . . . . . . . . . . . . . . . 174.4 11.9 110.8 704.3 78.1 62.9 89.8 1,232.1

1987 . . . . . . . . . . . . . . . . . 175.6 16.8 114.9 732.5 87.4 68.4 104.2 1,299.8

1988 . . . . . . . . . . . . . . . . . 187.0 19.3 115.0 770.0 91.2 77.8 114.1 1,374.2

1989 . . . . . . . . . . . . . . . . . 194.0 21.9 130.4 827.6 101.2 82.4 132.1 1,489.6

1990 . . . . . . . . . . . . . . . . . 203.6 20.0 143.9 877.9 113.8 91.6 145.7 1,596.5

a Funding is for the State Agricultural Experiment Stations only and does not include the 1890 universities, the Schools of Veterinary Medicine, or the

Forestry Schools. Funding is in current dollars.

bUSDA includes Hatch, Mclntyre-Stennis, Special Grants, Evans-Allen, Animal Health, and miscellaneous other funds administered by the Cooperative

State Research Service.

c USDA competitive is the USDA competitive grants program.

d other Federal includes funding from Federal agencies excluding USDA and includes funding from NIH, NSF, AID, DOD, DOE, NASA, TVA, HHS, PHS,

etc.

‘State is state appropriations.

‘Other includes funding from nonprofit organizations, and contracts and cooperative agreements administered by USDA.

SOURCE: Inventory of Agricultural Research, Cooperative State Research Service, U.S. Department of Agriculture, Washington, DC, various years.
Chapter l—Overview and Summary ● 29

fines society’s problems too narrowly, placing too much

emphasis on increasing agricultural productivity and too

little on nutrition, environmental, and rural problems

among others. Some also argue that too much attention

has been given to production agriculture and not enough

to postharvest technologies, value-added products, consumer preferences, and agribusiness problems.

No easy answers exist as to what types of research

should be conducted with public funds. What is clear,

however, is that as the traditional clientele (i.e., farmers)

continues to shrink. greater demands will be placed on

the system to address the needs of other groups. To be

able to do so may require some difficult choices concerning research mix, with some traditional research programs being eliminated and some new programs initiated.

Research Funding Based on Mission Functions—In

recent years the land-grant system almost exclusively has

embarked on a program to increase public funds through

competitive grants. Relatively little attention has been

given to securing other types of funding such as Hatch

formula funds. This strategy is questionable for the landgrant system in the long run. Research conducted in

conjunction with this study suggests that the most appropriate funding policy is a healthy mixture of formula

funds and competitive grants. The results indicate that

different funding mechanisms may be more appropriate

for the different functions or goals of land-grant universities. For example, if the goal is to increase cuttingedge basic research, increased funding for competitive

grants might be the best approach. If the primary goal

is to enhance research applicable to problem solving or

to train future researchers, the more stable and locally

controlled Hatch formula funds may be the more appropriate mechanism. The appropriate allocation of these

two types of grants depend on the relative priorities given

to the three missions of land-grant universities.

Potential Privatization of Research at Land-Grant

Universities—Two new sources of research funds are

private sector investment and product sales. Constrained

and basically stagnant research budgets provide many

incentives for universities to increase funding via these

mechanisms, but the development has raised many concerns. For example, incentives to privatize university

innovations for the benefit of the university rather than

society could conflict with the mandated mission of the

university. Using public resources to reap private gains

raises many ethical questions. Allowing individual researchers to share in the profits of their publicly funded

work and encouraging universities to produce consumer

products opens the door to potential abuses. Certainly,

potential exists for conflicts of interest. There may be

financial conflicts if individual researchers are allowed

to capture the returns of their innovations. To some extent, this situation already exists in that researchers use

public funds to generate new knowledge that can be sold

to the private sector in the form of consulting fees. But

there is a distinction between providing expertise to potentially multiple clients and having a vested interest in

the development of one or several products by companies. Universities also may face conflicts of interest. The

credibility of the university may suffer if it is viewed as

being too cozy with industry. If public universities are

viewed as being more concerned with their own private

good than with the public welfare, then the public may

not maintain its support for the university.

One underlying principal of scientific research is the

free exchange of research results. Concern arises that

with increased potential to earn income from research,

the results of research will become more proprietary.

Moreover, research results may not be freely or readily

exchanged if a researcher, university, or industrial sponsor attempts to patent the results or seek additional private-sector funding.

Given the level of underinvestment in agricultural research and the stagnation of public-sector funding for

this activity, the extra revenue earned from product sales

could provide great benefits for the university and for

society. Whether those benefits will be attained will depend on how the revenue generated from commercialized

activities is used. The extra revenue could be used to

fund socially underfunded research or to enhance the

teaching capacity of the university. The new arrangements may enable universities to contribute to economic

development in ways not previously possible. Whether

or not the funds are used for such purposes will depend

on how well university administrators are able to maintain a sense of priority for the overall research and teaching program, and whether they have the administrative

skills to keep scarce resources allocated to the proper

ends.

Policy Options

1. The new partnership between the public and

private sectors potentially can revitalize agricultural

research, but could also bias the overall research endeavor and damage the credibility of universities. Research and close monitoring will be needed to

understand the changes occurring within the landgrant system and to ensure that they are not undermining the system as a whole.
30. A New Technological Era for American Agriculture

. Congress could require the U.S. Department of Agriculture to monitor the increased private-sector, funding

of agricultural research and to prepare an annual report

for Congress containing the data.

Currently, little is known about the extent of privatesector funding at land-grant universities and the nature

of the relationship between the universities and the private sector. Congress could conduct oversight hearings

periodically on this issue. Furthermore, Congress could

direct USDA to collect data from the land-grant universities on the extent of public-private collaboration, to

prepare an annual report for Congress containing the

data, and to provide guidelines on the appropriateness of

various public-private sector research collaborations.

. Congress could direct USDA to require land-grant

universities to establish an explicit policy with regard to

research sponsored by the private sector and report that

policy to Congress.

The USDA would require each university using private-sector research funds for agriculture to establish a

specific policy as to how those funds are used based on

a broad policy established by the land-grant system. Establishing an advisory board that includes members of

the public in setting priorities for research funded from

the private sector might be an effective mechanism. This

would help to increase public confidence that the university is using funds to solve problems that confront

society.

2. High rates of return to public-sector investments

have been reported by numerous studies, including

past OTA reports. This indicates that public sectorresearch funding is below optimum rates.

. Congress could increase public-sector support of

agricultural research.

Increasing public-sector support of agricultural research might help to lessen the pressure on land-grant

universities to obtain funds from the private sector. Given

the high rate of return on public-sector funding of agricultural research, funding increases probably would prove

beneficial.

. Congress could maintain or decrease public-sector

funding for agricultural research.

Federal funding for agricultural research has been relatively flat for the last 30 years. As a consequence, States

have picked up the increased costs of conducting agricultural research. It is difficult for States today to take

on an ever increasing share of public supported research.

If the Federal Government continues to reduce its contribution to research funding, land-grant universities must

look for alternative sources of funding. Private-sector

funding from specific industries or individual firms or

product sales from technologies developed by the university are the most likely sources of additional research

funds. The impact of this shift in support is not known

but needs further analysis.

3. Recent research indicates that public-sector

funding mechanisms should be goal oriented.

. Congress could appropriate funds for agricultural

research through funding mechanisms bused on welldefined agricultural research goals.

The land-grant system provides teaching, extension,

and research functions. Preliminary research suggests that

Hatch formula funds are more suited to teaching and

extension activities and competitive grants more suited

to basic research. By appropriating funds according to

goals to be achieved, Congress could improve the effective use of public funds.

. Congress could maintain the current emphasis of 

increased funds for competitive grants and level or decreased funding of formula and intramural funds.

Implicitly, this would indicate that Congress places

greater emphasis on basic research than on adaptive research, extension, and teaching activities. Evidence does

not exist that the lack of basic research is the primary

constraint to the ability of land-grant universities to fulfill

their historic mission of addressing research aimed at

solving societal problems.

. Congress could extend competitive grants to extension and teaching curricula development.

A strong case can be made for formula funding of

agricultural research. However, if the only acceptable

political form of increased funds is competitive grants,

then expanding these grants to include adaptive research,

extension and teaching could be considered. Balanced

funding of basic research, adaptive research, teaching,

and extension would significantly strengthen the landgrant universities and help them meet their multiple missions more effectively.

. Congress could award certain competitive grants to 

basic research that clearly shows ties to adaptive research.

This would be a clear signal that Congress considers

the original mission of land-grant universities to be appropriate today. Currently, most grants for basic research

are not tied directly to adaptive research. Thus, it is
difficult to differentiate between funding provided by the

National Science Foundation (the major funding agency

for basic research) and the U.S. Department Agriculture.

4. The public is increasingly losing confidence in

land-grant universities’ credibility, and credibility

needs to be restored. Development of a more missionoriented system with increased public input could help

to restore confidence in the system.

The OTA report Agricultural Research and Technology Transfer Policies for the 1990s addresses this issue

in some detail and provides specific options that suggest

changes in the system to make it more mission oriented.

Those options are incorporated here by reference. Some

of the options were incorporated into the 1990 Food,

Agriculture, Conservation, and Trade Act of 1990( 1990

Farm Bill).

SUMMARY

Newly emerging biotechnologies and information

technologies hold great promise for American agriculture

and can provide solutions to many problems. In the decade of the 90s, however, public concerns about the

environment, food safety, industry structure, and institutions will focus on these emerging technologies. Whether

these technologies will be accepted and flourish, or stagnate, will depend in large measure on how U.S. public

institutions resolve the complex problems of regulatory

oversight and on whether scientists and policy makers can

allay public concerns about biotechnology in particular.
Part I

The Advancing Technologies
Chapter 2

Emerging Plant Technologies
Contents

Page

TOOLS AND TECHNIQUES OF BIOTECHNOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Biotechnology Techniques Used To Create Transgenic Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

Other Biotechnology Techniques . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

Application of Biotechnology Techniques To Create Transgenic Plants . . . . . . . . . . . . . . . . . . . . . 44

Biotechnology in the Food Processing Industry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

TOOLS AND TECHNIQUES OF BIOLOGICAL CONTROL . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Approaches Used in Biological Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

Use of Biological Control Agents To Control Pests in the United States . . . . . . . . . . . . . . . . . . . . 54

SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

CHAPTER PREFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61

Figures

Figure Page

2-1. Identification and Isolation of Desired Gene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

2-2. Gene Transfers With Bioblaster . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

2-3. Plant Tissue Culture Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

2-4. Antisense Technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

2-5. Preparation of Monoclinal Antibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

Tables

Table Page

2-1. Transgenic Crops Produced . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39

2-2. Current Targets for Crop Modification for Herbicide Tolerance . . . . . . . . . . . . . . . . . . . . . . . . . 47

2-3. Virus Coat Proteins Engineered Into Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48

2-4. Disease Resistance Genes Introduced Into Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49

2-5. Use of Tissue Culturing To Improve Food Characteristics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

2-6. Use of Parasite or Predator Insects To Control Insect Pests in the United States . . . . . . . . . 54

2-7. Pathogens Used To Control Insects in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55

2-8. Control of Weeds by Microbial Agents in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

2-9. Microbial Herbicides Commercially Available or in Development in the United States . . 58

2-10. Use of Insects To Control Weeds in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58

2-11. Biological Control Agents Commercially Available To Control Plant Disease in the

United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59
Chapter 2

Emerging Plant Technologies

Each year in the United States weeds, insects, diseases,

and poor weather conditions significantly lower crop yields.

On average, major crop production in the United States

achieves only about 22 percent of the yield theoretically

possible under ideal conditions, based on genetic potential.

Approximately 69 percent of this loss is due either to unfavorable climate and production using inappropriate farm

management practices or poor soils. However, weeds, insects, and disease result in an annual average loss in total

yield of 2.6, 2.6, and 4.1 percent respectively (6, 7, 8,

39). Seventy-one percent of crop insurance payments paid

in the United States (from 1939 to 1978) were for crop

losses caused by drought, excessive water, and cold (6, 8).

The financial value of these losses is staggering.

Diseases in fruits, vegetables, grains, and oilseeds result in annual average losses in value of 17, 13, 11 and

13 percent respectively. For some highly perishable fruits,

such as raspberries, blackberries, and cherries, losses

from disease are estimated to be 38, 34, and 24 percent

respectively of their total value. Annual losses in the

United States due to viral diseases alone are estimated

to be $1.5 to $2.0 billion dollars (5). A recent study

estimated that crop diseases resulted in lost revenues

equal to approximately 15 percent of the total crop in

North Carolina. This value, if extrapolated to the United

States as a whole, would result in losses of approximately

$12.6 billion per year (8, 28). Loss in value due to weeds

has been estimated at 10 to 20 percent of the total crop

value; nearly $16 billion per year. Approximately $5

billion is spent annually to control weeds on farms and

in rangelands, forests, and waterways ( 10, 26).

Traditional approaches to managing these problems

have included the use of traditional breeding techniques

to develop new crop varieties resistant to pests and better

adapted to geoclimatic conditions. cultural practices, and

the application of chemicals. Pest management is complicated by the fact that plant pests continuously adapt

to new management techniques.

The need to develop new approaches to control plant

pests is paramount. New pest management methods being

developed focus on biological approaches, including the

use of biotechnology to alter the plant genome and the

use of biological control agents.

Approaches that focus on improving the plant’s ability

to withstand adversity in general involve genetically

modifying the plant to have new characteristics. Scientists genetically modify organisms by altering or adding

to an organism’s genetic information with the intent to

improve the physical characteristics of the organism. The

genetic material of living organisms is composed of deoxyribonucleic acid (DNA).1 The universal nature of genetic material enables scientists to transfer genetic material

between species that are normally not sexually compatible, and can be used to modify microorganisms (e. g.,

bacteria, viruses, and fungi), animals, insects, and plants.

The genetic modification of plants can be accomplished using three different types of techniques: classical, cellular, and molecular (29). The classical methods

of genetic modification include those associated with traditional plant breeding. Such methods include:

fertilization of sexually compatible plants coupled

with the preferential selection of those plants containing the desired characteristics,

the use of chemicals or radiation to mutate the genetic material such that the mutated organism possesses preferred characteristics, and

traditional cell culturing of plant sex cells such as

anthers (the plant organelle that contains pollen)

ovules, and embryos.

Cellular techniques involve regenerating a whole plant

using culturing techniques, but unlike classical methods,

the cellular techniques use tissue cells other than sex

cells. Techniques include:

. cell fusion, in which two sexually incompatible plants

are hybridized, and

. somaclonal variation,2 which involves selecting plants

that have been regenerated from undifferentiated plant

cells—such plants often differ significantly from the

parent plants.

1 The exception (o this statement are the viruses whose genetic material is composed of ribonuclcic acid (RNA), rather than DNA.

2 Plants arising from the culturing of undifferentiated cells often differ strikingly from each other and from the parent plant from which the culture

was derived. In some unknown way, the process of culturing cells releases a pool of genetic diversity. Possible explanations of this phenomena

include chromosome breakage and reunion, DNA rewmmgement, and point mutations. The amount o(’ ~ariation that occurs is affected by some

factors that can be controlled, such as the length of time the cells are cultured, the genotype of the tissue, the medium, and the culture conditions

( 15. 30).

-37-
38 ● A New Technological Era for American Agriculture

The molecular techniques include those most commonly associated with biotechnology. Selected genes are

isolated and transferred to a host organism using vectors

(a piece of DNA that helps to incorporate a new gene

into a host organism) or direct transfer techniques such

as microinjection, electroporation, or particle guns. Molecular techniques allow for the transfer of selected genes

between sexually incompatible species of the same type

of organism, or between different types of organisms

such as between plants and bacteria.

This chapter will focus on advances made in the use

of biological methods to enhance crop production. Emphasis will be given to the use of molecular techniques

and the use of biological control agents to enhance both

pest resistance and the ability to improve crop production

in less-than-ideal conditions.3

TOOLS AND TECHNIQUES

OF BIOTECHNOLOGY

Biotechnology can be broadly defined as the use of

living organisms to alter other organisms. In a practical

sense, biotechnology is a set of tools that allow researchers to manipulate genetic material. These tools allow

researchers to develop products that could not have been

previously produced, and to explore new research questions that significantly expand our scientific knowledge.

This section will describe some of the most important

tools of biotechnology.

Biotechnology Techniques Used To Create

Transgenic Plants

Transgenic crops are those crops whose hereditary DNA

has been augmented by the addition of DNA from a

source other than parental germplasm, using recombinant

DNA techniques. The primary goals of transgenic crop

research is to produce crops with improved ability to

resist pests (i. e., disease, weeds, and insects); improved

ability to grow under less-than-ideal soil and climate

conditions; and to improve the quality characteristics of

crops (e. g., by changing the oil composition of oilseed

crops).

Many advances have been made that improve scientists’ ability to create transgenic plants, and several major

crops grown in the United States have been successfully

transformed (table 2-1). Production of transgenic crops

with improved characteristics, however, is constrained

by insufficient knowledge of the appropriate genes for

transfer; the knowledge base in plant biochemistry and

physiology has not kept up with the development of molecular biology and transformation technologies.

To create a transgenic plant, scientists must:

1.

2.

3.

4.

5.

isolate and purify the gene to be transferred,

find appropriate mechanisms (i.e., vectors or nonvector mechanisms) to transfer the gene into plant

cells,

attach appropriate regulatory sequences to ensure

proper expression of the new gene in the plant,

insert proper genetic markers to identify those cells

that have been transformed, and

regenerate the transgenic cell or tissue into a complete plant.

Advances and methods used to accomplish each step will

be described below.

Gene Identification, Isolation, and Purification

Isolating a single gene is complicated by the fact that

a DNA sample obtained from a plant usually contains

many genes. Researchers must be able to separate the

one gene of interest from all of the other genes. Once

isolated, the gene of interest is multiplied (cloned) to

produce enough genetic material for subsequent uses.

The process used to isolate and multiple the gene of

interest is generally referred to as shotgun cloning because the process allows for the replication (cloning) of

the entire genome (the sum of all genetic information

contained in the chromosomes) of the organism.

A sample of DNA is first cut into small pieces, some

of which may contain the desired gene. Special enzymes

(restriction endonucleases) are used to cut the DNA at

specific sites such that each piece has the same types of

ends (figure 2-1 ). Pieces of DNA that have been cut with

the same enzyme can be glued together regardless of the

source of the DNA. This feature allows, for example,

pieces of DNA from plants to be pasted together with

DNA pieces from bacteria. It also allows scientists to

paste DNA fragments into molecular vectors, pieces of

DNA capable of inserting foreign genetic material into a

cell. Scientists use vectors to help isolate and purify

specific genes. Commonly used vectors include bacterial

plasmids (circular pieces of DNA that can be easily in-

‘ Because of the large quimtity of research on these technologies. this chapter will cite mainly OTA commissioned background papers and other

review articles.
Chapter 2—Emerging Plant Technologies . 39

Table 2-1—Transgenic Crops Produced

Grains and

oilseedsa Fruits and vegetables Other

Cotton Tomato Alfalfa

Rice Sugar beet White clover

Sunflower Potato Poplar

Soybean Peas Lotus

Rapeseed Lettuce Arabidopsis

Corn Cucumber Petunia

Cabbage Tobacco

Asparagus Walnut

Carrot

Pear

Celery

a Wheat and barley have not yet been successfully transformed, but it is

anticipated that these crops WiII also be amenable to genetic engineering

by the mid-1990s.

SOURCE: Office of Technology Assessment, 1992.

serted into bacterial cells where they can replicate) and

bacteriophages (viruses that infect bacteria).4

To isolate a gene from an organism, the DNA sample

of the organism is cut into many pieces, and all of these

pieces are inserted into vectors (e.g., bacterial, plasmid,

or bacteriophage). The vectors are then inserted into bacterial cells. As the bacteria reproduce, the vectors containing the pieces of the organism’s DNA are also

reproduced. This process results in the production of

multiple copies of the organism’s DNA, which is contained in the vectors. Now scientists have enough copies

of genetic material to begin isolating the vectors that

contain only the genes of interest. Isolation of the appropriate vectors is accomplished using a probe, a sequence of genetic material that recognizes the desired

gene. The probe is used to identify the vectors containing

the desired gene. These selected vectors can then be

reintroduced into bacteria, where they are replicated many

times to produce millions of copies of the desired genes.

The desired gene can then be removed from the vector

in quantities sufficient to perform subsequent genetic

modifications (41 ).

The above procedure can be easily applied to organisms that possess small genomes, such as bacteria, but

is more difficult to apply to more complex organisms

such as plants, whose genome size is huge. Additionally,

difficulties occur as a result of the lack of knowledge

concerning the functions of many plant genes, which

precludes the development of probes. Because of these

difficulties, additional methods are being developed to

improve the isolation of plant genes.

Restriction Fragment Length Polymorphism (RFLP)

mapping is used to identify and clone plant genes and to

further our understanding of the function of plant genes.

RFLP maps take advantage of the fact that corresponding

sites in the DNA of individual plants may differ as a

result of mutations (referred to as polymorphisms). These

polymorphisms can be identified and correlated with known

markers (i. e., genes whose function have been identified), which helps to identify the general location of an

unidentified gene (2 1 ). This procedure identifies the approximate location of a specific gene within the plant

genome, which limits the amount of plant DNA that must

be searched to isolate that specific gene. Once the general

location of a specific gene is located, isolating the specific location of the gene depends on other methods still

under developments RFLP maps are being made for

corn, potato, tomato, rice, bean, pine, soybean, wheat,

barley, sorghum, alfalfa, and Arabadopsis (27).

Mechanisms To Transfer Purified Genes

Into Plant Cells

Once a gene has been isolated and purified, it can be

transferred to create a transgenic plant. For many dicotyledonous plants (i. e., plants having two seed leaves

(cotyledons) and net-veined leaves, such as soybeans),

the Ti plasmid of certain strains of the soil bacterium

Agrobacterium tumefaciens is commonly used as a vector

to insert foreign genes into the plant. Unfortunately, Ti

plasmids cannot be used to transform monocotyledonous

plants (i.e., plants having a single cotyledon and parallelveined leaves), which includes most of the major cereal

crops (e. g., corn, rice, wheat) (27).

Vectorless methods have been developed to transform

cereal crops. For example, chemicals (e. g., polyethylene

glycol or calcium phosphate) and physical methods (e.g.,

electrical stimulation) are used to make plant cells leaky

so that genetic material can flow in. These approaches

have been used successfully to transfer foreign genes into

rice and corn (27).

4 Plasmids are commonly used to construct cDNA libraries (see ch. 3 ) and bacteriophages are used to construct genomic libraries.

5 Methods being developed include chromosome walking in which successively smaller overlapping portions of the RFLP fragment are isolated

until one ‘‘walks’ to the desired gene. This method is constrained by the fact that RFLP fragments may still be too large to clone by the conventional

methods described above (27). Another method is called gene tagging, which uses a transpmon (a piece of DNA capable of moving around in the

genome) to activate the gene of interest. The gene can bc located by locating the transposon. Use of this method is inhibited by the size of the

plant genome, the lack of transposons for many crops, and the fact that the transposon is often naturally present in multiple copies in crops (27).
—

40 ● A New Technological Era for American Agriculture

Figure 2-1 —Identification and Isolation of Desired Gene

DNA containing gene to be isolated

Recombinant DNA Molecules

Multiplication of Bacteria Containing the Desired

Gene To Yield Many Identical Copies of Fragments

SOURCE: Office of Technology Assessment, 1989
Chapter 2—Emerging Plant Technologies . 41

Figure 2-2—Gene Transfers With Bioblaster

. . driving the

projectile carrying

new genes and

tungsten powder

against the

I I

The bolistic method is an alternative vectorless method

of gene transfer. This method uses a particle gun to shoot

high-velocity microprojectiles coated with DNA into a

plant (figure 2-2). It has been used to transfer genes to

tobacco, soybean, and corn (27) and can be used to

transfer genes to the plant cell nucleus (where the chromosomes are located) and potentially to other cell organelles that contain genetic material, such as the

chloroplast (e. g., genes involved in photosynthesis) and

the mitochondria (e. g., cytoplasmic male sterility genes

used in the development of some hybrid crop varieties).

Currently, there is little control over where the foreign

gene is inserted into the host plant. New methods are

being developed to target the insertion site, but the frequency of success is low.

Use of Selectable Markers To Identify

Transformed Plants

Cells that have foreign genes inserted need to be differentiated from those that have not been transformed.

Scientists use markers to identify the transformed cells.

The most commonly used marker is the kanamycin resistance gene. Cells containing this gene are resistant to

the antibiotic kanamycin and will grow on a culture medium containing high levels of that antibiotic. Untransformed cells not containing the kanamycin resistance gene

will not grow on this medium. Genes coding for herbicide

tolerance can also be used as a selectable marker to differentiate transformed plants from those that have not

been transformed.

Use of Promotors To Control the Expression of

the Foreign Gene

Once a foreign gene has been incorporated into the

genetic material of a plant, it must still function properly.

Scientists use promotors (regulatory genes) to control

when and where in the organism the gene is turned on.

To date, most transgenic plants contain constitutive promotors, which means that the foreign gene is expressed

equally in all tissues and at all development stages. Scientists are trying to isolate promotors that turn the inserted genes on only in specific tissues at certain

development stages of the plant, and at a specific time.

For example, it is desirable to direct the expression of

insect tolerance genes only to the tissues eaten by the

insect, such as leaves. The most commonly used plant

promotor to date is derived from the cauliflower mosaic

virus and is mostly constitutive. However, promotors that

respond to light, heat, wounds, and oxygen deficiency,

and that show tissue specificity for seeds, pollen, root

nodules, and tubers are being identified (27). Understanding the molecular basis of promoter-mediated regulation of gene expression as well as isolation of promoters

with varying specificities of expression is critical for the

development of new generations of plant-based biotechnology products.

Use of Tissue Culture To Regenerate

Transformed Plants

Once a plant cell or tissue has been genetically transformed, it must be regenerated into a complete plant.

Advances in plant tissue culturing techniques have now

made it possible to regenerate many of the most important

crops (figure 2-3).

Early genetic modification research used protoplasm

culturing to regenerate the transformed plant cells. Protoplasts are formed by enzymatically removing the outer

wall of plant cells. These protoplasts are genetically

transformed using the tools of biotechnology, then coaxed

into forming a cell wall and eventually growing into a

complete plant. However, such regeneration is difficult

to achieve with many plant cells, which has lead to the

development of callus culturing and cell-suspension

methods.

Callus tissue cultures originate from tiny pieces of

tissue snipped from seedling shoots or other appropriate

plant parts. The tissue is placed in a petri dish containing

plant hormones and other plant nutrients. The cells grow
42 . A New Technological Era for American Agriculture

Figure 2-3—Plant Tissue Culture Technology

immature fruit

1 I

i

SOURCE: S.K. Harlander, University of Minnesota

and divide, forming a mound of undifferentiated cells

called a callus. When transferred to a regeneration medium, the cells in the callus differentiate into roots and

shoots, which then grow into plants. Thousands of plants

can be regenerated from one piece of tissue, but the

process is labor intensive and expensive.

Methods for the growth of cell suspensions allow for

the regeneration of plants from single cells rather than

clumps of tissue. Tissues can be agitated in a flask containing a liquid medium, causing the cells to separate.

In the appropriate medium, these cells will form somatic

embryos that differentiate into entire plants. Embryo suspensions have been used to regenerate wheat, sorghum,

and corn (27).

Callus culturing and cell-suspension methods allow for

the use of a variety of plant tissues (e. g., leaves, stems,

shoot tips, or cotyledons) from many plant species to be

used to regenerate new plants. And, Agrobacterium particle gun technologies or other direct methods can be

used to transform these tissues. Thus, most major crops

can now be genetically engineered and regenerated to

complete plants.

Other Biotechnology Techniques

Biotechnology is most closely identified with the use

of recombinant DNA technologies to produce transgenic

crops as described above. However, other technologies,

some of which also involve the use of recombinant DNA,

will also play a significant role in the development of

new plant technologies. Some of these technologies are

described below.

Antisense Technology

Antisense technology is a powerful research tool that

enables scientists to study the physiology and development of organisms. It is also useful in the production of

transgenic crops that have new characteristics (37). For

example, this technology is being used to prevent softening in tomatoes (see Biotechnology in Food Processing). The power of the technique lies in its ability to

eliminate or reduce the expression of a gene in an organism.

An analogy that might help to explain how this technology works is to view the expression of a gene as being

similar to reading a sentence. For the sentence to make

sense, it must be read in a certain direction; sentences

that are read backwards, for instance, don’t make sense.

Gene expression is similar, A gene must be read in a

certain direction to produce a gene product that makes

sense to the organism (i. e., it is a functional compound).

The antisense technology consists of incorporating into

an organism a synthetic gene that reads backwards (i. e.,

a product is made that doesn’t make sense to the organism). The expression product of this backward-reading

gene is a mirror image of the expression product of the

same gene when it is read forward. When the expression

products of the forward and backward genes meet,6 they

stick together, thus inactivating the product of the forward-reading gene (figure 2-4). Thus, the antisense technology can be used to inactivate selected genes in the

plant. Use of the technique, however, is constrained by

the need to know the precise nucleic acid sequence of at

6TechnicaHy, when a gene is expressed, it is first copied and modified to a second compound called messenger ribonucleic acid (mRNA). The

mRNA then serves as the template for the subsequent production of proteins. It is the mRNA, rather than the protein, that meets and causes the

inactivation.
Photo credit: U.S. Department of Agriculture,

Agricultural Research Service.

Molecular biologist at UC/USDA Plant Gene Expression

Center successfully transferred new genes into cells of

corn using a gene gun.

least a portion of the gene that codes for the expression

product to be inhibited.

Polymerase Chain Reaction

The Polymerase Chain Reaction (PCR) technology enables scientists to rapidly generate large amounts of genetic material from a trace amount, which would otherwise

be too small to analyze. PCR is an enzymatic process

carried out in repeated cycles, each of which doubles the

amount of DNA present. Small flanking sequences of

DNA are identified on each end of the DNA sequence

that is amplified. These flanking sequences are then used

to create complementary strands of DNA that serve as

primers. These primers are then annealed to the flanking

sequences, and when appropriate enzymes and nucleic

acids are added under the proper conditions, a new DNA

strand is formed beginning at the primer and extending

across the sequence of DNA to be replicated, such that

a copy of this sequence is made. This methodology is

rapid, sensitive, and relatively easy to carry out; about

25 cycles can be carried out in an hour. PCR reduces the

difficulty of isolating and manipulating specific DNA

7 The spleen cells are fused in the presence of an agent. such a polyethylene giycol, to myclorna cells—tumors of B Iynlpht)c}’te origin.

X Alternatively the hybrid cells can be grown as tumors in the peritoneal cavltics of mice where very high levels of antibody accumulate in the

ascites fluid surrounding the tumor.
44 ● A New Technological Era for American Agriculture

Figure 2-5—Preparation of Monoclinal Antibodies

Myeloma cells

are mixed and

fused with

B lymphocytes

SOURCE: Office of Technology Assessment, 1988.

antibody production methods). It is this purity that makes

monoclinal antibodies so useful.

Application of Biotechnology Techniques

To Create Transgenic Plants

The tools of biotechnology are allowing researchers to

explore new means to control plant diseases, insect pests,

and weeds. Tissue culturing and genetic engineering,

combined with traditional agricultural research methods,

The products of this

fusion are grown in a

selective medium. Only

those fusion products

which are both “immortal” and contain genes

from the antibody-producing cells survive.

These are called

“hybridomas.”

Hybridomas are cloned

and the resulting cells

are screened for antibody production. Those

few cells that produce

the antibodies being

sought are grown in

large quantities for

production of monoclonal antibodies.

are allowing scientists to alter plants or biological control

agents to achieve enhanced efficacy and host range in

controlling plant pests. Biotechnology is also being used

to improve a plant’s ability to withstand environmental

stresses, such as cold, drought, and frost, improve the

shelf-life of fruits and vegetables and is being used to

develop value-added products from agricultural commodities (e. g., increased carbohydrates. modified oils,

and proteins that contain essential amino acids). In addition to developing new products, the tools of biotech-
Chapter 2—Emerging Plant Technologies ● 45

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service.

Plant molecular biologist examines successful results of

the cloning of a gene necessary for plants to synthesize

ethylene, the ripening hormone. More recently, scientists

have blocked this gene, producing genetically

engineered tomatoes that ripen on demand.

nology are expanding the knowledge base of plant

resistance and the interactions of plants, pests, and biological control agents with the rest of the ecosystem.

Genetic Engineering of Plants

for Insect Control

Traditional breeding programs have successfully produced varieties of alfalfa, cotton, corn, rice, sorghum,

soybean, and wheat that have been resistant to, or tolerant

of, key pests and will continue to play an important role

in developing insect resistant plants for some time in the

future. However, the tools of biotechnology have created

the possibility of selectively engineering plants for insect

resistance. Biotechnology will permit the transfer of resistance genes into plant species for which the resistance

gene is not inherent. Biotechnology is also being used

to improve the understanding of mechanisms by which

plants are resistant to insects.

Few genes known to produce insecticidal proteins have

been identified. Candidate genes must code for proteins

that are stable in the plant cell, are not rapidly digested

when consumed by insects, have high activity against

feeding target insects, and are safe for nontarget invertebrates and animals. Insecticidal proteins produced by

the spore-forming bacteria Bacillus thuringiensis (Bt) are

among the few known to meet these criteria,

The Bt bacteria produces crystals that contain compounds toxic to insects. Insects feeding on plants contaminated with Bt bacteria ingest the crystals, which are

dissolved in the insect midgut, releasing the protein toxPhoto credit: Monsanto Co.

Tomato plants that show one stripped by caterpillars and

one not. The plant not stripped contains the Bacillus

thuringiensis toxin gene.

ins. Different strains of the Bt bacteria produce insecticidal toxins specific to Lepidoptera (butterflies and moths)

only, to Diptera (flies and mosquitoes) only, to Coleoptera (beetles) only, and to both Lepidoptera and Diptera.

Genetic engineering is being used to improve the delivery of the Bt toxin to insect pests by incorporating the

insecticidal gene into other vectors (see Biological Control of Anthropoids: Pathogens) or by transferring the

insecticidal gene directly to plants. Genes coding for the

Bt insecticidal protein have been cloned and inserted into

tobacco, tomato, and cotton plants among others ( 1).

Transgenic plants producing Bt insecticide are expected

to be commercially available by the mid to late 1990s.

Genes for some insect trypsin inhibitors have also been

cloned. Trypsin inhibitors are compounds that, when

present in large amounts, may reduce the ability of an

insect to digest plant material. Some plants, such as the

seeds of cowpeas and beans, contain large quantities of

trypsin inhibitors (i.e., 1 to 2 percent of the total protein),

and the levels in plant leaves may be increased in response to mechanical damage or insect feeding. Trypsin

inhibitor genes derived from tomatoes have successfully

controlled the growth of insect larvae when transferred

to tobacco plants. Transgenic plants genetically engineered to produce trypsin inhibitors may be available by

the end of the decade ( 1).

Genes that code for lectins and for arcelin are also

potential candidates to confer insect resistance to transgenic crops. Lectins are sugar-binding proteins found in

the seeds of peas and common beans. They are effective

against bean weevils and cabbage weevils. Arcelin is
46 . A New Technological Era for American Agriculture

produced in the seeds of wild beans and is toxic to bean

bruchid pests (1).

Genes coding for insecticidal proteins other than Bt

toxins and trypsin inhibitors must be identified. RFLP

maps are being used in tomatoes, for example, to discover the location of insect resistance genes in plants.

The development of tissue-specific promotor sequences

and promotors that respond to selected environmental

stimuli are needed to improve the efficacy of insect control.

Genetic Engineering of Plants

for Weed Control

The presence of weeds in crops decreases productivity

and crop quality. To control weeds, farmers commonly

apply herbicides. Most herbicides act by inhibiting key

enzymes in photosynthesis or other essential plant biosynthetic pathways. Plant species respond differently to

herbicides depending on the sensitivity of plant enzymes

to the herbicide or the ability of the plant to metabolically

inactivate the herbicide. These abilities explain why herbicides are often effective against either grassy or broadleaf plants, but not both (26).

Herbicide manufacturers would like to develop broadspectrum herbicides active against all economically important weeds, but their efforts have be constrained because broad-spectrum herbicides not only kill weeds, but

they injure crops as well. Two approaches have been

taken to minimize crop damage when using broad-spectrum

herbicides. One approach is to use herbicide antidotes,

compounds that enhance the metabolic inactivation of

herbicides in plants (19, 20). Few such antidotes have

been discovered, however, and it is unlikely that this

approach will yield significant success in the near future.

The alternative approach is to develop crop varieties that

are resistant to the herbicide used.

Traditional methods have been used successfully to

develop herbicide-tolerant crops. Tissue culture and plant

regeneration techniques have produced tobacco and soybean varieties tolerant to sulfonylurea herbicides and corn

varieties tolerant of imidazolinone. Attempts to develop

herbicide-tolerant crops using tissue-culture techniques

are most successful when the herbicide affects only one

compound in a plant biosynthetic pathway (i. e., it has a

single target site) and a mutation in that compound confers herbicide tolerance without affecting the growth of

the plant, or when the mutation of a single plant gene

increases the ability of the plant to inactive the herbicide

or to absorb less of the herbicide. Use of these methods

is constrained by the lack of naturally occurring herbicide

tolerance genes in crops (26).

Genetic engineering techniques overcome the lack of

naturally occurring herbicide resistance genes in plants

by allowing for the transfer of these genes between crop

species. Thus, crops tolerant to a specific herbicide (but

not all herbicides) can be developed. Three different approaches have been taken to engineer crops successfully

for herbicide tolerance, the first of which are expected

to be commercially available by the mid 1990s (table 2-

2). One approach relies on making the crop produce

excess quantities of the enzyme normally affected by the

herbicide. By producing an excess quantity of the enzyme, a sufficient quantity is still available to catalyze

important plant biosynthetic pathways even though some

of the enzyme has been inactivated by the herbicide.

Excess production can be achieved by inserting several

copies of the gene coding for the enzyme into the plant,

or by using promotor sequences that cause excessive

expression of the genes coding for the enzyme, This

method has been used successfully to produce crops tolerant to glyphosate and phosphinothricin (26).

The most commonly used approach to produce crops

tolerant to herbicides is to alter the gene coding for the

enzyme affected by the herbicide in such a way that the

resulting altered enzyme is still effective in the plant, but

is not inactivated by the herbicide. This altered gene is

then inserted into the plant where it produces an altered

enzyme that confers herbicide tolerance. This approach

has been used to produce crops tolerant to glyphosate,

sulfonylureas, phosphinorthricin, atrazine, and imidazolinone.

The third approach is to transfer to plants those genes

that code for enzymes that inactivate herbicides. This

approach has been taken to confer plant tolerance to

bromoxynil, 2,4-D, and phophinothricin.

An alternative approach to weed control is to develop

crops that produce their own herbicides. These plantproduced herbicides, called allelochemicals, can be either volatile organic compounds released into the air or

soil where they can be absorbed by the weed or nonvolatile organic compounds released as root exudates or

leachates of other organs, such as seeds. Most volatile

allelochemicals are terpenoids whose secretion increases

with rising temperatures, while most nonvolatile allelochemicals are aromatic chemicals (26). Significant research is still needed before crops can be engineered to

produce allelochemicals. Alternatively, it may be possible to identify and use plants known to naturally produce allelochemicals as cover crops or in low tillage
Chapter 2—Emerging Plant Technologies ● 47

Table 2-2—Current Targets for Crop Modification for Herbicide Tolerance

Research Commercial Weed/crop

Herbicide institution introduction targets

Atrazine

Bromoxynil

Betanal

2,4-D

Dicamba

Glyphosate

Imazapyr

Metribuzin

Basta

Sulfonyl ureas

Ciba Geigy, Inc

Calgene, Rhone-Poulenc

Schering

Max Planck

Sandoz

Monanto, Calgene

American Cyanamid

Molecular Genetics

Mobay

Hoechst

DuPont

Not expected to be

commercialized

Mid 1990s

Late 1990s

Not a commercial target

Late 1990s

Mid 1990s

Early to mid 1990s

Late 1990s

Mid 1990s

Mid 1990s

NA

Broadleaf/dicots

Broadleaf/sugar beet

NA

Broadleaf/NA

Broad spectrum

soybean, rape,

cotton, corn

Broad spectrum/corn

Broad spectrum/

soybean

Broad spectrum/

rape, beet, potato,

soybean, corn

Broad spectrum/

soybean, rape

NA = Not applicable.

SOURCE: Off Ice of Technology Assessment, 1992

situations to control weeds. For example, it has been

shown that certain cucumber strains produce compounds

toxic to the weeds proso millet and barnyard grass under

field conditions. The possibility of using alleochemicalproducing plants is also being explored in fruit production

(33).

Understanding the nature of allelochemicals in addition to the advances that have been made in elucidating

the mechanisms of herbicide action is expected to enhance the design of future herbicides.

Genetic Engineering of Plants

for Disease Control

Bacteria, fungi, parasitic seed plants, nematodes, insects, and viruses, among other organisms, can destructively alter the structure or physiological processes of

plants, resulting in disease. However, plants possess the

ability to resist the invasion of pathogenic organisms.

All of the plants of a species can be resistant to a pathogen, or certain varieties of a plant species can be resistant to a subspecies of the pathogen (i. e., cultivar

specificity). The interaction of bacterial and fungal pathogens with plants is helping to elucidate the mechanisms

by which plants resist pathogenic organisms (27).

The ability of plants to resist pathogenic organisms

involves the complex interaction of genes in both the

plant and the pathogen. The interaction of compounds

produced by plant resistance genes and genes in the pathogen (i. e., avirulence genes) triggers a hypersensitive

response. Plant cells initially infected by the pathogen

die, preventing the spread of the pathogen to the rest of

the plant. Thus, the pathogenic effects remain localized

at the site of initial infection, and disease is prevented

from spreading throughout the plant.

The mechanisms by which pathogens infect plants are

also being elucidated. Pathogenic microorganisms contain pathogenicity genes that produce compounds toxic

to the plant and/or allow the pathogen to attach to the

plant, penetrate the cuticle and degrade the walls of plant

cells, and degrade chemicals produced by the plant in its

own defense. These pathogenicity genes can be activated

by signals from the plant itself. For example, the presence

of cell wall degradation products in plants can trigger

the production of enzymes in some pathogenic fungi that

degrade the cell wall. In a similar manner, compounds

produced by pathogens trigger a response by the plant

to the pathogen. Plant defense genes are stimulated to

produce compounds that may be toxic to pathogens, reinforce the cell wall, and/or inhibit enzymes produced by

the pathogen (27).

Efforts are underway to clone and characterize pathogen and plant genes involved with resistance. To date,

no plant resistance genes have been cloned, however,

avirulence genes from bacteria and viruses but not fungi,

have been. Additionally, few plant defense genes have

been identified and cloned. Only the gene coding for

chitinase, a compound that is toxic to fungi, has been

shown to confer disease resistance when transferred to

tobacco. Also a compound derived from moths, when
48 ● A New Technological Era for American Agriculture

Table 2-3—Virus Coat Proteins Engineered

Into Plants

Photo credit: Richard Nelson,

Samual Roberts Noble Foundation.

Transgenic tomato plant expressing the coat protein

gene of tobacco mosaic virus (left) and control

plant (right).

transferred to tobacco, decreased the severity of an infection by the bacteria Pseudomonas solanacearum. Given

the state of the art, it is highly unlikely that plants resistant to bacteria and fungi will be developed before the

year 2000 (27).

Greater success has been achieved in developing plants

resistant to viruses. Plants have long been known to display cross protection, a phenomena that occurs when

plants infected with a mild strain of a virus do not develop

severe symptoms when challenged with a stronger strain

of the same virus. Cross protection is comparable to

immunity in animals, although plants do not have immune systems and the mechanism of protection differs.

Although cross protection has been achieved in plants

by inoculating individual plants with a mild virus strain,

this process is very labor intensive and carries a small

risk that the virus strain used will become more virulent

and act in a synergistic fashion with other viruses (27).

Genetic engineering has been used to avoid these problems. Genes coding for virus coat proteins (i.e., the proteins that make up the shell that surrounds viruses), other

Alfalfa mosaic virus

Cucumber mosaic virus

Potato viruses S, Y, and X

Potato leaf roll virus

Tobacco mosaic virus

Tomato mosaic virus

Tobacco rattle virus

Tobacco streak virus

Soybean mosaic virus

Papaya ringspot virus

Tomato spotted wilt virus

SOURCE: Office of Technology Assessment, 1992.

virus proteins, and virus RNA sequences can be introduced into plants to elicit a resistance response (3, 4).

Plants engineered with coat protein genes from a specific

virus have resisted subsequent infection by the same virus, and in some cases to related viruses having similar

coat proteins. Currently, many viral coat protein genes

from different plant viruses have been transferred to plants

to confer resistance (table 2-3) (4). The mechanism by

which protection occurs is not fully understood. Most

evidence suggests that the accumulation of viral coat

proteins in plant cells interferes with the release of viral

RNA needed to initiate infection (4).

In addition to viral coat proteins, other viral genes

have been transferred to plants. Those having potential

for virus control include: genes for virus replication, antisense RNA, satellite RNA, and ribozymes. The antisense technology has also been used to inhibit viruses in

plants. Other approaches include transferring satellite RNA

sequences (small RNA sequences that depend on helper

viruses to replicate and package new virus particles) to

plants where they have protected the plant from developing symptoms in response to an infection by the helper

virus. Genes coding for RNA sequences that act like

enzymes (i.e., ribozymes) have also been transferred to

plants where they have cleaved invading viruses (27).

Genetically engineered dicotyledonous plants resistant

to certain viruses are expected to be commercially available by the mid 1990s. Monocotyledonous plants resistant to viruses will probably not be available until the

late 1990s or early the next century. Currently, only a

few genes with potential for controlling fungi and bacteria have been identified, cloned, and introduced into

plants (see table 2-4).

Genetic Engineering of Plants for Thermal

and Water Stress Tolerance

Progress in improving the tolerance of plants to water

and thermal stress will depend, in part, on better ways
Chapter 2—Emerging Plant Technologies . 49

Table 2-4—Disease Resistance Genes Introduced

Into Plants

Disease pathogen Gene/plant

Fungal. . . . . . . . . . . . . . . . . . Chitinase/tobacco

Bacteria. . . . . . . . . . . . . . . . . Antibacterial protein from moth/

tobacco, potato

Enzyme to detoxify bacterial toxin

Viral. . . . . . . . . . . . . . . . . . . . Viral coat protein

Other virus genes

Satellite RNA

RNA enzyme (ribozyme)

Antisense RNA

SOURCE: Office of Technology Assessment, 1992

of defining and quantifying these stresses as well as nonstress states. Defining these stresses is further complicated by the fact that water stress and temperature stress

are not easily separated, particularly at high temperatures. New tools, such as remote and contact sensing,9

are being developed to detect plant stress (9).

The lack of detailed knowledge of the physiology of

water and temperature stress tolerance also constrains

progress in this field. The root system of the plant exerts

major control over water uptake. Little research has been

conducted to measure root response to water and thermal

stress. Most measurement techniques used to date are

disruptive if not destructive to root systems. New techniques are needed to determine factors that affect the

distribution of roots in the soil and the ability of the roots

to absorb water and transport that water through the vascular tissues of the plant (9).

Plant-cell culturing, combined with selection for enhanced ability to adjust the salt and water concentration

of plant cells (osmotic pressure), has been shown to be

effective in improving drought tolerance. However, while

improved sensitivity to osmotic pressure has increased

the survival of the plant, it does so at the expense of

plant growth and yields (34).

Some plants contain genes that code for proteins conferring tolerance to extremes of temperature or drought;

these genes are possible candidates for isolation and transfer

to other plants through genetic engineering techniques.

For example, tobacco cells that are exposed to gradually

higher levels of salt synthesize several novel proteins.

One such protein is osmotin, whose synthesis is regulated

by several mechanisms, including exposure to low water

environments or changes in endogenous levels of the

hormone abscisic acid (ABA). ABA is known to lower

the rate of transpiration from leaves and prevent water

loss. The role of osmotin in cellular osmoregulation is

now under investigation (9).

Some plants, when challenged by elevated temperatures, produce heat shock proteins. Genes coding for

several of these proteins have been sequenced and their

promoter regions identified. However, the metabolic

functions of most of these proteins are not understood,

and this constrains their use in biotechnology to improve

plant tolerance to elevated temperatures (9).

In general, the fundamental research needed to understand the mechanisms of tolerance to thermal and

water stress simply has not kept pace with the development of biotechnology tools, and thus, scientists do

not currently know what genes to transfer into plants to

improve tolerance for these stresses. Thus, genetically

engineered plants tolerant to elevated thermal or water

stress are unlikely to be developed within this decade.

However, antifreeze proteins have been transferred to

plants and production of plants with improved cold tolerance may become available within 10 to 15 years.

Plants transgenic for antifreeze proteins have the potential

to improve cold hardiness by lowering the temperature

at which leaves freeze ( 12, 17). Antifreeze proteins from

fish are also being used to improve the post-harvest freezing and thawing qualities of fruits and vegetables by

inhibiting ice recrystallization in tissues (22).

Biotechnology in the Food Processing

Industry

Historically, the food processing industry has had to

accept and adapt to heterogeneous raw materials. Biotechnology can be used to better tailor food crops to meet

food processing and consumer needs. Tissue-culture

techniques are being used to select or construct crop

varieties with improved functional, processing, or nutritional characteristics (table 2-5).

Plant tissue-culture techniques can be used to produce

food flavor and coloring ingredients. These methods could

potentially replace production and extraction of these

ingredients from plants ( 15, 18). For example, a private

company recently has succeeded in using tissue culture

techniques to produce vanilla ( 14).

‘Contact sensing requires contact with plant tissues and may require destruction of at least part of the plant. It involves the direct ctetcrmination

of the state of a physical, biological, or chemical quantity. Remote sensing quantitates parameters meusured by using a sensor to detect electromagnetic

waves emitted or reflected by plants.
50 . A New Technological Era for American Agriculture

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service.

Framed by drought-dried cornstalks, drought-resistant

lima beans stand tall and lush in test plot. Scientists

hope that genetic engineering researchers can isolate

the genes that give the lima bean such a high degree of

drought tolerance.

Table 2-5—Use of Tissue Culture To Improve Food

Characteristics

Crop Characteristic

Tomato . . . . . . . . . . . . . . . . . Increased solids

Increased shelf life

Carrots . . . . . . . . . . . . . . . . . Increased sweetness, crunchiness

Celery . . . . . . . . . . . . . . . . . . Decreased stringiness

Corn. . . . . . . . . . . . . . . . . . . . Improved amino acid composition

Rapeseed. . . . . . . . . . . . . . Decreased saturated fatty acids

SOURCE: Office of Technology Assessment, 1992.

Genetic engineering is also a means of altering food

characteristics. Genes coding for enzymes involved in

starch and lipid biosynthesis are being isolated and cloned,

enhancing the prospects of engineering plants with specific composition of starch and oil. Genes coding for

floral pigment pathways are also being isolated. Plants

potentially can be engineered to produce pharmaceuticals

such as blood clotting factors and growth hormones. For

example, oilseed rapeseed has been genetically engiPhoto credit: DNA Plant Technologies, Inc.

Vegi Snax is an example of successful application of

plant tissue culture for selection of crop varieties with

improved functional, processing, and nutritional

characteristics.

neered to produce enkephalins (40). In addition,

ense technology is being used to eliminate toxins

compounds, or off-flavor components in plants,

delay ripening of tomatoes ( 15).

 antisallergenic

 and to

Biotechnology is also being used to improve microorganisms used as vegetable starter cultures and in brewing and baking (i.e., organisms used in making sauerkraut,

pickles, olives, soysauce, wine, beer, and bread) such

that these organisms tolerate different temperature and

pH ranges. Similar work is being conducted with microorganisms used to produce food ingredients such as acetic

acid, citric acid, niasin, vitamin B 12, xantham gum, and

monosodium glutamate. In addition, genetically engineered enzymes are being developed to treat food processing wastes ( 18).

Finally, biotechnology is being used to develop methods

to assay levels of pathogens, toxins, and chemical contaminants in raw ingredients and final products. DNA probes

and poly and monoclinal antibody kits are beginning to

replace traditional bioassay methods. For example, many

of the assay procedures used to detect pesticide residues in

food are monoclinal antibody kits ( 18).

THE TOOLS AND TECHNIQUES

OF BIOLOGICAL CONTROL

Approaches Used in Biological Control

Biological control of pests relies on using living natural

enemies (e. g., parasites, predators, and pathogens) to reduce pest populations to levels lower than would otherwise
Photo credit: Calgene, Inc.

Antisense tomatoes (left) and control (right) 3 weeks after harvest.

occur ( 13). Parasitic organisms are those whose development takes place in or on a single host organism; predator

organisms are those that consume other organisms as a

food source; and pathogenic organisms are those that cause

disease in other organisms. Many organisms, including

insects and other arthropods (e. g., spiders and mites), bacteria (and related organisms such as rickettsiae and mycopiasmas), viruses, fungi, protozoa, and nematodes are

being used as biological control agents to manage weeds,

insects, and other arthropod pests, as well as disease organisms in economically important plant species. Biological control methods have been used in the United States

on a limited basis for at least 100 years. Approaches used

can be classified into three common types-the classical

approach, augmentation, and conservation (25).

Biological control agents used to control nonindigenous pests, particularly those introduced from other countries, is called the classical approach. When a non-native

pest is introduced into a new environment, often there

are no natural enemies to control that pest. The classical

approach searches the area of origin of the pest and identifies natural enemies. These natural enemies are then

introduced into the new environment to control the pest

(25). Attempts are made to establish the introduced natural enemies as part of the ecosystem so that pest suppression will be permanent.

The augmentation approach focuses on increasing the

existing population of indigenous pest enemies. Small numbers of natural enemies can be released periodically, as

needed, to increase the indigenous population to levels

sufficient to control pest numbers at levels below those that

cause serious economic problems. The newly released natural enemies are expected to become part of the ecosystem,

and to help suppress more than one generation of pests

(25). This approach is similar to administering a booster

shot to augment indigenous-pest enemy populations.

Alternatively, large numbers of natural enemies can

be released at one time with the intent of quickly suppressing the pest population by creating an epidemic-like

situation. The control agent (i. e., natural enemy) is not

expected to become a permanent part of the ecosystem

and the natural enemy is not expected to control more

than one generation of the pest. The natural organisms

used with this approach are usually microorganisms, such

as bacteria and fungi. They are manufactured, formulated, standardized, packaged, registered as pesticides,

and applied to pests using methods and tools similar to

those used for chemical pesticides. Because of these similarities to chemical pesticides, this strategy is often referred to as the microbial pesticide or inundative approach

to augmentation. This approach generally requires regular application because the control agents do not survive

between crop seasons. or survive in insufficient number

to be effective the next season, or are prevented by other

factors from causing significant disease in the pest population ( 10, 16).

Conservation practices can be used to protect and

maintain natural enemy populations by manipulating the

environment. such as altering cropping patterns and farm

management practices to enhance the indigenous population, maintaining refuges and providing feeding and

nesting sites for natural enemies, and by applying pes-
52 ● A New Technological Era for American Agriculture

ticides only when pest populations exceed specified levels ( 16, 25, 35).

In general, the classical method of biological control

has been the approach most frequently and successfully

used to control weeds, insects, and other arthropods in

the United States. This is perhaps not surprising given

the large number of pests that are of foreign origin. For

example, an estimated 39 percent of the 600 most important arthropod pests in the United States are of foreign

origin and more than 630 additional foreign arthropods

are on the list of lesser pests (36). Based on past history,

it is predicted that exotic arthropod species will continue

to be added at a rate of about 11 species per year and

that approximately 7 of those species will become significant pests. Clearly the classical approach will continue to be a major biological control methodology.

Biological control approaches have had limited success

against pests in grain and row crops.

10Biological control

has been most successful against naturalized permanent

pests in areas of low disturbance (such as rangeland,

pastures, forests, and some aquatic habitats) where the

targeted pest is the dominant species, and where the end

goal is a stable plant community. The poor record of

success in grain and row crops is often attributed to the

fact that grain crops only persist for short periods of time,

during which the natural enemy must discover the crop

and become established, must find and attack its host

pest, and must increase its population to numbers sufficient to reduce the pest population significantly. The

abrupt end of the crop season precludes the establishment

of stable interactions between pests and natural enemies

in grain crops ( 13, 16, 25).

It is perhaps for these reasons that the microbial pesticide approach using fast-acting pathogens has received

more research attention than any other biological control

approach to pest suppression in grain and row crops. The

bacterium Bacillus thuringiensis, which produces compounds that are quickly toxic to some insects, can be

used effectively in this manner. The microbial pesticide

approach is also being taken to develop fungi that control

weeds ( 10, 16).

The conservation approach has received the least research attention. Little incentive exists for the private

sector to develop these technologies because the product

that is developed is management information. Successful

development of this approach will most likely fall to

public sector researchers. Methods to control communities of organisms in a systemic fashion rather than a

single control agent are needed (11 ).

Research Needs

Extensive research in many disciplines will be required

if biological control is to become more widely used. A

better fundamental understanding of pest-natural enemy

interactions, ecology, and population biology is needed,

as well as attention to more applied problems of mass

rearing, formulation, and delivery required to make these

control agents commercially viable. Successful development will require a multidisciplinary approach and will

draw from expertise in many fields, including: systematic (taxonomy), ecology, behavioral science, physiology, genetics, chemistry, and epizootiology (the study

of population disease at the population level), among

others ( 10, 16, 25, 38).

Taxonomic, biochemical. and genetic comparisons of

pests from the same or similar species taken from geographic areas of suspected evolutionary origin also are needed.

These studies can help identify pests and their natural enemies, improve understanding of the relationship between

pest and enemy, and determine the geographic distribution

of each. Use of classical biological control methods will

be enhanced if techniques can be developed to detect and

eliminate parasites and pathogens from the imported natural

enemy cultures ( 10, 16, 25, 38).

An improved understanding of the natural enemy-pest

dynamics and factors that enhance the effectiveness of

control is needed. Elucidation of the structure and roles

of insect hormones and compounds that attract or repel

pests is needed. Additional research is needed to understand the natural enemy population (i. e., infectivity, virulence, specificity of host; biological fitness including

survival, persistence, and dispersal; the role of population

density, etc.), the pest population (i.e., susceptibility,

development of resistance, mechanisms of immunity,

population density impacts, and distribution), the effects

of the abiotic and biotic environment (i. e., weather, soils,

host plants, biotic transport agents, sunlight, cropping

patterns, etc.), and the environmental impacts of releasing predators, parasites, and pathogens to control pests

(10, 16, 25, 38).

A major constraint to using the augmentation approach

to biological control is the inability to cost-effectively

10 Recent ~ork With bacu]ovi~~e~ tc) ~c)n[rol insects has been promising and this biological control agent may prove to be an cxceptk)n tO this

statement ( 16).
Chapter 2—Emerging Plant Technologies ● 53

raise large numbers of parasites, predators, and pathogens. The life cycles of many natural enemies are complex and raising these organisms in an artificial setting

is difficult. New mass rearing techniques need to be

developed for many biological control agents.

For natural enemies that are parasitic insects, laboratory rearing requires maintaining not only the host insect,

but the food source of the host insect as well, which may

include plants that are themselves difficult to grow. Thus,

mass rearing of a parasitic insect requires maintaining

both an appropriate plant population and host insect population, a costly arrangement that points to the need to

develop artificial diets ( 10, 25).

Viruses can also be difficult to mass produce. Viruses

are obligate cellular parasites and must be produced within

living cells. For viruses that are pathogenic to insects,

this can be accomplished either by infecting whole insects

or by infecting cultures of continuous cell lines derived

from the host insect. Recent advances in insect cell culture is improving the prospects of virus pesticide production. Significantly, most of these advances are being

made in the biomedical field rather than the agricultural

field, because biomedical industries are using certain

classes of viruses (such as baculoviruses) as vectors to

express foreign genes for high-level production of biological and pharmaceutical products ( 16).

Mass production techniques for fungal spores are also

needed. The application of automated systems and robotics

to mass production could potentially significantly reduce

the cost. Other problems encountered while mass rearing

natural enemies include the loss of genetic variability and

the loss of effectiveness of species that have been raised

for several generations in the laboratory ( 16, 25).

The performance of biopesticides in the field has often

been highly variable due to environmental factors, interactions with other organisms, and poor delivery to

target organism among other problems. Formulation of

biopesticides (mixing of the cultured microbial preparation with inert agents to achieve proper dilution, deposition, moisture holding capacity, protection from

ultraviolet rays, shelf life, slow release, etc. ) must be

improved to increase efficacy in the field. Long-range

needs include identifying new control agents, increasing

the toxicity of agents against susceptible pests, and expanding the range of hosts of the control agent (10, 16).

Delivery systems also need to be improved. Techniques must be designed to promote maximum efficacy

and ease of application. New sprayer technologies, application of biopesticides by irrigation methods, and timed release formulations are needed.

Finally, a general need exists to assess the efficacy and

impacts of control agents after release. Studies using biological control agents have rarely adequately documented

efficacy, reliability, and economic feasibility. Population

establishment and buildup, degree and timing of feeding

damage, plant population density and productivity, plant

stress, and nontarget side effects need to be assessed. Any

changes in the fitness of the naturalized bioagent need to

be ascertained to ensure efficacy and environmental safety.

While these questions are pertinent to all biological control

agents, they will be critical to regulatory approval of genetically engineered control agents ( 10, 16, 25, 38).

Use of Biotechnology in Biocontrol Research

Traditional technologies, such as chemical- or ultraviolet-generated mutations followed by selection for desired phenotypic traits, and sexual mating will continue

to play a role in producing and identifying natural enemies via improved control capability or host range. Additionally, traditional culture techniques can be used to

induce increased secretion of certain toxins and enzymes

involved in pathogenesis. However, new biotechnology

tools, such as protoplasm fusion and gene transfer, will

also be used to improve virulence, sporulation, fitness

for survival, infectivity under suboptimal conditions, and

production of pesticidal metabolizes; and to expand host

range and the tolerance of control agents to certain chemical pesticides ( 10, 16, 25, 38).

Biotechnology to improve biological control agents,

such as insects and other arthropods, nematodes, protozoans, and fungi, is technologically more complex than

biotechnology involving viral and bacterial control agents.

Use of genetic engineering in predator and parasitic insects is constrained by the lack of universal vectors or

other techniques to transfer foreign genes into the insect,

and the lack of useful insect genes that have been cloned.

Recombinant DNA techniques are being used to turn

slow acting viruses into quick acting viruses, and to increase virus virulence. Genetic engineering is being used

to improve the delivery of Bacillus thuringiensis toxin

to the pest. Methods include incorporating the toxin gene

into bacteria that inhabit seed coatings, roots, or surface

films where target insects feed. Genetic engineering in

fungi is being used to improve germination, penetration

of the insect cuticle, and increase toxicity. Little biotechnology research has been conducted using protozoans

and nematodes (10, 16, 25, 38). In addition to enhancing

the field efficacy of biological control agents, biotech-
54 . A New Technological Era for American Agriculture

nology provides powerful research tools to further our

basic understanding of the physiology and biology of

these control agents and their environment.

Institutions Involved in Biological Control

Research

Biological control research has been conducted primarily by public sector institutions, such as the U.S.

Department of Agriculture (i.e., the Agricultural Research Service, the Office of International Cooperation

and Development, the International Research Division,

and the Forest Service), the Land Grant University System, and other public and private universities. Other Federal agencies that have supported biological control research

include the U.S. Army Corps of Engineers (primarily for

aquatic weeds), the Department of Interior (mainly the

Park Service), the Department of Energy (through the

national laboratory system), and the Tennessee Valley

Authority. Selected State Natural Resources or Agricultural departments (notably those of California and Florida) also have supported biological control development.

The U.S. Environmental Protection Agency is involved

in registering biological control agents as pesticides. The

U.S. Department of Agriculture Animal and Plant Health

Inspection Service regulates the importation of natural

enemies and the environmental release of biological control agents. The State Department also is involved in

obtaining permission to search foreign countries for natural enemies of pests imported to the United States, and

with negotiating release conditions of natural enemies

with Canada and Mexico (10, 16, 25, 38).

Private industry interest has been focused primarily on

organisms that can be used in microbial pesticide applications, such as Bacillus thuringiensis to control insects,

and a few selected fungi (i. e., CASST, COLLEGO, and

DeVine) to control weeds. A limited level of privateindustry support exists for the use of predators and parasites to control arthropods. A few small, private firms

mass rear parasites and predators for release, but conduct

little or no research (10, 16, 25, 38).

Use of Biological Control Agents To Control

Pests in the United States

Biological Control of Arthropods: Parasites

and Predators

Arthropod (e.g., insects, spiders, mites) damage is a

major contributor to crop losses and decreased quality of

agricultural products. A wide array of biological control

agents can be used to control arthropods, bacteria, viruses, fungi, protozoa, and nematodes. In the United

Table 2-6—Use of Parasite or Predator Insects

To Control Insect Pests in the United States

Pest insect Host plant

Classical method

Rhodesgrass scale. . . . . . . . . . . . . . . . . . . . . . .

Citrus blackfly . . . . . . . . . . . . . . . . . . . . . . . . . . .

Walnut aphid. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cottony cushion scale. . . . . . . . . . . . . . . . . . . .

Olive scale. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Spotted alfalfa aphid . . . . . . . . . . . . . . . . . . . . .

Alfalfa weevil. . . . . . . . . . . . . . . . . . . . . . . . . . . .

California red scale . . . . . . . . . . . . . . . . . . . . . .

California purple scale. . . . . . . . . . . . . . . . . . . .

California yellow scale. . . . . . . . . . . . . . . . . . . .

Browntail moth . . . . . . . . . . . . . . . . . . . . . . . . . .

Satin moth , , , , , . . . . . . . . . . . . . . . . . . . . . . . . .

Oriental moth. . . . . . . . . . . . . . . . . . . . . . . . . . . .

Elm leaf beetle . . . . . . . . . . . . . . . . . . . . . . . . . .

European pine sawfly . . . . . . . . . . . . . . . . . . . .

European spruce sawfly . . . . . . . . . . . . . . . . . .

Larch casebearer . . . . . . . . . . . . . . . . . . . . . . . .

Larch sawfly . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Augmentation method

Mexican bean beetle . . . . . . . . . . . . . . . . . . . . .

Mealybugs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

California red scale . . . . . . . . . . . . . . . . . . . . . .

Spider mites . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Two spotted spider mite , . . . . . . . . . . . . . . . . .

Conservation method

European red mite . . . . . . . . . . . . . . . . . . . . . . .

Grasses

Citrus

Walnuts

Citrus

Olives

Alfalfa

Alfalfa

Citrus

Citrus

Citrus

Forests

Forests

Forests

Forests

Forests

Forests

Forests

Forests

Soybeans

California

citrus

Citrus

Almonds

Strawberries

Apples

SOURCE: Office of Technology Assessment, 1992.

States, these agents have been used to control several

arthropod species (table 2-6). The classical method of

control is the approach used most often, and the greatest

success has occurred in more stable habitats such as forests and orchards, rather than row crops.

Traditional selection methodologies have been used to

identify parasites or predators with improved control capability or host range. For example, such techniques were

used to identify strains of a parasitic mite resistant to

selected pesticides, which were subsequently released

into California almond orchards to control spider mites.

Increased pesticide resistance allows this parasitic mite

to be used in conjunction with Integrated Pest Management programs that use pesticides to control navel orangeworms above a threshold level. The ability to use

this predatory mite in conjunction with other insect control programs increased the acceptance of this parasite

for spider mite control (25).

Use of genetic engineering in predator and parasitic

arthropods is constrained by the lack of universal vectors

or other techniques to transfer foreign genes into the

arthropod. Current research is focusing on the use of

transposons to transfer genes, but transposons may be
Chapter 2—Emerging Plant Technologies .55

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service.

The parasitic wasp Microplitis croceipes lays her eggs

in the tobacco budworm. By putting this natural predator

to work, scientists hope to control members of the genus

Heliothis, which cause major damage to cotton, corn,

soybeans, and other crops.

specific to certain species of insects, and thus cannot be

used as a universal mechanism to transfer genes to all

insect species. Another major constraint is the lack of

useful arthropod genes that have been cloned (25).

Further development of predator and parasitic arthropods to control pest arthropods is being constrained by

several factors. Selection standards for classical control

approaches are needed. The economic importance of the

target pest is frequently the only factor considered when

selecting possible subjects for biological control. Characteristics of the natural enemy itself, such as its suitability of mass rearing at reasonable cost, additional host

requirements, impact on beneficial or endangered species, or dispersal characteristics may not be considered

(25).

Use of augmentation techniques to control pest arthropods with other parasitic and predator arthropods is

limited by the lack of artificial diets and subsequent high

cost of mass rearing, incomplete information on release

methods, lack of rapid and effective monitoring methods,

and lack of ability to stockpile or store natural enemies

or maintain gene banks. Quality control standards for

private firms that mass rear predatory or parasitic arthropods are lacking. Mixed colonies or even colonies

of the wrong species have sometimes been provided; in

some cases, firms have produced parasitic arthropods

unable to fly. Arthropods can be sold without guidelines

as to number to release, optimal timing of release, or

how to monitor efficacy of release. Professional quality

standards and appropriate management information are

Table 2-7—Pathogens Used To Control Insects

in the United States

Pest insect Host plant

Viruses

European pine sawfly . . . . . . . . . . . . . . . . . .

Douglas fir tussock moth . . . . . . . . . . . . . . .

Soybean looper. . . . . . . . . . . . . . . . . . . . . . . .

Velvetbean caterpillar moth . . . . . . . . . . . . .

Gypsy moth. . . . . . . . . . . . . . . . . . . . . . . . . . .

Bacteria

Japanese beetle. . . . . . . . . . . . . . . . . . . . . . .

Mosquito larvae . . . . . . . . . . . . . . . . . . . . . . .

Greater wax moth. . . . . . . . . . . . . . . . . . . . . .

Fungi

Browntail moth . . . , . . . . . . . . . . . . . . . . . . . .

Plant bug . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Aphids. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Spotted alfalfa aphid . . . . . . . . . . . . . . . . . . .

Mosquito larvae . . . . . . . . . . . . . . . . . . . . . . .

San Jose scale. . . . . . . . . . . . . . . . . . . . . . . .

Whiteflies . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Protozoa

Grasshoppers . . . . . . . . . . . . . . . . . . . . . . . . .

European corn borer . . . . . . . . . . . . . . . . . . .

Nematodes

Butterflies, beetles . . . . . . . . . . . . . . . . . . . . .

Face fly. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Mosquito larvae ., . . . . . . . . . . . . . . . . . . . . .

Trees

Trees

Soybeans

Soybeans

Trees

Turf grass

NA

Beehives

Trees

Apples

Potatoes

Alfalfa

NA

Trees

Trees

Rangeland

Corn

Cranberry, Citrus

Cattle

NA

NA = Not applicable,

SOURCE: Office of Technology Assessment, 1992.

needed (25). Conservation methods to maintain predator

or parasitic arthropods are constrained by gaps in the

knowledge of the role of natural enemies in crop systems

and how best to modify management practices to maintain natural populations.

Biological Control of Arthropods: Pathogens

In addition to parasitic and predatory arthropods, pathogens can be used to control pest arthropods. Pathogens

that have been used to at least partially control arthropods

(almost exclusively insects) in the United States include

bacteria, particularly different strains in the Bacillus genus; viruses, particularly members of the baculovirus

group; fungi; protozoans; and nematodes (table 2-7). Bacillus thuringienses (Bt), discussed earlier, is the pathogenic bacteria most frequently used to control insects.

The tools of biotechnology can be used to improve the

delivery of the Bt toxin to insect pests. The gene that

codes for the toxin can be incorporated into bacteria other

than Bacillus thuringiensis; these bacteria may inhabit

seed coatings, roots, or surface films where target insects

feed. Genes coding for Bt toxins have incorporated in

strains of Pseudomonas, a soil bacteria that colonize corn

roots, and into Clavibacter xyli, a plant-associated (endophytic) bacterium that grows in the vascular tissues of
56 ● A New Technological Era for American Agriculture

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service.

Entomologist compares an insect ravaged cotton leaf

from a control variety with one that has been genetically

engineered with a protective gene from Bacillus

thuringiensus.

plants. The Monsanto and Mycogen Corp. are incorporating Bt toxin genes into Pseudomonas, while Crop Genetic International is working with Clavibacter (1, 16).

Genetic engineering techniques are also being used to

modify Bt toxin genes to be toxic to a broader range of

pests and to be more potent. Traditional selection and

screening procedures applied to natural isolates are being

used as well, to identify strains of Bacillus bacteria that

are either more efficacious or that have different host

specificity. These methods will potentially extend Bt use

to include control of cotton bollworm, European corn

borer, and corn rootworms. Genetically engineered and

new, naturally selected strains of Bt are expected to be

commercially available by 1995 (1, 16).

Viruses are also being used to control insects. Many

types of viruses infect insects, but only a few cause

pathogenic epizootic diseases that are sufficiently fastacting and widespread to be considered useful for pest

control. The first virus to be registered by EPA and

produced commercially as a pesticide was a type of baculovirus that forms large polyhedral occlusions within

the nucleus of infected cells. It was marketed in the mid

1970s by the Sandoz Corp. under the name Elcar, and

was used to control cotton bollworm. Its market was

displaced by the new pyrethroid pesticides. It has not

been remarketed, although increasing resistance to pyrethroids may lead to renewed commercial interest. Three

other baculoviruses have been used by the U.S. Forest

Service to control the Douglas fir tussock moth, the gypsy

moth, and the European pine sawfly ( 16).

Baculoviruses are used to control lepidopterans (butterflies and moths) because they cause widespread lethal

epizootic diseases, lead to morbidity within a week of

infection, are compatible with other agrichemicals, can

be applied by conventional spraying techniques, and are

stable on the shelf for extended periods of time (years).

Further, the baculoviruses replicate only in arthropods.

Each is specific to a host or group of closely related

hosts, and must enter and replicate within a specific type

of host cell. This specificity is attractive from an environmental control perspective ( 1).

Two other viruses of potential usefulness for biological

control of insects are the Autograph californica virus

and the codling moth granulosis virus. A. californica has

a relatively wide range of hosts and could be used to

control alfalfa looper, cabbage looper, fally armyworm,

beet armyworm, and wax moth. The codling moth granulosis virus could be used to control insects that affect

pome fruits and walnuts ( 16).

Genetic engineering is being used to make viral pesticides faster acting. Neurotoxin genes that paralyze the

pest insect and quickly halt insect feeding are being introduced into baculovirus. Alternatively, insecticidal

hormones can be incorporated into the baculovirus to

disturb insect development or behavior. The genes that

code for an enzyme that regulates juvenile hormone levels in insects; a protein that regulates the release of a

major molting hormone; and a protein hormone that elicits several behavioral characteristics during molting all

recently have been isolated ( 1).

The lack of suitable cloned neurotoxins and insect

hormone genes is delaying further progress in improving

viral control agents. Promotors that can be recognized

by selected host cells of pest insects (i.e., cells of the

midgut, for example) are being used to extend baculovirus ranges. The recent discovery that baculoviruses

normally contain a gene regulating insect molting hormone activity is leading to the development of baculovirus strains in which this gene has been deleted. These

gene-deleted strains have been shown to reduce insect

feeding during infection, and to hasten the onset of insect

morbidity ( 1).

Baculoviruses genetically modified to delete the insect

molting hormone regulatory gene are expected to be

available before 1995. Baculoviruses engineered to carry
Chapter 2—Emerging Plant Technologies ● 57

Table 2-8—Control of Weeds by Insect and

Microbial Agents in the United States

Weed Habitat/crop affected

Alligator weed

Lantana

Musk thistle

Northern jointvetch

Persimmon

Prickly pear cactus

Puncture vine

Skeletonweed

St. Johnswort

Stranglervine

Water hyacinth

Aquatic

Rangeland, forest, crops

Rangeland

Rice and soybeans

Rangeland

Rangeland

Pasture, annual crops

Rangeland

Range and arable lands

Citrus

Aquatic

SOURCE: Office of Technology Assessment, 1992.

insecticidal genes such as insect hormones and neurotoxins could be available in the late 1990s.

The only fungus registered and commercially produced

for insect control in the United States was Hirsutella

thompsonii. This fungus was used to control citrus rust

mites, but was not commercially successful primarily

because it did not survive storage or transportation. Further, environmental factors, including insufficient moisture, adversely affected its efficacy. Genetic engineering

of fungi is now being used to improve germination, improve penetration of the insect cuticle, and increase toxicity ( 16).

A major limitation to using protozoans is that they kill

insects very slowly, if at all. Generally they affect arthropods by causing chronic disease with sublethal effects, reducing the ability of the arthropod to survive the

winter. Nosema locustae, used to control grasshoppers

on rangeland, is the only protozoan to be registered and

commercially available in the United States ( 16).

Research involving nematodes has been increasing.

Steinernema carpocapsae has been used in the United

States to control some lepidoptera species. It is not effective if applied to vegetation surfaces or other situations

where it can dry out, but it can be effective in the soil

or in burrows in plant tissues. Dedalenus siricidicola has

been used to control woodwasps, even though its action

is to sterilize its host rather than kill it. Very little genetic

engineering is being used with nematodes.

Biological Control of Weeds: Microorganisms

and Arthropods

Historically, biological control of weeds most commonly has been mediated by microorganisms (mainly

bacteria and fungi, see table 2-8) and insects. Worldwide,

89 species of weeds have been controlled using 192 species of introduced organisms (the classical approach);

an additional 25 weed species have been controlled

using 33 species of native organisms (the bioherbicide

approach) ( 10).

Pathogenic microorganisms kill or severely debilitate

their host plants by causing disease. Pathogenic and nonpathogenic microbes also produce metabolizes that are

toxic to plants, and these phytotoxins can also be used

as herbicides. For example, the fungus Gliocladium virens, when prepared and applied properly, can release

enough of the toxin viridiol in the soil to control pigweed

without harming cotton seedlings.

The private sector has shown interest in developing

microbial herbicides. Two microbial herbicides (COLLEGO and DeVine) are commercially available and four

others are undergoing trials for registration as herbicides

(table 2-9). Other microbial herbicide candidates are undergoing experimental development. About 107 fungi

and 1 bacterium are being evaluated worldwide as bioherbicides ( 10). Additionally, a parasitic nematode, Orrina phyllobia, has been shown to be a practical means

to control silverleaf nightshade.

Development of a microbial herbicide can take several

years. For example, it is estimated that the development

of COLLEGOR took 11 years of effort from the time of

discovery to commercial availability at a cost of about

$1 to $1.5 million. In comparison, a typical chemical

herbicide takes 7 to 10 years to develop and costs approximately $80 million. Early research on microbial

herbicides is subsidized by public funds, but the expense

of large-scale fermentation, toxicology testing, formulation, and registration are borne by industry. In some

cases, these costs could prove to be quite high ( 10).

Further development of microbial herbicides will require

improved mass production, formulation, and delivery

systems. Some native pathogens, such as the rusts and

certain smut fungi, cannot be artificially grown. Methods

to obtain sufficient quantities of these pathogens from

infected plants must be developed.

Weed pathogens are being genetically manipulated to

improve virulence, sporulation, fitness for survival and

infection under suboptimal conditions, and production of

herbicidal metabolizes; to expand host-range; and to increase tolerance to certain chemical pesticides. For example, it has been discovered that altering a single enzyme

(pisatin demethylase) can cause a fungal pathogen, but

not a nonpathogenic fungi, to become virulent on new

host plants. Genetic engineering techniques are also being

used to increase virulence by transferring genes encoding

herbicidal phytotoxins to pathogenic microorganisms (10).

297-937 0 - 92 - 3 QL 3
.58 . A New Technological Era for American Agriculture

Table 2-9—Microbial Herbicides Commercially Available or in Development in the United States

Herbicide Pest Crop/habitat effected

COLLEGOR Northern jointvetch Rice

DeVine R Stranglervine Citrus

CASSTTMa Sicklepod Soybean and peanut

BioMal TMa Round-leaf mallow Annual crops

Cercospora rodmaniia Waterhyacinth Aquatic

Mycoleptodiscus terrestrisa Eurasian watermilfoil Aquatic

aUndergoing trials

SOURCE: Office of Technology Assessment, 1992.

Table 2-10—Use of Insects To Control Weeds in the

United States

Weed Crop/habitat affected

Classical approach

St. Johnswort . . . . . . . . . . . . . . . .

Lantana. . . . . . . . . . . . . . . . . . . . .

Alligatorweed. . . . . . . . . . . . . . . .

Prickly pear cactus. . . . . . . . . . .

Puncturevine . . . . . . . . . . . . . . . .

Tansy ragwort . . . . . . . . . . . . . . .

Hydrilla . . . . . . . . . . . . . . . . . . . . .

Purple loosestrife . . . . . . . . . . . .

Leafy spurge . . . . . . . . . . . . . . . .

Diffuse, spotted

and Russian knapweeds. . . .

Yellow starthistle. . . . . . . . . . . . .

Salt cedar. . . . . . . . . . . . . . . . . . .

Field bindweed . . . . . . . . . . . . . .

Waterlettuce. . . . . . . . . . . . . . . . .

Broom snakeweed . . . . . . . . . . .

Baccharis neglecta. . . . . . . . . . .

Augmentation approach

Waterlettuce. . . . . . . . . . . . . . . . .

Purple nutsedqe . . . . . . . . . . . . .

Range and arable lands

Rangelands, forests, and

plantation crops

Aquatic

Rangeland

Pastures and annual

crops

Rangeland

Aquatic

Range and arable lands

Rangeland

Rangeland

Rangeland

Rangeland and forests

Various crops

Aquatic

Rangeland

Range and arable lands

Tried and discontinued

Tried and discontinued

SOURCE: Office of Technology Assessment, 1992.

Traditional techniques are also used to alter pathogen

characteristics. These include chemical- or ultravioletgenerated mutations followed by selection for desired

phenotypic traits, breeding, and nonsexual transfer of

hereditary properties. Cultural techniques also are being

improved to increase secretion of certain toxins and enzymes involved in pathogenesis.

In addition to microbial pathogens, insects and other

arthropods also can be used as biological control agents

for weed control (table 2-10). The relationship between

insects and weeds is complex. Some weeds (e. g., St.

Johnswort) can be controlled with just one insect. Others

may require more than one insect for control. For example, control of tansy ragwort, a poisonous weed found

in the Pacific Northwest, is mediated by a moth that

defoliates it and a second insect that feeds on its root as

a larva and on the resprouting growth as an adult. This

relationship between each co-evolved arthropod and its

weed host makes each study unique and raises the question of whether scientific expertise will ever be adequate

to fully assess the potential for weed control by arthropods (10).

Arthropod adults and immature larva and nymphs feed

and complete at least a part of their life cycles on certain

weeds. In this process, they damage the plants, weakening and reducing their productivity and competitiveness. In general, the feeding activity of immature

arthropods is more damaging than that of adult arthropods. The extent of the damage caused by arthropod

feeding depends on the particular weed tissues destroyed,

the timing of the damage as it relates to the plant’s growth

cycle, and the extent of other plant stresses present. For

example, sucking insects and grasshoppers defoliate plants

late in the plant’s life cycle and do not cause as much

damage as insects that defoliate plants early in their life

cycles. Arthropods that attack the seeds of weeds that

cannot reproduce vegetatively are likely to have the greatest impact on weed control. In addition to feeding damage, some arthropods weaken plants by introducing toxins

causing cell proliferation and gall formation ( 10).

Of the more than 250 naturalized plant species considered to be major weeds, only a few dozen have been

considered for classical biocontrol by arthropods. Nonetheless, this approach has been the most common and

successfully used method of biological weed control. It

is estimated that the control of St. Johnswort by insects

has yielded benefits worth approximately $2 million per

year. It takes 1 to 4 years to find and clear each insect

or other arthropod biocontrol candidate and development

costs are estimated at $1 to 2 million. However, the

estimated return on research is about $30 for every $1

invested ( 10). Few attempts to control weeds with ar-
Chapter 2—Emerging Plant Technologies ● 59

Photo credit: U.S. Department of Agriculture,

Agricltural Research Service.

Tiny (1/8th inch long) flea beetle, Apthona flava, on leafy

spurge is one of several biological control agents tested

to combat a costly weed that infests 21⁄2 million acres of

rangeland in the Great Plains.

thropods using the augmentation approach have been tried,

and generally they have been discontinued.

Traditional selection methods are used to select coldtolerant strains of weed-damaging insects and strains whose

larva have higher survival rates in hot weather, and whose

prediapause behavior has been altered. Genetic engineering is not currently used to improve arthropods as

biological control agents ( 10).

Biological Control of Disease

Biological control of plant diseases is achieved by

decreasing pathogen populations or by preventing the

occurrence of infections. Approaches taken include manipulating resident microbial communities to decrease

disease (conservation approach) or applying to the plant

organisms antagonistic to pathogens (augmentation). Only

three plant disease biocontrol agents are commercially

available (table 2-11 ) (38).

Table 2-1 l—Biological Control Agents Commercially

Available To Control Plant Disease

in the United States

Agent Disease controlled

Bacteria

Agrobacteriurn radiobacter . . . . . . . . . . Crown gall in dicots

(strain K84)

Pseudomonas fluorescent. . . . . . . . . . . Damping off and root

rot in cotton

Fungi

Peniophora gigantea. . . . . . . . . . . . . . . . Root and butt rot in

conifers

SOURCE: Office of Technology Assessment, 1992,

Use of Agrobacterium radiobacter to control crown

gall in dicots costs an estimated 1 to 5 cents per plant

treated, and less if the seeds are treated. Peniophora

giganted applied to freshly cut conifer stumps preempts

colonization by the pathogen responsible for root and

butt rot, diseases resulting in annual losses of nearly $1

billion. Pseudomonas j7uore.seen.s, sold under the name

of Dagger G by Ecogen, controls diseases in cotton. In

1989, it was used on approximately 75,000 acres of cotton in the Mississippi Delta region (38).

Diseases that potentially could be controlled in the next

decade include take-all disease in wheat, and dampingoff and root rot in crops other than cotton. Yeasts to

suppress Penicilliurm and other postharvest pathogens in

citrus and other fruit; the bacterium Bacillus subtilis to

control brown rot in peaches; and compost amended potting media to control Rhizoctonia and Pythium in nursery

stocks are other potential control agents (38).

The use of microbial disease control agents has been

plagued by inconsistent efficacy in the field. In some

cases, agents that have worked in one field have failed

to be effective in immediately adjacent fields. The biocontrol agent and pathogen interact in the midst of a vast

array of other microorganisms that sometimes decrease

the efficacy of the control agent (23, 24). A better understanding of the community dynamics, population and

community ecology, population genetics of plant-associated microorganisms and of the mechanisms that regulate the community structure and dynamics of plantassociated microorganisms is needed.

Much of the research in the area of biocontrol of plant

diseases has focused on improving the understanding of

the mechanisms by which biocontrol agents prevent disease. One mechanism of action called interference competition or antibiosis refers to the inhibition of one organism

by a metabolic product of another. The use of the bac-
60 ● A New Technological Era for American Agriculture

terium Agrobacterium radiobacter strain K84 to control

crown gall tumors caused by Agrobacteriurm tumefaciens

is an example of this type of mechanism. A. radiobacter

produces an antibiotic to A. tumefaciens. Control of takeall disease in wheat by Pseudomonas fluorescens strain

2-79 is another example of antibiosis (38).

Peniophora gigantea controls root rot in pine caused

by the fungus Heterobasidion annosum, on the other

hand, by competing with the fungus for nutrients and

space, a process referred to as exploitation competition.

A third mechanism, hyperparasitism, occurs when fungal

pathogens destructively parasitize another organism. Fungi

of the Trichoderma and Gliocladium family, for example, parasitize soil-born plant pathogens such as Rhizoctonia solani and Pythium species. A fourth mechanism

of disease prevention by biological agents is hypovirulence. For example, some strains of the chestnut blight

fungal pathogen Cryphonectria parasitic (those with

reduced virulence) can impart protection to chestnut trees

from more virulent strains of this pathogen.

Traditional screening techniques are being used to develop fungicide-resistant strains of the fungus Trichoderma, which allows this disease control agent to be used

with fungicides so that fewer chemicals need be applied.

Strains of the bacteria Pseudomonas syringae pv. tomato,

which controls bacterial speck in tomatoes, have been

made resistant to copper. The copper resistance allows

P. syringae to be used in the presence of copper bactericide. Combinations of P. syringae and copper bactericide gives greater control over bacterial disease than

occurs with the biocontrol agent or bactericide treatment

alone (31, 32).

Pathogenic organisms can become resistant to biological control agents. For example, A. radiobacter controls

the plant pathogen A. tumefaciens by producing a compound called agrocin. The gene producing agrocin is

carried on a plasmid, which can be naturally transferred

to A. tumefaciens. Thus, A. fumefaciens is becoming

resistant to A. radiobacter. Genetic engineering is being

used to construct mutant strains of A. radiobacter that

no longer have the ability to transfer the agrocin plasmid,

thus decreasing the potential of A. tumefaciens to develop

resistance to this natural pesticide. Protoplasm fusion techniques are also being used to construct strains of Trichoderma harzianum that are more effective than parental

strains in controlling Pythium ultimum (38).

Biological Control of Frost Damage

The temperature at which frost injury occurs in a number of crops is determined by the population density of

ice-nucleation-active bacteria on plant leaves. By decreasing the numbers of these bacteria, some protection

against frost damage can be achieved. The application

of non-ice-nucleating bacteria prior to colonization of

ice-nucleating bacteria can effectively prevent the establishment of the ice-nucleating bacteria by limiting the

resources (i.e., space and/or nutrients) available to the

ice-nucleating bacteria. Ice-minus deletion mutants of the

bacteria Pseudomonas syringae have been constructed to

control frost. The first planned introductions of genetically engineered bacteria into the environment in the

United States involved the field-testing of these ice-minus

bacteria.

SUMMARY

Pest control is a major concern of crop producers in

the United States. Each year, pest damage results in

billions of dollars of lost revenue to farmers. Poor weather

conditions add to those losses. To control pest damage,

farmers have traditionally used chemical approaches.

Biotechnology is now providing opportunities to use biological approaches such as transgenic plants resistant to

pests and better adapted to geoclimatic conditions, and

the use of biological control agents.

The ability to create transgenic plants with useful agronomic characteristics is constrained by the lack of

knowledge concerning plant physiology. Our understanding of plant metabolism has not kept up with the

development of biotechnology methods. However, plants

resistant to certain insects are approaching commercialization. Most of these plants have a Bacillus thuringiensis

toxin gene insert, but some research also is being conducted using insect trypsin inhibitors that disrupt the

digestion of feeding insects. Several transgenic Bt plants

are undergoing field trials, and it is expected that several

companies will begin petitioning EPA for approval for

commercial release soon.

Plants tolerant of herbicides are being developed to

aid the management of weeds. Development of broadspectrum herbicides has been constrained because they

not only kill most weeds, but also cause significant damage to crops. Crops tolerant to specific herbicides allow

the use of these herbicides in conditions where they previously could not be used, and may allow for the replacement of some environmentally damaging herbicides.

Some of these crops are nearing commercialization stages.

Transgenic plants are being developed that are resistant

to disease. Scientific understanding of the complex interactions between fungi or bacteria and host plants is

limited, so much of the early successes have been in
Chapter 2—Emerging Plant Technologies ● 61

developing plants resistant to certain viral diseases. Several virus-resistant plants are under development.

Development of transgenic plants tolerant to geoclimatic conditions is in the early stages. Research is being

conducted to understand the mechanisms of heat and

drought tolerance, and to enhance the ability of plants

to withstand cold temperatures. However, the successful

commercialization of these plants is unlikely to occur

before the end of the decade.

In addition to engineering crops themselves, there is

increased interest in developing biological control agents

to manage pests. The use of biological control in the

United States, to date, is relatively limited and most

successes have involved controlling pests in forests, orchards, grasslands and aquatic environments. Use of biological control in grain and row crops is very limited.

However, there is more emphasis placed on developing

such products to control weeds, insects, and disease in

the major food crops, and improved strains of Bacillus

thuringiensis to control insects and a few fungal strains

to control weeds are approaching commercialization. More

research still is needed to successfully develop other

products.

The food processing industry will also be affected by

biotechnology. Plants are modified for new quality and

processing characteristics. For instance, tomatoes with

delayed softening characteristics are nearing commercialization. Research is also underway to alter the starch,

oil, and protein content of selected crops to more closely

reflect consumer preferences and to enhance their processing characteristics for specific end uses. Diagnostic

kits are in various stages of development to detect the

presence of microorganisms, chemicals, and other contaminants in food products.

The development of transgenic plants and biological

control organisms offer new approaches to controlling

pests and to improving food processing characteristics.

However, many issues have been raised concering the

development of these products. Some groups are worried

about the effects these products will have on small farms,

and on food safety and the environment. Additionally,

many of these products will require extensive farm management capabilities for effective use. These issues will

be discussed in subsequent chapters.

1.

CHAPTER 2 REFERENCES

Adang, M.J. and Miller, L. K., “Genetic Technology for Resistance to Insect Pests, ’ commissioned

background paper prepared for the Office of Technology Assessment, 1991.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

18.

Amheim, N. and Levenson, C. H., “Polymerase Chain

Reaction, Chemical and Engineering News, Oct.

1, 1990, pp. 36–47.

Beachy, R.N. et al., “Expression of Sequences of

Tobacco Mosaic Virus in Plants and Their Role in

Disease Resistance, ’ Tailoring Genes for Crop Improvement, G. Bruening et al. (eds. ) (New York,

NY: Plenum Publishing Company, 1987), pp. 169–

180.

Beachy, R. N., Loesch-Fries, S. and Turner, N.,

“Coat Protein-Mediated Resistance Against Virus

Infection,” Ann. Rev. Phytopath. 28:451-474, 1990.

Bialy, H. and Klausner, A., “A New Route to Virus

Resistance in Plants, ” Bio/Technology 4, 96, 1986.

Boyer, J. S., “Plant Productivity and Environmerit, ” Science 218:443-448, 1982.

Boyer, J. S., “Water and Plant Productivity, ” Water

and Water Policy in World Food Supplies, W.R.

Jordan (cd. ) (College Station, TX: Texas A&M University Press, 1987), pp. 233–239.

Browning, J. A., “Plant Disease Management, ”

commissioned background paper prepared for the

Office of Technology Assessment, 1991.

Burke, J.J. and Upchurch, D. R., “Agricultural

Technologies Associated With Plant Temperature and

Water Stress, ” commissioned background paper

prepared for the Office of Technology Assessment,

1991.

Charudattan, R. and Andres, L. A., “Biocontrol for

Weeds, ” commissioned background paper prepared

for the Office of Technology Assessment, 1991.

Cook, R.J. and Baker, K. F., “Nature and Practice

of Biological Control of Plant Pathogens, American Phytopathological Society, St. Paul, MN, 1983.

Cutler, A.J. et al., “Winter Flounder Antifreeze

Protein Improves the Cold Hardiness of Plant Tissues,” Journal of Plant Physiology>, vol. 135, 1989,

pp. 351-352.

DeBach, P. (cd.), Biological Control of Insect Pests

and Weeds (New York, NY: Reinhold Publishing

Co.), 1964.

Discover, June 1991, p. 18.

Fraley, R. T., “Genetic Engineering in Crop Agriculture, commissioned background paper prepared

for the Office of Technology Assessment, 1991.

Fuxa, J. R., “Pathogens for Insect Control, ” commissioned background paper prepared for the Office

of Technology Assessment, 1991.

Georges, F., Saleem, M., and Cutler, A. J., “Design

and Cloning of a Synthetic Gene of the Flounder

Antifreeze Protein and its Expression in Plant Cells, ”

Gene, vol. 91, 1990, pp. 159-165.

Harlander, S., “Biotechnology in Food Processing

in the 1990s, commissioned background paper prepared for the Office of Technology Assessment, 1991.
62 ● A New Technological Era for American Agriculture

19.

20.

21.

22.

23.

24.

25.

26.

27.

28.

29.

30.

Hatzios, K. K., “Biotechnology Applications in Weed

Management: Now and in the Future, ” Advances in

Agronomy 36:265–316, 1987.

Hatzios, K. K., “Recent Developments in the Physiology and Biochemistry of Herbicide Safeners,

Brighton Crop Prot. Conf. Weeds 3:1207-1216, 1989.

Helentjaris, R. and Burr, B. (eds. ), Development

and Application of Molecular Markers to Problems

in Plant Genetics (New York, NY: Cold Spring Harbor Laboratory, 1989).

Hightower, R. et al., ‘‘Expression of Antifreeze Proteins in Transgenic Plants, ” Plant Molecular Biology, vol. 17, 1991, pp. 1013–1021 .

Hirano, S.S. and Upper, C. D., “Temporal, Spatial,

and Genetic Variability of Leaf-Associated Bacterial

Populations,” Microbiology of the Phyllosphere, N.J.

Fokkema and J. van den Heuvel (eds.) (Cambridge,

MA: Cambridge University Press, 1986), pp. 235-

251.

Hirano, S.S. and Upper, C. D., “Population Biology

of Pseudomonas syringae, ’ Ann. Rev. Phytopathol.

28: 1990.

Hey, M. A., “Use of Parasites and Predators To

Control Insect and Mite Pests in Agriculture, ” commissioned background paper prepared for the Office

of Technology Assessment, 1991.

Kishore, G. M., ‘‘Plant Genetic Modification for Weed

Control, commissioned background paper prepared for the Office of Technology Assessment, 1991.

Loesch-Fries, S., “Genetic Modification for Disease Resistance, ’ commissioned background paper

prepared for the Office of Technology Assessment,

1991.

Main, C.E. and Gurtz, S.K. (eds.), “ 1988 Estimates

of Crop Losses in North Carolina Due to Plant Diseases and Nematodes, ” Department of Plant Pathology Special Publication No. 8, North Carolina

State University, Raleigh, NC, 1989, 209 pp.

National Academy of Sciences, Field Testing Genetically Modified Organisms: Framework for Decisions (Washington, DC: National Academy Press,

1989), 170 pp.

National Research Council, National Academy of

Sciences, Board on Agriculture, Genetic Engineer31.

32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

ing of Plants: Agricultural Opportunities and Policy

Concerns (Washington, DC: National Academy Press,

1984).

Papavizas, G. C., Trichoderma and Gliocladium: Biology, Ecology, and Potential for Biocontrol., Ann.

Rev. Phytopathol. 23:23-54, 1985.

Papavizas, G. C., “Genetic Manipulation to Improve the Effectiveness of Biocontrol Fungi for Plant

Disease Control, ” Innovative Approaches to Plant

Disease Control, I. Chet (ed.) (New York, NY: Wiley,

1987), pp. 193-212.

Putnam, A.R. and Duke, W. B., “Biological

Suppression of Weeds: Evidence for Alleopathy in

Accessions of Cucumber, ” Science 185:370–372,

1974.

Quisenberry, J. E., Cartwright, G.B. and McMichael, B. L., “Genetic Relationship Between Turgor Maintenance and Growth in Cotton Germplasm,” Crop Sci. 24:479–482, 1984.

Rabb, R. L., Stinner, R. E., and van den Bosch, R,

“Conservation and Augmentation of Natural Enemies, ’ C.B. Huffaker & P.S. Messenger (eds.)

Theory and Practice of Biological Control (New

York, NY: Academic Press, 1976).

Sailer, R. I., ‘‘History of Insect Introductions, C. L.

Wilson and C.L. Graham (eds.), Exotic Plant Pests

and North American Agriculture (New York, NY:

Academic Press, 1983), pp. 15-57.

Sheehy, R. E., Kramer, M., and Hiatt, W. R., “Reduction of Polygalacturonase in Tomato Fruit by

Antisense RNA, ” Proc. Natl. Acad. Sci., 1988.

Upper, C.D. and Hirano, S. S., “Microbial Biocontrol of Plant Diseases, ” commissioned background

paper prepared for the Office of Technology Assessment, 1991.

U.S. Department of Agriculture, Losses in Agriculture, USDA Handbook No. 291, 1965, 120 pp.

Vandekerckhove, J. et al., “Enkephalins Produced

in Transgenic Plants Using Modified 2s Seed Storage

Proteins,” Biotechnology 7:929-936, 1989.

Wessells, Norman K. and Hopson, Janet L., Biology

(New York, NY: Random House, Inc., 1988).
Chapter 3

Emerging Animal Technologies

Photo credit: Grant Heilman, Inc.
Contents

Page

COMPOUNDS THAT PROMOTE GROWTH, ENHANCE FEED EFFICIENCY, AND

REDUCE .CARCASS FAT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Somatotropin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Beta-Agonists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Antimicrobial Agents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Anabolic Steroids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

REPRODUCTION TECHNOLOGIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Estrous Cycle Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Embryo Cloning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Embryo and Sperm Sexing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

TRANSGENIC ANIMALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Process of Creating Transgenic Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transgenic Poultry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transgenic Swine . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transgenic Ruminants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Transgenic Fish . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Research Needs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

ANIMAL HEALTH TECHNOLOGIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vaccines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Immunomodulators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Diagnostics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

FOOD PROCESSING APPLICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER PREFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Figures

65

66

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72

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77

77

79

79

85

85

86

87

87

88

88

90

90

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93

94

Figure Page

3-1. Bovine Somatotropin (bST) Production Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69

3-2. Nuclear Transplantation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78

3-3. Reproductive Technologies Used To Produce Transgenic Animals . . . . . . . . . . . . . . . . . . . . . . . . 80

3-4. Construction of a cDNA Library . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

3-5. Gene Transfer Using Embryo Stem Cell Culture . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84

3-6. Basic Steps in a DNA-Probe Hybridization Assay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93

Tables

Table Page

3-1. Effect of bST on Specific Tissues and Physiological Processes in Lactating Cows . . . . . . . . 67

3-2. Antimicrobial Agents Approved as Growth Promotants for Swine, Poultry, and Cattle in

the United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 72

3-3. Anabolic Steroids Commercially Available in the United States . . . . . . . . . . . . . . . . . . . . . . . . . . 74

3-4. Diagnostic Monoclinal Antibody Kits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91

3-5. Pathogens for Which Diagnostic Kits Using Nucleic Acid Probes Are Available . . . . . . . . . 91
Chapter 3

Emerging Animal Technologies

The U.S. livestock industry is immense, and the costs

of running it are correspondingly large. Feed and health

care costs for the Nation’s nearly 100 million head of

cattle (beef and dairy), 55 million pigs, 10 million sheep,

and 600 million chickens and turkeys amount to billions

of dollars annually. Disease and reproductive losses also

significantly erode industry profits.

Like any industry, livestock producers strive to reduce

costs and losses, and to maximize profits. Feed constitutes almost 70 percent of the cost of producing pigs for

pork. Improvements in feed efficiency (i.e., a lower

quantity of feed consumed per unit of weight gained)

and faster weight gain could potentially lower production

costs in this and other sectors of the livestock industry.

Animal diseases cost the livestock industry billions of

dollars each year. For example, anaplasmosis in cows

costs an estimated $300 million a year in losses and

disease control. The bacterium Staphylococcus aureus,

which causes 55 percent of mastitis, costs U.S. dairy

producers some $250 million annually. New vaccines

and diagnostic kits can help decrease disease in livestock.

Other economic losses in the livestock industry result

from low conception rates and embryo mortality. Such

losses can be minimized by a greater understanding of

reproduction as well as by emerging technologies for

improving reproductive success.

Biotechnology has the potential to improve feed efficiency, reduce losses from disease, and increase reproductive success in all sectors of the livestock industry,

in part by furthering our understanding of animal physiology, and in part through the development and commercialization of new techniques and products.

The term biotechnology refers to a wide array of techniques that use “living organisms (or parts of organisms)

to make or modify products, to improve plants or animals, or to develop microorganisms for specific uses’

(45). Under this broad definition, biotechnology includes

many long-practiced technologies, such as animal breeding and cheese, wine, and beer making. Generally, however, the term biotechnology is used in reference to such

new technologies as recombinant DNA techniques (also

called genetic engineering), cell culture, and monoclinal

antibody (hybridoma) methods. The application of these

new methods to the livestock industry has already generated a number of products for improving production,

animal health, and food processing, and will continue to

do SO.

Biotechnology is specifically used to produce products

that will promote growth and increase feed efficiency

and carcass leanness in growing animals, and significantly increase milk production in lactating animals. New

reproductive technologies are providing means to rapidly

upgrade herd quality. Transgenic animals are being produced to grow faster, have greater disease resistance, and

to produce high-value pharmaceutical products. New

vaccines and diagnostic kits are being developed to improve livestock health. Biotechnology is also being used

to process meat and dairy products and to detect food

contaminants that might be present in those products.

This chapter presents some new livestock biotechnologies currently under development. 1

COMPOUNDS THAT PROMOTE

GROWTH, ENHANCE FEED

EFFICIENCY, AND REDUCE

CARCASS FAT

Compounds currently used in the livestock sector to

promote growth and increase feed efficiency, such as

anabolic steroids and antimicrobial compounds, will continue to be used. However, new products are also being

developed, including protein hormones called somatotropins and catecholamine compounds called beta-adrenergic agents. These compounds increase growth rates in

young animals, improve the efficiency with which food

is converted to muscle, and significantly reduce carcass

fat so that meat products are leaner. Somatotropins also

increase milk production in lactating dairy cows. Currently, recombinantly-derived bovine and porcine somatotropins are undergoing Food and Drug Administration

(FDA) review for use in lactating dairy cows and pigs,

respectively, and one beta-adrenergic agent is undergoing

testing for approval in pigs.

1 Because of the large quantity of research on these technologies, this chapter will mainly cite OTA commissioned background papers and other

review articles.

-65 -
66 ● A New Technological Era for American Agriculture

Somatotropin

A hormone is a chemical that is produced by one organ

or cell and transported to another to cause a biological

effect (i. e., it is a chemical messenger between different

cells and organs of the body). Hormones can be steroids,

proteins, peptides, or modified amino or fatty acids. About

70 percent of the hormones in blood are protein hormones. Somatotropin is a protein hormone produced by

the pituitary gland, a small gland located at the base of

the brain. All vertebrates (i.e., animals that have backbones) produce somatotropin. In addition, evidence exists that some nonvertebrate animals, such as shellfish

(i.e., oysters, clams, etc.), also produce somatotropin.

All major livestock species produce somatotropins

unique to each species. Naturally produced bovine somatotropin (bST) contains 190 or 191 amino acids, and

each polypeptide can contain either the amino acid valine

or leucine at position 126, which gives rise to 4 variants

of bST. Pigs produce porcine somatotropin (pST) consisting of 191 amino acids. The amino acid sequence of

pST, however, differs from bST at 18 positions. In contrast, bST and ovine (sheep) somatotropin (oST) differ

by only one amino acid position (3, 16, 40).

Differences in the amino acid sequence of proteins

lead to species specificity. The amino acid sequence determines the unique three-dimensional shape characteristic of a specific protein. Only proteins of the appropriate

shape bind to a receptor, and thus elicit a biological

response. Proteins from one species that differ by many

amino acids from the equivalent protein in another species generally do not elicit a biological response in the

other species. Conversely, bST and oST that differ only

by one amino acid are active in either sheep or cattle.

However, human somatotropin differs from pST by 59

amino acids and from bST by 68 amino acids (a 35

percent difference). Bovine, porcine, and ovine somatotropin are not biologically active in humans (20, 23,

49).

Mechanism of Action

Somatotropins affect growth rate, feed efficiency, milk

yield, and the proportion of fat and protein in the carcass.

These effects occur in response to the coordination of

numerous metabolic pathways by somatotropin. These

metabolic effects are both direct and indirect. The direct

effects include nutrient partitioning among tissues, most

specifically liver and adipose (fat) tissue (table 3-1 ). indirect effects include those mediated by insulin-like growth

factor-1 (IGF-I), whose secretion is stimulated by somatotropin.

Somatotropin affects glucose metabolism. Glucose is

a carbohydrate used as an energy source by many tissues,

or as a raw material for the synthesis of other molecules

(as in the production of milk lactose). Administration of

somatotropin increases blood glucose levels by stimulating glucose production by the liver, and may possibly

reduce glucose use for energy by other body tissues.2 

Thus, additional glucose is available for uses such as

increased growth or milk production while normal body

functions are still maintained. The changes in glucose

use by body tissues and glucose production by the liver

appear to be caused by somatotropin altering the response

of these tissues to acute signals, such as to insulin and

other hormones that affect glucose metabolism (3. 16).

Somatotropin also adjusts lipid (fat) metabolism. In

growing pigs, for example, somatotropin redirects nutrients (primarily glucose) away from fat synthesis to

providing energy for lean tissue accretion. The adjustments in tissue lipid metabolism depends on the nutritional status of the animal. If an animal’s energy (food)

intake is greater than its requirements, somatotropin allows for the reallocation of nutrients to support increased

lean tissue accretion (growth) or milk production (lactation) instead of storing excess nutrients as body fat. If

the animal’s nutrient intake is equal to or less than its

requirements, somatotropin directs adipose tissue to mobilize deposits of body fat so that these energy reserves

can be used to support the increased lean tissue accretion

(growth) or milk production (lactation). The former situation is more likely to be the case for young growing

animals and the latter situation would be typical of lactating cows in early lactation. Like glucose metabolism,

adjustments in lipid metabolism result from changes in

the way adipose tissue responds to acute signals, such

as to insulin and other hormones (3, 16, 40).

In addition to the direct metabolic effects that somatotropin coordinates, it stimulates the release of other

compounds with metabolic effects, most notably insulinlike growth factor I (IGF-I). IGF-I probably mediates the

effects of somatotropin on animals such that the cellular

rate of milk synthesis is increased and the rate at which

mammary cells die is decreased, thus causing higher

daily milk yields for a longer period of time during the

2 Evidence in Iactatlng daiv cows suggests that glucose use by tissues other than the mammary gland is decreased when somatatroPin is

administered. It is still not clear whether glucose use by skeletal muscle is decreased in growing pigs (3, 16).
Chapter 3—Emerging Animal Technologies .67

Table 3-l—Effect of bST on Specific Tissues and

Physiological Processes in Lactating Cowsa

Process affected during first few days and

Tissue weeks of supplement

Liver

o

o

Muscle

Pancreas 0

(

(

I

secretory activity and maintenance of mammary

glands

blood flow and nutrient uptake

synthesis of milk with normal composition

production of glucose

response to acute signals (e.g., insulin) that allow

for greater glucose production

mobilization of fat stores to meet needs for

increased milk production if nutrient intake is

inadequate

use of nutrients for fat storage so that they can be

used for increased milk production if nutrient intake

is adequate

response to acute signals (e.g., insulin and other

hormones that affect lipid metabolism) that allows

for synthesis and breakdown of body fat reserves to

be coordinated with changes in use and availability

of nutrients

uptake of glucose

insulin and glucagon secretion reponse to changing

glucose levels

production of 1,25 vitamin D3

absorption of Ca, P and other minerals required for

milk

ability of 1,25 vitamin D3to stimulate calcium binding

protein

calcium binding protein

use of glucose by some organs so more can be used

for milk synthesis

use of fat stores for energy if nutrient supply is

Inadequate

use of nutrients to make body fat if nutrient supply is

adequate

insulin and glucagon clearance rates

energy expenditure for maintenance

energy expenditure consistent with Increase In milk

yield (i.e., heat per unit of milk not changed)

cardiac output consistent with increases in milk yield

productive effidency (milk per unit of energy intake)

occur in initial period of bST supplement when metabolic adjustments

occur to match the increased use of nutrients for milk. With longer term

treatment voluntary intake Inceases to match nutrient requirements.

demonstrated in nonlactating animals and consistent with observed

performance in lactating cows.

SOURCE: D.E. Bauman, ‘Bovine Somatotropin: Review of an Emerging

Animal Technology,” commissioned background paper for the

Office of Technology Assessment, Washington, DC, 1991.

lactation cycle (3). In growing animals, IGF-I stimulates

cell proliferation in a variety of tissues (bone, muscle,

connective, and adipose tissue) and increases protein synthesis in muscle ( 16, 40).

Poultry Somatotropin

Research using somatotropin to enhance growth and

carcass composition in poultry (i. e., chickens, turkeys,

and ducks raised for meat and egg production) is limited.

Earliest research involved chickens that had their pituitary glands removed. Administration of chicken somatotropin (cST) was shown partially to restore growth.

Chicken somatotropin also has been shown to increase

circulating levels of IGF-I (40).

Administration of cST to broiler chickens3 ( i .e., chickens marketed at 6 to 7 weeks) has not been shown to

influence growth, feed efficiency, or carcass composition. In young (post-hatched) chicks, the binding of somatotropin to its receptors in the liver is very low, whereas

in adult chickens high somatotropin binding has been

observed. There appear to be low somatotropin receptor

numbers and/or receptor affinity for somatotropin during

the early stages of chicken growth, potentially up to the

time when broiler chickens are marketed. This might

provide an explanation as to why cST has little or no

effect in young broiler chickens. The basis for this low

binding is not known, but some evidence exists that somatotropin itself regulates the number of somatotropin

receptors (40).

While most studies have reported no enhanced growth

in young chickens given cST, one study using daily injections of intermediate doses of native cST did elicit

improved growth in 4-week-old broiler chickens. This

raises the possibility that diet, frequency of cST administration, molecular form of cST, or dose may be necessary conditions to achieve a growth response in broiler

chickens. Thus, it cannot be ruled out that optimal conditions have not been employed in most studies. Based

on the evidence to date, however, cST administration

appears not to be an effective means of promoting growth

or productive efficiency in growing broiler chickens (40).

Administration of cST to roaster chickens (i.e., chickens more than 8 weeks old) has been shown to stimulate

growth and feed efficiency while reducing carcass fat.

The effects of cST on breast meat weight varied depending on the method of cST administration. For example, the weight of the breast meat was reduced when

cST was administered in a pulsatile (rhythmic dripping)

fashion, but increased when administration was by continuous infusion or daily injection. The extent of growth

and of fat tissue accumulation also varied with method

of administration and age of the chicken. These results

suggest that cST can be used to improve roaster-age

‘Chicken somatotmpin derived from chicken pituitary glands and from recombinant DNA procedures were tried
.

68 ● A New Technological Era for American Agriculture

chickens, but that the mode of administration and dose,

and potentially diet, need to be optimized to achieve

consistent results (40).

Turkeys that have had their pituitary glands removed

have been treated with bST and cST; neither influenced

growth. Administration of chicken or turkey somatotropin to intact turkeys has not been adequately explored.

Some evidence exists that bST or pST injections into

the egg increase the growth and feed efficiency of male

chickens after hatching, and reduce abdominal fat in both

male and female chickens.

In summary, it has not been definitively demonstrated

that somatotropin can be used to improve growth, feed

efficiency, or carcass composition of poultry. More research is needed to determine if this is in fact the case,

to optimize conditions needed to achieve growth, and to

improve the mode of administration. There is a general

lack of research on poultry biology and much basic research is needed to understand growth mechanisms in

poultry. There is also a need to characterize fully the

structure and control of the receptor(s) for chicken somatotropin, to identify the specific amino acid sequence

of somatotropin that binds to the receptors, to understand

the signal system used for somatotropin to elicit its biological response, and to identify hormones that may

counteract the effects of somatotropin in poultry. Given

the state of the art, it is unlikely that cST will be available

for poultry production before the later part of the 1990s

(40).

Porcine Somatotropin

Pigs administered porcine somatotropin (pST) for a

period of 30 to 77 days have been shown to increase

average daily weight gains by approximately 10 to 20

percent; improve feed efficiency by 15 to 35 percent;

decrease adipose (fat) tissue mass and lipid formation

rates by as much as 50 to 80 percent; and concurrently

increase protein deposition by as much as 50 percent,

without adversely affecting qualities such as taste and

texture of meat. Prolonged release formulations and daily

injections produced similar growth rates and feed efficiencies. In addition, similar growth rate increases were

observed in both barrows (castrated male pigs) and growing gilts (immature female pigs) ( 16).

Daily administration of pST to gilts weighing between

110 and 220 pounds did not affect the age at which

puberty occurred, the proportion of gilts reaching puberty

prior to 240 days, or the pregnancy rate. One study did

indicate that with pST administration, ovarian function

was impaired in prepubertal gilts, and that the onset of

puberty was delayed. Withdrawal of pST restored normal

reproductive function ( 16).

The minimally effective dose of pST needed to increase growth performance is approximately 20 micrograms of pST per kilogram of body weight per day. In

the commercial setting, pigs will likely be treated with

pST for about 60 days during the growing-finishing period ( 16).

Photo credit: Terry Etherton, Pennsylvania State University.

Comparison of pork loins that show the effect of pigs treated with porcine somatotropin (PST). The

loin-eye area of the loin treated with PST is 8 square inches; the control is 4.5 square inches.
Chapter 3—Emerging Animal Technologies ● 69

For effective use of pST, prolonged release formulations lasting at least 30 days need to be developed. Optimal nutrient requirements need to be determined. Initial

data indicate that the diet should contain about 1.2 percent lysine (6). Current corn-soybean meal formulations

containing about 16 percent crude protein may need to

be supplemented with additional lysine, and perhaps other

amino acids. Total feed intake will likely increase by 10

to 15 percent with pST administration. The nutritional

requirements of pST-treated pigs is currently being studied by the National Research Council.

One study found that porcine somatotropin increased

milk production between days 12 and 29 of lactation and

the nursing piglets have a greater weight gain which

matched the increased milk yield ( 16). However, this

increase in milk yield and piglet weight gain has not been

consistently observed (2, 8, 9, 10, 11, 42, 43, 44). Also,

in some cases, adverse health effects were noted in pST

treated sows ( 10, 42). Porcine somatotropin is currently

being reviewed by FDA for commercial use. (For additional information on pST and its effects on carcass

grades, see ch. 14. )

Bovine Somatotropin

Bovine somatotropin (bST) is currently undergoing

FDA review for use in lactating dairy cows to increase

milk production (figure 3-1 ). While individual milk yields

depend on the management ability of the producer, on

average, gains of about 12 percent can be expected with

bST administration. However, response varies with the

stage of lactation. Administration of bST early in lactation (i.e., immediately following parturition and prior

Figure 3-l—Bovine Somatotropin (bST)

Production Process

SOURCE: Elanco, a division of Eli Lily

to peak milk yield) evokes a small or negligible response

(3). Administration after peak milk yields evokes a high

response due to an immediate increase in milk yield, and

a reduction in the normal decline in yields that occurs as

lactation progresses. Maximum milk response is achieved

with a daily bST dose of about 30 to 40 mg/day. BST

does not alter the gross composition of the milk. The

fat, glucose, protein, mineral, and vitamin composition

of the milk all fall within the range of values normally

observed in milk from cows not given bST (3).

The relative ratio of nutrient requirements of cows

administered bST do not change, but the cow will eat

more feed to accommodate the increased milk production. The magnitude of the increase in feed intake depends on how much milk production increases and on

the energy density of the diet.

BST decreases pregnancy rates (proportion of cows

becoming pregnant) and increases days open (days from

parturition to conception). Conception rates (services per

conception) are not altered. The effects observed are

similar to those occurring in high milk producing cows

that do not receive bST (3). The implications of using,

bST in dairy production are discussed more thoroughly

in OTA’s 1991 publication U.S. Dairy industry at a

Crossroad: Biotechnology and Public Choices (47).

A small number of studies using somatotropin to increase growth in growing cattle has been conducted, but

research in this area is increasing. Results to date are

highly variable due to the fact that studies differ significantly with respect to source and type of somatotropin

used; dose and potency of somatotropin; route and frequency of administration; number, sex, type, and age of

animals; duration of treatment; level and type of nutrition;

and methodology used to determine characteristics measured. Thus, comparisons are tenuous, but on average,

administration of somatotropin to growing cattle increases average daily weight gain by” 12 percent, improves feed conversion efficiency by 9 percent, increases

carcass lean content by 5 percent, and decreases carcass

fat content by 15 percent ( 15). Additional long-term studies are needed. Optimal dose, nutritional needs, duration,

and withdrawal period before slaughter need to be determined.

Ovine Somatotropin

A small number of studies has examined ovine somatotropin (oST) or bST for use as a growth promotant

in sheep. Because oST and bST are similar on amino

acid sequence they both are effective. Like the studies

with growing cattle, investigations with sheep vary sig-
70. A New Technological Era for American Agriculture

nificantly in design and methodology. These studies suggest that on average, administration of somatotropin to

sheep will increase the average daily weight gain by 18

percent, improve the feed conversion efficiency by 14

percent, increase the carcass lean content by 10 percent,

and decrease carcass fat content by 15 percent.

Ruminants present some special challenges with regard

to supply of amino acids to support high rates of protein

accretion. Recent studies with growing cattle and lambs

demonstrate that nutritional constraints imposed by rumen fermentation may limit amino acid supply and ultimately the biological response to somatotropin (4, 2 1).

Long-term studies are needed, and optimal conditions of

somatotropin administration and nutrient requirements

must be determined ( 15).

Fish Somatotropin

Recombinant trout somatotropin injected into yearling

rainbow trout increased growth rates by 100 percent as

compared to control fish. Body length increased, and the

chemical composition of the muscle tissues was indistinguishable from that of the controls (34). However,

injection into individual fish is inefficient and different

modes of administration are needed. Other studies have

tried dipping and incubating test fish in an appropriately

balanced salt solution containing fish somatotropin. Results have been encouraging; within 5 weeks, body weight

had increased by 1.6 times over that of controls (34).

Evidence exists that invertebrates also produce somatotropins. Somatotropin from abalone has been isolated and shown to enhance growth in juvenile abalone.

Recombinant trout somatotropin has been shown to increase the size of oysters (34).

Somatotropin also can be used to increase growth in

finfish and shellfish. Research is needed to determine

the most effective and practical means of administration.

Large-scale production and purification of recombinant

fish somatotropin is paramount. Optimum dose, nutrient

requirements, and other related conditions must be established for each target species. Most studies to date

have been short-term studies. Long-term studies to understand the effects of somatotropin on fish must be conducted. Given the work that is still needed, it is unlikely

that somatotropin will be used commercially in the fish

industry before the second half of the 1990s.

Somatotropin Related Technologies

Recognition of the role that somatotropin plays in growth

and milk production has led researchers to search for

means to increase endogenous levels of somatotropin in

livestock as an alternative to administration of exogenous

somatotropin.

The production and secretion of somatotropin by the

pituitary gland is controlled by another protein hormone

called growth hormone releasing factor (GRF). Early

studies in pigs involved daily injections of 30 micrograms

of GRF. Neither growth rate nor feed efficiency was

significantly improved. There was a significant improvement in carcass composition (less fat), although the

improvement was not as great as with exogenous administration of porcine somatotropin. Using synthetic analogs of GRF that are resistant to degradation by protease

enzymes elicits a greater reaction; daily weight gain and

feed efficiency increased, and carcass composition changed

in a manner similar to that which occurs with exogenous

administration of porcine somatotropin (16). There is

some evidence that GRF does elicit some effects that are

different than those of somatotropin. For example, a small

improvement in the digestibility of dietary dry matter has

been observed in GRF-treated cattle and this has not been

routinely observed with bST-treatment (3, 16). GRF itself can be produced in bacteria, but some of the synthetic

analogs cannot, and alternative methods will be required

to produce sufficient quantities for commercial use. It is

not expected that GRF will be commercially available

before the later half of the 1990s.

An alternative way to increase endogenous somatotropin levels is to block compounds that prevent the secretion of somatotropin. Release of somatotropin from the

pituitary gland is blocked by a compound called somatostatin. Deactivating somatostatin will increase the levels of somatotropin in the animal. Somatostatin is

deactivated by stimulating the animal to produce antibodies to this compound. The process involves coupling

somatostatin with another compound that stimulates the

immune system in animals. Administration of this coupled compound to an animal causes the animal to produce

antibodies that bind to somatostatin and deactivate it,

thereby preventing it from inhibiting the release of somatotropin from the pituitary. When used in pigs, this

process doubled the concentration of porcine somatotropin and increased growth rates slightly, but it is likely

that higher somatotropin levels will be needed to increase

growth in pigs significantly. In cattle, use of this method

increased growth rates by 10 to 17 percent and improved

feed efficiency by 13 percent (16).

A third possible way of increasing the effectiveness

of somatotropin is to couple somatotropin with a monoclinal antibody specific for somatotropin. In dwarf mice
Chapter 3—Emerging Animal Technologies ● 71

that have deficient pituitary glands, a somatotropin-monoclonal antibody complex increased weight gains 400 to

600 percent more than administration of somatotropin

alone ( 16). In lactating sheep, a somatotropin-monoclonal antibody complex increased milk production more

than somatotropin alone ( 16). The mode of action is not

known with certainty. It is speculated that the complex

is selectively recognized by different target tissues and

receptors in preference to somatotropin alone. It is possible that the monoclinal antibody inhibits the receptor

from internalizing the somatotropin, which allows the

somatotropin to be active for a longer period of time.

The use of monoclinal antibodies from species other than

the animal being treated, however, may cause an immune

response by the animal.

Beta-Agonists

Beta-agonists (also called beta-adrenergic agonists) are

compounds similar to adrenaline. They are generally of

two types, the beta- 1 agonists that stimulate cardiovascular functions and the beta-2 agonists that regulate smooth

muscle function. Beta-agonists are currently used in humans to control bronchial asthma and to relax premature

uterine contractions.

Beta-agonists can also act as repartitioning agents. They

redirect nutrients away from the formation of adipose

tissue (fat deposits) and towards muscle growth (48).

Almost all cells have beta-adrenergic receptors. interaction of beta-agonists with the cell membrane receptors

initiates intercellular responses that affect fat and protein

metabolism and accretion.

Beta-agonists are not currently approved for use as

livestock growth promotants in the United States. At least

three companies have tested beta-agonists to promote

growth and enhance carcass leanness in meat-producing

animals. Beta-agonists tested include clenbuterol and

cimaterol in lambs, beef, swine, and broilers (American

Cyanamid); salbutamol in swine (Glaxo Animal Health,

United Kingdom) and ractopamine hydrochloride in finishing swine, beef and turkeys (Eli Lily and Co.). Results

of early studies with clenbuterol, cimaterol, and salbutamol were variable and available evidence suggests that

none of these compounds are under development as growth

promotants for livestock application (48).

Eli Lilly and Company is developing ractopamine hydrochloride to enhance carcass leanness and promote

growth in meat-producing animals. In finishing swine

(i.e., pigs weighing 100 to 250 pounds), ractopamine is

administered as a feed additive, at doses of 5 to 20 parts

per million (ppm), usually for a period of 42 to 49 days.

Ractopamine is registered under the trade name Paylean,

and is currently undergoing FDA review (48).

Trials involving finishing pigs were conducted in the

United States, Canada, and several other countries worldwide. Ractopamine increases the rate of daily weight gain

(maximum of 8.9 percent), decreases feed consumption

(average of 3.9 percent), and improves feed conversion

(up to 12.3 percent over untreated controls). s Additionally, two measures of carcass leanness—loin eye leanness and the 10th rib fat thickness—improved by a 14.9

percent increase and 13.6 percent decrease, respectively.

Total lean content of the carcass increased from 50.9

percent to 56.9 percent as determined by total carcass

dissection. Swine with superior genetics for leanness show

a greater response to ractopamine than those with low

lean-gain potential. Visual and taste panel evaluations of

meat palatability characteristics from the ractopaminetreated pigs appear to be unchanged (48).

While total feed consumption decreases slightly, use

of ractopamine requires crude protein levels greater than

current National Research Council recommendations for

finishing swine. Rations containing 16 to 20 percent crude

protein or lysine equivalent appear to optimize the growth

performance response to ractopamine. However, carcass

leanness effects are seen at lower crude protein levels.

Addition of fat to the diet, a common practice in swine,

did not affect carcass leanness, daily weight gain, or feed

conversion responses to ractopamine (48).

Some reports have indicated that beta-agonists cause

hoof lesions in swine. No such effects were observed in

another study with ractopamine given in amounts up to

25 times the highest intended level of use (550 ppm).

Similarly, at three times the intended use level (60 ppm)

during the finishing phase, there were no observed effects

on the subsequent percent of gilts in heat, the percent

4Clenbuterol is cumently marketed in Europe, Mexico, Canada, South America, and Asia as a veterinary prescription drug to treat bronchial

and smooth muscle disorders in animals (primarily race horses and sheep). It has not been approved for use in the United States. Salbutamol is

marketed as an anti-asthmatic in humans ( 17, 48).

‘Twelve trials involving 1278 barrows and gilts were fed rations of 16 percent crude protein and administered ractopamine as a feed additive

in quantities up to 20 parts per million.
72 ● A New Technological Era for American Agriculture

farrowing rate, the number of live or dead newborn pigs,

the 21-day pig weaning weight, or gilt weights at the

end of the nursing period (48).

Antimicrobial Agents

Biotechnology is being used to produce new compounds that can enhance livestock production, but traditional means will continue to be used for the same

purpose. One such traditional method is the addition of

antimicrobial agents to livestock feed. Antimicrobial agents

are compounds that, when administered in low concentrations, suppress or inhibit the growth of microorganisms. Antimicrobial agents include antibiotics (naturally

occurring substances produced by yeasts, molds, and

other microorganisms) and chemotherapeutic (substances that are chemically synthesized). Copper also has

antibacterial properties when present in relatively high

concentrations.

Antimicrobial have been widely used as feed additives

for swine, poultry, beef cattle, and dairy calves since the

early 1950s and numerous trials have been conducted

during that time to document the efficacy of antibiotic

use. Approximately half of the 4.65 million kilograms

of antibiotics and chemotherapeutic sold in the United

States in 1988 were for nonmedicinal use (12). In the

early 1980s, it was estimated that approximately 75 percent of pig feeds, 80 percent of poultry feeds, 60 percent

of feedlot cattle feeds, and 75 percent of dairy calf feeds

contained antimicrobial agents (12). An estimated 90

percent of all feedlot cattle are administered antibiotics

( 12). Today, approximately 88 percent of the antibiotics

used in livestock are given at subtherapeutic levels to

promote growth, improve feed utilization, reduce mortality, reduce liver abscesses, and improve reproductive

efficiency. Currently, 14 antibiotics and 6 chemotherapeutic have been cleared by the FDA for use as livestock

feed additives (table 3-2).

The exact mechanism by which antimicrobial stimulate growth is not known with certainty. Three mechanisms have been proposed: a metabolic effect, a nutritional

effect, and a disease control effect. Various antimicrobial have been shown to affect water and nitrogen excretion, to inhibit oxidation reactions that require

magnesium ions, and to increase protein synthesis in

muscle cells. However, none of these metabolic effects

is significant enough to account for the observed increases in growth (12).

The nutritional effect is based on the premise that

certain intestinal microbes synthesize vitamins and amino

acids essential to animals, while others compete with the

Table 3-2—Antimicrobial Agents Approved as

Growth Promotants for Swine, Poultry, and Cattle in

the United Statesa

Antibiotics Chemotherapeutics

Bacitracin zinc (S,P,C) Arsanilic acid (S,P)

Bacitracin methylene Carbadox (S)

disalicylate (S,P)b Sodium arsanilate (S,P)

Roxarsone (S,P) Sulfamethazine (S,C)

Bambermycins (S,P) Sulfathiazole (S)

Chlortetracycline (S,P,C) Lincomycin (S,P)

Erythomycin (P)

Lasalocid (C)c

Monensin (C)c

Oxytetracyline (S,P,C)

Penicillin (S,P)

Streptomycin (S,P)

Tiamulin (S)

Tylosin (S)b

Virginiamycin (S,P)

a

The letters in parenthesis refer to the species for which the drug is approved; S = swine, P = poultry, and C =cattle.

bBacitracin methylene disalicylate and tylosin are also approved in cattle

to reduce liver abscesses.

c Lasalocid and Monensin are approved for use in poultry to control coccidiosis.

SOURCE: Office of Technology Assessment, 1992.

host animal for these nutrients. Shifts in the intestinal

population of bacteria associated with the use of antibiotics could result in greater availability of nutrients for

the host animal. Some antibiotics have been shown to

stimulate yeast growth and bacteria that produce vitamins

while reducing population levels of lactobacilli, bacteria

that require amino acids in the same proportions as pigs

and chicks.

Increased intestinal wall thickness and total gut mass,

thought to be caused by bacterial invasion or toxins, are

reduced by antibiotics. This decreased mass possibly leads

to greater nutrient absorption and increases diversion of

energy and nutrients away from heat production by the

gut to body growth.

Evidence exists to support the hypothesis that the dietary protein requirements of animals administered antibiotics are lower than those of control animals. The

most striking evidence in support of the nutritional effect

is seen with the ionophore class of antibiotics, which

causes an increase in propionic acid and a decrease in

acetic acid in the rumen. Biosynthetic pathways using

propionic acid are energetically more efficient than those

using acetic acid, which could account for the marked

reduction in feed requirements per unit of gain for animals administered the ionophores.

The most widely accepted theory as to how antimicrobials promote growth is the disease-control effect.
Chapter 3—Emerging Animal Technologies ● 73

Antibiotics control subclinical disease, thereby allowing

animals to more closely approach their genetic growth

potential. The fact that antibiotics stimulate growth more

in young animals than older animals provides some support for this theory because young animals have lower

immunological competency and are more susceptible to

disease. Also, the degree of the growth response is strongly

influenced by the cleanliness of the living environment

and the disease load of the animals involved.

Most of the research concerning antimicrobial is conducted at the pharmaceutical firms that develop these

products. Research at universities evaluates the efficacy

of already approved antimicrobial agents under different

housing, management, and feeding programs. Some clinical studies of compounds in development are also conducted at universities.

Current research is focusing on the development of

new antimicrobial, new techniques for screening and

evaluating the safety of antimicrobial, detection of residues in meat, and the possible spread of antimicrobial

resistance. Genetic engineering techniques can be used

to alter the production of antibiotics by bacteria and to

develop nucleic acid probes for use in safety evaluation.

Other research is focusing on ways to improve the

efficiency of nutrient utilization and microbial fermentation in the gastrointestinal (GI) tract. Techniques that

modify membrane function in bacteria can increase the

transport of ions and substrates into bacterial cells, which

could enhance digestion in ruminants. Alternatively, the

use of live antagonistic microorganisms in feed can be

used to maintain the optimal microflora.

More efficient methods of delivering antimicrobial,

including intraruminal delivery devices, boluses, and rotation of two or more agents, are being developed. The

compatibility and synergism of antimicrobial combinations and the effect of the diet are also being explored

(12).

Antimicrobial Use in Poultry

Antimicrobial use in chickens up to 4 weeks old increases growth rate and feed efficiency by approximately

7 and 4 percent, respectively. Older chickens also show

improvement, although not as high. Young turkeys have

shown improved growth rates and feed efficiency of approximately 13 and 7 percent, respectively. When antimicrobial are used in laying hens, egg production improved by up to 4 percent, the feed required per dozen

eggs was reduced up to 5 percent, and matchability improved about 3 percent. Similar results were obtained in

turkeys. Antimicrobial use also appears to reduce mortality (12).

Antimicrobial Use in Swine

In pigs, antimicrobial have been shown to increase

growth rates, reduce feed requirements per unit of weight

gain, and reduce mortality and morbidity. Smaller (younger) pigs respond more to antibiotics than heavier pigs.

Antibiotics have been found to improve growth rate of

pigs weighing between 7 and 25 kg by 16 percent and

to reduce the amount of feed required per unit of gain

by 7 percent. In slightly heavier pigs (from 7 to 49 kg),

the improvements in weight gain and feed efficiency were

11 and 5 percent, respectively. Over the entire growingfinishing period, antibiotics improved weight gain by 4

percent and feed efficiency by 2 percent. Improvements

in growth rates, feed efficiency, and mortality rates from

antibiotic use are greater under farm conditions than in

highly controlled test conditions at universities and research stations. In addition, the effectiveness of antibiotics has not diminished over 40 years of use ( 12).

Copper gives growth rate and feed-efficiency utilization rates similar to those of antimicrobial, and in young

pigs a combination of copper and antimicrobial appears

to have an additive effect.

Antimicrobial are not usually continuously administered to breeding animals, but during certain critical stages

of the reproductive cycle, such as at the time of breeding,

administration of antimicrobial can improve conception

rates (by about 7 percent) and increase litter size (by

about a half a pig). Use of antimicrobial at farrowing

reduces the incidence of uterine infections. Data also

indicate a slight improvement in the survival and weight

gain of nursing pigs that have been given antimicrobial

in prefarrowing and lactation diets. Evidence also exists

that the withdrawal of antibiotics from animals that have

been administered antibiotics for a long time is associated

with a reduction in reproductive performance ( 12).

In the last 5 years, two new antibiotics were cleared

for use in swine. Three more antibiotics are currently

under development (12).

Antimicrobial Use in cattle

In beef, growth rates have increased up to 5 percent,

and feed efficiency gain has increased up to 7 percent

with antimicrobial use. Antimicrobial are also commonly used to reduce, by nearly half, the incidence of

liver abscesses. Animals with abscessed livers gained
74. A New Technological Era for American Agriculture

weight more slowly than those without abscessed livers—about 1/3 pound per day less. Antimicrobial can

be used to improve weight gain in dairy calves. but no

general beneficial response has been noted in lactating

cows (12).

Anabolic Steroids

Steroids are a class of lipid compounds composed of

four interconnected rings of carbon atoms linked with

various functional groups. Some steroids act as vitamins

while others act as hormones. The anabolic steroids used

to promote growth are estrogens and progesterone (female sex hormones) and androgens (male sex hormones).

Steroids have been demonstrated to promote growth, increase feed efficiency, increase lean meat production,

and reduce carcass fat. These hormones have been demonstrated to have growth-promoting properties in beef,

sheep, swine, poultry, and fish. Such effects are greatest

in ruminants.

Anabolic steroids were first approved for use in livestock in 1954. Currently they are approved for use as

growth promotants in the United States only for beef and

sheep. It is estimated that 10 percent of heifers and 60

percent of steers are treated with anabolic steroids as

calves; 70 percent of stocker cattle; and 90 percent of

feedlot cattle are administered anabolic steroids (35).

Anabolic steroids reduce the cost of producing beef by

an estimated $17 per head, and a complete ban on anabolic steroids in the United States would result in an

estimated net-return loss of $2.4 to $4.1 billion in beef

and sheep products (35).

Anabolic steroids are used in the United States either

singly or in combination, with the most common method

of administration being a prolonged release implant inserted at the base of the ear (see table 3-3). A combination

estradiol-trenbolone acetate implant is currently under

FDA review.

The mechanisms by which steroids act in livestock are

still not known with certainty, despite the fact that these

compounds have been used for nearly 40 years. It has

generally been postulated that estrogens stimulate the

production and release of somatotropin from the pituitary

gland, and that the increased sornatotropin, in concert

with insulin, increases the uptake of amino acids and the

synthesis of muscle protein (35).

New studies indicate, however, that estrogens and somatotropins are additive, and act independently, and

therefore it is unlikely that the action of estrogens occurs

via elevated levels of endogenous somatotropin. This

evidence has led to the proposal of alternative hypotheses. One such proposal postulates that because there are

estrogen receptors in bovine skeletal muscle, estrogens

could directly bind to these receptors and stimulate protein synthesis (35).

Alternatively, estrogens may stimulate the somatotropin receptor sites in the liver; greater binding and receptor

capacity has been observed following estradiol administration. However, estrogens do not elicit an anabolic

response in rats despite the fact that they stimulate somatotropin release and there are estrogen receptors present in rat skeletal muscles. This evidence suggests that

the mode of action of estrogens may in fact be different

than any of those hypothesized (35).

Table 3-3—Anabolic Steroids Commercially Available in the United States

Commercial Method of

Anabolic steroid name use

Estrogens

Beta-estradiol Compudose Implant

Zeranol a Ralgro Implant

Androgens

Trenbolone acetate Implant

Progesterone

Melengesterol acetate Feed additive

Combination

Beta-estradiol/testosterone Synovex-H Implant

Heifer-oid Implant

Beta-estradiol/progesterone Synovex-S Implant

Synovex-C Implant

Steer-oid Implant

a

Zeranol is technically not an estrogen (it’s produced by a fungus) but has estrogenic properties.

SOURCE: Office of Technology Assessment, 1992
Chapter 3—Emerging Animal Technologies .75

Most androgens have not consistently shown anabolic

activity in ruminants, although trenbolone acetate (TBA)

used alone, and especially when combined with estrogens. gives good response. TBA significantly elevates

plasma estradiol levels, which may explain at least part

of its activity. Androgens are thought to work by blocking

muscle receptors for another class of hormones, the corticoid hormones. This decreases muscle protein degradation and turnover, rather than increasing protein synthesis

(35).

The pharmaceutical industry conducts most anabolic

steroid research. Universities conduct some research concerning the mechanism of action of steroids and work in

conjunction with the pharmaceutical industry to conduct

clinical trials. Current research is focusing on using combinations of steroids and on methods to improve timedrelease implants so that they release lower levels immediately following implantation and continue to release

for a longer period thereafter. Researchers are also exploring the possibility of administering androgens to

pregnant ewes and cows in the hope of increasing growth

potential in the offspring (a process known as imprinting). Imprinting has been shown to improve growth. feed

efficiency, and carcass leanness in female offspring, but

leads to no observed changes in castrated male offspring

(35).

A clearer understanding of the mechanism of action

of anabolic steroids is needed. Research is also needed

to determine the optimum dose of steroids required to

maximize anabolic response. Current dosage rates are 14

to 36 mg for estrogens, 200 mg for progesterone, 200

mg for testosterone, and 140 to 200 mg for trenbolone

acetate, administered by implants lasting for 90 to 120

days. These doses are probably lower than those that

would yield maximum growth; however, to change dosage would require FDA approval (35). Determining optimal dosage for maximum anabolic effects might also

help determine the mode of action of these steroids and

whether steroids are additive in effect with other hormones.

Further research is needed to determine the nutrient

requirements for maximum response and to determine

the effects of steroids on meat marbling. Anabolic steroids do not appear to affect the texture, flavor, juiciness.

or cooking loss of meat, but some controversy remains

concerning the effect of steroids on carcass quality, marbling, and carcass grade, particularly with respect to TBA/

estradiol combination (35).

REPRODUCTION

TECHNOLOGIES

The field of animal reproduction is undergoing a scientific revolution. For example, it is currently possible

to induce genetically superior cows to shed large numbers

of eggs (superovulation). It is also possible to fertilize

these eggs in vitro with the sperm of genetically superior

bulls. Each resulting embryo can then be sexed and split

to produce multiple copies of the original embryo, frozen

for later use, or transferred to recipient ‘‘surrogate’ cows

whose reproductive cycle has been synchronized to accept the developing embryo. In the near future, it may

be possible to sex the sperm rather than the embryo and

to create greater numbers of copies of each embryo than

is currently possible. Embryos produced by new reproductive methods are currently being marketed. Techniques now being developed will make it easier to insert

new genes into the embryos to produce transgenic6 

animals. Although as yet no transgenic farm animals are

commercially available, these new technologies are being

used to improve the quality of livestock herds more rapidly than could be achieved with traditional breeding.

Currently, however, many of these technologies are still

relatively inefficient.

Estrous Cycle Regulation

Research has shed new light on the basic mechanisms

controlling egg growth and maturation, and corpus luteum7

function. This new knowledge is aiding the development

of precise methods to regulate the estrous cycle, induce

superovulation, and reduce the heavy losses due to early

embryo deaths that occur in all domestic animals.

Perhaps the most important development in ovarian

physiology in recent years is the discovery of the ovarian

hormone inhibin, which decreases the ovulation rate. g

Some breeds of animals with exceptionally high ovula-

‘Animals whose hereditary DNA has been augmented by the addition of DNA from a source other than parental germplasm, using recombinant

DNA techniques (46). Transgenic animals can be created that possess traits of economic importance including improved disease resistance, growth,

lactation, or reproduction.

7

The COWUS lu[eum is a temporary endocrine organ that is produced at the site of ovulation during each estrous cycle. lt produces hofmones

needed to maintain pregnancy.

x ]nhibln decreases ~)vu]atlon rates by suppressing the secretion of follicle stimulating hormone (FSH), a ho~one produced by the PituitaV

gland.
76 ● A New Technological Era for American Agriculture

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service.

Animal physiologist prepares an embryo for microscopic

examination before implanting it into an animal.

tion rates, such as the Booroola strain of Merino sheep

in Australia, are known to have low levels of circulating

inhibin. Cattle immunized against inhibin have lower

circulating levels in their blood and show increased ovulation rates, The genes controlling inhibin production

have been cloned, and the potential exists for producing

transgenic animals in which these genes are repressed or

deleted (18).

Progress has also been made in understanding the control mechanisms that regulate corpus luteum function and

its production of progesterone, a hormone that regulates

the length of the estrous cycle and helps maintain pregnancy. Regulation of the estrous cycle is needed to ready

surrogate mothers to receive embryos, and also to initiate

superovulation. Estrous cycle regulation is reasonably

well understood and developed in cattle and sheep. Conception rates in treated cows are similar to those obtained

with animals bred at naturally occurring estrus. The estrous cycle of pigs appears to be more complex than that

of ruminants and the process of controlling the cycle is

not as efficient. Currently, superovulation treatments for

cattle use highly purified hormones produced by recombinant DNA technology. About 10 viable eggs are produced, on average, per treatment (compared to the 1 egg

a cow normally produces per ovulation) ( 18). As new

knowledge of the factors controlling egg development

and corpus luteum function is applied, the number of

viable embryos produced by each superovulation treatment is expected to increase.

Once eggs are collected, they are matured and fertilized in vitro. In vitro fertilization occurs only when a

capacitated sperm (i. e., a sperm specially prepared to

penetrate the egg cell membrane) encounters an egg that

is in an optimal maturation state. Great progress has been

made in understanding the factors involved in egg maturation and sperm capacitating in livestock. As a result,

in vitro fertilization rates as high as 70 to 80 percent are

produced in cattle, swine, sheep, and goats, and offspring

are successfully produced. Conception rates with superovulated and artificially inseminated eggs in cattle are

the same as those obtained by artificial insemination of

control animals bred at naturally occurring estrus. Embryos produced with these techniques are currently being

marketed. It is estimated that about 100,000 calves are

born annually in the United States as the result of embryo

transfer techniques. Many more embryos are being exported (41).

Early detection of pregnancy can enhance a livestock

producer’s ability to identify and rebreed animals that

have not become pregnant. Traditionally, pregnancy has

been detected by rectal palpation. This procedure can be

conducted at 40 days post breeding, but at this early date

the possibility exists of damage to the fetus. In practice,

rectal palpation is usually carried out at 60 days or later

in cattle. An alternative method is to measure progesterone concentration in milk. Concentration can be measured at 20 days after breeding. However, the process is

expensive and results in about 15-percent false positives.

A new method under development involves using a radioimmunoassay procedure to detect protein B, a gly -

coprotein produced by cells of the ruminant placenta

(18).

High embryo mortality is a major cause of reproductive

loss in all livestock. Embryos of all species must signal

their mothers in some way to prevent regression of the

corpus luteum, so that the progesterone secretion needed

to maintain pregnancy can continue. Early pregnancy

recognition signaling systems are complex and apparently differ from species to species. In ruminants, compounds similar to alpha interferon may be early signals

of pregnancy. Administration of interferon early in pregnancy is being tested as a possible means of reducing

9spm ~-pacitatlon invo]ve5 the Uptake of calcium ions which changes the PH of the sperm
embryo loss. In mice and humans. platelet activating

factor is known to be an early pregnancy reccognition

signal. Preliminary data exist to suggest that it may play

a role in early pregnancy in sheep and cattle (18).

Embryo Cloning

Multiple copies of a mammalian embryo were first

produced by physically splitting an early embryo into

halves. giving rise to identical twins (18). If the embryo)

is dividemore than twice, however, few offsprings survive. Thus, no more than four indentical animals can be

produced by splitting, and generally only two empryos

are produced by this method. This procedure is already

used in the cattle empryo transfer industry nearly doubling the number of offspring produced.

A more efficient and promising method of producing

multiple copies of an embryo is a technique called nuclear

transplantation. Basically, the procudure involves the

transfer of a nucleus from a donor embryo into an immature egg whose own nucleus has been removed. The

recipient egg cell is activated by exposuure to an electric

pulse, allowed to develop into a multicelled embryo, and

then used as a donor in subsequent nuclei.ir transplantations to generate multiple clones. This procedure (outlined in figure 3-2) has been used successfully with cattle,

sheep, and swine. This technique has already produced

hundreds of embryos that have been successfully carried

to term in cattle. and recloning has resulted in as many

as eight calves from one embryo (29).

The value of this technique is enhanced by the ability

to transfer nuclei successfully from frozen embryos into

eggs whose nuclei havc been removed. Conception rates

obtained after transfer of embryos produced by neculear

transplantation are varible, but rates us high as 50 percent have been obtained. However, embryo losses after

transfer are higher than normal, resulting in actual pregnancy rates ranging from 15 to 33 percent (18). Combining the techniques of in vitro fertilization. embryo

cloning, and artificial estrous cycle regulation can result

in major changes in livestock breeding and in the rates

of genetic improvement.

Embryo and Sperm Sexing

The availability of a technique to preselect the sex of

the progeny holds great economic potential for the livestock industry. In the diary industry, females are the

major income producers. while in the beef industry, males

area economically more valuable. Until recently, no methods existed that provided the degree of separation needed

for commercial use. However, recent advances in the

seperation of the X and Y sperm, and sexing of the

embryo have been made.

It has long been a goal of mammalian phsiologists

to develop a method to effectively separte X and Y

chromosome-bearing sperm to control the sex of the offspring. Most sperm seperation techniques are based on

potential differenccs in the size and density of the two

sperm types. 10 These methods, however have met with

little success (41).

Development of cell-sorting techniques based on the

differences in sperm size and Fluorescence of sperm DNA

(flow cytometric measurements) has provied the first

effective mehod to sort the sperm Cellls. Johnsson et al.

(22) recenently reported successful serperation of intact vi-

.

able X and Y chromosome-bearing sperm using this

method. Although the differece in DNA contents of the

X and Y chromosome-bearing sperm in rabbits amounts

to only about 3 percent. 94 percent of the rabbits (does)

inseminated with X-bearing sorted sperm produced females and 81 percent of the does inseminated with Ybearing sorted sperm produced males. This method has

been used to separate X and Y bearing intact sperm of

cattle. swine, and sheep with greater than 80-percent

accuracy (2 ). Commercial use of this process is limited.

at present. by the number of sperm that can be sorted

per hour and by increased embryo mortality observed in

the embryos produced after insemination with the sorted

sperm. Neither of these factors is thought to represent

an insurmountable difficulty.

The most accurate method of sexing embryos is to

create a picture of the number, size, and shape of’ the

chromosomes contained in the embryonic cells, a process

called karyotyping. However. this method requires removal of about half of the cells of early stage embryos,

which decreases embryo viability and limits the number

of embryos that can be transferred. Another method uses

antibodies 11 to defect proteins (antigens) unique to male

embryos. This method is not damaging to the embryos

and encouraging results have been obtained in one laboratory; however, the technique yields variable results

and has not been widely adopted ( 18).

1“ Mcthocl\ used arc differential wxiimentation techniques including differential velc)clty sedimentation, free-t]ow clcc[roptlorcsis, amt con~ection

counter-stream ing galvanization.

11 The antibodies are attached ( labeled) to a tlourescent cxmlpound to allow for detection.
78 ● A New Technological Era for American Agriculture

Figure 3-2—Nuclear Transplantation

An embryo is nonsurgically removed

from a donor cow or is produced by

in vitro fertilization.

Individual embryo cells

are removed.

Each embryo cell is injected into

a specially prepared egg cell that

has had its nucleus removed. An

electric pulse is administered to

cause fusion.

Each egg cell is grown to a

multicell embryo at which point

the cloning procedure can be repeated

or

the embryo can be transplanted to

a cow that eventually gives birth.

SOURCE: Office of Technology Assessment adapted from R S Prather and N L First. Cloning Embryos by Nuclear Transfer, Genetic Engomeeromg of

Animals, W Hansel and B J Weir (eds.), Journal of Reproduction and Fertility Ltd . Cambridge, UK, 1990, pp 125-134
Chapter 3—Emerging Animal Technologies .79

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service,

Animal physiologist checks swine sperm cells on video

monitor to evaluate their motility, a procedure that

precedes laser X-Y sperm separation.

More recently, the sex of bovine and porcine embryos

has been determined by untempting to match fragments

of DNA that are contained only on Y (male) chromosomes with the same DNA fragments in the embryo. Due

to its chemical structure, a fragment of DNA will combine with a second DNA fragment that has a corresponding nucleic acid sequence. Therefore, a fragment of DNA

that is specific to males can be used as a probe to identify

male DNA fragments in the embryo. Combined with

technologies that produce multiple copies of the DNA

fragments, this method determines the sex of the embryo

using only a few cells. It is rapid (about 6 hrs) and

extremely accurate (up to 95 percent). but may be overtaken by the rapidly developing capability to separate

X and Y chromosome-bearing sperm ( 18).

TRANSGENIC ANIMALS

The new reproductive technologies of superovulation,

in vitro egg maturation and fertilization, nuclear transplantation. and embryo sexing can, and are being used

to upgrade livestock herds. When these technologies are

combined with recombinant DNA technologies (the identification, isolation, and transfer of selected genes), it

becomes possible to produce animals containing foreign

DNA in their germ lines (transgenic animals). (See figure

3-3. )

The tools of biotechnology provide the opportunity to

develop transgenic livestock that contain genes coding

for improved growth charticteristics, lactational performance, and resistance to disease and stress. Transgenic

animals have human medical implications as well. It may

be feasible to produce important pharmaceuticals in livestock. Only certain human drugs can be chemically synthesized or produced by bacteria, because some compounds

undergo modifications after the protein has been produced (referred to as post-translational modifications).

Animals are capable of performing these modifications.

but bacteria are not. Transgenic animals can also serve

as powerful research tools to understand genetic and

physiological functions, and provide a model system with

which to study human disease.

The production of transgenic animals is inextricably

linked to the new reproductive technologics discussed in

the previous section. lndeed, it is impossible to produce

animals containing foreign DNA in their germlines without first manipulating the embryo and transferring it to

a recipient animal.

Process of Creating Transgenic Animals

The process of making a transgenic organism is similar

for plants and animals, and many of the tools and methodologies used are the same. As in plants, to create

transgenic animals. the gene being transferred must first

be identified and purified. Appropriate mechanisms (vector or nonvector) must then be found to transfer the gene

into the animal cell, and appropriate regulatory sequences

must be included to ensure proper expression of the gene.

Unlike plant cells that are regenerated into whole plants

by tissue culturing techniques, animal embryos (with the

exception of fish) must be transferred to surrogate mothers for development and birth.

Gene Identification and Purification

The methods used to isolate and purify animal genes

for transfer are the same as those used in plants, and

have been described in detail in chapter 2. The method

described in chapter 2 is the creation and screening of

genomic libraries, libraries of DNA fragments that contain all of the genetic material of the chromosomes. An

alternative approach is to create what is called a complementary DNA (cDNA) library. This method can also

be used in plants, and it is frequently used in animals.

Genes are composed of DNA, and they code for proteins. But, before the protein is constructed, several intermediate steps occur. The DNA of the gene is first

transcribed and processed into another compound called

messenger ribonucleic acid ( mRNA). It is the mRNA

that serves as the actual template for the production of
Host cell preparation using Gene transfer.

superovulation combined with Gene insertion is random.

natural mating or artificial

I

by splitting I

Early stage embryo

(less than 64 cells)

been synchronized to

receive the embryo

I J

Cloned DNA obtained

by gene identification

and isolation

SOURCE: Off Ice of Technology Assessment. adapted from J P Simons and R.B. Land, Transgenic Livestock, J. Reprod Fert. Suppl. 34:237–250. 1987
Chapter 3—Emerging Animal Technologies ● 81

proteins. Messenger RNA is not identical to the genomic

DNA. This is because there are sequences of DNA contained within the gene that do not code for protein. After

the DNA of the gene is transcribed to mRNA, these

noncoding regions are snipped out and thrown away.

Thus, the mRNA contains the coding regions, but not

the noncoding regions of the genomic DNA.

Special enzymes exist that can use the mRNA as a

template to create DNA that has a complementary sequence to the mRNA. This new DNA is called complementary DNA (cDNA). It is identical to the sequence of

the genomic DNA with the exception that, like the mRNA

from which it was derived, it contains the protein coding

regions, but not the noncoding regions of the genomic

DNA (see figure 3-4). Thus. a library of cDNA sequences

can be constructed from mRNA rather than the chromosomal DNA used to construct genomic libraries.

The mRNA that serves as the protein template for the

desired gene can be obtained from tissues that express

high levels of the protein. For example. if one wanted

to find the gene that produces insulin, a reasonable approach would be to extract the mRNA from the pancreas,

which produces very high levels of insulin. This high

level of insulin production means that there is a significant amount of mRNA for insulin. Also, because the

pancreas is specialized for insulin production, mRNA for

other proteins, say for example, somatotropin, may not

be present in large quantities. Thus, the use of cDNA

libraries decreases the amount of genetic material that

must be searched to identify the gene of interest. The

process of looking for a particular gene is tantamount to

looking for a needle in a haystack. Use of a cDNA library, as opposed to a genomic library, provides a smaller

haystack that must be searched.

It might seem at first glance that the best method to

use would be to construct cDNA libraries rather than

genomic libraries. However, limits exist to the use of

cDNA libraries. To construct both cDNA and genomic

libraries, it is important to know the structure, sequence,

and function of the protein for which one is trying to

isolate the gene that codes for it. The lack of knowledge

concerning the sequence and function of important proteins is the major constraint to the isolation and purification of the genes coding for those proteins.

Additionally, construction of a cDNA library is easiest

when tissues exist in the organism that specialize in the

high-level production of the protein coded for by the gene

that is being isolated. This method does not offer significant advantages when the protein is produced in low

quantities by nearly every cell in the organism.

Figure 3-4—Construction of a cDNA Library

Chromosomal DNA consists of

reguiatory sequences ,

noncoding sequences - .

Each gene may contain

several coding and

noncoding sequences.

When genes are expressed,

the DNA is copied to a

strand of RNA.

Enzymes snip out and discard

the noncoding sequences to

form messenger RNA (mRNA)

that contains ony the

coding sequences.

noncoding in the cell.

sequences

To construct a cDNA library

mRNA mRNA is isolated from the cell.

I

I

reverse transcriptase

SOURCE: Office of Technology Assessment, 1992

Also, evidence exists that genes that do not contain

the noncoding regions do not function as well as genes

that contain the noncoding sequences (5, 7, 33). While

the functions of the noncoding sequences are not known
82. A New Technological Era for American Agriculture

with certainty, they may play some role in the regulation

and expression of the gene itself. Therefore, incorporating cDNA genes that do not contain the noncoding regions into transgenic animals results in the genes not

being expressed as well as a genomic gene. Unfortunately, many of the animal genes that have been isolated

and purified are cDNA genes rather than genomic genes.

Thus, the tradeoff is that it may be easier to isolate and

purify cDNA genes than genomic genes, but they don’t

work as well when used to create a transgenic organism

(5, 7, 33).

Gene Transfer

Once an animal gene has been purified, it must be

transferred to the host animal cell. Genes can be transferred using direct transfer methods (e.g., microinjection, electroporation, chemical) or vectors ( i.e., viruses).

The first transgenic animals created were mice in 1980

(37). Since then, transgenic cattle, sheep, swine, poultry,

and fish have been produced.

The most common method used to produce transgenic

animals is microinjection. This method involves directly

injecting cloned DNA into a fertilized egg. 12 The cytoplasm of cow and pig embryos is opaque, and the embryos must first be centrifuged to locate the nucleus;

otherwise the procedure for cows and pigs is similar to

that used in mice, rabbits, and sheep (36). Fish embryos

are surrounded by a tough membrane called a chorion,

and this membrane first must be removed before DNA

can be injected. Even with the removal of the chorion,

the nuclei are not visible and so the DNA is injected into

the cytoplasm. Injection into the cytoplasm rather than

the nucleus requires greater amounts of DNA (34).

Other direct transfer methods attempted include the

use of short electrical pulses (electroporation), or chemicals to make cell membranes permeable to the passage

of large molecules such as DNA. These approaches have

been used with sperm as well as eggs. The possibility of

using sperm as a method to incorporate new genes into

a species is an exciting prospect. One research group has

reported using this method successfully to create transgenic mice that passed the new gene on to their offspring

(27). Other researchers, however, have not yet been able

to duplicate this result.

The use of electroporation methods in fish have resulted in up to 40 percent of the embryos becoming

transgenic and this approach may be far more useful in

fish than microinjection. Another approach being attempted in fish is the use of liposomes, vesicles contained

in the phospholipid layer of cell membranes, as a means

to encapsulate foreign DNA for entry into the cell. This

method has not yet yielded any successes (34).

Poultry reproduction is significantly different from that

of other livestock species. By the time the fertilized egg

is layed, the developing embryo may already contain as

many as 60,000 cells. This precludes using the microinjection technique because the number of cells that might

incorporate the injected DNA could be small. Additionally, only some of the cells that incorporate the foreign

DNA will express it. Attempts have been made to inject

DNA directly into unfertilized eggs still in the ovary, but

this method did not yield any transgenic offspring (24).

As a result of the deficiencies of direct gene transfer

methods in poultry, a vector system has been developed.

The most commonly used vector is a retrovirus. The gene

that is to be transferred can be incorporated into the

retrovirus. The host animal cell can then be infected with

the retrovirus incorporating the new gene. Retroviruses

are attractive vectors because only a single copy of the

virus is integrated into a chromosomal site. Retroviruses

also tend to be either species specific or to infect only a

few closely related species.

Two types of retroviral vectors have been developed.

Replication-competent retroviruses are those that are capable of self-replicating. These viruses have been successfully used in chickens. One-day-old embryos were

infected with the retrovirus and transgenic chickens were

hatched. Furthermore, the virus successfully infected germ

line (sex) cells, and the new gene was passed on to the

transgenic animals’ offspring (24).

Replication-defective viruses lack the genes necessary

for self-replication. These viruses cannot reproduce without the presence of a helper vector. The retrovirus is

engineered in such a way that it contains all of the normal

viral genes except those needed to package its own genetic material. The helper vector (also engineered) possesses the genes needed for packing retroviral genetic

material, but does not include the other viral genes (i. e.,

genes that enable it to infect cells and cause virulence).

Introduction of the retrovirus and the helper vector into

host cells provides all of the elements needed to enable

the retrovirus carrying the desired gene to infect and

incorporate that gene into the host chromosomes. This

method is considered safer than using replication-comIZ Specifically, the DNA is in.jccted into the male pronuchm of the fertilized egg. The pronuclcii are the cg.g and sperm nucleii prwmt after the

sperm penetrates the cgg membrane.
petent ectroviruscs because the rcplictition-detective ectrovirus can only be infective and spread to other cells

if the helper vector is present. However, there is a small

possibility that the helper vector nd replicaton-defective

retrovirus might recombine to form a replication-competent retrovirus. Additionally the DNA sequences carried

by replication-defective retoviruses are not incorproated

in the germ lnes of hickens. hence they are not passed

to the offspring. Improved replication-defective retrovirus vectors are needed (2-I).

A number of transgenic cattle, pigs, sheep, chickens.

and fish have been produced using direct transfer methods (almost exclusively microinjection) and viral vector

methods. However, these techniques have several limi -

tations. Microinjection techniques are expensive to use

and the efficiency of transgenic animal production is very

low. For a transgenic animal to be created. embryos must

survive the physical manipulation and inflection of’ DNA.

must incorporate the DNA into their chromosomes, and

must express the gene product. The percentage of microinjected embryos that actually results in transgenic

animals is low, ranging, for example. from (). I to 4.45

percent in sheep and from 0.3 to 1.73 percent in swine

(36. 38). The low rate of efficiency limits the study of

transgenic livestock because of the high number of donor

and recipient females that must be maintained tot- experimentation. Efficiency rates are much higher in fish,

ranging from 35 to 80 percent, because fish undergo

external fertilization and do not require in vitro culturing

of the embryos and transfer to surrogate mothers.

Microinjection techniques are not only inefficient

methods of creating transgenic animals. but they also do

not provide any control over where the new gene is incorporated into the gernome (26). The site of gene incorporation is random. which also occurs with retroviruses.

Because the site of incorporation influences gene expression, random insertion causes reduced control over the

ability of researchers to control expression levels.

Because of these deficiencies. alternatives to viral vectors and microinjection are being sought. A promising

new method for gcnerating transgenic animals has recently been developed in mice and may be applicable to

other mammals. This new technique uses stern cells derived from an embryo. Stem cells are normally undifferentiated, that is. they do not become specialized tissue

cells such as muscle, brain, liver cells, ect. Howe\’er.

stem cells retain their ability to become specitilized cells

under the proper stimuli ( i.e., they are pluripotent ). 13

Stem cells can be used as vectors to introduce selected

genes into a host embryo. This method hits several significant advantages over microinjection methods. the most

profound of which is that it is possible to insert DNA at

specific, predetermined sites within the genomc of the

stern cells (18). Targeted insertion is possible bccause

stern cells have an intrinsic ability to recombine similar

(homologous) DNA sequences. which results in the replacement of an endogenous gene with the desired gene.

Stem cells can also be tested in vitro to ensure that integration of the new gene has occurred before these cells

are transferred to a developing embryo.

To isolate stem cells (see figure 3-5), an early stage

embryo is cultured on a monolayer of specially prepared

cells. The proliferating embryo cells are recultured until

individual sterns cells can be isolated. These individual

stem cells can then be cultured indefinitely. At this stage.

DNA sequences containing desired genes can be inserted

into the stem cells.14 A geneticallly transformed stem cell

is then microinjected into an immature embryo to produce

a chimera, an organism that contains cells from more

than one source. It the stem cells are incorporated into

the germ lines of these chimeric animals, then these animals can be interbred to obtain offspring homozygous

for the desired trait (18).

Use of the stem cell method will make it possible to

produce a broad range of transgenic animals that could

not be produced economically using direct microinjection

or viral vectors. Targeted gene insertion also has the

significant advantage of allowing host animal genes to

be inactivated or removed and replaced with modified

forms of the genes, such as ones that are expresses at a

higher level, have new patterns of tissue-specific expression, or have a modified biological activity.

A host organism’s endogenous genes can be inactivated by targeting an insertion into an essential region

of the gene. This fact is of particular interest to the

livestock industry, because inactivation of genes that have

inhibitory physiological effects is likely to result in improvement in a number of productive traits. For example,

bovine somatostatin is a hormone that inhibits bovine

somatotropin production; inactivation of this gene would

! ~ plurlpotcncy help ~ake s[cm ccl ]~ ~[[rac[iv~ vectors of DNA transfer. While in tiswe culture. DNA ctin cusily be inserted into stem CCIIS.

When stem cells w-e injec[cd Into an early stage embryo. the conditions for tissue specialization arc present, and stcm CCIIS undergo the normal

tissue development that occurs as the embryo develops during pregnancy. Thus. using stcm cells provides an efficient means to transfer DNA.

IJ Meth{)d~ u~ed include ~ iral infection and use of an electric pu]w to make cl?]] membranes Ietik)’ (clcctr~)pt)ruti(m ).
84. A New Technological Era for American Agriculture

Figure 3-5—Gene Transfer Using Embryo Stem Cell Culture

A mouse embryo (blastocyst)

is donated.

The embryo is cultured

onto a thin layer of

specially prepared

(feeder) cells.

The embryo attaches to

the cell layer, and the

inner cells of the embryo

begin to proliferate.

Groups of these differentiating

embryo cells are separated,

recultured and single colonies

of embryonic stem cells are

identified and transferred.

x

SOURCE: M.R. Capecchi, “The New Mouse Genetics: Altering the Genome by Gene

A second mouse embryo is donated

and is injected with a cultured

embryonic stem cell. This embryo

is transplanted into a surrogate

mouse, which gives birth to a

chimera (a mouse with cells from

both parent embryos). Mating two

chimeras gives rise to offspring

with the desired traits.

Targeting,” Trends in Genetics 5:70–76, 1989
Chapter 3—Emerging Animal Technologies ● 85

result in increased endogenous somatotropin secretion

and, presumably, increased milk production and more

efficient growth. If successful, this technology could be

used in lieu of administering bST exogenously to increase

milk production. The genes controlling the production

of inhibin, the ovarian hormone that reduces ovulation

rate, provide another example of potential tin-gets for

deactivation. The ability to inactivate genes also provides

a powerful research tool for the study of the function of

genes in vivo.

Stem cells have been isolated in mice and hamsters

and possibly rabbits. There are reports that stem cells

have also been isolated for swine ( 18). Progress is being

made in isolating stem cells in sheep, and much research

is being conducted to isolate bokvine stem cells, but to

date, this has not been accomplished. There has been no

documentation of embryonic stem cells being isolated

from poulty ”. However. in a similar type of procedure.

1-day-old embryonic cells from chickens have been isolated and introduced into immtaure embryos of other

chickens. About I I percent of the resulting embryos were

chimeric, and one embryo developed to hatching (24).

Stern cells have not been isolated in fish (34).

Promotors and Gene Expression

The expression of new genes in transgenic animals is

poorly regulated. Apprprate levels of gene expression

are important. because overexpression can lead to impaired health in the transgenic animal. Better understanding is needed of- how to turn genes on and off when

desired; of how to regulate the level of gene expression:

and of how to direct the expression of the gene to specific

tissues at different stages of development. At the present

time the factors that cause genes to have tissue and developmental specificity are not well understood.

Currently, fewer than 10 promotors or regulatory sefquences have been used to direct gene expression in

transgenic live stock. Most of these promotors are derived

from mice or viruses. The most commonly used promotor

is the mouse metallothionein promoter, which is responsive to dietary stimulation by heavy metals such as zinc.

Three promotors are being examined for their abilite to

direct gene expression in mammary glands. A fourth

promotor directs expression primarily to the liver.

It may be desirable to use promotors derved from the

same species that is receiving the new gene. Evidencc

euggests, for example, that using a mouse promotor sequence in pigs results in somewhat different gene expression than use of the same promotor in a mouse (18. 36).

Levels of gene expression do not aways correlate with

the number of gene copies incorporated into the chromosome of a transgenic animal. This suggests that the

site of the incorporate ion of the new gene in the host

chromosome also affects gene expression. Given that

embryonic stem cell procedures still require considerable

development before directed insertion can occur. some

researchers are examining methods to control gene

expression independently of the site of integration. Research is focusing on regulatory elements that allow the

new genes to provide their own environment for expression. 15

Transgenic Poultry

Research emphasis has been given to improving growth

and disease resistance. Bovine somatotropin has been

transferred to chickens and increased the mass of the

chicken. The envelope gene of avian leukemia virus has

also been transferred to chickens and the cellss that expressed this gene have been shown to be resistant to

subsequent infection with the same strain of vrirus (24).

Research is being conducted by USDA Agricultural

Research Service and universities in the United States.

as well as by a limited number of private firms. It is

interesting to note that most of’ the funding for transgenic

poultry research conducted in the United States is being

supplied by other countries (mainly Canada and France).

Commercial availability will take 7 to 12 years after the

production of an adequate number of transgenic fonder

male chickens.

Transgenic Swine

Several genes have been successfully transferred into

pigs, including those for somatotropin. human growth

hormone releasing factor (hGRF). human insulin-like

growth factor--l (hIGF-I ), mouse MX ( to investigate resistance to respiratory discuses), mouse whey acidic protein (WAP) (to investigate mammary- specific expression,

and light and heavy beta chains for antibodies to produce

specific immunoglobulns (36). With swine. as with other

livestock species. researchers are focusing on improving

growth. increasing disease resistance. and producing highvalue pharmaceutical products.
86 ● A New Technological Era for American Agriculture

Photo credit: U.S. Department of Agrculture,

Agricultural Research Service.

Rooster on left was injected with genes of avian Ieukosis

virus when it was a 1-day-old embryo. Roosters in

center and on right are of two succeeding generations

which directly inherited those virus genes.

Somatotropin transferred to pigs has been shown to

increase feed efficiency, enhance meat quality, reduce

carcass fat, and increase the rate of gain. When fed a

high-protein diet, transgenic pigs containing somatotropin genes gained weight nearly 17 percent taster than

controls. and showed up to 18 percent greater feed efficiency. Backfat was significantly reduced and meat was

leaner (36). Transgenic pigs that expressed the somatotropin gene passed that expression on to their offspring.

Offspring that contain the somatotropin and who were

fathered by boars that expressed the gene also expressed

the sornatotropin gene. The offspring containing somatotropin genes who were sired by boars that did not express the somatotropin gene, also did not express the

gene. This suggests that the stability and functioning of

the gene are the same in the parent and offspring (36).

Pigs that continuously expressed high levels of somatotropin experienced significant health problems including lameness, susceptibility to stress. peptic ulcers,

and reproductive problems. Animals that incorporated

the somatotropin gene but did not express it, or that

expressed it at low levels did not display these health

problems (36).

Researchers are interested in improving disease resistance. Genes that confer resistance have not been isolated. Attempts to transfer genes that code for antibodies

Photo credit: Mark Lyons

Transgenic pig at DNX research facility born with the

capability to make human hemoglobin.

to compounds contained on the surface of selected bacteria and internal parasites are being made (28.51 ). Also,

genes of the Class 1 Major Histocompatibility Complex 16

have been cloned. It may also be possible to induce

immunity to specific viral diseases by transferring genes

from the virus to the pig. This method has been used

successfully in chickens and may also be applicable t o

other livestock species (36).

Attempts are being made to produce rare. medically

important proteins in pigs. A U.S. firm ( DNX ) has announced that it has successfully produced human hemoglobin in pigs. Transgenic swine research is being

conducted by the Agricultural Research Service, a few

universities, and the private sector. The American Red

Cross is also interested in the production Of blood proteins

in livestock. Commercial availability of transgenic pigs

is not expected before the year 2000, and it is likely that

the first transgenic pigs marketed will be used to produce

pharmaceutical products. Additionally, pigs have a strikingly human-like physiology, and because of this, transgenic pigs are currently being developed to serve as a

model system to understand and treat gastrointestinal

cancers.

Transgenic Ruminants

The first transgenic ruminant to be successfully produced was a lamb, followed by goats and cattle. In cre16The major hlstoComPa[iblli[y complex is ~ chr~m~S~m~l re@on that COIltaillS SCVWd gCnCS lnVO]Ved In rCgUld[lng lnlI?NInC reSPOnSC.
Chapter- 3—Emerging Animal Technologies .87

ating transgenic ruminants. greatest research emphasis

has been to improve growth characteristics (i. e., rate of

weight gain, feed efficiency. and carcass composition).

to produce valuable pharmaceutical products, and to enhance disease resistance.

Genes coding for somatotropin and somatotropin releasing factor (GRF) have been purified and transferred

to sheep. While the genes have been successfully transferred and expressed. control of the level and timing ofexpression has not been achieved. Sormtotropin levels

in sheep have varied from a low of 40 nanograms (ng)/

milliliter (ml ) to over I ().000 rig/ml (31, 37). Extreme

overexpression of somatotropin can lead to serious health

problems in sheep. such as diabetes (39). In the future,

researchers would like to alter the composition of milk

and meat for improved processing characteristics, for

higher nutrition. for less fat. and to alter the types of fat

contained.

Another major research area involves transferring genes

that code for the production of valuable pharmaceuticals.

Production of blood clotting factors ( factors VIII and 1X ),

tissue plasminogen activator (TPA. used to dissolve blood

clots that cause heart attacks), erythropoietin (used to

treat bone marrow side effects resulting from AIDS treatment). and o-l-antitrypsin (AAT. used to treat emphysema are being investagated. A U.S. firm (Genzyme).

in conjunction with Tufts University. has successfully

produced TPA in goats (13.14). A Scottish firm (Pharmaceutical Prteins. Inc) has produced AAT in sheep.

and is conducting research to produce Factors VII and

IX and crythropoietin (30. 52). Transgenic cows producing high levels of pharmaceuticals in their milk have

not yet been reported, but these animals are under development in a number of public and private laboratories.

For example. a joint U.S. and Dutch group (GenPharm

International. Gene Pharming Europe BV, and two Dutch

Universities) has successfully produced tramsgenic cattle

incorporating the human lactoferrin (which has antibiotic

propertics) gene in the genome (25).

Attempts tire being made to identify promotors that

espress gene products only in milk. Research is being

conducted on whey acid protein. a protein only found in

milk. to identify the promotor that directs the synthesis

of’ this protein. The goat (3-cascin promotor is also being

used (14). Once appropriate promotors are found. the

high levels of U.S. milk production coupled with the

ease of milk collection may make this production method

more cost effectove than the cell culture systems currently

used in the production of certain pharmaceutical proteins.

Enhanced disease resistance is another focus of research. Diseases that may be potentially controlled by

the production of transgenic organisms include progressive pneumonia in sheep. and caprine arthritis-encephalitis in goats. The introduction of preformed antibodies

have been shown to provide resistance to specific infections in mice and the antibody gene antiphosphoryrlcholine has been inserted in sheep (28). Researchers are also

attempting to insert viral envelope genes that could possibly lead to enhanced resistance to viral infections.

Researchers in Australia are attempting to increase

wool production in sheep. Currently, wool production is

limited by the amount of cysteine contained in and absorbed from the diet. Researchers are transferring bacterial genes that code for enzymes that produce cysteinc

from sulfur in the diet (37).

Research to produce transgenic ruminants is limited

due to the high cost of’ the research. Research is conducted primarily in the United States by the Agricultural

Research Service. a handful of- universities. and a few

private sector firms. and in Austrulia, Great Britain, and

the Netherlands. It is not expected that transgenic ruminants will be commercially available before the turn of

the century.

Transgenic Fish

Several species of transgenic fish have been produced.

including rainbow trout, salmon, common carp. loach.

catfish, tilapia, goldfish, zebrafish. and medaka. Several

genes have been transferred to fish. including human.

bovine, and trout somatotropin; genes that confer antibiotic resistance; and fish antifreeze protein genes (34).

Transgenic fish containing the trout somatotropin gene

grew 22 percent more than controls. and transmitted this

increased growth rate to their offspring (34). Some species of fish produce a novel set of proteins that alloW

them to withstand extremely cold water without freezing.

These antifreeze proteins are produced year round by fish

living in polar regions, and during the winter in fish living

in temperate regions. The antifreeze genes in several

species have been purified. Antifreeze protein genes from

winter flounder have been transferred to salmon. Express ion levels of the gene were low. however. and protection

against freezing was not achicved (34).

Research Needs

While significant advances in transgenic animal production have been made, it is unlikely that transgenic

animals will be commercially available before the end
88. A New Technological Era for American Agriculture

Photo credit: Thomas Chen, University of Maryland

Resultant transgenic carp with trout somatotropin

incorporated into some but not all of their cells. The PI

(middle) and F1 (top) transgenic carp are on average,

22 percent larger than their nontransgenic

siblings (bottom).

of the 1990s at the earliest. The ability to produce transgenic livestock possessing traits of economic value is

currently limited by the absence of embryo stem cell

technology, the lack of appropriate gene expression promotors, and the lack of knowledge about the physiological consequences of specific gene expressions. While

the techniques for isolating and sequencing animal genes

are relatively well developed, understanding of the functions of the genes has lagged. Analysis of gene function

is complicated by the fact that many traits are controlled

by multiple genes. Thus, manipulation of such traits will

require detailed understanding of these genes and of their

interactions. Ultimately, identification and understanding

the physiology of the major genes controlling growth and

lactation, reproduction, and disease and stress resistance

in animals is needed. An active genome mapping program could enhance these developments.

ANIMAL HEALTH

TECHNOLOGIES

Improvements in animal health will provide considerable cost savings to the livestock industry. Biotechnology is rapidly acquiring a prominent place in veterinary

medical research. New vaccines and diagnostic kits are

being developed to detect and prevent a variety of major

livestock diseases.

Vaccines

Vaccines are agents that stimulate an effective immune

response without causing disease. Traditional methods

of vaccine development have involved killing or modifying pathogenic organisms to reduce the potential for

disease while preserving that pathogens’ ability to induce

an immune response. Biotechnology is being used to

create new vaccines. Approaches used include deleting

or inactivating the genes in a pathogen that cause disease,

and inserting into a vector genes that cause an immune

response to a pathogen. Synthetic peptides are also being

produced that stimulate the immune response.

Gene Deletion Vaccines

Gene deletion techniques have been used to develop

both viral and bacterial vaccines. The first gene deletion

viral vaccine to be approved and released for commercial

use was the pseudorabies virus vaccine for swine. initially, the removal of a single gene reduced the virulence

of the virus. Since then, other genes have been deleted

with a continuing reduction of virulence. Chickens that

have been inoculated with recombinant avian leukosis

virus (ALV) developed antibodies to the virus without

developing the disease. Methods to decrease the virulity

of live viruses lead to more effective vaccines because

live virus vaccines stimulate the immune response more

effectively than do killed virus vaccines (32).

Bacterial vaccines have also been produced. Escherichia coli that lack certain genes. for example, have

been shown to provide protection against gram-negative

bacterial infections in cattle and swine. Live Salmonella

modified to prevent reproduction in vivo have also proven

to be an effective vaccine for cattle (32).

Most gene deletion viral vaccines will not be available

before 1995 with the exception of the pseudorabies vaccine, which is already available, and possibly the rabies

and rinderpest vaccines, which are currently undergoing

field trials.
Photo credit U.S. Department of Agriculture,

Agricultral Research Service

Molecular biologists analyze DNA sequence reactions of

a gene detection vaccine made from a modified

bacterium.

Vectored Vaccines

New vaccines are also being created using vectors.

Development involves deleting disease-causing genes from

the vector if it is a pathogenic organism, or using a

nonpathogenic vector. Genes that code for protective antigens produced by pathogens can be inserted into a vector. Inoculation of the animal with the recombinant vector

stimulates an immune response to the inserted genes and

confers protection against the pathogen. Pathogen surface

protein genes are most commonly inserted into the vector. Inoculation of the animal stimulates production of

antibodies to these surface proteins. When an animal is

infected with the pathogen, it already recognizes that

pathogen and produces antibodies against it. As an example, recombinant vaccines have been developed against

the coat protein of a bacterial pathogen of the genus

Vibrio, in fish.

The most commonly used vector is the Vaccinia virus.

Vaccinia viruses are used because they are easy and relatively cheap to manufacture, large enough to accommodate the insertion of many new genes (1). and stable

without refrigeration. A single inoculation can induce

immunity, and the recipient produces the bulk of the

vaccine, eliminating the need for large vaccine factories.

Vaccinia viruses also stimulate more than one type of

immune response (i. e., they stimulate both B and T lymphocytes). However, there are disadvantages to using

vaccinia virises: they have a wide host range (including

humans), and could infect species other than target species; it is possible that they can revert to a virulent form;

they cannot be administered orally; and they may pose

a risk to immunosuppressed recipients. Vaccinia hosts

have been used to produce vaccines against rinderpest

(cattle), rift valley fever (sheep), Venezuelan equine encephalitis, bovine leukemia, rabies (cattle). vesicular stomatitis (cattle), avian influenza, avian infectious bronchitis,

and respiratory syncytial disease ( 1, 32).

Fowlpox virus is also being used as a vaccine vector.

This virus cannot replicate in humans and is being used

as a carrier for genes of pathogens that cause the poultry

diseases of Newcastle disease, Marek’s disease, bursal

disease, coccidiosis, avian influenza, and avian infectious bronchitis. Raccoon poxvirus is being developed

as a carrier for rabies. In fish, vaccines to control infectious haematopoietic necrosis virus (IHNV), a devastating viral disease of trout and salmon, are being developed

by inserting coat protein genes into vectors. Other genetically engineered virus vectors that are in the early

stages of development include avirulent adenoviruses,

herpesviruses, murine and avian retroviruses, and bovine

papillomavirus (1, 32).

Bacterial vectors are also being developed. Escherichia coli and Bacillus subtilis are being used to produce

antigenic proteins. They can be used to produce antibodies to Theileria annulata (a tick-borne parasite of

cattle and sheep), coccidia in poultry, anaplasma (a parasite of cattle), and cysticercosis (a tapeworm in ruminants and swine). Pili genes from Bacteroides nodosus,

the cause of foot rot in sheep, have been cloned into

Pseudomonas aeruginosa, and have been shown to be

an effective vaccine for foot rot (1, 32).

Natural and Synthetic Peptides

A number of animal species are known to produce

small peptides associated with white blood cells and that

are effective in destroying bacteria, fungi, and enveloped

viruses. Such peptides, referred to as antimicrobial peptides, include defensins in mammals, bovine nubopeptides in cattle, magainins from frogs, and cecropins from

moths. Some of the smaller peptides have been synthe-
90 ● A New Technological Era for American Agriculture

sized and appear to have biologic activity similar to that

of the natural peptides, and could be used in a manner

similar to antibiotics. The genetically engineered protein

lysostaphin, which kills Staphylococcus aureus, has reportedly achieved cure rates as high as 80 percent for

mastitis in some clinical trials (1). Commercial development will take 5 to 10 years.

Synthetic peptides can be constructed to stimulate an

immune response in animals. Small fragments of proteins

that are homologous to proteins coded for by the foot

and mouth disease virus have been used to stimulate an

immune response to that disease in cattle and pigs. Synthetic peptides have been used to inhibit critical functions

of lentiviruses in sheep. Administration of a viral surface

protein elicited production of an antibody and provided

protection in fish. Commercial availability is not likely

until the end of the decade.

Monoclinal Antibodies To Confer

Passive Immunity

Monoclinal antibodies can be used to provide passive

immunity to disease-causing microorganisms. They generally act not by stimulating the immune response of the

animal itself, but rather by providing exogenous antibodies to the pathogen. Because monoclinal antibodies

are specific to one antigen, they may provide only weak

immunity to pathogens that have more than one immunogenic region of their surfaces.

Certain strains of the bacteria Escherichia coli cause

diarrhea in newborn calves. For diarrhea to occur, the

bacteria must attach to the walls of the intestines. Attachments occur via cilia-like projections, called pili, that

cover the surface of the bacteria. Monoclinal antibodies

specific to the attachment proteins on the pili prevent

attachment of the bacteria to the intestinal wall and prevent calves from getting diarrhea. A product currently

on the market for diarrhea prevention in calves is Genecol-99 (50). Monoclinal antibodies specific for bluetongue also have been shown to protect sheep from this

virus in trials.

In addition to monoclonal antibodies, antisense agents

can also provide passive immunity. Antisense agents can

be synthesized and used as drugs, or used to block viral

genes. They are very sensitive, but are susceptible to

enzymatic degradation A delivery is a problem ( I).

Immunomodulators

Immunomodulators are hormone-like molecules that

play a role in coordinating immune defenses to infectious

agents, cancer, and autoimmune diseases. They act to

boost or accentuate the immune response. Some of these

molecules, the lymphokines, for example, are produced

by white blood cells. Other immunomodulators, the cytokines, for example, are produced by other body cells.

Two classes of lymphokines, the interleukins and the

interferon, have been the focus of research attention.

Interleukins are compounds that transmit signals between white blood cells. These signals help to stimulate

the proliferation of disease-fighting white blood cells and

the production of antibodies. Interferon induce the

expression of class 11 histocompatibility antigens (define)

and enhance their activity.

Several interleukins and interferon have been identified in mammals, and the genes encoding some of these

compounds have been isolated and cloned into bacteria

(e.g., bovine alpha, beta and gamma interferon, bovine

interleukin-2) (32). Lymphokines are being tested as adjuvants to boost immune responses to poorly immunogenic vaccines. For example, interleukin genes and genes

for compounds that cause immune responses in animals

(antigens) are being inserted together into viral or bacterial vaccines. This combination may enhance the immune response of the animal and lead to increased

protection against the antigen.

Recombinant interleukins produced in bacteria or other

expression vectors may also be used therapeutically to

assist in overcoming certain infections. For example,

recombinantly produced interleukin-2 is being tested as

a control for shipping fever and mastitis in cows. Mechanisms by which these regulatory proteins modulate immune response are now being investigated in domestic

animals. Biotechnology is being used to identify and

repilicate these compounds so that their function can be

investigated.

Diagnostics

Safe, accurate, rapid, inexpensive, and easy-to-use diagnostic procedures are critical to the livestock industry

at virtually all points in the production process. Examples

of diagnostic tests include pregnancy tests and assays for

pathogenic organisms. Many currently used diagnostic

tests are costly, time consuming. and labor intensive,

and some still require the use of aninml assay systems.

Monoclinal antibodies and nucleic acid hybridization

probes can be used to produce simpler, easily automated.

and highly sensitive and specific diagnostic procedures.

Antibodies are proteins produced by the body in response to foreign chemical substances. Monoclonal antibodies are produced by a cell line expressing only a

single antibody type. They are the primary tools for bio-
Chapter- 3—Emerging Animal Technologies ● 91

technology-based diagnostics. At least 15 different rapid

diagnostic tests based on monoclinal antibodies are on

the market or will be soon (table 3-4). These tests are

highly specific and most lend themselves to automation,

potentially allowing their application in mass screening

systems for disease surveillance and control. Some of

the tests have been adapted to field use and can be used

by veterinarians or producers. The rapid commercialization of these products is having a significant impact

on animal health management and disease control.

Monoclinal antibodies are also being used in enzymelinked-immunoabsorbent-assay (ELISA) systems to provide sensitive, quantitative blood assays of toxins, hormones, chemicals (e. g., pesticide and antibiotic residues),

and a variety of antigens including microbial agents.

Many of these tests are commercially available. In some

instances monoclinal antibody diagnostics have been used

to replace bioassays such as mouse inoculation tests.

The high specificity of monoclinal antibodies has generally been felt to make them less useful than polyclonal

antibodies in initial screenings for diseases that have many

serotypes. However, an ELISA kit containing just two

monoclinal antibodies was able to detect 800 different

Salmonella strains, so it may be possible that diagnostic

kits containing just a few monoclinal antibodies could

be useful for initial screening of pathogens ( l).

Nucleic acid hybridization can also be used to diagnose

the presence of microbes and parasites (table 3-5). Such

assays rely on the bonding of a specific DNA or RNA

segments (the probe) to complementary RNA or DNA

fragments in a test sample. The probe is attached to

(labeled by) a radioactive compound or to a color compound to allow for detection. DNA probes are most comTable 3-4—Diagnostic Monoclinal Antibody Kits

Avian Ieukosis

Avian reovirus

Bluetongue

Bovine virus diarrhea

Canine parvovirus

Coccidiosis

Episotic hemorrhagic disease

Equine infectious anemia

Feline infectious peritonitis

Feline Ieukemiaa

Feline T-lymphotropic Ientivirus

Feline T-lymphotropic lentivirus (

Feline leukemia

Mastitis

Pseudorabies a

Rotavirus gastroenteritis

Trichinosis

a More than one company has a kit on the market

SOURCE: Office of Technology Assessment, 1992.

men. The development of RNA probes is very recent,

and they are used to detect RNA viruses.

The major limitation of nucleic acid hybridization is

inadequate signal strength. The amount of target nucleic

acid present in some samples may be too small to emit

a signal the probe can detect. The polymerase chain reaction technique (PCR) (see ch. 2) can be used to amplify

the amount of target DNA present and improve the ability

of the probe to detect its presence. Similarly, bacteriophage replicase systems can be used to amplify the RNA

present in a sample.

Currently, the most reliable probes are those that are

radioactively labeled. Use of these probes requires expensive equipment and trained technicians. thus precluding their use in the field. Alternative calorimetric

techniques currently in development will replace the radioactively labeled probes and make the use of this technology more commercially attractive (32).

The advantage that nucleic acid probes have over traditional diagnostic techniques is speed. Conventional tests

for anaplasmosis and Johne’s disease (an intestinal disease in ruminants), for example, require about 6 and 14

Table 3-5—Pathogens for Which Diagnostic Kits

Using Nucleic Acid Probes Are Available

Viruses

Bluetongue

Bovine coronavirus

Bovine Ieukosls

Bovine virus diarrhea

Equine encephalosis

Foot and mouth disease

Infectious bovine rhinotracheitis

Porcine coronavirus

Porcine parvovirus

Rabies

Rotavirus

Bacteria

Anaplasma marginale

Campy lobacter

Enterotoxigenic Escherichia coli

Leptospira

Mycobacterium

Mycoplasma

Salmonella

Shigella

Parasites

Babesia bovis

Eimeria tenella

Eperythrozoon suis

Hammondia hammondi

Theileria parva

Toxoplasma gondii

Tritrichomonas foetus

Trypanosoma brucei brucei

Trypanosoma congolense

SOURCE: Office of Technology Assessment, 1992.
92 ● A New Technological Era for American Agriculture

weeks, respectively, to confirm the presence of the pathogen. This much time allows for interim spread of disease. With DNA probes the presence of these pathogens

can be confirmed within a few hours.

Restriction Fragment Length Polymorphism maps

(RFLPs) can also be used for diagnostic purposes. This

procedure has been used to distinguish different strains

of African swine fever virus and has shown that equine

herpesvirus- 1 can infect and cause abortion in cows under

natural conditions.

Research to develop diagnostic kits using biotechnology is being conducted in both the private and public

sector. Currently, several diagnostics kits are commercially available. Development time to bring new diagnostic kits to market ranges from 2 to 5 years. Generally,

less time is required to develop monoclinal antibody kits

than nucleic acid probes.

FOOD PROCESSING

APPLICATIONS

The processing of animal products into foods also will

be affected by biotechnology developments. Americans

consume many meat and dairy products that are fermented; genetically engineered fermentation starter cultures are being developed for these products.

Starter cultures are living microorganisms used to produce fermented products such as cheese, yogurt, butter,

buttermilk, sour cream, salami, and sausages. Culture

organisms have been safely consumed by humans for

centuries and serve as ideal hosts for the production of

these natural foods. The metabolic properties of these

organisms directly affect the properties of the food product, including flavor and nutritional content. In order to

improve various properties of food products, food microbiologists attempt to manipulate the traits of the microorganisms, primarily through mutation and selection.

The cloning and gene transfer systems developed in the

1980s are being used to construct strains with improved

metabolic properties more rapidly and precisely than is

possible with traditional methods. The development in

this decade of new strains with precise biochemical traits

will have an impact on several aspects of fermentation,

including production economics, shelf-life, safety, nutritional content, consumer acceptance, and waste management (19).

Although much of the current work to develop new

strains of microorganisms has focused on the use of E.

coli and other nonfood microorganisms, there are distinct

advantages to engineering starter cultures for producing

high-value foods. For example, construction of cultures

resistant to attack by viral infection will impact processing costs by eliminating waste. Cloning of the genes

responsible for ripening of aged cheeses can decrease

storage costs by accelerating ripening. Production of natural preservatives, such as nisin (effective in inhibiting

foodborne pathogens and spoilage organisms), will help

ensure the safety and extend the shelf life of fermented

meat and dairy products. Starter strains engineered to

mimic the function of nitrates could reduce the use of

these compounds in cured meats.

Cloning of the gene(s) responsible for enzymatic reduction of cholesterol or modification of the degree of

saturation of meat and milk fat will improve the nutritional quality of fermented products. The ability to engineer strains capable of producing enhanced flavors or

natural stabilizers will influence consumer acceptance of

fermented dairy foods. Enzymes, which are added to the

curd to accelerate ripening, or to produce dairy products

acceptable for digestion by lactose-intolerant individuals,

will also be produced more economically by engineered

microorganisms (19).

A genetically engineered version of the enzyme preparation rennet, which is normally extracted from the forestomach of calves, has recently been approved by FDA

for use in cheese manufacturing (See ch. 10).

Processing of animal products generates many wastes

such as blood, bone, collagen, shells, fish parts, and

milk whey. Bacteria and yeast strains engineered to convert these waste products into useful products could decrease the cost and problems associated with their disposal.

For example, engineered yeast strains are capable of fermenting the lactose in whey to value-added products,

such as vitamin C, biofuels such as ethanol and methanol,

or pharmaceuticals. Whey protein could potentially be

used to produce specialty chemicals with biotechnology.

Biotechnology products can be used to monitor animal

products for food safety. DNA probes and monoclinal

antibodies can be used to analyze raw materials, ingredients, and finished products for pathogenic organisms,

bacterial or fungal toxins, chemical contaminants (i.e.,

pesticides, heavy metals), and biological contaminants

(i.e., hormones, enzymes) (figure 3-6). Detection kits

are commercially available. For example, kits are available to monitor several pesticides and antibiotics. Kits

are also available to detect Salmonella. Animal cell cultures may partially replace whole animal systems to test

for acute toxicity. Biosensors may be used to monitor

food processing, packaging, transportation, and storage

(19).
Chapter 3—Emerging Animal Technologies ● 93

Figure 3-6—Basic Steps in a DNA-Probe

Hybridization Assay

Isolate organism Disrupt organism to

obtain dsDNA

Convert dsDNA to ssDNA - Add labeled probe

and bind to solid support

Hybridize probe Wash and detect signal

Organisms present in a food product are trapped on filters and

disrupted to obtain double-stranded DNA. Following denaturation

of the DNA to single strands, the labeled probe is allowed to

hybridize with target DNA. Hybridization can be detected by a

number of methods.

SOURCE: Journal of Food Protection 54(4):387–401, 1991

SUMMARY

Biotechnology will offer many new opportunities to

alter the manner in which livestock is produced in the

United States. New products are being developed to enhance feed efficiency, improve livestock reproductive

performance, and enhance herd health management. Producers, food processors, and consumers all potentially

may benefit from these new products.

Several new products are under development to enhance the feed efficiency and growth of meat-producing

animals, and to increase milk yields in lactating animals.

Increased feed efficiency could significantly decrease the

cost of producing livestock. New growth promotants result in meat that is far leaner than that which is produced

naturally, a benefit to consumers who desire less fat in

their diets. Three new products (bST, pST, and betaagonists) currently are undergoing FDA review for use

in livestock production. Additionally, traditional growth

promotants, such as steroids and antimicrobial agents,

continue to be improved.

New reproductive technologies offer producers the opportunity to rapidly upgrade herd quality by selecting and

incorporating desired traits at a faster rate than could be

accomplished with traditional breeding. It is now possible

to induce superior females to shed large numbers of eggs,

and then to fertilize those eggs in vitro with the sperm

of superior males. The embryos may be implanted into

surrogate mothers whose estrus cycle has been synchronized to accept the embryo. Cloned embryos are currently

marketed, and more efficient methods of embryo production are being developed. Advances in embryo and

sperm sexing will allow livestock producers to choose

the sex of the progeny and to breed for animals of highest

value (e. g., females in dairy, males in beef production).

Eventually, transgenic livestock will be commercially

available. Efforts are under way to produce transgenic

livestock with improved production characteristics such

as enhanced disease resistance, leaner carcasses. and faster

growth. However, the first transgenic livestock will most

likely be animals that produce high-value pharmaceuticals in their milk. Several firms have successfully

produced such transgenic animals; however, commercialization is not likely to occur before the end of this

decade.

New vaccines, therapeutics, and diagnostic kits will

improve the ability of livestock producers to manage herd

health. Several vaccines and diagnostic kits are commercially available, and more are under development.

The food processing industry will also be affected.

New enzymes and starter cultures for cheese and dairy

manufacturing, and meat processing are being produced

with biotechnology. One genetically modified enzyme

preparation, chymosin. has been approved as generally

regarded as safe (GRAS) by FDA for use in cheese making. Biotechnology can be used to improve the safety of

food products through the development of nucleic acid

probes and monoclinal antibodies to detect the presence

of microorganisms, chemicals, heavy metals, and other

contaminants in food products. Additionally, new methods to manage processing waste products. such as whey,

are under development.
94. A New Technological Era for American Agriculture

Despite the potential opportunities offered by biotechnology, these technologies are not without controversy.

Concerns have been raised about the effects of these

technologies on farm survival and structure, food safety,

animal welfare, and the environment. Additionally, many

of these technologies will place a premium on farm management skills, and thus may not be appropriate for all

farmers. These issues are discussed in more detail in the

following chapters.

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

CHAPTER 3 REFERENCES

Bachrach, H.L. “Genetic Engineering in Animal

Agriculture, ’ commissioned background paper prepared for the Office of Technology Assessment, 1991.

Baile, C.A. et al., “Effect of Somatotropin Treatment in Sows During Late Gestation on Birthweight

and Performance of Pigs, ” Journal of Animal Science, vol. 67( Supp. 2), 1989, p. 67.

Bauman, D. E., “Bovine Somatotropin: Review of

an Emerging Animal Technology, ” commissioned

background paper prepared for the Office of Technology Assessment, 1991.

Beermann, D.H. et al., ‘‘Abomasal Casein Infusion

and Exogenous Somatotropin Enhance Nitrogen Utilization by Growing Lambs, ” Journal of Nutrition,

vol. 121, 1991, pp. 2020–2028.

Brinster, R.L. et al., “Introns Increase Transcriptional Efficiency in Transgenic Mice, ’ Proceedings

of the National Academy of Science, U. S. A., vol.

85, 1988, pp. 836-840.

Caperna, T.J. et al., “Growth Response and Hormone Profiles of Growth Treated Pigs Fed Varying

Levels of Dietary Protein, ” Journal of Animal Science. vol. 67( Supp. 1), 1989, p. 210.

Choi, T. et al., “A Generic Intron Increases Gene

Expression in Transgenic Mice, ” Molecular Cell

Biology, vol. 11, 1991, pp. 3070-3074.

Crenshaw, T.D. et al., “Exogenous Procine Prolactin and Somatotropin Injections Did Not Alter

Sow Lactation Performance, ” Journal of Animal

Science, vol. 67( Supp. 2), 1989, p. 258.

Cromwell, G.L. et al., “Recombinant Porcine Somatotropin for Lactating Sows, ’ Journal of Animal

Science, vol. 67( Supp. 1), 1989, p. 257.

Cromwell, G.L. et al., “Weekly Administration of

Recombinant Porcine Somatotropin to Lactating

Sows, ” Journal of Animal Science, vol. 67( Supp.

1), 1989, p. 258.

Cromwell, G.L. et al., “Recombinant Procine Somatotropin for Sows During Late Gestation and

Throughout Lactation, ’ Journal of Animal Science,

1991.

Cromwell, G.L. and Dawson, K. A., “Antibiotic

Growth Promotants, ” commissioned background

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

paper prepared for the Office of Technology Assessment, 1991.

Denman, J. et al., ‘‘Transgenic Expression of a Variant of Human Tissue-Type Plasminogen Activator

in Goat Milk: Purification and Characterization of

the Recombinant Enzyme, ” Biotechnology, vol.

9, September 1991, pp. 839-843.

Ebert, K.M. et al., “Transgenic Production of a

Variant of Human Tissue-Type Plasminogen Activator in Goat Milk: Generation of Transgenic Goats

and Analysis of Expression, Biotechnology, vol.

9, September 1991, pp. 835-838.

Enright, W. J., “Effects of Administration of Somatotropin on Growth, Feed Efficiency, and Carcass

Composition of Ruminants: A Review, ” Use of Somatotropin in Livestock Production, K. Sejrsen, M.

Vestergaard, and A. Neimann-Sorensen (eds. ), Elsevier Applied Science, London, 1989, pp. 132–

156.

Etherton, T. D., “Porcine Somatotropin: Review of

an Emerging Technology, ” commissioned background paper prepared for the Office of Technology

Assessment, 1991.

Food Chemical News (Washington, DC: Jun. 3, 1991).

Hansel, W., ‘‘Reproduction and Embryo Transfer,

commissioned background paper prepared for the

Office of Technology Assessment, 1991.

Harlander, S., “Biotechnology in Food Processing

in the 1990s, ’ commissioned background paper prepared for the Office of Technology Assessment, 1991.

Hocquette, J.F. et al., “The Human Liver Growth

Hormone Receptor, ” Endocrinology, vol. 125, 1989,

pp. 2167 -2174.

Houseknecht, K.L. et al., “Effect of Abomasal Casein Infusion on Nitrogen Retention of Growing Steers

Treated with Exogenous Bovine Somatotropin

(bST),” Journal of Animal Science, vol. 68( Supp.

1), 1990, p. 272.

Johnson, L. A., Flook, J. P., and Hawk, H. W., “Sex

Pre-Selection in Rabbits: Live Births from X and Y

Sperm Separated by DNA and Cell Sorting, ” Biol.

Reprod., vol. 41, 1989, pp. 199-203.

Juskevich, J.C. and Guyer, C. G., “Bovine Growth

Hormone: Human Food Safety Evaluation, ” Science, vol. 249, pp. 875–884, 1990.

Kopchick, J. J., “Transgenic Poultry, ” commissioned background paper prepared for the Office of

Technology Assessment, 1991.

Krimpenfort, P. et al., “Generation of Transgenic

Dairy Cattle Using ‘In Vitro’ Embryo Production, ”

Biotechnology, vol. 9, September 1991, pp. 844-

847.

Lacy, E. et al., ‘‘A Foreign B-Globin Gene in Transgenic Mice: Integration at Abnormal Chromosome

Positions and Expression, ” Cell, vol. 34, 1983,

pp. 343-358.
Chapter 3—Emerging Animal Technologies ● 95

27. Lavitrano, M. et al., “Sperm Cells and Vectors for

Introducing Foreign DNA into Eggs: Genetic Transformation of Mice, ’ Cell, vol. 57, 1989, pp. 717-

723.

28. Lo, D. et al., “Expression of Mouse IgA by Transgenic Mice, Pigs, and Sheep, ” European Journal

of Immunology, vol. 21, 1991, pp. 1001– 1006.

29. Massey, J. M., “Animal Production Industry in the

Year 2000, ” Genetic Engineering of Animals, J.

Reprod. Fert. Suppl. 41, W. Hansel and B.J. Weif

(eds. ), 1990.

30. Moffat, A., “Transgenic Animals May Be Down

on the Pharm, ’ Science, vol. 254, Oct. 4, 1991.

31. Nancarrow, C.D. et al., “Expression and Physiology of Performance Regulating Genes in Transgenic

Sheep, ” Journal of Reprod. Fertil, vol. 43( Supp. ),

1991, pp. 277–291 .

32. Osburn, B. I., “Animal Health Technologies, ”

commissioned background paper prepared for the

Office of Technology Assessment, 1991.

33. Palmiter, R.D. et al., “Heterologous Introns Can

Enhance Expression of Trangenic Mice, ” Proceedings of the National Academy of Science, USA, VOI.

88, 1991, pp. 478-482.

34. Powers, D.A. and Chen, T. T., “Transgenic Fish, ”

commissioned background paper prepared for the

Office of Technology Assessment, 1991.

35. Preston, R. L., “Steroid-Like Anabolic Growth

Promotants, commissioned background paper prepared for the Office of Technology Assessment, 1991.

36. Pursel, V. G., “Prospects for Genetic Engineering

of Swine, ” commissioned background paper prepared for the Office of Technology Assessment, 1991.

37. Rexroad, C. E., “Transgenic Ruminants, ” commissioned background paper prepared for the Office of

Technology Assessment, 1991.

38. Rexroad, C.E. Jr., ‘‘Production of Sheep Transgenic

for Growth Hormone Genes, ” Transgenic Animals,

N. First and F.P. Haseltine (eds. ), Butterworth-Heinemann, Boston, MA, 1991, p. 280.

39. Rexroad, C.E. Jr. et al., “Transferrin- and AlbuminDirected Expression of Growth-Related Peptides in

Transgenic Sheep, ’ Journal of Animal Science, vol.

69, 1991, pp. 2995-3004.

40. Scanes, C. G., “Poultry Somatotropin, ” commissioned background paper prepared for the Office of

Technology Assessment, 1991.

41. Seidel, G. E., “Sexing Mammalian Sperm and Embryos, ‘‘ Proceedings of the 1lth International Congress of Animal Reproduction and Artificial

Insemination, vol. 5, 1988, pp. 136–145.

42. Smith, V.G. et al., “Pig Weaning Weight and

Changes in Hematology and Blood Chemistry of

Sows Injected With Recombinant Porcine Somatotropin During Lactation, ’ Journal of Animal Science, vol. 69, 1991, p. 3501.

43. Spence, C.A. et al., ‘‘Effects of Exogenous Porcine

Growth Hormone on Metabolic and Endogenous

Patterns in Sows During Late Gestation and Lactation, ’ Journal of Animal Science, vol 59( Supp. 1),

1984, p. 254.

44. Spence, C.A. et al., ‘‘Effect of Exogenous Growth

Hormone on Fetal Energy Storage and Lactation Performance in Sows, ’ Journal Animal Science, vol.

59(Supp. 1), 1984, p. 246.

45. U.S. Congress, Office of Technology Assessment,

Commercial Biotechnology?: An International Analysis, OTA-BA-218 (Springfield, VA: National

Technical Information Service, 1984).

46. U.S. Congress, Office of Technology Assessment,

New Developments in Biotechnology>: Patenting Life

Special Report, OTA-BA-370 (Washington, DC: U.S.

Government Printing Office, April 1989).

47. U.S. Congress, Office of Technology Assessment,

U.S. Dairy Industry at a Crossroad: Biotechnology

and Policy Choices-Special Report, OTA-F-470

(Washington, DC: U.S. Government Printing Office, May 1991).

48. Veenhuizen, E.L. and Anderson, D. B., “An Assessment of the Effects of Beta-Adrenergic Agonists

on the Food Animal Industry, ’ commissioned background paper prepared for the Office of Technology

Assessment, 1991.

49. Wallis, M., “The Molecular Evolution of Pituitary

Hormones, ” Biol. Rev., vol. 50, 1975, pp. 35–98.

50. Walsh, M.E. and Sundquist, W. B., “A Case Study

of Genecol-99: Possible Implication For Other Single-Use Agricultural Biotechnology Products,” North

Central Journal Agricultural Economics, vol. 10,

No. 1, January, 1988, pp. 25–34.

51. Weidle, U. H., Lenz, H., and Brem, G., “Genes

Encoding a Mouse Monoclinal Antibody are Expressed in Transgenic Mice, Rabbits, and Pigs, ”

Gene, vol. 98. 1991, pp. 185-191.

52. Wright, G. et al., ‘‘High Level Expression of Active

Human Alpha-1-Antitrypsin in the Milk of Transgenic Sheep, ” Bio/Technology, vol. 9, September

1991, pp. 830-834.
Chapter 4

Advanced Computer Technology

Photo credit: U.S. Department of Agriculture, Agricultural Research Service
Contents

Page

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

SPECIFIC COMPUTER TECHNOLOGIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Knowledge-Based Systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99

Interfacing Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109

Other Computer Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 115

SUMMARY/PROGNOSIS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

The Current State . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

Mid-1990s . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123

2000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

CHAPTER PREFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 124

Boxes

Box Page

4-A. An Example Rule for an Expert System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101

4-B. An Example of an Explanation provided by an Expert System . . . . . . . . . . . . . . . . . . 101

4-C. An Example Recommendation from FLAYER . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104

4-D. An Example Query and Answer to a Natural-Language Interface . . . . . . . . . . . . . . . . 112

Figures

Figure Page

4-1. Trends in Semiconductor RAM Density . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

4-2. Trends in Microprocessor and Mainframe CPU Performance Growth . . . . . . . . . . . 100

4-3. Effect of Quality of Management on Milk Response of Dairy Cows

Receiving bat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

44. Structure of an Expert System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 100

4-5. System Structure for an Object-Oriented Simulation System . . . . . . . . . . . . . . . . . . . 106

4-6. Functional Components of the Crop Production Expert Advisor System . . . . . . . . 115

4-7. Topology of BITNET Commections in the United States . . . . . . . . . . . . . . . . . . . . . . . 116

4-8. States with Participants in DAIRY-L . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

4-9. Volume of DAIRY-L Messages . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 117

4-10. Volume of DAIRY-L Requests for Remote Retrieval of Text Files

and Software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 118

.—

Tables

Table Page

4-1. A Partial Catalog of Research Applications of Robots in Agriculture.. . . . . . . . . . . 119

4-2. A Partial Catalog of Research Applications of Sensors in Agriculture . . . . . . . . . . . . 121
Chapter 4

Advanced Computer Technologies

INTRODUCTION

Since the industrial revolution, agricultural systems

have intensified, and agricultural productivity has significantly increased along with farm size. Labor-saving

devices on farms have increased output per worker

several-fold. and advances in understanding and application of biological principles have significantly boosted

agricultural yields. With greater production per acre and

animal, however, farm management becomes correspondingly more challenging and complex. In general,

methods for making management decisions have failed

to meet this challenge. As a result, many decisions are

‘‘ uninformed” and many agricultural systems poorly

managed.

The application of advanced computer technologies to

agricultural management can help remedy this situation.

improved access to information will allow farmers to

more effectively monitor progress toward optimal performance. Computer technologies of potential use to agricultural managers are advancing at a tremendous rate.

The performance of computers has increased several-fold

with each new generation of computer chip (figures 4-1

and 4-2). In the last decade. microcomputers have evolved

from 64-kilobyte machines with a 320-kilobyte floppy

drive to machines with several megabytes of memory

and several hundred megabytes of permanent storage;

such machines approach the performance of mainframe

computers (25 , 54) and can store massive amounts of

information.

Advances are also occurring in software technologies,

allowing improved utilization of stored information. Decision support systems, for example, provide enterprisespecific, expert recommendations to decisionmakers.

Several other types of information technologies allow for

rapid access to the latest information.

These advances will provide the tools to improve farm

management. For example. close monitoring of” animal

performance will allow early detection of diseases and

can help reduce stress in animals. Overall, advanced

computer technologies can provide managers with the

ability to systematically determine the best decision rather

than arrive at decisions in an ad hoc fashion. Optimal

decisionmaking requires a holistic view of a farm enterprise, factors that affect it, and the probable consequences of management decisions. Thus, a farmer deciding

whether to plant a specific crop on a specific field should

weigh the profitability of the crop as well as overall farm

needs (i. e., nutrition requirements if it is an animal enterprise). The decision will impact land sustainability and

the need to use certain pesticides and herbicides or other

pest-control methodologies. Computer technologies, by

providing the capability of taking these multiple factors

into account, can help producers arrive at the best possible decisions and management strategies.

The quality of management, in turn, will influence

productivity as well as the future impact of some biotechnologies. For example, the response of milk cows to

bST is directly related to management. Poorly managed

dairy herds have a lower response to bST than wellmanaged herds (figure 4-3).

SPECIFIC COMPUTER

TECHNOLOGIES

Computer technology is changing at an unprecedented

rate on three different fronts, causing a "three-dimensional" information revolution. Rapid advancements in

traditional database and computational programs: in symbolic computing and artificial intelligence: and in systems

that improve access to information constitute the three

dimensions of the information revolution.

Knowledge-Based Systems

Traditional database and computational programs, which

are largely numeric and follow established algorithms.

are invaluable resources, but they cannot easily deal with

symbolic data or mimic an expert’s reasoning process.

The so-called knowledge-based systems in the category

of symbolic computing and artificial intelligence have

these capabilities. American agriculture is just now beginning to capitalize on these resources.

Essentially, knowledge-based systems present expert

knowledge in a form that can be used to solve problems.

In addition to expert knowledge, such systems require

situation-specific databases. For systems that operate in

real-time, sensors may play an important part in collecting data for knowledge-based systems (40). General

uses

1.

2.

-99-

of knowledge-based systems include:

recommending solutions for problems (e. g., diagnosis),

monitoring the status of a system to determine significant deviations (i. e.. management-by-exception). and
.

100 ● A New Technological Era for American Agriculture

Figure 4-l—Trends in Semiconductor RAM Density

lo+@ I

1985 1975 1985 1995 2065

Year

SOURCE: J L Hennessy and N P Jouppi, Computer Technology and

Architecture: An Evolving Interaction, ’ IEEE Computer September:18. 1991

Figure 4-3—Effect of Quality of Management on Milk

Response of Dairy Cows Receiving bST

Excellent management

Good management

Average management

I

Somatotropin dose

SOURCE: D.E. Bauman, “Bovine Somatotropin: The Cornell Experience.”

Proceedings of the National Invitational Workshop on Bovine

Somatotropin, USDA Extension Service, Washington, DC, pp.

46–56.

Figure 4-2—Trends in Microprocessor and

‘Mainframe CPU Performance Growth Figure 4-4—Structure of an Expert System

1985 1970 1975 1980 1985 1990

Year

SOURCE: J L. Hennessy and N.P. Jouppi, “Computer Technology and

Architecture: An Evolving Interaction, ” IEEE Computer September:18, 1991

3. forecasting the behavior of a system (i. e.. simulation).

Expert Systems

Expert systems are the most popular knowledge-based

technology in agriculture. The main benefit of expert

systems is that they emphasize knowledge acquisition.

not programming.

User lnterface

Interface engine Knowledge base

control strategy domain knowledge

rule

facts

“How to do it” “what to do”

SOURCE: Office of Technology Assessment, 1992

Expert systems are distinguished by a unique structure

that separates ‘‘What to do’ from ‘‘How to do it’ (figure

4-4). The knowledge base tells the program what to do.

It contains the expertise for solving the problem without

the control structure found in traditional programs. The

second component of an expert system is an ‘‘inference

engine’ that, in effect, shows the program how to do

the task at hand. The inference engine contains the control strategy that determines how to combine domain

knowledge to solve the problem.

Domain knowledge can be represented in the knowledge base in several different forms, the most common
Chapter 4—Advanced Computer Technologies .101

of which is rules (e. g., “If the leaves are brown, then

apply insecticide X’ see box 4-A). Rules correspond

closely to the natural reasoning of experts, are modular,

and are easy to maintain. As a result. expert systems are

easy to develop and to support. The knowledge in an

expert system tends to be symbolic instead of numeric.

This feature allows rules to be “heuristic” in nature,

akin to "rules-of-thumb. ” When exact algorithms do not

exist, the rules represent the expert’s best guess (94).

Another interesting feature of expert systems is their

capability of incorporating uncertainty into rules. For

example, the rule "If the leaves are brown, then apply

insecticide X; 0.3’ means that there is a 30-percent certainty or confidence in the conclusion. Strategies have

been developed for combining the uncertainty of rules to

give a confidence value for each recommendation (7,

76). Therefore, the expert system is able to make recommendations even when the circumstances of the problem are uncertain. This ability mimics the reasoning of

an expert. Expert systems have the added capability of

explaining the reasoning used to derive a solution (see

Box 4-A—An Example Rule for an Expert

System

IF

● you are willing to speculate for higher prices AND

● the price trend is up A N D

● the basis trend is weakening AND

● the basis trend is not expected to reverse soon

AND

● the timing is harvest AND

● the type of available storage is farm OR

● the type of available storage is commercial AND

● you need downside price insurance AND

● Storage revenues are greater than storage costs,

THEN

● forward contract your grain and buy call options.

SOURCE: R.H. Thieme et al., “Expert System Techniques Applied to Grain Marketing Analysis,” Computers

and Electronics in Agriculture 1:299, 1987.

box 4-B), much as an expert might. The explanation is

a map of the rules chained together by the inference

engine ( 102).

Because expert systems separate the inference engine

and knowledge base, it is easy to remove the knowledge

from the expert system. leaving a shell that can be reused

in other applications. The shell contains the inference

engine, user interface. and other domain-independent

modules. The first expert system shell was EMYCIN,

which resulted when the knowledge base was removed

from MYCIN, an expert system that diagnosed human

blood diseases (89). Expert system shells have become

saleable products, and several are commercially available

for use in agriculture ( 14).

There are numerous examples of expert system applications in agriculture. These systems have tended to be

diagnostic systems for addressing relatively narrow problems. Large-scale, broad-based expert systems have not

been developed in agriculture. The following overview

of agricultural expert systems includes systems developed for business decisions. animal production, and crop

production.

Farm and Area-Wide Management—effective decisions regarding the planning, organization, and control

of a farm enterprise are essential to agriculture. The legislative, economic, and environmental demands placed

on farmers and government agencies that implement agricultural policy create a need for tools that help make

sound farm-level and regional policy decisions in agriculture. Tools that help with agricultural problems at a

watershed or farm will become increasingly important in

the future. This will involve integration of expert systems

with geographic information systems, area-wide monitoring systems (78 ), and remote sensing.

The financial difficulties of the 1980s vividly document the cost of poor decisionmaking in the business

sector. However, a major obstacle impedes the adoption

of expert systems in making business decisions. Business

decisions. unlike production decisions, are generally inBox 4-B—An Example of an Explanation Provided by an Expert System

I conclude that the patient has dreaded lurgy caused by bug-eyed germs with a certainty factor of .76.

WHY:

I concluded that the patient’s dreaded lurgy was caused by bug-eyed germs because tight abdomen (E3) and acid

saliva (E4) indicate swelling of the spleen (E), which taken together with yellowish skin cast (D) provide evidence

(CF = .76) that bug-eyed germs are the cause of the dreaded lurgy.

SOURCE: M. Van Horn, Understanding Expert Systems, Bantam Books. New York, NY, 1986.
102 ● A New Technological Era for American Agriculture

fluenced by values, goals, and risk attitudes. Thus, two

experts with the same knowledge and expertise may select different courses of actions (91).

Only a small number of expert system applications is

available for farm decisionmaking. Most existing expert

systems in this area relate to design, planning, and control. Unfortunately, such functions are considered relatively unimportant by farm managers. Expert systems

dealing with data acquisition and interpretation, prediction, and monitoring have not been developed. This may

indicate that expert system development efforts are focusing on applications not in the area of greatest need

for farm managers (91),

Farm-level planning and financial analysis are active

areas of expert system development. Several prototype

systems are under development. One effort at farm-level

planning directed at farmers’ needs is the Crop Rotation

Planning System (CROPS) developed at Virginia Tech

(6). This system uses a map-based interface to let farmers

enter data about their land (soil type, topography, landuse, and field sizes) and their farming enterprise. Based

on these data, CROPS provides farm-level or field-level

environmental risk evaluations for soil erosion, and nutrient and pesticide leaching and runoff. It then uses Al

planning and scheduling techniques to generate a wholefarm production plan so that the overall farming operation

can meet user-defined yield and/or acreage targets, economic return goals, while also reducing potential environmental risks to acceptable levels. The system runs on

Apple Macintosh 11 systems and is adapted for use by

the Soil Conservation Service and the Virginia Department of Conservation and Recreation in their farm planning activities.

The best known farm financial system is the Agricultural Financial Analysis Expert System (AFAES) from

Texas A&M University (63). AFAES consists of a

spreadsheet to prepare operating-year and multiyear financial statements; a program that calculates financial

ratios and trends from the spreadsheet; and two expert

systems that develop a performance operating-year analysis and multiyear analysis, respectively. This expert

system operates on an IBM-compatible microcomputer

and is marketed through the Texas Agricultural Experiment Station at a variety of prices based on the type of

user making the purchase.

Other agricultural expert systems have been developed

for specific business decisions. One example is the Grain

Market program developed at Purdue University (98).

This system provides advice for marketing storable commodities (e. g., crops). An example rule from this expert

system is shown in Box 4-A. The machinery selection

process is aided by the Farm-level intelligent Decision

Support system (FINDS) (49). This system integrates a

linear program (REPFARM), a database management

system, and an expert system. The expert system is used

to form the link between the linear program and the user

and to interpret the output of the linear model. The linear

program component operates on a minicomputer, but the

other components operate on a microcomputer. A decision support system for planning of land use and forage

supply for a dairy farm has been developed in Denmark

(34). The main components of the system are a knowledge base, a linear programming model, and a PASCAL

program connecting the knowledge base, model, and interface. The model integrates the varied business activities of a dairy farm, such as crop production, storing

feeds, milk production, and utilization of manure. Interactions between feeding and production of milk and

meat are established by use of knowledge sets. The user

interface allows for consequent analysis and can function

as a tool for calculation and optimization planning.

In addition to agriculture-specific expert systems for

business decisions, nonfarm business systems will impact

agriculture (91 ). For example, Dologite (24) developed

the Strategic Planning Advisor to provide strategic planning advice. This system provides recommendations such

as:

●

●

●

●

●

Get out of a business.

Hold current position.

Focus on one market niche.

Invest selectively.

Invest aggressively.

Animal Production—Expert systems for animal production deal with the management of farm animals and

generally focus on disease diagnosis and suboptimum

performance identification based on technical expertise.

Most expert system activity in the area of animal production focuses on the dairy industry. There are at least

two reasons for this. First, the dairy industry has a national data recording system (i. e., Dairy Herd Improvement, DHI), that provides centralized databases from

which expert systems can be built (99). A second reason

is that dairy animals are generally housed in confinement,

and they produce a product (i.e., milk) that can be routinely monitored on an individual animal basis. This is

conducive to intensive management. Spahr et al., (92)

outlined several potential applications of expert systems

for dairy herd management.
Chapter 4—Advanced Computer Technologies ● 103

Some of the earliest dairy expert systems were developed by Extension Specialists at the University of Minnesota. Their first system (DMGTSCOR) ranks dairyherd management strengths and best opportunities for

improvement using DHI management measures ( 16).

Management action is suggested for the three best opportunities for improvement. A second system,

SCCXPERT, was developed to diagnose herd mastitis

problems using DHI somatic cell data and to recommend

corrective actions. Another system, BLKTNKCL, provides interpretation and information about bulk tank culture data for primary mastitis causing organisms. A fourth

system, MLKSYS, provides expertise to troubleshoot

operational and design problems with a milking system

( 15). Two other systems have recently been developed

to assist in manure management and to provide an overall

analysis of the production and financial status of a dairy

farm. All of these systems were developed in the Level

5 expert system shell; as a result an effort is underway

to integrate them into a single system to allow data sharing among the programs. These expert systems are distributed by the Dairy Extension office at the University

of Minnesota freely to extension personnel and commercially for $75 ( 17).

Tomaszewski and others at Texas A&M University have

developed a Dairy Herd Lactation Expert System (DHLES)

to analyzes DHI milk production data and to provide recommendations for improving milk production ( 106). DHLES

contains a separate module (LacCurv) to graphically display

lactation curves. This system was developed in PROLOG

and operates on an IBM–compatible computer. It is marketed through Texas Dairy Herd Improvement Association

for $99 ( 100).

Several expert system projects are under development

for the dairy industry. Kalter and coworkers (45) are

developing a comprehensive expert system (Dairy Pert)

to evaluate dairy-herd management. The impetus behind

this effort is the possible future adoption of bovine somatotropin (bST), but the system has general applicability. This system currently contains over 320 rules in

the Nexpert expert system shell, a spreadsheet-based nutrition model, and entry and advice routines based on

Fox’s database management software. DairyPert does not

utilize DHI data because of inconsistencies among the

nine national Dairy Record Processing Centers. DairyPert

is funded by and will be distributed to the private sector

through a large pharmaceutical company. Cornell University will distribute the system to public agencies and

institutions. Oltenacu et al. (73) are developing a reproduction expert system that will analyze DHI reproductive

records and determine weaknesses in the reproductive

program. This system utilizes LISP on an IBM workstation. Allore and Jones (42) are developing an expert

system to evaluate DHI somatic cell counts that will

identify areas of management that predispose cows to

mastitis. This system is being developed in CLIPS and

will operate on an IBM-compatible microcomputer.

Oltjen et al. (74) have developed a prototype expert

system that recommends whether to keep or cull commercial beef cows. The rules contain knowledge relating

to the cow’s age, body condition score, calving difficulty, structural correctness, health, and previous reproductive performance. The expert system was integrated

with a simulation model to calculate net present value

for each animal. This expert system was developed in

the CALEX expert system shell.

An expert system to assist in the management of a

sheep enterprise has been developed in Scotland ( 104).

This system was developed without the aid of an expert

system shell. Once a working prototype that could be

delivered to an agricultural unit was developed, this project was halted as a research project. Expert systems for

the management of sheep flocks are also under development in Australia.

CHESS is a Dutch decision-support system designed

to analyze individual swine breeding herds within an

economic framework (22). It determines strengths and

weaknesses in the management of a pig enterprise. CHESS

consists of a decision-support system and three expert

systems. The decision-support system identifies and assesses the importance of relevant deviations between performance and standards. The expert systems combine

and evaluate deviations to identify management strengths

and weaknesses.

XLAYER (84) is a management expert system for the

poultry industry and is one of the most comprehensive

expert systems in animal production. XLAYER is designed to diagnose and estimate economic and associated

losses as well as recommend remedial management actions for over 80 individual production management

problems significantly affecting a flock’s profitability.

An example output is shown in box 4-C. This system

contains over 400 production rules and was developed

in the M1 expert system shell.

Crop Production—All commercial crop production

systems are potential candidates for expert system applications. In particular, expert systems should be considered for integrated crop management decisions that

would encompass irrigation, nutrition, fertilization, weed
104 ● A New Technological Era for American Agriculture

Box 4-C—An Example Recommendation From XLAYER

You are experiencing an economic loss of about $725 per week because of a sudden change in the grain portion

of your layer ration. Reformulate the ration and phase in new grains gradually, even if the cost per pound is higher.

Production losses amounting to some $500 per week are being experienced because temperature in your

layer house is exceeding 29.4 degrees Celsius. Use artificial cooling systems in regions where hot weather is

expected to continue. If layer barn has no cooling system, construct a partial budget to evaluate alternative pooling

systems such as evaporative cooling pads, roof sprinklers, high pressure misting and other forms of cooling,

Water intake is very low. Check watering systems to make sure that birds are getting adequate fresh, clean

water.

Equipment repair costs are running $100 per week higher than normal. Check management practices related

to the routine servicing of mechanical equipment. If repair and maintenance costs are consistently high, construct

a partial budget to evaluate the replacement of old or poor functioning equipment.

SOURCE: E. Schmisseur and J. Pankratz, “XLAYER: An Expert System for Layer Management,” Poultry Science 88:1047, 1989.

control-cultivation, herbicide application, insect control,

and insecticide and/or nematicide application (64).

The first expert systems developed in agriculture were

PLANT/ds (65), a program developed at the University

of Illinois that identified diseases of soybeans in Illinois.

and POMME(81 ), developed at Virginia Tech to identify

diseases of apple orchards. Both were written by computer scientists who were using agriculture as a novel

domain. Michalski, for example, was primarily interested in machine learning.

Of the major crops, cotton has received the most attention to date, with at least three expert systems and

one simulation-based management model now available

to the public (94). COMAX (COtton MAnagement

eXpert), the expert system component of GOSSYM/

COMAX was developed by the U.S. Department of Agriculture, Agricultural Research Service (USDA/ARS) in

Mississippi (56).1 Users of this system purchase a weather

station linked to a personal computer running the program. The GOSSYM component is a simulation model

of cotton production that uses weather data collected from

the weather station. The COMAX expert system uses the

model to project when to irrigate and fertilize to achieve

optimal agronomic goals. The entire GOSSYM/COMAX

system including the weather station and computer costs

several thousand dollars. Despite the high price tag, it

is used by as many as 500 cotton farms in 15 States.

COTFLEX is an integrated expert system and database

package developed at Texas A&M and released to the

public through the Cooperative Extension Service (93).

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service,

Farmer and consultant examine data from COMAX

(Cotton MAnagement eXpert) computer program.

The overall system will eventually include a whole-farm

economic analysis module that lets farmers evaluate

whether or not to participate in Federal farm programs

or to purchase Federal crop insurance. The component

released to the public, however, is devoted to insect pest

management of the three major insect pests of cotton in

Texas.

CALEX/Cotton is another integrated cotton expert system and database management tool (79). CALEX was

developed as an expert system shell, and cotton was the

1 GOSSYM is a hybrid term formed by combining (1).w]piwn. the scientific name for cotton and the word simul;ition.
Chapter 4—Advanced Computer Technologies .105

Photo credit U.S. Depatment of Agriculture,

Agricultural Research Service.

Farmer and engineer check automated weather station

that feeds daily weather information into the COMAX

system to update its prediction for cotton yield and

harvest dates.

first application area. The system was supported through

California’s statewide integrated pest management program and delivered to farmers for testing and use. It is

one of the best-documented attempts at delivering expert

systems to farmers for use in crop production (31). Because the program was developed with State support, no

revenue has been collected from its users and the project

continues to depend on State support.

Pennsylvania State University supports a laboratory

devoted to the development of expert systems and their

delivery through the Cooperative Extension Service. The

University has developed several expert systems using

an expert system shell (PENN-Shell) developed in-house.

One of these expert systems, GRAPES, recommends pest

control options for insects and diseases in vineyards (83).

Penn State’s expert systems all run on Apple Macintosh

computers, and the University supports a statewide computer network for these machines.

USDA-ARS researchers (28) developed a knowledgebased system for management of insect pests in stored

wheat. The system determines whether insects will become a problem and helps select the most appropriate

prophylactic or remedial actions. Simulation models of

all five major insect pests in wheat have been developed;

the model’s output feeds the expert system.

Evans and coworkers (26) at the University of Manitoba have developed an expert system to serve as a

Fertilization Selection Adviser. The current system considers only one type of crop (wheat), four different moisture regimes (arid, dry, moist, and irrigation), one soil

nutrient (nitrogen), and four different fertilizer compounds (urea, ammonium nitrate, urea ammonium nitrate, and ammonia). It provides return on investment

information; a risk analysis module is under development. This system was developed in the LISP programming language for the Macintosh: however, work has

already begun to develop a similar system using the C

programming language cm an IBM-compatible microcomputer.

In general, one can find expert system applications for

crop production for virtually all the major crops in this

country and in many countries around the world. Insect

pest management, weed control, and disease identification are the most common domains. Other systems that

have received wide recognition in crop systems include:

●

●

●

●

●

EasyMacs, an expert system and database program

developed at Cornell University for recommending

pest management strategies for apple production;

SOYBUG, an expert system developed in Florida

that helps farmers with insect pest control in soybeans (2);

SIRATAC, an expert system and simulation model

developed in Australia for helping cotton farmers

with pest management decisions that has since been

marketed internationally (36);

TOM, an expert system for diagnosing tomato diseases developed in France (5); and

WHAM, a wheat modeling expert system developed

at the University of Melbourne, Australia (3).

Research Needs— Development of commercial expert

system shells is being driven by forces outside agriculture
106 ● A New Technological Era for American Agriculture

and is proceeding at a relatively rapid rate. However,

agriculture applications generally will require expert system shells to operate in a microcomputer environment

whereas industrial applications often reside on workstations or minicomputers. Since this is a domain-independent

problem, it may be best addressed by computer scientists

outside of the agricultural sector.

The main limitation to development of expert systems

is adoption of computer technology. To promote this area

will require more trained personnel and incentives to

develop and deliver computer systems.

Object-Oriented Simulation Systems

In addition to expert systems, another type of knowledge-based system that is useful for planning is object–

oriented simulation. Traditional simulation systems model

the behavior of a system by explicitly simulating individual processes. The structure of the real system usually

is implicit in the model. Object-oriented simulation models have an inverse structure; they explicitly model the

Figure 4-5—System Structure for an

Field (a parent object)

structure of the real system, and the behavior of the

system is implicit in that structure.

Each component of the real-world system is represented in the simulation as an object. Objects are units

that consist of self-descriptive data and procedures for

manipulating that data. Objects can be represented in a

hierarchy such that they inherit properties from more

general categories (i.e., their parents). For example, an

object-oriented simulation of a farm (figure 4-5) would

contain a general FIELD parent object that describes the

general features of all fields (e.g., a method to calculate

the area of the field). Individual fields (e.g., field 23)

would be represented as unit objects that inherit the properties of the parent FIELD object and may also contain

some information specific to themselves (e. g., current

crop planted in the field). Objects in object-oriented systems communicate by exchanging messages. For example, if field 23 is to be harvested, a HARVEST message

is sent to the field 23 object. The field 23 object handles

the details (internally resetting its own values) and returns

the amount of crop harvested. This return message can

Object-Oriented Simulation System

Silo (a parent object)

PROCEDURE area - length x width/43,560

PROCEDURE harvest - yield x area

reset yield to zero

message: area /

I /

I

I

response: 98.7 acres

PROCEDURE harvest

volume = voiume + harvest

SOURCE: Office of Technology Assessment, 1992.
Chapter 4—Advanced Computer Technologies .107

be sent to a particular silo object which knows how to

add the crop to its inventory. Once the object-oriented

system is developed, the simulation sends messages to

appropriate objects in a fashion similar to farm managers

giving orders to their employees.

There are two main advantages to this type of simulation. First, the model closely corresponds in structure

to a real system. This facilitates maintaining and expanding the model. Second. procedures in an object can

be represented in a symbolic fashion similar to expert

systems. Thus, object–oriented simulation can be used

to model processes that may not be quantitatively well

defined.

Object-oriented simulations have been under development since the early 1980s. An early object-oriented

simulation language (ROSS) was developed in the LISP

programming language by the Rand Corp. for the Air

Force (62). This language has been used in military applications. Two early examples are SWIRL, an objectoriented air battle simulator, (47) and TWIRL, an objectoriented simulation for modeling ground combat between

two opposing tactical forces (48).

Object-oriented simulations are powerful tools for

modeling the behavior of biological systems that are otherwise difficult to describe mathematically. Output from

these systems can be used in planning and to determine

impacts of changing management procedures. However,

most existing object-oriented simulation models cannot

easily be transferred to production agriculture.

Several object-oriented simulation projects have been

developed specifically for agriculture. Researchers at Texas

A&M University developed an object-oriented model to

simulate animal/habitat interactions (82). The simulation

was specifically used to study the damage caused by

moose migrating through forest plantations. This system

was developed on a Symbolics workstation using LISP.

Another agricultural simulation was developed by USDAARS to model insect disease dynamics in a rangeland

ecosystem (9). This model is primarily a research tool

for studying the relationship between grasshoppers and

their pathogens to assist in integrated pest management

programs. This system was also developed on a Symbolics workstation using the FLAVORS object–oriented

programming language. Another LISP-based system was

the host-parasite model developed by Makela et al. (58)

to study the interaction between the tobacco budworm

and one of its parasites in cotton fields. More recently,

Crosby and Clapham ( 18) used the Smalltalk language

to simulate nitrogen dynamics in plants; Stone (95) used

an object-oriented model of a mite predator-prey system

to show that chaotic dynamics rather than stable or predictable cycles, might be the norm in agricultural systems; and Sequeira et al. (87) developed an object-oriented

cotton plant model for use in studying the interaction

between localized pest feeding and cotton lint yield and

quality. Another object-oriented simulation project is under development by Chang and Jones at Cornell University for use in agriculture ( 10). This project uses a

LISP-based, object-oriented programming language (Bobject, Kessler, University of Utah) to model the operation of a milking parlor. When completed, this model

will be useful to dairy–farm managers and their consultants for parlor configurations and for identifying changes

in performance when changes in parlor operation are

made.

Research Needs—The general paradigm of objectoriented programming is being incorporated into several

traditional programming languages (e. g., C, PASCAL),

but few inexpensive commercial shells exist in which to

develop object-oriented simulations. Smalltalk is a good

example. It is a language and a development environment

in one, and it generally comes complete with many predefine object classes developed specifically for simulation. Other expert system shells like KEE, Goldworks,

NExpert-Object, and Level-V Object include the objectoriented paradigm and can be used for simulation. LISP

offers many advantages for prototype systems such as

the parlor project. However, LISP is not a language in

which final products should be delivered, since it requires

too much memory and is too slow for agricultural applications. More research is needed to determine the potential value of object-oriented simulation for agriculture.

Knowledge-Acquisition

Knowledge-based systems are powerful computer tools

because they contain and apply a significant amount of

expert knowledge to problem-solving; however, this also

constrains systems development. Knowledge acquisition

is a slow and tedious process, and problem-solving rules

and procedures are often hard to articulate.

Artificial intelligence can help automate one type of

knowledge acquisition (21, 66), that of rule formation.

Machine learning, for example, is an artificial intelligence technique for automatically generating rules from

a set of examples. This is sometimes called “learning

from examples. ” It can be used to assist experts to develop rules or fill in where experts do not exist. For

instance, rules for a crop disease diagnostic expert system

can be generated using a machine learning system with

a database of plant descriptions and associated diseases.
108 ● A New Technological Era for American Agriculture

Michalski and others (65) compared rules derived by

experts and those generated by a machine learning algorithm (AQ11 ) when developing an expert system for

soybean disease diagnosis (PLANT/ds). The database

consisted of 630 examples based on 35 plant and environmental descriptors for 15 soybean diseases. One rule

was generated for each disease. When tested in an expert

system, the machine-generated rules outperformed those

generated by experts. The machine rules properly diagnosed 98 percent of the test cases while the expert derived

rules diagnosed 72 percent correctly.

A microcomputer-based machine learning system has

been developed for agricultural problems (27). This system was first used to generate rules for a grass identification system (WEEDER). Other generic machinelearning algorithms are available as commercial products

(e. g., Classification and Regression Trees, California

Statistical Software, Inc, Lafayette, CA; ID3, Knowledge Garden, Naussau, NY).

Due to the nature of rules generated from machine

learning (i.e., the rules indicate which variables are important for describing certain results), machine learning

can also be used as a data analysis tool. Liepins et al.

(57) investigated the use of three machine learning algorithms for analyzing natural resource data. They studied the effect of storm damage on lake acidification using

a data set generated after a major storm stuck the Adirondack Park in upstate New York. Application of machine learning to these data provided no new information

but reinforced many of the discoveries made using traditional statistics. Dill (23) also used a machine-learning

algorithm to analyze the sale price of cattle sold at public

auction. The data set contained all information available

to a buyer on sale day and the price for which the animal

was sold. Using machine learning. Dill was able to determine which variables influence the buyer’s decision

and now will be able to generate an automated appraisal

system from these results.

Research Needs—There are several problems associated with machine learning. One concerns data that

contain random errors (i. e., ‘‘noisy’ data). Some machine-learning algorithms are unable to handle this type

of data while others perform poorly (57). Much of the

data in agriculture is noisy. Another problem is that many

of the machine-learning algorithms require discrete data

(e.g., classification-based) while agricultural data is mainly

continuous (e. g.. numeric). A third problem is that machine learning requires a complete database with associated outcomes from which to operate. Few of these

databases exist in agriculture.

Despite these limitations, machine learning can be a

very valuable knowledge acquisition tool in certain situations. With continued development, these limitations

will likely be overcome.

Knowledge-Based Report Generation

One of the initial goals in artificial intelligence was to

develop systems capable of translating documents from

one computer language to another ( I I ). An integral component of machine translation is developing a knowledge

representation of the original document such that text can

be generated in another language. Though machine translation will not have a major impact on American agriculture, systems that are able to generate knowledgebased reports from a database will.

Farmers receive large volumes of production data with

little or no interpretation; hence, they may be unable to

convert these data into useful information. Knowledgebased report generation is an emerging technology that

can provide them with interpretive reports to better support management decisions.

In many respects, programs for knowledge-based report generation are similar to expert systems. Report

generation programs contain four components:

1. a domain-independent knowledge base of linguistic

and grammar rules,

2. a domain database from which the report is to be

generated,

3. a domain knowledge base for interpreting the data

structure, and

4. the text planning component for deciding what to

say and how to say it (69).

Once a system is complete, the domain knowledge can

be removed to create a shell that can be used in another

domain. Report generation is still largely in the research

stages and commercial shells have not been made available.

CoGenTex, Inc. has developed a proprietary linguistic

shell for knowledge-based report generation. This shell

has been used to generate weather forecasts in both English and French for the Canadian Government. A USDA

Small Business Innovation Research proposal has been

submitted to study the suitability of this approach for

generating knowledge-based reports that interpret DHIA

records for dairy farmers (46).

Research Needs— To date, there have been no applications of knowledge-based report generation in agriculture. Research should be directed at investigating the

potential benefit of this technology to American agriculture. Once the preliminary investigations are com-
Chapter 4—Advanced Computer Tehnologies ● 109

pleted, a better understanding of needs and benefits will

be established.

Interfacing Technologies

Farmers have been slow to adopt personal computers.

Recent surveys indicate that only 15 to 27 percent of

farm managers utilize computers in management (1, 55).

Two factors that may have contributed to this slow adoption rate are the lack of high quality management software

(71 ) and a computer phobia on the part of some farm

managers. Farm managers have available to them only

a limited selection of computer programs. most of which

perform similar functions. The computer phobia is caused

by a lack of exposure to computers but is exacerbated

by the type of user interfaces (both hardware and software) employed by most agricultural computer programs.

Hardware Issues

Currently, most microcomputer systems use a keyboard as the major input device. Keyboard entry is clumsy

for agricultural software as many farm managers are slow

typists. Even for programs that require little input. a

‘ ‘hunt and peck’ typing ability can frustrate the user to

the point of not using the system. Another problem with

keyboard entry is impaired dexterity from excessive

physical labor or injury that severely impairs the farm

manager’s ability to type. Consequently, software should

be developed allowing the use of alternative input devices.

Two relatively common input devices are the mouse

and the light pen. However, neither of these capture the

user’s natural pointing instincts (77 ). A more intuitive

input device is the touch-sensitive screen. Another alternative input device is speech.

Touch-sensitive screens are computer displays in which

portions of the display may be used as an input device.

This technology has been available since the mid-1960s

(41 ). Touch-sensitive screens are easy to learn, very durable, and require no additional work space. At the same

time they have the disadvantage of increased cost, increased development complexity, lack of software to take

advantage of touch-sensitive screens, arm fatigue. and

screen smudging. A major complaint of touch-sensitive

screen users is the lack of precision; however. highprecision screens have recently been developed (86). Due

to their durability and user-friendliness, touch-sensitive

screens have been used in specialized applications such

as kiosk information systems in shopping malls and airports and for order processing in restaurants. Both of

these applications have been developed to allow control

of a computer systems by nontechnical users.

A second area of research aimed at improving the

physical link between the computer and user is speech

recognition. This research has been glamorized by science fiction movies such as 200 l: A Space Odyssey, in

which computers carry on a dialogue with the user. Though

this is the goal of research efforts, it is not the current

state-of-the-art (52). A prominent researcher has predicted that totally spontaneous, unrestricted speech recognition is still as much as 30 years from fruition ( 105).

However, speech recognition appears to be suitable for

applications with restricted discourses. Agriculture is one

such application.

Speech recognition is based on the ability to distinguish between words and on natural-language processing

whereby natural language input is transformed into a

form that the computer can utilize. In a common method

for speech recognition, template matching, each spoken

word is matched against a predetermined lexicon. The

lexicon must be trained to recognize a user’s voice. thereby

resulting in a user-specific system (52). High-performance, speaker-independent, continuous-speech recognition systems use another approach. that of statistical

modeling. Commercial speech recognition systems range

from speaker-dependent, single-word recognition (64-word

vocabulary units) to speaker-independent, continuousword recognition (40.000-word vocabulary units ) (75).

Speech recognition is not a perfect function. Most

literature values for recognition accuracy range from 95

to 99 percent (97); some articles report 8 to 12 percent

error rates (61 ). Several factors affect the error rate; these

include presence of background noise. phonetic similarity of words, and mood of the user as he/she alters voice

quality (52). Furthermore, lack of a one-to-one correspondence of sounds to words distinguishes speech from

other inputs. For instance, when a key is pressed on the

keyboard, the output is unambiguous. With speech recognition, the output is the most likely output which corresponds to the input. Consequently, the performance of

current systems degrades (in both time and accuracy) as

the vocabulary increases. When speech input was compared to traditional input methods, it was found to require

the same amount of time as mouse input, 80 percent as

much time as a single key stroke and 48 percent as much

time as full-word typed commands (61).

A commercial speech recognition system recently was

added to a medical diagnostic system for clinical data

entry (88). The system was an isolated-word, speakerdependent system capable of recognizing eight continuous syllables. Utterances required a half a second to
110 ● A New Technological Era for American Agriculture

take effect and 90 percent of all utterances were recognized correctly. For this application, speech recognition

proved an effective interface for improving the acceptance of the diagnostic system.

Advances in hardware input devices to improve the

usability of computers are being driven by multiple nonagricultural sources. For example, speech recognition is

a goal of the Department of Defense ( 105) and of research

aimed at providing more environmental control to the

physically disabled (20). Since this technology is domain

independent, advances in other domains should also greatly

facilitate the use of speech recognition in agriculture during the next decade.

Software Issues

The software design of the user interface is the main

factor determining the effort required both to learn and

to use a computer program. The most important function

of the user interface is to match the needs of the user.

Novice users need interfaces that are easy to learn while

advanced users prefer interfaces that are easy to use. Most

easy to learn systems are not convenient to use. Thus,

no one interface will meet the needs of all computer users

(33).

In general, agricultural software has not been distinguished by sophisticated user interface designs. This partly

reflects the fact that most agricultural software is written

by people who understand agriculture. yet have little or

no training in user interface design.

Currently. there are nearly a dozen different interface

designs that can be used with computer programs. These

range from command languages to natural language.

Two common user interface designs in agriculture are

command and question/answer systems. A commanddriven user interface is similar to the DOS system where

a series of commands and arguments have to be known

by the user. For example. in the Cornell Remote Management System, which is used to ascess DHI data. a

command such as AIM 1-S1-DH1MO094 is used to run

a report. This type of user interstice is easy for an expert

to use, but because it is not intuitive. it is difficult to

learn. Another type of command-driven user interface

can be designed by mapping commands to special keys.

This interface is used by WordPerfect ( WordPerfect Corp..

Orem. UT) which uses multiple combinations of the

SHIFT. ALT. and CTRL keys with function keys forspecific commands. Question/answer systems require the

user to enter a response. If the type of response is unambiguous, this design can be easy to use but also tedious. This type of user interface should be limited to

responses which are Yes-No (e. g.. Y/N) or numeric.

A type of computer interface that is more intuitive to

use than command and question/answer systems is natural language. With this type of interface, commands are

given in normal spoken or written language instead of a

formal command language. An example of a natural–

language user interface is one that converts natural-language commands to DOS commands. For example, the

natural-language command ‘‘show me the files on drive

b:” is converted to the command “dir b:*.*” (53). Another example of a natural-language interface is one that

was developed for signal processing (68). This system

allows users who are knowledgeable about signal processing but ignorant of any programming languages to

manipulate wave forms using English commands oriented toward mathematical operations. However. the most

common use of natural-language interface has been in

database querying systems.

Natural language is attractive to the casual user and

to the user who is unwilling to learn a formal command

structure. However, natural-language user interfaces require more typing than command-language interfaces.

As discussed previously, typing requirements are an important consideration for agricultural software. Therefore, natural-language is probably not a desirable user

interface for systems that can be driven with a limited

set of commands (e. g.. DOS).

Another popular user interface design is the menu system. In the simplest form. a menu is a list of choices.

The user selects one choice by entering a number or letter.

Another version includes a light bar that can be positioned

over the menu using the keyboard. A more sophisticated

menu design, known as the graphic user interface (GUI),

is the icon and mouse system. This type of system represents menu selections using a picture that is ‘"clickedon’ with a mouse. The icon system was first developed

for the Xerox ‘Star’ workstation (90) to reduce the learning time of the user interface. The user is expected immediately to know which icon is appropriate. Thus. the

icon must be unambiguous and realistic. Distinguishable

and meaningful icons may be difficult to develop for

several similar items (96). Accompanying text is often

added to clarify the meaning of possibly ambiguous icons.

Another major factor of the user interface is data entry.

For this factor. interfaces called “form-filling” designs

have been developed. The user is presented with a series

of fields in which data are entered. The display relates

to a written form and allows the user to see all of the

fields together. Often. form-filling interfaces have data
Chapter 4—Advanced Computer Technologies ● 111

validation and editing capabilities. For more complex

data entry needs, multiple forms arranged as overlaid

windows can be used. As data are entered into a field,

it actuates the next form which displays with the appropriate related fields. This type of user interface is rapid,

easy to use, and easy to learn (96).

Design of sophisticated user interfaces has advanced

to a point where they should now be considered for all

agricultural software. Proper attention to user interface

design issues can result in agricultural software that is

more acceptable to use. For example, adaptive interfaces

are aimed at satisfying the differing needs of both novice

users and experienced users. An adaptive user interface

determines the skills of the user and changes the interface

to meet those skills. In general, novice users are provided

with menus and question-answer systems, while advanced users are given the option to use command languages and special key strokes. A prototype adaptive

interface has recently been developed (SAUCI); (101)

for processing UNIX commands. Using the adaptive interface, users made about half as many errors and required less time to perform tasks. Research in adaptive

interfaces should result in systems that are more intuitive

to use and easier to learn.

Information Retrieval Systems

Information retrieval systems are a set of advanced

computer technologies for accessing stored information.

These technologies differ from decision support systems

in that they offer no recommendations. Three technologies are emerging that may have a role in American

agriculture in the next decade. These are natural-language

interfaces, full-text retrieval systems, and hypertext

systems.

Natural-Language Inter-aces—Maintaining a complete set of production records is a critical component of

farm management. More important is the ability to rapidly and flexibly access information for management decisions. The best method of accessing production records

has been through database management systems; however, these systems generally have inflexible retrieval

facilities based on menus that present options of data to

retrieve or predefine reports to run. Traditional systems

require the user to learn the hierarchical structure of the

menu system and limit the type of reports available. A

natural-language interface for querying a database can

offer a more flexible retrieval system (43).

The current generation of natural-language interfaces

was made possible by a set of linguistic theories developed by Chomsky ( 12). These theories were first implemented in an efficient algorithm in a natural-language

interface for retrieving information about lunar rock brought

back from the Apollo space missions (LUNAR) (107).

LUNAR is based on a three-compartment model of

data retrieval. The first compartment is syntax analysis,

which determines the grammatical structure of the sentence. The second compartment of LUNAR is the semantic module, which is responsible for determining the

meaning of the syntactic structures. The meaning is translated to a formal query language in this module. The

third module of LUNAR is the retrieval component. This

module executes the formal query language, based on

the semantic analysis, to retrieve data from the appropriate database. When LUNAR was tested, it answered

78 percent of the questions presented to it ( 107).

The purpose of developing LUNAR was to assist scientists in retrieving data on lunar rocks. Its users were

primarily interested in specific data as that data related

to other scientific information that had been collected.

However, this style of data retrieval is not appropriate

for production agriculture where management decisions

need to be made. A natural-language interface for retrieval of data for decisionmaking should put the data in

the proper context so that an informed decision can be

made. Consequently, a knowledge-based, natural-language interface was developed to formulate more complete, intelligent answers to users’ questions from an

agricultural database (IDEA) (44).

IDEA is based on the LUNAR three-compartment model

but utilizes a new approach for semantic representation.

Unlike the formal query language used in LUNAR, IDEA

represents the query through a set of domain concepts,

which contain ‘‘expert’ information. IDEA has the capability of responding to a query and offering additional

pertinent information. An example of a query and answer

is shown in box 4-D.

IDEA was developed for a dairy database to assist

farm managers in decisionmaking. It is capable of responding to several different types of queries. The simplest query is about a single cow (e.g., “When is 5000

due to calve’?” or, simply, “Is 5000 pregnant’?”). More

complicated questions can be asked about subgroups of

cows (e.g., “Which daughters of Thor are bred to Bell’?”):

averages (e. g., “What is the average calving interval for

cows in the north barn’?’); and counts (e. g., ‘‘How many

heifers are due to calve in June’?”). Replies are designed

to contain important information that the user may not

have known was in the database or may not have even

asked for.
112 ● A New Technological Era for American Agriculture

Just as generic, domain-independent shells have given

expert systems widespread use; for natural-language interfaces to be successfully used in agriculture, a generic

natural-language shell capable of being transported to

other databases is needed. However, unlike expert systems, development of a generic shell for natural-language

interfaces has proven difficult. Hendrix and Walter (37)

point out that full synchronization is needed between the

database management system and the natural-language

interface. This is difficult to achieve when the naturallanguage interface is added as an afterthought. For example, in the dairy database that IDEA accesses, the

reproductive status of a cow is given as a numeric value

(e. g., O means ‘‘not bred’ ‘). To access multiple databases, the natural-language interface must be able to

translate all their representations.

TEAM is a natural-language interface developed at

SRI and designed to be transportable between databases

(32). However, a database expert still is needed to adapt

the system to each new database. The expert supplies

information describing the database and domain-specific

words, a process that TEAM has automated through a

series of questions. Another source of difficulty in making a natural-language interface transportable is associating meaning to phrases. For example, consider the

phrases “bred to Bell” and “bred in May. ” The first

refers to the ‘‘service sire’ while the second refers to

the “breeding date. ” Most natural-language interfaces

cannot handle these kinds of subtleties. Thus, for a natural-language interface to be successfully transported to

a new database, a database expert and a linguistic expert

are needed ( 19).

Because of the problems in developing generic shells,

natural language commercially lags behind many other

artificial intelligence technologies (70). One of the few

generic natural-language interfaces available commercially is the “Intelligent Assistant” interface for Q&A

(Symantic Corp., Cupertino. CA), which was introduced

in 1985. This system differs from most transportable

natural-language interfaces in that it has its own database

system. Users build their application directly in Q&A.

This system also uses synonyms for acquiring new words.

Box 4-D—An Example Query and Answer to a Natural-Language Interface

>> which cows are due to calve next week?

4897 was bred to STARMAN on 12/15/1987

and is due to calve on 09/18/1988

Projected calving interval: 347 days

>> when did 5281 calve?

5281 calved on 05/26/1988 with a heifer calf - #5535

The calf was in good condition

Gestation length = 278 days

5281 had a retained placenta

>> is 5239 pregnant?

YES

5239 was bred to TOPBRASS on 03/20/1988

and is due to calve on 12/19/1988

Projected calving interval: 466 days

>> is 5449 pregnant?

NO

5449 calved on 12/1 1/1987 with a heifer calf - #5478

The calf was in good condition

Gestation length = 283 days

5449 is 282 days in milk

5449 was bred to LEVI on 02/21/1988

5449 was pregnancy checked on 03/30/1988 and was open

SOURCE: L.R. Jones and S.L. Spahr, “IDEA: Intelligent Data Retrieval in English for Agriculture,” A/ Applications in Natural

Resource Management 5(1)56, 1991.
Chapter 4—Advanced Computer Technologies ● 113

An attractive feature of this system for agriculture is that

it operates on standard IBM-compatible microcomputers.

Another commercial natural-language interface is Natural Language (Natural Language, Inc., Berkeley, CA).

This system interfaces with any database that supports

Structured Query Language (i.e.. SQL).

Full-Text Retrieval Systems—A relatively new area

of human-computer interfaces that holds great promise

in making information more accessible is full-text retrieval. The goal of a full-text retrieval system is to search

a collection of documents to find relevant information

for the user (4). These systems can be particularly useful

for accessing a collection of documents that are authored

by several different people who potentially use different

words to express the same thing. Such a collection of

documents, including most Agricultural Extension publications, is unedited and generally not indexed.

Blair and Maron (4) evaluated the effectiveness of

STAIRS (STorage And Information Retrieval System). a

full-text retrieval system developed by IBM. They found

it to retrieve less than 20 percent of documents relevant

to a particular search when the database contained roughly

350,000 pages of text. They identified several pitfalls

that need to be considered in developing full-text retrieval

systems. STAIRS was efficient at retrieving documents

that exactly matched the wording of the request, but it

performed poorly in retrieving documents that contained

misspelled words, and words that were synonymous with

those in the request. For example, the word ‘‘gauge’

was spelled 9

‘guage’ in an original document, preventing

its retrieval. Full-text retrieval systems must be able to

account for such situations and retrieve relevant documents whose text may not match the exact wording of

the request. A simple key-word search or an indexing

scheme thus does not meet the needs for full-text retrieval.

A full-text retrieval system developed by Gauch and

Smith (30) contains an expert system and a thesaurus.

The thesaurus contains domain-specific information for

words, a list of synonyms for each word. its parent word(s),

and a list of children words. This structure allows a

particular search to be generalized or narrowed. Decisions as to the search pattern are made by the expert

system. If the recall is low, it will broaden the search.

If the precision is low (i.e., too many irrelevant passages

are retrieved) the expert system will use a more specific

search. The query is formed by the user and then passed

to a full-text retrieval system that has immediate access

to any passage in the text. The retrieval system requires

that the text undergo two stages of preprocessing. In the

first stage, the text is formatted for enhanced display.

Formatting includes insertion of format marks (line. tab.

italics, line, label ) and context information (section. paragraph, sentence. item). In the second stage of preprocessing. the file is converted to fixed-length records totfast access. Consequently. the system does not operate

on the original documents. This is an undesirable feature

as it precludes searching subsets of documents and requires additional storage.

A full-text retrieval system now commercially available (Metamorph; Thunderstone, Chesterland. OH) should

have wide application in agriculture. Metamorph operates on standard ASCII files using natural-language queries to search and find relevant passages in documents.

The natural-language input undergoes morphological

analysis to normalize each word. The normalization process converts words to morphemes—the smallest meaningful unit of a word. A set of morphemes that are related

to, but not necessarily synonymous with. the original

morpheme is generated. Metamorph then correlates these

equivalence sets to textual passages to determine passages that relate to the natural-language query. At the

first level of search, an equivalence must be present in

the passage for its retrieval. If this is unsuccessful, Metamorph will broaden the search. Another important feature of the correlation procedure is that it utilizes an

approximate match to account for minor discrepancies in

spelling. These features fulfill the conditions Blair and

Maron (4) identified as necessary for a full-text retrieval

system.

Numerous applications of full-text retrieval are possible. A recent project used a commercial full-text retrieval system to assist users in querying a specific DHI

computer manual (29). Additionally, with the advent of

mass storage systems for microcomputers (e. g., CDROM), full-text retrieval systems can play a significant

role in providing expert information (e. g., extension bulletins) to county extension offices and directly to farm

managers. An effort is underway to develop a national

dairy database (39) consisting of full-text documents covering major dairy-management areas. This full-text database is expected to be delivered on a CD-ROM and

accessed using a full-text retrieval system.

Hypertext-Hypertext is a method of connecting related passages of text, graphics, animation, or computer

programs in a multidimensional {i. e., hypercube) fashion

such that they can be accessed in a nonlinear fashion.

Each node can be connected to any number of other nodes

that provide additional related information. Hypertext

systems are analogous to footnotes or references in a
114. A New Technological Era for American Agriculture

document. For example, a footnote contains additional

information related to the text. The reader determines

when or if the footnote is to be read. Computerized hypertext systems are based on the same principle.

Hypertext systems are relatively easy to implement but

are difficult to build. They require the locations of the

related text to be stored with the location of the original

text. This is essentially a database management problem.

The difficult part of a hypertext system is to establish

the appropriate links between and among nodes. This

usually requires a domain expert, but the process can be

automated through full-text retrieval tools.

As Extension documents begin to be disseminated in

electronic form, hypertext should be considered as a method

of increasing access to related subject matter. For example, an extension bulletin that describes the use of

lactation curves for herd management should be linked

to other bulletins describing the use of butterfat and protein curves. To demonstrate the benefits of hypertext in

an agricultural setting, Rauscher and Johnson (80) delivered the six feature papers contained in an issue of Al

Applications: Natural Resources, Agriculture, and Environmental Sciences in hypertext form.

Integrated Systems

Management of an agricultural enterprise requires a

variety of decisions and, hence, a variety of decisionsupport tools. Long-range research in the area of humancomputer interface will be directed at integrating various

decision–support programs into a single system. Current

research is aimed at integrating autonomous systems,

developing intelligent user-interface managers, and integrating systems through a common representation shared

by an intelligent dialogue manager.

An overall controlling software system that allows the

user to access different decision-support tools yet maintains operational independence of tools themselves represents the lowest level of systems integration. The genera

operating system of a computer is an example in that it

allows the user to access multiple programs in the same

environment. More advanced integrated systems assist

the user in choosing the decision-support tool and provide

logical links between tools. This type of integration can

also be used to develop multimedia applications such as

full-color, full-screen graphics; full-color, full-screen video;

aural delivery of speech or music; and animation (50).

An example of an advanced multimedia system for

integrating several different decision-support tools is the

Whole Earth Decision Support System (WEDS; reference

(51. The WEDS project combines textual databases,

expert systems, simulation models, traditional programs

and laser-video images within the agricultural domain

into a single integrated system. Each module is developed

independently and inserted into WEDS. For example, an

expert system for lactation curve analysis developed independently from WEDS can be incorporated and linked

with other components dealing with lactation curves (e. g.,

documents in the textual database). In this system, the

user moves between the different modules guided by

logical connections. Systems such as WEDS should be

able to provide a complete information resource to extension agents, agri-service personnel, and farm managers for solving problems and formulating management

decisions. The multimedia approach utilized in the WEDS

project should be encouraged for systems developed in

the 1990s since people remember more if they combine

seeing, hearing, and doing during the learning process

(60).

A more tightly coupled method of integrating software

is to link different systems through a user-interface manager. The user-interface manager controls all user-interface functions for a set of application software (96) and

validates all inputs for the application software. Screen

displays, including error messages and on-line help, are

also controlled by the user-interface manager. There are

two major advantages to integrating software in this fashion. First, a system does not need to be redeveloped for

each piece of application software. Second, the user is

always presented with a consistent interface; thus, as the

user moves from one application to another, the user

interface remains the same. This is important for acceptability of software by laymen. Development of a

generic user-interface manager awaits further research;

however, several fourth-generation languages include facilities that can assist in development of generic user

interfaces (%).

A more advanced method of integrating software is

through an intelligent user interface; such an interface

allows problems to be formulated and appropriate application software selected using natural language. A prototype system for integrating crop production decisionsupport systems is under development (see figure 4-6);

(59). It uses an intelligent dialogue manager (IDM) with

unrestricted natural-language communication to develop

a problem description. The IDM parses input into a semantic representation using knowledge of the types of

queries that can be asked and the lexical entities that can

be discussed. The IDM also utilizes a model for inferring

the goal of the user’s input and relating it to the context

of the overall dialogue. The semantic representation is

passed from the IDM to an expertise module dispatcher
Chapter 4—Advanced Computer Technologies ● 115

(EMD), which selects the application to respond to the

query and formulates the appropriate control structure for

the application software. The EMD is an expert system

with knowledge of the problem-solving abilities of each

application software module. This system can provide

the user with a variety of problem-solving tools. Furthermore, the user does not need to know the nature of

the software, the details for using it, or the situations for

which it is appropriate.

Other Computer Technologies

Three other emerging computer-oriented technologies

will impact American agriculture in the 1990s. The first

involves dispersal of information to those who need it in

different geographic localities. The second. robotics, will

impact the labor problems associated with agriculture.

The third area is sensor technology.

Networks and Telecommunications

American agriculture is decentralized and widely distributed, making information dissemination problematic.

However, electronics can be used to provide mass distribution of information. Electronic information can be

transmitted essential y at the speed of light and duplicated

at minimal cost. Two electronic forms of information

delivery will dominate in the 1990s: a satellite-based

system and a wide-area computer network.

Satellite transmission of data has become a commonday occurrence for telephone and other communications.

A geosynchronous satellite receives a transmission from

Earth and rebroadcasts that message back to Earth over

a wide area. Different frequencies are used to send multiple simultaneous messages. Two common modes of

transmission are the Ku and C bands.

Interest in delivering agricultural information via satellite is growing. Several distance-learning programs have

been developed at the University of Utah for delivery in

Ecuador ( 13). Their developers are also preparing an

undergraduate animal breeding and genetics class to be

delivered over the national AG*SAT satellite instructional network, which routinely carries Extension programs. An Extension series of interactive dairy programs

has been developed and delivered by the University of

Washington (8) as well as by the University of Wisconsin

(35). The American Farm Bureau also maintains a satellite link to 46 States and 573 of their county offices

(72). This satellite link is used to transmit data as well

as instructional programs.

Satellites not only make possible mass distribution of

information, they do so in a way that makes this information easily accessible to end users. They only need a

satellite reception disk and a television. However, development of satellite-based instruction programs can be

expensive. Poor planning may also reduce attendance.

Other problems include limited audience interaction and

low motivation on the part of the end user to view the

program. The importance of in-person interactions with

the live speaker should not be underestimated. However,

Figure 4-6—Functional Components of the Crop Production Expert Advisor System

Deep reasoning

User IDM I

State Simulation

representation

Management Expert system modules

problem situations : domain-specific

The problem solving system component

SOURCE: L.R. Maran, “CPEAS: The Crop Production Expert Advisor System,” Knowledge Based Systems Research Laboratory, Department of Agronomy,

University of Illinois, Urbana-Champaign, 1989.
116 ● A New Technological Era for American Agriculture

if funds for education continue to dwindle, this may

remain the only feasible means to conduct an Extension

program.

Another method of rapidly delivering information is

through a wide-area computer network. Much of the western world currently is criss-crossed with multiple computer

networks. Two of the original computer networks are

BITNET (figure 4-7) and ARPANET. BITNET was initiated at the City [University of New York and was used to

connect major educational institutions. ARPANET was initiated by the Department of Defense. Today there are national computer networks for the government. commercial

companies, and educational institutions. A number of regional networks have also been developed. These include

networks such as Clemson University Forestry and Agricultural Network, CNET (Cornell University). and PENpages (Pennsylvania State University). Most of-these networks

interface through the national Internet system so that messages can be sent from one network to another. Internet is

funded by several government agencies and numerous companies (50).

The main benefit of wide-area computer networks is

the ability to rapidly share information and expertise. for

instance, an industry situation report can be posted on

the network and broadcast to all interested readers with

access to the network. County Extension agents on the

network can send and receive files in electronic format.

In this way. interdisciplinary work can be conducted over

long distances. Varner and Cady (103) have established

a bulletin-board type system, called DAIRY-L, through

which dairy professionals can request and receive information. DA IRY-L is only one of hundreds of bulletinboard systems, but a pioneer in the use of networking

for Extension education.

DAIRY-L, which resides on the University of Maryland mainframe computer. was initiated early in 1990.

Since that time subscription has grown to 150 subscribers

from 37 states and 20 foreign countries (figure 4-8).

Message traffic also has increased, approaching an average of 15 messages per month (figure 4-9). Messages

are submitted to a ‘‘list server’ which in turn transmits

them to all participants of DAIRY-L; therefore. all subFigure 4-7—Topology of BITNET Connections in the United States

SOURCE: J.R. Lambert, ‘(Networks, Telecommunications and Multimedia Information Bases for Agricultural Decision Support, ” commissioned background

paper prepared for the Office of Technology Assessment, Washington, DC, 1990.
Chapter 4—Advanced Computer Technologies .117

Figure 4-8—States with Participants in DAIRY-L.

New Hampshire

I

SOURCE Mark Varner, University of Maryland (M.A. Varner and R A Cady.

Dairy Science 74(Supp 1): 201, 1991

Figure 4-9—Volume of DAIRY-L Messages.

50 I

SOURCE Mark Varner, University of Maryland (M A Varner and R A

Cady. Dairy-L A New Concept in Technology Transfer for

Extension, Journal of Dairy Science 74(Supp. 1 ) 201, 1991

Dairy-L” A New Concept in Technology Transfer for Extension, Journal of

DA IRY-L has proven extremely useful to extension

specialists needing knowledge in areas outside their institution’s expertise. Because all members see all messages, DA IRY-L is also a powerful ediucational tool.

Information exchange through wide-area computer

networks makes efficient use of personnel and resources.

Therefore. a high priority should be given to maintaining

and enhancing the backbone systems (i. e.. satellites and

wide-area computer networks ) that provide rapid dissemination of information. Since these systems are national

in scope, this initiative should occur at the Federal level

with USDA-ES providing the leadership in agriculture.

Robotics

Robotics are machines that can be programmed to perform a variety of labor intensive tasks in agriculture.

Since 1968, when strew Dutch companies proposed

mechanisms similar to robotics for harvesting citrus, researchers have proceeded though the poposal stage and

currently are testing Laboratory and field prototypes for

fruit harvesting. transplanting, tissue culture propagation. and machine guidance (67) (table 4- I ).
118 ● A New Technological Era for American Agriculture

Figure 4-10—Volume of DAIRY-L Requests for Remote Retrieval of Text Files and Software

Number of requests

Date posted File/software o 10 20

3/21/91

3/22/91

4/22/91

4/22/91

4/22/91

5/09/91

6/19/91

6/25/91

6/25/91

6/25/91

7/18/91

8/29/91

8/29/91

8/29/91

&29/91

Cow price spreadsheet

Poison plant fact sheet

TMR fact sheet #1

TMR fact sheet #2

TMR fact sheet #3

FTP instructions

water coliform fact sheet

Heat stress fact s. #1

Heat stress fact S. #2

Heat stress fact s. #3

Staff design fact sheet

Dairy producer survey

Antibiotic residue fact sheet

Somatic cell count fact sheet

Somatic cell count fact sheet

SOURCE: Mark Varner, University of Maryland (M.A. Varner and R A Cady, ‘Dairy-L A New Concept in Technology Transfer for Extension, Journal of

Dairy Science 74(Supp. 1): 201, 1991.

Most robotic applications under development are foreign-based. The United States is noticeably lacking in

development efforts. Japan and Europe have much stronger

programs and are likely to capitalize on this technology

much sooner.

Agricultural robotics research is proceeding in two directions. One involves sensor technology (see following

section) and machine vision. This is because, unlike production line robots, agricultural robots will operate in environments where interferences will be encountered. For

example, a fruit-harvesting robot must be able to locate

irregularly shaped fruit despite the obscuring effect of leaves

and stems. A second research concern is robot end-effecters

(i.e., grippers). These are the mechanisms through which

robots conduct their work. Again, unlike industrial operations, agricultural robots will generally be working with

fragile products (e.g., bedding plants and fruit). Touch and

force feedback are necessary to avoid bruising or damaging

plants, fruits, or animal products.

Three other areas of research are important for robot

development but are not specific to agriculture. Manipulators are the physical linkages that move the end-effectors. Breakthroughs in speed and cost of manipulators

are necessary. Agricultural robots will likely require less

precision than industrial robots and will not require curvilinear motion, thus reducing the cost, Easily adopted

robot components from nonagricultural applications would

reduce the engineering costs of agricultural robots. A

second research area is the development of computer

algorithms for robot control. Significant advances in the

miniaturization and integration of control hardware are

needed. Integral feedback of the robot’s position is essential. More powerful integrated circuit chips to interface sensors and to control the manipulators are also

needed. New artificial intelligence approaches to task

selection will be important facets of robot control research. A final area of research, systems simulation,

allows evaluation of alternative robot configurations

through animated computer simulations. Advances in

computer simulation would reduce the development cost

and time required in engineering a robot.

One major use of robots in agriculture will be for laborintensive tasks. For example, there are two Dutch companies developing robots to milk dairy cows; one prototype is operating at the University of Maryland. Laborsaving robots will enable American farmers to remain

competitive in world markets despite higher labor costs

and a shortage of part-time, seasonal labor. They will

also help to stem the flow of young, struggling industries

such as ornamental horticulture, bedding plants, and plant

tissue cultures to countries with low-priced labor. If robotics can help these industries survive, they will create

or maintain jobs which would otherwise be lost.

Another major use of robots will be to micromanage

crops. For example, a robot with an image sensor to

detect weeds could be used to spot-spray herbicides. This
Chapter 4—Advanced Computer Technologies .119

Table 4-l—A Partial Catalog of Research Applications of Robots in Agriculture

Application Location Notes

Fruit harvesting

Apple harvesting France Able to harvest 500/. of fruit

Citrus fruit harvesting University of Florida 1 fruit every 3 seconds, able to harvest

a fruit on 750/0 of its attempts

Tomato harvesting Kyoto University 20 seconds per fruit

Cucumbers harvesting Japan In a laboratory study, the hand

successfully completed the

harvesting motion for 42 of 53

cucumbers.

Muskmelon harvesting Purdue University 5 seconds per fruit

Volcani Institute, Israel

Plant material sensing and handling

Transplanting

● pepper plants Louisiana State University Transplanting rates as low as 1 plant

● marigolds and tomatoes Purdue University every 3 seconds have been achieved

● move plugs from one flat to another Rutgers University with a 95°/0 success rate.

Automated tissue propagation University of Georgia, Operations include retrieving the

University of Florida, cuttings from a conveyor, trimming to

University of Illinois, size, stripping selected petioles,

New Zealand, Europe, applying rooting hormones, and

Israel, Japan, Switzerland sticking the finished product into a

plug flat cell.

Mushroom harvester England Uses a vision system to locate and size

mushrooms and guide a selective

robot harvester.

Forest thinning Performs automatically selective felling

within the tree ranks, bunching the

harvested trees and carrying them to

a process zone.

Animal

Robot milkers Netherlands

Sheep shearing Australia

Egg handling University of California. Facilitated candle inspection,

Davis

Pork protein sensing Purdue University Robot moves an electro-magnetic

scanner over a carcass.

Pork carcass sectioning Sweden

Oyster shucking University of Maryland Machine vision application to locate

oyster hinges.

Machine guidance

Automated guided vehicles Michigan State University Based on machine vision sensing.

Texas A&M University

Plowing robot France

Rice combine Japan Used edge-following to guide the

machine around a rectangular field.

Direct spot spraying Purdue University Machine vision application to recognize

Corn detasseling

plants.

Purdue University Machine vision application to recognize

plants

SOURCE Office of Technology Assessment. 1992

would encourage farmers to adopt conservation tillage robots to perform their tasks. Reliable sensors coupled

and post-emergence spray programs. with knowledge-basccl decision support systems will provide important managenment tools.

Sensor Technology
120. A New Technological Era for American Agriculture

Photo credits: Norman Pruitt, Maryland Agricultural Experiment Stat/on.

This research prototype automated milking system, developed in the Netherlands, allows scientists to study

system automation and robotics that can benefit dairy farms.
Chapter 4—Advanced Computer Technologies ● 121

or that require more vigorous sensing than we can provide. Sensor technology provides information the human

senses cannot access.

There generally are six classes of sensors. The newest

is machine vision which processes images (e. g., camera

input ) to detect patterns. Nuclear magnetic resonance

(NMR) is a noninvasive technique of resonating highfrequency electromagnetic radiation in the presence of

hydrogen nuclei. This technology is widely used for diagnosis in the medical field, but it is costly and difficult

to apply in field situations. Neur-infrared (N/R) spectroscopy is another noninvasive technique that measures

the reflectance of NIR radiation by a substance. Because

organic compounds absorb and reflect NIR radiation differently this is a quantitative sensor. Acoustical measurements provide another class of sensors for measuring

the density of substances. Biosensors are sensors that

incorporate a biologically sensitive material (e. g.. immobilized enzyme). Electrical sensors can monitor the

electrical properties (e. g., conductance) of a substance.

Considerable work has been done in environmental

sensing (i. e., crops, weather), somewhat less in animal

sensing (i. e., estrus detection) (40). A partial list of research efforts in sensor technology is presented in table

4-2. Animal sensors are difficult to engineer due to biocompatability problems and animal welfare constraints.

Photo credit: U.S. Department of Agriculture, Agricultural Research Service.

Drawing of pig (left) shows where cross section was made by magnetic resonance (MR) imaging. Spine, loin muscles, and

kidneys are visible in upper part of MR image (right). Scientists can measure fat development under the skin

quickly without injury to the pig.

Table 4-2—A Partial Catalog of Research Applications of Sensors in Agriculture

Application Type of sensor

Electronic navigation system Used the Global Position Satellite System

Automated plowing system Photodetectors sensed the furrow edge

Tractor guidance Computer vision

Monitor organic matter in soil Light and NIR reflectance

Application of spray material Electronic surface grid

Monitor gaseous ammonia NIR spectroscopy

Moisture sensors for irrigation Electrical resistance

Plant stress Infrared leaf temperature sensor

Crop growth Spectral reflectance

Weed identification Machine vision

Identification of plant embryo shapes Machine vision

Animal digestive system Radionuclide imaging

Estrus detection Electrical conductivity

Sex determination of baby chicks Machine vision

SOURCE: Off Ice of Technology Assessment, 1992
122 ● A New Technological Era for American Agriculture

Research on sensors for use in crop production generally

focuses on the following objectives:

●

●

●

●

●

Improving operations in crop production by machine guidance systems.

Applying pesticide and fertilizer chemicals.

Improving the management of irrigation water to

conserve the resource and reduce production costs.

Developing methods of monitoring crop growth to

incorporate with computer models for improving

day-to-day crop management and strategic planning.

Developing sensors for assessing crop maturity and

fruit location as basis for mechanical harvesting.

There remain numerous agricultural areas where sensors need to be developed (40). Doing so will require a

multidisciplinary approach with input from professionals

who understand the biology of the system in question as

well as professionals who understand sensor technology

(e. g., engineers and physical scientists). Some of the

areas that need to be addressed include:

●

●

●

●

Accurate three-dimensional fruit location sensor for

crop canopies. This will facilitate robotic fruit harvesting.

High-resolution navigation for field machines. Ability to program machine locations within inches, not

several feet, is needed.

A chemical drift sensor to monitor fertilizer and

pesticide application and production of air polluting

gases from animal units.

Irrigation demand sensors that are not affected by

soil properties and climatic factors.

Photo credit: Gerald Isaacs, University of Florida

An experimental fruit picking robot uses a machine

vision sensor and a computer to locate individual

fruit for detachment. Approximately 3 seconds per

fruit are required.

●

●

●

Animal stress sensors that can remotely detect early

animal health problems.

A fruit-ripeness sensor that can determine optimum

harvest times and detect early stages of fruit and

vegetable deterioration.

Microbial sensors that can detect early development

of spoilage or bacterial contamination in fresh meats,

including poultry and seafood.

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service.

Animal physiologists test a sensor that will detect when

this cow is ready to give birth.

An important component of the use of sensors in animal agriculture is telemetric data transfer and electronic

identification of animals. For sensors that are to be implanted (e.g., tissue conductivity for estrus detection),

telemetric data transfer must be accomplished within the

size constraints which make implantation feasible. This

remains a research issue. Implantable electronic identification systems have been developed and are currently

under review by the Food and Drug Administration. Concern centers on the possibility that implantable sensors

or identification units can enter the food chain.

The development of sensors will facilitate more forms

of automatic control over various aspects of agricultural

production. The development of robots is closely tied to

success in the area of sensor technologies. A broader

implication of sensor technology may be to provide a

data acquisition system and a database from which decision support systems can operate. This should result in

tighter controls for management and higher profitability

for the enterprise. Another important impact of sensor

technology will be in the food safety arena. Sensors to

detect food spoilage or contamination will greatly increase the safety of the American food supply.
SUMMARY/PROGNOSIS

Computer technologies change at such a rapid pace

that it is difficult to foresee their application in the next

decade accurately. Irrespective of agricultural policics.

computer technologies will continue to advance to support the needs of other industries. Meanwhile. a number

of impendiments exist that are likely to slow adoption of

these technologies in agriculture. These impediments can

be removed through changes in policy. Most projections

of agricultural application of computer technologies have

been overly optimistic. For example, Holts futuristic

view of the application of computer technoolgies for farm

management (38 ) is still 20 years from fruition.

OTA has developed a scenario for the application of

computer technologies in agriculture assuming that new

technologies have a 5-year development phase. That is

to say that once a research project begins it takes 5 years

before that technology is applied. It was also assumed

that incentives to bring new computer technologies out

of- the research laboratory and into production agriculture

would exist. There are almost no incentives to do so

today . Thus. American agriculture will not be affected

by these technologies in a major way for at least10 years.

The Current State

By and large. computers have had little impact on

production agriculture to date. Predictions that every farmer

would own a computer by 1990 have not come true. FeW

farmers have computers and those who do use them primarily for bookkeeping and routine calculations (e. g..

ration balancing ).

Computers have had somewhat more impact on agriculture support industries. Using computer networks and

tracking systems. equipment dealers are better able to

provide faster service and feed dealers are better able to

manage feed inventories. Most of these advances have

come from directly adopting general business software

with little or no input from the agricultural academic

community.

Another technology that currently is being adopted by

farmers is fax machines. This allows for rapid exchange

of printed material. An example of the use of- this technology is in ration balancing. A nutritionist can receive

the results of a feed analysis by fax from the laboratory.

formulate a ration. and fax that to the farmer all with-in

a few minutes. There is limited use of networks for exchange of information among Extension personnel ( i .e ,

Dairy-L) and among protoype full-text databases (i. e.,

National Diary Database).

Mid-1990s

Within the next few years. many technologies currently under development should find their way into application. By the mid 1990s, the performance of

microcomputers will likely double, eroding some of the

current constraints to farmer adoption of computer tech

nology. However. it still is unlikely that a high proportion

of farmers will own a personal computer by that time.

The primary application of advanced computer technology in the mid-1990s will be in the form of ad hoc

expert systems to solve well-defined problems. These

will be primarily problem diagnosis expert systems that

are currently under development. Farmers will have a

cadre of- expert systems at their disposal to diagnose

diseases and to evaluate animal and crop performance.

These systems will generally not be integrated with each

other and each will condisider one aspect of a problem.

Integrated systems that solve producton problems while

considering economic consequences will not become

available until later in the decade.

The primary use of expert systems within the next 5

years may be by agribusiness personnel, as they will be

able to leverage the cost of’ adopting these technologies

across more farms. Using expert systems to provide additional service to farmers may cause a shift in the role

of some professionals. For example. expert systems

help veterinarians take an epidemiological approach to

solving problems (85 ). It will also cause some diversification in services provided. For example. nutritionists

may be more likely to become involved in consulting for

the crop program when armed with an expertsystem.

Sensors will see limited application for collecting realtime data for expert systems. The primary use of sensors

will be for monitoring weather and field conditions for

crop management. Expert systems will help farmers to

interpret these data and suggest appropriate management

strategies such as irrigation, fertilization, or pesticide

treatment.

Another technology likely to see application within the

next 5 years is full-text retrieval systems. It will be possible for farmers and Extension personnel to have a CDROM with all of- the latest publications at their fingertips.

Using a full-text retrieval system they will be able to

retrieve pertinent information that will help them make

better decisions. For example. when a farm experiences

a corn mycotoxin problem, the manager can access an

information base to find relevant literature. Large information bases, such as the national dairy database, will

likey be developed and delivered by 1995.
124 ● A New Technological Era for American Agriculture

Robots for highly specialized, labor-intensive tasks

will begin to be applied to agriculture in the late 1990s.

This would include robot transplanting of seedlings and

pork carcass sectioning. Robots for milking cows could

reach application by the mid- 1990s.

2000

The turn of the century should bring with it significant

new applications of computer technologies in American

agriculture. Ten years will provide sufficient time for the

acceptance by farmers of computer technologies as a

valid management tool and for the development of integrated management programs. It will also allow time

for universities to become comfortable with these technologies and for personnel to be properly trained in developing these technologies.

By 2000, whole-farm advisors, or integrated “management workstations, should be developed. A management workstation will consist of integrated decision

support tools with a multimedia presentation of information. The workstation can thus serve as a diagnostic

tool, an information source, an advisor, and a planning

system. The expert systems will consider the holistic

view of an enterprise when making recommendations.

The systems will also share data so that information used

in one system will be available to other systems. This

generation of expert systems should operate as monitors

that can alert producers to potential problems, as opposed

to current expert systems which are situation-driven: that

is, the producer must perceive a problem and decide to

execute the system. The management workstation will

also contain an advanced user interface consisting of

speech recognition and touch-sensitive screens.

The future dairy management workstation might contain decision support systems that monitor the financial

records, the herd production records and the crop production records. Cropping decisions would be integrated

with the dairy needs, the financial situation, and the land

resources available. Currently, these decisions are all

made independently. When the farmer is alerted to a

problem (e. g., pest infestation). he or she can use the

multimedia features of the workstation to retrieve video

segments to learn how to identify the pest and the proper

techniques for applying a pesticide.

Robots for harvesting fruits and vegetables and for

automatically guided vehicles should become available

by 2000. Their application will depend on the cost associated with using human labor for the same job.

1,

2,

.34

4.

5.

6.

7.

8.

9.

1 ().

I 1.

12.

13.

14.

15.

16.

CHAPTER 4 REFERENCES

Batte, M. T., Jones. E.. and Schnitkey, G. D.,

‘

bComputer Use by Ohio Commercial Farmers, ”

American Agricultural E(onomic.v Asso(’iation

72:935, 1990.

Beck, H. W., Jones, P., and Jones, J. W., “SOYBUG: An Expert System foe Soybean Insect Pest

Management, Agrit,u[[[ir(ll S>,j[(,mif 30:269_~~6,

1989.

Berger, R.. “WHAM: A Wheat Modeling Expert

System. User Manual, Technical Report Department of Computer Science, University of Melbourne, Australia. 1987.

Blair. D.C. and Maron, M. E., b

’An Evaluation of

Retrieval Effectiveness for a Full-Text Docun~entRetrieval System. ’ C(Jttlt~ll(tli(~ltiotl.~ (!/’ Ihe ACI14

28(3):289. 1985.

Blancard, D., Bonnet. A., and Coleno. A., “TOM:

Un Systeme Expert en Maladies des Tomatoes.

P.H.M. RCIIIC Holti(olc. 261 :7– 13. 1986.

Buick, R.D. et al.. “CROPS, A Crop Rotation

Planning System for Management ot Whole-Farnl

Resources Implementing Low-Input Sustainable

Agriculture. Al Appli(wti~m.~ 6: 1992.

Buxton, R., ‘6Modelling Uncertainty in Expert

Systems. ltlt(’~.}t(ltiot~[[l J()[{rnal l)t’~(itl-~(1(.llitl(~

Studies 3 I:4 15, 1989.

Cady. R.A. et al., ‘‘The Role of Televideoconferences in Extension Programs. JoI/rnal (f L)t/ir\’

Stienfc 74( Supp. 1 ):290. 1991.

Carruthers, R.1.. Larkin, T. S.. and Soper. R. S.,

b’Simulation of Insect Disease Dynamics: An Application of SERB to a Rangeland Ecosystem..

Sim[(l[ltiotl 5 l: 101, 1988.

Chang. W. and Jones. L. R., “An Object-0 -iented

Approach for Modeling Milking Parlor Performance,” Journal oj’Dai\> Scien(c 74( Supp. 1 ):236.

I 991.

Charniak, E. and McDernlott. D.. ‘ ‘Introduction

to Artificial lntell igence’” (Reading. MA: Addison

Wesley Publishing Co., 1985 ).

Chomsky, N., “Syntactic structures. ” Mouton, The

Hague, 1957.

Christensen, C. et al.. ‘ ‘Preparing and 1nlplementing Distance Learning by Utah State University, “ Journal ~?j”Dait:} Siictlie 74( Supp. I ):289,

199 I .

Citrenbaum. R.. Geissmtm. J. R., and Shultz, R.

“Selecting u Shell, ” Al Appli(wtion.s in N[lt[iral

Re.~our(c klanagctnen~ 2( 1 ):3. 1988.

Conlin. B.J. et al.. “Machine XPERT. ’ Proceedings of the National Mastitis Council. 1989.

Conlin. B .J., Stcuernagel. G.R. and Peters,

R.R. ,“Design of an Expert System for ‘rr(~ublc

Shooting Dairy Hml Mtinugernent. ’ J(wt-tra/ {J/”

L)(/it-\’ .Stietl(c 72( Supp. I ):461. 1989.
17.

18.

19.

20.

21.

7? ---

23.

24.

25.

26.

?7.

28.

29.

30.

31.

Conhn. personal conlnlunications. Sept. 17. 1991.

Crosby’. C.J. tind Cluphwn. W’. M.. ‘‘A Simultition

Modeling Tool for Ni(rogcn D~mmlics Using Object-oriented Programming. Al App/ittl(i(~ll.\

4(2):94- 100. 1990.

Dtimerau. F. J.. ‘ ‘Prospects for Knomlcdgc-Bused

Custt~nlizati~~n ot Natural Language Query S~Istenls.‘‘ 111/i~rttl{[ti{jtl Pro~c.~.ii\l(q & kl~llllltqelllcllt

24:65 1. 1988.

Damper. R.].. ‘ ‘Voice-input Aids For The Ph~sicully Disublcd. ’ l~lt[~l”}~[iti~~}l~~l JtMIrIItIl {J/ kfLlIIM{[t}linc .%tl{dic.v 21 :54 1. 1984.

Dicttcrich, T. G.. b ‘Mtichine Learn ing. ’ AIII?IItI/

Rc\ic\\ ~J/’ C’(wIp[IttIr .$~iril~c 4:255, 1990.

Diikhuizcn, A.A. and Huirrw. R. B. M.. “’CHESS—

An Integrated Decision Support Sjstcm T() Antilyr/c

Individual Ct~\*-Herd Pcrt\mnancc. 1lll(’<qr(ll(’d

Dt’ci.~i(~il S[(pp(Jr( .%>.$tctlt.~ in t!,ql-icl~ltl{t-t’-.$ll[-

tv.~sfi[l Pr[i~tital Appli~wiio\t.~. Ikutschc Landsw i rt hsc h afts-Ge se 11 sch~ fts ( cd. ). Fran k fu rt,

Germany. 1990. p. 221.

Dill. D. E.. ‘‘An Electronic Model for Determining

Value and Predicting Stile Price of Holstein Cattle

Sold at Public Auction. Ph. D. Thesis. University

of Illinois. Urbtina. 1990.

Dologite. D. G.. ‘ ‘Developing a Knowrledyc-Based

System on u Personal Computer Using an Expert

S~stenl Shell.’” J(H{I-HIII (f .$>st(ws M(iml<qcmcnt

30, 1987.

Eckhousc, R.. “opcrtiting En\’ironnwnts for the

80386, ’ ‘ IEEE Compl(tcr 8:82, 1988.

Evans. M., Mtmdor. R.. A Flaten. D. b‘ Expert

Systems and Farm Mm.igement. (’[llwdiall ./(mrl~[tl of” Agri~l[lll{r~il E((Jtl~Jl)li(”.~ 37:639. 1989.

Fcrrntinian. T“. W.. Michtilski. R. S.. and Ktitz. B..

‘ bAgAssistant—A Tool For Dclreloping Expert

S)stcms. KII()\\led%qe B{~.\e(l .Y>.itcnl.$ i)! Agri(l{l -

tl{i-[~—Pl”().~]~t’c”t.~ ,fiw Appli(wtim. Jleutsche Landw’ifischafts-Gesellschaft (cd. ). Frtinkfurt. Gemumyz.

1988. p. 252.

Flinn, P.W. and Hagstrum, D.W. ,“Stored Grain

Advisor: A Knowledge-Based System for Mtinagement of Insect Pests of Stored Grain. Al Applitwti~)]t.~ ill Natliral Re.WH(r(aC kfanllgo~~l~)llt ~(~ ):~~.

1990.

Fourdraine, R. H.. Tomaszewski. M. A.. and Taylor. J. F.. ‘‘Using a Natural Language Interface to

Assist DH1 Supervisors, ” J~)[{rnal (!/’D{lil-> .~~ic}l(’c

73(supp. 1 ):209, 1990.

Gauch, S. and Smith. J. B.. “Intelligent Search of

Full-Text Databases, ” TR87-035, Department of

Computer Science. University of North Carolina.

Chapel Hill, 1987.

Goodell et al., CALEX Cotton: An Integrated Expert System for Crop Production and Management

in California Cotton, Cal{/iu-nitl A,qriculfut-e 44:(5 ):

I 8–20. 1990.

~-)

. -.

33.

M.

35.

36.

37.

38.

39.

40.

41.

42.

43.

44.

45.

46

47.

48.

Grosz. B.J. et al.. . ‘TEAM: An Experiment in the

Design of Transportable Nuturtil-Ltinguugc lntm_-

faces,. Arti/i~i[ll lntclli<qctl~c 32: 173. \9%7.

Grudin. J.. ‘‘The Cuse Agtiinst Uwr Intcrtticc Consistence). (’{~t~lt~lltllic[~tiott.~ of t~le A(’M 32:1 164.

1989.

Hunsen. J. P.. ‘ “DAIRY—an integrated decision

support sjstcm for planning of tied suppl) and lard

use on the duirj’ tarm. Illtc,grdted Dc~i.$i~jtl .Sllpport S>’.stt~ttl.s ij~ A<gric[{ltl{r[’: .5[{c~e.\.~/i[l Practi~[ll

Applit[~ti(w.s. Deutschc Lundwirtschaits-Gesellschat’t ( ed. ). Frtinkfurt. Germany. 1990. p. 182.

Hat-wood. E.Il.. Smith. T. R.. and Conlin. B. J..

“Devek~pment and Production ot’ Daig-LIVE Vidct~

Teleconference Programming. J~~I(rIl(I/ ~j/’ D(iirj

Sticll(c 74( Supp. 1 ):201. 199 I .

Hearn. A. B.. SIRTAC: ‘‘A llccisi(~n Suppt~rt S}Istern for Cotton Management. Rc\’ic\t of Markcti)l,q aIId A,qri~[{l(l(ral lic(ulot]li~.~ 55( 2 ): 170-173,

1987.

Hendrix. G.G. and Walter. B. A.. “The Intelligent

Assistant. BYTE Deccnlber:251. 1987.

Ho]t. D. A.. b’Conlputcrs in Production ,4griculture . ~~’~.i~,]l~,[~ ~~~:~~~ . I 985.

Hutiens. M.F. und Eastwood. B. R.. ‘‘An Update

on the National Dair\r Databtiw Program.. J()[IrIlal

~?/” D~/it-\’ .St”iclr(e 7 l~Supp. I ): 144. 1988.

lsaacs, G.W. . .Sensor Tcchnologj’. ” conlmissioned background paper preptirecl for the Oftice

of Technology Assessment. Washington. DC. 1991.

Johnson. E. A.. ‘‘Touch Displays, A Programmed

Man-Machine Interface. ” ~-i.,q(~tlot?li(,j 10:271. 1967.

Jones, L. R., personul communication. Sept. 17.

199 i .

Jones, L. R.. ‘‘Emerging Agricultural Technologies

in Human-Conlputer Interactions and Their impact

on American Agriculture, commissioned background paper prepared for the Office of Technology

~ssessment, Washington, DC. 1991.

Jones, L.R. and Spahr, S. L.. “IDEA: Intelligent

Data Retrieval in English for Agriculture. ” Al Applicwtiotls itl Natl{ral Re.w)urtv Mana,qemcnt 5( I )56.

1991.

Kalter. R.J. and Skidrnore. A. L.. “DAIRYPERT:

An Expert Systems Approach for Improving Dair~r

Farm Management and Assisting Technical Transfer , A.E. Res., Department of Agricultural Economics, Cornell University, Ithaca, NY, 1991.

Kittridge. R. I., Proposal: “An Artificial intelligence Approach to Providing Herd Management

Information. “’CoGenTex. Inc.. Ithaca. NY, IQ91 .

Klahr. P., McArthur, D. and Narain, S.. ‘ bSWIRL:

An Object-Oriented Air Battle Simulator.” Proc.

~[1 Al~jl. Nllt. Ccj}lf; OH Artif; Intel.. Pittsburgh. PA.

1982, p. 331. ‘ Klahr, P. et al.. “TWIRL: Tactical Warfare in the

ROSS Language, ” Rand Corp. R-3 158-AF, 1984.
126 ● A New Technological Era for American Agriculture

49.

50.

51,

~? . -.

53.

5-I.

55.

56.

57.

58.

59.

60.

61.

62.

63.

64.

Kline. D.E. et u]., ‘‘Machincr} Selection Using

Expert Systems and linear Programming. CcJnlp[(ter,j (iItd Elc(.troili(.s ill A,qri([(lt[tre 3 :45.

1988.

Lambert. J. I?.. ‘“Networks, Tclcc~~l~lnlunic;ltit~ns

iind Multi nwdi~l lnt~)rnlatit~n Buses for Agriculturtil

Decision Support ,“ cwmm issit~ncd background paper prcpwui for the OIficc 01” Tcchnolog) Assessment. W:ishingtt~n. DC. 1991 .

L~inlbcrt, J. Il. :Ind Deter. R. S.. ‘ ‘Whole Earth Decision Supp(wt Sjstenl. J{)l(I.IILII ofl>air]’ .Scicltcc

7Nsuppl I ):255. 1990.

Ltinduu. J .A.. Norwich. K. H.. :md E\ri.ins. S. J.,

‘‘Autom;itic Speech Rcc(~gnition-Can It ]mprokc

the Man-M:lchinc lntcrt’:icc in Mcdiciil Expert Systcms’!’ lltt[’1.lttltit~}~ill J(Jl(rn~Il ot’[)iol]lt’tli~[ll” C’OIIIpl{[it?,q 24: I I I . I 989.

Lunc. A.. . ‘DOS in English.’. BYTE Dccenlbcr:261. 1987.

Luyer. tl. A., ‘‘Microcomputer History and Prchistory-An Archueologictil Beginning, ’ Anncl/.Y

()/” tht~ Hi.~i(jr>’ ()/’ Cl)\ttpl{ti~l(q 1 l; 127. 1989.

Luzw-us, W.F. and Smith, T. I-l.. .’A&~ption of

Computers tind Consulting Su-\’ices by New York

DtiiD’ F:mmxs.’ J(mrIILIl (!/’D~~i\;\ .hiemv 7 I; I(j(j7,

1988.

Lcmmon, H .E., ‘ bCOMAX: An Expert System for

Crop Mantigcment. ’ S<-iellce 223:29-33. 1986.

Licpins, G.. Gocltz. R.. tind Rush. R.. b’Machine

Lc~irning Techniques t-or Nuturti] Resource Ihtu

.Anu]ysis, Al Applit “[lti(~n.~ ill Natl(ral Rc.~ol(rcc

Ivl(ln(i,qmen( 4(3):9. 1990.

Makclu. M. E.. Vins(ln. S. B.. tmd Stone. N. D..

‘‘ f+t)st-Pw-asitoid Pt)pulation Dynitmius in a Heterogeneous Enl’ir(Jnnlcnt. in Pr(M’. .$(x’. [’~)IHputcr Si\ttl{l[iti~)\t ,Mllltit{~\l/i~l.t’tl~[’ oil Art~/i~i[il

lit(clli,qctt~c (Ind .~inllll~iti(m: TiIc [~i~vr.~it> (){” Ap -

plitatio~t.$, Sun Diego. C,A. Feb. 3-5. 1988. pp .

n+~j~ .

Mm-an, L. R., ‘‘CPEAS: The Crop Production Expert Acl\iw}r S}’stcm. ’ Knowltxlge Bused Sjstenl\

Resciirch l.uborut~~r), Dcp:u-tment of Agronoml,

Univcr\it) t~t- lllim~is. Llrb:illu-Chai~lptiign, 1989.

Mw-cus. A. :md vun D:lnl. A., ‘ bUser lntcrfucc

Dciclopmcnts t’t)r the Nineties.’. IEEE C(N~/pI(tcr

Scptcmber:49. 1991.

Martin. G. L., “The Utilit~r of Spetch Input in UscrComputcr ln[crt-:lccs.. ltltt~)-ltil~iolltll J(NII-IW! @’M~(t~-

Machi}lc .7tl({iie~ 30:355, 1989.

h4cArthur. D., Kl~lhr, P.. and Narain, S., ROSS:

An Object-oriented Language for (lmstructing

Sinlul~it(ws. RLmd Ct~rp. R-3160-AF: 1984.

,M~.Grunn. J .iM.. Kurkt}sh. K., and F:dconcr. L..

A~ri~u]tur~l] Financiill Anulysis Expert S!’stcnls.

Texas A~!riuu]tur:l] Experiment Stution, ‘l-CXUS A&h4

(-,lni~~r~it~ . (’(~]lcgc St;ltion. TX. 1989.

McKinitm, J.ltl :Ind l.enlmtm. H. E.. ‘ Expert S~\-

65.

66.

67.

68.

69.

70.

71.

7~

73.

74.

75.

76.

77.

78.

79.

80.

terns for Agriculture, Computers und Electronics

in Agriculture I :3 1. 1985.

Michalski, R. S., b’Lem-ning by Being Told und

Learning From Examples: An Experimental Conlparison of’ the TWO Methods of Knowledge .Acquisition in the Context ot Dcvelt~ping tin Expert

System for Soybeun Disease Diagnosis. /ntermltiont{l J{~lIrnLIl ()/’ Poli~~” Anal~’.ji.s tIIId ln/i~rljI~IIion S~.\tem.\ 4: 125. 1980.

Michalski. R. S.. Curbonel]. J. G.. and Mitchell.

T. M.. kla~.hinc Ltvirnincq. AI1 Arti/i~i~~llntclli<gen~e

Appr(MIfh (Lt}s Altos, CA: Morgan Kuutr-mmn Publishers, Inc.). 1983.

Miles. G. E., ‘ ‘Robotics tind Intelligent Mtichines. commissioned b:wkground puper prepared for the Office of Technology Assessment.

Washington. DC. 1991.

Morris, D.T. and Asumu. [I. E.. “intelligent Natural Ltinyuagc Intcrt.ace for u Signal Processing

System. IEE P}-{)f([~tlitl,q.\ I 37(5):37 I. 1990.

M}kowiccka, A.. ‘ .Text Pl:mning-How T~J Make

Computers T~llk in Nutural-Language, ’ /iItcrIMtioni{l JOIII.11111 ~)[” l-liil~-kl~i~’llijje Studie.$ 34:575,

1991.

Newquist. H .P.. A Comprehensii’e Annual Report

on the Artificial Intel I igence Industry, DM Datu,

Inc., Scottsdtile, AZ, 1987.

Novuk, J.L. and Stcgelin, F.Ii.. “U.S. Fiirmer’s

Attitudes Toward Microcomputer Uses. ” C~Mnpllter.s and Electr{)ttic.~ in A,qri~llltllre ..3:81, 1991.

Olson. K. E., ‘‘Stitellitc Technt~logy-A Farm Orgtinization Perspective, J~)l(rnal {!/’ Daij-> .Y~icn~.c

74(supp. I ):290. 1991.

Oltenticu. PA., Fcrguson, J.Il., and Lcdnor, A. J.,

“A Data-Driven Expert System to Evaluate Management. En\rironnlentiil and Cow Fuctor lntluencing Reproducti\c Efficiency in Dairy Iierds.

Jol~rIlttl (!fDait;\ .~cietl~c 7.3( Supp. l): 145, 1990.

Oltlen, J. W. et al.. .9 Integrated Expert System for

Culling M:intigement t~t’ Beet COW’ S,’ Cfvlrplit~~r.\

attd Electr~~ni~.s ill A,qri~l{lturr 4:333, 1990.

Peacocke. R.D. and Grtif. D.H. “An Introduction

to Speech and Spei.ikcr Recognition, /EEL- C()/Ilputer August:26. 1990.

Petirl, J., ‘‘Rcast~ning Under Unccrttiinty.. AnnlIIIl

Re\’ic\\ of Cotttp[lter S~ictt~c 4:37, 1990.

Pickering, J .A.. ‘‘Touch-Scnsiti\e Scrccns: The

Tcchnolt~g} und Their Application. ” //?/i’/-/(ifJi?t/?t//

J(HII.IILI1 {!f”Mt~tl-hl[itltittt~ Stl{dic.s 25:249. 1986.

[~lckerlng. J. et ~11 ., “RAIN: A Novel Approuch to

Conlputer-Aided Decisitmmaking in Agriculture und

Forestr}’.. Cot)lp[(tcr.~ atd Ele~tr~)ni~j in A,qritl[ltllr(’ 4:275- 285. 1990.

Plunt. R. E., ‘‘An Integrated Expert System Decision Support S}stem for Agricultural System. A,y -

ricl!ltltr{ll .5)YttIIn.~ 29;49–66. 1989.

R:iuscher. 14 .N4. tind Jc~hns(~n. S., ‘ .Autht)ring Hy -
Chapter 4—Ad}7anced Computer Technologies ● 127

81.

82.

83.

84.

85.

86.

87.

88.

89.

90.

91.

()? .

93.

pcrtext Documents Using HypcrWriter. ’ Al Appli~[itit)tt,s in N(itiirtil Rc.~~)iIr~e IWLi II[itqCmCIIt

5(2): I 16. 1991.

Rotich. J. W. et al.. ‘‘POMME: A Computer-Btised

Consultation S}rstcm for Apple orchard Mwwgement Using PROLOG. E.rpcr[ .S)’stct)is 2(2 ):56–

69. 1985.

Swu-tmmtia. H. et al.. ..An Artiticitil lntclligcncc

Mt~delling Approach to Simultiting Animul Htibitut

lntertiutitms... E~olo(qi~[ilM() ~lt~llill<q” 44: 125.1988.

Suundcrs et u].. ‘‘GRAPES: An Expert S)stcm tor

Viticulture in Pcnnsjl\runia, ’ A/ App/i~(i[i(uis ill

N(iti{r(ii Rc.Yoiir(S(J A4[in[igc\tic}it I (2): 13-20. 1987.

Schmisseur. E. und Ptinkratz. J.. ‘X LAYER: An

Expert S>stcnl tor Lti~m Managcmcnt... Poi{/ti-\

Sticllte68: 10447. 1989.

Suhrcinemtikers. J.F. et al.. . ‘The Intr(xiuction of

Expert S}stcm\ in Animul Husbumir}. The \rc/-

crilifit~]’ Qii{irterl] i 0( -1 ):28 i. I 988.

Scars. A. and Shnciticrnum. B. ..liigh Precision

Touchscrceris: Design Strategies und Compurist~n\

With A Mouw. ’. lilt~’1.iititi~)il~il.Ioi{rtitil of” IVl~iII -

M(i(lli)te .Sti((lic.j 34:593. i 99 i .

Sequcir:i. R.A. et al.. . .Ob,lcct-oriented Simuliiti(~n: Pl:int Growth A Discrctc Org:in to (lytin

Intcrtict it~ns. Ectjl. Jl(dcllilt,q 58:55-89. i 99 i .

Shift-man. S. ct Lil.. . .13uilding :1 Spaxh intcrf’:iuc

to u Mcdiciil DiugntJstic S)stcm.. /h’E”L’ E“.I~wrl

Fcbruar)(:4 i. 1991.

Sht~rtlit’t’c, E.. 11.. Computer-ll:iwi Mtxiic.:il C~msult;iti(ms: MYC”IN. Amcricun Elsmricr. Nc\\ Y(wk.

i 976.

Smith. D.C. ct :ii.. .’Dc\igning the S’I”Ail L’wr

intcrt’acc.. BYTE 7:?-$2. 1982.

Sonk:i, S. T.. . .Expcrt S)\tcms t~~r Busincis Dcc ision M :ik in:.. ct~mnlisii(~nc~i b:ickgrt)lin(i p~ipcr

prepared t’(~r the (N’t’icc (~t” Tcchnd(lgy ASwS\mcnt.

I 99 i .

Spiihr. S. 1.., Jones. L. R.. :imi i~ill. D. E.. ‘. E\pcrt

Sy\tcm-Their Uw in [liiir~ 1 lcrci Nliin:igcmcnt ..

.Joi{rii[il of I)(iir> S’(i(’}1(() 7 I :879. 1988.

Storw. N. 1). ct :il.. ‘ .C~~tf]cx: A hf(xili[:i[” E\pcrt

S}stcnl thiit S~nthc\i/c\ Bi~~l(~yic:il iin(i Ec(~nt)nliC:II Aniilj\is: ‘l-hc f’cst hl LIn:igcnlcn( Ad\ iv)r A\ An

Exiinlplc.‘‘ i n Pr(jcct~[litig.$ (~/ IIic’ B1’ltliqii{() < ‘olloIi”

Pro[ii{~ti(j\i (iti(l fic.~c~ircII {’(~Ii/crctitc. N:it i(~n;tl

Cott(m Council of” Amcric:i. hlcmphi~. TN. 19X7.

94.

95.

%.

97.

98

99

i(M).

Ioi .

I 02.

103.

104.

i05.

106.

107.

Stone. N.1).. ‘‘Knowiedge-Based S>stcms tor

Crops, commissioned background paper prepared

for the otfice of Technology Assessment. U.S.

Congress, Washington. DC. i99i.

Stone, N. D.. b’Chat~s in an lndi\idual-Lc\ci Predator-Prey Model ..’ N(iti(r(il Rr.\oiircc M{)tieli}t<q

4(4): 539-553. iwo.

Sutciiffc. A.. Hi{tti~ilt-C’(~t ~il~i{tt’t. lntcrtii~c Dt)sicq}i

(New York. NY: Spririger-vcrltig NCW York. inc..

i989).

Taibot. M.. The M)th @Spw(h Ttdm(dogy, .YpwclI

[ind L[iII(qi{(i<qt’-B[i.~t’(l I}itcrtic tio}i,~ \\’itli hl~i~liille,~,

J.A. Wutcrww-th ~inci M. T:ilb(~t (cd\.). Ellis HorWIood. Chichcstcr. England. i 987.

Thiemc. R.H. et tii.. ‘ .Expcrt S)stem “techniques

Appiitxi To Grtiin M:irketing Anui}sis.. (’oi~)-

pi(tcr.s (iiId Elettr(}\iic”~ iii A,qrici(lliirc 1 :299. \ 987.

Tomaszcwski. M. A.. . ‘~i~c ~~f Expert S)stems in

Animtil Agricuiturc, uommiwioncd btickgrt}lind

ptipcr prcpurcci for the Office of” Tcchnt~lt~gy ,A\-

sessmcnt. I 9!) i .

Tomuszewski. M. A.. pcrson:il c(~lllll]llnic:itit~n. Sept.

i7. i99i .

‘r~rlcr. S.W. und Trcu. S.. . An intcrt’~icc Architecture To Pro\idc A~iiipti\c T:isk-Spccit’ic (“(mtcxt

for the Usci-. I}tt(’1.liii{it)tiiil .loiIrIitil of” I~l(iII-i\l(i-

[liiltc .~li(dic.~ 30:303”. i 989.

V:in H(~rn. Al.. [,lti(l(~l”.~t(iti(lijtq E.rperI .Y>.~[cIIi.~.

Banttim i30t~hs. Ncu Yoi+k. NY. i 986 .

Viirncr. M .A. iind C:iCi) . R. A., b.l)tiirj -L: ,4 New

Concept in Technology Trtin\t-cr i’(~r l-lxtcnsit~n...

.Ioi(rn(il ()/ ll[iir~ .%~ic}i~c 74( Supp. I ):20 i . I 99 I

Wtiin, N.. Iklilicr. C. D. F.. :imi lli~ri~. R. l}.. . ‘A

RuIc-B;IvA Inlkrencc Sjstcm l~)r Anim:il f%cduction Miinwymcnt. (.oi)tpi(lci.$ (in(l [llt’clrolli~~ ili

Acqri~i~lti{rc 2;277. i 988.

W;ildrop. M.M . . . A l.:incim:irk in Speech Rcut~gn it ion. .Sticii(c 2-I(): i 615. 1988.

Whittakcr. A.D. et :11.. . ‘Iliir) 1 {crci NLitritioniil

An~il~sis using Kmm Iccigc Sj’itcms “rCUhIll~LIC\.

A,qrici{ltiirtil .$].~tcjtl.~ 3 I :83. i 989.

W(N)cis. W.A. . . .Lun:ir R(~ch\ in N:itul”ti] Engliih:

Explorations in N:itur:ii i.linyu:i~c ~Licsti(m Ans ~+ c r I n g.” L illtq iii.~ t i~ .51ii(~ti(rt f>rf)ci~.~iliy. A .

Z~impt~lli (Mi. ) ( Ncm Yt~rk. NY: North-Hollund

p~l[l[lihlll,~ C(). . i 977). p. 52 I .

.-
Part II

Implications of New Technologies

for Agricultural Production
Chapter 5

Productivity Implications

of New Technologies
Contents

Page

TECHNOLOGY ADOPTION AND PRODUCTIVITY IMPACTS: NEW PROJECTIONS . . . . 133

Timing of Commercial Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

Primary Impacts . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Adoption Profiles . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

Projection of Animal and Crop Production Efficiencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

IMPACTS OF NEW TECHNOLOGIES ON THE STRUCTURE OF CROP AGRICULTURE 139

Large-Acreage Volume Crops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

Small Acreage Specialty Crops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

New Crops and New Uses of Existing Crops . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

IMPACTS OF NEW TECHNOLOGIES ON THE STRUCTURE OF ANIMAL

AGRICULTURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

Case Studies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 140

New Animal Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

IMPACT OF NEW TECHNOLOGIES ON AGRIBUSINESS, LABOR, AND RURAL

COMMUNITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

Agribusiness . . . . . . . . . . . . . .

Farm Labor . . . . . . . . . . . . . . .

Rural Communities . . . . . . .

POLICY ISSUES . . . . . . . . . . . .

Moratoriums on Agricultural

Technology . . . . . . . . . . . . .

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 144

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 147

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

Research or n he Implementation of New Agriculture

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 148

impacts of Emerging Technologies on Farm Size and Managerial Skill Requirements ..,.., 149

Displaced Farm Operators and Workers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Adjusting (o Change . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 149

Figure

Figure Page

5-1. Logistic Adoption Curves for Corn, Package A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 137

Tables

Table Page

5-1. Alternative Technology Scenarios . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 134

5-2. Timing of Commercial Introduction of Advancing Animal Technologies . . . . . . . . . . . . . . . . 135

5-3. Timing of Commercial introduction of Advancing Crop Technologies . . . . . . . . . . . . . . . . . . . 136

5-4. Estimates of Crop Yield and Animal Production Efficiency by 2000 . . . . . . . . . . . . . . . . . . . . 138

5-5. Projected Annual Rates of Growth (1990-2000) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 138

5-6. Summary Characteristics of Representative Moderate-Size and Large Dairy Farms, by

Region . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 142

5-7. Comparison of Average Annual Economic Payoffs From bST Adoption for Eight

Representative Dairy Farms Under Three Alternative Dairy Policies, 1989–98 . . . . . . . . . . 142

5-8. impacts of bST Adoption on the Economic Viability of Moderate-Size Representative

Farms, by Region, 1989–98 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

5-9. impacts of bST Adoption on the Economic Viability of Large Representative Farms, by

Region, 1989–98 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

5-10. Characteristics of Representative Moderate and Large Grain-Hog Farms in Missouri and

Indiana . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

5-11. Average Annual Net Cash Farm Income due to pST Adoption for Representative

Missouri and Indiana Hog Farms Under Alternative pST/Feed Response and Carcass

Merit Premium Assumptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146
Chapter 5

Productivity Implications of New Technologies

Technologies discussed in the preceding chapters have

the potential to increase American agricultural productivity, enhance the environment, improve food safety and

food quality, and help increase U.S. agricultural competitiveness. Many of these technologies are fast approaching commercialization. Research in crop agriculture

has advanced at a much faster pace than anticipated just

a few years ago. Much of the research is aimed at improving crop resistance to weeds, insects and diseases:

geoclimatic adaptation; and quality characteristics. In animal agriculture, new vaccines and diagnostics are on

the market or soon will be. Growth promotants are going

through the regulatory process. Reproduction technologies are advancing at a rapid pace and cloned embryos

are currently being marketed. Transgenics are still in the

future, but considerable strides are being made in the use

of livestock to produce high-value pharmaceuticals.

The advance of agricultural biotechnology and computer technologies will play an important role in increasing agricultural productivity and accelerating structural

change in agriculture. These technologies, however, are

not magic—a high degree of management skill will be

needed to capitalize fully on their potential benefits. It

will be important to develop management systems that

make the most effective use of these technologies. This

chapter and chapter 6 address these issues. In this chapter

the technologies’ impacts on productivity are analyzed

and implications for the agricultural industry are discussed. In the next chapter management issues will be

examined.

TECHNOLOGY ADOPTION AND

PRODUCTIVITY IMPACTS: NEW

PROJECTIONS

OTA conducted two workshops—one for animal agriculture and the other for crop agriculture—in part to

assess the impacts of these emerging technologies on

agricultural productivity. Workshop participants, carefully selected to include those with expertise in different

stages of technological innovation, included physical and

biological scientists. engineers, economists, extension

specialists, commodity specialists. representatives from

agribusiness and public interest groups, and experienced

farmers.

The workshop participants were provided state-of-theart papers on each technology prepared by leading scientists in the respective areas. These papers provided

data on: 1 ) timing of commercial introduction for each

technology area; 2) net yield increases (by commodity),

expected from the technologies; and 3) number of years

needed to reach various adoption rates (by commodity).

The Delphi technique’ was used to obtain collective judgments from each workshop participant on the development and adoption of the technologies.

Timing of Commercial Introduction

Workshop participants were asked to estimate the

probable year of commercial introduction of each technology under three alternative scenarios/environments

assumed to extend to the year 2000:

1.

2.

3.

Most likely scenario—a) a real rate of growth in

research and extension expenditures of 2 percent

per year, and b) continuation of all other forces

that have shaped past adoption of new technology.

More new technology scenario (relative to the most

likely scenario)—a) a real rate of growth in research and extension expenditures of 4 percent annually, and b) all other factors more favorable to

new technology adoption than those of the most

likely scenario.

Less new technology scenario (relative to the most

likely scenario) -a) no real rate of growth in research and extension expenditures, and b) all other

factors less favorable to new technology adoption

than those of the most likely scenario.

Table 5-l shows in more detail the sets of assumptions

made under the alternative scenarios. Table 5-2 shows

workshop participants’ estimates of the probable years

of commercial introduction of animal technologies, and

table 5-3 shows the same for crop technologies under the

three alternative scenarios.

-133-
Table 5-l—Alternative Technology Scenarios

More new Most likely Less new

Factors technology technology technology

Population growth rate

U.S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

GNP growth rate

U.S . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

World . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Trade policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Tax policy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Rate of growth of export demand

Grain . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Oilseeds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Red meat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Energy price growth rate (constant dollars) . . .

Growth rate of research and extension expenditures (constant dollars) . . . . . . . . . . . . . .

Inflation rate . . . . . . . . . . . . . . . . . . . . .

Regulatory environment . . . . . . . . . . . . . . . . . . . .

Consumer acceptance of new technology . . . .

1.0% 0.7%

1.8% 1.6%

4% 3.4%

5% 3.5%

Less protectionist, more Continuation of present

favorable terms of trade policy

More favorable toward Continuation of present

technology development policy

1.8% 1.4%

2.3% 1.8%

2.0% 1.0%

5% 3%

4% 2%

8% 5%

Less regulation, more fa- Continuation of present

vorable climate for tech- policy

nology development

High Moderate

SOURCE: Oftice of Technology Assessment 1992

These estimates range from the very near term for

genetically engineered growth promotants and animal

health technologies to 2000 and beyond for transgenic

animals and certain crops. Participants thought that many

of the advancing technologies may be available by the

mid- 1990s. Of the 41 potentially available animal technologies, 21 were estimated to be available by 1995 under

the most likely scenario. In crop agriculture, 19 of the

30 technologies examined were projected to be available

for commercial introduction by 1995.

Primary Impacts

When technologies are adopted on farm their immediate technical impact on crop agriculture is usually increased yields, a changed product characteristic, and/or

increased percentage of planted acreage harvested. For

animal agriculture the impact is on feed efficiency for

all animals, reproductive efficiency for beef cattle and

swine, milk production for dairy cows, and the number

of eggs per layer (producing hen) for poultry.

To estimate the net impact of emerging technologies

on agricultural production, workshop participants, using

information provided about the new technologies at the

meeting, projected net increases in crop yields, animal

feed efficiencies, and other performance measures that

0.5%

1 .3%

3.0%

2.0%

More protectionist, less favorable terms of trade

Less favorable toward

technology development

.8%

1 .2%

O.O%

1%

00/0

30/o

More regulation, less favorable climate for technology development

Low

could be expected if- the technologies were commercially

available and fully adopted by farmers ( i.e.. adopted by

all farmers). Since in practice most technologies would

be used in combination with other technologies (including existing technologies), the individual technologies

were grouped by the workshop participants according to

their probable impacts on particular commodities under

different scenarios. The commodities included corn. cotton, soybeans, wheat, beef cattle, dairy cattle, poultry,

and swine. Through a Delphi process. OTA obtained

estimates for each package of technologies on each of

the commodities under the three alternative scenarios.

Adoption Profiles

When a new technology is introduced into the marketplace, only a small number of farms, mostly the large

and innovative ones, will adopt the technology initially.

This is because the possible payoff of the new technology

is uncertain and because potential adopters need time to

learn how to use the new technology and evaluate its

worth. As early adopters benefit from using a new technology. more and more farmers are attracted to it, increasing the speed of adoption exponentially. Eventually.

as most farmers who will adopt a new technology do so,

the adoption rate will level off. Thus, the adoption profile

follows an S-shaped curve (2).
Chapter 5—Productivity Implications of New Technologies . 135

Table 5-2—Timing of Commercial Introduction of Advancing Animal Technologies

Technology scenarios

More new Most likely Less new

Technology technology technology technology

Somatotropins

Bovine:

Dairy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Beef . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Pork:

pas t . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

GRF . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Poultry:

Broilers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Turkeys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1991

1995

1991

1997

1991

2000

1995

1998

>2000

>2000

1995

1995

1995

1990

>2000

1995

>2000

1995

1995

1995

>2000

>2000

1990

1990

1990

>2000

>2000

>2000

>2000

>2000

>2000

>2000

>2000

>2000

2000

2000

>2000

1998

>2000

1991

1994

1992

1995

1998

1998

1991

2000

2000

Beta-agonists . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1992

Reproduction and embryo transfer

Control of ovarian functions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Separation of X&Y bearing sperm . . . . . . . . . . . . . . . . . . . . . . . . . . .

In vitro fertilization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Embryo sexing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cloning and nuclear transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Gene transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1993

1992

1990

1998

1993

2000

1995

1995

1990

2000

1995

>2000

Animal health

rDNA technology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Gene deletion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Monoclinal antibodies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Peptides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Immunomodulators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1993

1995

1995

1996

1996

1990

1991

1991

1991

1994

1994

Antibiotic growth promotants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1990

Steroid-like growth promotants

Estrogen/androgen combinations . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Controlled/sustained release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1990

1990

1990

1990

Transgenic

Ruminants:

Hormonally enhanced growth . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Pharmaceutical production . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Enhanced disease resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2000

2000

2000

>2000

>2000

2000

Poultry . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ‘>2000 >2000

Swine:

Improved productivity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Disease resistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Disease immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

2000 >2000

>2000

>2000

2000

2000

Fish:

Rapid growth... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Disease resistant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1995

1995

1992

2000

>2000

Expert systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1995

Human-computer interactions

Add-on systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Integrated systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1992

1995

1995

2000

Sensor technology/robotics

Reproduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Health, . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Stress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Carcass evaluation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Milking system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1992 1995

1995

1998

1992

1994

2000

>2000

1995

1995

>2000

1998

1998

>2000

2000

>2000

1996

Environment and animal behavior

Optimizing environmental stimuli . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Stress and immunity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cognitive processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Facilities and equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1992

1993

1995

1992

1995

1995

2000

1994

SOURCE Office of Technology Assessment 1992
136 ● A New Technological Era for American Agriculture

Table 5-3-Timing of Commercial Introduction of Advancing Crop Technologies

Technology scenarios

More new Most likely Less new

Technology/problem area technology technology technology

Pest control

Pathogens for insect control:

rDNA - microbial insecticides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Introduction and colonization/rDNA . . . . . . . . . . . . . . . . . . . . . . . .

Use of parasites/predators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Genetic modification for resistance to insects:

Bacteria . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Viruses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Insect and mite management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Weed control

Biocontrol for weeds:

Host specific pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Bioherbicides . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Anthropoids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Genetic modification for weed control

Herbicide tolerance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Allelopathy . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Disease control

Microbial biocontrol of plant diseases:

Manipulation of resident microbial communities . . . . . . . . . . . . .

Antagonistic organisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Genetic modification for disease resistance . . . . . . . . . . . . . . . . . . .

Disease management:

Crop loss assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cropping system/agroecosystem interaction . . . . . . . . . . . . . . . .

Plant stress

Temperature and water stress:

Biochemical/physiological indicators . . . . . . . . . . . . . . . . . . . . . . .

Genetic modification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Root responses to stress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Detection of stress . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Information technology

Knowledge-based systems for crops:

Farm-level planning systems . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Information networks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Expert systems for business decisionmaking . . . . . . . . . . . . . . . . . .

Networks/telecommunications:

Commercializing public databases . . . . . . . . . . . . . . . . . . . . . . . . .

Private databases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Commercializing public software . . . . . . . . . . . . . . . . . . . . . . . . . . .

Private software . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Robotics:

Plant materials sensing/handling . . . . . . . . . . . . . . . . . . . . . . . . . .

Machine guidance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1993

1998

1998

1992

1993

1995

1990

1995

1991

1997

1993

>2000

1993

1993

1995

1991

1990

1995

2000

2000

1991

1991

1993

1990

1992

1992

1992

1992

1993

1994

1995

>2000

>2000

1995

1995

1998

1990

1998

1995

2000

1995

>2000

1997

1997

2000

1995

1990

2000

2000

2000

1995

1993

1995

1990

1995

1995

1995

1995

1995

1997

SOURCE: Office of Technology Assessment, 1992.

>2000

>2000

>2000

>2000

>2000

>2000

1990

>2000

>2000

>2000

2000

>2000

>2000

>2000

>2000

2000

1990

>2000

>2000

>2000

2000

1998

2000

1990

2000

2000

2000

2000

1998

>2000

Many factors go into the decision to adopt a new tech- market segment is difficult to estimate, but it will probnology. A factor of growing importance is the ratio of ably support some producers who do not adopt hormones.

consumer acceptance to rejection of a new technology.

For example, it is likely that a portion of the population Other biotechnology products, suchas improved diswill prefer to purchase products that have been produced ease vaccines. most likely can be implemented effecwithout the use of growth hormones. The size of this tively by most producers and will have fewer new
Chapter 5—Prouctivity Implications of New Technologies ● 137

Figure 5-l—Logistic Adoption Curves for Corn,

Package A

0 2 4 6 8 10 12 14 16 18 20 22 24

Years from introduction date

— More-new-technology — -- Less-new-technology

soenario Soenario

— — Most likely soenario

SOURCE” Off Ice of Technology Assessment

management requirements than recombinant somatotropins. The extent to which such innovations are commercialized and adopted will depend on their profitability

and effectiveness compared to that of other available

technologies.

To derive an adoption profile for each package of

technologies under different scenarios, workshop participants were divided by expertise into commodity groups.

There were four groups in the animal technology workshop (beef, dairy, poultry, and swine) and four in the

crop technology workshop (corn, cotton, soybeans, and

wheat). The participants were then asked the question,

‘ ‘If a specific package of technologies was introduced in

the market today, how long would it take for farmers to

adopt it’?’ Based on their answers, a logistic curve depicting the rate of adoption was fitted for each package

of technologies applied to the eight commodities under

different scenarios (see example in figure 5-1).

Projection of Animal and Crop Production

Efficiencies

Based on information obtained from the workshops

on: I ) years to commercial introduction, 2) primary impacts by technology package, and 3) adoption profile,

OTA computed ‘‘performance measurements” for the

eight commodity areas by the year 2000 under alternative

scenarios. The results are presented in tables Table 5-4

and 5-5.

Under the most likely scenario, feed efficiency in livestock production will increase at an annual rate of from

0.39 percent for dairy to 1.62 percent for swine. In addition. reproduction efficiency will also increase, at an

annual rate ranging from 0.67 percent for beef cattle. to

1.25 percent for swine. Milk production per cow per year

will increase at 3.01 percent per year. from 14,200 pounds

to 19,200 pounds per cow, in the period 1990–2000.

During the same period, major crop yields are estimated to increase at rates ranging from 0.39 percent per

year for soybeans to 2.02 percent for wheat. Wheat yield,

for example, is projected to increase from 34.8 bushels

per acre to more than 42 bushels per acre in 2000 under

the most likely scenario.

How do these rates of increase compare with historical

trends and with OTA’s last projections (8)? The most

dramatic productivity increase is in milk production with

a 3-percent annual rate of growth. Since 1960. the annual

rate of growth has been about 2.5 percent. However,

OTA’s 1985 projection (24,200 pounds of milk per cow

by 2000) was higher than its current one ( 19.200 pounds

of milk per cow by 2000). A major reason for this discrepancy is the delay in marketing of bovine somatotropin. In 1985 it was predicted to be commercially available

in 1987. As of early 1992 it has yet to be approved. In

addition, the high milk yields projected in 1985 were

revised downward in 1990 as more knowledge about the

bST technology became available through additional research.

Further increases in feed efficiency in livestock will

lag behind historical trends in some cases and surpass

these trends in others. Poultry feed efficiency has been

increasing at about 1.2 percent per year for the past

decade. This has resulted in making the chicken an extremely efficient converter of feed to meat. Further increases in feed efficiency will be difficult. Feed efficiency

will continue to increase at 0.5 percent per year to 2000

under the most likely scenario. Feed efficiencies for beef

and swine, on the other hand, have been static for the

last decade. New technologies will increase feed efficiencies. Under the most likely scenario. feed efficiency

for beef is projected to increase at an annual rate of 0.74

percent, reaching 0.154 pounds of beef per pound of feed

in 2000; feed efficiency for swine will increase at the

rate of 1.62 percent per year, reaching O. 18 pounds of
138 ● A New Technological Era for American Agriculture

Table 5-4—Estimates of Crop Yield and Animal Production Efficiency by 2000

Less new Most likely More new

Actual technology technology technology

1990 2000 2000 2000

Crops

Corn—bu/acre . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cotton-lb/acre . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Soybeans—bu/acre . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Wheat—bu/acre . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Beef

Lbs meat/lb feed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Calves/100 cows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Dairy

Lbs milk/lb feed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Lbs.milk/cow/year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Poultry

Lbs meat/lb feed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Eggs/layer/year. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Swine

Lbs meat/lb feed . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Pigs/sow/year . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

116,2

600.0

32.4

34.8

0.143

90.0

1.010

14,200.0

0.370

250.0

0.154

13.900

113.8

NA

32.6

37.7

0.146

93.750

1.030

17,247.200

0.373

250.500

0.174

14.420

128.5

708.0

33.7

42.6

0.154

96.221

1.050

19,191.600

0.389

258.0

0.181

15.750

141.6

NA

36.4

53.8

0.169

102.455

1.057

20,498.800

0.428

273.125

0.196

17.791

NOTE” OTA expresses its appreciation to Yao-chi Lu and Phil Calling, Agriculture Research Service, U.S. Department of Agriculture for their assistance

in deriving the estimates for this table.

NA = Not available.

SOURCE: Office of Technology Assessment, 1992.

Table 5-5—Projected Annual Rates of Growth

(1990-2000)

Less new Most likely More new

technology technology technology

Corn –0.21% 1.00% 1.97%

Cotton NA 1,66 NA

Soybeans 0.06 0.39 1,16

Wheat 0.80 2.02 4,36

Beef

Lbs meat/feed . . . 0.21 0.74 1.67

Calves/cow . . . . . 0.41 0.67 1.30

Dairy

Lbs milk/feed . . . . 0.20 0.39 0.46

Milk/cow/year . . . 1.94 3.01 3.67

Poultry

Lbs meat/feed.. . 0.08 0.51 1.46

Eggs/lay/year . . . 0.02 0.32 0.89

Swine

Lbs meat/feed.. . 1.22 1.62 2.41

Pigs/sow/year . . . 0.37 1.25 2.47

NOTE: OTA expresses its appreciation to Yao-chi Lu and Phil Coiling,

Agriculture Research Service, U.S. Department of Agriculture, for their

assistance in deriving the estimates for twistable.

NA = Not available.

SOURCE: Office of Technology Assessment, 1992.

pork per pound of feed in 2000. OTA made the same

projection in 1985.

Efficiencies in crop production will about match historical trends or climb slightly, and for the most part will

exceed OTA’s 1985 projections. This, in part, reflects

the movement of many of the new technologies from the

laboratory to the field at a much quicker pace than thought

possible in the mid-80s. For example, in 1985 OTA

projected wheat yields to increase at an annual rate of

1.2 percent under the most likely scenario. In the early

1990s they are projected to increase at a rate of 2 percent

to the year 2000. Cotton was expected to increase at an

annual rate of 0.7 percent in the mid-80s, but now is

projected to increase at a rate of 1.66 percent to the year

2000. Soybeans are the exception. They were projected

to increase at a rate of 1.2 percent in the mid-80s but

now are projected to increase at the more modest rate of

0.39 percent, in part because biotechnology products are

projected to become available to the soybean industry

more slowly than previously thought. Note that corn is

expected to decline from actual 1990 yield under the lessnew technology scenario. This is due, in part, to the

anticipated loss of existing chemical technologies and a

very slow rate of new biological technologies to replace

them.

Even though annual rates of growth in many agricultural products may accelerate during the 90s. the absolute
quantity of yields will, for the most part, be lower than

projected in the mid-80s. This is due, in part. to the fact

that many of the early biotechnology inputs will be substitutes for chemical inputs and, hence, the absolute gain

in productive efficiency will in many cases be negligible.

This is expected to improve in the latter part of the decade

as more is learncd about the genetic makeup of plants.

IMPACTS OF NEW

TECHNOLOGIES ON THE

STRUCTURE OF CROP

AGRICULTURE

Production agricultural commodities generally fit into

two categories: large-acreage volume crops. such as wheat,

corn. and soybeans: and less volume small-acreage specialty crops, such as tomatoes, potatoes, and onions.

There are several important distinctions between the two

categories.

First. there is less verticul integration of input, production, and marketing stages for large-acreage volume

crops than for some small-acreage specialty crops. Second. the potential market for new technologies is much

greater for large acreage crops than for specialty crops.

This is an important driving force in terms of technoigical innovations. Third, biotechnology processes are

already available to alter the harvestable component of

some specialty crops such as tomatoes. This is due. in

large part. to the fact that many specialty crops are easier

to manipulate genetically than food and feed grain crops.

Such developments are for the most part further away

for the major food and feed grain crops (5).

Large-Acreage Volume Crops

As discussed in chapter 2, biotechnology i.implications

such as herbicide resistant plants and biopesticides should

be available in the near future. Unlike previous mechanical technologies. most biotechnologies will not, in themselves. generate significant economies of size. Also. there

appears to be lttlc incentive for firms supplying seed

and chemical inputs to expand vertically into crop production. Biotechnololgies that increase yield will have

supply-increasing, price-dampening effects. These will

adversely affect the survival of high-cost producers. which

for the most part are small to moderate-size farm operations.

Small-Acreage Specialty Crops

As indicated in chapter 2, biotechnology already has

the capability to modify the harvestable product for some

Photo credit’ Grant He//man, Inc.

Advancing technologies will have supply-increasing,

price-dampening effects on large-acreage volume crops

such as wheat. This will adversely affect high-cost

farming operations.

specialty crops. This capability will increase the extent

to which processes specify product quality. It will also

provide an incentive for vertical coordination between

production inputs and the production and processing stages

for a number of specialty crops. Thus, even though there

are no obvious economies of size to be captured with

biotechnology innovations, these innovations will facilitate vertical coordination in some cases. Small producers

will be at a competitive disadvantage in specialty crops

markets unless they have a particular market niche (5).

For fruits and vegetables, biotechnologies will be important where product quality, shelf life, and taste are

important characteristics. Technologies that allow for

greater selectivity in specifying performance characteristics of different crop varieties will allow more rapid

development of desirable cultivars and much more rapid

propagation of plant stocks. Markets for tomatoes, let-
140 . A New Technological Era for American Agriculture

tuce, and carrots are large and relatively focused on a

few specific varieties. Improvements in these crops have

the potential for rapid and widespread adoption to the

benefit of growers, plant stock breeders, and consumers.

There will be significant price differentials connected to

biotechnology-based improvements and consumers can

expect to pay higher prices for products more tailored to

specific segments of the market.

New Crops and New Uses of Existing Crops

Biotechnology offers great potential for developing

new crops and/or modifying existing crops for food, feed,

and industrial uses. Examples include the modification

of seed composition of corn and soybeans.

Industrial use of corn for glucose, dextrose, starch,

and alcohol has expanded rapidly, and biotechnology

offers the capability to modify the protein, starch, and

oil content of grain. Currently in the United States, approximately 3 percent of corn acreage is planted to special-use hybrids such as white corn for corn meal and

grits, waxy corn for use as thickeners in the food industry,

and hard yellow corn for snack chips. The other 97 percent is sold under the broad market classification of No.

2 yellow corn, without measurement of protein, starch,

or other quality characteristics (6).

For it to be economically feasible for farmers to grow

products such as special-use corn hybrids, they must be

able to capture price-premium incentives for these products. The current marketing system cannot easily accommodate new market channels for special varieties. It is

expected that direct contracting between processors and

growers will play an important role in the market development and growth of special-use products.

The above example for corn hybrids suggests the likely

pattern for marketing of other special-use crops. Where

specialty market niches are small, incentives for a high

degree of vertical integration in production and marketing

will be substantial. This will limit the production opportunities for most independent producers (5).

IMPACTS OF NEW

TECHNOLOGIES ON THE

STRUCTURE OF ANIMAL

AGRICULTURE

The U.S. livestock industry is divided into two components. One is increasingly space-concentrated, higher

technology, and intensively managed. This component

includes specialized cattle feedlots, broiler and swine

production under confinement, and some large, highly

specialized dry-lot dairy operations. A second component

is the range livestock sector, which includes a large number of beef cow-calf operations along with a variety of

small, lower technology livestock farms, many of which

are operated by part-time farmers.

A number of biotechnology applications is expected

to have rather high adoption rates within the higher technology component of the livestock sector, compared to

the lower technology, spatially dispersed sector. This is

due, in large part, to the fact that increased managerial

expertise is needed to use these new technologies effectively; such expertise tends to be associated with confinement systems.

Growth promotants will be the first major biotechnology products to be made available to U.S. agriculture.

The dairy and pork sectors will be the first to make use

of these technologies.

Case Studies

Dairy Sector

The dairy industry will most likely be the first to adopt

technologies from the biotechnology era of the 1990s,
Chapter 5—Productivity Implications of New Technologies ● 141

Photo credit: Grant Heilman, Inc.

In the dairy industry the trend toward fewer and larger farms has been on-going for decades. The trend will accelerate as a

result of new cost-reducing technologies

and also will feel the first profound impacts of the emerging technologies. Biotechnology advances in reproductive technologies. animal health technologies, and growth

promotants will make major contributions to the sector.

In particular, bovine somatotropin (bST), a growth promotant, will significantly increase milk production. Bovine

somatotropin is a naturally occurring hormone that increases milk yield in the dairy cow. Its effect has been

known for decades but until it could be produced by

rDNA procedures, it was not economically viable. This

technology will increase milk yield per cow in 1 year to

what it would take 10 to 20 years to achieve with current

reproductive technologies (7).

The economic effects of these emerging technologies

can be visualized by analyzing the impacts on different

sized farms in different regions. Representative farms

used in the analysis are briefly described in table 5-6.

Once bST becomes available, strong incentives will exist

to adopt the technology. Payoffs from bST adoption are

substantial, regardless of region (see table 5-7). Nonadopters of bST will have more problems surviving and

will be more likely to exit the industry.

Regional shifts in milk production patterns are expected for several reasons (tables 5-8 and 5-9). Upper

Midwest farms have problems realizing sufficient earnand a more market-oriented dairy policy.

ings to achieve a reasonable return on equity, compete.

and survive. While Northeast farms fare better, they too

were found to be at a disadvantage relative to Pacific

and Southeast farms. In all regions, adoption of bST

increases the potential to survive, especially for larger

farms.

Concern that bST will force many dairy farms out

of the industry, especially in the traditional milk-producing region of the Upper Midwest and Northeast,

has helped make this new technology the center of

controversy. BST alone, however, will not force these

traditional farms out of existence. The trend toward

fewer total cows and larger farms has been underway

for many decades. This trend is the result of a combination of emerging technology. economies of size,

and policy. The trend will no doubt accelerate in the

1990s as the result of a combination of bST and other

cost-reducing technologies, and a more market-oriented dairy policy. Such changes inherently put increased pressure on smaller traditional dairy farms.

These pressures are accentuated by technological change

but they are not new. For a more extensive discussion

and analyses of these trends see the OTA report entitled

U.S. Dairy Industry at a Crossroad: Biotechnology

and Policy Choices.
142 . A New echnological Era for American Agriculture

Table 5-6—Summary Characteristics of Representative Moderate-Size and Large Dairy Farms, by Region

Upper Midwest Northeast Southwesta Southeast

Characteristic Moderate Large Moderate Large Moderate Large Moderate Large

Cow numbers . . . . . . . . . . . . . . 52 125 52 200 350 1,500 200 1,500

Output/cow (pounds) . . . . . . . . 16,850 16,850 17,940 17,830 18,590 19,690 15,340 15,310

Total asset value ($000) . . . . . 470 940 608 1,395 1,097 3,858 1,569 7,723

Land value ($000) . . . . . . . . . . 133 295 274 640 118 492 813 4,591

Percent of feed raised . . . . . . . 63 60 50 46 0 0 25 2

a

lncludes farms from both the Pacific and Mountain USDA production regions

SOURCE: Office of Technology Assessment, 1992.

Table 5-7—Comparison of Average Annual

Economic Payoffs From bST Adoption for Eight

Representative Dairy Farms Under Three Alternative

Dairy Policies, 1989-98a

(thousand $)

Policyscenarios

Trigger b

Fixedc

Region size price support Quotad

Lake States:

Moderate , . . . . . . . . . . . 3.9

Large . . . . . . . . . . . . . . . . 10.3

Northeast:

Moderate . . . . . . . . . . . . . 3.4

Large . . . . . . . . . . . . . . . . 15.8

Southwest:

Moderate . . . . . . . . . . . . . 26.5

Large . . . . . . . . . . . . . . . . 90.5

Southeast:

Moderate . . . . . . . . . . . . . 21.9

Large . . . . . . . . . . . . . . . . 166.4

4.1

10.9

3.6

16.6

26.6

91.7

22.8

166.3

2.4

7.0

1.0

8.8

18.3

61.2

17.2

132.0

aEconomlc payoffs from bST are the average annual change in net cash

farm income between a nonadopter and a bST adopter over the 1989 to

1998 planning horizon. The payoff is net of the cost of bST, the added

transportation costs for milk, and the additional feed.

b

This option triggers a price support reduction each time the level of government purchases of milk products exceeds 5.0 billion pounds annually.

c

This option fixes the price support level at $10.60 per cwt. for all years.

‘The quota policy is designed to maintain government purchases at or

near a minimum government use target. This is accomplished by reducing

the number of cows in a herd through a two-tiered pricing system or some

other mechanism that provides disincentives for producing over quota levels.

SOURCE: Office of Technology Assessment, 1992

Swine Sector

As with the dairy industry, the swine sector will

benefit from biotechnology improvements in the areas

of reproduction, health, and growth promotants. Porcine somatotropin (pST), a growth promotant, will be

one of the first technologies from the biotechnology

era for the swine industry. Porcine somatotropin is a

naturally occurring hormone in swine that accelerates

the rate of growth, increases feed efficiency, and produces leaner hogs. Although the effects of pST on

feeder hogs has been known for many years, it was

not used commercially because of lack of availability.

The ability to produce recombinant pST has heightened

interest in using the product on commercial hog farms.

Porcine somatotropin research has shown that it increases feed efficiency by as much as 40 percent, reduces fat by as much as 30 percent, and increases

growth rate by as much as 33 percent. (See ch. 3.)

The economic benefits of pST can be discussed by

analyzing representative hog producers in the Midwest

who adopt pST, and the costs to producers who do not

adopt pST. An economic model was used to simulate

the economic viability of two Missouri grain-hog farms

(75 and 225 sows) and two Indiana grain-hog farms (150

and 600 sows) before and after the introduction of pST.

The Missouri and Indiana hog farms represent two different types of Midwest hog farms. The Missouri farms

raise fewer pigs per sow, in part. because their operations

are not total confinement operations like those representative of Indiana (table 5- 10). All the farms represent

high-level management by progressive. full-time farmers

intent on producing hogs efficiently with the best resources at their disposal. The farms were assumed to

adopt pST on its introduction ( 1992) or not adopt it over

the 6-year planning horizon (3).

Two pST/feed response scenarios were evaluated. The

first represented the average gains from pST, i.e., 25.1-

percent improvement in feed efficiency and a 12.7-percent increase in average daily gain. The second scenario

assumed a more optimistic pST/feed response, a 34.8-

percent improvement in feed efficiency and a 33.3 percent increase in average daily gain. In recognition of the

reduced fat to lean reported for pST-treated hogs, a 5-

percent price premium for market hogs was analyzed.

This 5-percent carcass merit premium is within the range

suggested in the literature.

Results of the analysis indicate that farms that do not

adopt pST will experience lower annual net cash farm
Table 5-8—Impacts of bST Adoption on the Economic Viability of Moderate-Size Representative Farms, by

Region, 1989-98 (in percent)a

52-cow 52-cow 350-COW 200-COW

Upper Midwest Northeast Southwest Southeast

Measure Non- bST Non- bST Non- bST Non- bST

of impact adopter adopter adopter adopter adopter adopter adopter adopter

Probability of survivalb 

. . . 580/0 740/o 100”/0 100”/0 95% 97% 100”/0 1 000/0

Probability of earning 5-

percent return on

equity . . . . . . . . . . . . . . . 58 74 100 100 95 97 100 100

Probability of increasing

equityc 

. . . . . . . . . . . . . . 0 0 3 3 60 79 13 24

Present value of ending

net worth as percent of

beginning net worthd 

. . 16 29 72 77 109 128 76 89

a

The analysis used a trigger-price dairy policy.

bChance that the individual farm will remain solvent through 1998, i.e., maintain more than a 10-percent equity in the farm cChance that the individual farm WiII increase its net worth m real 1989 dollars through 1998.

‘Present value of ending net worth divided by initial net worth indicates whether the farm increased (decreased) net worth in real dollars

SOURCE: Off Ice of Technology Assessment, 1992.

Table 5-9—impacts of bST Adoption on the Economic Viability of Large Representative Farms, by Region,

1989-98a (in percent)

125-cow 200-COW 1 ,500-COW 1 ,500-COW

Upper Midwest Northeast Southwest Southeast

Non- bST Non- bST Non- bST Non- bST

Measure of impact adopter adopter adopter adopter adopter adopter adopter adopter

Probability of survivalb 

. . . 95°/0 99% 100”/0 100”/0 100”/0 100”/0 100”/0 100”/0

Probability of earning 5-

percent return on

equity . . . . . . . . . . . . . . . 90 95 99 100 100 100 100 100

Probability of increasing

equityc 

. . . . . . . . . . . . . . 8 12 43 53 100 100 88 99

Present value of ending

net worth as percent of

beginning net wort h

d . 5 7 69 92 102 195 214 129 147

a

The analysis used a trigger-pnce dairy policy

bChance that the individual farm will remain solvent through 1998, I e , maaintain more than a 10-percent equity in the farm.

cChance that the farm WiII increase its net worth in real 1989 dollars through 1998.

‘Present value of ending net worth divided by initial net worth indicates whether the farm increased (decreased) net worth in real dollars.

SOURCE: Office of Technology Assessment, 1992

incomes (ranging from $13 to $33 per sow) due to lower

hog prices (table 5-1 l). (The lower hog prices are due

to the increased supply of meat caused by the availability

of pST. ) This range of lost income is about the same

across the four farms analyzed because it is a direct result

of lower hog prices. For pST adopters this loss is more

than offset by a 5-percent carcass merit premium for a

leaner carcass. Increases range from $110 to $134 per

sow (table 5-1 l).

Increasing the feed efficiency and average daily gain

from pST to the more optimistic feed response scenario

more than doubles the economic payoffs to adoption.

Without the carcass merit premium, the economic payoffs for pST average $265 per sow per year, more than

double the $100 spent for pST.2 If the producers can

garner a 5-percent carcass merit premium, the per sow

returns to pST adoption to a total of about $370 per sow

per year.

‘The pST figure aswmcs that pST costs $6 per pig and ii tidmlnl~tcrmf w cchly for 6 weeks. The balance of the cxwt IS xfdtxf Itihor and t’ccd

C(YJS.
144 . A New Technological Era for American Agriculture

Photo credit: Grant Heilman, Inc.

Production of lean meat with porcine somatotropin (pST)

will give meat packers a strong incentive to vertically

integrate or contract with farmers. Economic pressures

will be strong for most swine producers to either adopt

pST or to exit the industry.

The economic payoffs of pST adoption are about the

same regardless of farm size. For example, the moderatesize Missouri farm’s per-sow payoff is within 10 percent

of that for the larger Indiana farm. And, the difference

in payoffs between the 150-SOW Indiana farm and the

600-sow Indiana farm are within $18 per sow. These

results suggest that pST could be scale neutral.

Nevertheless, pST could accelerate the concentration

of the U.S. swine industry. PST adoption increases the

total income of large-scale farms more than that of smaller

scale farms due to the sheer volume of hogs produced

on the large farms. For example, pST increases average

annual net cash income $232,000 for the large Indiana

farm and only $57.000 for the moderate-size Indiana

farm. Thus, the large farm gains an internal source of

capital for future growth far in excess of what the smaller

farm gains. In addition, the smaller farms may experience

lower average pST/feed response due to lower management skills while the larger farm experiences a higher

than average pST/feed response and a 5-percent carcass

merit premium. This results in the moderate farm’s average annual returns to pST in the $3,300 to $18,500

per-year range while the large farm receives $232,000

or more per year.

PST may therefore contribute to a significant restructuring of the swine production sector. The production of

more lean meat will give meat packers a strong incentive

to vertically integrate or contract with producers and possibly pST suppliers. The economic pressures will be strong

for most swine producers to either adopt this new technology once it becomes available or to exit the industry.

New Animal Products

Biotechnology methods capable of producing transgenic animals may alter the use of these animals from

food to pharmaceuticals. Attempts are “being made to

produce rare, medically important proteins in pigs. Production of blood-clotting factors and tissue plasminogen

activator (used to dissolve blood clots that cause heart

attacks) are being investigated. A private firm has announced that it has successfully produced human hemoglobin in pigs. A blood-clotting agent has been

transferred to and expressed in sheep. Transgenic cows

producing pharmaceuticals have not yet been reported,

but these animals are under development in a number of

public and private laboratories. If successful, the production of pharmaceuticals will open new markets for

livestock. Incentives will be in place for pharmaceutical

companies to vertically integrate or contract with farmers

for the production of pharmaceuticals from livestock.

Capital costs for breeding stock is most likely to be quite

high indicating that successful, large farms are most likely

to meet this new market demand.

IMPACT OF NEW

TECHNOLOGIES ON

AGRIBUSINESS, LABOR, AND

RURAL COMMUNITIES

Agribusiness

Advancing products of biotechnology and information

technology will have major impacts on agribusiness (input suppliers, processors, wholesalers, etc. ). Historically. the commodity-oriented agribusiness sector has

been driven by economic forces to produce at maximum

efficiency and maintain low costs. This has resulted in

a system that is remarkably effective at converting un-
Chapter 5—Productivity Implications of New Technologies . 145

Table 5-10—Characteristics of Representative Moderate and Large Grain-Hog Farms in Missouri and Indiana

Missouri Indiana

Moderatea

Large Moderate Large

Hog Enterprise

sows . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Boars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Gilts (repI.) . . . . . . . . . . . . . . . . . . . . . . . . . .

Pigs raised/sow/year . . . . . . . . . . . . . . . . .

Gilts sold/year . . . . . . . . . . . . . . . . . . . . . . .

Borrows sold/year . . . . . . . . . . . . . . . . . . .

Sale weight . . . . . . . . . . . . . . . . . . . . . . . . .

Lbs. feed/lb. gain . . . . . . . . . . . . . . . . . . . .

Assets ($1,000)

Land . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Buildings . . . . . . . . . . . . . . . . . . . . . . . . . . .

Machinery . . . . . . . . . . . . . . . . . . . . . . . . . .

Livestock . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other Assets . . . . . . . . . . . . . . . . . . . . . . . .

Total . . . . . . . . . . . . . . . . . . . . . . . . . . .

Liabilities ($l,OOO)b

Real estate . . . . . . . . . . . . . . . . . . . . . . . . .

Intermediate Assets . . . . . . . . . . . . . . . . . .

Other . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total . . . . . . . . . . . . . . . . . . . . . . . . . . .

Net Worth ($l,OOO) . . . . . . . . . . . . . . . . . .

Acreage

Owned . . . . . . . . . . . . . . . . . . . . . . . . . . .

Leased . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Crops produced (acres)c

Corn . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Soybeans . . . . . . . . . . . . . . . . . . . . . . . . .

Wheat . . . . . . . . . . . . . . . . . . . . . . . . . . . .

75

6

32

15.68

556

588

240

3.875

232.0

70.0

86.5

34.4

0

422.9

30.2

24.2

20.8

75.2

347.7

220

110

330

144

80

76

225

10

100

15.68

,664

,764

240

3.787

520.0

175,0

289.1

65.7

0

1,049.8

69.5

70.9

54.8

195.2

854.3

520

500

1,020

300

333

316

150

10

90

17.00

1,185

1,275

240

3.763

630.0

120.0

280.2

49.9

0

1,080.1

75.0

66.0

70.6

211.6

868.5

280

520

800

540

175

24

600

30

245

18.00

5,155

5,400

250

3.299

2,475.0

500.0

834.3

158.6

0

3,967.9

297.5

198.6

40.6

536.7

3,431.2

1,125

1,125

2,250

1,800

400

50

a The moderate size Missouri hog farm also has 25 cows on 100 acres of pasture.

b Liabilites are reported assuming the farm has 10-percent debt on real estate assets and 20-percent debt on machinery and livestock.

cAcreage of crops represents actual planted acreage in 1990 after accounting for set aside. All farms except the large lndiana farm participated in the farm

program

SOURCE: Office of Technology Assessment 1992

differentiated commodities into relatively low cost food.

Today this sector is undergoing change inspired in part

by the evolution of a more demanding and differentiated

food consumer. In response, retailer strategies have

emerged which focus on improving service to the end

consumer. Information technology has facilitated the

shifting of marketing efforts toward the discovery of consumer preferences. Information technology along with

legal disclosure requirements have made it easier for the

consumer to see a wider range of product attributes.

Where buying decisions were once made on such aspects

as variety, convenience, price stability, and value, now

consumers can also evaluate additional characteristics

that were previously experienced only indirectly, such

as product quality, nutrition, food safety, and environmental aspects (4).

To respond to a more consumer-oriented environment,

input suppliers may need to explore how information technology can facilitate the coordination activities needed to

assure particular attributes. In the future information technologies may facilitate new business strategies by providing

improved information flows and by facilitating coordination

of production and marketing activities. For example, Pioneer’s Better Life Grains and Frito-Lay’s Frito Corn Chips

are two companies using information technology to assure

product quality. Pioneer seeks suppliers who use a specific

technology to tailor-make a seed that grows product specific

attributes. Producers are required to provide specific production assurances that allow the processor to label the

product for a specific set of nutritional attributes. Pioneer

stands behind the attributes and accepts the implicit role as

the enforcer, and information technology provides the linkages. Likewise, Frito-Lay contracts with producers for specific types of corn. The processed commodity is tracked

through the market channel on a bag-by-bag basis to assure

product quality (4).
146 ● A New Technological Era for American Agriculture

Table 5-n—Average Annual Net Cash Farm Income Due to PST Adoption for Representative Missouri and

Indiana Hog Farms Under Alternative PST/Feed Response and Carcass Merit Premium Assumptions

Representative

farms

Do Do adopt Do adopt

not average pST/feed response optmistic pST/feed response

adopt No CMPa

5 percent CMP No CMP DST 5 percent CMP

(thousand $)

Missouri

Moderate . . . . . . . . . . . . . 56.73 57.70 64.98 75.59 83.19

Large . . . . . . . . . . . . . . . . 149.16 153.93 175.66 209.15 231.85

Indiana

Moderate . . . . . . . . . . . . . 214.22 217.53 232.66 255.48 271.70

Large . . . . . . . . . . . . . . . . 818.17 838.18 898.78 979.24 1,050.98

$/sow

Missouri

Moderate . . . . . . . . . . . . . 756 769 866 1,008 1,109

Large . . . . . . . . . . . . . . . . 663 684 781 930 1,030

Indiana

Moderate . . . . . . . . . . . . . 1,428 1,850 1,551 1,703 1,811

Large . . . . . . . . . . . . . . . . 1,364 1,397 1,498 1,632 1,752

aCMP refers to carcass merit premium.

SOURCE: Office of Technology Assessment, 1992.

Input suppliers have experienced more consequences

of the biotechnology era than any other part of the agriculture industry to date. In anticipation of biotechnology-enhanced seed for large-acreage volume crops, seed

and chemical input industries already have transformed

structurally, just as the hybrid seed-corn industry developed to become a billion-dollar business after hybrid corn

became a reality 50 years ago. With the expected future

gains from biotechnology, multinational chemical and

pharmaceutical companies have acquired almost all of

the major seed companies. Only Pioneer Hi-Bred international and DeKalb remain independent firms (6).

Concentration of input industries increases the potential for monopoly power, hence the potential for exploiting farmers in their purchase of improved inputs.

Overdependence on a narrow set of genetic material also

raises the problem of ecological vulnerability.

Economies of size in process technologies also can

foster concentration in the input sector. For example, a

7 million dose-per-day bST plant can supply two-thirds

of the Nation’s dairy herd. To the extent that efficient

biotechnology manufacturing requires large plant sizes,

there will be economic pressures to concentrate industry

structure to a small number of firms. Moreover, in some

cases, there may be incentives for manufacturing firms

to integrate the manufacturing and retailing of inputs.

As discussed earlier. the trend toward vertical integration in agriculture and toward proprietary production

processes could result in a captive market for some biotechnology products. For example, a genetically engineered seed might be produced by a large, vertically

integrated chemical-seed company with specified inputs

such as fertilizer, pesticides, and herbicides produced

only by that company.

The potential for transgenic farm animals to produce

pharmaceuticals will also provide incentives for vertically integrated companies. Firms already involved in

pharmaceutical research can easily move into animal agricultural biotechnologies.

The increased importance of proprietary products and

processes in the input-supply sector and the increased

economic incentives for further industry concentration

imply a challenge for small-scale firms. The survival of

such firms may depend on public research in technologies

that they can effectively use in their production systems;

market access to these technologies; and easily acquired

information on use and management of available technologies (5).

Farm Labor

As has been true for most past technologies, the emerging biological and information technologies will generally shift labor from farming. At the same time, new

employment opportunities will be provided in the agribusiness sector supplying these new technologies. Today
Photo credit: Grant He//man, Inc.

Newly emerging technologies will displace less farm

labor than mechinazation, but labor will have to be

substantially more skilled than in the past.

only about 2 percent of the U.S. population is living on

farms; about 55 percent of nonmetropolitan jobs in the

food and fiber system are located off-the-farm in farm

input, marketing, and other service sectors.

Newly emerging technologies will displace less farm

labor than mechanization, but the farm labor force will

have to be substantially more skilled than in the past.

This will be particularly true for workers in animal agriculture. Demand for unskilled agricultural workers will

fall off. Hired field workers will be limited to specialty

crop ( mainly fruit and vegetable) farms.

One message seems clear: implementation of the new

technologies will require a broad range of specialized

Skills. For example, a key requirement of the new information technology will be computer literacy. Enhanced management skills will be needed generally to

succeed within a system characterized by increased

technical and economic compltexity. Programs to support skill upgrading of the farm labor force will be

needed to capture fully the potential benefits of new

technologies (see ch. 6 for a more thorough discussion

of these requirements. )

Rural Communities

The number of farms and farm population continued

to decline in the 1970s and 1980s. The impacts of declining farm numbers are difficult to ascertain. In general, land is bought by other farmers and continues to

remain in production so that total agricultural output does

not significantly decline. However, declining farm numbers negatively affect rural community employment levels. In farming-dependent communities, for every one

farmer that exits the industry, up to one additional job

may be lost to the community.

While in most urban areas the 1980s were years of

economic recovery and prosperity. this has not been the

case for rural areas. The rural economic crisis was due

in part to depressed conditions in export-dependent industries such as agriculture. forestry, and mining. However, even when these industries began to recover in the

mid- 1980s, the rural-urban gap widened. This was due,

in part, to the fact that rural problems run much deeper

than those of agriculture alone. extending to inadequate

infrastructure, poor schools. lack of access to quality

medical services, and lack of leadership to solve problems that exist. While rural communities may have once

been dependent on agriculture, only 23 percent of the

3,106 counties in (his country can now be described as

agriculture-dependent, nonetheless, more than 75 percent

of the Nations counties are nonmetropolitan. Rural communities and agriculture are no longer synonymous (1).

Much of the once agriculturally dependent popultition

has moved to larger trade-center communities ( many in

nonmetropolitan counties), which have therefore grown

in population and business volume. Growing communities in rural areas are often preferred locations for consolidated public schools, medical facilities. and other

public services. Those communities left behind are suffering the consequences, and some are particularly vulnerable to the structure of agriculture.

The emergence of biotechnology and computer technologies will most likely spur on the decline of many

small farms and agriculturally dependent rural communities. And, where product quality is influenced strongly

by biotechnologies, such as pST in pork. and where highly

specialized new markets are formed, such as pharmaceuticals, increased incentives for production-marketing links via contracting and other forms of vertical integration also can be expected. At the same time, increased demand by many farmers for one-stop shopping

centers for farm supplies and technical services— including those involving biotechnologies and computer
148 . A New Technological Era for American Agriculture

1.

2.

3.

A

open public discussion of biotechnology research

priorities;

enlightened policies and procedures regarding approval, patenting and regulation of biotechnology

innovations; and

insistence on high-quality and timely information

about biotechnology for public and private decisionmakers.

POLICY ISSUES ‘

number of policy issues surround the introduction

of technological innovations in U.S. agriculture and their

impacts on the industry. Many are already on the policy

agenda in one form or another. Several are discussed

below.

Photo credit: Grant Heilman, Inc.

Advancing technologies will most likely spur on the

decline of agriculturally dependent rural communities.

These business communities will need to substitute

additional nonfarm economic activities if they are to

remain viable.

technologies—may reduce the viability of business enterprises in smaller rural communities. These business

communities will need to substitute additional nonfarm

economic activities if they are to remain economically

viable (5).

In the near term, biotechnology’s effects on rural communities likely will be most significant in regions of

concentrated livestock production. The ability of rural

communities in these regions to absorb adverse changes

in agricultural employment will be closely related to the

availability of off-farm employment.

Because rural communities have diversified their economic base and are no longer dependent on agriculture,

most rural community residents have little or no personal

contact with farming, except as passive observers of environmental changes. The environmental impacts of production practices can, however, become a community

issue when such externalities as water quality, chemical

residues, worker safety, etc., become sources of concern.

Local sensitivities about the implications of novel substances employed in animal and crop production already

are significant. Perceptions of risk to health, safety, and/

or environmental diversity associated with transgenic organisms may become a further source of community conflict and controversy.

To ameliorate such conflict and controversy, communities should facilitate:

Moratoriums on Agricultural Research or

on the Implementation of New Agricultural

Technology

Moratoriums have already been placed on the use of

bovine somatotropin in Minnesota and Wisconsin. The

dairy case study discussed earlier clearly showed that

regardless of farm size or region, there will be strong

incentives to adopt bST. The farms in Minnesota and

Wisconsin, even if they do adopt this new technology,

still will have problems realizing sufficient earnings to

achieve a reasonable return on equity, compete, and survive. For farms not adopting the new technology the

dilemma will be even more severe. The agricultural industry of these States will be at a great disadvantage

relative to those States where a moratorium does not exist

if bST is approved by FDA for commercial use.

In the process of economic development a maturation

process occurs such that fewer human resources are required in primary industries (farming and mining) and

proportionately more workers are employed in the knowledge and service industries. American agriculture has

achieved its preeminence in the world by substituting

knowledge for resources. This knowledge, embodied in

more productive biological, chemical, and mechanical

technologies and in the managerial skills of farm operators, has given the United States a world-class agricultural industry at a time when many other sectors of our

economy are losing their preeminent position. For U.S.

agriculture to retain its status it is necessary to enhance

public and private-sector capacity for scientific research

and technology development. The costs, to consumers

and producers, of failure to maintain and enhance our
efficiency in production would greatly exceed the adjustment costs resulting from overabundance.

Impacts of Emerging Technologies on Farm

Size and Managerial Skill Requirements

The post World War 11 era of farm mechanization made

it virtually impossible for small unmechanized production

units to compete and survive with farming as the sole source

of family income. Some past chemical and biological technologies such as insecticides and hybrid seed, on the other

hand, have been rather scale neutral except for price discounts afforded producers who were able to purchase them

in large volume. The emerging biotechnology and information industries appear to have the potential for being

relatively scale neutral in their application on those farms

already large enough to support mechanization technology.

But two qualifying considerations are important. First, the

implementation of these emerging technologies will generally require increased management skills and, for some,

computer literacy. Second, at least some of these technologies will be effective and profitable only if they are integrated into rather technically complex production systems

at the farm level. Some of these systems in animal agriculture may involve environmentally controlled housing

and scientifically based feeding and management procedures. Thus, increased managerial skills, and, in some cases,

additional capital in the form of specialized buildings and

equipment will be important components of successful

farming in the future. This will most likely mean increased

concentration of farm production among larger units with

more sophisticated technology and management capabilities.

A number of persons who have moved out of farming

in the past four decades did have adequate skill levels

but had an inadequate resource base of land or operating

capital to succeed under a highly mechanical farming

regime. Future adjustments in farming will be dictated

less by large capital requirements than by the educational

and managerial skill requirements for farmers. This is

not to suggest that the future capital requirements in

farming will not be high. They will. In fact, the capital

requirements per worker in farming are very high compared to most other types of employment. But recent

major deflation in agricultural capital assets, particularly

farm real estate, together with creative procedures by

farmers for acquiring access to land and capital resources,

may result in educational and managerial skill levels becoming a more limited resource than capital. One clearcut conclusion emerges. Persons who want to compete

successfully in farming will need to upgrade their managerial skills. A critical role for Extension is to develop

programs and opportunities for farmers to enhance their

management capabilities.

Displaced Farm Operators and Workers

More workers have left farming since 1940 than now

remain on U.S. farms. Displacement of farmers and farm

workers will continue, though at a slower pace than in

the past half century.

Adjustment to alternative employment is most easily

accomplished by young people who are just graduating

from high schools, vocational schools, and colleges or

universities. Thus. strong educational programs and vocational counseling for youth in farming communities are

of vital importance. Selected public policies should aim

at ensuring the provision of such educational support

services. Other displaced farm workers will seek nonfarm

employment either with or without retraining for such

employment. A number of special training programs are

already in place for such individuals. These retraining

programs. however, need to be geographically and financially accessible and have appropriate entrance requirements for those displaced from farming. Moreover.

they need to target employment training to those skill

areas for which jobs are available.

A number of older farm operators and other family

members without new training may have to adjust to

whatever full- or part-time employment opportunities exist in the local community. The availability of such employment opportunities and the general quality of life in

many rural farm-dependent communities will be heavily

dependent on the local farm economy. And, in some

cases businesses based on newly emerging technologies,

particularly those supplying farm inputs, will provide

new local employment opportunities.

Adjusting to Change

Policies to help farmers adjust to technological change

on the farm or to off-farm employment are lacking. The

Food, Agriculture, Conservation, and Trade Act of 1990

and related farm policies are aimed almost exclusively

at reducing the use of farm inputs (mainly land) to curtail

farm output; providing a price (and income) floor for producers of selected commodities; and enhancing the position

of U.S. farm commodities in world trade. A unique exception was the dairy herd buyout program in the late

1980s, which provided some dairy farmers with an opportunity to “cash out” their dairy herds at more attractive

prices than those afforded by the free market. New or

expanded public policies are needed for upgrading the managerial skill levels of some farmers to cope with technical
150 . A New Technological Era for American Agriculture

change and for providing retraining opportunities for others

to enable them to exit from farming. Strong educational

programs are also needed for all rural young people whether

or not they have opportunities in future ‘‘high-tech’

farming. Expanded Federal and State assistance will be

required for effective educational programming in those

rural areas with an eroding local tax base.

At the institutional level, public institutions need to

aim policies and programs at two somewhat different

types of participants—those who will adjust by staying

in farming, and those who will seek alternative employment. Both groups need to be serviced by effective

public technology transfer and training programs and

supporting financial services. A reorganized and revitalized public extension service could play a major

role in technology transfer while public credit agencies

need to focus program delivery on the special needs

of the two target groups. At the farmer level, it is

crucial that individuals realistically assess their opportunities in and out of agriculture. Most should make

deliberate career choices and follow up with the acquisition of the managerial skills to succeed in hightech farming or the retraining required for employment

off-the-farm. Future farm commodity programs are not

likely to provide an umbrella of income protection adequate for any but those farm managers who can adjust

effectively and quickly to technological change.

CHAPTER 5 REFERENCES

1. Knutson, R. and Fisher, D., Options in Dei’eloping a

New National Rl{ral Polic>’, Texas Agricultural Ex2.

3.

4.

5.

6.

7

8

tension Service, Texas A&M University, College Station, Tx, 1989.

Lu, Y., “Forecasting Emerging Technologies in Agricultural Production, ’ in Yao-chi Lu (cd.), Emerging Technologies in Agricultural Production,

Cooperative State Research Service, U.S. Depm-tment of Agriculture, 1983.

Richardson, J., “Farm Level Impacts Of Somatotropin Introduction and Adoption on Representative GrainHo~ Farms in the Midwest, ” commissioned background paper prepared for the Office of Technology

Assessment, 1991.

Streeter. D., Sonka, S. and Hudson, M. ‘ ‘Information

Technology, Coordination, and Competitiveness in

the Food and Agribusiness Sector, ’ American Journal oj” Agricultural Ec”onotnic.s, VOI. 73, No. 5, December 1991.

Sundquist, B. and Molnar, J., “Emerging Biotechnologies: Impact On Producers, Related Businesses

and Rural Communities, in Agricultural Biot(~(hnolog~, Purdue University, West Lafayette, IN, 1991.

U.S. Congress, Office of Technology Assessment,

Agricultural Commodities as Industrial Ra}~* A4ate -

rials, OTA-F-476 (Washington, DC: U.S. Government Printing Office, May 199 1).

U.S. Congress. Office of Technology Assessment,

U.S. Dairy lndust~-> at a Crossroad: Bi(~t(~<’}ltl~~l(~g>

tlnd Polic?’ Choi(’es. OTA-F-470 (Washington. DC:

U.S. Government Printing Office, May 1991 ).

U.S. Congress, Office of Technology Assessment,

Te(.hnolog>’, Publit Polic>’, and the Chunging Stru[’-

ture of American Agriculture, OTA-F-285 (Springfield, VA: National Technical Information Service,

March 1986).
Chapter 6

Management Implications

of New Technologies

Photo credit: U.S. Department of Agriculture, Agricultural Research Service
Contents

Page

INTEGRATED PEST MANAGEMENT STRATEGIES FOR CROP AGRICULTURE . . . . . . . . 153

Molecular Genetics as a Tool for Detecting Resistance and Tracing its Origins . . . . . . . . . . . . . 156

The Influence of Genetically Engineered Crops on Pest Resistance . . . . . . . . . . . . . . . . . . . . . . . . . 157

POLICY IMPLICATIONS REGARDING THE DEVELOPMENT AND DEPLOYMENT

OF ENGINEERED CROPS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 166

ANEW ISSUE IN ANIMAL AGRICULTURE MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Farm Animal Well-Being . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 167

Biotechnology and Farm Animal Well-Being . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 172

CHAPTER PREFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 173

Box

Box Page

6-A. Glyphosate: A Risk to Weed Resistance? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 161

Figures

Figure Page

6-1. Successful Seed Mimicry by Common Vetch Weed of Lentil . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 154

6-2. Successful Mimicry of Barnyard-Grass Seedling for Cultivated-Rice Seedling . . . . . . . . . . . . 155

6-3. Number of Crop-Pest Species Resistant to Synthetic Chemical Pesticides . . . . . . . . . . . . . . . . . 155
Chapter 6

Management Implications of New Technologies

Biotechnology holds great promise for American agriculture, but this promise may not be realized if the

technologies are poorly managed. The new technologies

will demand considerable management skills and a holistic or systems approach to management. Pest resistance

to technologies that control pests exemplifies management problems in the past. Many chemical pesticides are

ineffective today because of pest adaptation. Evidence

suggests that pest adaptation could have been delayed

and, in some cases, avoided if proper management strategies had been implemented. As products from the biotechnology era are used to control pests, management

strategies for delaying or possibly avoiding pest adaptation need to be identified.

Good management will be of paramount importance

for the effective use of new biotechnologies in animal

agriculture. The new technologies are not magic bullets,

and will not improve animal productivity without effective management. With or without biotechnology, a

growing management issue in this decade is farm animal

well-being. Little scientific evidence is available on farm

animal well-being in the United States; much more is

available in Europe. It is important that the American

animal agricultural industries begin to focus more attention and resources on this growing issue and on the impact

of new technologies on farm animal well-being.

This chapter focuses on these critical management issues.

First, pest adaptation to various control technologies is explored for crop agriculture. Various management strategies

for delaying pest adaptation are identified for the new technologies developed through biotechnology. Second, the importance of the farm animal well-being is discussed, areas

of research are identified, and biotechnology’s potential

impacts on farm animal well-being are explored.

INTEGRATED PEST

MANAGEMENT STRATEGIES

FOR CROP AGRICULTURE

Pest infestation is a serious problem for agriculture

and effective methods to control pests are needed. Of all

crop pests, weeds boast the longest recorded history of

adapting to agricultural practices. It is a history dotted

with examples of one of nature’s most interesting adaptive strategies: mimicry (35). By mimicing crop seed,

weed seeds can lie hidden among crop seed stored for

the next season’s planting.

Successful mimicry of agricultural crops requires that

weeds possess a number of important characteristics. Weed

seeds must ripen by harvest time; remain on their stems

during harvesting; and have a shape and density similar

to that of the crop seed (35).

A surprising number of weeds have evolved all the

characteristics required to become crop-seed mimics. An

example comes from the mimicry of lentil seeds, Lens

culinuaris, by the common vetch, Vicia sativa. The lentil

seed has a convex shape. Normal seeds of the common

vetch are much more rounded than lentil seeds (figure

6-1 ). Another example is one of rice’s most serious rivals, barnyard grass. Barrett ( 1 ) discovered in weedy

forms of barnyard grass so many rice-like traits that they

found it more difficult to differentiate barnyard grass

from rice than to distinguish two variants of barnyard

grass from each other (figure 6-2).

In the mechanized farming systems dominant in the United

States, hand weeding may be a thing of the past, but the

battle between farmers and weeds continues. Chemical herbicides used to control weeds do not discriminate on the

basis of appearance. The nature of the game has switched

to biochemical mimicry. Agricultural chemical companies

spend millions of dollars each year inventing chemical agents

that kill weeds in cultivated fields without harming crops.

This has put enormous selection pressure on weeds to biochemically mimic crops. It is estimated that there are at

least 84 cases of weeds with resistance to at least one

chemical herbicide (figure 6-3).

Like weed resistance to herbicides, the resistance of

plant-pathogenic fungi to synthetic fungicides is a significant problem. By the mid- 1980s, more than 100 species were known to be resistant to at least one fungicide

(figure 6-3). 1

The real experts at resistance to synthetic chemical

agents are insects. Resistance to DDT, detected shortly

after its introduction as one of the first insecticides, is

1 (h the other hand, s(mw pe~ticidcs have remained effective over the long term. For example, glyphosatehas been used to control weds for

more thtit 17 years without any documented examplci of resistance. LIkew ise there is no evidence of cwiling moths (pests of apples) developing

rcsistuncc to organophosphate~” c~cn though these pesticides were uwd mtcnwly for’ 20 ywrs to control the moth (34).

-153 -

297-937 0 - 92 - 6 QL 3
154 . A New Technological Era for American Agriculture

frequently cited as a textbook case of rapid adaptation.

Since DDT, insects have been most successful at adapting to almost all insecticides. More than 500 cases of

insect adaptation to insecticides have been documented

(figure 6-3).

Besides the growing problem of pest resistance to

chemicals, there is much criticism of chemical pesticides

because of their adverse environmental side effects (95).

“Natural” control methods are often touted as safe and

effective alternatives to chemical pesticides, but there is

no guarantee that pests will not adapt to these methods

as well. Indeed, numerous examples abound of pests

overcoming a wide variety of control methods. Pests have

adapted to cultivation methods as illustrated by wild vetch

in lentils and barnyard grass in rice (34). Pests also have

adapted to crops bred to be pest-resistant. For example,

a random sample of 63 plants bred for resistance to viral

pests indicated that pests had adapted in 28 cases. Only

five cases showed no evidence of viral adaptation, and

the rest were inconclusive (20). Insects also have adapted

to crops bred for insect resistance. Hessian flies in wheat,

green bugs in grain crops. and leafhoppers and planthoppers in rice are examples (22, 33). Other insects have

adapted to biological control agents. For example, alfalfa

weevils and the forest pest Pristophora erichsonii have

adapted to parasitic enemies, and silkworms have adapted

to fungal control methods (34). Some strains of insects,

the diamond back moth, for example, have developed

resistance to biological control with Bacillus thuringiensis (56, 80, 91), a bacterium that is toxic to many insect

pests.

These examples lead to three basic conclusions:

1. pests have demonstrated tremendous ability to adapt

to almost any control mechanism,

2. unilateral pest suppression tactics rapidly can be

rendered ineffective due to evolutionary change in

pests, and

3. the assumption that natural pest control tactics are

superior to synthetic methods, at least in terms of

limiting pest adaptation, is false.

Control of pests requires the use of many approaches,

rather than reliance on one single method. A holistic

program that considers all causes of plant stress—pathogens, weeds, insects and other arthropods, water and

nutrient excesses and deficiencies, soil pH, salinity etc.,

is needed. However. developing such an integrated approach will require an enormous amount of information

and an understanding of the interactions among different

stress-reduction strategies. Much effort will also be needed

to educate farmers in taking such a multifaceted approach

to pest and other stress control.

Figure 6-l—Successful Seed Mimicry by Common Vetch Weed of Lentil

Photo credit: Virge Kask

Success at seed mimicry has given the common vetch the ability to contaminate lentil fields. At left is the typical seed shape of the

common vetch, Vicia sativa. In a lentil field near Albion, Washington, plant pathologists recently found vetch seeds that had a distinctly

different shape (center) that is quite similar to the flatter shape of the lentil, Les culinaris (right).

SOURCE: Richard M. Hannon, U.S. Department of Agriculture, Agricultural Research Service
Chapter 6—Management Implications of New Technologies ● 155

6-2-Successful Mimicry of Barnyard-Grass

Seedling for Cultivated-Rice Seedling

Photo credit: Beverly Benner

Survival in a hand-weeded field is easier for a weed that looks

like a crop plant. A barnyard-grass seedling, a serious nuisance

in rice fields, is easily mistaken for a cultivated-rice seedling. Left

to right, the plants shown are cultivated rice, the oryzicola variety

of barnyard grass, and another barnyard grass seedling.

SOURCE: Spencer C H Barrett, University of Toronto

Integrated Pest Management (1PM) represents an attempt at such an approach. 1PM strategies seek to create

a crop management system that combines compatible

production techniques and methods in a manner that

maintains pest populations at levels below those causing

economic crop injury. The 1PM approach is based on

Figure 6-3—Number of Crop-Pest Species Resistant

to Synthetic Chemical Pesticides.

●

●

●

●

●

1930 194 0 1950 196 0 1970 1980 199 0

Year

SOURCE: N.G Green, H.M. Lebaron, and WK. Moberg, Managing Resistance to Agrochemicals: From Fundamental Research to

Practical Strategies (Washington, DC: American Chemical Society, 1990).

ecological principles and requires a solid understanding

of the ecological system to be managed. Development

and deployment of integrated strategies requires basic

knowledge about target pest species and their interactions

with other pest and beneficial species, as well as with

the crops to be protected and other host plants (70).

Knowledge of the direct and indirect effects of other crop

production and protection inputs on nontarget pests and

beneficial species is also essential. Because crop/pest

interactions display tremendous geographical variation

for the same crop and pest, pest management systems

must be adapted to local conditions. The complexity of,

and lack of adequate knowledge about, pest populations

and agroecosystem dynamics make 1PM an unrealistic

goal at this time.

Limited 1PM strategies have been used in cotton and

apples to control insects, rather than weeds or disease

(2 I ). Presently, 1PM efforts focus on integrating cultural

controls (sanitation, crop rotation, appropriate selection

of planting dates, irrigation regimes, planting densities,

varietal selection); naturally occurring biological control;

and the application of chemical controls when pest populations or damage to the crop reaches a threatening level.

These action thresholds are based on the complex and

dynamic relationship between crops and pests throughout

a growing season (72).

Combinations of pest-control methods ideally should

act synergistically to control pests; at least they should

not counteract each other. Research shows that synergism

exists between some moderately resistant plants and biological control agents; in other cases, such plants adversely affect the activities of naturally occurring biological

control agents (32).

Compatibility with biological control agents must be

a significant consideration when biotechnology is used

to create resistant crop varieties and to extend the range

of biological control agents. Some preliminary research

involving tobacco that has been genetically engineered

to produce low levels of Bacillus thuringiensis (Bt), indicates that Bt does not negatively affect natural enemies

of tobacco budworm. It is possible that Bt enhances the

effectiveness of the natural enemy by slowing budworm

growth (34).

Crops that have low to moderate levels of pest resistance, generally have responded well to chemical controls. Several cases have been documented where pest

suppression has improved following insecticide use on

resistant crop varieties (48, 93). However, there are also

examples of antagonistic interactions (53, 55).
156 . A New Technological Era for American Agriculture

Crop rotation has been employed effectively to decrease pest infestation. However, continuous cropping

has also lead to a decline in incidence and severity of

pest infestation by providing a more stable environment

for the establishment of naturally occurring antagonistic

agents. For example, the severity of take-all disease in

wheat has naturally declined in fields that have been

continuously planted to wheat for years. The decline is

due to the establishment of a bacterium that controls the

disease (97). Little is known about the compatibility of

genetically engineered crops and cultural practices. Currently the use of constitutive genes (i. e., genes that are

expressed in all tissues at all times in the plant) leave

little room for temporal flexibility.

In the above examples, the compatibility of only two

control mechanisms for one pest is considered. However,

many other plants, animals, and microbes, some of which

are beneficial and some harmful to crops, are also part

of the agroecosystem. Most of these components are

studied in isolation; in a truly integrated system, all control mechanisms used to control all pests should be compatible. For example, mite management of almonds cannot

be discussed without considering how simultaneously to

manage codling moth, navel orangeworm, and weeds

(49, 101, 102). The information needed to do this currently is unavailable.

As practiced currently, 1PM strategies do not eliminate

but strive to decrease chemical use by improving the

timing of pesticide application to achieve pest suppression with minimal nontarget effects. Improved pesticide

application technologies to minimize off-target drift could

also decrease amounts of pesticides used. Pesticide delivery equipment designed to directly mix pesticides at

the proper rate, eliminating the need for tank mixing,

could increase the efficiency of pesticide application (78,

95).

Development of pest management technologies and

programs does not automatically lead to their adoption.

Many obstacles stand in the way of farmer acceptance

of these programs. The complexity of the programs requires high levels of management skill and this is a significant deterrent to many farmers. Information and

programs tailored to meet the local needs, perceptions,

resources, constraints, and objectives of farmers is imperative. Many farmers will need considerable training

to use these technologies. The lack of coordination among

organizations, personnel. and disciplines involved in pest

management at the local and regional levels inhibits educational efforts. Development of expert systems and

other information technologies may help in training and

in coordinating these efforts (see ch. 4) (34).

The failure of growers to perceive the long-term cost

advantage of integrated pest management strategies is a

significant deterrent to adoption. There is a general need

to demonstrate how these management strategies might

reduce production costs. For example, almond producers

were generally skeptical of adopting an integrated mite

management program, until it was shown that this program could be effective, was compatible with pest control

tactics already being used, and could result in decreased

production costs of $24 to $44 per acre (47). Developers

of pest management technologies generally lack the social science training needed to demonstrate cost-effectiveness to farmers. Input from social scientists is needed

to successfully develop and implement any new methods.

Management of pests will continue to be a major concern of agricultural producers. Successful development

and adoption of more comprehensive pest management

strategies will require extensive scientific research, as

well as improved methods of providing readily usable

information to agricultural producers. A better understanding of the interactions between crops and pests and

of mechanisms of resistance development is needed.

Changes in farm management practices also may be

needed. The ongoing battle to stay one step ahead of

pests, given their ability to adapt, will require the development of new biological control agents, improved

chemical pesticides and wholly new technologies such

as genetically engineered plants.

Biotechnology holds great promise for providing new

ways to control plant diseases, insects, and weeds. The

tools of biotechnology have created the possibility of

selectively engineering plants for insect, disease, and

weed resistance. In addition, these new tools are expanding the knowledge base of plant resistance and the

interaction of plants and pests with the rest of the ecosystem. In particular, biotechnology will be very useful

in detecting resistance by pests at a much earlier time

than traditional technologies and in developing strategies

to slow or alleviate pest resistance.

Molecular Genetics as a Tool for Detecting

Resistance and Tracing its Origins

Until recently, pesticide resistance could be detected

only after it became a problem in the field or through

laboratory bioassays in which samples from a pest population are treated with predetermined doses of the pes-
ticide in question. The number of samples that can be

processed in this fashion is low, especially with insects

and some weeds.

If an enzyme that leads to resistance has been identified. another approach to detecting resistance is development of monoclinal or polyclonal antibodies to that

enzyme (see ch. 3 for explanation of how they work).

Although there are certain drawbacks to this approach,

there is a potential with this system to detect resistance

at very low levels using kits that can be applied directly

in the field.

With many pests, resistance develops in a number of

localized geographic areas. It often is not clear whether

these localized resistant populations arise independently

or whether one population becomes resistant and rare

migrants invade new areas and become the dominant

form in the newly invaded area. It is important to know

which of these two scenarios reflects the dynamics of

resistance in order to limit further progression of the

resistance problem.

If the resistance developed in one location and spread

to another via migration, then the mutation(s) leading to

resistance are probably rare. It may be advisable to attempt to quarantine the areas of resistance and to eradicate pests within these areas. On the other hand, if

resistance arises independently in each area. then the

mutation frequency is probably high and the above strategy would be useless. If the biological mechanisms of

resistance in two areas are clearly different. it is safe to

assume that resistance arose independently. However,

when the mechanisms of resistance are similar it is possible that resistance had one origin.

Advances in molecular genetics have allowed scientists to clone the genes responsible for some kinds of

pesticide resistance. By determining the point at which

a mutation in the gene occurred in a number of different

populations it will be possible to more precisely determine the number of origins of resistance. Work in this

field is only beginning but progress in at least one case

has been astonishing. A French molecular biology group

working with a Culex mosquito species was able to demonstrate that a single, initial, mutation in an esterase locus

(an enzyme that accelerates the synthesis of esters) is

responsible for most of the organophosphate resistance

in this species worldwide (76). Their molecular analysis

demonstrated that the DNA sequences adjacent to the

coding region of the gene were identical in all resistant

populations.

The Influence of Genetically Engineered

Crops on Pest Resistance

Two primary questions arise about pesticide resistant

crops (and about herbicide tolerance in particular): whether

the level and pattern of pesticide use will be altered by

such crops; and/or whether crop production patterns will

be changed. Impacts that might occur as a result of these

changing patterns also need to be evaluated. Impacts

include environmental and food and water safety issues

and continuing or increased problems with resistance.

No definitive data exists on these issues, only reasonable

speculation on changing patterns (but not levels) of herbicide use that might occur. There is also reasonable

speculation about changing crop patterns and pesticide

use that might result from insect and disease resistance.

However, more data is needed to assess environmental

and food safety issues. Speculations about changing crop

patterns combined with knowledge of how pest resistance

develops does lead to some conclusions about the type

of resistance problems that might arise. It also suggests

some farm and industry management strategies that might

be pursued to minimize resistance. These issues are discussed below (34).

Herbicide-Tolerant Crops and Weed

Resistance to Herbicides

Today agriculture depends to a great extent on herbicides to control weeds. Herbicide use patterns (and

related pest-resistance problems) are affected by many

factors, including price, the spectrum of weeds controlled. residue effects, flexibility or timing of pre or

postemergence treatments, marketing strategies, and ease

of use. While biotechnology may contribute to pest resistance risks in some cropping situations, it is only one

of the factors involved, and its application to American

agriculture must be considered holistically.

Biotechnology-agrichernical companies. and seed

companies as well as public universities and laboratories

are using genetic engineering to develop crops resistant

to herbicides. With herbicide-tolerant crops greater quantities of particular herbicides can be used to control weeds.

As the name implies, herbicide-tolerant plants can grow

in the presence of herbicides that harm or kill a nontolerant plant. Some plants naturally tolerate particular herbicides. Grasses, for example, naturally tolerate certain

herbicides that kill broad-leaved plants. Despite this, use

of herbicides to control agricultural weeds is often limited

by the sensitivity of a cultivated crop to a herbicide or

by the sensitivity of other crops that subsequently will
158 . A New Technological Era for American Agriculture

be planted in the same field. Herbicide-tolerant crops

remove this limitation. They are designed to tolerate higher

levels or more potent doses of herbicides than non-tolerant crops. A concern is that herbicide-resistance weeds

may be created by the transfer of herbicide-tolerance

genes to weedy relatives of crop plants or by the change

in patterns or levels of herbicide use. Herbicide-tolerant

crops could lead to increased problems with weed resistance or diminish these problems depending on the types

of herbicide-tolerant crops developed and the manner in

which they are deployed (27, 28). We must proceed with

caution in developing and deploying herbicide tolerant

crops.

Resistance of weeds to herbicides is a recent problem

that is predicted to worsen during the next decade. As

herbicide use increases (a possible consequence of herbicide-tolerant crops) so does selection pressure for resistant weeds. Furthermore, gene mutation leading to

resistance to some of the newer herbicides occurs at a

reasonably high rate, leaving these herbicides in a vulnerable position.

Research has shown that a number of the new herbicides (e. g., sulfonylureas, imidazilinones, and triazolopyrimidines) have the same target site in the plant, the

ALS enzyme (acetolactate synthase), which is essential

for plant growth. These herbicides bind to a nonactive

site of the ALS enzyme, change its confirmation, and

thereby inactivate it. Resistance to herbicides that inhibit

the ALS enzymes has been found in eight weed species,

and primarily arises through a change in the nonactive

site of the enzyme (57). The mutation rate for this change

is quite high ( 1 in 1 million) and companies are well

aware that this presents a problem. Adaptation of a weed

to one herbicide moreover can render the weed resistant

to a number of other herbicides, a phenomenon called

cross resistance (75). Overuse of a single ALS inhibiting

herbicide or a group of ALS inhibitors in one area thus

could be problematic.

For example, continuous use of ALS inhibitors in soybeans and corn maybe ill advised in that it may accelerate

development of resistance in target weeds. In 1991, two

new herbicidal products, both ALS inhibitors, were labeled for use in corn. If these are used on a substantial

crop area and other ALS inhibitors are also used on

soybeans in the same area, risk of weed resistance will

be significantly increased. Because the spectrum of weeds

that a given herbicidal product can control is limited, a

single product is rarely used everywhere or all the time.

The higher the diversity of ALS inhibiting compounds,

the greater the acreage that is likely to be treated with

an ALS inhibitor.

Herbicide Use in Corn/Soybean Rotations—Many

herbicides fall into two groups based on their spectrum

of activity: broad-leaf herbicides; and grass herbicides.

This dichotomy presents a short-term agricultural problem. Broad-leaf herbicides can be used in corn (which

is a grass), but could be a problem in soybeans since it

is a dicot (i. e., broad-leafed plant). Conversely, a number

of herbicides that can be used in soybeans could be damaging to corn (e. g., Scepter).

Until this year, imidazilinone and sulfonyl urea herbicides were used only in the soybean component of corn/

soybean rotations. Care had to be taken so that residues

would not carry over to and damage the next year’s corn

crop.

Recently, collaborative work between American Cyanamid and Pioneer has lead to development of corn with

tolerance of the imidazilinone products, Scepter and Pursuit, both ALS inhibitors. Scepter is currently used in

southern areas on the soybean component of soybean/

corn rotations and Pursuit is used similarly in more northernly areas. If corn cultivars with imidazilinone resistance were introduced to areas with corn/soybean rotations,

the door would be opened for the use of more ALS

inhibitors in these areas. Pioneer is currently planning to

release imidazilinone-resistant corn cultivars in the early

1990s in areas that do not generally use soybean/corn

rotations ( 17). Since these areas grow continuous corn

this could mean continuous use of these ALS inhibitors.

Such an introduction must therefore be considered carefully. If tolerant corn cultivars were also released in areas

with soybean/corn rotations, more land would receive

continuous control with ALS inhibitors.

Biotechnology could, on the other hand, be used to

diminish risks of herbicide resistance in weeds. The ALS

inhibitors are being relied on increasingly as they replace

older herbicides with known environmental problems or

high costs. Other types of herbicides are available that

affect different target sites in weeds (e. g., glyphosate,

glufosinate). Some of these compounds are limited in

use because specific crops lack tolerance to them. If, for

example, corn cultivars were developed with glufosinate

or glyphosate tolerance, it might allow farmers to alternate use of ALS inhibitors and compounds with a different mode of action.

Monsanto is currently trying to develop soybeans with

tolerance to glyphosate based herbicides (e.g., Roundup).

If they are successful and such soybeans were introduced
Chapter 6—Management Implications New Technologies ● 159

Photo credit: Grant Heilman, Inc.

Research is ongoing to develop soybeans with tolerance

to glyphosate based herbicides. if successful, the cycle of

continuous use of ALS inhibitors could be broken, thus

slowing the development of resistance to target weeds.

into corn/soybean rotations, the cycle of continuous use

of ALS inhibitors could be broken.

Herbicide Use in Cotton—Although cotton is sometimes rotated with other crops such as soybeans and corn,

in major cotton producing areas of Louisiana. Mississippi, and Arkansas 75 to 80 percent of the cotton lands

are planted to cotton for 5 or more years in a row (6).

While soybean and cotton may be grown on the same

farms, the land with the highest yield potential generally

is reserved for cotton. Only about 5 percent of the land

in these areas is rotated between cotton and soybean.

Currently, mid-south cotton generally receives three

herbicide applications, one pre-emergence and two postemergence. The most commonly used post-emergence

treatments involve mixtures of Monosodium Methane

Arsenate (MSMA) and fluometuron (a substituted urea)

for the first post-emergence treatment, and Disodium

Methane Arsenate (DMSA) plus cyanazine or prometryn

(triazine compounds) as the second treatment. To date,

none of these has caused significant resistance in weeds

or environmental problems (7), although DSMA- and

MSMA-resistant cocklebur has been found in North and

South Carolina (58). Some of the major weeds requiring

control are the morningglories, cocklebur, prickly sida,

and sicklepod, but the weed complex varies geographically, and from farm to farm.

At least two companies have been working on developing transgenic cotton with herbicide tolerance. Calgene

has had success in engineering cotton with tolerance of

bromoxynil (a benzonitrile compound), which controls

broadleaf weeds (87). Bromoxynil is especially effective

against lambsquarters and young morningglories but is

less effective on some other weeds.

Monsanto has been attempting to develop cotton with

tolerance to glyphosate. The company seems to have had

some success but has altered its strategy because the

original approach was not leading to sufficient tolerance

levels. Monsanto has isolated what it considers promising

genes to insert into cotton but has not yet tested them in

any plants.

Even if a high-yielding cultivar of bromoxynil-tolerant

cotton were readily available, it is not clear how much

acreage would be treated. Bromoxynil has a limited spectrum of activity and it will probably be heavily used only

when lambsquarters or morningglory is the dominant problem. Where lambsquarters is the major problem, bromoxynil could be used twice a year. Where morningglory is

the problem, bromoxynil will probably only be used once,

in a post-emergence spray since other compounds can be

used more effectively later in the season.

Adding bromoxynil to the cotton system could result

in use of more diverse classes of herbicides (and mechanisms of weed toxicity) than are currently used in that

system. Little concern exists that bromoxynil will decrease this diversity (7). Thus, transgenic cotton with

Bromoxynil resistance is unlikely to present a problem

in terms of fostering weed resistance.

If Monsanto succeeds in producing cotton with glyphosate tolerance, a very different situation may arise in

cotton. Glyphosate is an effective broad-spectrum herbicide

that can kill broad leaf weeds as well as grasses. If cotton

were tolerant of glyphosate, this compound could replace

the current post-emergence herbicides in a large portion of

the cotton growing areas. While current post-emergence

herbicides are generally effective, they could not match

glyphosate for effectiveness nor for ease of use. Monsanto

feels that two applications of glyphosate could replace current post-emergence combinations ( 14). Monsanto plans to

lower the price of glyphosate to make it competitive with

current practices ( 14). The U.S. use patent on glyphosate

has been extended until the year 2000, but outside the

United States this patent will expire soon if it has not already

(26). A company in Canada is already gearing up to man-
160 ● A New Technological Era for American Agriculture

Photo credit: Grant Heilman, Inc.

Scientists have had success in engineering cotton with

tolerance to bromoxynil which controls broadleaf weeds.

Adding bromoxynil to the cotton system could result in

use of more diverse classes of herbicides and thus it is

not likely to foster weed resistance.

ufacture a glyphosate-based herbicide. These changes offer

incentives to reduce the price of the compound to gain

market share. This price reduction would tend to make the

compound appealing to farmers.

The potential, thus, exists for glyphosate to be used

over a large area, two or more times each season. If this

happens will there be a high risk of weed resistance

developing’? Given the information we have to date there

is no simple answer to this question. Box 6-A contains

a review of some points made by scientists involved in

the ongoing debate about this issue.

Most of the crops that have been targeted for herbicide

tolerance research are large-herbicide-use crops (i.e., the

money makers). Perhaps a more important need is for

herbicide tolerance in limited acreage crops for which

there are few herbicides available. Herbicide tolerance

could open the door for use of safer herbicides in these

crops. Additionally, with limited acreage crops the risk

of weeds evolving herbicide resistance is probably lower

than with major crops.

Crop-to-Weed GeneTransfer— Before the biotechnology era, resistance of weeds to herbicides evolved

through mutations in the weed plant’s own genetic material. The possibility that herbicide tolerance genes, engineered into crops, could find their way into weedy

relatives of the crop has recently received considerable

attention (e.g., Bioscience, June 1990).

What will be the fate of such transferred genes, and

will they increase the risk of herbicide tolerance evolving

in weeds? There is no answer to these questions yet but

some general statements can be made. First, it is generally assumed that natural rates of mutation leading to

resistant traits in weeds are one in a million or less. Thus,

any introgression (the entry of a gene from one gene

complex to another) between the crop and an important

weed that increases this rate without lowering the fitness

of the weed could be of importance.

If genes that reduce the fitness in the hybrid are tightly

linked to the herbicide tolerant gene(s), the latter might

not remain in the weed population long enough to cause

a problem. Only empirical studies will determine the

likelihood that a herbicide tolerance gene would free

itself from fitness-reducing, or ‘‘encumbering’ genes

and become a problem.

There are at least three things that could be done by

genetic engineers to lower the risk of herbicide tolerance

genes finding their way from crops to weeds, and leading

to resistant weed strains. First, when developing transgenic crops containing the herbicide tolerance gene, molecular geneticists could determine if certain inserts map

closely with specific crop traits that would tend to lower

fitness of a weed. Second, when developing the initial

constructs, a second gene could be inserted that would

serve as a suicide gene if expressed in a weed seed (i. e.,

it would kill the whole weed).

A final strategy would involve engineering herbicide

tolerance into plants that required two genes to be effective. If the two genes were placed on separate chromosomes the chance that both genes would segregate

when they were at low frequency in the weed population

would be minuscule in an outcrossing hybrid. This could

dramatically slow the rate of increase in frequency of the

tolerance trait. A similar result could be achieved if the

tolerance trait was controlled by a single recessive gene.

Crops With Resistance to Pathogens

The only breakthroughs in genetic engineering that are

likely to affect pathogen control practices in the near

future involve virus resistance. Work on engineering plants

to express viral coat protein genes and antisense genes

has resulted in plants with significant protection against
Chapter 6—Management Implications of New Technologies ● 161

Box 6-A—Glyphosate: A Risk to Weed Resistance?

History

Glyphosate hadbeen in widespread use for at least 17 years and no cases of resistance have been documented

that could be directly traced to its use. However, due to its broad spectrum of activity, glyphosate has not been

used on crop fields except in cases where weeds need to be controlled in fallow rotations. Most of the weeds that

it has been used to control are perennials, and these weeds are less likely than annuals to evolve rapidly resistance.

In at least one situation, however, glyphosphate has been used to control annual grasses in fallow rotations every

other year for a long period of time with no sign of resistance. it has also been used on orchards (14).

Chemistry

Although glyphosate rapidly is degraded by some soil bacteria, plants apparently lack enzymes that can degrade

this compound. in screening for resistance to glyphosate, Monsanto scientists have never found a plant enzyme

that could degrade glyphosate. This further suggests that weeds are unlikely to mutate such that they become

resistant to glyphosate (35).

Mode of Action

Unlike the sulfonyl ureas and imidazilinone herbicides that bind to an inactive site of a critical plant enzyme,

glyphosate binds to the active site of an essential enzyme for synthesis of certain amino acids. Crop tolerance could

be engineered by interfering with glyphosphate binding to this site. Any alteration in the active site that would inhibit

glyphosate binding, however, potentially could also impair the binding of the enzyme to its target molecule and diminish

the fitness of the plant. Monsanto’s experience indicates that this is indeed the case. This has apparently been one of

the factors that has made it difficult for them to engineer crops with glyphosate tolerance. While overproduction of a

less efficient form of the enzyme is possible, it still could lead to decreased growth efficiency.

Lack of Persistence

One important characteristic of glyphosate is that it does not persist in the environment. Therefore, weed control

exerted by this compound is restricted to those weeds that are actually sprayed.

Concision

Certainly the question of potential of weeds to adapt to glyphosate is not yet resolved. However, it seems clear

that glyphosate poses less risk than some of the ALS inhibitors. The information to date would suggest proceeding

with caution in developing and deploying glyphosate-tolerant cotton.

SOURCE: Office of Technology Assessment, 1992.

a number of viruses (2). Such plants could be used widely iment was reported on in an anecdotal fashion (2). He

in developed and developing countries. They certainly

have the potential to raise yields. The question is whether

this increase of yield will be stable.

For 28 of 63 traditionally bred virus resistant crops

examined, virus strains have been positively identified

that could overcome the resistance (20). In only four

cases was there good evidence that there had been no

adaptation. Results were equivocal for the remaining cases.

It is not clear whether or not we should expect the same

track record from crops with genetically engineered resistance.

Only one short-term experiment attempted to look for

genetic adaptation to engineered resistance. This experindicated that he had propagated a TMV virus to high

levels in an attempt to induce systemic infection of resistant plants. He passed the virus through the resistant

plant seven times, after which it was collected and tested

for rate of disease development. This rate was unchanged.

This experiment was obviously a good first step in

evaluating the potential of a virus to adapt to engineered

resistance. Studies using a broader base of viral isolates

and conducted over a longer period of time would be

advisable and very useful before any engineered germplasm is relied on to increase yields in developing countries.
162 ● A New Technological Era for American Agriculture

Engineered Plants With Insect Resistance

Background—There has been a great deal of interest

on the part of industry in developing plants with resistance to insects. Although most of the traditionally-bred,

resistant crop cultivars owe their resistance to secondary

plant compounds (e.g., alkaloids, phenolics, terpenes)

and changes in physical characteristics (e.g., spines, waxy

leaves, solid stems) these traits are generally controlled

by many genes and are not amenable to straightforward

engineering approaches.

Molecular geneticists have instead taken the approach

of 1 ) finding a protein from a bacterium, plant, or an

animal that is toxic to insects (e. g., venoms, bacterial

toxins), 2) finding the gene that codes directly for the

protein, and 3) inserting that gene into a plant. Sometimes this approach works well as with the crystal protein

toxins from Bacillus thuringiensis (Bt) (59). In other

cases, this approach is only partially successful, probably

because the proteins are digested in the insect gut before

they reach their site of action. If it were simple to design

toxic proteins that could withstand the gut enzymes, plants

would probably do so themselves. Another successful

approach to engineering insect resistance involves the

proteinase inhibitors, whose site of action is the insect

gut itself. Unfortunately, high levels of the proteinase

inhibitors are usually needed to inhibit insect growth.

Of all the potential approaches to engineering insect

resistant crops, those involving the Bt crystal proteins

are farthest along. Crops that have been successfully

engineered to produce insect-toxic proteins include tobacco, tomato, cotton, and potato. Other crops targeted

for Bt crystal protein production include but are not limited to corn, rice, soybean, cucumber, and eggplant.

The mother bacteria for the Bt toxin has been used for

many years as a biological insecticide by organic farmers

and to a limited extent by others. Recently, there has

been an increase in the use of these bacteria in conventional, production agriculture. This is in part due to increased pest resistance to conventional pesticides. For

example, few insecticides are still effective against diamondback moth and the Colorado potato beetle (23).

Other reasons for increased use of Bacillus thuringiensis

include better formulations and increased toxicity. Both

conventional breeding and genetic engineering have been

used to improve the potency of the bacterium. The Mycogen company in California has taken the gene from a

crystal protein and placed it in another bacterium. They

have reported field results indicating that their product

has slower decay in the field than normal Bt strains and

therefore is more useful for the farmer (23). Ecogen, a

company in Pennsylvania, has ‘‘bred’ a strain of Bt that

produces two crystal proteins, one effective against lepidoptera (caterpillars), the other effective against beetle

larvae. This product offers useful control of the Colorado

potato beetle and the European corn borer when they

infest potato.

There appear to be some good markets for Bt products,

whether engineered in plants or used as biological insecticides. One very good thing about using Bt is that it

is not likely to disrupt natural enemies of pests or hymenopteran pollinators found in the crop, because most

natural enemies and bees are immune to the effects of

Bt. This property should make the use of Bt or Bt genes

compatible with biological control.

Again, the major question is whether or not Bt will

offer long-term solutions to pest problems or whether

pest insects will adapt to Bts and nullify their utility.

There has been much concern over this issue. In the mid

1980s, there was a feeling among some workers that

insects would not adapt to Bt (8). Many early attempts

to select for resistance failed or produced very low levels

of tolerance (24). In 1985, however, McGaughey (65)

found that Indian meal moths selected in the laboratory

for Bt resistance became over 100-fold resistant.2 Further

work by McGaughey and his colleague led to a level of

resistance in excess of 250 fold. McGaughey and Johnson

(66) also found cross-resistance to a number of other Bt

strains. This was considered by some scientists to be an

exception, but in 1989 Monsanto scientists published

work (89) indicating 20 fold resistance to a Bt toxin in

one member of the cotton bollworm complex, a major

target for Bt toxin production. Further work by the Monsanto group found up to 70 fold resistance of cotton

bollworms to this toxin (60). Ongoing research has found

resistance in this insect to a number of Bt toxins, to plants

expressing the toxin, and to mixtures of Bt spores and

crystals (36).

However, all of the above work was done in the laboratory, and field results do not always match laboratory

findings. Nonetheless, in 1988 there was a report of field

failure of Bt sprays in the Philippines due to resistance

~The meaning of this term involves u ratio. For example, if it takes 200 micrograms to kill d resistant pest compared to 2 micrograms to kill a

susceptible pest, the pest has a 100-fold resistance (200 divided by 2).
Photo credit: Monsanto Co.

The large boll of cotton on the left is the product of a

transgenic plant with Bt genes. The boll on the right was

grown in the same field but comes from an unprotected,

nontransgenic plant. However, resistance to Bt by

bollworms is a very real possibility.

of the diamondback moth (56). in 1990 resistance was

carefully documented in a crop field in Hawaii (9 1 ). The

level of resistance in Hawaii was about 30 fold. Recent

evidence of Bt resistance in Florida, Southeast Asia and

Japan indicate levels as high as 400 fold in the diamondback moth (85 ). There is no longer any doubt that

at least some insects are very capable of adapting to Bt

and Bt toxins.

Recent work on the biochemistry of resistant Indian

meal moths indicates that the difference between susceptible and resistant individuals involves a change in a

receptor binding site in the midgut of the caterpillars.

Interestingly, a change in the receptor that leads to resistance to one Bt toxin does not necessarily lead to

resistance to other Bt toxins (96). For some insects (e. g.,

diamondback moth. cabbage worms), scientists have found

two or more distinct groups of toxins with high activity.

For species like the cotton bollworm. only one group of

toxins offers high activity.

There is high risk of resistance to Bt in some cropping

situations. If a crop or a set of crops is engineered to

produce a Bt toxin and is planted widely, the potential

for resistance must be considered.

Cotton—One of the first major crops in which Bt

genes may be commercialized is cotton. Monsanto claims

to have Bt toxin expression high enough to kill 100 percent of the insects placed on a cotton sample in the

laboratory. Close to that level of success was achieved

in the field. Monsanto intends to commercialize Bt-producing cotton in the early-to-mid 1990s.

In some areas of cotton production, cotton and soybeans

are grown on the same farms although not rotated on the

same field. This could be helpful in limiting selection pressure on bollworms to adapt to Bt-producing cotton because

some of the insects (a refuge sub-population) will feed on

soybeans. The effects of insects in refuges has been described earlier and can be quite important, especially if

adaptive genes are recessive. Unfortunately, large tracts of

cotton acreage are planted in solid blocks. Potential for

resistance in these areas will be quite high. As long as the

size of the bollworm populations is large there is likely to

be sufficient genetic variation to lead to resistance. While

it is impossible to say for sure that the bollworms will be

able to adapt to Bt in the field, laboratory results certainly

support this possibility.

Potato—Two types of Bt-toxin genes have been engineered into potato. Plant Genetic Systems in Belgium

has engineered a Bt toxin into potato that is active against

the potato tuberworm. Monsanto has engineered a beetlespecific Bt toxin into potato and reports to have achieved

high levels of Colorado potato beetle mortality.

The Colorado potato beetle (CPB) is notorious for

adapting to pesticides. One reason for this is that there

are few refuges for this beetle. When potatoes have been

heavily sprayed with insecticides. it has very few alternative plants on which to feed.

However, there is only one report of CPB resistance

to Bt. which comes from a laboratory study in Michigan

(68). Results of this study were only briefly described

but seem to indicate approximately 30-fold resistance.

No field resistance has been reported. It is difficult to

assess the meaning of this since Bt sprays capable of

controlling CPB have only recently come to market and

have not been used widely.

If potato plants with Bt expression are introduced and

used widely, the selection pressure for potato beetle adaptation is likely to be as strong as that exerted by insecticides.

Corn—Success with transgenic corn is very recent.

Therefore, it is too early to know just what levels of Bt

toxin expression will be obtainable in this crop. There

is no doubt, however, that one of the goals of molecular

geneticists in industry is development of corn with Bt

toxin levels high enough to control European cornborer.

The European cornborer currently causes over 10 percent yield reduction in certain areas of the United States

(54) but is rarely the target of chemical control measures.

In general, chemical control is not economically profit-
Photo credit: Grant Heilman, Inc.

Molecular geneticists have had recent success in

developing transgenic corn with Bt levels sufficiently

high to control the European cornborer. In the corn belt,

there would be few alternatives for cornborers so Bt

resistance could be strong, especially if corn is planted

in monoculture.

able because of the low value of the crop (on an acreage

basis) and the difficulty of controlling this insect because

of its habit of feeding in crevices and within plant tissue.

Bt expression in corn would be a very desirable trait from

the perspective of yield. If some farmers start to use it

early on, they will have at least a temporary yield advantage over their neighbors. Certain areas of the United

States where cornborers cause more yield loss than in

other areas would gain an advantage. This would occur

because their yield increase would be greater than in other

areas (54).

It is possible that corn seed with Bt genes would be

adopted widely if it were priced low enough. In the corn

belt there would be few refuges for the cornborers, so

selection pressure for Bt resistant strains would be strong.

In other areas of the country where corn is not planted

in huge monoculture and cornborers feed on other crops

(e.g., potato, beans, cotton, peppers, etc. ), selection

pressure would not be as intense.

Strategies for Delaying Pest Adaptation

Need for a Comprehensive Approach—From the

farmer’s perspective, the history of pest control is the

saga of a long struggle to stay a step ahead of pest adaptation. Some of the techniques used to combat pests

have proved relatively resistance-proof, but these successes have been limited (34). The experience with

synthetic chemical pesticides has been particularly disappointing.

There is growing recognition among scientists that they

need to maintain an arsenal of pest-control tools in anticipation of pests’ evolutionary responses. That arsenal

contains some potentially powerful weapons, among them

the novel approaches of biotechnology.

Much of the discussion of resistance management for

at least the past decade has centered on ways to reduce

the rate at which pests adapt to conventional pesticides.

Yet pests adapt not only to pesticides but also to other

agricultural pressures, and they interact with other parts

of the environment in important ways.

Thus, management strategies must take into account

the entire spectrum of pest adaptation. As discussed above,

insect adaptation to Bt toxin genes is a problem today.

The following discussion of management strategies to

delay insect adaptation to Bt is an example of a comprehensive approach that needs to be implemented generically for pest resistance in general.

Case Example—Adaptation to Bt—There exist six

basic strategies for delaying insect adaptation to plants expressing Bt toxin genes (31), each of which is appropriate

in a different crop/pest system. The basic strategies are:

1.

2.

3. .

4.

5.

6.

high expression of a Bt toxin gene with no refuges,

high expression of a Bt toxin gene with refuges,

high expression of two or more unrelated toxin

genes with refuges,

low expression of a toxin gene to slow the growth

and vigor of the pest to complement natural enemies of the pest,

expression of toxin genes only at times and in plant

parts where protection from pest damage is required, and

restricting Bt use to minor crops.

These strategies for delaying adaptation to Bt are based

on the same general principles of population genetics that

apply to resistance to conventional pesticides. The important differences between strategies for delaying resistance to Bt toxins produced by plants, and to mechanically

applied pesticides derive from inherent differences in

these two toxin delivery systems.

The mechanical delivery systems for insecticides usually have considerable temporal flexibility. When a scout

determines that the number of insect pests in a crop is
reaching an economic threshold, the information can be

relayed to the farmer or crop consultant who can make

the decision to spray the field with the appropriate insecticide. The farmer or consultant may have a number

of insecticides on hand to choose from or can purchase

them quickly. The insecticide can be applied to the field

within hours if weather is not a problem and equipment

and labor are available. Even in problematic cases, the

insecticide can generally be applied within a few days.

While there is some spatial flexibility in mechanical application procedures, it is generally not feasible only, for

example, to spray plants that have two or more insects

cm them.

Mechanical application also permits flexibility in dosage applied. Dosage can easily be adjusted to field conditions and to the species and developmental stage of

pest requiring control. The only lack of flexibility is in

cost: the more you apply, the more it costs. Given insecticide decay rates in the field. doses will decrease

after application and must be renewed at a cost. if needed.

When the plant’s genetic system is used as the delivery

system the situation is different. The genomes of plants

and other organisms are set up to turn genes on and off

as they are needed to produce specific proteins. It would

not be useful for a plant to turn on a gene in a root cell

if that gene was involved in producing the red pigment

for flower petals. A lot of work has been conducted by

molecular biologists’ to learn how genes are turned on

and off. An important component of these switches resides in DNA sequences that flank the sequences that

actually code for protein production.

Some flanking sequences cause a gene to be expressed

everywhere continuously; others turn the gene on only

in certain plant parts; still others activate the gene only

when the plant experiences a specific type of stress such

as drought or attack by insects. Comments from industry

(37) indicate that the first set of engineered plants to be

commercialized will express Bt toxins by relying on

“constitutive” promotors, that is, flanking sequences

that activate genes under almost all conditions. This means

that there will be little temporal flexibility regarding when

and where a toxin is produced.

In contrast to traditional pesticides, which can be applied as soon as reports of insect abundance warrant,

seeds with the Bt genes must be purchased weeks or

months before planting. Thus, a farmer has to assess how

intense pest problems will be before a crop is even in

the ground. If there is even a small chance of a pest

problem and Bt seed is not too expensive, the choice will

not be too hard unless the farmer has an individual concern about resistant pests. Use of Bt plants thus is generally referred to as prophylactic pest control as opposed

to responsive pest control where toxins are only delivered

when a problem is detected.

Another difference between transgenic plants and conventional insecticide-based control programs is that the

dose of a conventional pesticide can be adjusted based

on need; with engineered plants the "dose" of Bt delivered is predetermined. Once the seed is in the field there

is no flexibility.

However, there is room for spatial flexibility in the

use of engineered Bt plants. One option that a farmer

has with cultivars that produce Bt continuously is to mix

seed from the Bt cultivar with that of a closely related

cultivar that is not resistant to pests (Strategy 1 and 2).

Under certain conditions such a mixture would inhibit a

pest outbreak without producing strong selection for Bt

resistance. A number of models have been developed to

look at this resistance management strategy, and results

indicate that resistance does develop more slowly, especially if the Bt genes are recessive (29, 30).

As indicated above, a number of forms of Bt toxins

affect different insects. In cases where two or more distinct types of Bt toxin are available for use on one pest

it is possible to have both expressed in the transgenic

plant (Strategy 3). Theoretical models indicate that planting seed with two or more dissimilar toxins along with

20 to 50 percent seed that was entirely susceptible to the

insect pest could preserve crop resistance 20 times longer

than use of the single toxin strategy in some crop/pest

systems (29, 30).

There has been a good deal of work done on how

“partial” plant resistance to insect pests could “work

with’ natural enemies of the insect pest to deter an outbreak (Strategy 4) (38). Scientists have conducted field

tests with engineered tobacco that produces a low level

of Bt toxin that causes about 15 percent mortality of

larvae and slows the growth of survivors. The Bt was

found to have no negative effect on the natural enemies

of the budworm and may indeed lead to more natural

enemy-induced mortality of young budworms than would

otherwise be the case. This may be the result of larvae

growing slower or being more restless on the plant.

This low dose strategy may be a good one in some

cases but not in others. Two problems that can arise are

1 ) natural enemies that cause indirect selection for adaptation to the Bt, and 2) pest genes that mediate adaptation to mild (not high) Bt stress. This later problem

is considered important in the medical field where it is
166 ● A New Technological Era for American Agriculture

sometimes advised that if antibiotics are used they should

be used at high levels (9, 44, 73). Rigorous testing of

the basis for this advice seems to be lacking.

As indicated earlier, some genes in plants are only

activated in certain plant parts at certain times (Strategy

5). Molecular geneticists have been able to move the

gene activity promotors from one organism to another

and basically get the same pattern of gene activation. For

example a promotor region from soybeans that turns on

a gene only if it is in the developing seed’s cells was

moved to tobacco and only turned on the gene in the

tobacco’s developing seed (3). Promotor sequences from

tomato that only turn on adjacent genes when there is

pathogen or insect stress have also been moved to tobacco

and operate just as they did in the tomato (82).

In some crops only certain plant parts need protection

from insect damage. For example, the buds of the tobacco

plant must be protected against the tobacco budworm but

this insect also feeds on leaves. If the buds were protected, the budworm might switch to feeding more on

mature leaves. Studies indicate that the budworm is expected to develop Bt resistance more slowly if only some

plant parts express the Bt genes (36).

In some crops the plants only need to be protected at

certain times of the season (e. g., cotton). If Bt toxin

genes were only turned on at specific times in the plants’

developmental cycle, the insect would experience selection pressure in one instead of three generations a year.

This also should slow the development of Bt resistance.

Since some plant genes are turned on only when there

is tissue damage, it may be possible to find promotors

that would operate like an automatic pest scout and turn

on Bt genes only when a threshold of damage had occurred. Such a system would turn engineered plants from

a prophylactic pest control tool into a responsive pest

management tool. Such a change could significantly reduce selection for Bt resistance, especially with pests

that only reach outbreak numbers once every few years.

As with engineering crops for herbicide tolerance, much

of the work to develop insect-resistant transgenic plants

has focused on the major cash crops. This makes sense

because potential industry profits are higher from working with these crops than with minor crops. If profit were

not the major concern, other issues might dominate the

decisions about which crops to engineer. For example,

pesticides protect many small-acreage vegetable crops

from insect pests up to harvest. Pesticide residues in fruits

are a concern. If Bt is indeed harmless to mammals it

would be useful to replace the chemical pesticides with

Bt. In many cases only a small percentage of an insect

pest population feeds on these minor crops, so selection

for resistance to Bt would be much lower than it is in

cotton or corn. If use of Bt was restricted to such crops,

it would be possible to achieve long-term environmentally sound pest control (Strategy 6).

Weediness of Crops With Pest Resistance

Most traditional crops such as corn and tobacco are

unlikely to start reproducing like weeds (i. e., uncontrollably) solely because they have pest resistance. However, semi-domesticated crops are another matter. Poplars,

pine trees, and many pasture grasses and legumes can

already compete well in natural habitats. Pests help maintain a balance among plant species in a pasture or forest.

In mixed hardwood/pine forests, insects and pathogens

are important sources of tree mortality. If a gene for

insect or pathogen resistance were placed in a stand of

cultured pine trees, and pollen from these trees were to

reach native pines there could be a problem. Or if pine

trees became resistant to their insect or microbial pests

but the hardwoods did not, it is reasonable to expect a

significant shift in the balance of hardwoods to pines in

forest. The practical and aesthetic impact of such a change

in forests must be considered.

POLICY IMPLICATIONS

REGARDING

THE DEVELOPMENT

AND DEPLOYMENT OF

ENGINEERED CROPS

If we maintain a laissez-faire policy regarding pest

control, it is likely that developed products will be those

expected to sell best. For example. farmers who have

not been specifically educated about Bt-producing plants

are unlikely to buy seed that produces moderately resistant plants (with hopes that natural enemies can control

the rest ) if seed selling on the same shelf for an equivalent

or lower price produce highly resistant plants.

Only if companies exert restraint in marketing their

seed will there be any potential for a multifaceted approach to resistance management. For example, if only

one company has a product (such as Bt in cotton) priced

such that only 50 percent of the farmers in an area decide

to use it, other approaches will be adopted. When two

companies have the product this is less likely to happen.

Even when one company controls the market, economic

analyses may dictate going for the highest volume of

sales.
Chapter 6—Management implications of New Technologies . 167

In that Bt is a naturally occurring organism that has

been used by organic farmers for many years, there may

be potential for regulating the use of Bt products based

on resistance risk, even though synthetic chemicals have

not been regulated on that basis. If it can be shown that

the traditional uses of Bt would not lead to evolution of

resistance as rapidly as new biotechnology approaches

using Bt toxins, there may be grounds for some regulation

of use. This issue is not yet resolved and the Environmental Protection Agency (EPA) does not seem to be

pursuing the issue.

Weed resistance problems may be somewhat different

than insect resistance problems. In the case of most insects, resistance is an area-wide phenomenon—what one

farmer does affects other farmers in the region. The stage

is set for a tragedy of the commons with no farmer willing

to comply with practices that would help others who may

be cheating. Weed seed and pollen do not move as far

as most insects, so resistance can become a single-farm

or even a single-field phenomenon. If one farmer overuses a herbicide and winds up with a resistance problem,

other farmers who hear about it may be cautious about

using that herbicide too frequently, even if it is inexpensive. If glyphosate use leads to resistance in one area

of the mid-south, farmers in other areas may respond by

becoming more cautious in decisions to use the product.

Educational programs to point out risks to farmers would

be very appropriate, and could be very effective in this

case, but much research is needed to bolster the information content of such educational programs.

Overall, we already have enough information to formulate general policies that prescribe judicious use of

engineered crops with insect and pathogen resistance and

herbicide tolerance. However, if we are to make detailed

rulings about the development and use of specific products of biotechnology, we will need to generate a body

of empirical knowledge relevant to these products. And,

we will need an educational program designed to bring

these results to the farmer and the public.

A NEW ISSUE IN ANIMAL

AGRICULTURE MANAGEMENT

The use of new animal technologies will place a premium on the management capabilities of livestock producers. Research results clearly show the extent of response

achieved depends heavily on the management capability

of the producer. Use of somatotropins, for example, may

require altering the animals’ diets. Growing pigs receiving somatotropin will require diets high in protein, and

with adequate levels of the necessary amino acid, lysine.

Administration of somatotropin to lactating cows may

require extending the reproductive cycle to 14 months

instead of using the current 12-month cycle. The availability of many different types of growth promotants may

result in the use of more than one at the same time.

Compatibility of these promotants will be an important

management issue. Thus, producer management skills

are critical to the optimal use of these technologies.

As important as these management issues are, a more

pressing management issue is that of animal welfare—

with or without biotechnology as a complicating factor.

Society has focused on many of the resulting impacts of

technologies such as environmental quality, food safety,

and decline of the small farm and rural communities.

Farm animal well-being is the most recent concern to

receive attention. Much of the success in increased productivity in agriculture has been the result of lowered

costs through the use of confinement systems—which

some have coined factory farming. The question from

an animal welfare perspective is whether we have gone

too far.

Farm Animal Well-Being

In the decade of the nineties, the advance of new

animal technologies will coincide with increasing interest

in farm animal well-being. This interest is not new. It

nucleated in England at the turn of the 19th Century with

the formation of the Royal Society for the Prevention of

Cruelty to Animals. This in turn led to the organizing of

more radical groups. In America, the American Society

for the Prevention of Cruelty to Animals was formed in

the 1860s by a Special Act of the New York State Legislature. However, it was not until the late 1970s and

early 1980s that the majority of animal welfare/rights

organizations were formed. Although no specific records

are kept, estimates indicate that today there are a total

of 7,000 animal welfare/rights groups in the United States

with a combined total budget of $50 million (81).

Widespread public concern for farm animals began to

develop in 1963 with the publication of Animal Machines. This book by Ruth Harrison (46) chronicled the

problems in farm animal well-being in the United Kingdom that led to the Brambell commission and its report

enunciating the famous ‘‘Five Freedoms’ ‘—to lie down.

stand up, turn around, stretch, and groom.

Concern built steadily in Europe, and in 1979 the first

European meeting on farm animal welfare was held. European governments have allocated significant public funds

to research on alternative farm systems and the European
168 . A New Technological Era for American Agriculture

Community (EC) has supported numerous symposia on

the well-being of various farm animals. Legal protection

for farm animals includes far-reaching laws in Sweden

and Switzerland.

In the United States the level of concern has grown

more slowly. However, in the past few years the pressure

on farmers and animal scientists to address the issue of

farm animal welfare has increased steadily. The issue of

farm animal welfare has provided important impetus to

a movement that may eventually be considered as significant by policy makers as that for environmental and

food safety concerns. Today, the issues of animal welfare/rights foster well-entrenched polar positions. The

polarity between the agricultural establishment and animal well-being advocates has highlighted the extremes

of each group’s position. Economics, values, and institutions determine care and treatment of farm animals.

These factors divide into two animal welfare paradigms:

the traditional and the alternative. Which paradigm will

dominate future public policy for animal welfare remains

to be seen (94).

The Traditional Paradigm

Those who hold the traditional paradigm of animal

welfare draw on the market model of free enterprise, and

on Judeo-Christian ethics.

The Market Model—Advocates of the market model

argue that farm animals subject to cruelty and neglect

give fewer eggs and less milk, meat, or wool than welltreated and properly cared for animals. Why not, they

ask, depend on profits to ensure farm animal welfare?

Quantifiable variables such as feeding efficiency, rate

of growth or productivity, morbidity, and mortality rates

can provide proxy measures of animal welfare. Favorable

values for those objective measures of humane treatment

for the most part are consistent with good management

and high profits.

Advocates of the market model further argue that confinement systems improve some dimensions of animal

welfare. Temperature, disease, and pest control are improved. Predators are kept away. Nutrition is enhanced.

Modern farming systems have lowered costs and expanded utilization, allowing more animals to exist.

The Judeo-Christian Ethic—Advocates of the traditional paradigm hold the Judeo-Christian ethic that God

created man in his own image, that man is unique in

having a soul, that man has dominion over animals, and

that man as husbandman and steward of God’s kingdom

is not to practice cruelty to or neglect animals (77, 86).

Many advocates of this position hold that no element of

society has more compassion for poultry and livestock

than does the farmer (45). Other than laws protecting

animals from cruelty and neglect, advocates of this view

consider laws, rules, and regulation on care and treatment

of farm animals to be unwarranted infringement on free

enterprise. This creed holds that 1 ) proprietors deserve

the right to prescribe rules under which they operate; and

2) a prime function of government is to prevent anyone,

including the government, from infringing on the managerial freedom of proprietors (5).

Some traditionalists will admit that, despite market

incentives, cruelty-neglect laws, and producers with the

Judeo-Christian ethic, animal welfare falls short of the

ideal. But they contend that ‘‘Big Brother’ intrusions of

an expensive and often incompetent bureaucracy into

managerial prerogatives of farmers would entail more

social cost than the abuses government is attempting to

correct. They favor minimal policy intervention consistent with the traditional paradigm as the lesser of two

evils.

Alternative Paradigm

An increasing number of people reject the Judeo-Christian ethic and market paradigm in favor of an alternative

paradigm emphasizing animal rights or much enhanced

animal welfare. As with the traditional paradigm, the

alternative has economic and ethical dimensions.

Market Failure—Animal welfare has public goods

properties, implying that the market alone will not bring

the proper level of animal welfare. Externalities are apparent: all the public benefits from seeing livestock freely

grazing in a meadow. Animal rights activists contend

that the market results in confinement cages allowing too

little space per animal for laying hens, sows, and veal

calves. The drive to reduce costs and cater to consumer

demand has kept veal calves isolated, in the dark, and

on low iron diets; has disfigured animals, by encouraging

practices such as trimming chickens’ combs and beaks

and pigs’ and lambs’ tails. According to activists, animals are not allowed their “natures’ ‘—socialization, sex,

exercise, nest building, nurturing of offspring, the outdoors, and a full life.

However. the role of markets in shaping the way farm

animals are raised cannot be denied. Market forces have

raised real prices of land and labor, and reduced the

relative price of capital. Rising labor and land prices have

placed a premium on labor-saving and land-saving meth-
Chapter 6—Management Implications of New Technologies . 169

ods of production. Gains in income and population along

with changes in production technologies, including disease control, have interacted with prices to create economies of size and to make confinement systems feasible.

Small may be beautiful but it is frequently not competitive. The small-scale poultry operator is nearly extinct;

the small Wisconsin dairy has difficulty competing with

the large industrial-type California dairy farm; and the

family hog farm in Iowa has difficulty competing with

the large confinement operations in Arkansas. Animal

welfare enthusiasts view these outcomes of market forces

as a disaster to farm livestock and to traditional farmers,

rather than as a means toward cheaper food. more land

for urban use, and higher income for the Nation.

Ethics—The alternative paradigm views man as an

evolutionary product of a holistic Nature. Man is one

with nature and must live in harmony with plants and

animals. If he has primacy, it is to be used to ensure the

rights of the rest of nature.

Philosopher Jeremy Bentham’s (4) much-quoted comment summarizes the basis for the ethical treatment of

animals under the alternative paradigm: ‘‘The question

is not Can they reason’? nor, Can they talk’? but, Can

they suffer’?’

Animals that are sentient (can experience pleasure or

pain) are to be afforded rights given to people. Killing

an animal is murder and eating its flesh is cannibalism.

Hard-core animal rights adherents have little alternative

to vegetarianism. Other advocates do not go that far but

insist on improving animal welfare through provision for

each species’ nature.

Animal suffering and pain is probably the most powerful rationale for the public’s concern over farm animal

welfare. This concern must be addressed by objective

research.

Research Needed

To understand and fulfill agricultural animals’ needs,

more must be learned about their fundamental psychological and behavioral processes. Researchers must be

able to elucidate farm animals’ cognitive and motivational processes before it is possible to begin to answer

such rudimentary and obvious questions about their wellbeing such as: How does this animal feel in one environment versus another? Is the animal suffering—and if

so. how much? For example, when the animal’s farm

environment is devoid of a particular feature that would

characterize its natural environment, does the animal suffer—and if so, how much (11, 12)?

The scientific community generally has been slow to

accept the notion of animal awareness and only recently

has such recognition been forthcoming. Many in agriculture now acknowledge that animals are aware of themselves and their surroundings, and thus scientists are

beginning to give attention to animals’ conscious sensations of well-being. Only recently have factors that

affect conscious well-being been considered logical criteria for the design of animal accommodations. However,

there exists little hard data on which to base such a design

strategy.

How an animal feels, some assume, depends largely

on how it expects to feel. How it expects to feel in turn

depends on how it thinks, remembers, and imagines.

How an animal feels also depends on factors such as the

predictability and controllability of its environment ( 100).

Feeling, thinking, remembering, and imagining are

cognitive processes. To the extent that feeling and thus,

thinking, remembering, and imagining affect an animal’s

overall well-being, and therefore its health and productivity, these cognitive processes are factors to be considered in the economic and humane production of

agricultural animals.

There is reason to believe that when an animal experiences a feeling of malaise, its productivity is reduced,

if only slightly. However, such decrements are cumulative; and together they can reduce productivity significantly. In the chicken, for example, there is recent evidence

that as many as six stressors—ammonia, beak trimming,

coccidiosis, electric shock, heat, and noise—can combine in additive fashion to affect feed intake, growth,

and several important physiological and pathological traits

(64). In addition, stressors and combinations of stressors

occurring in various sequences affect productive performance of chickens in predictable, repeatable ways (52).

This linear additivity of stressor effects on such a variety

of traits suggests that some single phenomenon is governing the animals’ overall response. This could be psychological stress. The following discussion depicts some

of the production practices that animals encounter and

areas of research that are needed ( 12).

Thermal Comfort— Little is known about the perception of thermal comfort by farm animals ( 10). Animals

do respond to changing conditions in their thermal environment with different thermoregulatory behaviors. But

the degree to which animals suffer when experiencing

heat stress or cold stress is not known. One experiment

to find the answer to cold stress of farm animals is cur-
170 ● A New Technological Era for American Agriculture

Photo credit: University of Illinois

An example of a thermal comfort experiment involving

pigs operating a heat switch. The sitting pig—

presumably because it felt the environment was too

cool—has just operated the switch in the panel to

engage the heater.

rently underway involving pigs operating a heat switch

when they feel cold.

Another thermoregulatory behavior response is wallowing by swine under heat stress. Wallowing in mud

compensates for the pig’s absence of thermal sweating.

Research has shown that sows wallow only when environmental temperature exceeds some threshold (e.g., 12 “C

for sows in one experiment) (83). This limited research

suggests that swine wallow only to achieve thermal comfort, not because they need to wallow or enjoy wallowing

as play. If the thermal environment is maintained below

12 “C all the time, sows never take advantage of a mud

wallow even if it is provided.

Quality of Space-The richness of an environment is

somehow perceived by animals because it affects how

they behave and function. The behavior repertory of swine

in natural settings is larger than it is in typical production

environments (88).

When contemporary production environments are furnished with enriching features, pigs readily make use of

these features and thereby expand their behavior repertories. Nehring (71) built a maze in a pig pen. McGlone

and Curtis (67) provided pigs hiding places for their heads

allowing them to submit to and subsequently avoid an

aggressive pen mate. Fraser provided pigs a mezzanine

for use in getting away from group mates ( 19, 74). Grandin (40) enriched pig environments with suspended manipulanda (pig toys). Pigs reared in enriched environments

proved easier to be moved about than pigs in traditional

production environments (43). Pigs residing in pens

equipped with suspended manipulanda fouled their feeder

markedly less often than did those in a relatively barren

environment (92).

From the above, it might be inferred that animals in

richer natural or artificial environments behave differently and experience an enhanced sense of well-being

compared to those in more barren surroundings. But this

has not been determined scientifically to be the case, and

many questions persist. For example, do pigs enjoy a

higher sense of well-being when able to use enriched

features’? Are they starved for stimulation in less rich

environments’? If so, does this lead to a craving for stimulation’?

Commercial gilts and sows often reside during pregnancy in rectangular crates that prevent them from turning around. When living in a crate shaped so as to permit

her to turn around, a pregnant gilt will turn around approximately 13 times daily in a crate 61 cm wide, but

only 9 times daily in a 56 cm wide crate (in which it is

more difficult for the gilt to turn around) (63). Little is

known about what motivates a gilt to turn around. Does

she need to turn around’? Does this need affect her productive performance’?

How an animal perceives its living space may be crucial to its sense of well-being. Sometimes space can be

modified physically or rearranged so as to make it more

accommodating to the animal. For example, animals in

pens have a propensity to keep their heads at or to lie

around the perimeter of a pen instead of in the middle

(39, 90). A triangle has 28 percent more perimeter and

a square 13 percent more than a circle of equal area.

Thus, of the three, triangular pens maximize the ratio of

perimeter to area. Should animal facilities be built with

triangular pens and cages instead of rectangular ones to

enhance the animals’ comfort’? Is it necessary to have

more space in a rectangular pen to engender the same

feeling of well-being that an animal would experience in

a square pen of equivalent perimeter’?

Learned Helplessness— Animals often encounter

frustrating situations and presumably these may decrease

their well-being. For example, when anything gets in the

way of an animal on its way to the feeder to eat, that

animal becomes frustrated. Frustration is one of the prepathological states indicative of stress (69). Frustrating

situations generally are stressful, as indicated by various

physiological indicators ( 13).
Chapter 6—Management Implications of New Technologies . 171

Farm animals may be frustrated when engaged in any

strongly motivated behavior pattern, whether eating,

nesting, and engaging in sexual activities, among others.

Depending on the circumstances, for example, frustrated

hens may show displacement behavior—behavior patterns that occur out of context with preceding and succeeding behavior ( 16).

In other settings, an animal may find that it can neither

control its environment nor predict what its environment

will be, and the animal may learn to act in a helpless

manner. In a state of learned helplessness, an animal

stops initiating behavior aimed at controlling or making

use of environmental features because it has learned to

expect that these features are uncontrollable and that these

attempts would be futile (84).

Animals residing in certain intensive production systems might well learn to expect that they have little or

no control over their surroundings. It is possible that

agricultural animals living in certain housing systems

may develop learned helplessness ( 14, 61. 62). Learned

helplessness would be another of the prepathological states

indicative of stress (69).

Nestbuilding—Females of all domestic avian species

build nests in which they lay their eggs. The domestic

hen will engage in nest-building every day, even when

a previous nest exists. It seems that the performance of

nest-building is itself positively reinforcing to the hen

(50).

Most sows attempt to construct a farrowing nest beginning 12 to 16 hours prior to delivering the first pig,

regardless of where they are (51). In many modern farrowing environments, there is neither the space in which

to conduct nest-building behavior nor the material with

which to build a nest. Sows nevertheless direct substantial amounts of time toward small amounts of material

even though a nest may not result. This suggests that for

the sow, as for the hen, nest-building behavior in itself

is rewarding (99). Research is needed to answer such

questions as: Do hens and sows need to build nests’? How

much frustration do they experience when they either

cannot move enough material to nest-build or cannot find

nesting material? How do they feel when they cannot

build a nest? Does this feeling in sows result in hormonal

changes that are an anathema to oxytocin’s actions in

birth and lactation’?

Electro-Immobilization— Animal may find certain

procedures routinely performed in agricultural production to be uncomfortable or even painful. When an animal

Photo credit: University of Illinois

The sow—in anticipation of delivering a litter of piglets

within a few hours—is building a maternal nest to

protect the piglets from cold and predators.

actively avoids a procedure it is presumably revealing

negative feelings about the procedure. Ewes having experienced restraint by electro-immobilization and by a

squeeze-tilt table, when given the choice between the

two in a Y-maze avoid-avoid test, chose the squeeze-tilt

table 79 percent of the time, and the electro-immobilizer

13 percent (42). Questions that need answers include:

What was the ewe thinking as she hesitated at the decision

point, indicating by her head movements that she is vacillating? Was she actually imagining the feeling she experienced during electro-immobilization earlier’? Based

on the ewe’s reactions, when should the electro-immobilizer not be used? What behavior indicators identify

the point beyond which it would be inhumane to continue

subjecting the ewe to the procedure?

Chicken-Harvesting Machine— Animals can adapt in

a matter of seconds to machines with which they are

forced to interact, provided that the machines are designed with the animal’s nature in mind. Take, for example, the chicken harvesting machine developed in the

United Kingdom. The harvesting of birds from growing

houses is a monumental task. Moreover, considerable
172 ● A New Technological Era for American Agriculture

losses are incurred in the process of harvesting and transportation, especially in the hand-catching and hand-crating

processes (25).

A prototype chicken-harvesting machine has been

evaluated in terms of the stressfulness of the harvesting

process ( 15). By means of electrocardiograms and immobility tests, it has been found that the stress from

harvesting could be reduced by catching and picking up

broiler chickens with a carefully designed machine, rather

than by hand. Heart rate dropped back to normal more

quickly and duration of tonic immobility (a phenomenon

that increases with fear) was much shorter in machineharvested birds than in those caught by hand. Research

questions include: What is a chicken thinking when it is

manually caught by one leg and carried upside down to

the crate in which it will be transported to the processing

plant’? How does this contrast to what it is experiencing

when it is caught by the long rubber fingers of a chickenharvesting machine, moving it onto a moderately inclined

conveyer belt, which it rides to the gathering stage’?

Double-Rail Restrainer Conveyor System—Means of

rapidly moving large numbers of animals of all kinds are

needed in the production and processing industries. The

V-restrainer, in which animals are moved along and wedged

between two v-angled conveyor belts, with their legs

dangling, is a vast improvement over driving animals

through a chute, but it gives rise to additional problems.

A prototype of this system was developed in the late

1970s, and it caused little premortem stress in animals

when used in a processing plant (98). The system was

further developed for applications ranging from veal,

lamb, and swine slaughter lines to feedlot cattle processing. When designed specifically for the species and

size range to be handled, the animals apparently find the

conveyer belt comfortable to ride. Adjustable sides prevent the animal from leaning sideways which is important

because tilting sideways seems to frighten the animal.

As the above discussion illustrates, there are many

questions to be answered regarding animal welfare. Of

particular importance is the effect of animal well-being

on the animal’s performance. Some research seems to

indicate that the amount of psychological stress an animal

experiences determines how the pituitary-adrenal axis

responds. In other words, psychological stress may be

reducing the animal’s performance as well as the animal’s

well-being. Much more research is needed to understand

such relationships. To date, little research has been done

in the United States on animal well-being.

Biotechnology and Farm Animal Well-Being

In the past few years, animal protection groups have

begun to voice concerns about biotechnology. Their concerns are rather diffuse and it is difficult to determine

precisely what could be done to address those concerns.

The new techniques for manipulating genetic material

strike at some deep-seated fears amongst animal protection groups. While there are few concise papers explaining animal protection concerns, a reading of the relevant

literature leads to the identification of the following issues:

. reinforcing notions of animals as mere property to

be manipulated at the whim of human owners, and

. animal well-being issues (81).

Manipulation of Property

Genetic engineering conjures up images by some in the

animal protection movement of animal machines being reconstructed by ingenious scientists to meet human needs.

The push to be allowed to patent animals (discussed in

ch. 15) merely reinforces the idea of animals as patentable

machines. At a time when the animal movement is pushing

to increase the moral status of animals to, at the very least,

something between persons and property, the biotechnology era and patenting seem to be a major step backwards.
Chapter 6—Managenwnt Implications of New Technologies ● 173

Animal Well-Being Issues

The impact of biotechnology on animal well-being is

probably the most challenging issue genetic engineering

raises. The technology is most likely impact-neutral in

that one could use biotechnology to improve animal wellbeing (e.g., engineer disease resistance, eliminate detrimental genes from a population) as well as compromise it.

The clearest example of compromised well-being is the

"Beltsville pig” (discussed in ch. 3). This pig is the result

of research at the U.S. Department of Agriculture (USDA)

in Beltsville that involved the insertion of extra growth

hormone genes. When the extra genes were expressed, the

animal grew fast but, as it gained weight, it became lame

and lethargic and suffered from degenerative joint disease

and a variety of other disorders (41 ). There is little doubt

that the animal was under stress as a result of the genetic

manipulation. Questions also have been raised about the

quality of life for the “oncomouse’ and some of the other

mice that have been developed to shorten the time of standard carcinogen and mutagen tests.

It is also possible, however, that some genetically engineered animals might reduce the need for research animals and hence qualify as alternatives. Among farm

animals, moreover. it may be possible to use genetic

engineering to eliminate the horn gene in cattle, thereby

removing the welfare problems associated with dehorning (4 1 ). While some object strongly to the proposal that

farmers should create breeds of microcephalic (small

brained) farm animals that are quite content in close

confinement (41 ), others say that as long as the animal

is in a state of positive well-being, such a creation would

not be morally objectionable though there may be some

esthetic problems with such creatures (79). To date, there

has been little discussion or debate of these questions.

and about the most that can be concluded at this stage

is that careful monitoring of transgenic animals to determine their state of well-being is essential. As more

experience and research with transgenic animals takes

place, it will be possible to develop more sensible guidelines and conclusions.

Biotechnology is a priori neither good nor bad for

animals. Its impact depends on what is done and its

effect. If it is used judiciously to benefit humans and

animals, with foreseeable risks controlled, and the welfare of the animals is kept in mind, it is morally defensible

and can provide great benefits.

CHAPTER 6 REFERENCES

1. Barrett, S., “Crop Mimicry in Weeds, ” Economic

Botany 37:255–282, 1983.

7k.

. . 3

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

16.

17.

Beachy, R.N. et al., “Genetic Engineering of Plants

for Protection Against Virus Diseases, ” Plant Resistance m Viruses. D. Ever and S. Harnett (eds. )

(New York, NY: Wiley & Sons, 1990), pp. 151-

158.

Benfey, P.N. and Chua, N. H., “Regulated Genes

in Transgenic Plants. ’ Sciencr 244: 1 74– 181, 1989.

Bentham, J., The Work.v of JeremJY Bet~tilam, .I.

Bowring (cd.), vol. 1 (New York, NY: Russell and

Russell, 1962). pp. 142-143.

Brewster, J.. ‘‘Societ y Values and Goals in Respect

to Agriculture, ’ Chapter 6 in Goals ~~nd VLllue.Y in

Agricultural Policj’ (Ames. 1A: IOWa State University Press, 1961 ).

Burch, T., Professor, Cooperative Extension Program, Louisiana State University. Baton Rouge,

LA, personal communication, Dec. 20, 1990.

Coble, H., Professor, Crop Science Department,

North Carolina State University, Raleigh, NC, personal communication, Dec. 18 and 20, 1990.

Comai, L. and Stalker, D. M., ‘‘Impact of Genetic

Engineering on Crop Protection, ” Crop Pro?. 3:399–

408, 1984.

Curtis, C.F. and Otoo, L. N., “A Simple Model

of the Build-Up of Resistance to Mixtures of AntiMalarial Drugs, ” Trans. Roy. Sot. Trop. Med. &

kl~g. 80:889-892, 1986.

Curtis, S.E. “Perception of Thermal Comfort by

Farm Animal s,’ Farm Animal Welfilre and Holt.Ying, S. H . Baxter, M.R. Baxter, and J. A.D.

MacCormack (eds. ) (Boston. MA: Mafiinus Nijhoff,

1983), pp. 59-66.

Curtis, S., ‘‘Environment and Animal Behavior, ’

commissioned background paper prepared for the

Office of Technology Assessment, 1991.

Curtis, S. and Stricklin, R., “The Importance of

Animal Cognition in Agricultural Animal Production Systems: An Overview, ’ a paper presented at

the symposium, Cognition and Awareness of Animals: Do Farm Animals’ Perceptions Affect Their

Production or Well-Being’? 1991.

Dantzer, R. and Mormede, P., “Can Physiological

Criteria be Used to Assess Welfare in Pigs?” The

Welftlre of Pig.~, W. Sybesma (cd. ) (Boston. MA:

Martinus Nijhoff, 1981), pp. 53–73.

Deaton, R., Monsanto Agriculture Co., St. Louis.

MO, personal communication, Dec. 18, 1990.

Duncan, 1.J. H. et al., “Comparison of the Stressfulness of Harvesting Broiler Chickens by Machine

and by Hand,’” Br. Poultr. Sci. 27: 109, 1986.

Duncan, 1. J. H., “The Welfare of Farm Animals:

An Ethnological Approach,” Sci. Prog. 71:317, 1987.

Fincher, R., Pioneer, personal communication. Dec.

21, 1990.
174 ● A New Technological Era for American Agriculture

18.

19.

20.

21.

22.

23.

24.

25.

26.

27.

28.

29.

30.

31.

32.

Fox, M. W., “Farm Animals: Husbandry, Behavior, and Veterinary Practice’ (Baltimore, MD:

University Park Press, 1984), pp. 237–249.

Fraser, D., Phillips, P. A., and Thompson, B. K.,

“A Test of a Free-Access Two-Level Pen for Fattening Pigs, “ Anim. Prod. 42:269, 1986.

Fraser, R. S. S., “Genetics of Plant Resistance to

Viruses, ” Plant Resistance to Viruses, Ciba Found.

Symposium /3.?, D. Evered and S. Hamett (eds. )

(New York, NY: Wiley & Sons, 1990), pp. 6-15.

Frisbee, R.E. et al., “Implementing 1PM in Cotton, ’ Integrated Pest Management Systems and

Cotton Production, R.E. Frisbee, K.M. E1-Zik,

and L.T. Wilson (eds. ) (New York, NY: J. Wiley

& Sons, 1989), pp. 389-412.

Gallun, R. L., “Genetic Basis of Hessian Fly Epidemics,” Ann. N.Y. Acad. Sci. 287:223–229, 1977.

Gelemter, W. D., “Targeting Insecticide-Resistant

Markets, ” Managing Resistance to Agrochemicals, ACS Symposium Series 421, M. B. Green,

H.M. LeBaron, and W.K. Moberg (eds. ), Am.

Chem. Soc., Washington, DC, 1990, pp. 105-

117.

Georghiou, G. P., ‘‘Overview of Insecticide Resistance , Managing Resistance to Agrochernicals,

ACS Symposium Series 421, M.B. Green, H.M.

LeBaron, and W.K. Moberg (eds. ), Am. Chem.

Soc., Washington, DC, 1990, pp. 18-41.

Gerrits, A. R., de Koning, K., and Migchels, A.,

“Catching Broilers, ” Poultry 1(5):20, 1985.

Goldberg, R., Environmental Defense Fund, New

York, NY, personal communication, December

1990.

Goldberg, R. et al., “Biotechnology’s Bitter Harvest, ” Biotech. Work. Group, Rural Advancement

Fund International, Pittsboro, NC, 1990.

Goodman, R. M., “Future Potential, Problems, and

Practicalities of Herbicide-Tolerant Crops from Genetic Engineering, ” Weed Sci. 35:28–31, 1987.

Gould, F. “Simulation Models for Predicting Durability of Insect-Resistant Germ Plasm: A Deterministic Diploid, Two-Locus Model, ” Environ.

Entomol. 15: 1– 10, 1986a.

Gould, F., “Simulation Models for Predicting Durability of Insect-Resistant Germ Plasm: Hessian

Fly (Diptera: Cecidomyiidae)-Resistant Winter

Wheat, Environ. Entomol. 15: 11–23, 1986b.

Gould, F., “Evolutionary Biology and Genetically

Engineered Crops, ” Bioscience 38:26–33, 1988.

Gould, F., “Managing Pest Adaptation to Genetically Engineered Crops, ’ pp. 80–86, in National

1PM Coordinating Committee, 1989, Proceedings

National Integrated Pest Management Symposium/

Workshop, Las Vegas, Nevada, Apr. 25-28, 1989,

Communications Service, NY AES, Cornell Univ.,

Geneva, NY., 1989, 276 p.

33.

34.

35.

36.

37.

38.

39.

40.

41.

42.

43.

44

45.

46.

Gould, F., “Ecological Genetics and Integrated

Pest Management, ” Agroecolog~, C.R. Carroll,

J.H. Vandermeer, and P.M. Rosset (eds. ) (New

York, NY: McGraw-Hill Publishing Co., 1990),

pp. 441-458.

Gould, F., ‘‘Evolution of Resistance to Toxic Compounds by Arthropods, Weeds and Pathogens, ”

commissioned background paper prepared for the

Office of Technology Assessment, 1991.

Gould, F., “The Evolutionary Potential of Crop

Pests, American Scientist, vol. 79, November/

December, 1991.

Gould, F. and Anderson, A., “Effects of Bacillus

thuringiensis and HD-73 Delta-Endotoxin on Growth,

Behavior, and Fitness of Susceptible and ToxinAdapted Heliothis virescens (Lepidoptera: Noctui-

&e) Strains,” Environ. Entornol. 20:30-38, 1991.

Gould, F. and Weissinger, A., “Roles for Public

and Private Sector Scientists in Developing PestResistant Crops, ” New Directions in Biocontrol,

P. Dunn and R. Baker (eds. ), Proc. Univ. California Los Angeles Molecular Biology Symposium, 1990, pp. 641-648.

Gould, F. et al., “Feeding Behavior and Growth

of Heliothis virescens Larvae (Lepidoptera: Noctuidae) on Diets Containing Bacillus thuringiensis

Formulations or Endotoxins,” Entomol. E.rp. Appl.

58:199-210, 1991.

Grandin, T., “Livestock Behavior as Related to

Handling Facilities Design, ” lnt. J. Stud. Anim.

Prob. 1 :33, 1980.

Grandin, T., ‘*Double Rail Restrainer Conveyor for

Livestock Handling, ” J. Agric. Eng. Res. 41:327,

1988,

Grandin, T., “Biotechnology and Animal Welfare, ” Animal Biotechnology?* and Qualih of Meat

Production, L.O. Fiems, B.G. Cottyn, and D.1.

Demeyer (eds. ) (Amsterdam: Elsevier, 1991), pp.

145-157.

Grandin, T. et al., “Electro-immobilization versus

Mechanical Restraint in an Avoid-Avoid Choice

Test for Ewes, ” J. Anim. S(’i. 62: 1469, 1986.

Grandin, T. et al., ‘‘Richness of Pig’s Environment

Affects Handling in Chute,” J. Anim. Sci, 63( Suppl.

1): 161 (Abstr. ), 1986.

Grogl, M. et al., “Leishmania spp.: Development

of Pentostam-Resistant Clones in vitro by Discontinuous Drug Exposure, ” Exp. Parasite/. 69:78–

90, 1989.

Guither, H. and Curtis, S., “Changing Attitudes

Toward Animal Welfare and Animal Rights, ” FS8,

The Farm and Food S>stem in Transition (East

Lansing, Ml: Cooperative Extension Service,

Michigan State University, 1983).

Harrison, R., Animal Machines (London, England:

Stuart, 1964).
Chapter fi-kfanagement Implications of NeMY Tt~c.ll\l~~l~~,qi(~.s ● 175

47.

48.

49.

50.

51.

52.

53.

54.

55.

56.

57.

58.

59.

Headley, J.C. and Hey, M. A., ‘b Benefit/Cost

Analysis of an Integrated Mite Management Program for Almonds, ’ J. Ecwn. Entomol. 80:555-

559, 1987.

Heinricks, E.A. et al., “Susceptibility of Rice Plant

Hoppers, Nilapar\wta lugens and Sogatella ji4r(’i-

/i)ra ( Homoptera: I)elphacidae) to Insecticide as ]ntlucnced by Level of Resistance in the Host Plant. ’

En}’iron. Entomol. 19:455-458, 1984.

Hey, M. A., “Almonds (California): Integrated Mite

Management for California Almond Orchards. ’

Spider Mites, Their Biolog>, Natural Enemies [Jnd

Control, W. Helle and M.W. Sabelis (eds. ) (Amsterdam: Elsevier, 1985), pp. 299–3 10.

Hughes, B. O., Duncan, I. J. H., and Brown, M. F.,

“The Performance of Nest Building by Domestic

Hens: 1s It More Important Than the Construction

O( a Nest’?’ Anim. Behatt. 37:2 10, 1989.

Hurnik, J. F., ‘‘A Review of Periparturient Behavior in Swine, ’ Can. J. Anim. Sci. 65:777, 1985.

Johnson, R. W., Curtis, S. E., and Shanks, R. D.,

“Effects on Chick Performance of Ammonia and

Heat Stressors in Various Combination Sequences, ’ Poulf. Sci. 70: 1132, 1991.

Kennedy, G., ‘‘2-Trldecanone, Tomatoes and ~e_

Iio[his ceu: Potential Incompatibility of Plant Antibiosis with lhsecticidal Contro l,’ Entomol. Exp.

& Appl. 35:305-3 I I , 1984.

Kennedy, G., Department of Entomology. North

Carolina State University, Raleigh. NC, personal

communication, August 1990 and October 1990.

Kennedy, G. G.. Farrar, R. R., and Riskallah, M. R.,

‘ ‘Induced Tolerance of Neonate Heliothis zea to

Host Plant Allelochemicals and Carbaryl Following

Incubation of eggs on Foliage of L]copersicon hirsutum f. glabrutum, Oecologia 73:615-620, 1987.

Kirsch, K. and Schmutterer, J.. “Low Efficacy of

a Baci//us thuringiensis (Ber. ) Formulation in Controlling the Diamondback Moth, Plutella .rylostella

(L.), in the Philippines, “J. Appl. Entornol. 105:249-

255, 1988.

LeBaron, H.M. and McFarland, J., “Herbicide

Resistance in Weeds and Crops, ” Managing Resistance to Agrochemicals, ACS S>’mposiurn Series

42/, M.B. Green, H.M. LeBaron, and W.K. Moberg (eds. ), Am. Chem. Soc., Washington, DC.,

1990, pp. 336-352.

LeBaron, H., Ciba Geigy Corp., Greensboro, NC,

personal communication, March 1991.

Leemans, J. et al., “Insecticidal Crystal Proteins

from Bacillus thuringiensis and Their Use in Transgenic Crops, ” New’ Directions in Biological Control, R.R. Baker and P.E. Dunn (eds. ), Proceedings

of Univ. California Los Angeles Molecular Biology

Symposia, 1990, pp. 573-588.

60.

61,

6~

63.

64.

65.

66.

67.

68.

69.

70.

71.

72.

73,

74.

75.

Marrone, P.G. et al., ‘‘Discovery of M icrobial Natural Products as Sources of Insecticidal Genes, Novel

Synthetic Chemistry. or Fermentation Products. ’

Bi{~t[~(ht~{~l~jg~’, Biolo<qi~’a[ Pestit.ides and NOLCI

Plant-Pest R(~.si.st[~tl([~,/i~l- In.set’t Pest Management,

D,W. Roberts and R.R. Granados (eds. ), Boyce

Thompson Inst.. Cornell Univ., Ithaca, NY, 1989,

pp. 1 12– 114.

McBride, G., “Feral Animal Studies in Animal

Science: The Uses and Limitations of Feral Animal

Studies to Contemporary Animal Science, ’ J. Anim.

Sci. 58:474, 1984.

McBride. G. and Craig. J. V., “Environmental Design and Its Evaluation for Intensively Housed Animals, Appl. Anim. Beha\’. Sci. 14:2 I I , 1985.

McFarlane. J. M., Bee. K. E., and Curtis. S. E.,

*’Turning and Walking by Gilts in Modified Gestation Crates, J. Anim. S~i. 66:326. 1988.

McFarlane, J.M. et al., ‘‘Multiple Concurrent

Stressors in Chicks. 1. Effect on Weight Gain, Feed

Intake, and Behavior, ” Poult. Sci. 68:501. 1989.

McGaughey, W. H., ‘

b Insect Resistance to the Biological Insecticide Bacil/us tlzl(~-i~?gi(~l? .si.st’, Sciem’e 229: 193– 195, 1985.

McGaughey, W.H. and Johnson, D. E.. “Toxicity

of Different Serotypes and Toxins of Bacillus thuringiensis to Resistant and Susceptible Indianmeal

Moths (Lepidoptera: Pyralidae), ” J. Econ. Entomo/. 80: 11 22– 1126, 1987.

McGlone, J.J. and Curtis, S. E., “Behavior and

Performance of Weanling Pigs in Pens Equipped

with Hide Areas, ’ * J. Anim. S~i. 60:20, 1985.

Miller, D. L., Rahardja, U., and Whalen, M. E.,

“Development of a Strain of Colorado Potato Beetle Resistant to Bt, ” Pestk’ide Resistan(’e Ni~~~.VIetter 2(2):25, 1990.

Moberg, G. P., ‘*A Model for Assessing the Impact

of Behavioral Stress on Domestic Animals. Y.

Anim. Sci. 65: 1228, 1987.

National 1PM Coordinating Committee, Proceedings National Integrated Pest Management Symposium/Workshop, Las Vegas, Nevada, Apr. 25-

28, 1989, Communications Services, NY AES,

Cornell Univ., Geneva, NY, 1989, 276 p.

Nehring, A., “One Answer to the Confinement Pig

Problem, ” Int. J. Stud. Anim. Prob. 2:256, 1981.

Pedigo, L. P., Entomology>* and Pest Management

(New York. NY: MacMillan Publishing Co., 1989).

Peters, W., ‘

b

The Problem of Drug Resistance in

Malaria,” Parasitology 90:705-715, 1985.

Phillips, P. A., Thompson, B. K., and Fraser, D.,

‘‘Preference Tests of Ramp Design for Young Pigs, ’

Can. J. Anim, Sci. 68:41, 1988.

Powles, S.B. and Howat, P. D., “Herbicide-Resistant Weeds in Australia, ” Weed Technol. 4: 178-

185, 1990.
176 ● A Ne}~~ Technological Et-u-for American Agriculture

76.

77.

78.

79.

80.

81.

82.

83.

84.

85.

86.

87.

88.

89.

90.

Raymond, M. et al., Nature 350: 15 1–153, 1991.

Regan, T. and Singer, P., Animal Rights and Human Obligations (Englewood Cliffs, NJ: Prentice

Hall, 1989).

Reichard, D.L. and Ladd, Jr., T. L., “Pesticide

Injection and Transfer Systems for Field Sprayers , Trans ASAE, 1983, 26 p.

Rollin, B. E., ‘‘The Frankenstein Thing: The Moral

Impact of Genetic Engineering of Agricultural Animals on Society and Future Science, Genetic Engineering of Animals: An Agricultural Perspective,

J.W. Evans and A. Hollaender (eds. ) (New York,

NY: Plenum Press, 1986), pp. 285-297.

Roush, R.T. and McKenzie, J. A., “Ecological Genetics of Insecticide and Acaricide Resistance, *

Anw. Rev. Entomol. 32:361–380, 1987.

Rowan, A., “Agricultural Animal Welfare issues, commissioned background paper prepared

for the Office of Technology Assessment, 1991.

Ryan, A., “Proteinase Inhibitor Gene Families: Strategies for Transformation to Improve Plant Defenses

Against Herbivores, ” BioEssa}s 10:20–23, 1989.

Sambraus, H. H., “Das Suhlen von Sauen, ”

Deutsches Tieraerztliche Wochenschrift 88:65,

1981.

Seligman, M. E. P., Helplessness (San Francisco,

CA: W.H. Freeman, 1975).

Shelton, A., New York State Agriculture Experiment Station, Geneva, NY, personal communication, Dec. 21, 1990.

Singer P., Animul Liberation (New York, NY: Avon

Books, 1975).

Stalker, D. M., McBride, K. E., and Malyj, L. D.,

“Herbicide Resistance in Transgenic Plants Expressing a Bacterial Detoxification Gene, ’ Science

242:419-423, 1988.

Stolba, A., “A Family System in Enriched Pens as

a Novel Method of Pig Housing, ” in Altet-natit’es to

lntensi~~e Husbandn S>’stem.s, Univ. Fed. for Animal

Welfare, Potters Bar, UK, 1981. pp. 52–67.

Stone, T. B., Sims, S. R., and Marrone, P. G., “Selection of Tobacco Budworm for Resistance to a

Genetically Engineered P.selt~i{)r?l[jtl{l.y .fll!orc~.~’(”[~t~.j

Containing the Delta-Endotoxin of Bacillus thuringiensis subsp. hwrstaki,” J. In}w-t. Pathoi. 53:228-

234, 1989.

Stricklin, W. R., Graves, H. B., and Wilson, L. L.,

“Some Theoretical and Observed Relationships of

91.

92.

93.

94.

95.

96.

97.

98.

99.

I 00.

101.

102.

Fixed and Portable Spacing Behavior of Animals, ’

Appl. Anim. Ethel. 5:201, 1979.

Tabashnik, B. E., Finson, N., and Johnson, M. W.,

“Managing Resistance to Bacillus thur-ingiensis:

Lessons from the Diamondback Moth (Lepidoptera: Plutellidae), ” J. Econ. Entornol., 1990.

Taylor, 1. A., Grandin, T., and Curtis, S. E., “Pig

Toys: Effects on Feeder-Fouling and Dunging Pattern , J. Anim. !$ci. 63( Suppl. 1): 161 (Abstr. ),

1986.

Teetes, G. L., Becerra, M.1., and Peterson, G. C.,

“Sorghum Midge (Diptera: Cecidormyiidae) Management with Resistant Sorghum and Insecticide, ’

J. Econ. Entomo/. 79: 109 I- 1095, 1986.

Tweeten, Luther, “public Policy Decisions for Farm

Animal Welfare, ’ paper presented to International

Conj?rence on Farm Animal Weffare, June 1991.

U.S. Congress, Office of Technology Assessment,

Beneath the Bottom Line: Agricultural Approaches

to Reduce Agrichemical Contamination of Ground-

}t~ater, OTA-F-417 (U.S. Government Printing Office, Washington, DC: May 1990).

Van Rie, J. et al.. “Mechanism of Insect Resistance to the Microbial Insecticide, ’ Bacillus thuringiensis. Science 247:72–74, 1990.

Weller, D. M., “Biological Control of Soilborne

Plant Pathogens in the Rhizosphere with Bacteria, ’

Ann. Re\. Phytopathol. 26:379-407, 1988.

Westervelt, R.G. et al., ● ’Physiological Stress

Measurement During Slaughter in Calves and

Lambs, ” J. Anim. S[i. 42:831, 1976.

Widowski, T.M. and Curtis, S. E., “The Influence

of Straw, Cloth Tassel, or Both on the Prepartum

Behavior of Sows,” Appl. Anim. Behav. Sci. 27:53,

1990.

Wiepkema, P. R., ‘‘Behavioral Aspects of Stress,

in P.R. Wiepkema and P.W. M. Adrichem (eds. ),

Biolog?’ qf Stress in Farm Animals: An lntegrati~+e

Approach (Boston, MA: Martinus Nijhoff, 1987).

pp. 113-133.

Wilson, L. T., “Estimating the Abundance and Impact of Arthropod Natural Enemies in 1PM Systems, Biological Control in Agricultural lPi14

S?stems. M.A. Hoy and D.C. Herzog (eds. ) (Orlando, FL: Academic Press, 1985), pp. 303-322.

Zalom, F,G. et al., Sampling Mites in Almonds:

11. Pr(~.~etl~e-Al>.~’etl(t~ Sequential Sampling .fbr Te -

tran>(’hus Mite Species 52: 14–24, 1984.
Part III

Environmental Quality
Chapter 7

Environmental Issues: Institutions

and Their Regulatory Roles

Photo credit Jamie Notter, OTA Staff
Page

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 181

Agriculture, Field Trials, and Deliberate Release of Genetically Engineered Organisms . . . . 183

Brief Overview of Concerns . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

Evolution of Regulation and Oversight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 183

USDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Authority for Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 184

Application to Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

Authority for Veterinary Biologics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 191

Application to Veterinary Biologics . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 192

Authority for Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

EPA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 193

Authority of FIFRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 194

Application of FIFRA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 196

Authority of TSCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 197

Application of TSCA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ....200

OTHER AGENCIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ......201

National institutes of Health (NIH) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

Food and Drug Administration (FDA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 201

STATE AND LOCAL GOVERNMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 202

Spectrum of State Approaches to Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ................202

Spectrum ofLocal Approaches to Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 203

INTERNATIONAL REGULATORY CLIMATE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...........204

Europe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...204

Canada . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 206

Japan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....206

Developing Countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

POLICY ISSUES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ............207

Jurisdiction and Coordination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 207

Coverage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

Potential impacts of Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ....213

Public Participation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .............216

Problematic Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218

CHAPTER PREFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 219

Boxes

Box Page

7-A. The National Environmental Policy Act (NEPA) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 185

7-B. The Types of Information Requested by APHIS in a Permit Application for Genetically

Engineered Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 188

7-C. Council on Competitiveness . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 210

7-D. Fish Regulations—Something To Carp About? . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ..............211

7-E. EPA Research and USDA Research . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 215

7-F. Two Experiences With Public Response . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 218
Chapter 7

Environmental Issues: Institutions

and Their Regulatory Roles

INTRODUCTION

Preface

Many biotechnology products, especially agricultural

products, are intended for use in the environment. Examples are transgenic cows in feed lots, insect resistant

crop plants in fields, microbial pesticides applied to cropland, and transgenic fish reared in outdoor aquiculture

ponds. Virtually anything introduced into the environment will have an impact, whether it be concrete slabs

used to construct a highway or a chemical pesticide used

to control insects on cotton. The task of environmental

protection legislation is to determine what types of products to be used or activities to be carried out in the

environment would have adverse effects significant enough

to warrant regulation. Ideally, Federal environmental

protection laws and regulations would be based on complete information on all the environmental risks associated with products and activities as well as their benefits,

so that decisionmakers could weigh one against the other

objectively. In reality, complete information is rarely

available, particularly for new products: thus, the balancing of risks and benefits is difficult and open to bias.

Biotechnology has appeared on the scene during a time

of intense environmental and political scrutiny of new

technologies. Oversight of biotechnology thus is significantly different from that of emerging technologies in

the past and may foreshadow the reception of new technologies in the future. For example, planned introductions of recombinant DNA-modified organisms will occur

in a regulatory climate vastly different from that which

existed as dramatically new crop varieties were introduced in the past. Key policy documents to be discussed

later (e. g., 1986 Coordinated Framework statement of

Federal agencies’ philosophy on biotechnology, and the

Council on Competitiveness’ report on Administrative

philosophy) stress the need to regulate biotechnology

only on the basis of the risk of its products. not simply

because it entails the new process of recombinant DNA

technology. Tension exists, however, between this philosophy and operational development of oversight treatment. This tension often seems to be triggered by the

technology itself, and has led to controversy over regulation of field tests. Special regulatory attention to a

new agricultural technology could have implications for

environmental safety and for the successful adoption of

that technology and thus for U.S. economic competitiveness.

Most agricultural biotechnology products intended for

use in the environment are or will be regulated according

to legislation enacted prior to the advent of modern biotechnology, including laws intended to protect agriculture and the environment from chemical contamination,

plant pests, pathogens, and so on. Despite the unusual

level of scrutiny focused on biotechnology, its oversight

is meant to arise naturally from the responsibilities traditionally held by different offices or services within the

Environmental Protection Agency (EPA) and the U.S.

Department of Agriculture (USDA). Given the panoply

of laws applicable to biotechnology. this chapter provides

a road map through the confusing territory of oversight

responsibilities.

Figure 7-1 is the reference point used throughout the

chapter. It gives a capsule overview of roles and relationships of policymaking bodies, key documents relating to designation of authority over environmental uses

of biotechnology products, agencies with regulatory authority, the specific services or offices involved in regulation of biotechnology, and statutes that pertain to the

use of biotechnology products in the environment. Following an introductory description of why and how regulation and oversight for biotechnology products has

evolved, this chapter describes USDA’s and EPA’s role

in these activities. The complementary roles of the Food

and Drug Administration (FDA), National Institutes of

Health (NIH), and State and local governments, as well

as the international regulatory climate also are covered.

Finally, policy issues are discussed here, among them

issues of jurisdiction and coordination among agencies,

scope of coverage, potential impacts of regulation on

research and on agribusiness, and public participation.

(See also OTA, 1988 New Developments in Biotechnologg 3, Field Testing Engineered Organisms.” Genetic and

Ecologic Issues (102) and 1991 Biotechnology in a Global

Econony) ( 103). This chapter lays the foundation for

ensuing discussion (ch. 8) of risk assessment and risk

management issues related to impending large scale,

commercial uses of agricultural biotechnology and biocontrol products.

-181-
Figure 7-l—Jurisdiction and Coordination of Environmental Policy for Biotechnology-Derived Agricultural Productsa

Natiorlaf Environmental

Policy Act (NEPA)

I

United States Department

of Agriculture (USDA)

Animal and Food Office of National

Plant Health Safety and Agricultural BIological

Inspection Inspection Biotecnology Impact

Service Service Agricultural Assessment

(APHIS) (FSIS) Biotechnology Program

Research (NBIAP)

Advisory

Committee

(OAB/ABRAC0)

I President I

I

I 1 I 1

I

i

Coordinated framework

Scope document

I

I

I

Environmental Protection Food and Drug

Agency (EPA) Administration (FDA)

.

I

Office of Biotechnology Office of Office of Center for Center for

Pesticides Sciencee Advisory Toxic Biotechnology Veterinary Food Saftey 

Program Committee Subtances (OB) Medicine Nutrition

(BSAC) (OTS) (CVM) (CFSN)

I!

National Institutes

of HeaIth (NIH)

USDA statutes EPA statutes FDA statute

- Plant Pest Act - Federal Insecticide, Fungicide, - Food, Drug, and Cosmetic Act (FDCA)

- Plant Quarantine Act and Rodenticide Act (FIFRA)

- Noxious Weed Act - Toxic Substances Control Act (TSCA)

- Vims-Semm-Toxin Act

- Federal Meat Inspection Act

- Poultry products Inspection Act

aOSTP, Council on Competitiveness, and OMB do not have direct oversight of the Federal agencies; the connections shown are those

of influence through directives, key policy documents, or review.

SOURCE: Office of Technology Assessment, 1992.

Recombinant

DNA Advisory Biotechnology

Committee (NBPB )

(RAc)
Agriculture, Field Trials, and Deliberate

Release of Genetically Engineered

Organisms

Progress in agriculture traditionally has depended on

selection of the best of new varieties based on field testing

of cultivars. The seed industry views cultivar field testing

as an essential part of cultivar development programs.

The main purpose of field testing is

. . . to determine the regional environmental adaptability

and market fit of the new cultivars or hybrids to know

whether the items to be tested have the required disease

resistance for the areas, whether they meet the needs of

the industry as far as type or quality is concerned. and

whether they will perform well under the environment of

the region (98).

Field tests also can provide evidence that the application of currently available scientific principles and

information can ensure safe commercialization of new

products.

Genetically modified organisms, like any other organisms, must be field tested in the environment in

which they would be cultivated. For example, whether

the engineered trait is expressed effectively must be

evaluated in condition-s representative of those the cultivated crop will encounter. Characteristics intended

to confer drought tolerance to a plant. for instance,

must appear and function effectively within the plant

as it copes with representative drought-stressed environments. Greenhouse experiments, conducted in facilities designed to meet containment specifications,

can provide only an initial screening; the field trial is

an essential evaluative step.

Brief Overview of Concerns

As necessary and rational as field testing is, concerns

have arisen over any release of genetically engineered

organisms. Living creatures reproduce themselves; they

may increase in numbers; and they may even exchange

genes with other wild organisms. Many are worried in

particular about the uncertain possible impacts that an

organism with a new trait might have on other species

in the local habitat.

Evolution of Regulation and Oversight

These concerns and uncertainties have stimulated efforts to articulate regulatory oversight; the spelling out

of jurisdiction in the Coordinated Framework for the

Regulation of Biotechnology [51 Federal Register (FR

2302-23393] (77) was a significant step in the organization of regulatory oversight. This fundamental document outlining the roles, responsibilities, and policies

of the Federal agencies involved in biotechnology first

actually appeared in the Federal Register in 1984, when

the Domestic Policy Council of the White House announced the ‘‘Coordinated Framework for the Regulation

of Biotechnology” (49 FR 50856-50907). The framework set forth certain premises, which have guided subsequent policy:

●

●

●

previously existing knowledge was regarded as pertinent,

existing laws were for the most part regarded as

adequate for biotechnology oversight, and

different biotechnology products were regarded as

falling under the mandate of different agencies

(table 7-1 ).

Other key points of the framework include the following:

●

●

the products of biotechnology, not the process itself,

would be regulated; and

biotechnologically altered organisms are not fundamentally different from nonmodified organisms

(although the introduction to the framework recognized that certain microbial products would require the establishment of additional regulatory

requirements).

The framework included a compilation of existing laws,

regulations, and guidelines that are potentially applicable

to biotechnology, policy statements from the regulatory

agencies on how they intend to apply their existing regulatory authority to biotechnology, and proposed criteria

for determining what should be subject to oversight.

In a basic sense, agencies draw their authority to evaluate ramifications of the new technology based on their

own mandates, and from the National Environmental

Policy Act (NEPA). (See box 7-A. ) Since the framework

was introduced, agencies have accumulated experience

with deliberate releases; based on this experience, they

are continuing to refine their regulatory roles. As of September 1991, USDA-APHIS (Animal and Plant Health

Inspection Service), which oversees most plant-related

work and animal biologics, has issued some 181 permits

for field testing of genetically engineered plants or microorganisms (not including veterinary biologic). At least

half of these have been issued since the beginning of

1990. (See table 7-2. )

USDA permits issued for transgenic plants with pesticidal properties have been informally reviewed by the
184 ● A New Technological Era for American Agriculture

Table 7-l—Jurisdiction for Review of Planned Introductions in Research

Proposed research Responsible agencies

Contained research, no release in environment

Federally funded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Nonfederally funded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Foods and food additives, human drugs, medical devices, biologics,

animal drugs

Federally funded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Nonfederally funded . . . . . . . . . . . . . . . . . . . . . . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Plants, animals and animal biologics

Federally funded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Nonfederally funded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Pesticide microorganisms

Genetically engineered

Intergeneric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Pathogenic intrageneric . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

lntrageneric nonpathogen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Nonengineered

Nonindigenous pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Indigenous pathogens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Nonindigenous nonpathogen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Other uses (microorganisms) released in the environment

Genetically engineered

Intergeneric organisms

Federally funded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Commercially funded. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Intrageneric organisms

Pathogenic source organisms

Federally funded . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Commercially funded. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Intrageneric combination

Nonpathogenic source organisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Nonengineered . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Funding agency,a

NIH or S&E voluntary review, APHISb

FDA,c NIH guidelines and review

FDA.c NIH voluntary review

Funding agency,a APHISb

APHIS, b S&E voluntary review

EPA,d APHIS,b S&E voluntary review

EPA,d APHIS,b S&E voluntary review

EPA,d S&E voluntary review

EPA, dAPHIS

EPAdAPHIS

EPAd

Funding agency,a APHIS, b EPAd

EPA, APHIS, S&E voluntary review

Funding agency,a APHIS, b EPAd

APHIS, b EPAd(if nonagricultural use)

EPA Report

EPA Report,e APHISb

aRewiew and approval of research protocols conducted by NIH, S&E, or NSF.

bEPA jurisdiction for research on a plot greater than 10 acres.

CAPHIS issues permits for the importation and domestic shipment of certain plants and animals, plant pests and animal pathogens, and for the shipment

or release in the environment of regulated articles.

‘EPA reviews federally funded environmental research only when it is for commercial purposes,

‘Designates lead agency where jurisdictions may overlap.

KEY:NIH - National institutes of Health; S&E = U.S. Department of Agriculture Science and Education; APHIS = Animal and Plant Health Inspection

Service; EPA = Environmental Protection Agency; NSF = National Science Foundation

SOURCE: 51 Fed. Reg. 23305 (Office of Technology Assessment, 1988).

EPA Office of Pesticide Programs under an interagency

agreement. EPA has reviewed a total of 94 notices for

field tests of microorganisms since the framework was

published in 1986, 74 of which were for microbial pesticides. Under an interagency agreement, EPA has in

addition provided comments on approximately 100 permits submitted to USDA-APHIS for transgenic plants

with pesticidal properties. (See table 7-3. )

These field tests provide the foundation of information

and regulatory experience for decisions regarding fullscale agricultural use of transgenic organisms. This report

comes at a critical point in the evolution of agricultural

biotechnology, as it moves from the laboratory toward

large-scale commercialization and use.

USDA

Authority for Plants

Statutory Authority

The Animal and Plant Health Inspection Service,

APHIS, was established in 1972 as a regulatory agency

within USDA with responsibilities for protection of the

environment. APHIS unites the programs within USDA

designed to protect American agriculture from destructive pests and diseases. APHIS’ activities include the

development of exclusion procedures to keep pests and

diseases out of the United States; and monitoring, de-
Box 117-A–The National Evironmental Policy Act (NEPA)

The National Environmental Policy Act (NEPA) is the sole Federal law that is broadly applicable to all agencies

and departments involved in the research or regulation of biotechnology products intended for use in the environment.

Enacted in 1970, NEPA is a reflection of increasing concern about environmental quality and calls for a “balance

between population and resource use which will permit high standards of living and a wide sharing of life’s amenities”

[section 101(b)(5)]. NEPA requires that any agency decision on a major Federal action significantly affecting the

quality of the human environment include consideration of the environmental impact of the proposed action and

alternatives to the proposed action. NEPA does not, strictly speaking, restrict or prohibit any activity that may

adversely impact the environment but rather outlines procedural requirements by which Federal agencies must

become aware of and consider the environmental consequences before making a decision on a proposal.

The Council on Environmental Quality (CEQ) is responsible for the implementation of NEPA (CEQ Final

Regulations for Implementing NEPA, 43 Fed Reg 59978, 1978), but the specific method used for compliance by

individual agencies is broadly discretionary. Because EPA’s mission is to consider and protect the environment

through its regulatory activities, most EPA actions are considered the functional equivalent of NEPA compliance.

[Warren County v. North Carolina, 528 f. Supp. 276,286 (eDNC 1981)]. Most other Federal agencies have issued

their own regulations to implement NEPA.

Although agencies are given broad discretion in how they evaluate and balance environmental impacts in

making decisions, NEPA does open agency actions to public and judicial scrutiny. The establishment and protection

of certain environmental values by NEPA gives public interest groups and private individuals standing to bring suit

to ensure compliance even though they are not directly affected by an agency action. In short, NEPA has had two

principal impacts on the Federal decisionmaking process: ensuring evaluation of environmental issues by Federal

agencies and increasing public participation.

SOURCE: Office of Technology Assessment, 1992.

tection, eradication, and control programs to control the vironment) are the Federal Plant Pest Act, the Plant Quarmovement of pests and the spread of disease. APHIS

operates under a myriad of legislative authorities, some

dating back to 1884.

Under the Coordinated Framework, APHIS is designated the lead agency responsible for the regulation of

plant and animal biotechnology products. The assumption underlying this jurisdictional determination was that

Agriculture and forestry products developed by biotechnology will not differ fundamentally from conventional products and that the existing regulatory framework

is adequate to regulate biotechnology ( 51 Fed. Reg. 3123,

p. 23302).

The primary regulatory authorities available to USDA

that are most applicable to biotechnology (and the enantine Act, the Noxious Weed Act. the Virus-SerumToxin Act. the Organic Act, the Federal Seed Act, the

Federal Meat Inspection Act. and the Poultry Products

Inspection Act. Of these statutes, two are used as the

basis for the regulation of the environmental release of

genetically modified organisms: the Federal Plant Pest

Act, and the Plant Quarantine Act (7 CFR 340). Like

the Noxious Weed2 Act, these two acts are exclusionary

statutes intended to prevent the entry into or dissemination within the United States of living organisms considered dangerous to American agriculture. These three

legislative authorities traditionally have been used as the

basis for inspection, quarantine, and pest eradication programs of the Division of Plant Protection and Quarantine.

With the exception of the Noxious Weed Act, they now

also are used by the Division of Biotechnology, Biol1 A Plant PCS( is defined ii~ my living Sttigc of: any inxcts, m itcs, nemiitodm, slugs, mails, protozoa. or other invertebrate ~nimali, b~ctcrl~,

fungi. other pmmitic plmt~ m reproductive pw-ts thcrw)t’. viruw~, or an} . (~rgtmiw]s simi Iar to or all id w ith any of (he f{mgoing, or any infectious

substances. which can ciirwtly or indirectly in jurc or cause diwaw or dtinmgc in any plant~ or parts thereof, or any processed, manufactured, or

other products of plants.

~ “ ‘NOXIOUS weed’ ‘ is defined a~ tiny I I ving stage (including but m)t I imitwl to , swds and reproductive parts) of any parasitic or other plant of a

kind, or subdivisi(m ot” a kind. w hlch is of foreign origin, is nev to or not w idcly prmalcnt in the Unwd Sttitcs, and can directly or indirectly

inlurc crops. other useful plants. 1 iwstock, or poultr}’ or other interests of agriculture, including irrigation. or na~’igat ion or the fish or W’ ildl ife

rcs{)urccs t)f the Unltmi States or the public health.

297-937 0 - 92 - 7 QL 3
186 ● A New Technological Era for American Agriculture

Table 7-2—Federally Approved Biotechnology

Agricultural Research Field Test Applications, USDA

(through September 24, 1991)

Private Public

1987 . . . . . . . . . . . 9 0

1988 . . . . . . . . . . . 17 1

1989 . . . . . . . . . . . 31 7

1990 . . . . . . . . . . . 42 15

1991 . . . . . . . . . . . 47 12

Total . . . . . . . . . 146’ 35b

a

41 tomato; 23 cotton; 17 tobacco; 14 corn; 13 potato; 13 soybean; 10

cantaloupe/squash; 6 alfalfa; 4 clavibacter/corn; 1 clavibacter/rice; 1 TMV/

tobacco; 1 rapeseed; 1 sunflower; 1 chrysanthemum.

b 11 potato; 9 tobacco; 3 cucumber; 3 rice: 2 pseudomonas; 2 walnuts; 2

xanthomonas; 1 tomato; 1 poplar; 1 alfalfa.

SOURCE: APHIS BBEP Biotechnology Permits Unit, Issued Permitss List,

Sept. 24, 1991.

Table 7-3—Federally Approved Biotechnology

Agricultural Research Field Testa Applications, EPA

(through April, 1991)

Total Repeats

Office of Toxic Substances . . . . . . . 20b

7

office of Pesticide Programs , . . . . 74” 34

‘Field tests of microorganisms reviewed by EPA since the publcation of

the 1986 Coordinated Framework.

b 10 Rhizobium, 8 Bradyrhizobium, 2 Pseudomonas.

c Includes a variety of bacteria, fungi and viruses, both nonindigenous and

genetically modified

SOURCE: David Giamporcaro, Environmental Protection Agency, personal communicatlon, Oct. 18, 1991.

ogics. and Environmental Protection [established in October, 1988] to regulate the movement and environmental

release of genetically engineered organisms.

The Noxious Weed Act has not been used to regulate

genetically modified organisms. The applicability of the

Noxious Weed Act to genetically modified organism is

limited by the requirement that the plant be of “foreign

origin’ and the requirement that an organism be placed

on the noxious weed list before it can be regulated.

The Federal Plant Pest Act. the Plant Quarantine Act,

and the regulations issued to implement them are not

intended to present unreasonable barriers to commerce.

For example, inspection at ports of entry should be expedient so as not to retard shipment of agricultural products, particularly fresh produce whose value could be

diminished or destroyed if the product to be inspected is

held at the inspection station too long.

Agency Interpretation/Regulatory Policy

USDA’s overall philosophy regarding biotechnology

products is articulated in the National Academy of Sciences 1987 publication, Introduction of Recombinant DNAEngineered Organisms into the Environment: Key Issues

(72); and in the National Research Council 1989 publication, Field Testing Genetically Modified Organisms.”

Frumework for Decisionmaking (73). Consistent with

U.S. Federal policy, USDA-APHIS bases its regulatory

policy on certain key premises:

1.

2.

A .

3.

4.

the products of biotechnology do not differ fundamentally from either unmodified organisms or

conventional products,

the product should be regulated rather than the process by which it came to be,

end-use of the products and review conducted on

a case-by-case basis should form the basis for regulation, and

sufficient authority for regulating the products of

biotechnology is provided by existing laws.

Along with these premises is a commitment to the safe

development of the new technology, and to a balanced,

scientifically based and risk-based regulatory framework

that protects agriculture as well as facilitates technology

transfer (55).

The USDA regulations (7 CFR 340), that pertain to

genetically engineered organisms are applicable to a broad

range of organisms, including

Any organism which has been altered or produced through

genetic engineering. if the donor organism. recipient organism. or vector or vector agent belongs to any genra

or taxa designated ...and meets the definition of plant

pest. or is unclassified. . or any other organism or

product altered or produced through genetic engineering

which the Deputy Administrator deterrmines is a plant pest

or has reason to believe is a plant pest.

Excluded are microorganisms that are not plant pests and

produced by the addition of well characterized or noncoding regulatory regions.

Any person may petition to amend the list of organisms

subject to regulation under 7 CFR 340. Such a petition

must include the factutal grounds as to why the organism

is not a plant pest and include scientific literature in

support of this conclusion. Petitions should not include

Confidential Business Information (CBI). The petition

also should include any information known to the petitioner that would be unfavorable to the petition. APHIS

then publishes a notice in the Federal Register for comment. A must respond to the petitioner within 180 days

either by approving or denying the petition in whole or

in part. Once an organism or class of organisms is delisted, it may move unhindered in commmerce with no
reporting requirements or monitoring required by the

Federal Government. If, however, new information becomes available that leads the Secretary of Agriculture

to conclude that a delisted organism does, in fact, pose

a plant pest risk, an interim rule can be issued, effectively

bringing that organism back under regulatory authority

of the Federal Plant Pest Act.

It is unclear whether industry will try to petition to

exempt broad classes of organisms or single. well-defined

organisms. Initially some industry executives thought that

they might like to delist broad classes; but some have

since reevaluated this approach since the organism-byorganism delisting procedure is a market barrier to competitor-s. Broad class delisting might make it easier for

some competitors to enter commerce. Furthermore, APHIS

approvals provide a ‘‘stamp of approval useful in acceptance by the public and by State governments. In

addition, environmentalist groups might pose a legal

challenge to stop a broad class delisting under the Federal

Plant Pest Act.

Implementation

Under the APHIS regulations. anyone wishing to move

or introduce an organism fitting the definition of a regulated article must receive a permit. The four kinds of

permits for which applications are made are as follows:

1. a permit for release into the environment (application submitted 120 days in advance).

2. a single 1 -year permit for interstate movement of

multiple regulated articles between contained facilities,

3. a single 1 -year permit for importation into the country of multiple regulated articles into contained facilities, and

4. a courtesy permit to expedite movement of organisms not subject to regulation under 7 CFR 340

(application submitted 60 days in advance) (55)

Permit applications require submission of information

on the biology of the donor and recipient organisms. the

molecular biology of the introduced gene(s), and plans

for containment during the trial and post-trial clean-up.

Information is used by APHIS to prepare an Environmental Assessment (EA) and to determine whether and

under what conditions to allow the release.

The application process for Environmental Release

permits is clearly delineated by USDA-APHIS, with process and pemmitting requirements contained in Plant Pests,.

Introduction of Genetically Engineered Organisms of

Products, Final Rule (52 FR 22892 (1987). In addition,

Biotechnology, Biologics and Environmental Protection

(BBEP). USDA-APHIS. has developed a User's Guide

 for Introducing Genetically Engineered Plants and Microorganisms to provide assistance to those submitting

applications for a permit under 7 CFR 340. The folloowing

steps

1.

2-.

. . 3

4.

.5.

6.

7.

8.

must take place:

completing an application for permit under 7 CFR

340, Genetically Engineered Organisms or Products. APHIS Form 2000:

assigning an accession number;

preliminary pest and environmental assessment;

state review/input;

site inspection;

issuance or denial:

appeal. if permit request has been denied: and

inspection of site at initiation of experinment.

From day one, scientific review proceeds. The State

authorities are forwarded material by day 30 and respond

by day 60. At or before day 120. the biotechnology

permit is issued or denied ( 104).

Scientific review is based on the dutti provided in response to the APHIS permit application data requirements. Fourteen such requirements (box 7-B) include a

detailed description of’ the organism. the location of’ the

field test, and containment protocols.

Provision is made for companies to protect Confidential Business information: they can submit both a full

proposal and one for public abvailability that has CBI

deleted. The APHIS Policy Statement on the Protection

of Privileged or Confidential Business Information (50

FR 30561 -63) delineates data or information, such as

trade secrets and confidential commercial or financial

information, that can be protected from disclosure under

section (b)(4) of the Freedom of Information Act

(5 U.S.C.552 (b)(4). This can include production data,

formulas and processes, and quality control tests and

data, along with research methodology and data generated in the development of the production process. To

qualify as CBI, this information must be: 1 ) commercially

valuable, 2) used in one’s business. and 3) maintained

in secrecy. Furthermore, APHIS must be persuaded on

review of information on competition that significant

commercial harm would result from disclosure. BBEP

explains this option to applicants, while encouraging them

to be selective as to what truly calls for CBI designation

(63). APHIS requires claims of Confidentiality to be

substantiated at the time of submission.

An Environmental Assessment (EA) is prepared by

APHIS in accordance with the provisions of the National
Box 7-8—The 14 Types of Information Requested by APHIS in a Permit Application for

Genetically Engineered Plants. 7 CFR 340

1. Information on responsible person and type of permit requested, such as movement or release.

2. All names (scientific, common, and trade) and designations necessary to identify the donor, recipient, vector,

or vector agent constituents of the transgenic plant.

3. Information on the persons who developed the transgenic plant.

4. Movement of the plant.

5. The anticipated or actual expression of the altered genetic material in the plant and how the expression differs

from the nonmodified plant in respect to characteristics such as morphology, physiology, number of copies of

the gene, products, etc.

6. The molecular biology of the system used to produce the transgenic plant—donor, recipient, vector, or vector

agent.

7. Country and Iocality where the donor, recipient, vector, or vector agent were collected, developed, and produced.

8. The purpose of the experiment and the experimental design.

9. The quantity, schedule, and number of introductions.

10. The processes, procedures, and safeguards used to prevent contamination, release, and dissemination in the

production of the transgenic plant.

11. The intermediate and intended destinations of the product; the field trial site.

12. Safeguards to prevent dissemination at each site.

13. Biological material accompanying the plant, such as inoculum or soil.

14. Method of disposal of plant material after termination of the experiment, such as autoclaving or discing.

SOURCE: S. McCammon and T. Medley, “Certification for the Planned Introduction of Transgenic Plants in the Environment,”

The Molecular and Cellular Biologics of the Potato, Michael Vayda and William Park (eds.), Wallingford, U.K. (CAB. International),

1990.

Environmental Policy Act (NEPA) of 1969 (42 U.S.C. Application to Plants

4332 ( 1970)). Among the components of the EA are

procedural and physical precautions against risk, envi- Small-Scale Research

ronrnental consequences, and background biology. The

development of the EA is a process intended to assure

public safety.

A permit to move or introduce an organism is issued

if there has been a Finding of No Significant Impact

(FONSI ) from such action, and a full-scale environmental

impact statement is not required. Notice of the action

and the availability of the EA and FONSI is published

in the Federal Register. Special additional conditions may

be added to the permit that require monitoring and data

collection to ensure containment. Such test data can also

contribute to the information base from which future

assessments can draw. The issuance of the permit constitutes certification by APHIS that no significant risk

exists to the environment or to agricultural crops from

the action. Recommendations for improving APHIS assessments have included making justifications for assessment conclusions more explicit, including more

opportunities for gathering data on gene flow and weediness during field tests, and encouraging more timely and

complete monitoring reports (110).

Theory— Small-scale releases in the form of field trials

are experiments. Even if companies conduct them, and

although field trials are the first step toward full-scale

agricultural use in the environment, they are nonetheless

still research rather than commercialization activity. This

activity raises some concerns, but these are, to some

extent, alleviated by the small scale of field trials. The

first release into the environment of an organism with a

novel trait can arouse concerns simply because something

relatively new is happening. The regulatory policies and

procedures described above represent an attempt to address such concerns. However, given the low numbers

of organisms involved, the small-scale field trial is quite

a carefully controlled situation. In fact, some argue that

USDA requirements for most field tests exact financial,

administrative, and time costs that are disproportionate,

relative to any risks presented. USDA-APHIS views the

small-scale field trial as playing an educational role; data

compiled from these tests will provide the underpinnings

for sound and rational assessment of large-scale releases

in the future. As noted earlier, each permit issued for a
small-scale field trial requires the submission of subsequent data.

One of the players in the oversight of field trials is the

Office of Agricultural Biotechnology (OAB ), which was

established in 1987 under the Deputy Secretary of Agriculture and transferred to the Assistant Secretary for

Science and Education in 1989. OAB is designed to

ensure coordination of biotechnology activities within

USDA. Within Science and Education, it is separate in

many ways from APHIS. It provides staff support for

the USDA Committee on Biotechnology in Agriculture

(CBA ) comprised of administrators of agencies: conducts

outreach programs; and provides leadership in the development of guidelines and the dissemination of information about them. For example, a handbook, Agricultural

Biotechnology: Introduction to Field Testing was produced in large part to help the "users" of the regulatory

system in applications for field trials ( 11 ).

In line with its particular responsibility to provide guidance to researchers. the OAB staffs the Agricultural Biotechnology Research Advisory Committee (ABRAC)

composed primarily of academic and industry scientists.

Industry field tests. of course, are handled through APHIS.

ABRAC was established in 1988 to provide advice for

the Secretary of Agriculture, through the Assistant Secretary for Science and Education, on biosafety issues in

the use of agricultural biotechnology and it has assisted

in the development of biosafety guidelines, as well as

case-by-case review of the minority of USDA-funded

research projects that do not fall under other agency authorities. Its review process is modeled after that of the

NIH Recombinant DNA Advisory Committee (RAC),

with meetings open to the public and announced in the

Federal Register. Two working groups established early

in 1991 focus on the area of biotechnology risk assessment research as set out in the Farm Bill of 1990. These

groups help set priorities and are developing a classification system and confinement protocols, integrating public

comments received on the proposed guidelines for risk

assessment research (70). The Proposed USDA Guidelines for Research Involving the Planned Introduction

Into the Environment of Organisms With Deliberately

Modified Hereditary Traits was published in the February

1, 199 Iissue of the Federal Register, part 3, with public

comments due on April 2; a principal intent was to assist

academic scientists and their institutional biosafety committees in the design of safe field trials.

USDA’s Cooperative State Research Service established a new program in response to recommendations

in a 1985 report of the National Association of State

Universities and Land Grant Colleges’ Committee on

Biotechnology. NBIAP (National Biological Impact Assessment Program ) has a mandate to facilitate safe field

testing of genetically modified organisms and. thus, safe

development of agricultural biotechnology. A principal

charge to the program is to facilitate the appropriate application of knowledge derived from conventional field

testing in the past to biotechnology field tests today. The

program supports three areas of activity related to this

function: information networks: facilitation of the development of biological monitoring techniques: and supper-t for biosafety research.

An information network to support the needs of publicand priate-sector researchers is being developed by NBIAP

in conjunction with a number of institutions. The information network is available, over telephone lines, through

an "800" number: through interlinked mainframe computers (BITNET): on floppy disks: and in printed format.

An electronic bulletin board gives up-to-date information

on biosafety related research activity and serves as the

gateway for 14 databases. Individuals can use the network to communicate with other scientists as well. Databases include, among others: bibliographic and other

listings; current literature; U.S. patents on genetically

engineered species: current text of all Federal laws, regulations, and guidelines pertaining to biotechnology and

biosafety; Institutional Biosafety Committee listings: and

all approved applications for federally approved field test

permits. licenses. and scientific reviews.

A knowledge base has been designed to help researchers identify the responsible Federal agencies to which an

application should be directed and to prepare applications

for permits, licenses, or scientific reviews. An ‘‘intelligent form generator" will actually help the investigator

prepare first drafts of applications. By dissembling information from existing knowledge. the intelligent form

generator provides users with access to previously written

standard text, technical descriptions, test-site information, and other resources from databases. Combining information with use of extensive menus leads to a technically

specific application. The first, current version of the intelligent form generator is expected to be expanded from

coverage of 8 groups of organisms to 79. The intent of

the intelligent form generator is to lift some of the regulatory burden from the researcher. "Hyrpertext" information on biosafety is also provided.

A second function of the NBIAP is to facilitate biological monitoring of genetically modified organisms de-
literately released in the environment. NBIAP is surveying

field studies that have been conducted; the information

gathered should help guide future regulatory decisions.

NBIAP also supports biosafety research on genetically

modified organisms to improve understanding of their

dispersal in the real world, and their impact on human

health and the environment, to improve biosafety methods and to develop useful prediction models (51. 52).

Experience Base—Between July 16, 1987 and February 27, 1991, 102 permits were granted by APHIS for

field testing of genetically engineered plants and microorganisms, along with 843 permits for importation or

interstate movement of organisms regulated under 7 CFR

340. Twenty-one companies were issued permits by this

date, including: Agricetus, Agrigenetics, Amoco Technology Co., Biosource Genetics, Biotechnica, Calgene,

Campbell Institute for R&D, Canners Seeds, Ciba-Geigy,

Crop Genetics International, DeKalb, DNA Plant Technology, DuPont, Frito-Lay, Monsanto, Northrup King,

Pioneer, Rogers NK Seed, Rohm & Haas, Sandoz Crop

Protection Corp., and UpJohn. Twelve research institutions. two of them USDA institutes, had received permits; they are: Auburn University; Iowa State University;

Louisiana State University: New York State Agricultural

Experiment Station (Geneva); North Carolina State University; Pennsylvania State; USDA-ARS (Agricultural

Research Service), Albany, California: USDA-ARS,

Fresno, California; University of California at Davis;

University of Kentucky; University of Wisconsin; and

Washington State University. Field trials were approved,

with the agreement of the host State, for 33 States and

Puerto Rico; the 102 permits granted as of February 27,

1991, gave rise to some 140 field test sites. By April

1991, 115 permits had been granted (78). By September

1991, 181 permits for field tests had been granted.

Figure 7-2 lists the new crop plants entering field trials

between 1987 and early 1991, along with the novel characteristics, or genes expressed.

About half of the first generation of field tests, especially the 2 I in 1988, were for herbicide tolerance in

tomato and tobacco. while the rest were almost entirely

for disease and insect resistance in these two crops. Many

more crops showed up in the 1989 applications, including

potato, soybean. alfalfa, cotton, poplar, and cucumber:

new sorts of characteristics included slowed fruit ripening

and improved nutritional qualities. Modified pathogenic

bacteria entered the applications in 1990, along with an

increased range of cultivars and modifications, particularly in two of the country’s most economically important

crops, rice and corn (60).

Figure 7-2—Field Trials of New

Crop Plants, 1987-91

1987-88 1989 1990 1991

Tobacco Alfalfa cantaloupe Rapeseed

Tomato Cotton Sunflower

Cucumber Rice

Poplar Squash

Potato Walnut

soybean

Genes expressed

Herbicide tolerance

Insect tolerance

Virus tolerance

Fungal tolerance

Slowed fruit ripening

Heavy metal sequestration

Increased lysine production

Antibiotic resistance

SOURCE: S. McCammon, U.S. Department of Agriculture, internal memo,

1991.

Biotechnica Agriculture. Inc., then a subsidiary of

Biotechnica International, Inc., received in May of 1990

the first USDA approval to field test genetically engineered corn plants. The tests, to be conducted at the

company’s corn breeding station in Iowa. will analyze

growth under field conditions and collect environmental

data for future use. Biotechnica has coordinated other

field tests, including one on tobacco with a gene coding

for high levels of lysine expression (9). The company

has applied for permission to conduct multiple field tests

of corn engineered for improved nutritional quality; the

gene transferred is one of several intended to improve

corn for feed (4).

Northrup King has begun a 3-year field test of alfalfa

plants genetically engineered to be compatible with a

new herbicide claimed to be highly biodegradable and

environmentally safe. With Monsanto. Northrup King

has planted genetically engineered cotton in Hawaii to

assess its resistance to various caterpillars (71 ).

An even longer term project was initiated by USDAARS researchers at the University of California-Davis. They

inserted two marker genes into walnut tree embryos and

will need to wait 5 years for the trees to reach maturity to

assess expression brought about by the genes (76).

The first field trial of genetically engineered rice was

approved at Louisiana State University. The test, taking

place since June 1990 in a 110 x 63 foot plot in Baton

Rouge, involves a marker gene and a transposon gene

(that regulates gene movement) from corn (5).
USDA-ARS scientists are field testing potatoes with

marker genes in Idaho, to see if the genetically engineered potatoes match the quality of conventionally bred

products, under a permit issued in 1989. Some 1,000

potatoes, originally produced in a greenhouse from genetically engineered microtubers, are planted on a halfacre plot at the University of Idaho’s research and extension center in Aberdeen (29).

Calgene successfully harvested field plots of its FLAVR

SAVR tomato in the fall of 1990. Its permit for tomato

plants engineered with an antisense gene for the pectalytic enzyme, or cytokinin pathway, was issued in May

of 1990 (76). A complete listing of permits issued, applicants, organisms, and genes engineered along with

date of issuance and location (State) is available in "Environmental Release Permits,” printed by BBEP, APHIS,

September 24, 1991.

Large-Scale Release

Theory-The USDA plans to use data from smallscale field trials to ensure the safety of large-scale releases. A variety of analyses and conferences are addressing the issue of large or commercial-scale release.

For example, APHIS has organized the following three

workshops to identify issues related to the large-scale use

of genetically engineered crops in the environment:

1.

2.

 . 3

Workshop On Safeguards for Planned Introductions of Transgenic Oilseed Crucifers, October 1990.

Ithaca. New York;

Workshop On Safeguards for Planned Introductions of Transgenic Crops: Maize and Wheat. December 1990, Keystone, Colorado; and

Workshop on Biosafety Issues of Field Tests with

Transgenic Potatoes, August

Scotland.

A fourth workshop is planned for

sues for transgenic rice plants.

Experience Base—No commercial

1991. St. Andrew’s,

1992 on biosafety is-

 releases have yet

occurred, nor have applications been made, although preliminary discussions have been held between company

representatives and APHIS officials.

Authority for Veterinary Biologics

Statutory Authority

Under the authority of the Virus-Serum-Toxin Act

(VSTA). as amended, USDA-APHIS regulates three cat.

egories of veterinay bioiogical products derived through

biotechnology. The establishment of these three categories was announced by APHIS in theJune 1986Coordinated Framework policy statement (51 FR 23339,

June 26, [986). Based on that framework’s premises that

recombinant DNA derived products are not significantly

different from more conventionally derived products and

can be handled by a network of existing statutes, the

three new categories were subsumed under VSTA’s treatment of other biologics. APHIS supervises all experimental uses of veterinary biological products outside of

containment conditions, under the provisions of the VSTA

as amended by the Food Security Act of 1985. The implementing regulations (9 CFR 103.3) require approval

from the Director of BBEP for shipment and describe

required information for evaluating unlicensed biological

products prior to granting such approval. APHIS also

licenses biological products for unrestricted shipment in

or from the United States under the VSTA, as amended.

Agency Interpretation and Regulatory Policy

The agency’s policy is to balance control with flexibility in its review and approval procedures, and to adapt

as necessary to new information. Products and organisms

are categorized to provide practicable. reasonable procedures for review and approval: review takes place on

a case-by-case basis.

Category 1 is comprised of inactivated (nonviable or

killed) products prepared from recombinant DNA-derived

vaccines. viruses. bacterins, bacterin-toxoids. viral subunits. or bacterial subunits. Monoclinal antibodies used

prophylatically, therapeuticall y, or as diagnostics are also

included. These products are viewed as presenting no

risks to the environment or to safety.

Category 11 consists of products containing live microorganisms that have had one or more genes added (for

expression of unique marker antigens or production of

biochemical by-products) or deleted (i.e.. genes for virulence, oncogenicity, enzyme activity, or other biochemical functions). Such changes in genetic information must

not lead to increased virulence, pathogenicity, survival

advantages, or undesirable new or increased abilities to

invade or survive in the animal host; and they must not

compromise the safety characteristics of the organisms.

Under category III fall products that uselive vectors

to carry recombinant-derivecl foreign genes coding for

immunizing antigens or other immune stimulants. Live

vectors may carry multiple such genes and successfully

can infect and immunize the host. These organisms must

be completely characterized and compared with the parent virus, and environmental and human or animal safety
192 ● A New Technological Era for American Agriculture

concerns must be addressed in an Environmental Assessment or Environmental Impact Statement.

Implementation

As with all other veterinary biologics, recombinant

DNA products must be shown to be pure, safe, potent,

and efficacious, and not worthless, contaminated, dangerous, or harmful, with assurance of lack of negative

effects on the environment and human and animal health

prior to licensing. Additional information (e.g., demonstration of nonpathogenicity and nonreversion to virulence, or ability of the organism to maintain itself in a

livestock population) may be requested. For recombinant-derived products the manufacturer also must report

the cloned nucleotide sequence coding for the product.

For category 11 and 111 organisms, authorization procedures for shipping and guidelines for review of applications for field trials are done on a case-by-case basis.

The categories of physical containment involved in

movement of experimental products to the field are the

following:

1. stringent containment conditions (level 4, isolation),

2. controlled environment (level 3).

3. Quarantined field conditions (level 2), and

4. Restricted field tests (level 1).

Unrestricted geographical distribution may occur only

after issuance of a license.

In considering approval of these movements. APHIS

requires four kinds of scientific information: human safety,

ecological concerns, characterization of the vaccine virus, and animal safety. In addition, appropriate data would

include: survival and reproduction of the engineered microorganism; interactions with other organisms; effects

on the ecosystem if applicable; and scale, scope, and

frequency of plasmid introduction. In short, an ecological

risk assessment would include the biology of the phenotypic trait and of the parent organism, as well as characterization of the environment into which the introduction

will be made; the product organism’s host range and

potential effect on other species might also be included.

The review cycle includes review and approval by an

Institutional BioSafety Committee (IBC). State animal

health regulatory officials and, if appropriate, public health

officials. For trials with a small number of animals in

quarantined conditions, APHIS must prepare a Safety

Factor Evaluation assessing all parameters of the trial

( 19).

Application to Veterinary Biologics

Small-Scale Research

Theory—The theory underlying the approach to release of veterinary biologics is consistent with the National Research Council report (73) and the Scope Principles

(i.e., that products of biotechnology are not inherently

more dangerous than products of other techniques; and

that existing regulations can cover them).

Experience Base—Some 46 licenses that have already

been granted for small-scale release of veterinary biologics went through the full testing and now qualify for

‘‘large-scale’ release. Other projects are still in the research stage (95).

One of the best known small-scale field test cases is

that of the genetically engineered rabies vaccine developed by the Wistar Institute, with its corporate partner

Rhone-Merieux. This is a Vaccinia virus expression system, with a gene for a protein of the rabies virus, that

is intended to stimulate an immune response, but that

cannot cause rabies. Provisional approval was given early

in 1989 by USDA; the actual distribution of 3,000 ampules of rabies vaccine in an odoriferous bait took place

on uninhabited Parmmore Island, Virginia, in the fall of

1990. South Carolina had declined to have an offshore

island field test take place within its boundaries.

The owner of the Virginia island, the Nature Conservancy. negotiated long and hard regarding the release.

The Wistar Institute had to agree to provide full insurance

coverage and indemnification against any lawsuits to the

Nature Conservancy. The Conservancy demanded a strong

voice in field trial and animal monitoring protocols. Although Wistar researchers assert that any risk from the

release is very remote, the apparent ‘‘lack of control

(putting bait in the wild and waiting for animals to eat

it) certainly helped to arouse concerns. A similar vaccine

is being tested widely in Europe, and the Wistar Institute

has had discussions regarding additional sites in the midAtlantic States (25).

On the basis of satisfactory results from the Virginia

field trial and additional data confirming safety in other

species, APHIS authorized a second field trial in Sullivan

County, Pennsylvania, on June 7, 1991, with little or no

adverse public comment, and New Jersey is considering

a field trial as well. In contrast. early in APHIS’ review

of animal biologics, a suit by Jeremy Rifkin’s organization, the Foundation for Economic Trends, resulted in

a voluntary 2-week suspension of the license issued for

the first recombinant-DNA derived category 11 pseudo-
rabies vaccine while APHIS prepared documentation of

the assessment conducted during the licensing process.

Large-Scale Release for Veterinary Biologics

Theory-The USDA uses information from early smallscale trials in its subsequent assessment procedure. Biological products progress from physical containment to

large-scale use in the field as follows:

1. Movement from stringent containment conditions

(level 4) to quarantined field conditions (level 3).

2. Restricted field tests (level 2).

3. Unrestricted geographical distribution on issuance

of a license (level 1).

Experience Base—As of October 1, 1991, APHIS

had approved field testing and subsequently granted licenses for 39 Category One veterinary biological products. Twenty-six of these were for diagnostic kits; five

were for bacterins, and three were for monoclinal antibodies for prophylactic or therapeutic use. The first, a

bacterin, was licensed in October 1983; all have been

used successfully on a large scale. Seven licenses were

granted for category 11 products, all of which were designed to treat pseudorabies in swine. No licenses have

yet been granted in category III, but APHIS has received,

evaluated, and approved an application to field test a

recombinant-DNA derived live rabies vaccine (95).

The following category I and 11 licenses have been

issued:

●

●

●

●

Salsbury Labs and Norden Labs were the first licensees for bacterins in category for genetically

engineered Escherichia coli against swine disease.

Molecular Genetics Inc., received licenses for category 1, therapeutic or prophylactic use, for monoclonal antibodies.

Among the category 1 diagnostic test kits licensed

were kits for equine infectious anemia, avian reovirus antibody, and feline leukemia and feline Tlymphotropic lentivirus.

At least four companies received category 11 licenses

for a modified live virus used as a pseudorabies

vaccine.

Authority for Animals

Statutory Authority and Regulatory Policy

The Federal Meat Inspection Act (FMIA) (21 U.S.C.

601 et seq. ) and the Poultry Products Inspection Act

(PPIA) (21 U.S. C. 451 et. seq. ) give responsibility to

USDA’s Food Safety and Inspection Service (FSIS) for

the safety, wholesomeness, and proper labeling of food

products made from domestic poultry and livestock. FSIS

inspects the organisms and cleaned products intended for

use as human food.

Under the slaughter of research animal provision of

the FMIA and the PPIA, FSIS has developed regulations

stating that no livestock or poultry used in a research

investigation is to be slaughtered at an official establishment until sufficient data demonstrate to FSIS that the

edible products derived from the research animals are

safe for human consumption (9 CFR 309.17 and 381.75).

These regulations pertain to the slaughter of transgenic

animals as well as animals treated with recombinant DNAderived products.

Implementation

In the event of a request for slaughtering approval,

FSIS would coordinate its review with the agency having

jurisdiction over the experimental product (e.g., APHIS—

biologics, FDA—drugs, food. and feed additives, EPA—

pesticide chemicals. ) Usually, data gathered by each individual agency is adequate for FSIS evaluation. Once

approved for slaughter, research animals are subject to

the same inspection standards as nonresearch animals. If

some animals derived through new technology, such as

mosaics, chimeras, and some hybrids, differ significantly

from currently inspected animals, the FSIS will determine on a case-by-case basis whether the animals are

covered under FMIA or PPIA or if the acts need to be

amended to require inspection. FSIS also has authority

over substances used in processing meat and poultry

products; the use must be in compliance with applicable

FDA regulations and must be functional, suitable, and

kept to the lowest level necessary ( I I).

The FSIS has not yet had to test its interpretation or

implementation process in a case involving animals modified through biotechnology ( 1 I ).

EPA

EPA has jurisdiction over two broad classes of products (pesticides and ‘‘new’ chemicals) under three Federal statutes—the Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA): the Food, Drug, and Cosmetic

Act (FD&C); and the Toxic Substances Control Act

(TSCA). Under the authority of FIFRA, EPA regulates

the manufacture, processing, distribution, and use of pesticides and sets tolerance levels for pesticides in food

and feed as directed by the Food, Drug, and Cosmetic

Act (discussed in the food safety chapter). Under TSCA,
194 ● A New Technological Era for American Agriculture

EPA must screen any ‘*new” chemical before it is introduced into commerce to determine whether or not its

use presents an unreasonable risk to health or the environment and is not otherwise regulated. This section reviews EPA’s statutory authority under FIFRA and TSCA

and discusses its application to the regulation of biotechnology products.

EPA attempts to forge a coordinated and consistent

approach to its biotechnology responsibilities under FIFRA and TSCA to the extent possible given the different

mandates of the two statutes. Despite these different mandates, both approaches to regulation are concerned with

microorganisms having:

● ‘‘new’ characteristics (intergeneric combinations

of genes) that are new to the environment in which

they will be released;

● potential for adverse effects on other organisms; and

● potential for widespread exposure because they are

used in the environment.

Because FIFRA regulations were already applied to

microbial pesticides, an interim regulatory policy announced in the Federal Register on small-scale field

trials in relation to Experimental Use Permit (EUP)

regulations was the only change necessary for the ‘‘new’

biotechnology. However, a set of regulations for microorganisms is needed under TSCA so that EPA can

regulate living microorganisms more readily. The agency

heretofore has dealt principally with new chemicals,

although microorganisms have been included in the

TSCA Inventory of Chemical Substances since its establishment. Regulations could be developed by applying the statutory provisions of TSCA and EPA’s

current oversight program for new chemicals to microorganisms. The delay in the development of these

regulations has been noted with particular concern by

the biotechnology community as likely to have caused

uncertainty among applicants and would-be applicants

for deliberate release.

For assistance in regulating biotechnology, the EPA

formed its Biotechnology Science Advisory Committee

(BSAC) in 1986 to give peer review of EPA assessments

of product submissions, as well as scientific advice on

its biotechnology program. Among other responsibilities,

the BSAC has been involved in advising on terms for

regulations, on benefits and risks of the use of antibioticresistance genes as markers in field tests, and on peer

reviews of some EPA assessments of field test submissions (67).

Authority of FIFRA

Statutory Authority

As noted above, pesticides, including those produced

using biotechnology, are regulated by EPA under the

aegis of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). FIFRA was enacted June 25, 1947,

“to regulate the marketing of economic poisons and devices” (6 I STAT. 168; 7 USC sec 135c); it has been

amended multiple times in the intervening years with

major substantive amendments in 1972. 1978, and 1988

and more anticipated in the early 1990s.

The heart of FIFRA is the requirement that all pesticides be registered. EPA must certify that the use of a

pesticide does not pose an ‘‘unreasonable adverse effect’

in order to register a pesticide. In deciding whether a

pesticide use poses ‘‘any unreasonable risk to man or the

environment, EPA must take ‘‘into account the economic, social, and environmental costs and benefits of

the use of any pesticide. ” EPA must also consider the

impact of any regulatory action "on production, prices

of agricultural commodities, retail food prices, and otherwise on the agricultural economy. Registration requires the submission by the manufacturer of extensive

data on the efficacy and human and environmental effects

of the pesticide. EPA uses this data in deciding whether

to register the pesticide and whether to impose conditions

on its manufacture, processing, distribution, and use.

After registering a pesticide, EPA retains regulatory

control via the reregistration, cancellation. and suspension provisions of FIFRA. Section 6 (a) of FIFRA establishes that registrations are canceled after 5 years unless

EPA receives a request for a new registration, at which

point EPA may request new data about the pesticide and

may, on the basis of this new information, alter the conditions of the registration. EPA also has the power to

cancel a registration at any time if the agency finds that

the pesticide poses an unreasonable adverse effect; however, the cancellation procedure is complex and timeconsuming. If the use of a pesticide poses an imminent

hazard, EPA may immediately suspend a registration.

Agency Interpretation and Regulatory Policy

EPA’s principal experience base lies in evaluating conventional chemical pesticides where risk issues may differ significantly from those of living organisms.

Nonetheless, microbes (e.g., bacteria. viruses, fungi, and

protozoa) producing pesticides or pesticidal substances.

as well as plants modified to produce substances to control pests, can be interpreted as falling within the statutory
definition of pesticide. EPA’s office of Pesticide Programs has built a group and experience in regulation of

microbial pesticides since the late 1970s. EPA will register these products it it concludes that the benefits of

their use outweigh the risks. More controversy has arisen

over whether pest-resistant plants are equivalent to pesticides. since all plants have some pest-resistant characteristics naturally. EPA has never, for instance, regulated

plant varieties. such as virus-resistant lines, classically

bred to have “pesticidal” properties.

Microorganisms- On October 17, 1984, EPA published in the Federal Register a notice that it would "require notification prior to all small-scale field tests involving

certain microbial pesticides in order to determine whether

experimental use permits are required. This is in contrast to small-scale field tests of conventional chemical

pesticides. An EUP is not required for the latter if under

10 acres of land or 1 acre of water is involved. The

difference in policy is based on the premise that the

concepts of "small scale" or ‘‘small quantity’ arc not

applicable to living organisms capable of movement and

reproduction. Notifications are required for field tests

involving non indigenous microorganisms. microorganisms genetically altered by ‘‘traditional means, such as

mutagenesis, and recombinant microorganisms. In the

case of most of these notifications. no problem is perceived by EPA and no EUP is required.

In a February 15, 1989, Federal Register notice. EPA

announced its intent ion to amend FIFRA regulations to

require notice for small-scale releases involving I ) microorganisms whose pesticidal properties have been altered by introducing intentionally manipulated genetic

material; and 2 ) microbial pesticides formed by the combination of genetic material from organisms from different genera.

In an attempt to maintain flexibility, EPA is currently

considering a mechanism for exempting small-scale field

tests of microbial pesticides from the notification requirement as increasing information and experience so

justify. Only organisms with higher risk and those that

arouse higher levels of public concern would remain the

targets of reviews. A draft amendment to the regulations

is circulating within EPA that would clarify the scope of

organisms requiring notification, emphasizing only those

organisms that carry significant possibility of risk or raise

high levels of public concern. There has been some support for exempting nonindigenous microorganisms and

microorganisms genetically altered through traditional

means from notification requirements, expressed in terms

of the very absence of comments received on publication

of such notification in the post (67, 91 ).

Plants—In 1987, the EPA Office of Pesticide Programs (OPP) and USDA’s Animal and Plant Health Inspection Service ( APHIS ) agreed to review cooperatively

proposals for field tests transgenic plants that fall under

the Federal Plant Pest Act. Currently, while tests are at

a small scale. on an operational level APHIS takes the

lead, with OPP providing comments. Under discussion

is the possibility that OPP take the lead when the plants

are grown on a large scale for food use. In some cases,

the products of large-scale tests might be intended for

food or teed USC. Modifications to 40CFR 152.40 CFR

158, and 40 CFR 172 may be needed fo new data requirements and variations on Experiment Use Permits.

EPA might regulate field trials of plants with pesticidal

properties, or it might set tolerance levels for residues

in approved food products.

To gain input as it develops procedures t-or evaluating

transgenic plants, EPA conducted a workshop in June.

1990 to discuss scientific issues and seek guidance on

the information needed to conduct these evaluations (23).

In November of 1990, EPA held a second information

gathering conference, this one focusing exclusively on

pesticidal transgenic plants. One topic addressed is how

to adopt the agency’s usual "maximum hazard". testing

approach, in which artificially high concentrations of a

chemical are used to evaluate the safety of plants that

produce a pesticidal chemical in small amounts; if extra

supplies of the chemical are generated (in bacteria) for

the tests, will this material be identical to the plants

chemical, so that the test is valid? Such complexities

not withstanding, EPA under FIFRA has a much more

focused task—regulating substances designed to harm

some living systems—than FDA, which will have to

consider the much broader arena of genetically engineered plants as food. (See ch. 10 and 11. )

Other Organisrns-Microorganisms used against other

insects, such as nematodes or parasitic wasps, do not fall

under the purview of FIFRA. However, the demands of

particular isolated cases can elicit FIFRA staff involvement. In one case, parasitic wasps were used to control

infestations in certain grain elevators in Texas. The FDA

inspector checking for insect parts in the food requested

a tolerance level from EPA. EPA could not comply because it had never registered the wasps as a pesticide.

After much interagency communication back and forth,

EPA developed a memo of exemption. This was the one

case to date in which EPA staff has dealt with animal
196 ● A New Technological Era for- American Agriculture

microorganisms. EPA is not involved, for example, in

a case of a pesticidal nematode carrying bacteria because

it is seen as a microorganism system. If, however, the

bacteria in the system were genetically engineered, OPP

would want to take a look at it (91).

Implementation

Basically, EPA reviews a proposed test and decides

whether to allow the test, request more information, or

require an Experimental Use Permit, for which the target

review time is 90 days. Companies are encouraged to

hold discussions with FIFRA officials prior to the notification and EUP stages.

Review is conducted on a case-by-case basis by FIFRA

staff. A list of data that must be submitted with a notification is available and includes, among other components:

●

●

●

●

●

●

●

the identity of the microorganism;

means and limits of detecting the microorganism in

the environment;

physical, chemical, and biological features influencing the growth and survival of the microorganism;

information on likely survival in the environment(s)

into which the microorganism will be introduced;

the genetic manipulations involved. in detail;

data on potential for gene transfer, detailed description of the test program, including monitoring; and

any additional factual information on possible adverse effects.

Aspects considered by staff include: hazard and exposure, potential problems or issues, important questions

needing answers, and likelihood of risk.

Staff positions are then shared for comment with intraagency workgroups, other Federal agencies if appropriate, State agencies, and, if needed, the BSAC. Although

a State-FIFRA Issues Research and Evaluation Group

exists, EPA does not yet seem to have tapped or developed an established, extensive system of State-level biotechnology contacts comparable to that of USDA. Public

comment is regarded as important; for some proposals,

several opportunities have been provided. Notice of all

notifications appear in the Federal Register; significant

EUP’s, including all biotechnology EUP’, are placed in

the Federal Register as well. Companies are encouraged

to inform local communities of upcoming field tests.

If the analysis indicates unreasonable risks are likely,

EPA can impose restrictions. Risk management can include constraints on use, disposal, and manufacture, as

well as mitigation, monitoring, or other actions. As a

way of checking on its evaluations, and adding to its

information base for future tests, EPA has worked on

the development of monitoring methods that will lead to

understanding of the possible fate and dispersal of microorganisms in the environment (67).

Application of FIFRA

Small-Scale Release

Theory—EPA under FIFRA approaches small-scale

field trials on a case-by-case basis.

Experience Base—From 1984 up to 1989, the Office

of Pesticide Programs (OPP) reviewed 36 submissions

(notifications and EUPs) under FIFRA. Of 25 notifications reviewed, 21 were approved with no EUP required,

1 was withdrawn, and an EUP was required for the remaining 3. Of 11 EUPs reviewed, 10 were approved,

with a decision on 1 pending (96). Companies making

submissions included: AGS, Mycogen, Monsanto, Ecogen, Rohm and Haas, Crop Genetics International, and

Sandoz. Universities included the University of California, Montana State University, Cornell, and the University of Arkansas. Nearly half of the tests involved Bacillus

thuringiensis (85). So-called ‘‘pesticidal plants," transgenic plants that produce pesticidal chemicals, are reviewed in conjunction with USDA-APHIS, with EPAFIFRA staff providing comments to USDA-APHIS. Tomato plants engineered with Bacillus thuringiensis toxin

genes and tobacco plants engineered with Tobacco Mosaic Virus coat protein genes are examples. Both have

been explored by more than one company. Companies

whose applications for transgenic pesticidal plants received informal review by EPA are: Rohm and Haas,

Monsanto, Agrigenetics, Sandoz, DuPont, and Agracetus (97).

The first review of an EUP application for a genetically

engineered microbial pesticide (a test by Advanced Genetic Sciences, Inc., of the Ice-minus (INA) Pseudomonas syringae) took nearly 2 years from receipt of

application to the field test. Two lawsuits involving Federal and State courts temporarily stopped the test; many

administrative proceedings at the State and local levels

caused further delays.

In contrast, a later application on an EUP submitted

by Crop Genetics International in December of 1987 was

granted in May of 1988, less than one-half year later.

The field test was begun in June and data for the test

were submitted in application for an extension and ex-
pansion of the EUP. This test involved the insertion of

a Bacillus thuringiensis toxin gene into a plant endophytic bacteria (67).

OPP considers any microbial pesticides to be biotechnological in the broadest sense; even biochemically based

pheromone products are biologically active systems designed to alter the behavior of insects. At least threequarters of the Office’s workload is comprised of nonrecombinant microbial pesticides; recombinant products

represent only 1 to 5 percent of the number of notifications received. While numbers of new chemicals to be

reviewed have plateaued over the last 5 to 6 years, microbiological/biotechnology products are increasing linearly such that they now comprise approximately onethird of the reviews. Plans exist to add biologically trained

staff during the upcoming year (91).

The early stages of the regulatory life cycle of a new

microbial pesticide is illustrated by a planned introduction of dead recombinant organisms into the environment. In 1986, Mycogen discussed its killed recombinant

bacteria with FIFRA staff who, on receiving requested

data proving that the bacteria were in fact dead, told the

company that it did not need to submit a notification. In

1988, the company was moving its trials into sites larger

than 10 acres, the stage where an EUP was obtained from

EPA. In 1989-90, field tests took place on some 5,000

acres per year. In 1991. the company had several products approved for registration as a pesticide (91).

EPA has also approved field trials of live recombinant

organisms by Repligen and Sandoz Research Corps. Field

trials of recombinant Bacillus thuringiensis on soybeans

infected with beet army worms were approved for the

fall of 1990 at Sandoz’s Mississippi station (86). Interest

in microbial pesticides is growing among large companies.

Large-Scale Release

Although naturally occurring, classically derived, and

killed recombinant products have moved through largescale testing and commercial registration, no large-scale

releases of liverecombinant organisms have as yet been

approved under FIFRA. However, at least one company

has had a series of discussions with EPA staff on testing

design.

Authority of TSCA

Statutory Authority

The Toxic Substances Control Act (TSCA) was enacted in 1976 to regulate the manufacture, processing.

and use of chemicals that may pose an unreasonable risk

to human health or the environment ( 15 USC section

2601-54) (13, 87). Because Congress intended TSCA to

be gap-filling legislation. it gives EPA broad regulatory

authority over a range of substances not regulated under

other Federal laws. In determining the appropriate type

and level of regulation to impose. EPA must ‘‘consider

the environmental, economic, and social impact of any

action [it] takes or proposes to take" {15 USC sec. 2601

(2)]. AS with FIFRA. EPA must carry out a risk benefit

analysis before imposing restrictions on the manufacture,

processing, or use of any chemical.

TSCA primarily is a mechanism for screening new

chemicals. EPA can review new chemicals for unreasonable risk through the mechanism of manufacturers

being required to submit a premanufacture notification

(PMN) to EPA prior to the manufacture of any new

chemical, i.e. , any chemical not included on the EPA

inventory of chemical substances (TSCA sec. 5, 40CFR

720.25). Under TSCA. EPA has the authority to limit

or prohibit the manufacture, processing, or distribution

in commerce of a new chemical substance if it determines that the chemical substance may present an unreasonable risk to health or the environment, or pending

the development of sufficient data to assess whether

the chemical substance presents an unreasonable risk.

The burden is on EPA to establish risk rather than on

the manufacturer to establish the absence of risk. If

EPA ascertains that a chemical poses an unreasonable

risk or that there is insufficient data to determine the

effects of the chemical, EPA can require the manufacturer to test for toxic effects. TSCA subsection 8(e)

requires that manufacturers and processors maintain

records of "significant adverse reactions to health

and the environment (40 CFR 717. 12) and requires

submiss ion to EPA of any information supporting a

conclusion that a chemical or microorganism presents

a substantial risk to health or the environment.

Under its authority to limit or prohibit use of new

chemicals posing unreasonable health or environmental

risks, EPA may establish conditions for the manufacture.

processing, packaging, exposure. and labeling of such

chemicals or ban them outright. EPA also can issue controls over chemicals through the significant new use (SNU ),

reporting, and imminent hazard provisions. The SNU

provision requires prior notification for a significant new

use of a chemical as defined by EPA. The agency then

can set conditions, limitations. or prohibitions based on

a new intended use of a chemical. Finally, as with many

Federal statutes, TSCA has an imminent hazard provision
198 . A New Technological Era for Americun Agriculture

that enables EPA to take action quickly if a chemical

poses a serious risk (15 USC sec. 2606).

Agency Interpretation and Regulatory Policy

1986 Coordinated Framework Policy—EPA primarily uses TSCA section 5, with its requirement for a PMN

prior to the manufacture of any new chemicals to deal

with products of biotechnology. The Coordinated Framework (51 FR 23302-23393, June 26, 1986) (77), which

designated responsibilities for various biotechnology

products held by various Federal agencies, included a

policy statement by EPA as to how the agency intended

to use TSCA for the regulation of biotechnology; the

statement described the categories and microorganisms

subject to TSCA, review procedures, and types of information to be submitted for risk assessments. At the

most fundamental level, living organisms are considered

to be chemical substances under TSCA. Basically, EPA

views certain intergeneric microorganisms (microorganisms formed by deliberate combinations of genetic material from organisms in different genera) as ‘‘new

chemicals’ and therefore under its purview. TSCA pertains to microorganisms used in commercial applications

not regulated under FIFRA, FDCA, and other statutes;

these applications include chemical production, waste

degradation, conversion of biomass to energy, and other

environmental and industrial uses.

While intergeneric microorganisms are subject to review, naturally occurring microorganisms are not considered ‘‘new’ and therefore are not subject to the

prenotification requirements of section 5(a)(1) of TSCA,

although they may be subject to regulation under other

sections of TSCA (i. e., the significant new use rules

under section 5(a)(2)). Naturally occurring organisms are

implicitly considered to be on the TSCA inventory of

substances available in commerce. As for all substances

subject to TSCA, manufacturers, processors, or distributors of microorganisms must notify EPA immediately

if they become aware of new information suggesting risk

from the microorganisms to human health or the environment (section 8(e)).

1988–89 Draft Proposed Regulations—in general,

EPA’s efforts to develop regulatory policy have not met

with success, and 5 years after the appearance of the

Coordinated Framework there still exists no firm EPA

biotechnology regulations. Two principle efforts towards

developing those regulations will be discussed here—the

draft proposed regulations of 1988–89, which did not

come to be; and, in the next section, the draft proposed

regulations of 1991, which are the source of current controversy. Since the issuance of the Coordinated Framework, EPA, in consultation with its Biotechnology Science

Advisory Committee, worked in 1988 and 1989 to develop draft TSCA regulations for biotechnology. Under

the 1986 Framework policy, small-scale biotech R&D

efforts involving field tests of intergenerics were requested to submit a PMN. The 1989 draft regulations

under TSCA proposed a new regulatory mechanism, the

TSCA Experimental Release Application. This mechanism involved the use of Environmental BioSafety Committees (EBC’s), based on the concept of Institutional

BioSafety Committees (IBC’s) established earlier through

the NIH-Recombinant DNA Advisory Committee (RAC).

This draft EPA rule was reviewed by the interagency

Biotechnology Science Coordinating Committee (BSCC)

at several meetings. Many concerns were reportedly raised,

including the scientific basis for the draft regulations.

EPA responded to some comments by sister agencies by

making some modifications and then sent the draft proposed regulations to the Office of Management and Budget (OMB) for clearance. BSCC requested that OMB

hold clearance until BSCC had time to review its interagency; friction ensued (92).

A Request for Comment on Regulatory Approach was

published by EPA in the Federal Register on February

15, 1989 (54 Federal Register 7027). Questions raised

for comment included: scope of the microorganisms to

be subject to EPA’s review; scope of EPA’s review of

R&D field releases of microorganisms into the environment; breadth of definition of ‘‘commercial purposes’

by which EPA would have authority under TSCA in

educational and research facilities; definitions of ‘release

to the environment’ and ‘‘contained facility”; and to

what extent review was to be performed for EPA by

independent expert review groups, such as Environmental BioSafety Committees. The draft regulations did not

survive. Rulemaking was delayed until EPA policy and

plans for TSCA could incorporate the scope document

arrived at by interagency consensus.

1991 Draft Proposed Regulations—The most recent

draft TSCA regulations, integrating some eight specific

rules, appeared and were extensively reviewed in 1991.

Once EPA has completed the process of responding to

the recommendations of the BSAC Subcommittee regarding this draft, the regulations enter the final phase

of the Agency’s internal review process.

Under EPA’s portion of the 1986 Framework Policy,

reporting by persons intending to introduce intergeneric
microorganisms into the environment for R&L) purposes

is voluntary. EPA is now proposing that this is no longer

voluntary. However, researchers intending to introduce

intergeneric microorganisms into the environment for R&D

purposes would at least have the option of filing a TSCA

Experimental Release Application. or TERA, as an exemption from a full 90-day notification that would otherwise be required from commercially oriented applicants.

The expedited TERA review would generally be completed in 60 days. The extent of the reporting of environmental R&D required will depend on the eventual

selection of an interpretation of the statutory phrase

‘‘commercial purposes. In addition, EPA proposes to

exempt some categories of microorganisms when introduced into the environment for R&D purposes (30). The

proposed approach is different from the agency’s treatment of chemicals, for which review of small-scale R&D

activities is not required, presumably because, unlike

microorganisms, chemicals cannot reproduce, disseminate, and transfer genetic material.

In 1986, EPA had stated that it would try to derive

exemptions for some organisms used in contained facilities: in the current draft, some organisms in contained

facilities are exempted from review and only a short

review is required for specified lists of industry’s "workhorses, such as Bacillus subtilis. The list is expected

to grow with experience.

The agency views the new document as following directly from the coordinating principles and scientific

rationale of the ‘‘scope document’ published by the Office of Science and Technology in 1990 as proposed

“Principles for Federal Oversight of Biotechnology:

Planned Introduction in the Environment of Organisms

with Modified Hereditary Traits’ [55 Fed. Reg. 31, 120

(1990)] (discussed later). EPA has stated that it will subject to regulatory scrutiny only those “new” organisms

that seem likely to present risks. Definitions of “new*’

and “risk” are subjects of debate. Some view the 199 I

draft-proposed regulations as inconsistent with the OSTP

draft’s risk-based philosophy. The TSCA 1991 draft proposal effectively singles out recombinant-DNA modified

microorganisms for oversight. by exempting other categories such as classical transformation systems (e. g.,

conjugation or chemical mutagenesis). or rearrangements, deletions, or amplifications of genetic material

by recombinant techniques. These exclusions are based

on EPA’s view that such things could—and do—occur

naturally and are thus not . ‘new. in contrast to recombinations formed with genes from different genera.

EPA is proposing three alternative interpretations of

‘‘commercial purposes’” in its current draft rule: it may

draw a very big net. The first involves selection of commercial indicators that would govern whether a particular

field trial would be subject to oversight. The second

would apply commercial indicators to R&D conducted

in laboratories and greenhouses, for example, and would

consider any environmental field release as commercial.

and thus subject to screening. The third would permit

researchers to rebut the presumption that a field trial was

for commercial purposes by showing a lack of commercial intent.

Having potentially drawn so many activities into its

‘‘commercial” net, TSCA would defer to whatever agency

would most sensibly handle that activity. TSCA’s own

coverage might not increase to a great extent. Academic

laboratories may well fall under the scope of this ‘‘con~-

mercial purpose’ if, as is so often the case today. they

have some form of a relationship with a company or

perhaps even if their home institutions have dealings with

industry—as most universities do. Another point of controversy of the proposed draft is its attempt to institutionalize good laboratory procedure and record keeping

even in academic laboratories, which previously have

not been considered under its jurisdiction (21).

The outcome and the acceptability of the draft are not

yet known. It contains controversial points and, 5 years

after the appearance of the Coordinated Framework, there

exists no track record for quick finalization of EPA biotechnology regulations.

Implementation3

EPA currently requests industry to comply voluntarily

with the PMN (remanufacture notice) requirements for

commercial R&D involving field test releases with intergeneric microorganisms. (Commercial-scale releases

are subject to mandatory reporting requirements. ) Because the standard TSCA PMN form is not applicable to

microbial products, the Program Development Branch of

the Chemical Control Division prepared a document,

“Points to Consider in the Preparation and Submission

of TSCA Premanufacture Notices (PMNs) for Microorganisms, ’ in 1990. The document is intended to give

guidance for contained system (fermentation) PMNs and

~ Note - the preceding section, “Agency Interpretation and Regulatory Policy .“ discusws dmrclopmcnt of EPA policy, which includes proposed

implementation. This section examines <urrcn/l\ pructiled implementation.
200 ● A New Technological Era for American Agriculture

environmental release PMNs. It specifies points of desired information, including: description of recipient and

donor microorganisms, construction of the PMN microorganisms, characteristics of the PMN microorganisms,

production process, worker and consumer exposure, environmental behavior of the PMN strain, and environmental release protocols.

Manufacturers or importers of intergeneric microorganisms in and for commerce are required under TSCA

section 5(a)(1) to submit a PMN at least 90 days prior

to manufacture or import. Communication with a Program Manager in the Program Development Branch,

Chemical Control Division, and EPA’s Office of Toxic

Substance is recommended prior to submission of a PMN.

Submitters are encouraged to minimize information withheld as confidential; however, two versions, one with

and one without CBI, can be submitted. Companies must

now pay a fee of $2,500 for each PMN or consolidated

PMN submitted; small businesses must remit $100 per

PMN. The EPA publishes a notice on each PMN submission in the Federal Register ( 17).

Review of PMN’s is conducted on a case-by-case basis, and can involve both EPA scientists and outside

scientific experts. Following submission of the PMN,

EPA has 90 days to make a determination as to if and

how to regulate. During this time a scientifically based

hazard assessment and an exposure assessment are conducted. (See ch. 8 and U.S. EPA ( 1987) Toxic Substances Discussion of Premanufacture Testing Policy and

Technical Issues; Request for Comment. Federal Register

44, 16243-44).

Among the items of information reviewed are:

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If

the identity and characteristics of the source organism,

the methods and genetic material used to manipulate

the source organisms,

the nature of any new traits or functions,

purpose and intended effect of application or release,

characteristics of the site of application,

method and numbers involved in application,

containment and mitigation methods,

monitoring procedures, and

data on environmental fate and effects ( 10).

EPA determines during the 90-day period that a new

chemical substance may present an unreasonable risk to

health or the environment, EPA can prohibit or regulate

the substance; if it does not do so, the submitter may

proceed. An extension to a 180-day review period can

occur, for good cause. Other agencies may be asked for

comment, and appropriate State regulatory agencies are

contacted. Visits to test sites may occur. The BSAC may

review submissions and EPA evaluations. Public comment is viewed as important (67).

Application

Small-Scale Research

Theory—EPA approaches

of TSCA

small-scale field trials on

a case-by-case basis. Unlike commercial research involving chemicals, under the 1991 draft of proposed regulations, recombinant DNA small-scale field tests will

receive no automatic exemption from the PMN requirement, although an alternative application process (the

TERA) may be used.

Experience Base— Since 1986, EPA’s Office of Toxic

Substances (OTS) has reviewed 20 premanufacture notices (PMNs) for release, with the most recent review

completed in April, 1990 ( 18). It has been speculated

that the absence of notices over the last year may reflect

an economic climate unfavorable to commercial development of environmental uses of microorganisms (economic climate seems not to have affected plant submissions); uncertainty as to EPA’s regulatory role; or the

evolution of the science itself. It may be that biotechnology is to some extent moving away from deliberate

release of microorganisms; plants may be easier to manipulate than previously thought. Some suggest that the

lack of notices received under TSCA simply reflects the

fact that no company is now actively developing rhizobia

or other microorganisms subject to TSCA. Bioremediation, the commercial use of microorganisms to degrade

toxic waste, will probably not significantly utilize genetic

engineering in the near future. It has been suggested,

however, that this particular delay may be related not

simply to technical reasons but also to uncertainty about

regulatory interpretations.

The first biotechnology application under TSCA was

filed by Biotechnica in February 1987. The application

was to field test, in Wisconsin, genetically engineered

strains of Rhizobium meliloti to see if these increased

alfalfa yields through nitrogen fixation.

A Subcommittee of the Biotechnology Science Advisory Committee reviewed the field test protocols and

recommended that Biotechnica provide a fuller description of the experimental methods being employed at the

site in terms of plot design and monitoring of the organisms after release into the field plot. After consideration
Chapter 7—Environmental Issues: Institutions and Their Regulatory Roles ● 201

of BSAC suggestions and other public comments, Biotechnica obtained EPA approval to conduct the field test

in spring of 1988.

Another early submission was a request in June of

1987 from Monsanto to field test a fluorescent microorganism genetically engineered to be more easily distinguished from other soil microorganisms under laboratory

conditions. EPA completed its review in October of 1987.

The field trial was held and it demonstrated the usefulness

of the gene as a marker for monitoring. Monitoring of

the field trials demonstrated that the organism colonized

roots; that the population continued to decline; and that

migration was limited (67).

With the exception of Monsanto’s field trial, all other

environmental use submissions under TSCA have been

from Biotechnica. Biotechnica’s tests have involved microorganisms genetically modified for improved detection in the environment (antibiotic resistance) and for

enhanced nitrogen fixation resulting in potential yield

increases ( 18).

Commercial-Scale Release

Commercial-scale release of genetically modified microorganisms has not yet occurred. EPA might be expected to follow the same case-by-case pattern for

commercial-scale release as it has for small-scale release

research. As a matter of interest, there have been commercial-scale uses of genetically modified microorganisms in contained systems. Reviews have been completed

on 10 PMNs involving the commercial-scale use of intergeneric microorganisms in contained fermentation systems for the production of microbial enzymes.

OTHER AGENCIES

National Institutes of Health (NIH)

The RAC, the Recombinant DNA Advisory Committee at NIH, wrote the now-classic Guidelines for research

in recombinant DNA at federally funded institutions and

has reviewed cases for compliance with the guidelines.

The original Guidelines, issued in 1976, counted deliberate release as one of five classes of experiments ‘‘not

to be initiated at the present time”; in the Guideline

revisions of 1978, ‘‘deliberate release into the environment of any organism containing recombinant DNA”

was prohibited, but provisions were made for waivers

through the RAC and NIH; in 1982 revisions, such ‘‘prohibitions” became ‘‘experiments that require RAC review and NIH and IBC approval before initiation’ (66).

“Deliberate release” was listed as one of the triggers

for RAC review (May 7, 1986, Federal Register, vol.

5 1(88), p. 16960). In fact, however, the RAC has not

reviewed any cases since 1987. Since then, EPA and

USDA have interpreted their authority to have purview

over the vast majority of experiments involving deliberate

release. RAC’s acquiescence to this allocation of oversight is made clear in its ‘‘Talbot Amendment, stating

that once approvals or other clearances have been obtained from an agency other than NIH, the experiment

may proceed (Aug. 24, 1987, Federal Register 52( 163),

p. 31, 849). In addition, the RAC at its February 4, 1991

meeting, voted to consider deleting planned environmental deliberate release as one of the triggers for its

involvement in biotechnology regulation. After duly publishing notice and receiving public input, the RAC met

on May 31, 1991 and voted to relinquish this overview.

The decision now stands before the Director of NIH.

NIH funds very few scientists involved in deliberate release; it also lacks qualified staff to conduct EA’s. The

RAC, however, intends to maintain its overview of work

with transgenic plants and animals inside laboratories,

animal rooms, and greenhouses. RAC’s relinquishing of

national overview does not preclude local Institutional

Biosafety Committees (IBCs) from considering planned

introductions or from bringing up problems to the RAC

( 108).

Food and Drug Administration (FDA)

Because FDA’s authority is over the final food product

in interstate commerce. it does not regulate research and

therefore is not involved currently in the environmental

issues concerning deliberate release research. Exceptions

are its jurisdiction over live attenuated vaccines and feed

additives including live microorganisms. However, if FDA

gives some form of approval for the commercial use of

transgenic plants for food, it may have to evaluate the

potential environmental consequences of that approval,

under the National Environmental Policy Act (NEPA).

If a company asked FDA to affirm GRAS (Generally

Recognized as Safe) status for a food or to state that a

particular variety of plant is acceptable as a source for

food, FDA would likely have to assess the environmental

consequences of the field use of the plant as part of its

evaluation of the food product. An FDA ‘‘advisory opinion , however, might not be a major Federal action

requiring an environmental assessment.

In its reviews, the agency in the past has limited its

environmental assessment to the manufacture and use of

the petitioned-for substance. It typically has not reviewed

the environmental consequences of the original produc-
tion or development of the materials used at the manufacturing site. In the case of agricultural commodities,

however. the plant itself might be viewed as analogous

to the manufacturing facility.

If USDA has evaluated the environmental consequences of the field use of the plant, FDA should be able

to make use of that information in its own evaluation. It

is also possible, although not necessarily likely, that FDA

may be able to exclude categorically from its own environmental review those plants that have been reviewed

by USDA for commercial use (24).

STATE AND LOCAL

GOVERNMENT

Spectrum of State Approaches to Regulation

Significant concern has been expressed regarding the

involvement of State governments in the regulation of

biotechnology. In addition to coordination with Federal

agencies. discussed in a later section. a significant question is the degree to which States should take on independent review authority. On the one hand, State

governments may be argued to be "closer to" the people

that they are safeguarding and therefore regarded as particularly able or trustworthy as regulators. On the other

hand, duplication of Federal regulatory requirements could

prove to be an untenable burden on companies. Excessive. idiosyncratic requirements at the State level also

might inhibit industrial development. Furthermore, a

patchwork of varying State regulatory regimes across the

Nation could lead to significant uncertainty on the part

of industry, a shopping around for receptive States, or a

simple unwillingness to move into product lines related

to biotechnology. Compliance with different standards

in different States could be a costly problem for industry.

State legislation relevant to biotechnology in 1990 included 19 bills spread among 13 States. These fall in the

areas of DNA testing (9). bST (4). R&D and economic

development (3), deliberate release ( l), general regulations ( I ). and other ( I). In the same year, some 48 bills

in 18 States were introduced but not enacted. These referred to bST (20), DNA testing ( I l), R&D) and economic development ( 10), deliberate release (3), general

regulations (2), and other (2).

Over the past several years, the nine States of Florida.

Hawaii. Illinois, Maine. Minnesota. New York. North

Carolina, Oklahoma, and Wisconsin have enacted statutes pertaining directly to field testing of genetically

modified organisms. with Maine and New York simply

creating advisory committees to study issues. In 1991,

West Virginia amended its plant pest act to pertain specifically to biotechnology. Many State statutes simply

require notification of field test applications to particular

State agencies that are to cooperate with the Federal

process. Only North Carolina and Minnesota require additional permits. Policy stances taken by various States

fall into a broad spectrum. from no or very little administrative or legislative activity (approximately half the

States) to moderate activity to, in a few cases, initiation

of new regulatory procedures ( 16). Case study illustrations of this range of activity follow.

North Carolina

In June 1988 the North Carolina Department of Agriculture and the North Carolina Biotechnology Center

formed an Advisory Committee to determine whether or

not any State regulation was needed and, if so, to develop

a suitable regulatory framework. The 27-member Committee included university and private-sector researchers,

administrators, business executives, lawyers. and farmers and representatives of government, public interest,

and other groups. The committee’s recommended regulation was passed by the North Carolina General Assembly in August of 1989 as the Genetically Engineered

Organisms Act. Funds were appropriated for a staff biotechnologist in the North Carolina Department of Agriculture to administer the law, which requires a permit

(either general or limited) for environmental release and

for the sale of genetically engineered organisms, with

public notice given (8, 16).

Minnesota

In response to public suggestions in 1987 for rule changes

to the Minnesota environmental review regulations, the

Minnesota Environmental Quality Board formed a working group on environmental release, which recommended

that the EQB should be a coordinating body for genetic

engineering. A Task Force was formed, and its report

was implemented by legislation in 1989. A permit is

required for environmental release of genetically engineered organisms. The EQB is charged with establishing

an advisory committee. reviewing proposals, and adapting rules for an environmental work sheet and for a permit

for releases (8, 16). Recently, issuance of resultant proposed regulations under the EQB law have caused much

controversy. A process for permitting, including an environmental assessment worksheet, would be required

for each release of a genetically engineered organism

(defined fairly broadly. ) Legislation in 1991 created areas

of specific permit authority for the Minnesota Agriculture
Department (transgenic plants; genetically engineered and

experimental pesticides; and genetically engineered fertilizers. soil, or plant amendments). EQB regulations

would therefore cover transgenic animals and nonagricultural engineered microorganisms. Both agencies,

however, must follow the same specific procedures in

proposing environmental assessments (34).

California

The well-publicized field tests of ice-minus bacteria

in Monterey County in 1983-84 (see U.S. Congress,

OTA. 1988 for the full case study) ( 102) led to a recommendation that California clarify its biotechnology

regulations. Thus, an Executive Order in 1985 established the California Interagency Task Force on Biotechnology. The Task Force systematically identified,

evaluated, and communicated the level of regulatory control already pertaining to various biotechnology activities

in California. The first product was a handbook, ‘‘Biotechnology-California Permits and Regulations,” published in 1986, with at least 3,000 copies distributed by

the summer of 1989. The chief finding was that the

current regulations were quite complete in their coverage

of biotechnology. Four permit procedures were enhanced

to provide for increased input from the public (8, 16).

New Jersey

Stimulated by the repeated introduction (without enactment) of a State legislative bill that would have regulated environmental release, and by the enactment of

several local ordinances for such regulation, the New

Jersey Department of Environmental Protection developed a white paper on recommendations for the development of State policy on biotechnology. Following

informal discussions among agency representatives, an

Interagency Committee on Biotechnology was appointed

by Departmental Commissioners in the fall of 1989. with

university advisors. The committee is evaluating:

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The

the effectiveness of State laws to regulate biotechnology,

coordination with Federal agencies,

the needs of industry in complying with regulations,

other States’ policies,

the need for biotechnology education, and

appropriate roles of the State and its agencies.

first priority is evaluation of New Jersey statutes and

coordination with Federal agencies, with the objective

of compiling a California-like handbook (8).

Inter-State Gatherings and Consensuses of

State Regulators

In recognition of the importance of State regulatory

agency officials as part of the full system of regulation.

the USDA hosted conferences in 1989. 1990. and 199 I

on “Federal and State Regulation of Biotechnology .“

Emphasis was placed on clear communication from Federal agency representatives to State agency representatives about the details of the implementation of Federal

biotechnology regulations. The 1990 meeting attracted

some 130 people. the great majority from State agencies.

University, private-sector. and environmentalist representatives attended as well. The third meeting, in 1991.

concentrated on the issues of large-scale commercial release.

In recognition of the varying degrees of unease felt by

State regulators having to come to grips with biotechnology, a special workshop for State agencies, “State

Oversight of Biotechnology, ” was held in conjunction

with the second Federal conference, sponsored by the

University of California Systemwide Biotechnology. Research and Education Program and the New Jersey Department of Environmental Protection. Case histories of

the development of various State policies were shared.

Brainstorming seminars led to a consensus set of recommendations for State regulatory officials. The resulting document, “Guidance for State Governments on

Oversight of Biotechnology, ” included the following

“Points to Consider” for States considering how to handle biotechnology oversight:

1.

2.

3.

evaluation of the existing (Federal and State) oversight framework for biotechnology;

organization of a task force to include representatives from multiple agencies, industry, academic

and public interest groups; and

activities of the task force, which should include

identifying and reviewing existing State statutes

and Federal agency roles; recommending needed

actions. if any; delineating clear pathways for applicants to follow; working with local governments;

and communicating with and involving the public

(39, 59).

In 1991, a follow-up workshop emphasized specific points

at which coordination between State and Federal agencies

could be fine-tuned.

Spectrum of Local Approaches to Regulation

The first local response to biotechnology occurred in

Cambridge. Massachusetts. in the ordinances passed in
1977. Concerns over genetic engineering research in university laboratories led to sometimes heated hearings and

local regulations. Some years later, an equilibrium seems

to have been reached between town and gown. Some

companies find the existence of known local regulations

to be positive, although others find them problematic and

subject to change with newly elected local politicians.

Such an open clash has been fairly unusual, although

in one 1989 case the city of Burlington, Vermont and

the University of Vermont clashed over the construction

of a building to house much of the university’s molecular

biotechnology research. The city demanded input into,

if not the approval of, experiments to be conducted in a

new building. The University refused, and the press attacked the University’s stance (6). In March of 1991, a

Memorandum of Understanding between the city and the

University called for the establishment of a task force to

discuss plans together. Like Cambridge, Burlington was

not particularly concerned with deliberate release.

 In New Jersey, on the other hand, initial local concerns

focused on perceived risks associated with deliberate release of genetically engineered organisms. When Statelevel legislation was not enacted, concerned politicians

provided to municipal governments model ordinances to

restrict the environmental release of genetically engineered microorganisms. By early 1990, six municipalities had adopted such ordinances. Other municipalities

debated such ordinances, but decided against enactment,

in part because pertinent expertise was recognized as

lacking at the local level (41).

To forestall negative public reactions, the AgBiotech

Center of Rutgers University in New Jersey began working with the local community from the earliest moment.

They formed a Citizens’ Advisory Committee to provide

input and air public concerns over its planned field-trial

facility for genetically engineered plants. Local planning

boards, a homeowner’s association, farmers, and agricultural organizations appointed members to the committee. The committee reviews plans for the facility and

applications for field trials therein. The committee also

is charged with communicating information to the public

(88).

INTERNATIONAL REGULATORY

CLIMATE

Biotechnology, as a scientific endeavor and an industrial activity, is international in scope. Those concerned

with U.S. economic competitiveness or with the global

environment have reason to be interested in the degree

to which deliberate release regulations are internationally

consistent and coordinated. A brief sketch of regulatory

approaches in several countries follows.

Europe

Status of Regulations, EC 1992

European Community (EC) directives were passed in

April of 1990 concerning contained use and deliberate

release of genetically modified organisms. Member States

were supposed to draft national laws by October, 1991,

in alignment with these ‘‘minimum standard’ directives.

Each State can, and some may well, add more restrictive

measures; different member States will achieve different

balances regarding restrictiveness of regulations. Pressure groups such as the Greens in Germany, for example,

will attempt to counteract the voices of industry concerned with economic competitiveness. Despite the potential for some country-to-country variation in regulatory

rigor, the directives are meant to provide more of a ‘ ‘bottom line” consistency among States in terms of protecting the environment than was present in the past.

According to the EC Directive on the Deliberate Release of Genetically Modified Microorganisms, No. 90/

220/EEC, releases are permitted only in countries with

relevant national approval procedures. The EC hopes for

an EC-wide approval procedure for releases of commercial products. This would allow free distribution of products throughout the EC. Deliberate releases will be

evaluated and approved or disapproved on a case-by-case

basis; hence, there may be room for flexibility in and

evolution of regulations. Environmental impact assessments and consent by competent authorities are prerequisites of release.

Different stages in establishing a basis for national

decision making have been reached by different EC countries. Approximately one-half of the member States passed

implementing legislation by the October 1991 deadline.

In the United Kingdom (UK), a biotechnology regulatory

framework is part of an introduced Environmental Protection Bill that is intended to form the basis of future

detailed regulations. In Germany, the Gene Law was

enacted in July 1990. Under pressure from some of its

largest industries, Denmark retracted its extremely stringent 1986 law; deliberations as to implementation of EC

directives are ongoing. In France, procedures are

straightforward and nonburdensome; over 50 field trials

have taken place. In the Netherlands, permits for field

trials are granted by the Ministry of the Environment
( 105). In France, some 67 “uncontained experiments”

took place between 1987 and 1990 ( 12).

Some analyze EC directives with a positive spirit and

view the goal of developing a coordinated science-based

approach to regulation as helpful to biotechnology in the

long run. Science-based regulation, even if it varies among

member countries, may well be preferable to idiosyncratic applications of disparate laws already on the books

in different countries (47).

In any event, it is not yet clear what balances will be

achieved by diverse countries weighing such factors as

environmentalist pressures, industry lobbying, scientific

findings, and competitiveness concerns. The foundation

is laid for commonality, but the likelihood is that different

countries will find their own paths. True homogenization

is not likely to be achieved by “Europe 1992. The

loathing that industry feels for regulatory uncertainty might

give the United States at least a transient competitive

advantage over at least some countries if regulatory uncertainty here is minimized.

The Fourth Hurdle

The “fourth hurdle” causing real worry among biotechnology advocates refers to a fourth criterion for European regulations of biotechnology. This fourth criterion

would be the inclusion of socioeconomic values in the

approval process. The usual three technically based hurdles for regulations generally are safety, quality, and

efficacy ( 15). The fourth hurdle is controversial, and of

great concern even to U.S. industry. Perhaps discussion

of this hurdle has peaked already, and it may be declining

in importance. However, observers believe that interest

could intensify again at any moment. An attempt based

on socioeconomic values to ban veterinary growth hormones was voted down late in 1990, suggesting that

institutionalization of such values may be unlikely (47).

Harmonization

Despite differences among member states and among

EC directorates, European countries and the United States

are making good-faith efforts to harmonize regulations.

Enlightened self-interest regarding economic competitiveness doubtless plays a role.

Several forces for harmonization include: The Organization for Economic Cooperation and Development

(OECD). the Office of International Epizootics (OIE),

United Nations Agencies (UN), The World Bank, and

bilateral discussions with the European Commission (EC).

The OECD, which includes 25 industrialized countries,

many but not all of which are European, has several

projects related to regulation of biotechnology, including:

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OIE

Good Development Practices;

Guidance for the Design of Small-Scale Field Research With Genetically Modified Plants and MicroOrganisms;

Good Industrial Large-Scale Practices:

Monitoring of Genetically Modified Organisms Introduced into the Environment: Findings and Suggestions;

Performance Evaluations for Plant Cultivar Development; and

Food Safety.

discussions focus on development of internationally

equivalent. appropriate standards for evaluation of veterinary biological products derived through biotechnology. Within the EC, bilateral discussions have occurred

through the U.S./EC Bilateral Discussions on the Environment, the High-Tech Group, and the Task Force on

Biotechnology Research (57).

Perhaps the most compelling example of harmonization is the development of a common document on biotechnology safety by the 23 member countries (including

many European countries, as well as the United States.

Canada. and Japan) of the OECD. First published inhouse as “Good Developmental Practices (GDP) for SmallScale Field Research, ” it was reworked and released f-or

public comment in 1990. GDP outlines scientific principles and conditions for proposal review and also gives

guidance to researchers designing small-scale field tests

of plants and microorganisms. The document may be

augmented by another paper(s) as more data are compiled: the basic approach is aligned with the principles

advocated in the 1989 National Academy of Sciences

report on safety in field testing (73). Acceptance of this

document by 23 countries has been a significant step

toward international harmonization of biotechnology fieldtrial regulations. The fact that the United States was the

lead country in developing the document ensures good

harmonization with U.S. regulations: this. in turn, should

facilitate international trade (55).

Currently, the United States is the designated lead for

OECD in drafting an OECD discussion paper on scientific issues associated with performance trials of plant

cultivars. A principal objective of this endeavor is to

enable policy bodies to make recommendations and decisions based on sound science when they consider largescale plantings of new agricultural crops. including those

developed with new biotechnology techniques (24). This

represents a stage beyond the small-scale research cov-
206 . A New Technological Era for American Agriculture

ered by GDP as performance trials involve more plants

and there may be no means of ensuring that plants remain

confined to experimental sites. Performance trials, however, still qualify as R&D; issues associated with commercialization of plant crops are not directly addressed

in this OECD paper.

Canada

Status of Regulations

Following the lead of a Federal Government task force

in 1980, Canada implemented a national biotechnology

strategy in 1983 and established the Interdepartmental

Committee on Biotechnology in 1985. The committee

began with the premises that the product rather than the

process would be regulated, building on current legislation. Additional concerns could be addressed with

guidelines. Canadian regulations would harmonize with

those of other countries wherever possible and practicable. A biotechnology users’ guide to Federal regulations

has been updated recently, assisting applicants with identification of appropriate agencies, contact people, and

procedure. In 1987, an ad-hoc committee was formed

on environmental release. Agriculture Canada, dealing

with organisms used in agriculture, and Environment

Canada, along with Health and Welfare Canada, dealing

with microorganisms used for nonagricultural uses, are

the chief players in the regulatory arena ( 14).

Currently, regulatory bodies and others in Canada are

considering a draft of Proposed Notification Regulations

for Biotechnology Products under the Canadian Environmental Protection Act. Developed by Environment

Canada and Health and Welfare Canada. notification requirements will eventually become regulations under the

new substances provisions of the Canadian Environmental Protection Act (CEPA) and will apply to new biotechnology products manufactured in or imported to

Canada. Notification and assessment periods as well as

information required are defined based on whether the

biotechnology product will be used in contained manufacturing or released into the environment. All biotechnology products will be considered new substances under

these regulations.

Environment Canada is currently in the process of

developing a Domestic Substances List for those biotechnology products in commercial use in Canada between 1984 and 1986. Once a microorganism is added

to this list, no further notification is required by a user

if the product is used for the purpose specified in the

list.

Guidelines are being prepared to assist those needing

to submit notifications for this list. For release into the

environment, notification would be required prior to importation. commercial manufacture, small-scale field trials,

or large-scale field trials. Currently, information required

for a field trial would include: objectives, site details,

experimental design, site supervision, introduction protocols, containment procedures, monitoring procedures,

termination procedures, and mitigation procedures. In the

interim, while the proposed regulations are being developed, notification to Environment Canada is recommended for those with intent to manufacture or import

into Canada biotechnology products (80).

Harmonization

Probably the closest working international relationship

in the area of biotechnology regulation exists between

the United States and Canada, which may not be surprising given their geographical proximity and free trade

agreement. EPA officials have met with representatives

of Environment Canada and have had informal contact

with other relevant Canadian agencies. USDA officials

have met with Agriculture Canada officials yearly for 4

years and communicated between meetings on rationale,

procedure, and so on. U.S. companies can do field tests

in Canada; requests that U.S. officials accept Canadian

field test data are expected in the near future. Review

systems similar to the U.S. biotechnology permitting system have been established by Canada, taking into account

the basic principles on the safety of field testing shared

by all OECD countries (60).

Japan

In general terms, Japan’s regulation of biotechnology

is in line with international standards. Research guidelines are based on the early NIH guidelines, and industry

guidelines are consistent with OECD. The Ministry of

Agriculture, Forestry, and Fisheries (MAFF) issued the

first regulations on environmental release of plants in the

summer of 1989 ( 103). Government guidelines emphasize a step-by-step approach to field tests and a case-bycase basis for approval (94). USDA has worked with

MAFF on how to conduct reviews and in a consultative

group on monitoring. Japan’s environmental directorate

is looking at microbiological field releases. One field test

has been approved to date in Japan; Japanese companies

are requesting field trials in Mexico (58).

Recognition of the importance of facilitating field trials

is growing in Japan. In the second half of 1990, for

example, Japan’s MAFF announced its intention of or-
ganizing an incorporated association of over 100 Japanese biotechnology-related companies. In addition to

promoting biotechnology in relevant industries. the Society for Techno-innovation of Agriculture, Forestry, and

Fisheries (STAFF) is expected to be involved in promoting and authorizing field trials of genetically modified

organisms (45 ). In addition, Japan’s first isolated. openair field site for transgenic plants has been constructed

in Tsukuba, Ibaraki Prefecture, by the National Institute

of Agro-Environmental Science (NIAES). NIAES scientists plan to test environmental effects of tomatoes

engineered to resist the tobacco mosaic virus.

Developing Countries

In general. developing countries have neither biotechnology regulations nor focused biotechnology staff

in their regulatory agencies. One relatively unusual

example of activity is the recent formtaion of the Genetic Engineering Approval Committee in India. The

group regulates the production and release of genetically engineered organisms and potentially harmful microorganisms (76). A variety of efforts from the

developed countries, some based on differing premises, are being made to include developing countries

in current regulatory approaches.

The early stages of harmonization may take place quite

naturally in developing countries that have some serious

interest in biotechnology. Such countries tend to send

representatives to the United States to learn about approaches taken here. APHIS-BEEP for instance. has

exchanged information with China, India, Mexico. Costa

Rica. Brazil, Argentina, Chile, Nigeria. Kenya, Zimbabwe, Thailand. and the Philippines on regulatory philosophy, mechanisrms by which that philosophy is

implemented, and ways to handle risk assessment and

risk management. USDA has held a variety of conferences on related topics, which are well attended by international representatives.

Various U. N. agencies are exploring different avenues

through which to assist technology transfer of biotechnology to developing countries while safeguarding environmental and human health. The U. N. Industrial

Development Organization (UNIDO) has developed a

voluntary code of conduct to provide guidance for introducing biotechnology products into developing countries. The World Bank has hired a biotechnology advisor

to consider biotechnology issues with the Consultative

Group on International Agricultural Research (CGIAR).

although most of the 18 CGIAR centers are not yet close

to field trials. The National Research Council has published a panel report on “Plant Biotechnology Research

for Developing Countries. * Some developing world observers question the appropriateness of automatic wholesale adoption of stringent regulations by developing

countries (42).

POLICY ISSUES

Jurisdiction and Coordination

Mechanisms of Coordination

at the Federal Level

The 1986 Coordinated Framework, described earlier,

was a crucial step in establishing and clarifying jurisdictional authorities for a new technology with diverse applications. To further clarity jurisdiction as biotechnology

matured toward products, and to help Federal agencies

formulate regulations and guidelines based on existing

statutory authority, the Biotechnology Science Coordinating Committee (BSCC) was established by the Office

of Science and Technology Policy (OSTP). (50FR 47174-

47195, November 14. 1985). BSCC was charged “to

monitor the changing scene of biotechnology and serve

as a means of identifying potential gaps in regulation in

a timely fashion, making appropriate recommendations

for either administrative or legislative actions.

Until recently, the BSCC provided a forum for senior

policy officials from USDA, EPA, FDA. NIH. and NSF

as they attempted to coordinate policy. promote consistency in review procedures, and identify key issues. One

outcome of this forum was the interagency funding of

the 1989 National Academy of Science (NAS) report,

‘‘Field Testing of Genetically Modified organisms: A

Framework for Decision-Making.” The BSCC also has

helped to resolve jurisdictional conundrums, such as

whether EPA or USDA is the lead agency in cases of

dual jurisdiction. Despite such positive contributions,

however, the BSCC had difficulties achieving consensus

on important issues such as risk assessment and management, levels of oversight appropriate for certain organisms. definition o! deliberate release, and coherent

standards for oversight (11). These difficulties arose in

part because different agencies have different statutory

mandates and built-in approaches to regultaion. BSCC

also waS criticized for its ‘‘closed-door’ deliberations

and for ‘‘rneddiling” in regulatory agency affairs. Nonetheless. the committee helped initiate formulation of broad

principles for regulation (27).

In the absence of agreement within the BSCC, Dr.

Allen Bromley. director of the Office Of Science and
208 ● A New Technological Era for American Agriculture

Technology Policy, decided that the identification of organisms subject to Federal oversight ‘‘had policy implications beyond the jurisdiction of the BSCC” [55 Fed

Reg. 31,120 ( 1990)] and the issues should be addressed

by the appropriate policy body—the President’s Council

on Competitiveness. Moved under the aegis of the Working Group on Biotechnologyof the Council on July 31,

1990, a “scope document” pertaining to initial releases

of biotechnology-derived organisms into the environment

was published for public review and comment [55 FR 147,

31118 ( 1990)] by the Office of Science and Technology

Policy. The document, ‘‘Principles for Federal Oversight

of Biotechnology: Planned Introduction into the Environment of Organisms with Modified Hereditary Traits, ’

proposed principles for ensuring the safety of planned

introductions, while still not unnecessarily inhibiting the

process. Certainly, interagency disagreement has existed. It has been said, however, that the extent of collaboration on biotechnology issues among Federal agencies

that took place in the drafting of the Principles is unprecedented (61 ).

The scope document expands on the Coordinated

Framework; its criteria for regulatory oversight are riskbased, with the objective of differentiating between organisms that do and do not require oversight at various

levels of jurisdiction. Federal agencies may implement

the criteria in their own ways as they categorize organisms according to the risks associated with environmental

release and thus can be excluded or exempted from oversight. Some introductions may be considered similar

to preceding, safe introductions; for others, risk information or current regulations make additional Federal

oversight unnecessary. On the other hand, unfamiliar

organisms or organisms that might present a risk not yet

assessed would be subject to an assessment (62).

The scope document considered all organisms with

deliberately modified hereditary traits as potentially subject to oversight, regardless of the techniques used to

produce them. However, exclusions from such oversight

should be granted to introductions posing no risk. Examples include: plants and animals produced through

natural reproduction or breeding and microorganisms

modified by chemical or physical mutagenesis or the

transfer of nucleic acids through physiological processes.

Such exclusions are based on previous safe experience

with products produced with these traditional processes.

In addition, organisms produced by other processes, including recombinant DNA techniques, should be exempt

from oversight if they pose no greater risk to the target

environment than parental strains that are considered safe.

An extremely broad class of organisms potentially is

subject to oversight. In this sense, the products of new

biotechnology are not singled out as inherently more

risky than those resulting from nonmolecular techniques

such as plant breeding (55 Fed. Reg. 147,13 1118 (1990).

Nonetheless, exclusion from oversight, based as it is on

criteria of familiarity, is possible for virtually all methods

of modification except those using molecular or rDNA

techniques. Just as operationally, regulatory examination

to date has been triggered by the process of recombinant

DNA, in the near future, at least, other novel techniques

are equally likely to draw the attention of regulators, if

only because they point to the presence of a novel product. The apparent contradiction between this reality and

the scope documents attempt to focus on products, not

processes, mirrors the conflicting views of those scientists and industry representatives who maintain that the

products of biotechnology pose no unique risks; and those

who believe that the novel characteristics of biotechnology products and scientific uncertainty about risks warrants extra caution. The ‘‘product versus process’ debate

continually resurfaces. An exceedingly fine line divides

regulation of a biotechnology product and regulation of

a process. USDA’s approach to the balancing act between

process as trigger and product as legitimate focus is to

review any implications for the safety of the end-product

that might arise from the technique applied. For example,

clean characterization of the gene transferred is particularly important if the genetic material is taken from a

plant pest, so it is clear that no unwanted genetic information is transferred.

This pragmatic approach should be readily applicable

to novel techniques in addition to recombinant DNA itself. Using the safety of the product as the focus for

review allows regulators to take into consideration any

and indeed all pertinent aspects of any techniques or

processes leading to novel products, thereby avoiding

gaps in coverage. Algorithms for using risk as the trigger

for oversight have been and are being developed (69).

Some companies. well advanced in their product development, desire regulations that effectively will end the

product v. process debate so that progress can be made

in bringing products to market.

On February 27, 1992 the Office of Science and Technology Policy published in the Federal Register (vol. 57,

No. 39) its revised scope document, describing policy

on “Exercise of Federal Oversight Within Scope of Statutory Authority: Planned Introductions of Biotechnology

Products Into the Environment. ” A principal change from

the draft published earlier is the elimination of a previously controversial exclusion category—exclusion for
conventional technologies. By eliminating this exclusion

from oversight, some policy makers believe the new scope

document is more consistent with its own premise, i.e.,

that no special risk is attached to the recombinant DNA

modification process. Oversight of conventional and new

technologies is, however, left to the regulatory agencies.

Agencies are continuing to craft regulations and guidelines in response to the scope document’s policy directives that existing statutes provide sufficient authority for

adequate regulation and that regulation should be riskbased. EPA, for example, is crafting its regulations for

biotechnology; regulations under TSCA still have not

been finalized. USDA’s ABRAC guidelines for research

have been put out for comment. As biotechnology moves

to the commercialization stage, where releases could occur on a large scale, amendments may or may not be

needed.

Coordination among agencies is critical, as regulatory

policy evolves to avoid redundancy and delays in policymaking. Several interagency bodies will play a coordinating role, including the Office of Management and

Budget (OMB), BRS (the research-oriented successor to

BSCC), the National Biotechnology Policy Board. and

the President’s Council on Competitiveness (COC).

The Biotechnology Research Subcommittee (BRS), of

the Committee on Life Sciences and Health, is part of

the Federal Coordinating Council on Science, Engineering, and Technology (FCCSET). Formed in 1990, the

BRS succeeded the BSCC and focuses on issues such as

research priorities, needs, and training rather than on

policy issues. As an interagency body, the BRS includes

the acting heads of the NIH and the FDA, with additional

representatives from the State Department and its Agency

for International Development. the EPA, USDA. NSF,

NASA, Department of Commerce, Department of Defense, Department of Interior, Department of Energy,

Office of Management and Budget, and OSTP.

The Administration’s final policymaking body for biotechnology, the Council on Competitiveness (COC), includes the Vice President; the President’s Science Advisor:

White House Council; the Secretaries of HHS, Commerce, Defense, Treasury, Energy, and Agriculture,; the

EPA Administrator; the NSF Director; the U.S. Attorney

General; and the Chairman of the Council of Economic

Advisors. Biotechnology issues will be considered first

by the Council’s Working Group on Biotechnology.

A significant action in biotechnology by the COC was

the publication of its “Report on National Biotechnology

Policy’ in February, 1991. (See box 7-C. ) The thrust of

the report is that biotechnology products essentially are

equivalent to products developed through other procedures and that, therefore, the domestic biotechnology

industry should not be burdened by ‘‘excessive restrictions. The report also suggested that the COC and its

Biotechnology Working Group take the lead in coordinating regulation of products introduced subsequent to

the 1986 Coordinated Framework. The Working Group

was also charged with coordinating communication among

industries; streamlining review procedures; reevaluating

regulations as necessary; and dealing with inconsistencies

of international. State. and local policies, regulations,

and laws (28).

Responses to the COC Report are predictably diverse,

ranging from those of environmentalist groups, who still

call for special regulatory attention to biotechnology, to

industry representatives, who hope that the report will

push toward clearly defined regulatory criteria. thus enabling company executives to estimate accurately the

time and costs involved in winning approval for testing

and marketing biotechnology products (2).

The new National Biotechnology Policy Board, established by the Administration according to the instructions

from the Senate Appropriations Committee in its report

on the 1989 HHS budget. will play a purely advisory

role. Its public members as well as voting governmental

members report to the HHS Secretary ( 100). The Board

will review research. nonconfidential privately funded

biotechnology activities. and the development of industries and products and make recommendations to the

President and Congress (84).

Comparison of USDA and EPA Approaches to

Biotechnology Oversight

Each of the two major agencies involved in biotechnology oversight must, under its own specific mandates, attempt to provide technically sound judgments

on risk, while expediting regulatory procedures and

developing a foundation of experience on which to base

future judgments. Types of information used by EPA

and USDA to make regulatory judgments include 1) that

required for the evaluation of deliberate release applications or notifications, 2) experience base, and

3) application and notification processes. By far, the

largest experience base with regard to field trials is that

of USDA-APHIS in working with transgenic plants.

In terms of products licensed for real-world use, USDA’s

largest experience base is with category I (animal biologics). While EPA’s Office of Pesticide Program deals
210 . A New Technological Era for American Agriculture

I

1.

2.

3.

4.

Box 7-C—Council on Competitiveness

Report: Four Principles of Regulatory Review

Federal Government regulatory oversight should focus on the characteristics and risks of the biotechnology

product-not the process by which it is created.

For biotechnology products that require review, regulatory review should be designed to minimize regulatory

burden while assuring protection of public health and welfare.

Regulatory programs should be designed to accommodate the rapid advances in biotechnology. Performancebased standards are, therefore, generally preferred over design standards.

In order to create opportunities for the application of innovative new biotechnology products, all regulation in

environmental and health areas—whether or not they address biotechnology-shouid use performance standards rather than specifying rigid controls or specific designs for compliance.

SOURCE: The President’s Council on Competitiveness, Report on National Biotechnology Policy, 1991.

with increasing numbers of microbial pesticides, the

Office of Toxic Substances has had few recent applications for planned introductions of recombinant DNA

modified microorganisms and the subject matter of its

applications has been limited narrowly to nitrogen fixation. The time required for, and general types of steps

involved in application and notification processes are

roughly comparable for the two agencies. From 3 to 6

months seem to be required for these processes. APHIS,

with its large body of experience, probably has the

most regularized review processes today.

Coordination With States

A few State governments independently have promulgated deliberate release regulations (see State and

Local Government). Most feel that effective coordination

with the Federal agencies will suffice.

The COC’s Biotechnology Working Group is charged

with coordinating Federal laws, regulations, and poilcies

with those at the State level. As a practical matter. the

task of coordination lies with the individual agencies

themselves. USDA and EPA use State input in different

ways. Based on its traditional network of connections

with State-level agricultural departments, USDA has explicitly incorporated State review applications for field

tests into its overall review process. USDA also has brought

together Federal and State regulators of biotechnology in

annual national meetings. EPA, on the other hand. does

not have a tradition of elaborate, direct connections to

State environmental departments. Recently. EPA has attempted to identity biotechnology “point people” in State

environmental departments (68). However. many State

regulators may not feel “bin the loop” in terms of knowing

what EPA is doing in biotechnology regulations and how

their State should play a part (64, 93). EPA pubilcty

acknowledges the importance of receiving State input.

but procedures for gathering this input are far less formalized than is the case in USDA. Still, EPA’s TSCA

Office did consult with State regulators for each of Biotechnica’s seven field test requests (32). For the relatively

few release PMNs handled, EPA-OTS has developed an

informal set of steps to:

●

●

●

●

●

●

include telephone contact with the appropriate State

regulatory agency or agencies concerned with a particular submission;

make available a nonconfidential version of the PMN

on request;

include State personnel in a site visit;

make available public docket materials on request;

provide opportunity for State personnel to comment

on the Agency’s draft risk assessment; and

give State personnel a draft of the TSCA section

5(e) order. with conditions for the field test (30).

Coverage

Scope

Possible Gaps—Some concern has been voiced that

under the current allocation of regulatory responsibility

for biotechnology, some releases might slip through the

cracks. An often cited potential gap in jurisdictional authority pertains to genetically engineered plants that are

neither pesticidal nor themselves plant pests. In such a

case, where neither EPA-FIFRA nor USDA-APHIS has

clear responsibility, the question has been raised, who

would have oversight over field trials’! (35)

In the past, regulatory oversight for field trials largely

has been allocated with “traditional” recombinant DNA

in mind. Even newer techniques have arisen. however.

such as biolistic or gene gun approach to injecting genes

into organisms. How will the new techniques being de-
veloped fit into the oversight structure’? Should they be?

Can the experience base derived from “traditional’ recombiant DNA be applied to new techniques?

As the science of biotechnology advances. it is likely

that genes of more than one trait will be inserted into a

plant variety being developed. This mixing of genes could

lead to an overlap of authority. For example. a Bacillus

thuringiensis gene for pest resistance could trigger EPA

review under FIFRA in a food crop; a gene for a nutritional component could trigger FDA responsibility: while

the use of a plant pest vector could trigger USDA oversight. Even though USDA-APHIS and EPA-FIFRA

have a history of cooperation, some difficulties could

arise in treating such situations. A company might have

to submit three packages for review due to the different

roles of each agency. This could comprise a regulatory

burden.

It also has been asserted that. apart from federally

funded research, Federal oversight of genetically engineered animals is limited to selected invertebrates and

animals with genetic material from plant pests. While

most livestock animals would probably generate little risk

to the environment if genetically engineered, aquacultural species have been cited as potentially more problematic. The possibility of escape of genetically engineered

fish from outdoor aquacultural ponds to watersheds. where

interbreeding with natural populations could occur. gives

rise to ecological concerns (35). (See box 7-D. )

Thus, while some observers are concerned about

possible limits to and gaps in Federal oversight of transgenie plants and animails. some assert that by far most

cases of release of transgenic animals wuld be covered

by USDA Science and Education (for research), USDAAPHIS (for plant pest invertebrates and animals carrying animal diseases ). FSIS or FDA ( for use of animals as food). FDA and APHIS (for animal drugs and

biologics). and the Public Health Service (for interstate

movement of etiologic agents that carry human disease. ) Only research not receiving Federal funding, in

which the animal is not a plant pest. not an agent for

animal or human disease, not given a drug or biologic.

and not to be sold as food (92) could constitute gaps

in oversight of transgenic animals. Thus, while some

observers are concerned about possible limits or gaps

in Federal oversight of transgenic plants and animals,

others expect the natural evolution of oversight to occur. It remains to be seen whether the regulatory framework is flexible enough to catch such cases, and how,

for example, the system handles genetically engineered

plants that are neither engineered for pest resistance

nor themselves plant pests.

Current and Projected Treatment of Such Organisms

and Products—For its part, USDA-APHIS seems to be

willing to extend its range of oversight regarding genetically modified plants. Plants’ abilities to act as pests can

be viewed in a broad context. Potential disruption of the

environment by novel plants could in the broadest sense

qualify a plant as a potential pest. Some environmentalists feel that USDA already is stretching its statutory

scope to deal with biotechnology, and may not have the

authority to extend its scope still further.

Box 7-D—Fish Regulations: Something To Carp About?

The gene that regulates growth in the rainbow trout was transferred into carp by a team of scientists from the

University of Maryland, Auburn University, and Johns Hopkins University. In experiments to date, the carp have

grown 20 to 40 percent larger than their unmodified relatives. Among some participants in the fish farming and

research industry, enthusiasm runs high over the prospect of impacting the Nation’s $900 million fish farming

industry and, eventually, helping to feed the hungry of the world. Others emphasize caution. The American Fisheries

Society, composed of fisheries scientists, has recommended close monitoring by the Federal Government, tight

control over the environmental release of a modified fish, and sterilization of the fish (75).

The transgenic fish project was started in 1986; in February 1990, USDA approved the project but protests

from four public groups persuaded the North Auburn Fisheries Research Unit, at Auburn University, the site of the

project, to redesign the pond. The new place was approved by USDA in November 1990, pending inspections early

in 1991.

Current design places the fish in 10 outdoor earthen ponds, set on concrete stabilizers, surrounded by chainIink fences covered with bird netting, double and triple screened drains and ditches. Beyond these is a 17-acre

lake filled with predatory fish, and then a pond with chemical and mechanical barriers before the local creek (1).

SOURCE: Office of Technology Assessment, 1992.
212 . A New Technological Era for American Agriculture

Exemptions—Exemptions, as opposed to accidental

gaps in coverage, are cases or classes of planned introductions deliberately excluded from regulation. Many

questions underscore the dynamic, evolving nature of the

regulatory situation. For example, will—or should—the

trend toward examining new products of biotechnology

carry over to the products of ‘‘traditional field trials.

which now are exempted implicitly from review’? Or, as

novel techniques become more familiar, will they be less

likely to serve as triggers for product review? In other

words, will we learn enough to exempt certain products

resulting from certain biotechnology techniques’?

The NIH RAC has relaxed its recombinant DNA

Guidelines as an increasing experience base has indicated

the appropriateness and safety of so doing. The 1989

National Research Council’s report on biotechnology endorsed such an experiential approach to environmental

releases:

As field tests are performed, information will continue

to accumulate about the organisms. their phenotypic

expression, and their interactions with the environment.

Eventually, as our knowledge increases, entire classes of

organisms may become familiar enough to require minimal

oversight . . . (73).

The 1990 draft Scope principles reinforced the idea that

information-based familiarity can lead, when appropriate, to exclusion from oversight. Both EPA and USDA

endorse the concept that biotech oversight can evolve on

the basis of information gathered. Already, these agencies are beginning to exempt from review or expedite

review of certain classes of organisms or products if

certain conditions are met (65).

EPA Definition of a Microorganism as a

Chemical Compound

The application of TSCA to biotechnology has raised

some controversial and as yet unresolved issues. Paramount among these concerns is the inclusion of biotechnology products under the definition of a chemical

substance, whence EPA draws its authority to regulate

genetically engineered microorganisms. Although it is

clear that DNA molecules can fall under the definition

of chemical substances, it is less clear whether the host

organism can be so defined. On the one hand, Witt writes:

“Calling microorganisms chemicals is tantamount to

calling chemists chemicals—or regulators chemicals.

On the other hand, some in industry feel strongly that

microorganisms have uses that are directly connected to

their chemical nature and that EPA jurisdiction is very

reasonable ( 107). EPA’s interpretation has on occasion

been called “ripe for litigation” (53).

In any case, it is unclear “whether the scheme of

regulation envisioned and currently employed for conventional chemicals is suitable for oversight of biotechnology’ (48 ). Regulatory approaches for chemicals may

be difficult to apply to living organisms. Indeed, the fact

that TSCA regulations for biotechnology products have

not yet been finalized, despite having gone through various iterations, may result in part from the difficulties

inherent in manipulating rules conceptualized for chemicals into rules appropriate for living organisms, although

EPA has reviewed microbial PMNs under TSCA since

1986. Other problems may include technical difficulties

in defining ‘‘new organisms, interagency disagreements, interpretation of ‘commercial purposes, and the

small-quantities exemption. Nonetheless, the intent of

Congress that TSCA serve as gap-tilling legislation seems

to invite its use for some biotechnology products that

would otherwise have no obvious regulatory home. From

the coordinated framework, the role of TSCA in biotechnology seems to have been accepted. on at least an

operational level, even it’ the broad definition of a chemical compound has not been universally popular.

The trigger under TSCA for PMN is manufacture of

a chemical, not the issue of safety. Therefore, when this

traditional trigger for TSCA is applied to biotechnology,

it is not consistent with the emphasis based on technical

risk in the Scope Principles. It is often argued, however,

that since all new chemicals must be reviewed. no implications of risk are ascribed automatically to biotechnology products falling into this net.

Commercial v. Research Authority

EPA—Because TSCA is a commercial statute, it arguably does not apply to the deliberate release of genetically engineered microorganisms in nonindustrial

settings. EPA currently requests industry to comply voluntarily with the PMN requirements for commercial R&D

involving field test releases with intergeneric microorganisms. Academic researchers performing comparable

releases may be seen as left out of the loop, in a regulatory

limbo. Congress expressly exempted small-scale research and development from TSCA authority. Much

depends on the breadth of EPA’s interpretation of “commercial purposes. For example, academic research may

be colored by commercial intent because it maybe funded

by an industry source: because patent rights are assigned

to a company for commercial development; or even because a researcher’s home institution receives private-
Chapter 7—Environmental Issues: Institutions and Their Regulatory Roles ● 213

sector funding. One possibility is that all field test releases will count as commercial in intent. However, problems may arise with a broad net approach. Other agencies,

as well as universities, may question the validity of this

approach. EPA’s possible move into the R&D laboratory

under a similar approach is likely to arouse fears of excessive layers of bureaucracy among laboratory researchers.

USDA—The possibility of EPA penetrating further

and further into the realm of research, despite its commercial mandate, has a counterpoint: USDA appears

to be exploring ways to step back a pace from its review

of field trials conducted as academic research. The

agency’s “Proposed USDA Guidelines for Research

Involving the Planned Introduction in the Environment

of Organism With Deliberately Modified Hereditary

Traits.” (FR56 (22):4134–4151 ) seems to place much

of the weight of the research review process at the

institutional level, with the goal of minimizing the weight

of bureaucracy on researchers while still ensuring safety.

The agency’s Agricultural Biotechnology Research

Advisory Committee (ABRAC) played a substantial

role in developing these guidelines. It is important to

note that, in any event. these guidelines are just for

USDA-funded research; APHIS still supplies the principal regulatory coverage.

Criticism of the current situation regarding research

includes alleged confusion over agency jurisdictions. For

example, when Biotechnica International field tested genetically engineered nitrogen-fixing bacteria. it did so

under a 1989 consent order from EPA. However, when

a researcher at Louisiana State University sought to do

followup studies at the site, State officials, various Federal officials, and ABRAC became involved as EPA oversight and jurisdiction became less evident. EPA clarified

its position with State officials, and USDA agreed that

EPA would maintain jurisdiction until it chose to relinquish that jurisdiction. While the main question appears

to have been over the research value of continuing to

monitor the site. rather than any safety question. it demonstrates some degree of uncertainty over jurisdiction

(26).

Potential Impacts of Regulation

Negative Impacts

Questions have been raised regarding the short-and

long-term impacts of’ the regulatory climate on research. It is frequently postulated that academic researchers do not possess the organizational whet-withal

to proceed through a regulatory maze, and may find

the bureaucratic and financial weight of regulatory approval procedures so burdensome that they will choose

not to carry experiments through the field trial stages

(74). This perception could block research at a key

step, since the field trial is the stage at which * ‘the

rubber meets the road, at which the predictions of

the lab are tested in the real world. The impacts on

research of the rulemaking process in Federal regulation of biotechnology were explored in a national survey conducted in 1989 (52, 83). Of 355 responses to

the question. ‘‘Have you ever been discouraged from

conducting field tests with genetically modified organisrns?,” 16 percent said yes. Among private-sector

responders, 23 percent felt they had been constrained.

Some 12 percent of responders replied that they had

chosen not to proceed with a field trial even though

they had a genetically modified organism ready. Legalities, uncertainties about regulation, time needed,

and paperwork required were cited as reasons for the

decision not to proceed (52. 83). Criticism has been

leveled as to the methodologies employed in the survey. Whether or not the percentages point to a dramatic

‘‘regulatory burden on research seems open to interpret at ion.

Some feel that the survey captured a real reluctance

among some researchers to go through the field trial. In

any case, it is not clear that regulation rather than tough

resource allocation decisions drives the decision to delay

(or forego) field trials (83).

A 1990 survey based on personal interviews of 35

researchers and regulatory affairs specialists revealed

overwhelming agreement that the coordinated framework

is working and that APHIS is helpful and timely in its

response to permit requests, while EPA seems to be improving. Most responders, however, asserted that biosafety and biological monitoring protocols were overly

cautious, with potential implications for allocation of

personnel time ( 16).

A third study surveyed 430 recombinant DNA scientists regarding their perceptions of the influence of activist pressures on recombinant DNA research. Some 63

percent view current safety mechanisms as adequate and

26 percent view them as overstringent; many perceive

public controversy and litigation as having led to unwarranted obstacles in the regulatory arena ( 81).

A premise of USDA’s Proposed ABRAC Guidelines

is that the local Institutional BioSafety Committees (IBC’s)

can provide helpful advice to academics, streamlining

the regulatory procedure. According to the level of safety
concern, IBC oversight ranges from simple notice to IBC

review and either approval or disapproval by the IBC

and the USDA. Since IBC’s previously have dealt principally with laboratory-contained experiments, they may

require training to play a helpful role at the field trial

stage; more agriculturally and ecologically trained members will need to be added. The University of California

system-wide biotechnology program has sponsored an

educational meeting for institutional biosafety officers

who can work with the IBC’s on matters of deliberate

release (43 ).

Possible Positive Impact on Research

Although regulations of genetically engineered organisms may possibly inhibit one line of research (field trials).

it may stimulate another—ecological research. As risk

assessment methodologies are being devised for evaluating releases of recombinant DNA modified organisms

into the environment, ecologists and population biologists are turning their attention toward related questions.

The Ecological Society of America report on deliberate

release describes a pressing need for interdisciplinary

research (99). The concept of deliberate release has provided a compelling focus for questions of ecological community dynamics, migration of genes into populations,

evolutionary change, and other fundamental problems.

Furthermore, many researchers are stimulated by the opportunity to channel their research toward a useful analysis. Such lines of work do not fall neatly into most

categories of research funding; thus funding sources may

need to adjust their emphases since this work has an

important role to play in the evolution of agricultural

biotechnology. The 1990 Farm Bill addressed this need

by setting aside funds for risk assessment research, equaling 1 percent of whatever the department spends in biotechnology research. Questions pertinent to risk assessment

research, as well as the relationship between ecological

research and risk assessment are described at greater length

in chapter 8.

As guidelines are finalized and disseminated, and riskassessment research proceeds, regulatory uncertainty

should be reduced for researchers. With reduced ambiguity, as well as steady increases in information and

experience, researchers may well venture more boldly in

greater numbers into the field trial stage. Institutional

BioSafety Committees may become better versed at giving advice and assistance to researchers, as may other

university offices and field trial supervisory staff. Thus,

the potential negative impacts on research could prove

to be short-lived. In the future, technology transfer of

genetic engineering advances may be mediated through .

industry-sponsored, university-based field trials. Although many companies would prefer to keep work ‘binhouse. ’ others may place greater value on the objectivity y

of university research and the capacity of university facilities. While possible contlicts of interest would have

to be resolved, both parties could thus continue to contribute to field trial research. (See box 7-E. )

The positive stimulus of the regulatory climate to ecological research may be at or nearing its peak at this time:

in the short- and mid-term, assessment methodology will

be developed and refined. Data gathered will be synthesized. Eventually, in the long run, assessments of the

results of releases may well become yet one more subfield

of ecological research, one more way to approach interesting problems that exist in a real-world context.

Impacts of Regulation on Agribusiness

Only half of the agricultural biotechnology companies

surveyed by Burrill and Lee ( 7 ) consider Federal agency

jurisdiction over the testing and selling or distribution of

biotechnology products clear-cut. Nonetheless. only a

minority believed that they had experienced Federal regulatory delays. Some 16 percent found delays in relation

to product testing; some 16 percent found delays in relation to selling and distribution (7).

For the most part, at least the large agricultural companies find that the APHIS system is predictable and

works well, without inhibiting industrial activity (38,

40). Moreover, even those concerned with the competitiveness of industry also acknowledge the role of regulations in ‘‘shielding” industry from unfortunate

occurrences that could. by thus capturing public attention. slow commercial product development (79).

At least one small start-up agricultural biotechnology

company, Calgene. has fared well under the current regulatory structure; between November of 1987 and October of 1990, Calgene received approvals from USDA

for some dozen field trials for three genetically engineered crops in five States; the average approval time of

113 days is viewed as extremely reasonable. Representatives of Biotechnica, Pioneer, and Northrup King have

also testified as to the effective workings of the APHIS

system for genetically engineered plants (89).

It has long been alleged that the strategic business plans

of some smaller companies may have been, and may

continue to be, influenced by the regulatory climate, as

well as by public concern over biotechnology. The company Mycogen, for instance, deliberately used killed rather

than living recombinant bacteria as pesticides; Ecogen
Box 7-E—EPA Research and USDA Research

EPA has established a research program focused on the use of microorganisms in biotechnology and intended

to meet the technical needs of the regulatory program. The six areas of research are as follows:

1. development of methods for detecting, enumerating, and analyzing microorganisms in complex samples

from a variety of real-world habitats;

2. development of data and predictive models related to transport or spread between the point at which release

occurs and other locations;

3. determination of potential for survival, growth, or colonization of released microorganisms under various

conditions and environments;

4. assessment of factors affecting stability of genetic material and likelihood of gene exchange;

5. detection of any negative environmental response; and

6. criteria and methodologies for controlling risk.

Inhouse EPA scientific staff are developing a complementary extramural research program. Regular independent

peer review is intended to keep the orientation of the research toward the risk assessment needs of the regulatory staff

while still encouraging scientific quality and contributing basic information on microorganisms in the environment (67).

The Research Office is thought to have worked very closely with the FIFRA staff, directing research towards assistance

in developing evaluation procedures. The biotechnology assessment budget, however, was cut in 1991.

The 1990 Farm Bill (S. 2830) contained provisions governing USDA research. In addition to promoting Federal

funding for “high-priority research” in areas including biotechnology, the bill created a Biotechnology Risk Assessment Research Program. A competitive research grant program is authorized for environmental assessment research “to the extent necessary to help address general concerns about the environmental effects of biotechnology”;

research is authorized that will assist regulators as they develop policies on planned release. Eligible areas of

research include: biological and physical containment methods, methods of monitoring dispersal of genetically

engineered organisms, and gene transfer between genetically engineered organisms and related cultivated or wild

species. The Secretary of Agriculture is required to consult with APHIS, ABRAC and OAB on specific areas of

research (44).

SOURCE: Office of Technology Assessment, 1992.

has developed products with naturally occurring or nonrecombinant organisms (33). DNA Plant Technology

(DNAP). which has to consider agricultural and food

regulations, has deliberately adopted a “bifocal’ business development approach, developing products through

innovative uses of nonrecombinant technologies, such as

tissue culture, as well as exploring the potential of recombinant plants. This reduces their vulnerability should

regulations for the commercialization of biotechnology

prove untenable to them. While DNAP currently has one

regulatory staff member, it foresees the likelihood of

adding more (20 ). With training in use of the “Intelligent

Form Generator, ” a software program designed by the

National Biotechnology Impact Assessment Program to

walk scientists through the production of an application,

the NBIAP program director predicts th\aut a field trial

application can be generated in less than 2 hours. Without

this computer aid, he estimates. completing an application could take 1 to 2 months, with a staff, and up to 6

months without a staff (3). Resolution of regulatory processes and ambiguities will be critical as companies ready

themselves to move to large-scale use of recombinant

plants.

One point raised by the private sector is the need for

clarification of EPA role under FIFRA regarding transgenic plants with pest-resistant properties. Clarification

of scope of review, preparation of a guidance document

on data requirements, and harmonization with APHIS

are regarded as necessary to reduce regulatory uncertainty

for industry (37, 109).

The vast magnitude of trials necessary for the development of any new crop variety makes it particularly

important to clarify regulatory roles and requirements

with respect to recombinant technology. The seed company ICI Garst, for example. has compiled figures on

the development of corn varieties (82). In 1990, some

350,000 plots were used for nonrecombinant plants. The

following numbers demonstrate the sheer number of lincs

involved in generating new varieties in 1990 and expected in 1994 (table 7--l).
Table 7-4—Genetic Lines Needed for

New Corn Varieties

Number of Lines

Stage of developement 1990 1994

New inbreds . . . . . . . . . . . . . . . . . . .

Preliminary hybrids . . . . . . . . . . . . .

Advanced hybrids . . . . . . . . . . . . . .

Experimental hybrids . . . . . . . . . . . .

E - hybrids . . . . . . . . . . . . . . . . . . . . .

R - hybrids . . . . . . . . . . . . . . . . . . . . .

N - hybrids . . . . . . . . . . . . . . . . . . . . .

New commercials . . . . . . . . . . . . . . .

79,000

34,000

5,600

1,600

125

30

10

9

92,000

39,000

8,000

2,400

150

30

12

9

NOTE: E-Hybrids are hybrids exchanged among breeders with the company; R-Hybrids are regional uniform strip tests; N-Hybrids are

national uniform strip tests.

SOURCE: ICI Garst Seed Co., 1991,

Obviously, were genetically engineered plants involved in such trials, and if these had to pass a complex

set of regulatory requirements, agricultural companies

would be forced to weigh their options very carefully.

The costs of meeting regulatory requirements might prohibit them from bringing promising recombinant plants

to full commercialization as new varieties. On top of the

sheer numbers involved, another key point is that multitrait selection is the normal approach to plant breeding

and development of improved varieties; the approach is

to improve a number of traits concurrently; multiple recombinants might be combined in different trials. Furthermore, seed from the later stages of testing is sold.

Agricultural practices do not separate variety from variety; all seed corn is stored in grain elevators in bulk.

Clearly this is not a set-up readily amenable to special

treatment for biotechnology. The restrictions governing

small-scale field trials would be logistically infeasible.

Developing even a conventional hybrid can cost approximately one million dollars. Although biotechnology can

improve efficiency in the early research stage, by making

new genes available quickly and precisely, industry emphasizes that the rigors—and the orders of magnitudeof the hybrid testing scheme will not change.

Thus, the regulatory climate will have a significant

impact on whether or not biotechnology is widely used

as a tool in the seed industry. Assessments of the impact

of regulations on industry will need to take this into

account. A responsible but reasonable and clear regulatory path towards commercialization will be crucial to

the successful implementation of biotechnology in agriculture.

Public Participation

The U.S. public today questions the use of new technologies . Based in part on general environmental awareness, skepticism about science, and negative experiences

with the chemical industry and the nuclear power industry, this questioning attitude is now a potent force. Today, many analysts of biotechnology sound the clarion

call of public participation; if the public is to accept

biotechnology, people must have access to information,

and be able to play a role in debating controversies, and

achieve a sense of trust in policy makers (54, 90). Federal

regulatory agencies sometimes do not receive the full

trust of the public. State agencies tend to be somewhat

better trusted. When Federal agencies share information

and involve the public, they are likely to build confidence

in their procedures. FDA attempted this by publishing

scientific information relevant to its decision on bST in

Science. The meetings for media and other segments of

the public held by USDA represent another example of

public confidence-building through involvement. A positive public perception of biotechnology is obviously critical to its growth; beyond this, participation by the public

can contribute to the beneficial development of biotechnology; questions raised can indeed be pertinent. Although the public has channels through which it can

participate in regulations. it may not be aware of them.

For example, public input into the review process for

field trials is officially ensured through notifications in

the Federal Register. Environmental assessments and

pending approvals are so published. Clearly, however,

the ‘‘general public’ does not as a rule pore through the

Federal Register. Various environmentalist and public

interest groups do, however, and can bring matters to a

wider audience. In some cases, such groups challenge

approvals. For example. ice field tests (102) of ice-minus

bacteria used to protect crop leaves from frost in 1987

were significantly delayed due to such challenges. A very

narrow nongovernment subset of the public is brought

into the picture when scientists external to the agencies

perform scientific reviews to augment staff review in

problematic cases.

Public input also can arise when States receive field

trial applications from the Federal agencies. Depending

on an individual state's review process, representatives

of the public may well participate. The 1990 Special

Workshop for State Agencies, “State Oversight of Biotechnology, came to consensus on the importance of a

public participation component for any State biotechnology task force (39).

At the institutional level, public membership is mandated for Institutional Biosafety Committees (IBC’s), which

seem likely to be called on more and more frequently to
examine plans for field trials at an early stage within

institutions.

One somewhat sensitive area in terms of public participation is that of confidential business information. As

discussed earlier. Federal agencies have the legal right

to protect confidential information deemed critical to a

company’s competitiveness. In fact, companies submitting applications for field trials can submit two forms of

an application. one for in-house review. under confidentiality terms. and one with confidential information deleted. for open distribution. Only the few States with

legal protection for confidential business information can

be sent the complete form. Of course, the more blanks

that appear in an application, the more likely that proposal will be regarded with public distrust or unease. To

minimize public unease, Federal officials encourage

companies to keep their designated CBI to a minimum.

Complaints have been voiced when information unnecessarily designated as CBI has been unavailable to the

public (35).

Public input into the process leading toward field trials

has changed since the early and mid 80s, when court

injunctions and vandalism were commonplace. Relative

acceptance of the role of field trials and their safety has

grown. Indeed, evidence exists that, together with an

increased experience base, positive public involvement

in biotechnology regulation can expedite the field trial

process. (See box 7-F.)

The quieting of local public opposition to biotechnology field trials seems to be evidenced quite widely. The

great majority of field trials approved at the Federal and

State level have met with little if any opposition by the

public (106).

Opposition activity now seems to be directed primarily at special cases. A current example is that of

crop plants genetically engineered to withstand particular herbicides, which can then be sprayed readily over

the field, as they will cause a problem only for the

noncrop plants. Environmentalist spokespeople specializing in biotechnology are far from happy about

this as a goal for agricultural biotechnology. In brief,

despite industry protestations that this approach allows

the strategic use of particularly benign herbicides, environmemtalists see this as a mechanism to excuse, if

not encourage, application of environmentally hazardous chermicals. (See Goldburg et al., 1990 (36) for a

thorough discussion of antiherbicide tolerance views;

also Goldburg, 1989 (35). ) Early in 1991, the National

Wildlife Federation (NWF) petitioned the USDA regarding Calgene Inc.'s application to field test genetically engineered cotton in 12 States. Calgene’s October

1990 application to USDA proposed a 25-site test of

cotton engineered to break down the herbicide bromoxynil. Whereas Calgene maintains that use of this

cotton would significantly decrease herbicide use. NWF

has petitioned the USDA to halt this broadscale testing

until a thorough risk assessment has been conducted

as to the impact on aquatic ecology and human health

(22). In this case, the value question relating to herbicide tolerance begins to be tied to questions of

progressively larger scale release. moving toward commercial release.

The responses of public interest groups to large-scale

releases may well intensify: it remains to be seen whether

other components of the public will take a similar view.

such that the current atmosphere of acceptance turns to

opposition as commercilazation is approached. Significant factors will include: technical experience base derived f-rem small-scale tests to date, activism on the part

of environmentalist groups, media attention. public confidence in the regulatory agencies. and public perception

of-—-and education about—biotechnology and risk-benefit assessments.

If decisionmaking is to be informed. education of

the public about biotechnology risks and benefits must

take place. Many advise that the evolution of biotechnology regulations benefit from the hard lessons of

other industries. such as the nuclear industry, and emphasize education of and participation by the public.

Thomas Jefferson has been quoted appropriately in this

regard: “ If we think the people not enlightence enough

to exercise their control with a wholesome discretion,

the remedy is not to take it from them. but to inform

their discretion’” (46).

Public perception of biotechnology has been analyzed by OTA (101), and others (50). Apprehension

over the novelty and power of biotechnology is mixed

with a desire for the products of biotechnology. Two

biotechnology trade associations (the Industrial Biotechnology Association (IBA) and the Association of

Biotechnology Companies (ABC) have prepared materials and established committees related to public education. USDA ran several meetings as early as 1987

to work with the media and others toward public eductaion. Many of the Nations State and university

biotechnology centers view education about biotechnology as one of their principal roles. Increasingly,

high school teachers are taking courses in, and teaching. biotechnology’: the media also is becoming more

297-937 0 - 92 - 8 QL 3
Box 7-F—Two Experiences With Public Response

In the early years of field trials, 1983-87, two sets of experiments involving ice-nucleating bacteria in California

drew local public opposition as well as public interest group opposition. Suits were filed in the case of Tulelake,

California, and an injunction was enforced against the University of California researchers until an environmental

amendment was made; in the case of Monterey County, the County Supervisors, making use of their zoning

authority, banned such experiments for 1 year, forcing Advanced Genetic Sciences (AGS) to go to the Contra

Costa County’s Board of Supervisors for approval. Although a legal challenge was not upheld, many of the plants

were uprooted as vandalism. (AGS had aroused particularly negative response beginning in 1985, when it had

tested the bacteria in trees on its headquarters’ rooftop, without authorization.) Through the various vicissitudes,

the University of California test was delayed from 1983 to 1987; the Advanced Genetic Science’s test was delayed

from late 1985 to spring of 1987 (102).

in 1988, Biotechnica International received Federal and State approval for a small-scale field test in Wisconsin

of Rhizobium genetically engineered to increase alfalfa yield for which the PMN’s had been filed the year before.

In 1987, Biotechnica had conducted an extensive community relationship program in the county and the state

where the field trial was to take place. This program involved: presubmission briefings to opinion leaders; press

releases and brochures in layman’s language, including a risk-benefit, “Question and Answer” style brochure; public

meetings in the county sponsored by the company as well “as attendance by company representatives at State

government and legislature committee meetings; and media relations. For the first 6 months, interest was high in

the community and a small group of activists opposed the trial. After the last public meeting in the summer of 1987,

no further opposition emerged and, despite intense media interest, no demonstrations or protests occurred at the

time of the test itself in April of 1988. For subsequent tests, the company has followed a scaled-down program of

community relations, with substantially less community interest. The local comfort level with this biotechnology

venture seems to have increased significantly (31).

SOURCE: Office of Technology Assessment, 1992.

sophisticated and therefore more able to convey ac- partmental regulation of biotechnology [delegation of accurately technical and issues in biotechnology.

Problematic Issues

USDA Conflict of Interest?

The criticism has been leveled that USDA faces an

internal conflict of interest because it has a dual responsibility to promote research and to regulate in areas of

biotechnology (49). USDA officials make the argument

that the Department of Health and Human Services is in

the same situation, but has the luxury of having its division of’ labor more readily perceived by the public as

distinct. Within the same Department of HHS. the National Institutes of Health have responsibility for research

and the Food and Drug Administration has responsibility

for regulation. A comparable, but less visible or publicly

understood, division exists within USDA. The Assistant

Secretary for Science and Education is responsible for

biotechnology research activities (including those of the

Agricultural Research Service and the Cooperative State

Research Service), whereas the Assistant Secretary for

Marketing and Inspection Services is responsible for dethority by the Secretary of Agriculture, published July

19, 1985 (Fed. Reg. 29367 (1985).] APHIS and the Food

Safety and Inspection Service (FSIS) are the USDA regulatory agencies involved (55). Coordination between the

research and regulatory arms of USDA is the responsibility of the Committee on Biotechnology in Agriculture (CBA). The Office of Agricultural Biotechnology

(OAB) is set up to develop policies and procedures for

research in agricultural biotechnology, coordinate environmental safety review of proposed USDA-supported research with genetically y engineered organisms,

provide staff support for the CBA, and provide staff

support for the Agricultural Biotechnology Research

Advisory Committee (ABRAC). ABRAC in turn is to

review research guidelines and proposals and provide

scientific advice to research and regulatory agencies

in biotechnology (56).

The existence of these committees demonstrates that

the research and regulatory arms of USDA do interact.

In fact, the agency would be criticized if there were no

attempts at coordination, although the degree of coordination actually achieved has been questioned. The co-
existence within one agency of NIH and FDA seem to

set a relevant precedent. Conflict of interest may be avoideed

within USDA by:outside Crotiques, such as advice from

ABRAC and othcr external sources of review. as well

as by the perception of. and loyalty to, distinct yet complementray missions on the part of APHIS and Science

and Education.

Burden of Proof of Safety

U.S. society today desires a zero-risk society. Arising

naturally from this attitude is a desire for regulatory agencies, or science, to prove safety. The agencies are attempting to build databases through small-scale field trials

and, by analyzing and extrapolating from such information. to significantly reduce the probability of any risk

occurring from larger scale releases. However, absolute

proof of safety will never be achieved in biotechnology

field releases, just as it will never be achieved in any

other dimension of society.

1.

7-.

. 3 .

4.

5.

6.

7.

8.

9.

10.

CHAPTER 7 REFERENCES

‘‘After Four Years Awaiting USDA Okay, Transgcnl~ Fish Gc)nna Swim, ‘ Bi{)tt~(lltl{~lt),g>’ Ne\\.~-

}twf(”h, Jan. 7, 1991. p. 1.

Andrews. Edmund L. . ‘‘Proposuls on Genetic

Technology. The Ne\\v York Times, Feb. 19.1991,

pp. DI . D7.

‘. ‘Artificial Expert’ Trims Permit Preparation From

Months to Minutes, ” Bi~)tt~~lt\l~Jl{)(q~ Nc\\*s}~wt~h,

Aug. 8, 1990, p. ~.

‘‘Biotechnica Applies for Field Testing of Genetically Engineered Corn. ’ Getw[i( Engitwcring Nc\\Is,

March 1991, p. 32.

bi~~~~~~.}~tt{~l{)cq). Ntw’.s\~wtch, Aug. 6. 1990, p. 6.

“Blinded by Science’?’ Va)zguard Pt-e.ss, Oct. 8–

Iz, ]9~9, ‘b High] 

and Par-k Weighs Bill Regulating

Experiments in Genetic Engineering, ” Dec. 4. 1988.

The SundaJY Star Ledger.

Burrill. G. Steve and Kenneth, B. Lee, Biofcth 9/:

A C}wnging Etl\’it-{jtl~t~[~tlt, Ernst and Young. 1991,

pp. 57-59.

“Case Histories of the Development of State Bi;~-

technology Oversight. “ “Conference Document,””

“State Oversight of Biotechnology Workshop. ”

Sacramento, CA, UC Systemwide Biotechnology

Research and Education Program, New Jersey Department of Environmental Protection. 1990.

“Company News, ” AgBit~tt~(lltl~)lt~cq). N[ws. July/

August, 1990, p. 14.

Cordle, Maryln and Langston, Althaea, b’Regulatory Requirements, ” Agricultural Bi{~ti~(lltl(?l{~g>9:

Introduction to Field Tc.~titlg, H. Graham Purchase

Il.

12.

13.

14.

15.

16.

17.

18.

19

20.

21.

and David MacKenzie ( eds. ). CMfice of Agricultural Biotechnology. USDA, 1990, pp. 26–27.

Cordle. Maryln K.. Pa}’ne. John H.. and Y(mn.g.

Alvin L.. “Regulation and oversight of Biotechnologica] Applications for Agriculture tind Forestry, ’ A.we,~,vin,g E[.~d(~,qicwl Ri.vk.~ (!f’l]iot~’clltlolotq~%.

Lc\I R. Ginzburg ( Boston. MA: Buttcr\~orth-Heinemann. 199 I ).

Deshayes. A lain. ‘ bThe French Rc\icm Prtxxss for

Dclibcrtitc Release of Genetically Modit’itxi Orgunisms. BiOlO,qi~’[tl A4fotlitorin<q 01” ~t~ncti([ill>’ ~tl -

,qinect-ed Plants ~~mi klitroiw.~. D. R. Mac Kcnzic

and Sw.mnc C. Henry (eds. ) ( Intcmational SYrnlposium on the Biosatctj’ Rc\ults t~t Field Tests of

Gcneticully Modified Plants ml Microorgtinisms.

Kiuwah Island, SC, Nov. 27–30, 1 W()) ( Bethesda.

MD: Agriculture Research 1nstitutc. 1~~1 ). pp. 1o1-

106.

Drulej, Ray M. and Ordway. Gird L.. The Tot-it

S1/bstt~t~(’c.s Ccmtrol A(t. The Burcuu ot Nationul

Affairs. Inc., Wtishington. DC.

Duke, Louise, presentation. “Canaditin Fcdmd

Regulations for Biotechnology. ” Fourth international ABC Biotechnology Meeting. Toronto, Cunada. May 23, 1990.

EC Communication to the Council and the European Parliament. “Pronmting the Competitive Environment !’or the Industrial Activities Based on

Biotechnology within the Community. ” Directorate-General, Internal Market and Industrial Affairs,

Apr. 15, 1991.

Emcr,qitl,q Bit~ti’~./ltlolo,gi~).~” ill A,qril-l!ltllro: ISSUCS

and Politics (Program Report IX), Di\’is ion of Agriculture Committee on B iotcchnology. National

Association of State Universities and Land-Grant

Colleges, November 1990.

EPA Office of Toxic Substances, ‘‘Points to Consider in the Preparation and Submission of TSCA

Premanufacturc Notices (PMNs) for Microorganisms, I 990.

EPA Office of Toxic Substances, Chemical Control

Division, Program Development Branch. 1. Status

Report: Biotechnology Premanufacture Notification (PMNs), Oct. 1. 1991.

Espeseth. David A. and Shibley, George P.,

Chapter 18: ‘ bRegulatory Policies for Field Testing 13xperimcntal Recombinant-Derived Vetcri -

n a ry B i 01 og i c a 1 Prod ucts, . ‘ A d~it~ n (’es it~

Bru(ello.sis Rc.\earc’l?, L. Gary Adams (cd. ) (Col -

Iegc Station. TX: Texas A&M University Press,

1990). pp. 277–289.

Evans, David. DNAP, personul communication,

199 I .

Evans, Ron, Office of Toxic Substances, EPA,

personal communication, 199 I.
220 ● A New Technological Eru jbr American Agriculture

22.

23.

24.

25.

26.

27.

28.

29.

30.

31.

32.

33.

34.

35.

36.

37.

38.

39,

Ezzell, Carol, ‘

b Proposed Cotton Test Comes Under Fire, ” BioWor/d ToduJ’ Feb. 1, 1991, p. 2.

Final Report: Transgenic Plant Workshop, Maryland Biotechnology Institute, USEPA Office of

Pesticide Programs, College Park, MD, Jun. 18–

20, 1990.

Flamm, Eric, FDA, personal communication.

Fox, Jeffrey, “U.S. Field Test Underway, Another

Planned, ” Bio/Technolog~’ (8):897, 1990.

Fox, Jeffrey L., “Guidelines Drafted, Still Not

Released,” Biotechnology (9, April), 1990, p. 326.

Fox, Jeffrey, “More Changes in U.S. Regulatory

Bodies, BiolTe(’hnolog? (8) November 7:996,

1990.

Fox, Jeffrey, “Quayle Likes Biotech, Not Regulation,” Bi~~/T(~th/z~~l~~g~’ (9), Apr. 7.1991, pp. 322-

5.

“Genetically Engineered Potatoes, AgBiotechnolo~y Ne}tu’ (September/October, 1990),

p. 7.

Giamporcaro, David E., EPA, Personal communication, Oct. 18, 1991.

Glass, David, “Regulating Biotech: A Case Study, ”

Forum .f{w Applied Research and Public Policy.

VOI. 4(3), 1989, p. 92–95.

Glass, David, personal communication, 1991.

Glass, David, “Impact of Government Regulation

on Commercial Biotechnology, ’ The Business of”

Biotechnology>’: From the Benc’h to the Street, R.D.

Ono (cd. ) (Stoneham, MA: Butterworth-Heinemann, 1991) pp. 169– 198.

Glass, David, “Analysis of Proposed EQB Biotechnology Regulations, ’ D. Glass Associates Report. 1991.

Goldburg, Rebecca J., ‘‘ USDA’s Oversight of Biotechnology’ in Rejorm and Imnmwtion qf Science

und Education: Plunning for the 1990 Farm Bill;

Printed for the Use of the Senate Committee on

Agriculture, Nutrition and Forestry, U.S. Government Printing Office, 1989, pp. 137– 147.

Goldburg, R. et al., Bi{~tec”l~\~~~l{)g?’.~ Bitter Harvest.. Herbicide Tolerant Crops and the Threat to

Sustainable Agriculture, Biotechnology Working

Group, 1990.

Goldhamrner, Alan, ‘ ‘Regulatory Issues Related

to Plant Biotechnology Products. ’ paper prepared for the Industrial Biotechnology Association,

1990.

Goldhammer, Alan, personal communication, 1991.

Guidance for State Governments on Oversight of

Biotechnology, Consensus Report, State Oversight

of Biotechnology Workshop, Sacramento, California: University of California Systemwide Biotechnology Research and Education Program, Jul. 12–

13, 1990.

40.

41.

42.

43.

44.

45.

46.

47.

48.

49.

50.

51.

52.

53.

54.

Herrett, Richard, ICI, personal communication,

1991.

“Highland Park Weighs Bill Regulating Experiments in Genetic Engineering’ The Sunda~* Star

Ledger, Dec. 4, 1988.

Hodgeson, John, “Appropriate Biotechnology for

Africa, Biotechnology (8), September 1990,

p. 793.

Huttner, Suzanne, University of California, personal communication, 1991.

Industrial Biotechnology Association, “Legislation Enacted in the 101st Congress: A Comprehensive Summary of Legislation Affecting the

Biotechnology Industry, ” 1990.

‘ ● Japan Roundup, ‘‘ BiolTechnolog> (8): September

1990, p. 802.

Jefferson, Thomas, letter from, to W.C. Jarvis,

Sep. 28, 1820, quoted in David L. Bazelton,

“Governing Technology: Values, Choices and Scientific Progress, Biotechnolog>j in Sociehv: Pri-

~’ate Initiati}’es and Public O\~er.~ight, Joseph Perpich

(cd. ) (New York, NY: Pergamon Press, 1986),

pp. 75–83.

Knight, Pamela, “U.S. and Europe Finding Common

Ground, ” Bio/Technolog~’ (9):January 1991, p. 17.

Korwek, Edward, The 1989–90 Biotechnology

Regulations Handbook, Center for Energy and Environmental Management, 1989, p. 137.

Krimsky, Sheldon et al., “Controlling Risks in

Biotech, ’ Technology>* Review, July 1989, p. 65.

Lacy, William, Busch, Laurence, and Lacy, Laura,

“Public Perception of Agricultural Biotechnology, ‘ ‘ Agricultural Biotechnology?’: !ssues and

Choices, Bill R. Baumgardt and Marshall A. Martin (eds. ) (West Lafayette, IN: Purdue Research

Foundation, 1991 ), pp. 139-162.

MacKenzie, David R. and Larson, Jean, ‘‘The National Biological Impact Assessment Program, ”

Toxicological and En\’ironmental Chemistn, vol.

23: 115-120, 1990.

MacKenzie, D.R. and Vidaver, Anne K., “U.S.

BioSafety Regulations: Too Much or Not Enough’?”

Agricultural Biotechnolog?l: issues and Choices,

Bill R. Baumgardt and Marshall A. Martin (eds. )

(West Lafayette, IN: Purdue Research Foundation,

1991 ), pp. 86-88.

Marchant, Gary, “Modified Rules for Modified

Bugs: Balancing Safety and Efficiency in the Regulation of Deliberate Release of Genetically Engineered Microorganisms,” Harvard Journal of Law

and Technolog~’ (1, Spring): 163–208, 1988.

Marois, James J., Grieshop, James 1., and Butler,

L.J. , “Environmental Risks and Benefits of Agricultural Biotechnology, ’ Agricultural Biotechnolog~~: Issues and Choices, Bill R. Baumgardt and
55.

56.

57.

58.

59.

60.

61.

6~

63.

64.

65.

66.

67.

Marshall A. Martin (eds.) (West Lafayette, IN:

Purdue Research Foundation, 1991), pp. 67-80.

McCammon, Sally and Medley, Terry. “Certification for the Planned Introduction of Transgenic

Plants in the Environment.”’ The MoltIcular and

Cellular Biologi[s of the Pot~~to. Michael Vayda

and William Park (eds. ) Wallingford, U.K. (CAB.

International), 1990, pp. 239-244.

McCammon, Sally and Medley. Terry, “Certification for the Planned Field Introduction into the

Environment of Transgenic Plants and Microorganisms, ’ Biological Monitoring of Gencti(wll?%

E\~,qi\lt~<)rt)[lPl[~llt.s andkli~robe.s, D.R. MacKenzie

and Suzanne C. Henry (eds. ) ( lnternatiomd Symposium on the Biosafety Results of Field Tests of

Genetically Modified Plants and Microorganisms,

Kiawah Island, SC, Nov. 27–30, 1990) (Bethesda,

MD: Agriculture Research Institute, 1991 ). pp. 107-

1 I 7.

McCammon, Sally, internal memo, 1991.

McCammon. Sally. personal communication, 1991.

Meagher, L. R., “Guidance Document for State

Governments on Oversight of Biotechnology. ’

Geneti~ En,qitleerin,g Ne\i’s, October 1990, p. 3.

Medley, Terry L., ‘‘Agricultural Products of Biotechnology: U.S. Department of Agriculture Certification. ” Presentation, Fourth International ABC

Biotechnology Meeting, Toronto. Canada, 1990.

Medley, Terry L., “APHIS Seeks to Aid Tech

Transfer While Ensuring Environmental Safety, ”

Genetic E~l(qim~critz,q NeJ\’s, September 1990. p. 14.

Medley, Terry L., “Ask the Feds. ” Genetic Engineering Nei~s, February 1991, p. 3.

Medley. Terry, Form letter, ‘‘Dear Potential Permit

Applicant. ” USDA-APHIS-BBEP.

Messerschmid(, M. Olav, “Biopesticides-the Next

Steps, Biological Llonitoring of” Gcncticall> Engineered Platlts and A4icrobes. D. R, MacKenzie

and Suzanne C. Henry (eds. ) (International Symposium on the Biosafety Results of Field Tests of

Genetically Modified Plants and Microorganisms,

Kiawah Island, SC. Nov. 27–30, 1990) (Bethesda,

MD: Agriculture Research Institute, 1991 ), pp. 257-

~6~.

Milewski, Elizabeth and Anderson. Elizabeth. “EPA

Stresses the importance of Flexibility in Biotechnology Regulations. Gencti( En,qitteeritl<q Ni~\\Y.s,

November/December 1990, pp. 14, 58.

Milewski, Elizabeth, .’Proposals Involving Field

Testing of Recombinant DNA Conttiining Orgtmisms, Rc~omhinant DNA Tct’hni~’al Bulletin. vol.

6(4), i983, pp. 1~1– 145.

Milewski, Elizabeth, ‘ ‘EPA Regulations Governing Release of Genetically Engineered M icroorgan isms, B iote th no l{),q> ~![’ Pl[l n t - M it’rol)c

ltltt~rcl(tiotl.\. James Nakas and Charles Hagedorn

68.

69.

70.

71.

7~.

73.

74.

75.

76.

77.

78.

79.

80.

81.

82.

83.

84.

85.

(eds. ) (New York, NY: McGraw-Hill Publishing

Co.. 1990), pp. 329-330.

Milewski, Elizabeth. EPA, personal communication, 1991.

Miller, H.]. et al.. “Risk-Based Oversight of Experiments in the Environment, ’ Science 250: 1990,

pp. 490-491.

Minutes of ABRAC Meeting, Feb. 20-21. 1991.

“Monsanto/NK Test Engineered Cotton, ’ AgBiotcchnolog> Ne\t’s (January lFebruary. 1990),

p. 18.

National Research Council, Intr{dut’tion of’ Re(wnlbinant DNA-E~tgi\lt)[)~-[)tl Org~~nisnls i~lto the En-

~’ironment: Ke>s Issues (Washington, DC: National

Academy Press, 1987).

National Research Council, ‘ ‘Field Testing of’ Ge -

twticull>’ A40d(fied Organisms, A Frame }\fork .fbr

Dt~L.i,\ic~~l-M~lkil?g (Washington, DC: National

Academy Press, 1989).

National Association of State Universities and LandGrant Colleges. Division of Agriculture Committee

on Biotechnology, Emerging Biot[’(’/~tlologi[’.s in

Agriculture: Issues llnd Politics. 1990.

‘‘New Prospects for Gene-Altered Fish Raise Hope

and Alarm, ’ Ne}t’ York Times, Nov. 27, 1990.

“News Briefs, ” AgBiotL~l./ljll)lo,g>” Ne\\Ys. Novem -

ber/December 1990, p. 18.

Office of Science and Technology Policy, (51 FR

23302–23393), Coordinated Framework for Regulation of Biotechnology: Announcement of Policy

and Notice for Public Comment, Jun. 26, 1986.

“Permits Issued for Release into the Environment

Under 7CFR 340, ” Printed by APHIS. Apr. 13,

1991.

President’s Council on Competitiveness. The, Report on National Biotcchnolog~’ Polic>, February

1991.

Proposed Notification Regulations for Biotechnology Products under the Canadian Environmental

Protection Act, Environment Canada, Ottawa, Ontario, Sep. 21, 1990.

Rabino, Isaac, ‘‘The Impact of Activist PressuresRecombinant DNA Research, ’ S[iencc, Tr(hnolo,q?’, and Hunlcltz Va/ucs 16( I ): 199 I , pp. 70–87.

Randall, Jo, ICI-Garst Seeds, personal communication, 1991.

Ratner, Mark, “Survey and Opinions: Barriers to

Field Testing Genetically Modified Organisms. ”

Bic~/T~~(/?llol~~,q? (8) March 1990, pp. 196-198.

Rc(mnbim~nt DNA Te(hnical Bl{l(ctin, vol. 13(3).

pp. 181– 184.

“Regulatory Mechanisms for EPA (Pesticides). ’

Presentation, Workshop in Dealing with Field Test

Regulations tind Public Acceptance of Engineered

Plants and Microbes. University of Maryland, Jul.

I I , 1989.
222 ● A Ne}~* Technological Era jiw American Agriculture

86.

87.

88.

89.

90.

91.

92.

93.

94.

95.

96.

97.

“Repligen/Sandoz to Start BT Field Trials, ” Biotechnology> Ne\i’si~wtch, Oct. 1, 1990, p. 2.

Rodger, William H. Jr., Et~\~ir(~rlt?l~~\lt[ll LaMI: Pesticides and Tari( Substances, vol. 3, Section 5.1

to 7.5. (St. Paul, MN: West Publishing, 1988).

‘‘Rutgers Scientists Plant Seeds of Trust with Local

Community, ’ The Scientist, Feb. 18, 1991, p. 6.

Salquist, Roger H.. Hearing before the Subcommittee on Department Operations, Research, and

Foreign Agriculture of the Committee on Agriculture, House of Representatives, One Hundred First

Congress, Second Session on H.R. 5312, Serial

No. 101-75, pp. 76–82, Also testimony of David

Glass (p. 179), Warren Springer (pp. 189-192) and

Rod Townsend, pp. 197-198.), Oct. 2, 1990.

Sandman, P. M., “Apathy Versus Hysteria: Public

Perception of Risk, Public perception of biotechnology]’. L.R. Batra and W. Klassen (eds. ) (Bethesda, MD: Agricultural Research Institute, 1987).

Schneider, William, USEPA, personal communication, 1991.

Shapiro, Sidney, Biotechnology>* und the Design of

Regulation. Report for the Administrative Conference of the United States, 1989, pp. 3– 10.

Smith, Roger, New Jersey Department of Environmental Protection, personal communication.

Soejima, Junichi, “Biosafety Review and Regulatory System of rDNA Organisms in Ministry of

Agriculture, Forestry and Fisheries, ” Biologi[ui

Monitoring of Genetically>* Engineered Plants and

Microbes, D.R. MacKenzie and Suzanne C. Henry

(eds. ) (International Symposium on the Biosafety

Results of Field Tests of Genetically Modified Plants

and Microorganisms, Kiawah Island. SC, Nov. 27–

30, 1990) (Bethesda, MD: Agriculture Research

Institute, 1991), pp. 127–132.

“Summary of Biotechnology Regulatory Activities, USDA-APHIS, 1991.

“Summary of Reviews Conducted Under FIFRA

( 1984-Present), ” 1989.

“Summary of Reviews Conducted Under TSCA

and FIFRA, ” updated Jan. 31, 1991, draft.

98.

99.

100.

101.

102.

I 03.

104.

105.

106.

107.

108.

109.

110.

Thomas, Paul, “Cultivar Testing, A Seed Industry

Perspective, HortSciente 22(6), 1987.

Tiedje, James M. et al., “The Release of Genetically Engineered Organisms: A Perspective from

the Ecological Society of America. E(”olo<q!

70(2):297-315, 1989.

“20 Agencies Mesh to Network Federal Biotechnology Plans, Biot~~tl~\lolo,q> Nen*snwtch, Oct. 15,

1990, p. 9.

U.S. Congress, Office of Technology Assessment,

NcM’ D(’\*c~l~~p\?~[~\~t,s in Bi{jt[~ti~\lc)l~~g>* (2): Plibli(’

fer~.eption.s of Biote(.hnolog? (Washington, DC:

U.S. Government Printing Oftice, 1988).

U.S. Congress, Office of Technology Assessment,

Ne\tY Dt~\~t~l~~p/llt~tlt.~ in Bic~t[~[.l~~~~~l{~(q>’ (3): Field

Testing Engineered (9rganisnts: Genetic” and ELYjiogical Issues (Washington, DC: U.S. Government

Printing Office, 1988).

U.S. Congress, Office of Technology Assessment,

Biotechnology in a Global En~ironntent, OTA-BA494 (Washington, DC: U.S. Government Printing

Office. October 1991 ).

USDA-APHIS BBEP Fact Sheet.

Ward, Mike. “EC States Rush to Harmonize National Laws with Directives on Biotechnology, ”

Geneti( Engineering Ne}\*s, November/December

1990. pp. 6-7.

Wheeler, David L., “Field Tests of Genetically

Altered Organisms Increase as Public Opposition

to the Experiments Fades, ” The Chronicle of’ Higher

Education, Jul. 26. 1989.

Witt, Steven C., Bi{jtt~c’l~ll(jl~jg>*, A4i(.robes. {lnd the

Etz\i~”~~lzl?/t~izt, Center for Science Information. 1990,

p. 120.

Wivel, Nelson, NIH-RAC. personal communication, 1991.

“Workshop on the Field Releases of Genetically

Modified Organisms, ABC annual meeting,

Washington, DC, May 1991.

Wrubel, R., Krimsky, S., and Wetzler, R., ‘bField

Testing Transgenic Plants,*’ Bio.$t’ience. vol. 42,

No. 4, 1992, pp. 280-289.
Chapter 8

Scientific Issues: Risk Assessment

and Risk Management

Photo credit: Grant Heilman, Inc.
Contents

Page

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ........225

RISK ASSESSMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... .....225

Concerns and Postulated Environmental Risks of Biotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . 225

Major Risk Assessment Reports . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 227

Biotechnology Ecological Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 231

Applicability of Diverse Bodies of Knowledge to Assessments of Large-Scale

Commercial Release . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 235

Commercial Release Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 240

RISK MANAGEMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... .....247

Design of Science-Based Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 247

Generic v. Case-by-Case Approach . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...247

Relative Risks Compared to Traditional Practices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248

Cost-Benefit Analyses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248

Small-Scale v. Large-Scale Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248

SCIENTIFIC METHODS OF MANAGING RISK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ..........249

Promoters Turned On or Off by Specific Stimuli . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249

Suicide Genes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 249

Prevention of Gene Transfer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

Combinations of Genes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ......250

AGRONOMIC METHODS OF MANAGING RISK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... .......250

Physical Barriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 250

Spatial Barriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251

Temporal Barriers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 251

SUMMARY POINTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ...251

CHAPTER PREFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 252

Boxes

Box Page

8-A. Ecological Risk Assessment Questions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 233

8-B. Learning by Doing: Successive Field Releases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 238

8-C. Monitoring Microorganisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 245

8-D. Relevant Research Fields . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 246

Figures

Figure Page

8-1. Alternative Risk Analysis Approaches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 229

8-2. Risk Assessment Framework for Environmental Introductions . . . . . . . . . . . . . . . . . . . . . . . . . . . . 232

Table

Table Page

8-1. Comparison of Traditional and Developing Biotechnology . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 248
Chapter 8

Scientific Issues: Risk Assessment and Risk Management

INTRODUCTION

The large-scale commercial use of agricultural biotechnology gives rise to several questions. Does the release of large numbers of genetically engineered organisms

into the environment pose special risks’? If so, what is

the order of magnitude of these risks compared to the

risks of traditional agricultural practices’? What benefits

offset such risks?

Generally, concerns about genetic engineering focus on:

possible ‘‘escape” of a genetically engineered organism, such that it invades new ecological niches

or outcompetes naturally occurring organisms and

becomes a pest;

possible disruption of a delicately balanced ecosystem;

possible direct risks to humans or wildlife;

possible problems of gene stability and of gene transfer

to unintended recipient organisms;

possible impact on evolution; and

the sheer “newness” of the technique.

This chapter addresses these concerns and describes

the range of scientific views on biotechnology and risk.

A consensus has developed that risk assessment is desirable and feasible. Risk assessment in general is founded

on principles and methodologies that can apply to biotechnology. We know what questions to ask in assessing

ecological risks of planned introductions. A knowledge

base already exists pertinent to these questions and risk

assessment studies on this topic are proliferating. Science-based risk management builds on this technical

knowledge and on our capabilities for risk assessment.

Risk assessment methodologies and our technical

knowledge base make it possible to conduct effective

risk assessments of specific introductions and to manage

risks of acceptable introductions. Science-based regulations are central to effective management of risk. A variety of scientific and agricultural methods can be used

to manage risk in particular situations.

RISK ASSESSMENT

Concerns and Postulated Environmental

Risks of Biotechnology

General Concerns

Questions arise concerning the impact of introduced

genetically engineered organisms: What is the likelihood

that such organisms will persist in the environment”? What

is the likelihood that they will spread, constituting an

invasion into the ecological community’? Will they become pests, with a deleterious effect on other species’?

Will the expression of the gene itself lead to an unwanted

effect on the ecosystem’?

Other questions have to do with the recombinant gene

itself (38): What avenues exist for gene transfer within

and between various species in nature’? How probable

are such exchanges and at what rates would they occur.

if at all? If introduced genes are transferred to genomes

existing in nature. how well— and how stably—will the

functions for which they code be expressed?

Finally, broader, more fundamental questions can be

posed: Are we in fact dealing with a phenomenon so

novel that we have no way of predicting outcomes, of

Performing adequate risk assessment? Do we have a moral

right to manipulate still further the species and the ecology of our planet’? Are we losing an intangible, aesthetic

quality to our lives by so doing’? Can we at-ford to say

no to the benefits that this technology can confer on

agriculture

Concerns About Plants

Specific concerns relating to genetically engineered

plants include the possibility that transgenic plants will

persist and become serious agricultural weeds; that the

transgenic plants will invade natural habitats and disrupt

local ecological interactions; and that the pollen of transgenic plants will act as a vector. bringing the introduced

genes to other species that may then themselves become

problem weeds. The likelihood of such possibilities occurring remains somewhat controversial, underscoring

the importance of information from field trials and research. It is noteworthy, however, that transfer of genes

from conventionally bred crop plants to noncrop plants

has not created obvious problems in the past, and that

traditional crop plants rarely have invaded natural ecosystems ( I 4).

lnvasions of plants (by seeds. fruits. or vegetatively

reproducing units ) involves dispersal, persistence. and

establishment: all three stages must be ‘‘successful if’

engineered plants are to become weeds. For transgenes

(introduced genes) to move from crop plants and cause

or contribute to a weed problem, hybridization with a

reproductively compatible species must occur. For tiny
given crop species, only a small number of the wild

relative species that are reproductively compatible are

actually likely to present serious weed problems; however, it is theoretically possible for a plant to become a

weed in a novel environment (43).

One specific concern posed frequently by some environmentalists, among others (32), is that genes for herbicide tolerance might be transferred from crop plants to

weeds. If this were to occur, natural selection could favor

the trait in weedy neighbors of crops treated with the

herbicide. With any use of herbicides, furthermore, increased selection pressure is put on wild species for any

herbicide tolerance traits they might already possess. Such

developments might lead eventually to increased use of

chemical herbicides. A fundamental debate has arisen

between industry scientists who maintain that crops can

be genetically engineered to be tolerant of particularly

‘‘environmentally friendly’ herbicides and some environmentalists who say. essentially, that no new technology should be used to favor continued use of chemicals

in the environment.

Concerns About Microorganisms

In part because they are invisible and relatively “unknowable, ” microorganisms tend to elicit more concerns

on the part of the public than do plants. Parameters of

concern related to genetically engineered microorganisms

include the possibility of gene transfer and recombination.

the possibility of movement into new environments, and

the possibility of infection of nontarget organisms. Questions asked include: Will genetically engineered microorganisms give rise to biological risks for humans or other

species? Will they give rise to environmental problems’?

Do we have the technical understanding to evaluate and

predict any such problems’?

Whether bacteria, fungi. viruses, or baculoviruscs, microorganisms suffer from a bad reputation at the broadest

level of public perception: they are. after all often equated

with“germs. ” One specific concern raised with regard

to genetically engineered organisms is the possibility of

genetic material from such organisms being transferred

to human gut bacteria. The risk of infection of humans.

or other deleterious effects, is clearly going to be examined for planned introductions of microorganisms. For

example. among the questions raised by Monterey County

staff considering the Advanced Genetic Sciences (AGS)

proposal to field test FrostbanR was whether or not the

Pseudomonas fluorescens could ‘ ‘sensitize or aggravate

existing health conditions among sensitive human populatitons living near the proposed test site’ (66).

To assess risk of problematic infection of humans by

genetically engineered organisms. information must be

available on exposure level. This hinges on such factors

as bioavailability or likelihood of absorption into cells

or tissues, specificity, and level of interaction possible

of the microorganisms or their chemical products with

nontarget (human) tissues; and potential of the microorganisms for colonization or infectivity. The degree of

pathogenicity must be considered as well. Some relevant

factors include virulence. Possession of toxins, host range,

and relative susceptibility. Generally. risk assessment

will factor in predictability of the behavior of the recombinant DNA identified microorganisms based on their

parent organisms, as well as knowledge of specific recombinant techniques used (40).

Scientists’ concerns focus less on pathogenicity and

more on the possible impacts of genctically engineered

microorganisms on the environment. Suggested impacts

include possible influences on: indigenous population size.

diversity of species. the ecological community. natural

cycles, and evolution of the introduced organisms (76).

Microbial environments are complex. By one estimate

some 109 microorganisms, representing a variety of taxonomic groups, inhabit one gram of- soil. Uncetanties

exist as to possible consequences of sudden introductions

on balanced microbial ecosystems (46). Microbial diversity in the soil is high (88). This limits the niches

available to introduced mirorganisms (86). While introduced microorganisms may thus compete poorly. they

may persist in low-density populations. A key issue is

whether or nor an unexpected later resurgent bloom or

population expansion from a low-density population can

be reasonably envisioned (84).

Since microorganisms can and do change location.

questions of dispersal—and possible subsequent reproduction in nontargeted ecological sites—also are raised.

The ability of a particular strain to transfer genes to other

specics will affect the likelihood of other microorganisms

being affected in new. nontarget areas. All questions

bearing on survival, multiplicaton, and dispersal of genetically enginered microoganisms: on possible exchange of genes between introduced and indigenous

microorganisms: and ultimately on issues of environmental and public safety, are engaging attention of academic and industrial scientists, the public, and

governmental regulators alike (22).

Views Held in the Scientific Community

Particularly in the early days. the issue of planned

introductions of genetically engineered organisms sparked
a range of views on safety even among scientists (50).

In the mid-eighties, microbiologist Winston Brill argued

that. for centuries, traditional breeding has altered animals and plants without negative consequence: and that

microorganisms, including pathogenic species, have been

added to the soil in hopes 0ft beneficial impacts. also

without negative consequences (7). His conclusion that

these observations alone formcd a basis for risk assessments of’ organsms that have had one or a few genes

added drew fire from a group of ecologists ( lo). These

critics pointed out that mutations that increase an organisms niche range can be ecologically significant. and

that some ramifications of an organism’s impact on the

environment are not predictable from knowledge of its

introduced genes alone. Casc-by-case quantitative risk

assessment for deliberate release was recommended.

In 1987, Science published side-by-side articles by

Frances Shw-pies (75) and Bernard Davis ( 15). Sharples.

an ecologist. reaffirmed the need for casc-by-case assessments, given the complexity of any organism’s interactions with the environment. Molecular biologist Davis

suggested that the experience of ecologists with introductions of higher organisms is less pertinent to risk

assessment of engineered microorganisms than are the

insights of fields mom concerned with the specific properties of those microorganisms: population genetics. bacterial physiology. epidemiology. and the study of

pathogenesis.

The range of possible views on safty runs from “zero

risk’ to catastrophic risk’; those who presume " smallrisk, pending research occupy the middle of the spectrum. In the mid-eighties, molecular biologists tended to

stress the relavance of the safty record of laboratory

biotechnology and graviated toward the ‘‘zero-risk” end

of the spectrum. Ecologists, who tended to stress the

complexities of the natural environment. were less sanguine about potential risks. but stopped short of the cat

astrohic-risk position taken by certain envronmentalists.

An important distinction exists between ecologists and

evironmentaists. The former are:

●

The

●

scientists concerned with the fundamental properties, proccsscs, and components of ecological systems .

latter,

by definition, are concerned with various sociopolitical aspects of environmental quality and management. They may or may not be experts in

understanding ecological processes and the organization of ecological systems (63).

Some environmentalists, keenly aware of problems posed

by past technologies, argue that the proposed user of new

technologies bears the burden of proving safety. Biotechnology proponents, in contrast, argue that any risks

are to date hypothetical. so that the burden of proof

should rest with the doomsayer ( 5 I ).

In the late 1980s and early 1990s. discussion has increasingly centered around developing appropriate riskassessment parameters and frameworks and designing

regulator-y treatment according to risk. The current ‘‘operational’ approach is in agreement with analyses in key

reports that will be described in the next section (50).

‘‘Presumed small risk. or risk in exceptional cases. with

research or risk assessment required. is becoming more

of a common theme. Arguments are tending to become

more refined. revolving about such issues as legitimacy

of risk-assessment parameters; the degree to which lessor-is from past field trials can be generalized: correct

assessment procedures for casc-by-evaluations; development of predictive science related to these issues;

science-btised regulations; and scientific mainagement of

risk. Today the imminence of large-scale release is bringing all these discussions into sharp focus.

Major Risk Assessment Reports

Introduction to Risk Assessment

Why Risk Assessment Is Needed-Society today has

been ‘‘sensitized’ to technology the public, in all its

many forms, looks at past technnologies—those of the

chemical or nuclear industries for example-and sees

negative outcomes that were not thoroughly considered

prior to implementation of the technologies. Along with

skepticism is a strong strain of environmentalism. a growing

uneasiness that far too often, for our convenience. we

carelessly and permantly harm the environment. Furthermore, however unrealistic it may be, a desire for

‘‘zero-risk seems to underliie many responses to technology and to life in general today.

For these reasons as well as to achieve the fundamental

objective of promoting safety it behooves regulatrs and

other responsible parties to conduct reasonable risk assessments of new technologics. Biotechnology, in particular planned introductions of recombinant DNAmodified orgainisms. is among the technologies for which

risk assessment is now done. This is necessary for regulators. important to the public’s sense of cconfidence,

and useful to ‘‘users’ of biotechnology’. including researchers in academdia, industry. and government.
Principles of Risk Assessment—’ ’Risk” can be defined as the potential for negative or adverse consequent

to arise from an activity or an event (23). Risk also can

be defined as the probability of an event occurring multiplied by the cost of its occurrence (44). Risk assessment

can be viewed as ‘‘the process of obtaining quantitative

or qualitative measures of risk levels. including estimates

of possible health effects and other consequences as well

as the degree of uncertainty in those estimates’ (23).

Risk assessment simply is an analytical tool that pulls

together a great deal of diverse data in order to estimate

a potential risk from an event or a process (81). Often,

historical data on possible adverse consequences are difficult or impossible to obtain, making risk assessment

‘‘an inexact process that attempts to characterize and

quantify uncertainty, but never completely eliminates it. ”

Nonetheless, despite the limitations and challenges, use

of risk assessment principles makes it possible to organize and interpret knowledge so as to improve the prediction of possible outcomes and ultimately to manage

risk (23).

Risk assessment has been defined as a five-stage process:

1.

2.

3.

4.

5

Risk identification— defining the nature of the risk,

source, mechanism of action, and possible adverse

consequences;

Risk-source chracterization—characterizing the

source of potential risk;

Exposureassessment— assesing the intensity. frequency and duration of human or environmental

exposures to risk agents;

Dose-response assessment— assessing the relationship between dose of the risk agent and health or

environmental consequences; and

Risk estimation— intergrating a risk-source characterization with an assessment of exposure and

dose-response, leading to overt measures of the

level of the health, safety or environmental risk

involved (59, 92).

Clearly these stages can be adapted to fit a variety of

kinds of risks, and the entire process can take several

different forms. (See figure 8-1. )

The choice of an approach to risk assessment depends

in large part on the extent and quality of available knowledge, degree of expected precision, and importance attached to outcomes at a low probability. Where the

knowledge base is large and little uncertainty exists, a

risk or hazard may be described quite readily and a more

precise “deterministic consequence analysis” might even

be performed. On the other hand, when less knowledge

is available and the level of uncertainty is high. a qualitative risk screening may be all that is possible. perhaps

leading to a more quantitative ‘probabilistic risk assessment.

A much-used framework to assess risk is that developed for the evaluation of health effects associated with

chemicals in the environment. This was endorsed by a

National Academy of Science report (67) and refined at

the Environmental Protection Agency (EPA). This chemical risk-assessment framework sometimes has been

adapted for evaluation of planned introductions of recombinant DNA-modified organisms into the environment (13. 16. 30).

The National Research Council (NRC) and the Ecological Society of America (ESA) (69, 85) developed in

1989 risk assessment frameworks designed for recombinant DNA-modified organisms. But they were quite

different from the chemical approach. The NRC procedure takes account of the degree of “familiarity”of a

planned introduction; the ESA uses a risk attributes categorization; both lead towards the determintaion of an

appropriate level of concern. While differing somewhat

in perspective. the two approaches nonetheless resemble

each other in basic conclusions and therefore together

provide a solid framework for risk assessment of planned

introductions. Clearly, choice of framework for risk assessment will influence the kinds of data required for

evaluation and for permit applications (50). The two reports described below have had significant impact on the

recent framing of discussions about planned introductions. Even proponents of chemical risk-assessment procedures point out that these procedures can be used to

determine whether or not a particular organism should

be evaluated intensively using an analogue of a chemical

risk assessment (81).

National Research Council Report

Background—In late 1989, the National Research

Council published Field Testing Genetically Modified

Organisms: Framework for Decisions. This was requested by the Biotechnology Science Coordinating

Committee (BSCC) on behalf of its member regulatory

agencies. The report covered:

● plants and microorganisms,

● field-test introductions (but not large-scale commercial applications and related issues),

● environmental (but not human health) effects,
Figure 8-l—Alternative Risk Analysis Approaches

Precision

of ananalysis

Probabilistic

risk assessment

Consequence

analysis with

confidence

bounds

Hazard Qualitative

description risk screening

I >

Level of

Uncertainty

SOURCE: J. Fiksel and V.T. Covello, “The Suitability and Applicability of Risk Assessment Methods for Environmental Applications of Biotechnology” in 

Biotechnology Risk Assessment: Issues and Methods for Environmental Introductions (New York, NY: Pergamon Press, 1986), pp 1–34-

scientific issues principally (but not regulatory policy).

field test conditions in the conterminous United States,

and

general procedures for determining categories (not

specific case recommendations ).

fundamental principle underlying the study. and first

introduced in an earlier National Academy of Science

document (68), is that safety assessments of a recombinant organism ”should be based on the nature of the

organism and the environment into which it will be introduced, not on the method by which it was modified.

A related point is that ‘‘no conceptual distinction exists

between genetic modification of plants and microorganisms by classical methods or by molecular methods that

modify DNA and transfer genes.

Topics analyzed for the 1989 report include: relevant

biological characteristics of genetically modified plants;

experience with genetic modification and introductions

of plants modified ‘ ‘traditionally” and by molecular genetic techniques; potential weediness: the features of the

genetic modification in microorganisms; phenotypic

characteristics of the parent organism and of its genetically modified derivatives: and relevant features of the

environment into which the organism will be introduced.

Findings-The report recommends that the impacts

of’ genetic modification on the phenotype of the organism

and the mobility of the altered gene be assessed. In some

cases. when persistence of’ the modified orgtanism is not

wanted or when uncertainty exists as to effects on the

immediate environment. risk assessment should emphasize the phenotypic properties relating to the persistence

of the organism and its modification. Questions to be

considered include: fitness of the genetically modified

organism; its tolerance to physicochemical stresses; its

competitiveness range of available substrates; and. if

applicable. pathogenicity, virulencc. and host range. The

report describes the long historry of safety in the useful

employment of’ plants and microorganisms. and underscores the need for field tests to increase the capability

to assess any risks of large-scale introductions.

Specific scientific conclusionss of the report pertaining

to plants include:

1.

2.

3.

4.

5.

6.,

The current means for making evaluations of introductions of traditionally bred plants are appropriate (on the basis of experience with field tests

of hundreds of millions of genotypes over decades).

Crops altered by molecular and cellular techniques

should pose risks no different from those posed by

crops modified by traditional genetic methods for

similar traits.

The potential for enhanced weediness is the principal risk to the environment seen from introductions of genetically moditied plants. although the

likelihood of this occurring is low.

Confinement by biological. chemical spatial,

physical. environmental and temporal means is the

principal means of maintaining the safety of field

introductions of classically modified plants.

Experimental plants grown in field confinement rarely

if ever escape to cause problems in the environment.

Established confinement options are equally applicable to field introductions of plants modified with
——

230 . A New Technological Era for American Agriculture

molecular or cellular methods and to plants modified with classical genetic methods.

Conclusions concerning microorganisms included:

1. Many molecular techniques make possible genetic

changes in microbial strains that can be fully characterized.

2. The molecular techniques are powerful in their capability to isolate genes and transfer them across

biological barriers.

3. Field experience has given rise to a great deal of

information about some microorganisms; nonetheless, less information exists on microbial ecology

and less experience with planned introductions of

genetically modified microorganisms than there is

for plants. No adverse effects have been noted from

microbial introductions to date; a field test should

gO forward when sufficient information is available

for its safety evaluation.

4. The probability of adverse effects can be minimized

or eliminated by appropriate means of confining

the microorganism to the environment into which

it was introduced; one example would be the use

of “ suicide genes.

The framework for evaluating risk developed in the

report is structured around the following questions:

1.

2.

3.

Are we familiar with the properties of the organism and the environment into which it may

be introduced?

Can we confine or control the organism effectively?

What are the probable effects on the environment should the introduced organism or a genetic trait persist longer than intended or spread

to nontarget environments? (69)

The familiarity criterion is key to this report and has

reappeared consistently in risk assessment discussions

since. Familiarity means having sufficient information

on which to base a reasonable assessment of safety or

risk. Thus, as our information base increases, so does

the scope of “familiarity.” When the familiarity criterion

is not met. the possibility of confining or controlling the

organism and the potential consequences of failing to

control it must be evaluated.

The report is intended to provide a basis for a “flexible, scientifically based. decisionrnaking process. The

classification of an introduced organism into a particular

risk category is made possible by the framework for

evaluating field tests (69).

The 1989 NRC report is often cited and has provided

a conceptual framework for many approaches to risk

assessment of planned introductions of genetically engineered organisms into the environment. Its level of

detail made it more palatable to technical audiences than

the 1987 pamphlet, which was at times criticized for

making assertions without documentation ( 11, 50).

The Ecological Society of America Report

Another seminal assessment was published in 1989,

The Planned Introduction of Genetically Engineered Organisms: Ecological Consideratons and Recommendations (85). This report was prepared for the Public Affairs

Committee of the Ecological Society of America (ESA)

and also has been broadly disseminated and cited. Dr.

James Tiedje chaired a workshop committee in April

1988, examining ecological aspects of planned environmental introductions of genetically engineered organisms. The Workshop Committee’s initial draft was

reviewed at great length by the ESA Public Affairs Committee, the ESA Executive Committee, and other ecologists. The report

supports the use of advanced biotechnology for the development of environmentally sound products. and states

that the phenotype of a transgenic organism, not the process used to produce it, is the appropriate focus of regulatory oversight. Ecological risk assessment of proposed

introductions must consider the characteristics of the engineered trait, the parent organism, and the environment

that will receive the introduced organism (85).

Like the NRC report, the ESA report emphasizes product, rather than process, as the appropriate focus of evaluation and regulation. Thus, ‘‘genetically engineered

organisms should be evaluated and regulated according

to their biological properties (phenotypes), rather than

according to the genetic techniques used to produce them”

(85). Yet the report acknowledges the potential for novelty and consequent likelihood of evaluation inherent in

the new techniques. The report acknowledges, however,

that ‘‘because many novel combinations of properties

can be achieved only by molecular and cellular techniques, products of these techniques may often be subjected to greater scrutiny than the products of traditional

techniques. Moreover, it recognizes that even precise

genetic characterization of transgenic organisms does not

necessarily allow scientists to predict all ecologically important expressions of phenotype in the environment.

The ESA report emphasizes the importance of considering a variety of ecological factors in ecological ramifications of planned introductions. Among these are
survival, reproduction, interactions with other organisms, and effects on ecosystem function and dynamics.

Potential undesirable impacts must he weighed in evaluations. While explicitly calling attention to the complexities of ecological risk assessment, the report supports

the position that “ecological oversight of planned introductions should be directed at promoting effectiveness

while guarding against potential problems. Thus, the

authors observe that most cases will present a minimal

risk to the environment and provide a set of specific

scientific criteria for ‘‘sealing the level of oversight to

individual cases. The four categories of criteria included:

1. attributes of genetic alteration,

2. attributes of the parent organism,

3. phenotypic attributes of the engineered organism

in comparison with the parent organism. and

4. attributes of the environment.

Specific attributes are grouped according to level of risk

presented and corresponding level of scientific risk assessment needed. Coming as it did from a group of ecologists, the ESA report is often cited as a touchstone for

those wishing to balance the positive potential of biotechnology with a sensitivity to the environmental consequences of actions.

Biotechnology Ecological Risk Assessment

Introduction

A central goal of ecological risk assessment of planned

introductions of recombinant DNA-modified organisms

is to ‘‘make a reasonably accurate prerelease prediction

of the behavior an organism is likely to exhibit in its new

ecological context and given its particular genetic modification, and to be able to detect and avert potential

problems before they occur” (76).

Most scientists seem to concur that the focus of risk

assessment should be on a particular organism, with its

characteristics (genetically modified or not) and the genes

that code for them, in a particular environment. Experimental protocols for ecological risk assessments need to

be refined to screen out potentially problematic introductions before release (l4).

While scholars argue as to which risk assessment model

would best apply to environmental introductions of recombinant DNA-modified organisms, all agree that the

complexity of ecological factors renders biotechnology

risk assessment particularly challenging. Living organisms can change locution, reproduce, and perhaps exchange genes. Once released into the environment. they

will interact in a dynamic fashion with other species.

They are indeed different from chemicals.

Ecological risk assessment is a still young methodology, and not standardized. Some argue that directly relevant data are scarce enough, and ecological phenomena

are sufficiently complex that resasoned qualitative judgments are more feasible than more precise quantitative

assessments. In practice, expert review panels using good

scientific judgment and common sense. along with guidelines of points to consider, achieve qualitative assessments of the riskiness of various combinations of factors.

As experience is gained. codification of the principles of

review should evolve for application to future cases.

Augmentation of” human judgment with knowledge system technology has been suggested as a means of facilitating the process (24, 66).

One way of conceptuall y applying risk assessment procedures to planned introduction of recombinant DNAmodified organisms into the environment is to match the

three classic risk assessment stages (A. risk-source characterization: b. exposure assessment: and c. dose-response assessment) with the five stages involved in planned

introductions. (See figure 8-2. ) Information about stage

one. formation of a recombinant DNA-modifiedd organism. and stage two, its deliberate release or accidental

escape into the environment contributes to risk-source

characterization. Exposure assessment would take into

account data on stage three. proliferation of the organisms, including dispersal and possible exchange of genetic material, as well as stage tour. their establishment

in an ecosystem. Stage five, human and ecological effects, relate quite directly to dose-response assessment

(23).

Another way of looking at risk assessment of planned

introductions is to consider the defination of ”risk” as

the product of’ ‘‘exposure’ and “hazard.” Exposure is

related to the possibility of escape of the arganism, its

survial. reproduction. and spretd. as well as to the gene

transferred and the vector, if present. Assessment of the

hazard, or potential environmental impact. depends on

the ultimate fate of the introduced organism-whether

it becomes extinct. establishes a balance with indigenous

species. or overruns the recipient environment (53).

Specific objectives of ecological risk assessment for

plants. for example. include:

1. determination of the potential for crops to persist

and spread in a variety of habitats,

2. discovery of the range of species that can crosspollinate with various transgenic crops.
232 ● A New Technological Era for American Agriculture

Figure 8-2—Risk Assessment Framework for Environmental Introductions

1 Release

3

5

f I 1

Establishment

In ecosystem

I I

SOURCE: Office of Technology Assessment, 1992.

3.

4.

Box

investigation of the ecological performance of hybrid plants produced, and

development of protocols making it possible for

crop breeders to carry out ecological risk assessments on new transgenic plants in the future.

8-A illustrates the sorts of specific questions that

can be asked and answered about plant introductions

based on field observations, field experiments, and contained experiments ( 14).

Risk assessment pertaining to genetically modified (or

nonmodified) viruses used in weed biocontrol, as an additional example, would include:

1.

2.

3.

4.

In

information on virus attributes such as virulence,

host range, vector specificity, survival, and dispersal characteristics;

information on desirable and undesirable virus attributes and on the stability of these attributes;

information on the virus’ effect on the target weed’s

genetic stability; and

information on the release site and how a variety

of ecological variables affect infection, dispersal,

population dynamics, and safety (87).

summary, key features of ecological risk assessments of planned introductions include properties of the

Risk-source

characterization

Exposure

Dose-response

Ecological effects assessment

introduced organism (not the method by which it was

produced) and of the recipient environment. including

the demographic characteristics of the organism, the genetic stability and likelihood of gene transfer, and the

interactions between the species and the physical and

biological parameters of the environment. Scale and frequency of introductions should also be factored into risk

assessments. Furthermore, since recapture or recall of

introduced organisms usually will not be feasible, assessments should also consider possible means of containment, monitoring, and possible mitigation if adverse

consequences occur (74).

Research Needs and Promise of Risk

Assessment

The current interest in effective risk assessment of the

products of biotechnology has stimulated workshops,

conferences, discussions. and articles. More and more

frequently. insights from the fields of ecology. population biology, population genetics, and evolution are being

recast into the language of risk assessment (31, 50, 52.

62). Additional research needs to be undertaken on a

variety of fronts to facilitate risk assessment. For example, a need exists to develop models and use data from

field tests to predict the rate of spread of introduced

organisms in various situations (54).
Box 8-A—Ecological Risk Assessment Questions

Field observations Field experiments Contained experiments

Persistence

What is the survival of the What is the fate of seeds sown into How is pollen viability affected in

vegetative parts of the plant under a range of plant communities, transgenic plants?

a range of climatic conditions, on including other arable crops, forage How is seed dormancy affected?

soils of different kinds with different crops, permanent grasslands, and

categories of drainage? natural habitats? How do transgenic plants perform

How is perennation affected by the What is the fate of transplanted

in competition experiments with

crop plants and with selected introduced genes? seedlings in different habitats? native plants?

What factors influence plant What is the fate of transplanted

mortality outside arable fields and mature plants (or rootstock) in

how are these influenced by the different vegetation types?

novel genes? How long does experimentally

What is the nature of seed planted seed remain dormant but

dormancy under different viable in a range of soil types?

environmental conditions, and how

does the introduced genetic

change influence triggering,

duration, and hardiness during

dormancy?

Spread of the vegetative plant

What is the seed production of the What is the vegetative growth rate Is seed size or morphology

plant when grown in a crop and in on different substrates and with different in transgenic plants, and

natural vegetation? different competing species? how might this affect seed

Is seed production limited by the Is the thinning rule (i.e., density- dispersal?

rate of pollination? dependent plant mortality) similar Do transgenic plants present

What is the germination rate of for transgenic and nontransgenic greater risks of spread by

seeds in soil? plants? vegetative fragments?

What is the mortality of seeds and What kind of compensatory growth

seedlings in arable soils and is exhibited (e.g., gap-filling)?

beneath native vegetation?

What is the phenology of seedling

emergence and growth?

What are the natural enemies of

the seedlings?

What is the role of vertebrate and

invertebrate herbivores in crop and

noncrop habitats?

What is the mechanism of seed

dispersal?

How far are seeds dispersed and

how does this vary with

environmental conditions?

Do the seeds produced by plants

grown outside arable fields give

rise to a second generation of

plants? (continued on next page)
234 ● A New Technological Era for American Agriculture

t

Box 8-A—Ecological Risk Assessment Questions—Conthuecf

Field observations Field experiments Contained experiments

If the plant were to prove invasive,

at what rate would it spread and

which habitats would it occupy?

Which plant species (if any) are

displaced when (and if) the plant is

established in natural habitats?

Which plant species are responsible for the competitive suppression

of the plant in different natural habitats?

Horizontal gene transfer through

pollen

How much pollen is produced? What is the fate of labeled pollen? Which plant species allow pollen

What is the phenology of pollen How much pollen reaches the stig- germination on their stigmas?

production and what is the phenol- mas of other wild plants under dif- How is pollen dispersal affected in

ogy of stigma receptivity of other ferent conditions? transgenic plants?

plant species growing in the neigh- Which insects carry the pollen? Which plant species form viable, borhood of crops (i.e., within 500-

How far away from the crop can an hybrid seed and at what rate is this 1,000 m)?

individual, potted crop plant be pol- seed produced?

Over what distance is pollen dis- Iinated and how does the rate of What is the germination rate of hy- persed under different meteorologi- pollination fall off with distance un- brid seed? cal conditions? der a range of habitat conditions? What phenotypes are exhibited by Which is the pollen deposited, on What plants make the most effi- hybrid individuals? which species, and in what numbers? cient ‘pollen barriers’ for the con- What is the performance of hybrid struction of guard rows; is it

Where is the pollen deposited, on plants in competition experiments nontransgenic members of the with crop plants and with selected which species, and in what num- same species or plants that form native plants? bers? physical barriers to pollen flow or to

insect flight? What is the nature of perennation What is the geographic distribution and vegetative dormancy in hybrid of closely related wild plants in the and transgenic plants? vicinity of centres of crop cultivation

and what is their small-scale (100’s

m) distribution as weeds within arable fields and on land adjoining

field foundaries?

What natural habitats are found

within 1,000 m of arable fields, in

those areas where the crops are

grown, and what flora is supported

by these habitats?

SOURCE: Michael J. Crawley, “The Ecology of Genetically Engineered Organisms: Assessing the Environmental Risks,” Intorduction of Genetically Modified Organisms into the Environment, Harold A. Mooney and Giorgio Bernardi (eds.) (New

York, NY: John Wiley and Sons, 1990).
Achieving predictive capabilities in extrapolating from

field tests to large-scale introductions is an additional

goal. Along with further research, data from field tests

and research then can feed into the design of future field

tests and large-scale introductions. our scientific understanding pertinent to ecological risk assessment should

increase exponentially over the next few years.

This explosion of knowledge not only can improve

safety but also the effectiveness of introduced organisms

in various habitats. There seems to be general agreement,

even among ecologists and environmentalists, that most

biotechnology products will not be harmful. However,

because uncertainty does exist, for instance, as to which

applications might be harmful. reasonable caution and

willingness to assess risk are appropriate (76).

Risk assessment prior to introductions is a reasonable

and necessary step, consensus dictates. More research

can sharpen our powers of prediction and build on an

.

already sol id foundation of information. Eventually, criteria can be developed to match individual cases with

appropriate risk categories. In the meantime, as a broader

knowledge base is being built, the safety of each introduction needs to be judged, basically, on a case-by-case

basis (51). Understanding gained from case studies and

other relevant research can be employed in the current

transition to risk assessments of large-scale introductions.

Applicability of Diverse Bodies of Knowledge

to Assessments of Large-Scale Commercial

Release

Introduction

In all approaches to risk assessment, the key question

is predictability. Do we have sufficient information to

make a reasonable prediction as to what will occur for

a particular release’? Can we in fact legitimately draw on

knowledge gained from agricultural experience, laboratory tests, past field tests of recombinant DNA-modified

organisms, and accumulated knowledge of genetics, microbiology, molecular biologics, and ecology? Are the

characteristics of any individual large-scale release familiar enough that we can bring such knowledge to bear

on the risk assessment’?

Species Introductions

Those interested in the evaluation of risks from biotechnology sometimes turn to the experience base with

introduced ‘‘exotics, species accidentally or deliberately released in a completely new environment. Dutch

elm disease is often-cited as a consequence of the accidental introduction of a fungus; kudzu vine. running rampant in the South after being brought in as a roadside

ground cover, is pointed to as a deliberate introduction

gone awry.

One viewpoint holds that species invasions may be

useful analogues of planned introductions of genetically

engineered species, i.e., an invasion is an invasion. Thus.

experience with analyses of key properties of ‘successful

invaders, as well as of vulnerable environments. theoretically can be brought to bear in evaluating planned

introductions (63).

Most scientists agree, however, that invasions by exotics have limited applicability to planned introductions

of genetically modified species. For example, introduced

exotic plants that have caused problems come with many

traits that enhance weediness; whereas genetically modified plants, by contrast. are modified in only a few

characteristics (69). The distinction between the introduction of modified genotypes of crop organisms and the

introductions of totally new exotics-whether or not they

are genetically engineered—is, in fact, generally regarded as an important one (14). Even so. lessons learned

as to the ecological parameters of ‘‘invading species’

and recipient environments may be useful in categorizing

degrees of risk for a specific planned introduction of a

recombinant DNA-modified organism. For example,

comparisons can be made between the characteristics of

such an organism and the characteristics often found in

very successful invading species. Habitat characteristics

can also be compared to help assess site for vulnerability

or resistance to invasion (63).

Agriculture

Perhaps the oldest analogue to planned introductions

of genetically modified species is agriculture itself. For

much of human history, new forms of crops and domesticated animals have been introduced to the environment. Major crops have been bred by the millions for

centuries; all these field tests and commercial releases

provide a substantial experience base. Throughout this

vast experience, no significant harm to human or animal

health has occurred due to these introductions per se, nor

have major crop plants become bad weeds. Normal selection procedures have eliminated plants with problems.

Furthermore, “recalls” of crop varieties are common

under the laws of supply and demand. In short, no evidence exists in the United States that plant breeding leads

to ecological problems (6).

The NRC report’s call for ● ’familiarity” as a criterion

for risk assessment makes drawing on the experience base
236 ● A New Technological Era for American Agriculture

Photo credit: Monsanto

Genetically engineered tomato plants are shown being

planted by researchers at a Monsanto-leased farm in

Jersey County, IL.

co.

of agriculture logical for most planned introductions of

genetically modified agricultural organisms. A specific

example of how the agricultural experience can be applied to biotechnology risk assessment is the 80 years of

usage of Bt (Bacillus thuringiensis with its toxin) as a

natural insecticide; its history of safe use is often regarded

as evidence that transferring the gene for a Bt toxin would

be environmentally safe (6). The 100-year experience

base with vaccines, rhizobial bacteria, and other biological controls provides information applicable to largescale microbial introductions (20, 29, 62, 90). As a final

example, corn breeders have significantly changed the

corn genome and have conducted planned introductions

into the environment of these modifications for the past

70 years, without negative ecological experience. Breeders have gained experience in protecting the purity of

these genomes, calculating the likelihood that the modifications will spread to other plants, deploying the modified genomes, and maximizing their strengths and

minimizing their weaknesses ( 18).

Although there are limitations to the analogy between

seed purity and gene transfer to weeds (notably, the risks

associated with weed genes contaminating seed for planting crops are quite different from those associated with

engineered genes getting into a weed population), this

analogy does represent a useful starting point for risk

assessment in controlled release.

Although some observers emphasize the novelty of

gene combinations that can be brought about through

biotechnology, a key difference between traditional crop

breeding and the “new biotechnology” is that changes

in genomes are more precise using biotechnology. With

genetic engineering, one gene is moved at a time; by

contrast, huge numbers of genes are recombined in crosses

that lead to new plant varieties. It is nonetheless true that

ecological effects of a changed phenotype sometimes

may not be predictable even with precise changes in

genotype (85).

Certainly, risk assessments are needed of individual

cases involving particular genes. For example, forage

crops such as alfalfa, which are not so dependent on

cultivation practices, may have higher—and perhaps

problematic—survival capabilities outside of the farm

than others (6).

Two of the chief concerns about planned introduction

of genetically modified species have no analogs in traditional agriculture. With the exception of some introduced crops that become weeds in tropical countries, crop

plants have not invaded natural habitats. Furthermore.

no obvious problems have arisen due to transfer of genes

from traditionally bred crops to wild plants ( 14).

Laboratory Testing

Results of laboratory tests have been drawn on by those

interested in risk assessment of genetically engineered

microorganisms in particular. Various studies of microbial genetics, as well as use of soil microcosms (or laboratory model ecosystems) that mimick the natural

environment, have provided useful information.

A great many reported laboratory tests involve investigations of mechanisms and likelihoods of gene transfer.

For example, transformation (the uptake of naked DNA

into a competent or receptive cell) is a form of gene

transfer well understood in the laboratory, but not well

described in natural settings. Laboratory records on transduction (the transfer of genes between bacterial strains

by virus particles) have led to theoretical models predicting the possibility and frequency of transduction from

an introduced genetically modified microorganism to a

natural species. Another mechanism of horizontal gene

transfer studied in the laboratory is conjugation, the process of genetic exchange between bacterial cells. Finally,

transposition, the process by which mobile genetic sequences change positions within a genome can be associated with gene transfer.

Soil microcosms, even with sterile soil, are a feasible

way of assessing what kind of gene transfer mechanisms

can occur in nature; they are therefore a useful tool in

risk assessment (38, 70). Research has now been done

using more realistic soil microcosms, with the objective

of learning more about the impact of conjugation on
introduced genetically modified microorganisms. For example, some experiments have been done using nonsterile soils, in an attempt to produce a closer analogue

to nature.

Another set of questions that laboratory tests can help

address is related to population biology. Relative fitness

of genetically modified microorganisms in the laboratory, for example, pertains directly to establishment and

possible spread of introduced organisms in an environment; some information toward quantitative risk assessments can be gained from contained laboratory testing

in chemostats (44). Laboratory tests also can help illuminate the role played by various soil environments in

successful introductions (93).

Of course, constraints exist on the applicability of laboratory tests, having to do with feasibility and with the

impossibility of reproducing the full complexity of a natural environment. Some important parameters relevant

to introductions are, for example, the relative fitness of

the introduced recombinant DNA-modified organism in

the new environment with its multiple dimensions of

biological, chemical, and physical features, including

competition with other microorganisms; microbial population density, which may vary over time and space;

population dynamics; and availability of habitats (5). The

dynamic complexity of many such features makes it impossible for a laboratory test to mimic reality completely.

Work is beginning on testing for effects such as pathogenicity or toxicity in more realistic multispecies systems

or microcosms (26).

Perhaps the principal lessons learned from laboratory

research have to do with the potential to work creatively

with soil microcosms. The more realistic the soil microcosm used, the higher the predictive value of the laboratory tests is likely to be, particularly where extrapolation

from the laboratory to the field is relatively well understood. It has been suggested that mesocosms (larger contained walk-in chambers, the environmental parameters

of which can be controlled) could provide more realistic

complexity than soil microcosms. This added realism

might improve risk assessment (93).

Small-Scale Field Tests

Field tests of conventionally produced crop varieties

represent part of a step-wise progression toward full-scale

commercialization; the same is true of field tests of recombinant DNA-modified organisms. Initially. new varieties are assessed in a laboratory or greenhouse; then

they are observed in small-scale field plots where they

are evaluated according to various protocols, statistical

Photo credit: Monsanto Co.

Researchers begin test of tomato plants carrying

the Bt toxin gene in test plant.

procedures, and analytical methods. Large-scale tests and

commercialization complete the process. Each stage provides information for the next stage (53 ). For the most

part. principles and procedures useful in small-scale field

tests are also relevant at the large-scale test and commercialization stages as well (36). Field testing and monitoring constitute ‘‘real world empirical methods’ that

are important components of risk assessment (23).

Small-scale field tests can be used to elucidate characteristics that will be factored into risk assessments of

possible large-scale planned introductions. For example,

survival and spread of particular recombinant bacteria in

a particular soil environment, as well as efficacy of function and stability of an introduced gene. can be estimated

in field tests ( 1, 3, 47). Field tests also can be used to

assess ‘‘invasiveness’ of transgenic crops (73). Data

from field tests can be integrated into quantitative predictive models of gene flow and gene spread (39).

Field tests also provide agronomically significant information, including data on the expression or performance of the introduced gene and on the overall growth

and vigor of the genetically modified plant (64). For

example, 1990 field tests of insect-resistant cotton plants

have allowed such agronomic traits as yield, fiber length,

fiber strength, fiber quality, seed composition, and quality to be evaluated by Monsanto, which is planning for

commercial introduction in 1994 or 1995 ( 28).

Well-designed, well-monitored field tests of increasing scale and complexity also should allow undesirable

impacts to be observed while there is still an opportunity

to correct them (43). A ‘‘stepwise progression in test
design” is seen as an approach to field trials that will

reduce complexity and otherwise benefit later I urge-scale

efforts (47 ). (See box 8- B.) An important stage is expansion from single-site into multisite field testing, which

allows sites to undergo different conditions, such as

weather, and thus provides information on the variation

possible in performance and impact (73). Testing over

more than 1 year can provide information on the consistency of measured characteristics such as survival and

efficacy. Such information will have significant implications for commercial scale planned introductions. Good.

statistically sound experimental design can be important

in facilitating effective transitions from the field test to

commercial-scale introduction (57). For agronomic and

risk assessment purposes. scale-up from field tests is a

useful and informative process.

There are, however. a few constraints on the applicability of small-scale field tests to large-scale tests or

commercialization. An important one is the emphasis

often placed on containment in small-scale field tests

involving recombinant DNA-modified organisms. Containment is, of course, the antithesis of uncontained,

large-scale introduction (36). Bagging plants, for example, prohibits pollination and, furthermore. would not

be feasible at a large-scale (53).

When a product is commercialized. it will be far more

widespread in the environment than it was in the days

of its field test; many more ‘‘nontarget species will be

exposed to it (26). As people increasingly use transgenic

plants. the chance for errors will increase because some

users may not follow safety procedures (43 ).

Despite these limitations, field tests are providing the

datai about agronomic qualities and risk assessment considerations needed for the design of’ large-scale tests and

commercialization. Detection and monitoring techniques

are improving. A step-by-step progression from individual field tests through multisite field tests to large-scale

testing to commercialization is being followed for recombinant DNA-modified organisms as it has been for

conventionally produced organisms. without problems.

Research still needs to be done to identify important

distinctions between small-scale and large-scale tests; this

should improve experimental design and efficiency (53).

Deliberations on Field Tests and on

Large-Scale Release

Over the past several years. field tests have made important contributions to risk assessments for large-scale

release of- DNA-modfied organisms. The data from field

tests provide the most directly relevant basis for predicBox 8-B—Learning by Doing: Successive Field Releases

Crop Genetics International (CGI) is a company that has used a “stepwise progression in test design” as it

has moved from an initial field test to later tests. The focus was the delivery of biopesticidal gene products by

endophytic bacteria inoculated into seeds. First tested was a bacterial endophyte (Clavibacter xyli subsp. cynodontis)

genetically modified to produce low levels of the delta-endotoxin of Bacillus thuringiensis (Bt) subsp. kurstaki, and

inoculated into corn seed. CGI developed a strategy for multiple risk assessment studies of field releases. The

focus of the field release studies was twofold: performance of plants grown from endophyte-inoculated seed; and

persistence and spread of the genetically modified strain under different environmental conditions. The first two

releases were used to develop a profile of the recombinant strain’s behavior in the environment. In 1989, the test

design was extended to multiple sites in four States to examine its behavior overdiversified environmental conditions.

This was the first release to take place in multiple States of a viable microorganism genetically modified to produce

a biopesticide. In 1990, a new recombinant strain selected for its activity against the target pest (European corn

borer) was incorporated readily into the well-established testing procedures and program, with the objective of

determining efficiency. As the study progressed between 1988 and 1990, by agreement with regulators, levels of

containment were gradually lowered as data on safety were obtained. In fact, the early tests were specifically

designed to address risk assessment issues such that future small-scale introductions could be made with less

rigid containment and such that containment requirements could be eliminated in large-scale field tests. Efficacy

studies now can be done under reduced containment requirements. Multiple-site field testing of the improved strains

is the next logical step toward large-scale tests and commercialization. Stepwise progression of tests is a rational

strategy from a company’s point of view, as well as from a regulator’s point of view.

SOURCE: Stanley J. Kostka, “The Design and Execution of Successive Field Releases of Genetically Engineered Microorganisms,” Biologicd Monitoring of Genetically Engineered Plants and Microbes, D.R. MacKenzie and Suzanne C. Henry

(eds.) (International Symposium on the Biosafety Results of Field Tests of Genetically Modified Plants and Microorganisms, Kiawah Island, SC, Nov. 27-30, 1990) (Bethesda, MD: Agriculture Research Institute, 1991), pp. 167-176.
(ion as to the safety of large-scale release, particularly

in cases where a small-scale field test is itself scaled-up

to a large-scale introduction. Equally important, scientists in many disciplines have been gaining practice through

field testing in the process of risk assessment. Now that

applications for large-scale release are imminent, researchers familiar with comparable evaluations at a smallscale can begin to integrate their experience and apply

it to the new assessment task at hand.

Several recent conferences have helped to define approaches to the risk assessment of large-scale introductions. Commonalities arc emerging, suggesting that a

state of readiness for large- scale introductions is in fact

being reached.

Several biological principles with implications for assessment of large-scale introductions emerged from the

International Symposium on the Biosafety Results of Field

Tests of Genetically Modified Plants and Microorganisms (November 27–30, 1990. Kiawah Island. South

Carolina). For example:

●

●

●

●

●

The integration of genes into the chromosomes of

recombinant DNA-modified organisms has proven

to be predictably stable.

Gene transfer frequencies of recombinant DNAmodified organisms are consistent with patterns recorded for natural populations.

The frequencies of transposon relocations in recombinant DNA-modified organisms are consistent with

those of natural populations.

Some microorganism detection methods are extremely sensitive. and this contributes to better understanding of- the fate of a microorganism in the

environment.

Background microbial populations have been characterized as complex. and thus the release of genetically modified microbes may be insignificant by

comparison..

The symposium also highlighted the strong foundation

of conventional knowledge in crop improvement, microbial testing. and food processing that is available to support safe commercialization of biotechnology products.

Research needs cited included: detection methods, sampling methodologies. monitoring protocols and modeling

techniques, and empirical data for improved design and

evaluation of experiments (53).

A workshop on transgenic plants conducted by the

Maryland Biotechnology Institute and the USEPA Office

of Pesticide Programs (June 18–20, 1990) evaluated the

human and environmentall impacts that could result from

the ‘‘widespread. full scale”use of plants genetically

modified to produce a pesticidal substance. Workgroups

discussed: 1) studies and information needed for assessment; 2) scientific rationale for determining the occasional need for specialized studies; and 3) availability

and test protocols for developing risk assessment information.

The consensus of all groups was that such transgenic

plants posed concerns and possible effects that are not

unique, and risk assessment issues can be addressed through

readily obtainable information on possible effects of the

plant or of the pesticidal substance (89).

The USDA-sponsored ‘‘Workshop on Safeguards for

Planned Introductions of Transgenic oilsecd Crucifers’

(October 9, 1990, Cornell University’) was held to identify agricultural biosafety issues relevant to oilsecd rape

(or canola) as soon as possible. Unlike most crops, oilseed rape has weedy relations in North America. The

potential for. and possible results of, gene transfer are

therefore of concern. The workshop group agreed that

with mill ions of acres planted. gene transfer will occur.

Therefore, an ‘‘ecological map’ of wild species was

called for, so that the location of field trials could be

planned to deliberately minimize proximity and hence

possibility for gene transfer. Experimental trials and research were recommended to quantify risks. as were studies of the factors influencing gene transfer potentiali .e.. travel of pollen. effective fertilization, the production of viable seed, and the plant reaching reproductive

age and passing on its new set of genes. The group agreed

that studies should emphasize the conditions under which

transfer and expression of the transferred gene take place.

and the consequenses-relative risk—of such events (61).

A comparable meeting was held for maize and wheat

(Keystone, Colorado, December 6–8, 1990); another is

planned for rice.

Summary

A long history of agriculture provides an immense

bunk of data relevant to risk assessment: diverse scientific

fields contribute principles and knowledge. Data from

small-scale field tests of recombinant DNA-modified oganisms not only provide specifics necessary for the evaluation of large-scale counterparts. they also provide a

risk assessment testing ground. Each risk assessment ofa field test adds to the regulator's experience base in

adopting risk assessment methodologies to planned introductions. This learning through experience is a natural

part of the evolution of oversight as we move from smallscale to large-scalec introductions.
240 ● A New Technological Era for American Agriculture

Commercial Release Issues

A variety of issues relevant to planned introductions

of recombinant DNA-modified organisms are receiving

heightened attention as large-scale commercial releases

become imminent. Principal concerns focus on the fitness

of the engineered organism (defined as overall genetic

contribution to future generations, usually quantified as

number of offspring produced) and its potential to become established as a weed or a pest, the stability of the

engineered gene, the potential for gene transfer, and impact on other organisms and the environment. Basically,

these concerns are the same ones raised with regard to

small-scale field tests of genetically engineered organisms. Large-scale agricultural uses involve large numbers

of organisms that are usually less contained than their

less numerous counterparts in field trials.

Fitness and Potential to Become Established

For a species to become established in a natural community, its relative fitness must be such that it competes

successfully with other species. The lack of weediness

on the part of most major crops illustrates a direct contrast

between domestication and what is useful for survival in

the wild ( 14. 43). Many traits necessary for successful

weediness either have never existed in or have been deliberately bred out of crop plants to maximize productivity in a cultivated setting. One analysis showed that

serious weeds tend to have on average 10 to 11 ‘‘weedy

characteristics’; crop plants have on average only 5 of

these characteristics (42). Thus, the chances of any crop

plant simultaneously undergoing five to six relevant gene

changes to become a weed are vanishingly small (37).

Features of organisms that ecologists identify with

weediness include broad ecological tolerance, ability to

exploit an under-utilized resource. or ‘‘readaptation’

to a new habitat to which the organism is well-suited and

in which controlling biological agents do not exist (76).

Other characteristics that help to make a plant thrive as

a weed include the following:

●

●

●

●

●

●

●

●

●

rapid growth to a flowering stage,

continuous seed production as long as growing

conditions allow,

high seed output.

long-lived seed,

pollination by wind or unspecialized insects,

high competitive ability,

broad environmental tolerance,

seed dispersal over short and long distances, and

vegetative persistence and propagation.

The probability of successful establishment of a recombinant DNA-modified organism as compared to its

unmodified counterpart will naturally be dependent on

the nature and phenotypic expression of the specific genotypic modification made, along with the rest of the

organism’s phenotype, in relation to these ecological criteria. Different kinds of engineered genes will vary in

the degree and nature of their impact on the phenotype

of the engineered organism. Also, engineered genes may

vary in terms of the conditions under which they will be

expressed. For example, if a gene is only induced to be

expressed under specialized conditions, then its phenotypic impact will be negligible the rest of the time.

It has been well established from studies of induced

mutations that most dramatic phenotypic changes in an

organism result in reduced fitness (2, 14). Engineered

genes that affect the growth, resource allocation, or some

other aspect of an organism may convey added economic

value, but may also produce a maladapted plant that is

unlikely to survive outside of cultivation. On the other

hand. genes that have relatively little effect on the overall

phenotype, such as genes induced only on certain occasions for disease or pest resistance, might confer a real

fitness advantage, even in natural populations. It is generally assumed that genes for disease resistance present

a physiological cost that reduces fitness in the absence

of disease, although the importance of that cost has been

challenged (7 I ). However, sometimes if the gene is not

expressed, such costs go down, contributing to its potential long-term persistence.

Assessments of the risks of introduced organisms becoming pests must take these factors into account as well

as others. For example, introducing a character into an

organism whose ecological properties are otherwise wellknown, or taking a particular property associated with

terrestrial bacteria and introducing it into another terrestrial bacterium, enables some prediction of how that character might respond in that target ecological setting. Thus,

in assessing the potential risk associated with a particular

phenotypic modification, the target environment should

be considered.

If a species became established as a pest, existing

communities would be disrupted; fortunately, the likelihood of either a genetically modified plant or a microorganism becoming a pest is relatively low. Most crop

varieties produced through conventional means do not

become pests (6). Experiments to date indicate that genetically modified microorganisms in some cases may

not persist at significant levels (3) and therefore may
often be unlikely to proliferate and disrupt existing com

munities composed of vast numbers and numerous species of microorganisms (19. 86). So for all organisms

modified in any way. emphases in risk assessment of

microorganisms should be placed on the specific product.

Until more is known about consequences of large-scale

use of genetically modified plants. a deliberate approach

rather than complacency seems warranted.

Gene Stability

The stability of an engineered gene is important to risk

assessments of planned introductions of recombinant DNAmodified organisms. A gene that has become a stable

component of the transgenic organism is more predictable

in its function, expression. and possible mobility than

one that has not. one aspect of gene stability is persistence. An engineered gene construct usually consists of

several components, all of which must be present and

intact for the gene to function. In addition to the structural

gene that codes for the desired gene product. a promoter

gene is needed for it to be expressed—to be turned ‘‘on’

or ‘‘off. Such constructs maybe broken apart by natural

genetic recombination. A promoter separated from its

.

structural gene is useless; the structural gene without the

promoter remains unexpressed.

The stability of a particular gene also may be directly

influenced by the vector used to introduce it into the

engineered organism. Bacterial plasmids or DNA-carrying bodies, are potentially the most mobile of the vectors used to insert genes. Plasmids function by inserting

themselves into the bacterial chromosome. carrying an

engineered gene along with them. Insertion sites for such

plasm ids are nonrandom; they are specific sequences that

could be recognized by other plasmids, which may pick

up the inserted gene and carry it along to another organism. on the other hand, it also is often true that insertion

of a particular plasmid will immunize the cell against

insertion of similar plasmids.

Genes directly inserted into chromosomes are more

stable than genes carried by plasmids. However, chromosomes are complex structures, and the manner in which

particular genes express or recombine is determined by

their relative positions on chromosomes. An engineered

gene inserted in some parts of the chromosome may be

more exposed to recombination than genes on other parts

of the chromosome. The relative stability of an engineered gene in a plant species can be increased by inserting it into portions of chromosomes subject to lower

levels of recombination.

To summarize. a gene’s stability depends on the nature

of the gene itself and on the means of introducing it into

the recipient organism. Either of these can be manipulated deliberately to increase stability.

Gene Transfer

Another appropriate focus for risk asessments of planned

introduction of recombinant DNA-modified organisms is

the possibility) that novel genes may become incorporated

into related wild species. Such transfers, it is argued, might

lead to harmful bacteria or weeds with an " improved"

characteristic such as resistance to pest attack: this might

make them more difficult to control. Three key questions

to be considered are: What is the probability that a gene

will move from an agricultural organism to wild species’?

What can be done to lower the probability? What would

be the consequences of such gene transfer on agricultural

and natural communities<? (37 )

The probability of gene transfer from a recombinant

DNA-modified organism to a wild relative depends on

the introduced organism and the nature of the original

gene transfer mechanism. For microorganisms such as

bacteria the primary means of genetic transformation is

by vectors that, as noted above. are readily incorporated

into organisms and mobile between organisms. This opens

up the prospect of horizontal transfer of modified genes.

In addition to vector-mediated gene transfers, or transduction, genetic transfer in bacteria can occur by transformation, in which DNA freely existing in the environment

is incorporated into living cells; and conjugation, in which

DNA is transferred by direct organism to organism contact (27). These mechanisms are well known from in

vitro studies of microorganisms under laboratory conditions; indeed, transduction has become a common tool

in the introduction of engineered genes into bacteria (55).

However, little is known of the properties of these transmission mechanisms in nature (80). Due to the complexity of the bacterial environment, the scope for bacteria

to bacteria contact or for mobility of bacteriophages and

bacteria are much more restricted in soil than in laboratory culture.

Risk assessment of gene transfer in natural bacteria

populations is also problematic because species composition and potential for gene transfer among species is

poorly understood. Only a small fraction of the bacterial

species growing in soil occur in sufficient numbers to be

recognized by standard isolation techniques (48). It has

been argued that slow-growing organisms occur in sufficiently low numbers that their potential interactions and

any subsequent possible risks are negligible.
On the bright side, a number of recently developed

techniques exist that can greatly facilitate studies of bacterial interactions in natural substrates (48), including

flow cytometry (a technique that involves the use of laseractivated fluorescence of stained particles) and polymerase chain reaction (PCR) (65), involving the amplification of a particular gene contained at low concentration

in soil to sufficiently high concentrations that it can be

detected by standard DNA analysis. PCR can be used to

monitor the movements of introduced genes in natural

substrates (79). This allows the population dynamics of

the engineered organism to be more closely monitored,

the transmission of the engineered gene to background

organisms to be quantified, and potential risks to be evaluated. Also, the introduced population can be “tagged’

with a specific but nonfunctional DNA sequence such

that the growth or decline of that population in the soil

can be monitored independently of the engineered gene(s).

Actual probabilities of gene transfer of various kinds

among microorganisms are still being researched. Although differing opinions certainly exist, one school of

thought is that the order of magnitude of microorganisms

present in the natural community, and the probable frequency with which they exchange genes, renders the

potential impact of most recombinant genes being transferred relatively low.

For higher organisms. vector-mediated transfer of engineered genes is not a major concern. For example, a

widely used vector for dicotyledormus plants, Agrobacterium tumefaciens (crown gall virus) can be readily

screened out of transformed organisms before they are

released. Furthermore. for many important crop species,

notably cereal crops, vectors for gene transfer are not

used: rather ballistic incorporation of genetic material

into tissue-cultured cells (using ‘“gene guns’ ) is the method

currently in development. Using this method there is no

chance of vector-mediated gene transfer. This leaves gene

transfer through hybridization of crops and reproductively compatible (i. e., closely related) weeds as a

possibility.

In higher plants, the main risk associated with gene

transfer from transgenics into surrounding populations

is. in fact, that of hybridization. Modified genes potentially could be transferred from transgenic plants and

incorporated into the genome of a weedy species through

introgressive hybridization, whereby genes are transmitted through pollen in sexual reproduction. However,

working against this possibility are limited viaility of

pollen, distance and physical barriers to pollination. genetic dissimilarities (i. e., incompatible fertilization processes), and failure to produce viable, fertile offspring.

Most crops grown on a large scale in temperate regions, such as corn and wheat, are grown outside of their

geographic region of origin; consequently there typically

are no related weed species growing in association with

them. Therefore, for most crop species in the United

States, pollen-mediated transfer of modified genesis only

of theoretical concern. However, there are several important crop species for which closely related weed species have become introduced. Specifically. many crops

in the family Brassicaceae. such as canola (oil-seed rape)

and radishes, have co-occurring weedy relatives (21).

Sunflowers had their center of origin in the United States

and have related weedy species here as well.

Most major crop species originated in what arnow

regarded as developing countries. For example, corn was

developed in Central America, wheat was first cultivated

in the Middle East, rice in Southeast Asia. and potatoes

in South America (77). Consequently, introduction of

genetically engineered crops into such regions should be

handled with particular attention to the probability of

gene transfer into background populations.

Additional concern focuses on the potential impact of

introduced genes on the genetic structure of natural populations of plants related to important crop species. These

populations represent the genetic heritage of the crop and

are an irreplaceable reservoir of diverse genetic variation

that may be needed in future development of the crop (8).

If, because of a novel gene effect, one strain or lineage

became a super weed it might outcompete and therefore

eliminate other lineages; genetic variation potentially useful

for crop development could be lost. More generally, biodiversity is intrinsically valued by many ( 12).

Pollen-mediated transfer of novel genes from crops

into related weeds might also result in weeds becoming

similar to the crop species. A number of well-known

instances exist where selection pressures exerted by traditional agronomic practices have caused weedy species

to evolve to resemble the crop species. Such weeds cannot be eliminated by standard control practices (4). Thus,

weeds are capable of a wide range of genetic adaptation

even without the introduction of novel genes. Although

there could clearly be problems associated with potential

gene transfer from transgenic plants into weed populations. there is also a large experience base in agricultural

and natural populations on which to draw for predictions

in this area.
A great deal is known about pollen transfer in plants

(35) and associated Likelihoods of gene transfer. In the

past few years, there has been a growing interest in tracking pollen in natural populations through ‘‘paternity analysis, ” a technique directly analogous to human paternity

analysis (58, 82). The development of such approaches

provides a useful means of evaluating the potential spread

of modified genes, as well as a means of testing the

efficacy of various measures to prevent pollen spread

into wild relatives.

Gene flow in many crop species has also been studied

extensively in order to determine necessary distances for

genetic isolation of different plots to reduce genetic contamination of seed crops in conventional agriculture. For

example, genetic contamination of seed in plantations of

conifers can reach levels of 30 to 50 percent and is an

extensively studied problem (78). A review of gene transfer from corn to related species concluded that the prospects for introgressive hybridization in corn were limited

(17). However. it is unwise to dismiss completely consideration of gene transfer because genes transmitted at

low levels could be rapidly enhanced through natural

selection if they confer an advantage to their recipients.

A study of hybridization among six different rice cultivars developed through conventional agriculture and the

related weed red rice (Oryza sativa L.) found widely

varying rates of hybridization with the different cultivars.

The hybrids generally showed evidence of convergence

towards the crop, thus opening the possibility of generating a particularly noxious weed that closely resembles

the crop (49).

For specific applications of biotechnology, it is possible to articulate potential risks of gene transfer and

evaluate their probability. Furthermore, long-standing

agricultural practices (e. g., isolation of crops for seed

certification) can be useful in managing this risk. For the

few U.S. crops with weedy relatives (i.e., canola), and

for other countries where crops have multiple related

species, careful risk assessment should lead to reasonable

risk management. It is important to remember that successful cross hybridization is in fact a complex multistep

process and does not usually lead to viable, fertile hybrids. unless the species are closely related.

Evolutionary Pressures Placed on Other

Organisms

Evolutionary pressures on indigenous organisms can

arise in several ways. Novel organisms in a biotic community may provide new levels of competitive interactions; they may impose direct selection pressures on the

native organisms; they may also enhance one species at

the expense of others. Thus the assessment of risks (and

benefits) associated with the planned introduction of recombinant DNA-modified organisms must consider the

engineered organisms’ probable interactions with the target biotic community.

Many such interactions occur in convolution of a cultivated species and its associated pathogens. pests. and

weeds. One interaction that should be beneficial in terms

of controlling crop pathogens involves a pathogen’s response to “resistance factors.” Factors conferring resistance to pathogens can be conventionally bred or genetically

engineered into plants. It is well established that the

introduction of pathogen resistance factors imposes selection pressures on pathogens to overcome these factors

by evolving greater virulence (34). Using conventional

breeding methods, it can take longer to introduce a resistance factor into a crop species than it does for pathogens to respond. Genetic engineering promises greatly

to reduce the time frame for introducing resistance factors. This ‘‘buys” the crop some lead time before the

pathogen evolves a response.

Strong selection pressures also are exerted on pest

species to evolve counter measures to control technologies. The use of Bacillus thurigiensis ( Bt. for example,

is an effective means of controlling insect pests that could

become overutilized and thus rendered ineffective. The

bacterium itself often is used in broadcast spray applications to control insect pests, and the gene for toxic

agents in Bacillus thuringiensis has been cloned. The

gene now is being incorporated into crop species in field

tests. This will exert even stronger selection pressure on

insect pests. Several approaches may help to diminish

selection pressure and thus slow down the rate of evolution of resistance. (See ch. 6.) It may be possible, for

example, to introduce the Bt gene in such a way that it

is only turned on during certain stages of development,

only in certain parts of the plant. or only at times of

insect attack, thus decreasing its impact. Scientists from

several agricultural companies have formed a Bt resistance ‘‘club’ to discuss how to slow the evolution of

resistance to Bt.

Another concern is that use of genetically engineered

crops for herbicide resistance may result in overuse of

specific herbicides and thus impose strong selection on

weeds to evolve resistance to those herbicides. For example. if even ‘‘environmenttally friendly" herbicides are

overused in conjunction with transgenic monoculture,

weeds might evolve resistance fairly rapidly. This may

lead to a “desperate” use of far more damaging herbi-
244 ● A New Technological Era for American Agriculture

cides. Management strategies for slowing the development of resistance may be needed. (See ch. 6.)

The convolution of a cultivated species and its associated pathogens and weeds is a quite predictable

process if one genetic locus for one resistance factor

is considered. The sequential introduction of resistance

factors in a crop species ultimately can lead to the socalled ‘‘gene for gene’ condition in which each gene

for some resistance factor in the host is matched by a

gene for virulence in the pathogen. One way to break

this cycle is simultaneously to introduce multiple resistance factors, thus impeding the pest’s evolutionary

response. Similarly, different resistance factors might

be cycled from year to year so that the pest never fully

responds to any one resistance factor (34). The use of

genetic engineering techniques could greatly facilitate

such strategies because it provides a tool for rapid

generation of new lines containing different combinations of resistance factors.

Monitoring

Assessing the potential risks of environmental introductions of recombinant DNA-modified organisms, and

evaluating how best to manage these risks, entails spatial

and temporal monitoring of the organisms and of their

introduced genes. Monitoring contributes to risk assessment and management in two ways. First. in a specific

situation, it tracks indicators of gene transfer or spread

of introduced organisms so that action can be taken if

needed. Beyond this, monitoring adds to our database,

so that risk assessments of subsequent introductions are

even more accurate. Monitoring of field tests can provide

information pertinent to subsequent field tests and to

large-scale introductions. For example, presence or amount

of gene transfer from transgenic crops to related or nonrelated weedy species could be estimated from monitoring species surrounding a test field containing a recombinant DNA-modified crop. These data can be used in

future field tests or large-scale introductions involving

similar crop/weed complexes. Monitoring also can help

elucidate any spread of introduced microorganisms. As

the ecology of their spread is understood more fully, risk

assessments of new introductions can be improved. Thus,

monitoring has an important role to play in the natural

evolution of science-based. risk-based regulatory oversight. Highly sensitive monitoring techniques are developing rapidly. (See box 8-C. )

The following is an example of the kind of data that

the Animal and Plant Health Inspection Service (APHIS)

can require from monitoring (in this case recombinant

entomocidal or insect-killing bacteria were field tested).

Required monitoring provided data on:

1.

2.

3.

4.

5.

6.

7.

8.

9.

plant colonization by the recombinant bacteria at 4

weeks after inoculation;

colonization of all plant parts by the recombinant

bacteria monthly for 4 months;

dispersal, natural and mechanical, in the field of

the recombinant bacteria after 60 days;

presence in run-off water of the recombinant bacteria;

presence in soil of recombinant bacteria populations;

effect on crop yield of the recombinant bacteria;

effect on crop residue decomposition of the recombinant bacteria;

effect on vesicular-arbuscular mycorrhizae of the

recombinant bacteria 3 and 6 weeks after planting;

and .

effects of the recombinant bacteria on saprophytic

gram-negative bacteria in the phylloplane.

Other points of interest needed to be addressed through

the ability to track the recombinant bacteria, as well (22).

The monitoring data collected enabled APHIS to assess

patterns of the spread of the recombinant bacteria on the

targeted plant and its various parts, the dispersal of the

bacteria in the field water and soil, effects of the bacteria

on crop yield and decomposition, and the effects of the

recombinant bacteria on mycorrhizae and other plant bacteria. In short, required monitoring of plants and soil

contributed directly to understanding of dispersal and

effects of the recombinant bacteria.

Plants generally are easier to monitor than microorganisms. As techniques for monitoring improve, field

test data and, soon, large-scale test data will improve our

knowledge of survival and spread of recombinant DNAmodified organisms and their genes. thus aiding us in

reasoned risk assessment and management.

Research Needs

For the past two decades, basic research in molecular

biology has generated many novel scientific insights and

products. As a result of strong government support for

such research, we have reached a point where the planned

introduction of recombinant DNA-modified organisms is

a reality. However, the fields of ecology and evolutionary

biology, which can provide the kind of information and

expertise needed to predict the impacts of planned introductions, have enjoyed less support. Fortunately, ecologists are now taking a leading role in defining a research
Chapter 8—Scientific Issues: Risk Assessment and Risk Management ● 245

Box 8-C—Monitoring Microorganisms

Detection and tracking (monitoring) of recombinant DNA-modified organisms and their genes makes possible

quantification of persistence or spread. Highly sensitive new techniques, among them polymerase chain reaction

(PCR) and antibodies, are being utilized to contribute to the efficacy of monitoring. Data resulting from monitoring

in turn contribute to the knowledge base on which risk assessments of prospective small-scale and large-scale

introductions can be based. In fact, regulatory agencies’ request that certain parameters be monitored in field tests

allows them to fine tune upcoming assessments of large-scale applications, and to make plans for their management.

The first approved environmental introduction of a living genetically modified soil-borne bacterium in the United

States, in fact, had as its goal monitoring of the bacterium’s population dynamics, persistence, and movement

through the soil. The genes “lac Z“ and “lac Y“ were engineered into a root-colonizing fluorescent pseudomonas

(P. aureofaciens), part of a bacterial group that often promotes plant growth and protects against some plant

diseases. The added genes allow the bacterium to use lactose as a source of carbon and energy and result in

readily discernible deep blue bacterial colonies on a petri dish, thus providing an excellent monitoring tool. Scientists

from Clemson University and Monsanto studied bacterial spread, population dynamics, and persistence over three

crop cycles (19 months) in a wheat field and found similar values for both the modified and the nonmodified strains.

Both strains declined to below detectable limits 38 weeks after inoculation. Also monitored were the foliar tissue

of the first winter wheat crop analyzed 3 weeks before harvest and found not to have either strain present; and

native soil bacteria, to which the Iac Z and Iac Y genes were not found to have transferred. The study’s multifaceted

sampling design, use of new techniques such as chromosomal DNA fingerprint patterns, presence of a control in

the form of a nonengineered strain, and followup over three crop cycles set good examples for thorough monitoring

studies in other situations (45). This work also is noteworthy as the first study analyzing frequency of genetic

exchange in the environment of genes inserted into bacterial chromosomes rather than plasmids. This “success”

of the chromosomal approach has implications for scientific management of gene transfer in microorganisms.

In future monitoring studies, the transgenic organism or the inserted gene itself might be tracked by a nucleic

acid probe for a specific DNA sequence; as well as by selective media for metabolic characteristics or by antibodies

to a characteristic antigen. Some tracking techniques require that bacteria be isolated and grown in the laboratory,

but others are being developed that can analyze bacterial DNA as isolated from environmental samples, a capability

useful in estimating the population of the introduced organisms. Still other techniques, including pulsed field electrophoresis, can be used to analyze total DNA in a simple community and possibly to then quantify different members

from the sample. In communities that are more complex, higher resolution is needed and probes maybe necessary.

In such cases, antibodies may give a great deal of information by tracking phenotype through detection of proteins

present (19). Polymerase chain reaction methodology is an innovative technique that can be used essentially to

“magnify” sensitivity of detection. Flow cytometry, a cell-sorting technique, may also have some application to

monitoring.

SOURCE: Philip C. Kearney and James M. Tiedje, ‘

tMethods Used to Track Introduced Genetically Engineered Organisms,”

Biiotechno/ogy for Crop Protection, Paul Hedin, Julius Menn, Robert Hollingworth (ads.) (Washington, DC: American

Chemical Society, 1988).

agendna to respond to a variety of social needs, including tributions to these predictive capabilities. However. funding

the planned introduction of’ recombinant DNA-modified

organisms (85 ). Since introduced species or their genes

may be incorporated into natural biota, over time. a similar agenda is needed for evolutionary biology to assess

the likelihood of propagation and persistence.

The likelihood of an introduced organism becoming

established. competing with other organisms. spreading.

exchanging genes with members of other species. indirectly affecting nontarget species, or changing over evolutionary time all need to be predicted in risk assessment.

A number of fields in biology are already making confor further research is needed. (See box 8-D. )

Development of mechanisms for effective coommunication between fields is critical to meeting research needs

associated with the planned introduction of recombinant

DNA-modified organisms. It has been noted that interdisciplinary research is critical for the development of

risk assessment and risk management pertinent to planned

introductions (92). In particular. the gap between ecology

and molecular biology needs to be spanned. Scientists in

both areas need to be trained or encouraged to be more

aware of each other’s fields.
130x 8-D—Relevant Research Fields

Community Ecology

Community ecology is the study of interactions of populations of different species in a given habitat. Interspecific

competition, predation, and other interactions are the province of this field. Modern community ecology is an

experimental field; however, most experimental studies are limited in scope to consideration of two, or at most

three interacting species. Larger experiments focusing on more realistically complex interactions, and desirable

predictability of response to perturbation, will require more research. Ecological systems research on topics such

as nutrient cycling can provide relevant information as well.

Population Ecology

Population ecology is the study of the dynamics and growth of populations. Such studies may emphasize

properties of the species itself, such as fecundity or mortality rates, or they may emphasize effects of environmental

or biotic interactions. There is a growing trend to incorporate population ecology into conservation biology. Analysis

of life history can be used to determine which stages (e.g., seedling establishment versus adult survivorship) are

limiting to population growth. Such analyses of sensitivity in population dynamics (9) could be useful in risk assessment of ecological impacts of recombinant DNA-modified organisms.

Population Genetics

Population genetics is the analytical study of properties of genes and changes in gene frequency over time.

The mechanism by which genes are transmitted from one generation to the next and the relationship between

particular genes and fitness are key to this field. This field is distinctive among biological fields because of its

sophisticated theoretical framework. The theory enables some level of prediction about the behavior of genes in

populations, but more emphasis on empirical studies is needed to generate useful predictive models of gene change.

Evolutionary Biology

One way to encourage empirical work in population genetics would be to place more emphasis on research

in evolutionary biology. Changes over time in genetic structure—and consequent phenotypes-of populations are

foci of evolutionary theory. Emphasis on dynamics of change predisposes the field towards questions of relative

Spread of genes and impact of phemotypes in an ecosystem over time; these are questions that are relevant to risk

assessment of planned introductions.

Systematic

The field of systematic encompasses analysis of variation of different levels of taxonomic organization. Although

the ultimate goal of such analysis is taxonomic classification, this field is increasing in importance in analysis and

monitoring of biotic diversity. This field could contribute to risk assessment through analysis of species relationships

and species ranges to evaluate the probabilities of hybridization.

Mathamatical Modeling

Mathematical modeling entails construction of a mathematical framework to describe a process and predict

outcomes from that process. Modeling has been an effective approach in risk assessment and strategic planning

in agriculture, For example, models have demonstrated that allowing the existence of marginal populations of pests

lets them serve as reservoirs for genes that confer susceptibility to pesticides and other means of control, such

populations therefore can beneficially slow the rate of evolution of resistance (34). This seemingly counterintuitive

result contraindicates a straightforward program of eradication.

Risk Assessment Methodologies

Risk assessment involves the ranking of probable outcomes from possible events. As such, in order to rank

risks, one needs to first define the risks of a given practice. Development of risk assessment methodologies is an

ongoing practice, and practitioners must always be ready to adapt to new problems as they arise in different

situations, such as commercialization of diverse crops in a variety of environments.

SOURCE: Office of Technology Assessment, 1992.
Chapter 8—Scientific Issues: Risk Assessment and Risk Management .247

More communication between scientists involved in

basic research and applied research is also needed. Just

one example is the need for communication and interaction between plant-resistance breeders and evolutionary biologists (33). Another example would be

communication between farm management systems research and ecology. Many people who work in basic

research are in part motivated by applied concerns.

However, it does little good to generate insights on an

applied problem unless there are lines of communication whereby the results of those insights are incorporated to solve the problem. Questions regarding

applied problems also need to be articulated to basic

researchers.

RISK MANAGEMENT

Genetically modified organisms introduced into the

environment do not present us with radically novel problems. Furthermore, we have a sufficient enough base of

technical knowledge and risk assessment methodologies

that we can make reasonable, science-based assessments

of the likely impacts of individual proposed introductions. The concerns raised do not need to paralyze agricultural progress based on biotechnology. These concerns

can be respected, weighed, and addressed as necessary

through science-based regulations and scientific and agronomic methods of managing risk.

Design of Science-Based Regulation

The 1986 Coordinated Framework (5 I FR 23302-23393,

1986). the more recent scope document (55 FR 147,

3118. 1990). and other reports attempt to create a technically sound context for biotechnology oversight. (See

ch. 7. ) Reviews of field trials to date have been based

on technical issues of risk reduction. Technically sound

evaluations of safety can provide principles for regulation

and oversight. Agencies receiving proposals can add specific stipulations for risk management (66). A variety of

scientific fields ranging from molecular genetics to ecology need to be brought to bear on the design or performance of oversight. As research progresses. predictability

about risks and insights as to how they should be managed

will improve.

The imminence of large-scale introductions underscores the need for clarification of how risk will be managed in various situations. Identification of issues.

development of policy, and structure for large-scale tests

and commericializations, along with modifications of the

approval process for small-scale field tests, are all being

requested from regulatory agencies, who are themselves

grappling with the issues involved (36).

Generic v. Case-by-Case Approach

Extrapolation of results of risk assessment from one

site to another still needs refining; this has ramifications for multisite, large-scale introductions. Many believe that ‘evaluation of risks must be specific to the

particular application. However, attempts have been

and doubtless will be made to associate individual cases

with appropriate categories of risk and to manage them

accordingly (51).

One key issue in the approach to risk management in

planned introductions of recombinant DNA-modified organisms is whether to use a case-by-case analysis approval process or a process built on generic categories.

Some, looking at the large number of applications coming down the pipeline, advocate a shift from the current

case-by-case review of experiments toward more of a

generic approach. Possible strategies under this approach

include categorical exemptions, licensing certain categories of tests. licensing individual scientists. or delegating authority to institutions (53). Others fully expect

large-scale tests and commercialization. in particular, to

be reviewed on a case-by-case basis. but they do encourage the rapid appearance of protocols or some other

form of guidance so that safe and effective products can

be developed (36).

Advocates of a case-by-case approach point to its flexibility. As different cases arise, each can be dealt with

in a manner appropriate to its nature; no one set of rules

and regulations, it is argued, will cover all of the many

and varied applications of biotechnologgy.

Nonetheless, over time, as our experience and research

base grows it is likely that some generic approaches to

certain sorts of introductions in certain sorts of environments will emerge. The criteria by which these generic

approaches are defined (some requiring more attention

than others) will themselves change over time (74). These

developments were anticipated in the ESA report (85),

which made a significant step toward scaling risks. Eventually. generic categorizations of likely risk are probable,

yet each case will need to be double-checked for any

idiosyncratic particularity that could trigger more focused

review. It is important for the successful application of

biotechnology to agriculture that sufficient long-term

flexibility is built into the regulatory and oversight system
so that risk management can evolve based on improved

understanding.

Relative Risks Compared to Traditional

Practices

Risk management involves the weighing of costs and

benefits. To put planned introductions in context, their risks

could be compared to risks of traditional practices in agriculture and society. For example, risks today are associated with the widespread use of chemical pesticides;

accumulation of nonbiodegradable materials; toxic wastes;

agricultural practices giving rise to genetic uniformity in

farm animals and crops, with loss of biological diversity;

and ‘‘natural biological calamities, ’ such as the current

epidemic of AIDS. Not only are risks of planned introductions put into perspective by these nonbiotechnologyrelated problems, but biotechnology itself may help to solve

some of them. For example, biotechnology can provide

alternatives to chemical pesticides, assist in the degradation

of toxic wastes, provide alternatives to selective inbreeding,

and contribute to development of diagnostics and vaccines

for AIDs and other illnesses (74).

On a more specific level of cost/benefit comparisons,

new biotechnology techniques can be compared to those

associated with traditional biotechnologies. (See table 8-

1 for one view of such a comparison. ) Certainly controversy exists—for instance, over the relative predictability

of the ecological behavior of the phenotypes of transgenic

organisms even when genotype changes are precise and

well-understood. On the other hand, conventional breeding changes many genes simultaneously, with consequent

multiple phenotypic changes. The newer, more precise

techniques may actually show up well in the comparison.

Cost-Benefit Analyses

Risk management includes the weighing of risks or of

actual costs on the one hand against benefits on the other,

and then trying to achieve a reasonable balance (74).

Agricultural biotechnology has potential to create positive benefits for agriculture. horticulture, range management, and forestry in the 21st century (43) if it is not

stalled in its developmental stages; on the other hand, it

is to no one’s best interests to proceed without attention

to identifying and minimizing any likelihood of risks.

An appropriate balance is necessary.

In a time when the expansion potential of land for

agriculture is small, when labor is expensive, and when

additional use of chemicals in agriculture generally is

regarded as a negative, the possible exploitation of new

capabilities and new information through new technologies cannot be ignored. Thus, regulations that are not

science-based could exact a very real ‘‘cost, that of not

introducing an innovative, promising product.

Small-Scale v. Large-Scale Issues

As agricultural biotechnology nears the commercialization stage, risk management must take into account a

number of realities, as was mentioned in the previous

chapter. For example, large plots at a number of locations

are needed to test a recombinant corn line. This testing

needs to be done within I to 2 years of the creation of

the recombinant line for a company to stay competitive

in the development of new varieties. Furthermore, many

hybrids will be undergoing evaluation at the same time;

several of these may contain the same recombinant gene

and several recombinant genes might be examined simultaneously. In short, if the recombinant material goes

Table 8-l—Comparison of Traditional and Developing Biotechnology

Characteristics Organismal Cellular Molecular

Processes Breeding Culture - Cell rDNA

- Anther

- Embryo

Selection Regeneration

Mutation Fusion

Control over changes Random Semi-random Directed, precise

Primary changes Unknown Semi-known Known

Number of variants needed Large Intermediate Small, in vitro selection methods

Species restriction Mainly within Within & across Within & across

Familiarity Very high Intermediate Low but expanding

Ability to ask and answer risk questions Low Intermediate High

Containment Dependent on organism and independent of method;

established procedures for domesticated organisms.

SOURCE: R.W.F. Hardy, ‘(Large-Scale Field Testing and Commercialization: Thoughts on Issues,” Biological Monitoring of Genetically Engineered Plants

and Microbes, D.R. MacKenzie and S.C, Henry (ads. ) (Bethesda, MD: Agriculture Research Institute, 1991),
Chapter 8—Scientific Issues: Risk Assessment and Risk Management ● 249

successfully and quickly through testing, the breeder will

soon work to combine it with other useful traits, in different genetic backgrounds, as part of genetic improvement. Large numbers of new lines will emerge from the

integration of recombinant genes into conventional breeding

programs so that new hybrids can be tested and commercialized.

Specific recommendations for risk management of the

transition to large-scale could include: I ) making geographic maps of crop relatives and placing them in an

accessible database, and 2) modifying the process for

approving small-scale introductions based on experience

base or familiarity (36). Marshaling evidence from experiences in agriculture, laboratory tests, introductions,

field tests, and current, ongoing research will make possible reasoned risk assessment and management.

SCIENTIFIC METHODS OF

MANAGING RISK

The power and precision of biotechnology can be harnessed for risk management itself. Controlling the spread

of introduced genes through the manner in which they

are introduced is one example. Risk management can be

greatly aided by using supplementary transferred genes

to ensure that the ensuing recombinant DNA-modified

organism only functions on certain occasions, under certain environmental conditions, or for a finite period of

time. The genetic modification can be designed to: 1 )

constrain the potential for gene transfer (increasing the

“containment’ of the gene within the organism into which

it was inserted), and 2) maximize its key activity while

minimizing effects in the recipient environment (60).

Mechanisms for fine-tuned technical control of this sort

still are being developed; a few approaches are described

briefly here. In general. in addition to turning the gene

on or off under certain conditions, several approaches to

containment could be considered: ‘‘autodestruct’” mechanisms (e. g., suicide genes), engineering genes such that

the host has diminished survival (as through defective

regulation of metabolism), and decreasing chances of

horizontal gene transfer to other organisms (as through

reducing the stability or ease of inheritance of the introduced genes) ( 19).

Promoters Turned On or Off

by Specific Stimuli

One way to limit the effect of the engineered gene

itself is to attach it to a promoter that only allows expression under certain conditions (83). When a gene is not

being expressed, the physiological expenditure associated with expression of the gene can be allocated to other

purposes. This maintains the “efficiency” of the organism and keeps the impact of the gene’s phenotype to a

minimum. For example, some genes are only expressed

when triggered or induced (usually through a ‘‘promoter’ gene) by a certain chemical, such as a herbicide,

or in the event of local disturbance of tissue, such as a

wound response resulting from chewing by insects. A

gene for some form of pest resistance attached to such

an ‘‘inducible promoter’ gene would have little phenotypic impact except in the presence of a pest. This is a

realistic strategy with diverse applications, some of which

already have been field tested. For example, a field test

was conducted by Iowa State University to assess whether

or not transgenic tobacco plants would respond to insect

attack by turning on an inserted gene. Plants often can

respond to insect attack by activating genes coding for

defensive compounds. Such compounds may, for instance, block the digestive system of insects, reducing

their leaf consumption. A marker gene—one used to

trace the success of the recombination experiment—

(chloramphenicol acetyl transferase, CAT). modified from

proteinase inhibitor II genes in the tomato family, was

put into tobacco to determine levels of its activation by

insects under actual field conditions. Upon insect attack

on foliage, the transgenic plants showed induction of the

transferred proteinase inhibitor genes. This has positive

implications for using the wound-inducible inhibitor promoter in biological control of insect-caused foliage damage. The potential exists for a well-managed. efficient

system, in which the inserted genes function only on an

as-needed basis (83).

Suicide Genes

When it is important that particular recombinant DNAmodified organisms not establish viable populations, a

mechanism that has been proposed for their containment

is to include, along with the desired gene, a "suicide"

gene that will sufficiently cripple the organism that it

will not survive beyond its intended use. The suicide

gene may, for example. prompt a metabolic pathway

resulting in death of the cell in the presence of a specific

external cue (44, 70). Another approach to containment

is to introduce mutations that inactivate the transgenic

organism’s ability to synthesize necessary aromatic amino

acids or other key metabolic pathways of the cell ( 19).

Alternatively. a “kill” gene can be inserted to be

expressed constitutively — all the time-unless a ‘‘protection” gene is turned on by the same promoter gene

that causes expression of the key functional gene. That

297-937 0 - 92 - 9 QL 3
250 . A New Technological Era for American Agriculture

promoter can be geared to respond to some signal from

the environment, such as temperature or presence of a

pollutant chemical. For instance, if a protection gene for

a vaccine strain is only activated above temperatures of

30 “C.. the vaccine organism will express the kill gene

and die if it passes out of the host’s body ( 19).

The advantages of a “suicide” strategy are straightforward. Existing experimental data indicate that genetically modified microorganisms introduced into the

environment usually fail to establish viable populations

unless the numbers of introduced organisms are very

large. To accomplish a useful effect, as in agricultural

treatments or environmental clean-up, planned introductions of microorganisms generally will require inocula

of large populations. Once the goal of the planned introduction has been met, a trigger factor to set off the

suicide gene can be introduced that will leave behind

only a small fraction of the introduced population, which

may then be at too low a frequency to sustain itself.

Suicide genes are most frequently suggested for containment of microorganisms; their feasibility in plants

has been questioned. With plants’ complicated physiology. difficulties could exist, for instance, in triggering

the action of specific genes by any environmental cue

other than some deliberate applied chemical, such as a

herbicide (37). Overall, the potential effectiveness of

suicide genes at this point is controversial (25). One key

problem with the use of suicide genes is that natural

selection would encourage the evolution of genetically

based mechanisms counteracting the suicide effect.

Prevention of Gene Transfer

In the case of transgenic plants, concerns exist about

the possible transfer of engineered genes to neighboring

weedy populations of related species. One way to prevent

gene transfer through pollen would be to shut down pollen production in the transgenic plant. This can be accomplished by introducing a male-sterility factor into the

plant along with the desired trait. The use of naturally

occurring male-sterility mutants has been a significant

tool in traditional plant breeding. Quite recently, genes

for male sterility have been cloned and reintroduced into

several plant species, including canola (56). These genes

were expressed in the transgenic plants and hence brought

about male sterility. This strategy has a great deal of

promise and currently is feasible. Its application to canola

is especially pertinent because that species is among the

most likel y to effect vector gene transfer to related species

in North America.

For leafy crops (e.g., spinach) or root crops (e. g.,

sugar beets), male sterility would not be problematic. In

fact, it has been suggested that male sterility used in

timber tree plantations would channel more of a tree’s

resources to board feet production, in lieu of reproduction. Some crops (e. g., cereals), however, require pollination, so that mixed varietal plantings of male sterile

transgenic plants and male fertile. untransformed varieties could be needed (37).

Several strategies seem to have potential to decrease

the risks associated with gene transfer between microorganisms. For example, a protection gene might be inserted far away from a kill gene. which itself is close to

the desired gene being introduced to a host; then, if the

functional gene happens to be transferred, the new recipient microorganism also would receive the kill gene,

without the protection gene. Another approach might be

to insert a gene for a particular active nuclease so that

when a cell dies, its DNA—including the introduced

fragment-released after death will have been significantly reduced. A variety of ways of inserting defects

that would disrupt the host’s mobilization and conjugation systems could also cut down significantly on horizontal gene transfer (19). Engineering changes into a

chromosome rather than a plasmid may decrease the likelihood of gene transfer between microorganisms; this

approach also is being explored (45, 48).

Combinations of Genes

As the number of genes involved in a desired effect

goes up. so does the possibility that that effect will be

lost in the next and subsequent generations because of

natural recombination. Thus, a possible strategy for decreasing the long-term probability of establishment of an

engineered genetic effect would be to have the desired

effect depend on the interaction among several separate

genes.

AGRONOMIC METHODS OF

MANAGING RISK

Physical Barriers

Complete containment was the preferred method of

controlling risk when genetic engineering was introduced

on a small scale. Examples of physical containment are

“boundary strips” in the form of fences or hedgerows

that can trap some large percentage of pollen. particularly

that dispersed by wind. This might, however, be unfeasible to install or cause unwanted shade (37). Overall.
Chapter 8—Scietific Issues: Risk Assessment and Risk Management ● 251

Photo credit: Grant Heilman, Inc.

A traditional approach to isolation of plants is to spatially

separate desired plants from other plants. Similar

guidelines for spatial segregation have been applied to

transgenic plants as well.

a complete containment strategy has extremely limited

applicability beyond small field tests. Once an organism

has been placed in the field in the numbers required by

agricultural production, it is likely to be exposed to a

variety of biotic interactions beyond the control of reasonable physical barriers.

Spatial Barriers

The traditional approach to isolation of plants genetically improved through conventional breeding, usually

for the purpose of generating a seed crop, is to isolate

spatially the desired plants from other plants. Similar

guidelines for spatial segregation have been applied to

transgenic plants as well (64). Certainly this is feasible

at the small field trial stage, and could be effective in an

experimental setting to evaluate the properties of the organism as a potential pest. Some spatial separation may

be feasible at the large-scale test stage, as well. Another

approach to separating plants in terms of gene flow is to

surround a field with flowers that will attract pollinators

of the transgenic crop, so that these trap flowers rather

than surrounding wild vegetation would be more likely

to receive any transgenic pollen. This approach might

conceivably diminish the pollinators’ activity in pollinating the crop itself, however. Weed control practices

using herbicides or cultivation could also decrease the

chance of hybridization between the crop and wild species. A straightforward mechanism is to decrease the

length of the boundary of the field and thus decrease the

number of opportunities for neighbors along the boundaries to exchange genes. Large, square fields minimize

these opportunities (37).

Temporal Barriers

Many problems associated with planned release could

be addressed by the timing of the release. For example,

if a given engineered line is released in an area with an

uncultivated relative that could incorporate the engineered genes, one could manipulate the flowering (phenology) of the engineered organisms so that the crop did

not flower at the same time as the weed. For example,

wild relatives need short days for flowering, bush type

green beans do not (72). Similarly, one could release the

introduced plant at a time of year when the weed is

dormant or even engineer the crops for cold tolerance,

for example, to shift its flowering and production period

away from that of its wild relatives. Agricultural experience and ecological understanding will play a significant role in the development of such barriers. Some

agronomic practices such as irrigation can allow crop

production at a time of year unfavorable for related weeds,

diminishing the possibility of cross hybridization.

Crop rotation could be used to force a weed rotation.

This could decrease the number of weed individuals present in the field and, therefore, the likelihood of gene

transfer; it might also eliminate hybrids produced in preceding crop production periods. Crop rotation could prevent genes from being transferred to weeds outside the

field for a whole season or two at a time, diminishing

the chances that the gene would become established in

the weed community and making it more likely to be

lost due to genetic drift. The timing of harvesting could

also build a barrier to cross hybridization. For some crops,

such as cabbage, spinach, collards, lettuce, sugarbeets,

carrots, turnips, radishes, celery, garlic, and onions, the

crop product is vegetative; careful harvesting would remove the plants before their flowering, reproductive stage,

thereby diminishing pollen transfer (37).

SUMMARY POINTS

Issues and concerns raised by planned introductions

of recombinant DNA-modified organisms can be addressed by the integration of risk assessment methodologies with the currently existing knowledge base,

continuously augmented by ongoing research and by

additional data resulting from field tests. Risk management is therefore possible, with its chief compo-
252 . A New Technological Era for American Agriculture

nents being science-based regulation, scientific

management methods, and agronomic management

methods. A natural evolution of risk management and

regulatory oversight is occurring as our experience base

with field tests and in performing ecological risk assessments grows. This step-by-step progression in the

use of recombinant DNA-modified organisms in the

environment, emphasizing science-based risk assessment strikes a balance between a laissez-faire approach

and a paralysis of the use of new technology. Biotechnology has the potential to contribute significantly

to agriculture; scientifically sound risk assessment and

management promote its acceptance as well as its safety.

CHAPTER 8 REFERENCES

1.

2.

-.-Z

4.

5.

6.

7.

8.

9.

Amarger, Noelle and Delgutte, Dominique, “Monitoring Genetically Manipulated Rhizobiurn leguminosarum bv Viciae Released in the Field, ” Biological

Monitoring of Genetically Engineered Plants and

Microbes, D.R. MacKenzie and Suzanne C. Henry

(eds. ) (International Symposium on the Biosafety

Results of Field Tests of Genetically y Modified Plants

and Microorganisms, Kiawah Island, SC, Nov. 27-

30, 1990) (Bethesda, MD: Agriculture Research institute, 1991 ), pp. 22 1–228.

Antonovics, Janis and Grant, Michael, “Experimental Evidence on the Frequency of Neutral Mutations, ” J. of Heredity 65: 241-242, 1974.

Bakker, P. et al., Biological Monitoring of Genetically)’ Engineered Plants and Microbes, D. R.

MacKenzie and S.C. Henry (eds. ) (International

Symposium on the Biosafety Results of Field Tests

of Genetically Modified Plants and Microorganisms,

Kiawah Island, SC, Nov. 27–30, 1990) (Bethesda,

MD: Agriculture Research Institute, 1991 ), pp. 201-

204.

Barrett, S. C. H., “Crop Mimicry in Weeds, ” Economic Botan?~ 37: 255–282, 1983.

Berry, Duane F. and Hagedom, Charles, “Soil and

Groundwater Transport of Microorganisms, ” Assessing Ecological Risks of Biotechnolog>l, Lev R.

Ginzburg (cd. ) (Boston, MA: Butterworth-Heinemann, 1991), pp. 57–73.

Boyce Thomson Institute, Regulator}t Considerations: Genetically Engineered Plants, Center for Science Information, San Francisco, CA, 1988.

Brill, W. J., “Safety Concerns and Genetic Engineering in Agriculture, “ Science 227;381–384, 1985.

Brown, A.H. D. et al., The Use of Plant Genetic

Resources (New York, NY: Cambridge University

Press, 1989).

Caswell, H., Matrix Population Models, Sinauer Associates Inc., Sunderland, MA, 1989.

10.

11.

12.

13.

14.

15.

16.

17.

18.

19.

20.

21,

22.

Colwell, R.K. et al. ,“ Letters, Genetic Engineering

in Agriculture, ’ Science 229: 11 1–1 12, 1985.

Colwell, R. K., ‘‘Another Reading of the NAS Gene

Report, ’ Bioscience 38:421–423, 1988.

Colwell, R. K., ‘‘Natural and Unnatural History: Biological Diversity and Genetic Engineering, ” Scientists and their Responsibility, W.R. Shea and B.

Sitter (eds. ) (Canton, MA: Watson International

Publishing, 1989).

Covello, V. T., and Fiksel, J.R. (eds. ), “The Suitability and Applicability of Risk Assessment

Methods for Environmental Applications of Biotechnology, ” Final report to the Office of Science

and Technology Policy, Executive Office of the

President, Report No. NSF/PRA 8502286, National Science Foundation, Washington, DC, 1985.

Crawley, Michael J., “The Ecology of Genetically

Engineered Organisms: Assessing the Environmental Risks, ” Introduction of Genetically Modfied Organisms into the Environment, Harold A. Mooney

and Giorgio Bemardi (eds. ) (New York, NY: John

Wiley and Sons, 1990) pp. 133-150.

Davis, B., “Bacterial Domestication: Underlying

Assumptions, ’ Science 235: 1329–1335, 1987.

Dean-Ross, D., “Applicability of Chemical Risk

Assessment Methodologies to Risk Assessment for

Genetically Engineered Microorganisms,” Rec. DNA

Tech. Bull. 9( 1): 16-28, 1986.

Doebley, J. “Molecular Evidence for Gene Flow

Among Zeq Species, “ Bioscience 40: 443-448, 1990.

Duvick, Donald N., “A Case Study: Development

and Release of a Corn Hybrid for the U.S. Corn

Belt, ” talk presented at B1OTECH USA, Nov. 27–

29, 1990, Washington, DC, 1990.

Dwyer, Daryl F. and Timmis, Kenneth, “Engineering Microbes for Function and Safety in the

Environment, ” pp. 79–98, Introduction of Genetically’ Modified Organisms into the Environment,

Harold A. Mooney and Giorgio Bemardi (eds. ) (New

York, NY: John Wiley and Sons, 1990), pp. 167-

189.

Ehler, L. E., “Planned Introductions in Biological

Control, Assessing Ecological Risks of Biotech -

nologj~, Lev R. Ginzburg (cd. ) (Boston, MA: Butterworth-Heinemann, 1991), pp. 21–39.

Ellstrand, N.C. and Hoffman, C. A., “Hybridization

as an Avenue of Escape for Engineered Genes, ’

Bioscience 40:438-442, 1990, p. 40.

Faust, Robert M, and Jayaraman, Kunthala, “Current Trends in the Evaluation of the Impact of Deliberate Release of Microorganisms in the

Environment: A Case Study with a Bioinsecticidal

Bacterium, ’ [introduction of Genetically Modified

Organisms into the Environrnen?, Harold A. Mooney

and Giorgio Bemardi (eds. ) (New York, NY: John

Wiley and Sons, 1990), pp. 167-189.
Chupter 8—Scientljlc Issues: Risk Assessment and Risk Management s 253

23.

24.

25.

26.

27.

28.

29.

30.

31.

32.

33.

Fiksel, Joseph and Covello, Vincent T., “TheSuitability and Applicability of Risk Assessment Methods for Environmental Applications o f

Biotechnology, ” Biotechnology? Risk Assessment:

Issues and Methods fijr E\l\ir{~\~t?li~tlt~~lintroductions, Joseph Fiksel and Vincent T. Covello (eds. )

(Final Report to the Office of Science and Technology Policy, Executive Office of the President,

Report No. NSF/PRA 8502286) (New York, NY:

Pergamon Press. 1986), pp. 1–34.

Fiksel, Joseph, “Applications of Knowledge Systems for Biotechnology Risk Assessment and Management, Risk Assessment in Genetic Engineering,

Morris A. Levin and Harlee S. Strauss (eds. ) (New

York, NY: McGraw-Hill, Inc., 199 l), pp. 354-367.

Fox. J.L. , ‘ ‘Suicide as b ‘Painless’ Eco-Safeguard’!’ BiolTech 7:412-413, 1989.

Frederick, Robert J. and Pilsucki, Robert W., “Nontarget Species Testing of Microbial Products Intended for Use in the Environment, ” Risk Assessment

in Genetic Engineering. Morris A. Levin and Harlee

S. Strauss (eds. ) (New York, NY: McGraw-Hill,

Inc., 1991 ), pp. 32-50.

Fristrom, J.W. and Clegg, M. T., Principles of Genetics, 2d ed. (New York, NY: W.H. Freeman, 1988).

Fuchs. Roy L. and Serdy, Frank, S., “Genetically

Modified Plants: Evaluation of Field Test Biosafety

Data, ’ Biological Monitoring of Genetically? Engineered Plants and Microbes, D. R. MacKenzie and

Suzanne C. Henry (eds. ) (International Symposium

on the Biosafet y Results of Field Tests of Genetically

Modified Plants and Microorganisms, Kiawah island, SC, Nov. 27-30, 1990) (Bethesda. MD: Agriculture Research Institute, 199 l), pp. 25–29.

Fuxa, James R., “Release and Transport of Entomopathogenic Microorganisms, Risk Assessnwn?

in Genetic Engineering. Morris A. Levin and Hat-lee

S. Strauss (eds. ) (New York, NY: McGraw-Hill,

Inc., 1990), pp. 83–1 13.

Gillett, J. W., “Risk Assessment Methodologies for

Biotechnology Impact Assessment, ” Potential lnzpacts of Environmental Release of Biotechnology

Products: Assessment, Regulation, und Research

Needs, J.W. Gillett et al. (eds. ), Report no. ERC075, Ecosystems Research Center, Cornell University, Ithaca, NY, 1985.

Ginzburg, L.R. (cd.), Assessing Ecological Risks of

Biotechnology (Boston, MA: Butterworth-Heinemann, 1991).

Goldburg, ‘Rebecca et al., Biotechnolog~l’s Bitter

Harvest: Herbicide-Tolerant Crops and the Threat

to Sustainable Agriculture, Biotechnology Working

Group Report, 1990.

Gould, F., “Genetics of Plant-Herbivore Systems:

Interactions Between Applied and Basic Study, ”

Variable Plant and Herbivores in Natural and Man34.

35.

36.

37.

38.

39.

40.

41.

42.

43.

aged S}’stems, R. Denno and B. McClure (eds. ) (New

York, NY: Academic Press. 1983), pp. 599-653.

Gould, F., “Evolution of Resistance to Toxic Compounds by Arthropods, Weeds and Pathogens, ”

commissioned background paper prepared for the

Office of Technology Assessment, 1991.

Handel, S. N., “Pollination Ecology, Plant Population Structure, and Gene Flow, ” Pollination Biology, L. Real (cd. ) (New York, NY: Academic

Press, 1983), pp. 163-211.

Hardy, Ralph W .F., ‘‘Large-Scale Field Testing and

Commercialization: Thoughts on Issues, ” Biological Monitoring qf Genetically}’ Engineere<i Plants and

Microbes, D.R. MacKenzie and Suzanne C. Henry

(eds. ) (International Symposium on the Biosafety

Results of Field Tests of Genetically Modified Plants

and Microorganisms, Kiawah Island, SC, Nov. 27–

30, 1990) (Bethesda, MD: Agriculture Research Institute, 1991, pp. 239–248.

Hoffman, Carol, “Exchange of Genetic Material

Between Genetically Engineered Crops and Close

Relatives, commissioned background paper prepared for the Office of Technology Assesment,

1991.

Istock, Conrad A., “Genetic Exchange and Genetic

Stability in Bacterial Populations, ” Assessing Ecological Risks qf Bi~]t(~(.h~l~~l(~g>, Lev R. Ginzburg

(cd. ) (Boston, MA: Butterworth-Heinemann, 1991 ),

pp. 123-149.

Kareiva, Peter, Manasse, Robin, and Morris. William, “Using Models to Integrate Data from Field

Trials and Estimate Risks of Gene Escape and Gene

Spread, ’ Biological Monitoring of Geneticwllj’ Engineered Plant.s andMicrobes, D.R. MacKenzie and

Suzanne C. Henry (eds. ) (International Symposium

on the Biosafety Results of Field Tests of Genetically

Modified Plants and Microorganisms, Kiawah Island, SC, November 27–30, 1990) (Bethesda, MD:

Agriculture Research Institute, 1991), pp. 31–42.

Katz, Lori S. and Marquis, Judith K., “The Toxicology of Genetically Engineered M icroorgan -

isms, Risk Assessment in Genetic Engineering,

Morris A. Levin and Harlee S. Strauss (eds. ) (New

York, NY: McGraw-Hill, Inc., 1991), pp. 51-63.

Kearney, Philip C. and Tiedje, James M., “Methods

Used to Track Introduced Genetically Engineered

Organisms, ” Biotechnology> for Crop Protection, Paul

Hedin, Julius Menn, and Robert Hollingworth (eds. )

(Washington, DC: American Chemical Society,

1988), pp. 352–358.

Keeler, Kathleen H., “Can Genetically Engineered

Crops Become Weeds’?” Biotechnology vol. 7: 1134–

1139, 1989.

Keeler, Kathleen H., Turner, Charles E., “Management of Transgenic Plants in the Environment,

Risk Assessment in Genetic Engineering, Morris A.
— —

254 ● ANew’Techrrological Erafor American Agriculture

Levin and Harlee S. Strauss (eds. ) (New York, NY:

McGraw-Hill, inc., 1991), pp. 189-218.

44. Kim, Hunhyong, Ginsburg, Lev R.,andDykhuizen,

Daniel E., “Quantifying( heRisks of Invasion by

Genetically Engineered Organisms,” Assessing

EcologicalRisks ofBiotechnology, Lev R. Ginzburg

(ed.)(Boston, MA: Butterworth-Heinemann, 1991),

pp. 193-214.

45. Kluepfel, D.A. etal., “FieldTesting ofa Genetically Engineered Rhizosphere Inhabiting Pseudomonas: Development of a Model System, ’ Biological

Monitoring of Genetically Engineered Planl.s and

Microbes, D.R. MacKenzie and Suzanne C. Henry

(eds. ) (International Symposium on the Biosafety

Results of Field Tests of Genetically Modified Plants

and Microorganisms, Kiawah Island, SC, Nov. 27–

30, 1990) (Bethesda, MD: Agriculture Research Institute, 1991 ), pp. 189– 199.

46. Kluepfel, D.A. and Tonkyn, D. W., “Release of

Soil-Borne Genetically Modified Bacteria: Biosafety

Implications from Contained Experiments, Biological Monitoring of Genetically Engineered Plants

and Microbes, D.R. MacKenzie and Suzanne C.

Henry (eds. ) (International Symposium on the Biosafety Results of Field Tests of Genetically Modified

Plants and Microorganisms, Kiawah Island, SC, Nov.

27–30, 1990) (Bethesda, MD: Agriculture Research

Institute, 1991), pp. 55–65.

47. Kostka, Stanley J., “The Design and Execution of

Successive Field Releases of Genetically Engineered

Microorganisms, Biological Monitoring of Geneticullv Engineered Plants and Microbes, D. R.

MacKenzie and Suzanne C. Henry (eds. ) (International Symposium on the Biosafety Results of Field

Tests of Genetically Modified Plants and Microorganisms, Kiawah Island, SC, Nov. 27–30, 1990)

(Bethesda, MD: Agriculture Research Institute. 1991),

pp. 167-176.

48. Lacy, George H., Stromberg. Verlyn K.. “Pre-Release Microcosm Tests with a Genetically Engineered Plant Pathogen, ’ Biological Monitoring of

Genetically Engineered Plants and Microbes, D.R.

MacKenzie and Suzanne C. Henry (eds. ) (international Symposium on the Biosafety Results of Field

Tests of Genetically Modified Plants and Microorganisms, Kiawah Island, SC, Nov. 27-30, 1990)

(Bethesda, MD: Agriculture Research Institute, 1991 ),

pp. 81-98.

49. Langevin, S. A., Clay, K., and Grace, J. B.. “The

Incidence and Effects of Hybridization Between Cultivated Rice and Its Related Weed Red Rice (Oryza

sativa L.), ” Evolution 44(4): 1000-1008, 1990.

50. Levin, Morris und Strauss, Harlee, “Introduction:

Overview of Risk Assessment and Regulation of

Environmental Biotechnology,” Risk Assessment in

Genetic Engineering, Morris A. Levin and Harlee

S. Strauss (eds. ) (New York, NY: McGraw-Hill,

Inc., 1991), pp. 1-17.

51. Levin, Simon, “Ecological Issues Related to the

Release of Genetically Modified Organism into the

Environment, ’ Introduction of Genetically Modified

Organisms into the Environment, Harold A. Mooney

and Giorgio Bernardi (eds. ) (New York, NY: John

Wiley and Sons, 1990), pp. 151-159.

52. Levy, Stuart B. and Miller, Robert V. (eds. ) Gene

Transfer in the Environment (New York, NY:

McGraw-Hill Publishing Co.), 1989.

53. MacKenzie, D.R. and Henry, Suzanne C., “Towards a Consensus, Biological Monitoring of

Geneticailj Engineered Plants and Microbes, D.R.

MacKenzie and Suzanne C. Henry (eds. ) (international Symposium on the Biosafety Results of

Field Tests of Genetically y Modified Plants and Microorganisms. Kiawah Island, SC, Nov. 27-30,

1990) (Bethesda, MD: Agriculture Research institute, 1991 ), pp. 273–283.

54. Manasse, Robin and Kareiva, Peter, ‘‘Quantifying

the Spread of Recombinant Genes and Organisms, ’

Asses-sing Ecological Risks of Biote~’hnolog>’, Lev

R. Ginzburg (cd. ) (Boston, MA: Butterworth-Heinemann, 1991), pp. 215–231.

55. Maniatis, T., Fritsch, E. F., and Sambrook, J., Molecular Cloning: A Laborator> Manual (Cold Spring

Harbor, NY: Cold Spring Harbor Laboratory Press,

1982).

56. Mariani, C. et al., “Induction of Male Sterility in

Plants by a Chimaeric Ribonuclease Gene, ’ Nature

347:737-741, 1990.

57. McIntosh, Marla S., “Statistical Techniques for Field

Testing of Genetically Engineered Microorganisms, Risk Assessment in Genetic Engineering,

Morris A. Levin and Hat-lee S. Strauss (eds. ) (New

York, NY: McGraw-Hill, Inc., 1991 ), pp. 219-239.

58. Meagher, T. R., “Analysis of Paternity Within a

Natural Population of Chamae/irium luteum, 1. identification of Most-Likely Male Parents, ’ Amer. Nat

128: 199-215. 1986.

59. Merkhofer, M. and Covello, V., Risk Assessment

and Risk Assessment Methods: The State of the Art,

NSF study, Washington, DC, as cited in Fiksel and

Covello, 1986.

60. Miller. Robert V. and Levy, Stuart B., “Horizontal

Gene Transfer in Relation to Environmental Release

of Genetically Engineered Microorganisms, ’ Gene

Transf&r in the En\’ironment, Stuart B. Levy and

Robert V. Miller (eds. ) (New York, NY: McGrawHill Publishing Co. 1989), pp. 405-420.

61. Moffat, Anne, “Workshop Discusses Biosafety Aspects of Oilseed Crucifer Field Trials, ” Genetic Engineering News: January 1991: p. 15.

62. Mooney, Harold A. and Bernardi, Giorgio (eds. ),

Introduction of’Genetically Modljied Organisms into
Chapter 8-S~.ientific Issues: Risk Assessment and Risk Management ● 255

63.

64.

65.

66.

67.

68.

W.

70.

71.

72.

73.

the Environment (New York. NY: John Wiley und

Sons, 1990).

Mooney, Harold A. and Drake, J. A., “The Release

of Genetically Designed Organisms in the Environment: Lessons from the Study of the Ecology of

Biological Invasion s.” Introdut’tion of Genetically>

A40dlfied Org[itlisms into the L’)t\*i)”~)tl\?~t~tlt, Harold

A. Mooney and Giorgio Bernardi (eds. ) (New York,

NY: John Wiley and Sons, 1990). pp. I 17– 129.

Muench, Stephen R., “Rcquircmcnts tind Considerations in Successful Field Releases of Gcnetictilly

Engineered Plants, ’ Bi(dogit’[11 Monitoring(!f’ Ge -

ncticall~~ Engineered Pl[int.$ an(i Mi~robes, R.

MacKenzie and S.C. Henry (eds. ) (International

Symposium on the Biosatety Results of Field Tests

of Gcneticul Iy Modified Plants tind M icroorgtinisn~..

Klawah Island, SC, N(JY . ~7–30, 1990) ( Bcthe\dti<

MD: Agriculture Research Institute, 199 l), pp. 3-

7.

Mullis, Kary B., “The Unusual origin of the Polymcrase Chain Rctiction, ” .?ticntlfi~ Anwritwn. April

1990: 56-65.

Naimon, Jonuthun S.. ‘ ‘Using Expert Panel~ to Assess Risks of Envirtmmental B iotechnolog~’ Applications: A C’tisc Stud) of the 1986 Fr(~stban~ Risk

Assessments, Risk A.~.~t’.~.~I?It~IIt ill Genetit En,qi -

nccrin,y. Morris A. Levin and Har]ec S. Strauss (cd\. )

(Ncw York. NY: McGraw-hill. Inc., 1991 ), pp.

31 9–353.

National Academy of Scicncm (NAS ), National Research Counc i]. Ri\k A.~.v[’.s.s\ttt~\tt ill the Federal G-lJ\’-

crntnent.’ M~~\l~Igin<q the Process (Washington, DC:

N:itiona] Academy Press. 1983).

National Academy of Sciences. Itltt-(dlic(iotl (?f’Rc-

~t~ttlbinant DNA -En<qincercd Org~inism.v int[) the EnI’iront?letl(.. A’e} 1,~.YL[r,s, Wa\h ington, DC, 1987.

Nuti(~nal Rese~rch Council, Field Tcstin<y Gcnetic[[II>’ A40dlficd Or,qanit~i?15~.. FI-{lI~I(~IIq{jI.k ,fi)r De~.i-

.si~~n.s ( Wush ingt(~n, DC: Nutit)nal Acudemy Press,

1989).

Olson. B.H. et al., “The Implicatit)ns of Horizontal

Gene Transfer for the Environmental Impact of Genctical Iy Engineered Microorganisms, Risk A.\-

.ws.ittlcnt ill G’enctic Etlcgi\lcerin,g. Morris A. Levi n

tind Harlce S. Strauss (cds. ) ( Nev York, NY:

McGraw-Hill. Inc., 199 1). pp. 163-188.

Parker, M., ‘ ‘The Pteiotropj Thtory for Pol~mmrphism of Disease Rc\istant Genes in Plmts.. ~“)’(~lutioll

44: 1872-74, 1990.

Purse glove. J. W., Tr~~pi~~il (’rl)p~, [licot>lt~lo)l~”

(London. Englimd: Longmtin. 1974).

Rces, Mark et al., “An Ecolt)gictil Pm_spccti\re to Risk

Assessment, Bi{dc)gittll M{)iti[(willg of” (heticwlly

hlcqintw’ed Pll[nt.$ LInd kli~-r~h),$, D.R. k9acKenzie

and Suzanne C. Ha-g (cA. ) ( Intematkwil Symposium on the Bkwifkt} Re\ults t~f Field Tests ~)t’ Gc -

74.

75.

76.

77.

78.

79.

80.

81.

g~

83.

84.

85.

netically Modified Plants and Microorganisms, Kiawah

Island. SC, Nov. 27-30, 1990) (Bethesda, MD: Agriculture Research Institute, 1991, pp. 9– 19.

SCOPE/COGENE, Joint Statement, Mooney and

Bernard, 1990, pp. xvii–xxiv.

Sharples, Frances E., “Regulation of Products from

Biotechnology, ’ Science 235: 1329–1332, 1987.

Sharples, Frances E., “Ecological Aspects of Hazard Identification for Environmental Uses of ~Jeneticaliy Engineered Organisms, Risk A,\.\(~.\-.\’t?I(~tl/

i)? Genetic Engineering, Morris A. Levin and Harlee

S. Strauss (eds. ) (New York, NY: McGraw-Hill,

Inc., 1991 ), pp. 18-31.

Sinlnl{~nds. N. W., E\dution of’ Crop P[allt.v (New

York. NY: Longman, Inc., 1976).

Smith, 1;. B. md Adams. W.’I’., ‘ ‘measuring Pollen

Contamination in Clonal Seed Orchards With the

Aid of Genetic Markers, ” Pm. 17th South. Forest

Tree Imprm. Conf. Athens, GA. 1983. pp. 69-77.

Steffan, R.J. and Atlas, R. M., ‘” DNA Amplification

to Enhunce Detection ot Genetically Engineered

Bacteria in Environmental Samples.. App/icd ~Ind

Etl\i\-(~\lt}t[~~lt~~l kli~robiolog-y 5-I: 2185-2191, 1988.

Stotzky. G., “Gene Transfer Among Bacteria in

Soil, ’ Gene Transfir in the Ell~i~oilltlt~\lt, Stuart B.

I,evy and Robert V. Miller (eds. ) (New Yt~rk. NY:

,McGraw-Hill Publishing Co., 1989). pp. 165–222.

Strauss, Harlee S., “Lessons from Chcmical Risk

,4ssessment, Risk Assessment ill Geitcti~ Ettcqi -

nceri~~,q. Morris A. Levin and Harlm S. Strauss (eds. )

(New York, NY: McGraw-Hill. Inc.. 1991 ), pp.

297–3 18.

Thompson. Elizabeth, Prdigree .4/lal\’.si,\ in HI(ttIa/1

Geneti(’.s ( Baltimore, MD: Johns Hopkins University

Press, 1986).

Thornburg, Robert W., b’Modes of Expression of u

Wound- inducible Gene in Field Trials of Transgenic

Plants, ’ Biological Monitoring qf Gewticallj Engitwered Plants andkficrobes, D.R. MacKenzie and

Suzanne C. Henry (eds. ) (International Symposium

on the Biosat’et y Results of Field Tests of Genetically

Modified Plants and Microorganisms, Kiawah Isltind, SC, Nov. 27–30, 1990) (Bethesda, MD: Agriculture Research Institute, 199 l), pp. 147– 154.

Tie(ijc, James M., “Environnwntd Monitoring of Microorganisms (Appendix G), ” Pr(~ywctL$ ,jiN. Ph>sitwl

md Bi(dogicwl C~Mainment {!fGt’tlt’tic[{llj L“)l<qinecrcd

Organisms. James W. Gillett (cd. ) Pro&eciings, the

Shackleton Point Workshop on Biotechnology Impact

Assessment. Oct. 14, 1985. Ecosystems Research

Center, Cornell University. 1985.

Ticdje, James M. et al., “The Planned Introduction

O( Genetically Engineered Organisms: Ecological

Considerations and Recommendations. ” Ecology

70( 2):29$3 ] S, 1989 (introduction special feature

by H.A. Mooney and P.G. Risscr).
256 . A New Technological Era jor American Agriculture

86. Tiedje, James M. “Ecological Principles and Experiences in the Environmental Release of Genetically Engineered Organisms, ’ pp. 1 I 5– 127, Advances

in Biotechnolog~*: Proceedings of an International

Conjtirence, organized by Swedish Council for Forestry and Agricultural Research and Swedish Recombinant DNA Advisory Committee, pp. 115– 130,

SJFR, Stockholm, 1990.

87. Tolin, Sue A., “Persistence, Establishment, and

Mitigation of Phytopathogenic Viruses, ” Risk Assessment in Genetic Engineering, Morris A. Levin

and Harlee S. Strauss (eds. ) (New York, NY:

McGraw-Hill, Inc., 1991), pp. 1 14–139.

88. Torsvik, Viadis, Goksoyr, Jostein, and Daae, Fridalise, “High Diversity in DNA of Soil Bacteria, ”

Applied and Environmental Microbiology>. VOI

56(3):782-787, 1990.

89. Transgenic Plant Workshop. Final Report, Maryland

Biotechnology Institute and USEPA Office of Pesticide Programs, Jun. 18–20, 1990.

90. Upper, Christen D. and Hirano, Susan S., *’Aerial

Dispersal of Bacteria, ” Assessing Ecological Risks

qf Biotechnology?’, Lev R. Ginzburg (cd. ) (Boston,

MA: Butterworth-Heinemann, 1991, pp. 75–93.

91. U.S. Congress, Office of Technology Assessment,

Impacts of Applied Genetics: Microorganisms, Plants,

and Animals, (OTA-BA-218) (Washington, DC: U.S.

Government Printing Office, 1981).

92. U.S. Congress, Office of Technology Assessment,

Ne~’ De\~elopments: Biotechnology>: Field Testing

Engineered Organisms, Genetic and Ecological !s -

sues, (OTA-BA-350) (Washington, DC: U.S. Government Printing Office, 1988).

93. van Elsas, J. D., Heijnen, C. E., and van Veen, J. A.,

‘‘The Fate of Introduced Genetically Engineered Microorganisms (GEMs) in Soil, in Microcosm; and

the Field: Impact of Soil Textural Aspects, ” Biological A40nitoring qf Genetically Engineered Plants

and Microbes. D.R. MacKenzie and Suzanne C.

Henry (eds. ) (International Symposium on the Biosafety Results of Fieldtests of Genetically y Modified

Plants and Microorganisms, Kiawah Island, SC, Nov.

27–30, 1990) (Bethesda, MD: Agriculture Research

Institute, 1991), pp. 67–79.
Chapter 9

Issues and Policy Options

Photo credit: MichaelJenkins
Page

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...........259

Adequacy of Knowledge Base for Conduct of Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . 259

Adequacyot’Knowledge Base for Science- and Risk-Based Regulations . . . . . . . . . . . . . . . . . . . 259

Managing Risks of Large-Scale Introductions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 260

ISSUES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ......... 260

Extent That Regulations Are Product-Based Rather Than Process-Based . . . . . . . . . . . . . . . . . . . . 260

Appropriate Review Authority for Plants Modified Via Recombinant-DNA

To Be Pest-Resistant . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 261

Delay in EPA Regulatory Development . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 262

TSCA’s Applicability to Living Organisms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 263

Implications of Past Treatments of small-scale Planned Introductions for the Future of

Commercial, Large-Scale Introductions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 264

States and the Federal Regulatory Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265

Potential Conflict of interest Within USDA . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 265

Risks of Genetically Modified Plants or Microorganisms Becoming Pests . . . . . . . . . . . . . . . . . . 265

Gene Transfer or Cross-Hybridization Between Genetically Modified Plants

and Wild Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266

Regulations on a Case-by-Case Versus a Generic Basis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 266

POLICY OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ..........267

CHAPTER PREFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 270
Chapter 9

Issues and Policy Options

INTRODUCTION

In many ways, this is an inopportune time for a new

technology to appear on the scene. Negative experiences

with the nuclear and chemical industries have made the

American public wary of new technologies; confidence

in institutions has eroded. For both reasons, relative to

technologies of the past, biotechnology has been subjected to extensive and apprehensive scrutiny and regulatory oversight. Probably, many institutions will choose

to “go the extra mile” to ensure public confidence as

some policy issues are resolved. In making policy decisions, it remains important, nonetheless, to distinguish

between the technical basis for assessment and regulation

of risk resulting from planned introductions of recombinant-DNA modified organisms and what might or might

not be done additionally to maintain public confidence.

Particular clarity in this regard is called for when assessing possible costs as well as benefits of new biotechnologies. Balancing safety and institutional credibility

against economic competitiveness will be a fine art in

much demand throughout the decade.

Adequacy of Knowledge Base for Conduct

of Risk Assessment

After several years of experience with planned introductions, there seems to be a growing consensus among

scientists that the risks of planned introductions of recombinant-DNA modified organisms into the environment can for the most part be assessed with available

analytical capabilities.

The fields of community ecology, population biology,

population genetics, evolutionary theory, and agricultural science as well as others have contributed to our

current understanding of the ecology of planned introductions. Several decades of research in life history dynamics, competition, characteristics of colonizing species

or disturbed habitats, disease resistance, and gene flow

have provided a basis for risk assessment analysis today.

Of course, further research will add to current knowledge. Many ecologists and evolutionary biologists already

are addressing the research questions generated by planned

introductions; scientific presentations and publications on

this topic are increasing. With increased research funding,

more experiments could be undertaken to focus specifically

on planned introductions. This may be especially important

now as more large-scale introductions are planned. Research is needed in the fields of community ecology, population ecology, population genetics. evolutionary biology,

systematic and mathematical modeling, as well as risk

assessment methodologies. Interdisciplinary communication among scientists in these fields will be particularly

important for future risk assessment of planned introductions.

The relatively young field of risk assessment, which

is concerned with the capacity to identify and weigh risks

and benefits in a structured and analytical way, has matured rapidly. Experience with other technologically oriented issues, such as pollution control and food safety,

has generated principles and methodologies that can be

adapted for planned introductions of recombinant-DNA

modified organisms in the environment.

The often heard opinion that it is impossible to assess

possible risks of any specific planned introduction sets

a tone of apprehension over agricultural biotechnology

that is belied by this knowledge base. Ecological understanding combined with risk assessment methodologies

make it possible to analyze the potential risk of each

introduction before it is allowed to take place. However,

if American agriculture is to benefit from biotechnology,

need exists for public education concerning the extensive

capabilities on which scientists draw to ensure the safety

of planned introductions of recombinant-DNA modified

organisms in the environment.

Adequacy of Knowledge Base for Scienceand Risk-Based Regulations

Reports of the National Research Council, the Ecological Society of America, and the scope document of

the Office of Science and Technology Policy (OSTP) and

Council on Competitiveness all advocate science- and

risk-based regulations of biotechnology’s applications.

The implementation of such regulations draws on the

ability of regulators to conduct adequate risk assessments.

Regulations are implemented through oversight by personnel in Federal regulatory agencies, with varying degrees of involvement by State regulatory personnel. The

U.S. Department of Agriculture’s Animal and Plant Health

Inspection Service (USDA-APHIS) has taken the lead in

designing a smoothly functioning process for the evaluation of possible risks and benefits when a specific

planned introduction is proposed. Technical information

to be provided by an applicant is clearly defined, so that
260 . A New Technological Era for American Agriculture

a thorough, science-based risk assessment can be performed. Technical personnel in fields such as genetics

and ecology have joined the staff of USDA-APHIS Biotechnology, Biologics, and Environmental Protection Division, to ensure vigorous assessments. State regulatory

personnel are drawn into the process so they can provide

additional technical information specific to local habitats

and add an additional perspective.

The Environmental Protection Agency’s (EPA’s) Office of Pesticide Programs has extended its review processes under the Federal Insecticide, Fungicide, and

Rodenticide Act (FIFRA) to planned introductions of

microbial pesticides; it also cooperates with USDA-APHIS

in reviewing proposals for introduction of pest-resistant

plants. EPA’s Office of Toxic Substances recently has

published draft regulations to cover planned introductions

of genetically modified microorganisms; significant controversy exists as to whether these regulations are indeed

science- and risk-based, or whether they simply single

biotechnology out for attention because it is biotechnology. The final status of these regulations, and their implementation processes, are not yet known. State agencies

have yet to be pulled into EPA regulatory processes to

the extent that they are involved in USDA’s.

Managing Risks of Large-Scale

Introductions

As agricultural biotechnology moves toward commercialization and large-scale planned introductions, the

combination of several approaches can maximize benefits

and minimize risk. Technically sound implementation

processes for science-based regulations are critical to risk

management. Technically competent regulatory personnel must work within a framework of adequate technical

information to assess actual risks and base regulations

on these risks.

Beyond this, specific scientific and agronomic methods are needed to manage risks of particular planned

introductions. These might include mechanisms to isolate modified plants spatially, physically, or temporally; to minimize gene flow from modified organisms

into natural populations; or to lower the survivability

of modified organisms or nontarget organisms that might

incorporate a novel gene. The same knowledge base

that has led to the generation of recombinant-DNA

modified organisms is now being extended toward

managing risks presented by them at an extremely fine

and precise level of control.

The effectiveness of such methods can be evaluated

through monitoring. Various methods of monitoring are

being refined to make possible statistically valid sampling

for presence or absence of genes or recombinant-DNA

modified organisms in other than the target species or

the target environment. As monitoring techniques improve, we can extend our knowledge of the basic dynamics of introduced organisms and genes. This will

provide a foundation for assessing and managing any

risks associated with planned large-scale introductions.

ISSUES

Extent That Regulations Are Product-Based

Rather Than Process-Based

The reports of the National Research Council and the

Ecological Society of America stated that the techniques

of biotechnology are not themselves inherently risky or

unmanageable. (See ch. 8.) In line with these findings,

the early Coordinated Framework and the scope principles put forth by OSTP and the Council on Competitiveness recommend that biotechnology should not be

regulated as a process. (See ch. 7.) Rather, a central

tenet for biotechnology regulation is that the various

products of biotechnology should be regulated, just as

are products of other technologies. For example, a biotechnology-derived microbial pesticide should be assessed and managed for any risks offered by that particular

product in the same way that a traditionally produced

microbial pesticide would be handled. Of course, different specific questions may be asked that are appropriate to the techniques and characteristics of each product,

but biotechnology is not to be prejudged as especially

dangerous.

The product and process distinction has generated a

great deal of controversy in the past. However, as the

experience base with biotechnology has grown, the premise of judging each product on its own basis rather than

automatically implementing special regulations has gained

wide acceptance. The extent to which this premise has

been implemented is questionable.

USDA-APHIS

Through its focus on plant pests, USDA-APHIS has

been able to include, along with other organisms under

its purview, any vector, vector agent, donor, organism,

recipient organism or any other organism or product produced through genetic engineering if it can be defined

as a pest. (See ch. 7.) This approach also makes it possible for regulated articles to become exempted from
Chapter 9—Issues and Policy Options ● 261

special review, as evidence indicates their safety. This

provision is particularly important as large-scale commercialization arises.

Even though the oversight net has deliberately been

cast broadly in these early days of genetic engineering,

the process of genetic engineering itself is not the trigger

for special review by USDA-APHIS. Rather, the product

or organism itself—and its salient characteristics, such

as the vector involved—is the trigger for review primarily in accord with the scope principles.

EPA-FIFRA

Under FIFRA, the Office of Pesticide Programs (OPP)

also has applied an existing mandate to products of biotechnology, not only microbial pesticides but also plants

that produce compounds aiding them in resisting pests.

(See ch. 7.) By pulling these so-called “pesticidal plants”

under the rubric of its oversight for pesticides, EPA-OPP

seems in one sense to be focusing on the product rather

than the process by which it was generated. However, a

question exists as to whether or not “pesticides” is the

appropriate category for these particular products, especially since naturally occurring and agriculturally bred

plants all produce some antiinsect compounds. To assume authority over plants genetically modified to be

resistant to pests, EPA-OPP seems to have chosen to

look only at plants that had gone through a biotechnology

process, leaving naturally occurring and agriculturally

bred pest-resistant plants alone.

EPA-TSCA

Under TSCA, EPA’s Office of Toxic Substances (OTS)

has promulgated a draft rule for oversight of microorganisms that does not fall under other authority. (See ch.

7.) However, under these draft regulations, essentially

all microorganisms other than those modified through

biotechnology techniques are automatically exempted from

review, whereas those modified through biotechnology

techniques are labeled “new” and therefore subject to

regulation. When the only products subjected to special

review are biotechnology products, a question arises as

to whether or not the regulations are contradicting the

scope principles by focusing on process. The draft regulations under TSCA have been charged by some with

automatically and unfairly assigning a special riskiness

to organisms modified through biotechnology, while exempting organisms known to be potentially dangerous,

but that are not produced through a biotechnology process. This discrepancy, and perhaps its final resolution,

underscores a central tenet of regulation—that regulation

should be based on scientifically determined risk.

Evolution of Regulations

In the early stages of establishing regulation, special

attention naturally is focused on the new technology, and

a framework of flexible guiding principles is adopted as

different agencies begin to deal with its ramifications.

Regulations based on scientific assessment of risk begin

to be defined. As these regulations are discussed and

tested through early implementation, additional scientific

data on risk becomes available. Regulators can distinguish between early posited risks and actual risks, as

well as identify any risks not predicted in the early days

of the technology. As oversight for the products of the

new technology becomes more technically valid and precise, based on the salient characteristics of the product,

it increasingly becomes a matter of standard operating

procedure.

As the ramifications of a new technology become more

familiar the process behind it subsides in importance and

its products provide the focus for risk assessment and

oversight. In this way society can benefit from useful

new products, while being assured that the risks of that

product have been assessed and controlled. With regard

to biotechnology, agencies are at various stages of this

idealized evolutionary pathway for regulatory oversight.

As more experience is gained and data are fed into the

system, further progress should be made.

Appropriate Review Authority for Plants

Modified Via Recombinant-DNA

To Be Pest-Resistant

Under the Coordinated Framework, EPA’s Office of

Pesticide Programs took on authority for plants into which

genes coding for compounds toxic to insects had been

introduced. (See ch. 7.) The premise was that these were

special ‘‘pesticidal plants’ that presented similar risks

to the environment, food, and human health as traditional

chemical pesticides applied externally in large volumes

to plants.

This premise has been questioned for several reasons. EPA-OPP has in the past dealt with chemicals

and, to a small but growing extent, microorganisms.

For the most part, EPA-OPP has expertise in chemicals

and some microorganisms but not plants. Furthermore,

compounds that are part of plant tissue obviously do

not cause pesticide run-off and other such environmental problems (so long as they are alive); they are

distinctly localized. Most of the compounds are not

complex, like many synthetic compounds, and may

well be more readily biodegradable.
262 . A New Technological Era for American Agriculture

Another key argument with the premise of singling

out plants genetically modified for enhanced resistance

to pests is that all plants have natural pest resistance

characteristics. Selection pressures over evolutionary time

have favored the spread of genes in natural populations

that code for characteristics unattractive or harmful to

insects. Furthermore, such characteristics have been selected in breeding programs throughout the history of

agriculture. In short, making a distinction between recombinant DNA modified plants and naturally occurring

or agriculturally bred plants that are pest resistant is arbitrary, not science-based. If the “pesticidal plant” premise

is disallowed, there is then an argument that EPA-OPP

is not automatically the best home for regulatory review

of such plants. When specific new compounds are introduced into crop plants, food safety testing through FDA,

rather than regulations based on the spraying of pesticides, may or may not be more relevant to human safety.

The OPP has not yet finalized the approach that it will

take to implement oversight of ‘‘pesticidal plants, ” particularly at a large scale, and USDA-APHIS has been

taking the lead at the field trial stage. Companies and

universities have moved ahead and conducted tests.

Clearly, however, the unclarified status of the OPP's

approach to large-scale commercialization worries companies. Moreover, treating all crop plants as pesticides

would take an immense toll in State government time

and personnel; yet States cannot plan because they have

not as yet received guidance from EPA as to what is

coming.

Informal suggestions have been made that since USDAAPHIS already takes the lead in field tests of plants

genetically modified for enhanced pest resistance, has

appropriately trained personnel, and has a clearly articulated approach and established implementation procedures, it could take on oversight authority for large-scale

release as well. Whether or not this matches the intent

of the original Coordinated Framework, conferring this

authority on USDA/APHIS could be compatible with the

framework’s product emphasis and would consolidate

oversight of plant biotechnology within an efficient,

functioning system with a track record of accomplishment in this arena. Perhaps maintaining consultation with

EPA personnel would ensure diversity of perspectives

on complicated cases.

Delay in EPA Regulatory Development

EPA-Office of Pesticide Programs (OPP)

The OPP’s progress toward implementation of oversight of biotechnology under the Federal Insecticide,

Fungicide, and Rodenticide Act (FIFRA) has been patchy.

A system has been developed for the oversight of microbial pesticides, whether derived through genetic engineering or not; implementation in this arena is reasonably

straightforward. Staff expertise and procedure fairly readily

can be adapted to “new” biotechnology. On the other

hand, as indicated above, plant expertise is lacking and

no clear vision of oversight implementation has been

articulated for review of "pesticidal plants," particularly

not for large-scale introductions. It is unclear at this time

when clarification of oversight might be made; therefore,

it is difficult to project a timeframe for regulatory development. It may be that assistance, or perhaps the

provision of a model, from another agency could break

the logjam.

EPA-OTS (Office of Toxic Substances)

Under the Toxic Substances Control Act (TSCA),

new draft regulations have emerged after a prolonged

hiatus since the time when earlier draft regulations

failed. (See ch. 8.) It is not yet clear whether the new

draft regulations will survive. A principal point of controversy is that all microorganisms other than genetically modified ones are eliminated from oversight. Thus,

it seems the regulations automatically ascribe special

risk to biotechnology processes, contrary to the recommendations by the National Research Council and

others. In addition, some proposed regulations subject

academic research to the same procedures as industrial

research. This has the potential of limiting nonindustrial research done in this area. Clearly defined mechanisms for exempting specific classes of biotechnologyderived microorganisms from TSCA review might soften

the impact of the new regulations, but such actions are

not evident at this time. By treating biotechnology as

an inherently risky process, the regulations send a negative message about biotechnology to the public, as

well as to industry and academia, and may well inhibit

nonpesticidal uses of genetically modified microorganisms in agriculture and other applications. For example, the emerging industry of bioremediation based

on the biodegradation or breakdown of toxic chemicals

by microorganisms may be stifled by the TSCA regulations.

Comparison With APHIS Process, Personnel,

Structure

EPA’s regulatory logjam might be remedied by adopting the model provided by USDA-APHIS. USDA-APHIS’s

track record with field tests has been widely commended.

Industry representatives have testified to that effect; en-
vironmentalists appear to have conceded that the system

works well at the field trial stage although they remain

concerned over large-scale introductions.

Personnel with relevant technical and legal training

have implemented USDA oversight authority effectively

(see ch. 7), and in a science-based, risk-based manner.

The review process is carried out in a straightforward

manner. Furthermore. that process and criteria by which

applications will be assessed are clearly delineated and

accessible to anyone with an interest in how the system

works. Experience gained through early field trials is

applied to review of later field trials and now is being

applied to large-scale introductions. Flexibility, combined with a willingness to learn with experience and

change over time, has characterized USDA’s mode of

operation. The EPA could make good use of all of these

regulatory features: use of highly trained personnel with

relevant scientific expertise: a clearly delineated and visible process for implementation; and an overall structure

with the capacity to evolve over time based on experience

gained.

Competitiveness Factor

The delay in EPA regulatory development needs to be

addressed because it could impair American competitiveness in the agricultural industry (as well as the environmental industry). Certainly, industry progress should

not be facilitated blindly, regardless of risk. Equally important, however, it should not be needlessly blocked in

cases where risk is negligible or can be managed. Regulations that are not risk-based send a negative message

to industry that can readily stifle innovation. Furthermore, unpredictability itself can have a real impact on

corporate strategies; lack of confidence in the eventual

settling of the regulatory situation may decrease the uptake of innovative, competitive technologies by American companies.

TSCA Applicability to Living Organisms

Questions arise when a law written for chemicals, specifically TSCA, is stretched to cover living organisms.

Essentially, the traditional role of “gap filler” played

by TSCA is being extended to planned introductions of

microorganisms used for purposes other than as pesticides. (See ch. 7.) Approval for the introduction of microorganisms rests on determination that they will not in

some way harm human health or the environment. Microorganisms are not themselves toxic; neither are they

likely to be applied in the volumes typical of chemical

applications. Instead of persisting as do many synthetic

chemical compounds. living organisms are biodegrada

ble. However, because they potentially can reproduce

themselves and spread in the environment, their use brings

up concerns different from those aroused by chemicals.

TSCA could be stretched to cover microorganisms.

However, biologically trained staff will have to be given

the authority to develop the procedures and requirements

of the office. Managers will have to acknowledge the

difference between microorganisms and chemicals, and

support their biologically trained staff accordingly, when

different treatments are necessary. Shifts in regulatory

paradigms will have to occur if EPA is to adapt laws,

premises, and procedures designed for chemicals to living organisms. EPA’s ability to do so appropriately has

been questioned.

On the other hand, acceptance of EPA’s new regulatory role under TSCA has grown with the passage of

time. EPA has yet to prove that it can implement oversight of more than a handful of field trials under TSCA.

A different issue regarding EPA authority under TSCA

is that of who is affected. TSCA is a statute explicitly

designed to regulate activity conducted “for commercial

purposes. Academic research has therefore always been

exempt from TSCA oversight. The new draft rules for

microorganisms, however, greatly expand the regulatory

‘‘net. Presumably, one rationale (an unusually broad

interpretation) for including academic research is that

sometimes universities engage in technical transfer or

patent filing; or receive research money from companies.

Scientifically, the effects of microorganisms placed in

the environment by a professor are no different from the

effects of those same microorganisms placed in the environment by an industry scientist. However, many question the legal precedent that could be set by extending

TSCA’s scope to noncommercial research and worry that

the draft rules could have a negative impact on academic

research. It has been estimated that an application for a

single field trial of genetically modified microorganisms

could cost between $180,000 and $623,000 (2). Even a

cost at the lower end of this scale is more than most

universities or research grants will be able to cover, particularly in these difficult economic times. While companies have personnel and budget items dedicated to coping

with regulatory processes, universities by and large do

not have regulatory policy officials, nor do they even

have budget items for the cost of filing applications to

regulatory agencies.

Academic research thus could shift away from topics

that entail placing organisms in the environment, possibly

giving industry a “lock” on this research arena. In spite
264 ● A New Technological Era for American Agriculture

of the fact that objective basic research has always played

an essential role in this country’s development of science

and technology. Furthermore, free communication of the

results of such research is necessary for the building of

a knowledge base to be used in future risk assessments.

The absence of academic scientists and their open publication of their research results therefore could represent

a significant cost to risk assessment and management.

If under proposed TSCA rules the coverage of academic research is upheld, the agency will need to explore

with university representatives a variety of mechanisms

for mitigating negative impacts. An alternative application process may need to be developed by the agency,

perhaps based on a form already developed that is meant

to be streamlined. Other possibilities include giving oversight authority to Institutional Biosafety Committees

or to funding agencies, further streamlining the academic’s application process, or reimbursing the university for

the costs of application.

Implications of Past Treatments of SmallScale Planned Introductions for the Future

of Commercial, Large-Scale Introductions

One key element in successful oversight of large-scale

introductions is the effective communication of agency

requirements to the applicant. As noted above, USDAAPHIS-BBEP has won kudos from applicants for the

clarity of requirements for small-scale field tests. USDA

now has drafted a users handbook on how to apply for

large-scale introductions. EPA has received more critical

reviews, although it has taken steps to outline the information needed from applicants for field testing. It seems

likely that the requirements for approval of large-scale

introductions will be clarified more quickly for USDA

applicants than for applicants to EPA.

Another key element in the development of sound

treatment for large-scale introductions is willingness

to make use of input from a variety of perspectives.

USDA-APHIS has sponsored meetings, among them

three (to date) national conferences on Federal and

State Regulation of Biotechnology, that are attended

by participants from State and Federal Government,

industry, universities, and public interest groups. This

is one vehicle for ensuring the receipt of outside input.

In addition, numerous handouts and other materials

make the internal workings of APHIS more visible and,

therefore, accessible to outsiders wanting to make comments. EPA personnel also make presentations at conferences, but with the exception of two transgenic plant

workshops cosponsored by the agency, they tend to

take a less proactive role in fostering a public presence

to encourage communication.

Perhaps the key component in facilitating safe largescale introductions is a clear direction, a set of operating

principles, a map with guidelines. USDA preparation of

a draft users’ handbook for treatment of large-scale introductions is a specific example of a way in which an

agency can send clear signals. Certainly, USDA has shown

that it is willing to build on its experience with smallscale field tests to begin to come to grips with large-scale

introductions in a way that is accessible to applicants.

Given its track record, EPA-OPP may be able to move

to large-scale introductions of microbial pesticides in a

similarly straightforward manner. Whether it can do so

for large-scale introductions of plants with enhanced pest

resistance properties remains unclear. The recent circulation of draft rules by the Office of Toxic Substances

has been a positive step toward clarifying future directions; even as they generate controversy, clarification

should eventually be achieved.

With the concerns attendant on any new technology

today, it makes particular sense for agencies to monitor

the impacts of planned introductions, particularly if potential problems have been identified. Judging by their

track records with small-scale field tests, both USDA

and EPA seem amenable to appropriate use of monitoring

in larger scale introductions.

Effective regulatory treatment of planned introductions is certainly enhanced by competent, technically

trained personnel working in a structure designed to

facilitate science-based risk assessments, reviews, and

decisionmaking. USDA has put together a staff of scientists focused on planned introductions; the structure

in which they work has made it possible for the group

to learn from experience and to modify the system so

that relatively unfamiliar or risky applications can receive the most attention. EPA’s OPP can draw on microbiologically trained personnel, but does not have

the plant specialist staff of USDA. EPA’s OTS has had

so few biotechnology applications, all but one of which

were from the same company, that it is hard to extrapolate as to the effectiveness of personnel or structure for future cases.

Clearly, sound, effective oversight of large-scale planned

introductions will make a difference to the future of agricultural biotechnology and thus to the future of agriculture. (See ch. 7.) Review processes that protect human

health and the environment while still facilitating safe

introductions will benefit the competitiveness of American agriculture by ensuring the uptake of new techno-
Chapter 9—Issues and Policy Options .265

logical tools. The American economy will be harmed,

on the other hand, by unnecessary blocking of these new

technological tools through:

reviews based on criteria that are not science or riskbased;

unclear directions within regulatory agencies;

inadequate communication of requirements;

minimal learning from experience and from input

from outside perspectives; or

insufficiently trained personnel in a structure not

conducive to building on experience and streamlining procedures while maintaining safety.

As the era of large-scale introductions opens, the challenge before EPA as well as USDA is to strike the appropriate balance of protecting the American public’s

health and environment while allowing the American

public to benefit from significant advances in agriculture.

States and the Federal Regulatory Process

The USDA has an extensive network of partner State

organizations throughout the country, and has been able

to bring appropriate State government officials into the

review process for planned introductions (ch. 7). In addition to identifying appropriate contacts and sending

them copies of applications for that State, USDA has

integrated the State-level review into its own review

“timeline. ” State officials are respected for the germane

local issues and environmental knowledge they can contribute. In addition, USDA has underscored its partnership relationship with the States by holding three annual

national Conferences on Federal and State Regulation of

Biotechnology at which information and views were

shared, communication improved, and issues raised.

USDA can be regarded as a model for the inclusion of

States as partners in oversight of planned introductions.

EPA under FIFRA has somewhat of an analogous relationship to the States, in that State officials implement

Federal rulings regarding monitoring, labeling, and other

treatment of pesticides. The lack of clarity in OPP as to

future handling of plants genetically modified for enhanced pest resistance, however, has significant ramifications for the States. State officials charged with

implementing FIFRA and setting up the procedures for

handling “pesticidal plants” have complained of being

in the dark about EPA policy with regard to these products. Mechanisms to improve communication between

the Federal officials setting policy and the state personnel

who will have to implement it are needed as soon as

possible. (See ch. 7.)

Federal officials under TSCA barely have initiated relationships with State agencies. and there is no explicit

legal directive for TSCA to involve State officials. There

is no tradition of connection between specific State environmental department personnel and the Office of Toxic

Substances, yet States are interested in being involved

in biotechnology-related policy and implementation. A

joint biotechnology meeting for State and EPA regional

personnel, to explore ramifications of the draft TSCA

rules, would be a positive step toward building relationships with the States.

Potential Conflict of Interest Within USDA

USDA occasionally has been accused of conflict of

interest in that it both funds research to promote agriculture and regulates agriculture. (See ch. 7.) USDA

officials point out that the Department of Health & Human Resources also has within it both the research-funding National Institutes of Health and the regulatory Food

and Drug Authority. More specifically, however, USDAAPHIS-BBEP has several important “checks” built into

the system that greatly decrease the chances for conflict

of interest. One significant check is provided by the openness of the system; the workings of BBEP are highly

visible. Information is readily accessible through presentations, widely available printed materials, and responses to inquiries.

Another check is provided by the inclusion of States

in the permit process. State officials watching out for the

well-being of their own State provide external yet informed monitoring of APHIS decisions. In addition to

being monitored continually by State officials, the APHIS

system is sufficiently open that specters of conflict of

interest can in all probability be laid to rest.

Risks of Genetically Modified Plants or

Microorganisms Becoming Pests

Any novel organism potentially represents some level

of risk to the environment, whether that organism is

naturally occurring or genetically modified. Therefore,

for any new variety, some risk assessment is appropriate.

The likelihood of a genetically modified plant or microorganism actually becoming a pest, however, is relatively low. (See ch. 8.) The track record of agriculture

(in a sense, a form of long-term genetic engineering) has

shown that current crops are not likely to become established as weeds. For the most part, long-established

mechanisms for containment in agricultural systems have

been highly successful in the United States. Moreover,
266 . A New Technological Era for American Agriculture

recombinant-DNA modified organisms, unlike wild, naturally occurring organisms, are designed to exist only in

a specific environmental regime—the nurturing surroundings of a cultivated field.

Microorganisms modified for agricultural purposes are

constrained somewhat similarly to plants, although they

probably are not so dependent on cultivation for continued survival. However, the extensive agricultural experience with microorganisms (i.e., microbial pesticides)

has not resulted in a pest problem. To become a pest

organism, an agricultural plant or microorganism has to

exist independently of cultivation—outside the planted

field. Several steps are necessary to its success; each

one, from dispersal to the production of viable, competitive offspring, is relatively unlikely to occur. (See

ch. 8.) In general, the chances of a genetically engineered

plant or microorganism becoming established as a pest

are low, simply because each step of the process is fraught

with difficulty.

Gene Transfer or Cross-Hybridization

Between Genetically Modified Plants and

Wild Plants

Cross-hybridization, the crossing of two plants of different species to produce fertile offspring, is a rare phenomenon. (See ch. 8.) While gene transfer between

individuals of the same species is, of course, straightforward, gene transfer between different species is not;

their genomes, or genetic compositions, are usually sufficiently different that they do not line up and match well

for the key molecular and cellular events of reproduction,

Even if a transferred gene were involved in such a cross,

it would be cast onto an ‘‘alien’ genetic background—

its expression could be problematic. Even if a viable first

generation resulted from such a random crossing, as in

the case of a horse crossed with a donkey producing a

mule, that hybrid would most likely be sterile, so the

new recombinant gene would not be passed along.

In any case, most crop species in the United States do

not have indigenous weedy relatives with which they

could cross-hybridize. Canola is the only major crop for

which there are related weedy species in the United States.

A recent conference on large-scale introduction of canola

analyzed the ramifications of the potential for cross-hybridization and made recommendations for scientific and

agronomic risk management. (See ch. 8.)

The possibility of cross-hybridization is greater in other

countries, where crop species and related weedy species

do coexist. Weedy species of rice, for example, can

impose tremendous economic costs in the far East. Canola has many relatives in Europe. The developing countries, in particular, are the center of origin for many crop

species. This means that related weedy species are especially likely to be found close to agricultural fields.

Stocks of an ancestral line could conceivably be “contaminated” through cross- hybridization with any crop

plant, including genetically modified plants.

As it exports agricultural biotechnology capabilities,

the United States should offer advice to developing countries as to the management of risk from cross-hybridization. Agency regulatory staff have already begun this

sort of communication, passing on information regarding

scientific and agronomic mechanisms of risk management and encouraging their regulatory colleagues to employ such mechanisms. This advisory function needs to

grow with the export of technology; also, companies,

foundations, and international agencies need to integrate

risk management transfer with their agricultural biotechnology technology transfer to developing countries.

Regulations on a Case-by-Case Versus a

Generic Basis

Currently, review of applications for field trials is done

on a case-by-case basis. This approach has been recommended for several reasons. (See ch. 8.) First, we are

learning by doing as we handle a new technology, so

one step at a time has seemed appropriate. Specifically,

each field test is unique in terms of the transferred gene,

the vector by which that gene is transferred, the recipient

individual’s genetic background, the resulting combination of phenotypic characteristics, the likelihood of

further gene flow, and the likely impact of the phenotypic

characteristics on various components of particular target

and nontarget environments. Risk assessment should focus on those unique aspects of a field trial that may

present potential risks.

A rationale also exists for reviewing applications by

grouping them into generic categories for which guidelines of “approvability” have been developed. Risk assessment review would certainly be more streamlined

under this approach. As knowledge is gained, categories

can be updated continually.

Key reports have stressed “familiarity” as an appropriate theme for risk assessment: if we are familiar with

a component of an application package (a particular organism, or vector, or characteristic, for instance) we

more readily can assess the level of risk it presents than

if it is new. As we become more familiar with greater

numbers of genetically engineered products (through research and field trials) it should become easier to predict
Chapter 9—issues and Policy Options ● 267

the levels of risk they present and to design effective management. Thus, as oversight for planned introductions of

recombinant-DNA modified organisms into the environment naturally evolves, certain (more familiar) categories

of features automatically may be designated low risk, or

high risk depending on certain conditions. However, each

feature might be double checked for any specific idiosyncratic risk it might present; the overall package of features

also might be assessed to ensure that no interactive effect

among the features produces a new level of risk. The recipient organisms and vectors, may be the first features of

biotechnology introductions to be categorized by riskiness;

the characteristics most likely to be transferred eventually

might be broadly categorized. The interactions between the

genetically modified organism and the local environment

(including probability of gene flow) will always bear close

scrutiny, even if general categories suggest just what needs

to be examined to assess risk.

The evolution from case-by-case to generic categories

as a basis for review is likely to occur naturally; it is

dependent on the accumulation and analysis of knowledge gained in the early stages of dealing with a new

technology. Risk assessment of planned introductions of

recombinant-DNA modified organisms now is undergoing this evolutionary process.

POLICY OPTIONS

ISSUE:

Option:

The tools of biotechnology offer great potential to American agriculture; regulatory

treatment of any agricultural products derived with such tools will play a dominant

role in any related gains or losses in economic

competitiveness. Science- and risk-based regulation of products can ensure safety without

unnecessarily impeding the economy.

Congress could direct Federal regulatory agen -

cies to make science-based, risk-based regulation of biotechnology products (not process) a

unifying policy across agencies.

This would be a clear message to the executive branch

that Congress expects a unified approach across Federal

agencies based on the product not on the process. Communication through interagency groups would help to

ensure a common approach based on scientifically determined product risk. This approach can help protect

health and environment and, at the same time, should

generate a comprehensible, workable regulatory apparatus for incorporating the tools of biotechnology into

American agriculture. However, EPA will need to address staff needs to conduct technical risk-based reviews.

Option: Congress could direct appropriate agencies to

review and regulate biotechnology as a process,

rather than the products.

EPA-OTS has been accused of regulating the process

of biotechnology, not the products, in its proposed rules,

for example. It would be a clear signal that biotechnology

is so unique that it must be scrutinized for each use. This

would satisfy those concerned with the application of

biotechnology to agricultural products. However, no scientific evidence exists to justify such an approach. If

some agencies ignore the use of risk assessment of products and automatically penalize any efforts made using

biotechnology, several impacts are likely to occur. Industries and universities would be likely to "agencyshop, ’ orienting their efforts toward the agency with the

clearest analytical assessment of science-based risks—

that agency will be the least arbitrary and the most predictable, an approach certainly favored by industry. Research and industry activity in areas not regulated on the

basis of science-based risk would diminish, at what may

be a real cost to society. The agency regulating biotechnology as a process sends out an obvious negative message to industry and perhaps an equally important, if

more subtle, message to the public. Regulations based

on the assumption that biotechnology is inherently unpredictable and highly risky can lead to public reaction

and political pressures that may be detrimental to the

economic competitiveness of American agriculture.

ISSUE:

Option:

Enhanced pest resistance is one of the most

promising applications of the tools of the new

biotechnology. Obstacles to its development

could send a negative message to agribusiness, slowing its incorporation of biotechnology as a mechanism towards increased

economic competitiveness.

Congress could keep the oversight authority for

plants genetically modified for enhanced pest

resistance under EPA Office of Pesticide Programs (OPP), but direct EPA to strengthen OPP.

If oversight of “pesticidal plants” introduced at a largescale is to be handled by OPP, several implementation

steps would need to occur. Technical staff with plant

expertise would need to augment current staff; clear definitions would have to be devised for review, given that

some naturally occurring plants contain more ‘‘pesticidal

compounds” than will the products of biotechnology;
268 . A New Technological Era for American Agriculture

communication with State-level implementors would need

to be improved immediately; and a clear approach (even

if wisely flexible over time) would have to be articulated,

so that the public, industry, and academia would know

where the agency stands and how it will implement its

policy.

Option: Congress could direct USDA-APHIS to regulate

large-scale introductions of plants genetically

modified for enhanced pest resistance.

Since USDA-APHIS-BBEP has taken the lead for field

tests of plants genetically modified for enhanced pest

resistance, APHIS could handle large-scale introductions. This has the advantages of centralizing plant oversight and making effective use of an already well

functioning technical staff and organizational unit. The

chief disadvantage would be a departure from the Coordinated Framework, which ascribed authority to EPAOPP.

Option: Congress could direct EPA to work with USDA

to develop a similar model of operation and to

report on progress to Congress within a specified period of time (e.g., 6 months).

Despite disadvantages of ‘forcing’ two very different

offices to work closely together, this has the advantage

of allowing USDA to handle any risk concerns related

to planned introductions, while allowing EPA to continue

to handle food safety concerns related to “pesticidal”

toxins in the food supply. USDA has established a strong

track record for taking the lead in field tests of pestresistant plants; it is on the verge of establishing a track

record in handling large-scale introductions generally.

Building on this base such that USDA handles largescale introductions of pest-resistant plants is a logical

extension of capability and responsibility. Similarly, EPA

has developed expertise in setting tolerance levels for

pesticides in plants; after scientifically determining the

relative risks of genetically engineered pest-resistant

compounds compared to naturally occurring compounds,

it could

ISSUE:

set tolerances in this case as well.

TSCA is a statute explicitly designed to regulate activity “for commercial purposes.>’

Academic research, therefore, has been exempt from TSCA oversight. The proposed

draft rules for microorganisms, however,

greatly expand the regulatory “net.” One

rationale for including academic research is

that sometimes universities engage in technical transfer or patent filing, or receive research funds from companies. Obviously, the

effects of microorganisms being placed in the

environment by a university scientist are no

different from the effects of those same microorganisms being placed in the environment by an industry scientist. Concern exists,

however, that the draft rules could have a

negative impact on academic research.

Option: Congress could allow the proposed rule to stand,

placing the same requirements on academic research as on industrial research.

Subjecting universities to the requirements placed on

companies seems contrary to Congressional intent behind

TSCA. It could have significant impacts on university

research. Faced with the added bureaucracy and high

costs entailed by this rule, the majority of university

researchers might deliberately avoid planned introductions of genetically modified organisms. This would leave

industry in charge of an area of research that could continue to benefit from objective, openly published study.

Such a situation would inhibit the production of new

knowledge for use in future risk assessments. However,

it is an arbitrary decision to automatically exclude universities from oversight—the release of organisms that

pose a risk should be regulated regardless of who conducts the release.

Option: Congress could direct EPA to develop an oversight mechanism by public scientists for planned

introductions as an alternative to the proposed

TSCA rule.

Universities could make use of their already existing

system of oversight committees and institutional biosafety officers to regulate biotechnology field trials “in

house. ” Just as the Institutional Biosafety Committees

(IBCs) review laboratory research involving recombinant

DNA, they could review proposals for planned introductions (3). It would entail education of laboratoryoriented personnel as to the ecological considerations of

field release, as well as possible expansion of committee

membership to include appropriate disciplines. Serving

on an IBC is a time-consuming effort for university personnel. Many feel that there are already too many university committees on which they must serve and that

there time could be used more productively. Use of those

committees to provide oversight is a possible trade off

for the university between being able to conduct this

research or not.

Option: Congress could direct EPA-OTS to develop special procedures to minimize or eliminate the
This option would still hold public scientists accountable but would be aimed at lessening the regulatory burden if the appropriate procedure is used. Several possible

procedures exist. One possibility would be that the agency

funding the research would take the responsibility for

monitoring and reviewing the work. As part of the funding contract, the principal investigator agrees to follow

EPA guidelines on management and to contact EPA if

the need arises. This makes it possible for the funding

agency to monitor the project and enforce regulations

through the distribution of funds ( 1).

Another approach is to streamline the application for

public researchers. For example, an abstract from a grant

proposal would be sufficient to trigger important questions that arise about the project from EPA. Another

possibility would be for EPA to set aside a budget that

would reimburse universities for costs incurred in filing

an application. However, even if a cost-savings mechanism is developed. a bureaucracy-minimizing mechanism will also be necessary if Congress desires to encourage

public researchers and their home institutions to conduct

the objective research that will contribute further to our

knowledge base.

An argument can be made for including academic researchers. Obviously, genetically modified organisms released into the environment by a public researcher have

the same effect as the same organism placed into the

environment by an industry scientist. On the other hand,

concern exists about the legal precedent that could be set

by extending TSCA’s scope to noncommercial research

and that it could have a negative impact on research. An

application fee for a single field trial costs between

$180,000 and $600.000. Even the lower cost is more

than most universities or research grants are able to cover.

Even though companies have personnel and a budget to

cope with regulatory processes. universities for the most

part do not have regulatory policy offices or the budget

for filing applications. Congress could make its intent

for universities clear by stating it in legislative language

through TSCA.

ISSUE:

Option:

As large-scale planned introductions become

imminent, companies are looking to the regulatory agencies for guidance as to how to

proceed. Clear guidance is critical to commercial development of agricultural biotechnology.

Congress could direct EPA-OPP and OTS to

clarify their regulatory approaches to large-scale . .

introductions and report back to Congress within

a specified period of time.

The interagency work groups. as well as leadership

of EPA, can orient efforts toward assisting EPA staff

in clarifying the regulatory guidelines. A flexible approach, capable of evolution as additional data are

gathered seems appropriate, and individual case discussions between EPA and applicants are useful. Clarifying regulatory guidelines would be particularly helpful

to agribusiness working with "pesticidal plants” or

microorganisms other than microbial pesticides. USDAAPHIS-BBEP could provide model mechanisms for

clear communication of requirements, use of input from

outside the agency, addition of technologically trained

personnel, and creation of an effective structure as well

as clarification of direction.

Option: Congress could direct EPA to continue on its

present course.

.

This is basically a status quo option. It would mean

a continuation of the lack of clarity of regulating policy

for potential applicants at the large-scale stage. The

absence of applications to EPA-OTS for environmental

release under TSCA over the last year may illustrate

industries’ response to lack of predictability in the regulatory arena. It also undermines public confidence in

the ability of regulatory agencies to regulate biotechnology.

Option: Congress could conduct oversight hearings of

EPA and USDA reguarding regulatory policy for

large-scale release.

Oversight hearings could assist the agencies in developing policy to meet congressional intent for regulating

these products even though the regulatory agencies have

stated that current laws are sufficient for regulation of

products derived from biotechnology. This could help

clarify differences in laws written primarily for chemicals

instead of genetically modified organisms.
270 ● A New Technological Era for American Agriculture

ISSUE:

Option:

The institutions handling new technology, including biotechnology, need credibility. In

the past, far less attention was paid to this

issue; today several elements of what should

be “standard operating procedure” can be

emphasized by institutions to gain or maintain vital public trust. A balance between

maintaining public interest and ensuring industry competitiveness must be achieved.

Congress could direct EPA and USDA to emphasize: 1) increased input of public participation into their systems; 2) an open process;

3) scientifically sound procedures communicated clearly to other scientists; and 4) followup on appropriate cases.

Most systems are sounder when external input is factored

into decisions. External advisory committees, hearings, and

informal workshops are examples of mechanisms by which

Federal agencies can obtain such input. EPA-OPP, for example, cosponsored workshops on transgenic plants to gain

scientific advice as they deliberated on their approach to

so-called “pesticidal plants, ” and has used its scientific

advisory board in deliberations over the draft TSCA rule.

USDA-APHIS has held a variety of conferences and workshops, stressing public input and State officials’ input. In

fact, USDA-APHIS has made State input an integral part

of its review process; EPA could wisely adopt this approach, in OPP and OTS. Input at the State level can

provide important relevant ecological information, perhaps

equally important, it serves as a credible system of external

checks and balances on a Federal agency.

By developing scientifically sound procedures for data

needs and communicating them clearly, an agency can build

an accessible database and contribute to and benefit from

the scientific community. USDA’s Agricultural Research

Service is complementing the work of APHIS by building

a database on field tests. The draft TSCA rule refers to a

similar accumulation of data, although specific implementation processes could be made clearer. Along with ARS,

USDA-APHIS-BBEP, in particular, has highly trained staff

in relevant areas to interact with outside scientists.

Parties concerned about a new technology want to

know that potentially problematic cases are being subjected to followup. While USDA and EPA can and do

impose monitoring requirements on field tests, both agencies could benefit from selectively implementing more

extensive followup (perhaps by monitoring indicators

identified for a possible worst-case scenario) on specific

cases that might prove troublesome. This is, of course,

time consuming. This approach should be used in a manner that does not put undue burdens on straightforward

cases; but so that the public feels secure in the knowledge

that problematic cases will be tracked past the time of

introduction.

Option: Congress could require regulatory agencies to

develop explicit plans for building public confidence and report those plans to Congress.

This option would give agencies maximum flexibility.

It would allow for the evolution of regulation based on

the experience of the agency. Moreover, this approach

would allow for a true solution to be developed within

the agency as opposed to it being imposed on the agency

from outside. Reporting the plan to Congress would allow the public to express its opinion and to exert pressure

on the agency to change those parts of the plan found to

be to unacceptable. On the other hand, it is a time consuming effort for the agencies and Congress. With the

large demands on Congress, some members could be

concerned that it was not the best use of their time.

Option: If regulatory agencies fail to maintain public

confidence, new law(s) or congressional oversight could be established to satisfy the public

demand for accountability.

This option is relatively drastic and could have several

disadvantages. Managing a system from the outside invites logistical and other difficulties. Moreover, the tendency with this approach would be to “freeze” procedures

at a particular moment. This could hamstring the natural

and positive evolution of regulation, such as the gradual

extraction of generic principles from case-by-case reviews. More generally, this approach would be more in

the nature of imposed management rather than a true

solution developed within the agencies; as such its own

credibility may be weakened. However, it is an option

that could ensure accountability to the public if regulatory

agencies are incapable of doing so themselves.

CHAPTER 9 REFERENCES

1.

2.

3.

Day, Sue Markland and Sayler, Gary S., comments

on the proposed biotechnology rule under TSCA, letter to Dr. Rita Calwell, Jul. 12, 1991.

Day, Sue Markland, personal communication, July

1991.

Huttner, Susanne L., letter to Linda J. Fisher on behalf of the Executive Committee of the University of

California Systematic Biotechnology Research and

Education Program, July 18, 1991.
Part IV

Food Safety and Quality
Chapter 10

Regulatory Agencies and Their

Statutory Authority
Contents

Page

THE FOOD AND DRUG ADMINISTRATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .............. 275

Statutory Authority for FDA Regulation of Food Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275

Statutory Authority for FDA Regulation of Animal Feeds and Drugs . . . . . . . . . . . . . . . . . . . . . . . 277

Outside Input into the FDA Decision Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 277

FDA Inspection Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..............278

FDA Enforcement Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279

THE U.S. DEPARTMENT OF AGRICULTURE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...........279

Statutory Authority for USDA inspection of Meat and Poultry Products . . . . . . . . . . . . . . . . . . . . 280

FSIS Inspection Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

AMS Inspection Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282

APHIS Inspection Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

Outside Input into the USDA Decision Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

THE ENVIRONMENTAL PROTECTION AGENCY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ......283

Statutory Authority for EPA Food Safety Regulations . . . . . . . . . . . . . . . . . . . . . . . . . . . . ..........283

Outside Input into EPA Decision Process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 284

EPA Enforcement Activities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285

OTHER FEDERAL AGENCIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 285

FOOD SAFETY COORDINATION AMONG FEDERAL AGENCIES . . . . . . . . . . . . . . . . . . . . . . . . 286

INTERPRETATION OF FEDERAL FOOD SAFETY LAWS WITH RESPECT TO

PRODUCTS PRODUCED WITH BIOTECHNOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .287

FDA Regulation of Biotechnology-Derived Food Products . . . . . . . . . . . . . . . . . . . . . . . . . . .. ......287

FDA Regulation of Biotechnology-Derived Animal Drugs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 290

FSIS Regulation of Biotechnology-Derived Meat and Poultry Products . . . . . . . . . . . . . . . . . . . . . 290

EPA Tolerances for Biotechnology-Derived Pesticides . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ........290

Responsibility for Transgenic Finfish and Shellfish . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...........291

INTERNATIONAL COORDINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291

CHAPTER 10 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 291

Box

Box Page

IO-A. Federal Agencies Primarily Responsible for Food Safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 275

Tables

Table Page

10-1. FDA Staffing Levels, Selected Years . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 278

10-2. FDA Domestic Inspection Activities, Selected Years . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 279

10-3. Food Service Establishments Covered by FDA-State Cooperative Inspection

Programs, 1991 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...............279

10-4. FDA import Inspection Activities, 1984-1991 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ......280

10-5. FDA Enforcement Activities, 1988–1991 . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ................280

10-6. FDA Import Enforcement Activities, 1988–1991 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 281

10-7. USDA Residue Testing in Slaughtered Animal Tissues, 1988–1990 . . . . . . . . . . . . . . . . . . . 281

10-8. FSIS Inspection Staff, 1988-1990 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282

10-9. AMS Inspection Activities, 1988–1990 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 282

10-10. AMS Enforcement Activities, 1989 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 283

10-11. Selected State Pesticide Enforcement Activities, 1988–1990 . . . . . . . . . . . . . . . . . . . . . . . . . . . 285

IO-12. National Marine Fisheries Inspection Activities, 1981–1989 . . . . . . . . . . . . . . . . . . . . . . . . . . . 286
Chapter 10

Regulatory Agencies and Their Statutory Authority

In the United States, five Federal agencies operating

under a variety of laws have primary responsibility for

maintaining the safety of the food supply (box IO-A).

These are the Food and Drug Administration (FDA); the

U.S. Department of Agriculture (USDA Food Safety and

inspection Service; USDA Agricultural Marketing Service); the Environmental Protection Agency (EPA); and

the National Marine Fisheries Service (NMFS).

THE FOOD AND DRUG

ADMINISTRATION

The Food and Drug Administration, within the Department of Health and Human Services, is responsible

for ensuring that domestic and imported food products

sold in interstate commerce are safe, sanitary, nutritious,

wholesome, and honestly labeled. For the purpose of

oversight, food is defined as 1 ) articles used for food or

drink for man or other animals, 2) chewing gum, and 3)

articles used for components of any such article (U.S.

Code, 1982a, Title 21, Food and Drugs, sec. 321(f)).

By this definition, food includes that consumed by human

beings as well as by livestock. Because animal drugs

may leave residues in meat consumed by humans, FDA

also has regulatory authority for drugs used in livestock.

FDA’s Center for Food Safety and Applied Nutrition

(CFSAN) is responsible for conducting and supporting

human food safety research; developing and overseeing

the enforcement of food safety, quality, and labeling

requirements of the Food, Drug, and Cosmetic Act

(FDCA); coordinating and evaluating FDA and Federal/

State cooperative surveillance and compliance programs

relating to foods; and developing and disseminating food

safety and regulatory information to consumers and industry. FDA’s Center for Veterinary Medicine (CVM)

regulates animal drugs and livestock feeds marketed in

interstate commerce, and is responsible for the safety of

these veterinary products.

Statutory Authority for FDA Regulation of

Food Products

The first food safety law passed in the United States

was the Food and Drugs Act of 1906. This law contained

provisions for the seizure of adulterated foods, that is,

foods that contained added poisonous substances or other

added substances that were deleterious and that may render the food injurious to health. In 1938, this act was

substantially revised to become the Federal Food, Drug,

and Cosmetic Act (FDCA), which still authorizes FDA’s

food safety responsibilities.

Like the Food and Drug Act, the FDCA authorizes

control of adulterated foods caused by added substances,

and extends the adulteration clause to cover naturally

occurring substances (Section 402 (a) ( 1 )). FDA takes a

Box I0-A–Federal Agencies Primarily Responsible for Food Safety

Agency

Food and Drug Administration

USDA-Food Safety and inspection Service

USDA-Agricultural Marketing

Service

Environmental Protection

Agency

National Marine Fisheries

Service (also FDA, PHS)

Principal statutory authority

Federal Food, Drug, and Cosmetic

Act

Federal Meat Inspection Act and the

Federal Poultry Products inspection Act

Egg Products Inspection Act

Federal Insecticide, Fungicide,

Rodenticide Act

Federal Food, Drug, and Cosmetic

Act

Agricultural Marketing Act

SOURCE: Office of Technology Assessment, 1992.

Responsibilities

Safety/quality/effectiveness of animal

feeds and drugs, and all foods

except meat and poultry.

Safety/wholesomess/accurate

labeling of meat and poultry

products

Safety/quality of egg products and

shell eggs.

Safety of Pesticide products

Pesticide residue tolerance in food

feeds.

Voluntary Seafood Inspection

-275-
276 ● A New Technological Era for American Agriculture

broad view of what is considered added, and this view

has been upheld in several court cases. Any substance

that is not an inherent natural component of food may

be treated as an added substance, including but not limited to, those of environmental or industrial origin that

become components of food (e.g., mercury in fish). Consequently, pollutants from the air, pesticide residues, and

minerals from fertilizers, for example, all fall within the

scope of added substances (9).

The distinction between an added substance and a natural substance is substantial because added substances

are held to a higher safety standard. The FDA can request

that legal action be taken against inherent natural components of food if that substance would ordinarily render

the food injurious to health. For added substances, if the

FDA can establish that a substance may render the food

injurious to health, the food is adulterated under FDCA.

Under this standard, FDA must show only that there is

a reasonable possibility that the food will be harmful if

consumed. The FDA rarely applies the standards for natural components except for obvious cases such as crops

that produce cyanide when improperly processed (e.g.,

cassava, lima beans, etc.). Other sections of the FDCA

(406 for example) authorize FDA to establish tolerances

for added substances when their presence in food cannot

be avoided or if their use is necessary to produce the

food (9).

The FDA is responsible for demonstrating that a food

is adulterated. As originally enacted, the FDCA provided

no authorization for the premarket evaluation of added

substances. FDA could only challenge a food ingredient

after it was marketed. However, rising concern over the

addition of chemical additives to foods prompted Congress to enact the Food Additives Amendment in 1958.

This FDCA amendment broadens the definition of adulterated foods to include those foods that contain any food

additive not specifically approved by the FDA (Section

402(a)(2)(c)). Approval is granted in the form of a regulation, which shifts the burden of proof for the safety

of these additives to the food industry (7, 8, 9). This

amendment defines a food additive as:

A substance, the intended use of which results or may

reasonably be expected to result, directly or indirectly in

its becoming a component or otherwise affecting the characteristics of any food (including any substance intended

for use in producing, manufacturing, packing, processing,

preparing, treating, packaging, transporting, or holding

food; and including any source of radiation intended for

any such use), if such substance is not generally recognized, among experts qualified by scientific training and

experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the

case of a substance used in food prior to January 1. 1958,

through either scientific procedures or experience based

on common use in food) to be safe under the conditions

of its intended use. [U.S. Code 1982c, Title 21, Food and

Drugs, Sec. 321(s). ]

The FDCA also covers the regulation of pesticides,

color additivesl

, and new animal drugs. Additionally,

substances used in accordance with a sanction of approval

granted prior to September 6, 1958 under FDCA, the

Federal Poultry Products Inspection Act and/or the Federal Meat Inspection Act (i. e., the prior sanctioned substances) are not included in the definition.

To avoid placing unnecessary restrictions on the development of new food additives or forcing the evaluation

of food additives already safely used, Congress provided

for some exceptions to the food additive amendment.

One clause, for example, allowed the continued use of

a substance that is generally recognized as safe (GRAS)

by qualified experts for its proposed use in food (U.S.

Code 1982c, Title 21, Food and Drugs, Sec.321 (s)) (9).

GRAS food ingredients are those generally considered

safe by qualified experts based on either 1 ) a safe history

of use in food prior to 1958 or 2) scientific information

(U.S. Code 1982c, Title 21, Food and Drugs, Sec.321(s)).

A safe history of use generally involves substances of

natural biological origin widely consumed for their nutrient properties prior to January 1, 1958, are subject

only to conventional processing as practiced prior to 1958,

and exhibit no known safety hazard (FDA 1986b, Title

21, Food and Drugs, Sec.346), To be granted GRAS

status based on scientific information requires expert

knowledge backed by “substantial support in the scientific literature’ (Weinberger v Bentex Pharmaceuticals

1973, U.S. Reports 412,645) (9).

The same quantity and quality of scientific evidence

is required to obtain regulatory approval of a food additive or a GRAS substance. The information critical to

affirming a substance as GRAS must be widely available

and generally published. The validity of the published

literature must also be agreed to by those qualified to

judge food safety issues. Disputes by qualified experts

I Color addi[ivesme ma[efialstha[ ~edyes, plgrnen[s, orothersubstances chemically synthesized orextracted, isolated, or otherwise derived

with or without change from vegetable, animal, mineral, orothersources that arecapableof imparting color (including black, white, and gray) to

food, drugs, cosmetics, or the human body. Color additives must receive premarket approval or be GRAS.
Chapter 10—Regulatoy Agencies and Their Statutory Authoriy~ ● 277

could prevent the granting of GRAS status. Thus, obtaining affirmation of GRAS status can be more difficult

than obtaining regulatory approval as a food additive (21

CFR 170.30).

The FDCA requires premarket approval only of food

and color additives. By a strict interpretation of the food

additive amendment, any substance that becomes a component of food, or affects the characteristics of food,

may be regulated a food additive. This implies that the

development of new crop varieties could be classified as

food additives. FDA has rarely enforced this strict interpretation, however. New crop varieties have generally

been viewed as not being so significantly different from

crops consumed prior to 1958 to warrant formal review

of the GRAS status. However, FDA can review the GRAS

status of substances of natural biological origin that have

undergone significant changes as a result of breeding and

selection or a new process introduced into commercial

use after 1958 (FDA 1986c, Code of Federal Regulations, Title 2 1,Food and Drugs, Sec. 170.30(f))(9). A significant increase in the use of a particular food ingredient,

a change in the composition of the food ingredient, or a

change in the manufacturing method could trigger a loss

of the GRAS status based on the common use in food

criteria. Substances altered such that they are no longer

generally recognized as safe are regulated as food additives (9, 14). FDA can review food products derived

from a new variety of food crop prior to marketing if

that crop is known to contain toxins that have the potential

to be acutely toxic if in high enough concentration.

In addition to the authority to regulate adulterated foods,

FDCA also confers on FDA authority to remove misbranded foods from the market. Food products are considered misbranded if, among other things:

. the labels are false or misleading,

. if they are offered for sale under the name of another

food,

. if they are an imitation of another food and the label

does not clearly state so,

. if the container fill is misleading, and

. if label information required by law is not present.

Statutory Authority for FDA Regulation of

Animal Feeds and Drugs

The Center for Veterinary Medicine (CVM) carries

out FDA’s Animal Drugs and Feeds Program. CVM is

responsible for ensuring that drugs administered to, and

feeds eaten by, animals are safe and effective for the

animal, are properly labeled, and produce no human health

hazards when used in food-producing animals. For the

purpose of regulation, an animal drug is defined in part

as ‘‘articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals’

(21 U.S.C. section 321(g)). Animal feeds are considered

to be articles used as food for animals or intended to

provide a substantial source of nutrients for animals (21

U.S.C. section 321(x)). CVM is responsible for monitoring animal drug sales and distribution as well as good

manufacturing practices (i. e., compounding, formulation, and production and manufacturing) associated with

animal drugs and medicated feed production. FDA estimates that about 80 percent of the livestock and poultry

in the United States is treated with some animal drug or

medicated feed. FDA’s automated animal drug data system contains information on over 12,000 animal drug

products ( 18).

The FDCA provides the statutory authority for FDA

regulation of animal feeds and veterinary drugs, and its

provisions are the same as those for human foods: Thus,

FDA must provide premarket approval for new animal

drugs and for new additives (e.g., medications) that may

be included in livestock feed; pesticide tolerance levels

are set by EPA for livestock feeds, as they are for human

foods; pesticide and drug residue levels are established

for meat products that might be consumed by humans.

GRAS status can also be granted for livestock feed

additives. Similar to human food additives, livestock feed

additives can attain GRAS status if they have a substantial

history of safe consumption by a significant number of

animals in the United States or by scientific consensus.

Adulterated or misbranded products can be removed from

the market using the same criteria that apply to human

foods (21 CFR 570.3 (f)).

Outside Input Into the FDA Decision

Process

The FDA uses notice and comment procedures for

decisions concerning food additives and advisory committees for decisions concerning human drugs. Any person may petition FDA to establish a food additive regulation

to approve the use of a food additive (21 U.S.C. 409(b)(l)).

If a regulation is required, a notice of that decision is

published in the Federal Register. Following publication

of a final rule, any person who might be adversely affected by the proposed decision has 30 days to request

a hearing. FDA is not required to publish receipt of a

new animal drug application.
Public participation in new drug approvals comes primarily from the use of advisory committees. FDA currently has 38 standing advisory committees of which

almost all are concerned with human drugs and medical

devices. There is one veterinary drug advisory committee. FDA uses advisory committees to provide expert

opinion, and as such the voting members of the committees are usually technical experts. Some committees

have nonvoting industry and public representatives. FDA

generally does not use advisory committees for food additive petitions, but does seek input from scientific organizations such as the National Academy of Science

and the Federation of American Societies for Experimental Biology (2, 10, 16).

FDA Inspection Activities

All FDA inspection and enforcement activities are carried out by the Office of Regulatory Affairs (ORA). The

ORA is headquartered in Rockville, MD and has field

offices in 49 States and Puerto Rico. Six regional offices

coordinate the activities of all of the various FDA offices

and coordinate FDA activities with those of State authorities. Facilities to test products for safety, quality,

and conformance with labels are provided by 21 district

offices and 18 district laboratories. The Office of Regulatory affairs also conducts research necessary to evaluate health hazards and to develop detection methodologies.

Additionally, there are 136 resident posts staffed with

inspection personnel ( 18).

FDA considers its food safety responsibilities as being

primarily preventive rather than corrective. Its resources

are inadequate to continuously monitor every sector of

the food industry (table 10- 1). Therefore, FDA tries to

ensure that safety is “built into” products rather than to

continuously monitor for safety after the products are

produced. However, FDA’s ability to carry out its responsibilities is being strained by the lack of resources.

While the workload increased during the 1980s, FDA

had nearly 8 percent fewer staff and 8 percent less funding

in 1989 than in 1980 ( 17).

FDA’s food inspection procedures focus primarily on

inspecting food establishments for sanitation, ingredient

labeling, nutrition labeling, good manufacturing practices. low-acid canned foods, acidified foods, and food

standards, although follow-up monitoring of some marketed food products is conducted (primarily for microbial

contamination and chemical residues).

The number of food establishments in the United States

is enormous-at least 636,000 in 1991. About 53,000 are

subject to FDA inspection in that they produce products

sold in interstate commerce or products made in whole or

in part from ingredients shipped in interstate commerce.

The States regulate firms that produce food products that

contain no ingredients shipped in interstate commerce and

are to be sold only within that State. The States also have

primary inspection responsibility in some food and drug

areas such as milk, shellfish, retail food stores, and food

service establishments (restaurants). To help carry out its

regulatory responsibilities, FDA cooperates with State

agencies to cover all food establishments.

FDA can contract State programs to inspect firms within

its responsibility. In fiscal year 1989, FDA had 113 contracts in 45 States and Puerto Rico at a cost of approximately

$5.3 million. FDA and contracted State agencies inspected

nearly 17,000 food establishments and analyzed over 20,000

laboratory samples in 1991 (table 10-2) ( 18).

For those food establishments under direct control by

State agencies, FDA has established cooperative agreements. These agreements are valued at approximately

$175 million, involve over 400 different State agencies,

and cover millions of sites where food is sold or processed

(table 10-3) ( 18).

Table 10-1—FDA Staffing Levels, Selected Years

Staffing 1980’ 1985a 1988a 1989a 1990 1991 1992

CFSAN . . . . . . . . . . . . . . . . . . 976 859 826 817 821 b

884b

895b

CVM . . . . . . . . . . . . . . . . . . . . 238 253 244 244 278’ 282C

284C

ORA

Headquarters . . . . . . . . . . . 94 106 112 114 NA NA NA

Field offices . . . . . . . . . . . . 1,222 1,118 1,151 1,162 NA NA NA

NOTE: Not all of CFSAN and CVM personnel are directly involved in food safety and quality activities.

KEY: CFSAN = Center for Food Safety and Applied Nutrition; CVM = Center for Veterinary Medicine: FDA = Food and Drug Administration; ORA =-

Office of Regulatory Affairs; NA = Not applicable.

SOURCES: aU.S. Congress, General Accounting Office, “Food Safety and Quality: Who Does What in the Federal Government,” RCED-91-19B, December,

1990.

b

The Center for Food Safety and Applied Nutrition, Food and Drug Administration

c

The Center for Veterinary Medicine, Food and Drug Administration
Chapter 10—Regulatpru Agencies and Their Statutory Authority . 279

Table 1O-2—FDA Domestic Inspection Activities,

Selected Years

Number of Inspections

State Samples

Year FDA contract analyzed

1980a . . . . . . . . . 16,243 NA 16,440

1985a . . . . . . . . . 12,463 11,943 23,010

1988a ., . . . . . . . 8,232 7,152 19,965

1989a . . . . . . . . . 7,568 7,766 20,098

1990 b ... , ., . . 7,054 7,031 20,849

1991b . . . . . . . . . 9,195 7,633 20,780

NA - Not available

SOURCES: aU.S. Congress, General Accounting Off Ice. “Food Safety and

Quality: Who Does What in the Federal Government,” RCED91-19B, December 1990.

b

Food and Drug Administration, Office of Leglislative Affairs

In addition to cooperative agreements and State contracts, the FDA commission program provides authority to

367 State and local officials to assist the FDA in enforcing

the Federal Food, Drug, and Cosmetic Act. This program

uses State and local officials to perform specifically designated functions that are subject to Federal jurisdiction,

such as conducting examinations. inspections, and investigations. The purpose of this program is to provide State

officials with the authority to conduct inspections, review

and copy records, and collect samples in FDA regulated

establishments: in some States there is no other statutory

authority for such inspections ( 18).

FDCA contains little specific preemption language regarding Federal versus State regulatory requirements. Thus,

FDA is not in a position to oversee and approve State

programs and employees. FDA does provide guidance

and training to State agencies, evaluates State programs

using national standards, and rates State officials for their

Table 10-3—Food Service Establishments

Covered by FDA-State Cooperative Inspection

Programs, 1991

Food service establishments . . . . . . . . . . . . . . . . . . . 636,000

Retail food stores . . . . . . . . . . . . . . . . . . . . . . . . . . . 150,000

Food vending locations . . . . . . . . . . . . . . . . . . . . . . . 1,090,000

Grade A milk farms . . . . . . . . . . . . . . . . . . . . 126,000

Milk pasteurization plants . . . . . . . . . . . . . . . . . . . . . . 724

Shellfish processors . . . . . . . . . . . . . . . . . . . . . . . . . 770

Shellfish shippers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 750

Shellfish growing areas . . . . . . . . . . . . . . . . . . . . . . . 3,000

SOURCE. Off Ice of Legislative Affairs, Food and Drug Administration

competency, familiarity with, and uniformity in applying

national standards within individual States ( 18).

In addition to its domestic responsibilities, FDA is

mandated to ensure that imported products meet the same

safety and labeling standards as domestically produced

products. Field office personnel inspect imported food

products at ports of entry and warehouses. Paperwork

accompanying products subject to FDA regulation are

reviewed to determine whether physical inspection is

warranted. A physical inspection is conducted on those

products suspected of being adulterated, misbranded. or

otherwise in violation of the FDCA. The physical inspection ranges from a quick, visual examination of products at a wharf to sample collection and laboratory analysis

(table 10-4) ( 18).

FDA Enforcement Activities

The FDA can issue written warnings to violators, request voluntary recall of violative food products. initiate

seizures of violative food products, seek court-ordered

injunctions, and seek criminal prosecutions. Warning

letters2 are issued by FDA only for violations of regulatory significance. Warning letters do not commit FDA

to take an enforcement action if action is not taken to

promptly correct violations. However, warning letters do

contain specific notice that failure to promptly correct

violations may result in enforcement action. The letters

usually allow the company 15 working days to respond

(table IO-5).

Imported products that fail to meet requirements must

be exported, destroyed, reconditioned. or relabeled to

bring them into compliance with Federal laws and regulations (table IO-6).

THE U.S. DEPARTMENT OF

AGRICULTURE

The U.S. Department of Agriculture (USDA) is responsible for implementing a comprehensive system of

inspection that ensures that meat, poultry, meat and poultry products, and selected eggs and egg products moving

in interstate and foreign commerce are safe, wholesome,

and correctly labeled and packaged. The USDA Food

Safety and inspection Service (FSIS) is responsible for

the safety, wholesomeness, and accurate labeling of meat
280 ● A New Technological Era for American Agriculture

Table 1O-4—FDA Import Inspection Activities,

1984-1991

Wharf Samples

Year examinations examined

1984a 

. . . . . . . . . . . . . . .

1985a 

. . . . . . . . . . . . . . .

1986a 

. . . . . . . . . . . . . . .

1987a 

. . . . . . . . . . . . . . .

1988a 

. . . . . . . . . . . . . . .

1989a 

. . . . . . . . . . . . . . .

1990b 

. . . . . . . . . . . . . . .

1991b 

. . . . . . . . . . . . . . .

26,200

28,800

35,650

33,040

38,760

63,006

39,112

43,769

19,150

20,600

26,350

29,890

32,590

37,570

37,163

38,042

SOURCE: aU.S, Congress, General Accounting Office, ’’Food Safety and

Quality: Who Does What in the Federal Government,” RCED91-19B, December 1990.

bFood and Drug Administration, Office of Legislative Affairs.

and poultry products, and the Agricultural Marketing

Service (AMS) is responsible for the safety of egg products.

Statutory Authority for USDA Inspection of

Meat and Poultry Products

Statutory authority for meat and poultry product inspection is provided by the Federal Meat Inspection Act

of 1906 (PL 59-242) as amended by the Wholesome Meat

Act of 1967 (21 U.S.C. 601 et seq) and the Federal

Poultry Products Inspection Act of 1957 (PL 85-175) as

amended by the Wholesome Poultry Products Act of

1968 (21 U.S.C. 451 et seq).

For the purpose of regulation, meat food products are

defined in part as

Any product capable of use as human food which is

made wholly or in part from any meat or other portion of

the carcass of any cattle. sheep, swine. or goats, excepting

products which contain meat or other portions of such

carcasses only in relatively small proportion or historically

have not been considered by consumers as products of the

meat food industry and which arc exempted from definition.

The term meat products applied to food products of horses,

mules, and other equines shall have a comparable meaning to that provided for cattle, sheep, swine, and goats

(Section l(j)). Poultry is defined (Section 4(f)) as

A domesticated bird whether Iive or dead, and poultry

product means any poultry carcass or part thereof. or any

product which is made wholly or in part from any poultry

carcass or part thereof, excepting products which contain

poultry ingredients only in relatively small proportion or

historically have not been considered by consumers as

products of the poultry food industry.

FSIS is responsible for the inspection of meat and poultry

products. FDA is responsible for premarket approval of

any food and color additives added to meat and poultry

products, and for products that contain meat but that are

not traditionally considered to be meat products (e. g.,

sandwiches with meat in the filling).

The Federal Meat Inspection Act and the Federal Poultry Inspection Act allow USDA to remove adulterated or

misbranded products from the market. Adulterated meat

and poultry products are those that contain poisonous or

deleterious substances that may render the product injurious to health. In cases where such substances are

natural, the product is not considered adulterated if the

quantity of poisonous or deleterious substances in or on

the product does not ordinarily render it injurious to health.

For added substances, meat and poultry products are also

Table 1O-5—FDA Enforcement Activities, 1988-1991

Regulatory letters Recalls

Food and Animal drugs Food and Animal drugs

Fiscal year cosmetics and feeds cosmetics and feeds

1988 ., . . . . . . . . . . . . . . . . . . . . . . . 36 169 470 54

1989 . . . . . . . . . . . . . . . . . . . . . . . . . 13 93 570 89

1990 ., . . . . . . . . . . . . . . . . . . . . . . . 24 166 725 62

1991 . . . . . . . . . . . . . . . . . . . . . . . . . 122 123 566 91

Seizures Injunctions Prosecutions

Animal Animal Animal

Food and drugs Food and drugs Food and drugs

Fiscal year cosmetics and feeds cosmetics and feeds cosmetics and feeds

1988 . . . . . . . . . . . . . , . . . . . . . . . . . 121 17 6 2 13 5

1989 . . . . . . . . . . . . . . . . . . . . . . . . . 88 9 3 6 5 3

1990 , . . . . . . . . . . . . . . . . . . . . . . . . 78 9 4 3 5 3

1991 . . . . . . . . . . . . . . . . . . . . . . . . . 66 4 5 2 2 3

SOURCE: Food and Drug Administration, Off Ice of legislative Affairs.
Chapter 10—Regulatoy Agencies and Their Statutory Authority . 281

Table 1O-6—FDA Import Enforcement Activities,

1988-1991

Table 1O-7—USDA Residue Testing in Slaughtered

Animal Tissues, 1988-1990

Import samples

analyzed Adverse findingsa

Animal Animal

Fiscal Food and drugs Food and drugs

year cosmetics and feeds cosmetics and feeds

1988 . . . . . . . 32,801 251 11,648 88

1989 . . . . . . . 37,936 189 14,294 73

1990 . . . . . . . 37,678 197 15,080 35

1991 . . . . . . . 38,147 148 13,487 38

aThe number of analyzed samples that failed to meet established standards

and policy guides, or would for other reasons support a regulatory action.

SOURCE: Food and Drug Administration, Office of Regulatory Affairs.

considered adulterated if they contain substances deemed

unsafe by the appropriate meanings defined in the Food,

Drug and Cosmetic Act (i.e., section 408 for pesticidal

chemicals, section 409 for food additives, and section

706 for color additives).

Meat and poultry products are considered misbranded

if among other things, the labels are false or misleading,

if they are offered for sale under the name of another

food, if they are an imitation of another food and the

label does not clearly state so, if the container fill is

misleading, and if label information required by law is

not present.

FSIS Inspection Activities

Plans for meat and poultry plant facilities, equipment,

and procedures must be approved by FSIS prior to operation or use to ensure that such operations will be

sanitary. The floor plan, water supply, waste disposal

systems, and lighting for each plant must be approved.

Facilities and equipment must be easy to clean. In 1989,

FSIS reviewed 3,851 blueprints of meat and poultry plants

and 2,864 drawings of equipment. Once in operation,

facilities and equipment are monitored for sanitation.

Inspectors monitor operations in meat processing plants,

and processing procedures and product formulations are

reviewed to ensure that the products will be safe. Labels

are checked for truthfulness and conformance with labeling laws and regulations (18).

All cattle, sheep, swine, goats, horses, mules, and

other equines slaughtered for use as food must be inspected prior to slaughter at the slaughtering plant. Their

carcasses also are examined after slaughter. Slaughtering

cannot take place without the presence of an inspector,

Veterinarians check the live animals for symptoms of

disease or other abnormal conditions. After slaughter,

inspectors under the supervision of veterinarians, exSample type 1988 1989 1990(est)

Food chemistry . . . . . . . . . . .

Food microbiology . . . . . . . .

Chemical residues . . . . . . . .

Antibiotic residues . . . . . . . . .

Pathology . . . . . . . . . . . . . . . .

Serology . . . . . . . . . . . . . . . . .

Additives in nonfoods . . . . . .

Radiation . . . . . . . . . . . . . . . .

TOTAL . . . . . . . . . . . . . . . . . .

70,021

37,410

102,714

223,210

11,160

3,928

12,007

3,184

463,634

62,435

36,908

185,163

255,851

11,017

1,630

10,907

139

564,050

62,000

37,000

185,000

256,000

11,000

1,600

10,900

563,500

SOURCE: General Accounting Office, compiled from the Food Safety and

Inspection Service,

amine each carcass and internal organs for symptoms of

disease or contamination that would make all, or part,

of the meat unfit for human consumption. Animal tissues

may also be analyzed for drug and chemical residues to

ensure that they meet tolerances as established by FDA

(animal drugs) or EPA (pesticides) (table 10-7).

FSIS interprets its inspection mandate to apply to species and not breeds. The offspring of two breeds of the

same species, such as Hereford and Angus beef cattle,

would be classified as beef and amenable to inspection.

The hybrid offspring of two different species, however,

may or may not be inspected depending on which parent

the offspring physically resembles. For example, the offspring that results from crossing a cow and a buffalo will

be amenable if it resembles the cow, but not amenable,

and therefore not subject to mandatory inspection, if its

physical appearance is that of a buffalo ( 15). The slaughter of experimental animals at official establishments is

not allowed unless certain conditions are met. These conditions include statements from FDA, EPA, or the Animal and Plant Health Inspetion Service (USDA-APHIS)

that experimental drugs, chemicals, or biological have

been used in accordance with regulations and are below

tolerances (9 CFR 309.17 and 381 .75).

FSIS is developing methods to streamline inspection

activities based on hazard assessment and using statistical

sampling methods, a system known as the Hazard Analysis Critical Control Point (HACCP). The agency currently is conducting a study to determine the most effective

way to implement the HACCP system into meat and

poultry inspection, and is working with industry to develop model HACCP plans and is soliciting volunteer

plant participation to develop the pilot program. Workshops have been or will be held for application of HACCP

to minimally processed foods that are refrigerated, cooked

sausage, fresh ground beef, young chicken slaughter, and

market hog slaughter.

297-937 0 - 92 - 10 QL 3
282 . A New Technological Era for American Agriculture

Table 1O-8—FSIS Inspection Staff, 1988-1990 Table 1O-9—AMS Inspection Activities, 1988-1990

Staff years

1990

Program area 1988 1989 (est)

Slaughter inspection . . . . . . . . 6,969 7,004 7,042

Processing inspection . . . . . . . 2,847 2,791 2,805

Import-export inspection . . . . . 230 231 232

Laboratory services . . . . . . . . . 384 373 376

TOTAL . . . . . . . . . . . . . . . . . . . . 10,430 10,399 10,455

SOURCE: General Accounting Office, compiled from the Food Safety and

Inspection Service.

FSIS also inspects imported meat and poultry products

to ensure that they meet the same standards as domestic

products. Countries wishing to export to the United States

must impose inspection requirements at least equal to

those enforced in the United States. FSIS evaluates the

inspection programs of these countries to determine eligibility and reviews the way the systems are operated.

As of the end of 1989, 1,431 plants in 34 countries were

certified to export meat and poultry products to the United

States. FSIS also reinspects imported meat and poultry

products, on a sample basis, when they enter the United

States.

FSIS is responsible for inspecting and monitoring about

6,720 meat and poultry plants throughout the United

States, and 220 official import establishments. FSIS employs approximately 7,800 Federal inspectors of which

6,050 are food inspectors, 180 are food technologists,

and 1,050 are veterinarians (table 10-8). Between 1980

and 1989 funding declined by 3 percent (in constant 1989

dollars) and staff years declined by 6 percent. However,

during this same time period, inspection activities increased considerably. Pounds of processed poultry inspected increased by 134 percent, pounds of slaughtered

poultry inspected increased by 52 percent, and samples

analyzed increased by 182 percent. Compliance reviews

also increased by 45 percent ( 18).

FSIS monitors State programs for inspecting meat and

poultry products that will be sold only in the State in

which they are produced. State programs are required to

beat least equal in rigor to Federal programs. About half

of the States conduct their own meat and poultry inspections and about 5,700 plants are inspected by State

programs. FSIS is authorized to reimburse these programs for up to 50 percent of the inspection costs. FSIS

provided about $36.5 million in grants to 28 States in

1989. If States abolish their inspection programs, FSIS

is required to assume inspection responsibility (18).

1990

Activity 1988 1989 (est)

Egg products inspected

(billion lb) . . . . . . . . . . . . . 1.7 1.6 1.6

Egg product plants . . . . . . . 86 83 86

Egg handler surveillance

visits . . . . . . . . . . . . . . . . . 9,723 8,769 8,200

Lab samples analyzed

Food chemistry/

microbiology . . . . . . . . . . 46,481 40,969 42,000

Chemical residues . . . . . 384 517 500

SOURCE: General Accounting Office, compiled from the Agricultural Marketing Service.

AMS Inspection Activities

Agricultural Marketing Service (AMS) activities are

primarily related to food quality rather than food safety

issues. AMS establishes standards of quality and grades

for dairy, egg, fruit, poultry, and vegetable products (see

ch. 14). Food safety responsibilities are in the area of

egg products and shell egg surveillance programs. Statutory authority is granted by the Egg Products Inspection

Act as amended (21 U.S.C. 1031 et seq).

The Egg Products Inspection Act requires continual

USDA inspection of all egg products processing plants.

For the purpose of regulation, egg products are defined

as liquid, frozen, and dried egg products. Further processed products, such as noodles and custards, which

contain egg products but have not been considered as

products of the egg food industry, are not subject to

inspection by USDA (but are subject to FDA authority).

Facilities, equipment, and methods of processing are inspected for cleanliness and the ability to perform intended

functions. Inspections include visual evaluations and laboratory tests. Egg products can be analyzed for microbial

and chemical residues and other contaminants (table 10-

9) ( 18).

The Egg Products Inspection Act also requires mandatory quarterly inspections of shell egg handlers who

pack eggs for consumer sales, and restricts certain types

of shell eggs from moving into consumer channels. Restricted eggs include checked eggs (those with cracked

shells that are not leaking); dirty eggs (which may be

sent only to official USDA inspected processing plants

for proper handling and processing); incubator rejects

(infertile or unmatchable eggs); leakers (cracked eggs with

contents leaking); and inedible and loss eggs (unfit for

human consumption). Inedible eggs and egg products
Chapter 10—Regulatoy Agencies and Their Statutory Authority .283

Table 1O-10—AMS Enforcement Activities, 1989

Penalty Cases closed

Letter of information . . . . . . . . . . . . . . . . . . . . . . . 197

Letter of warning . . . . . . . . . . . . . . . . . . . . . . . . . . 86

Closed without penalty . . . . . . . . . . . . . . . . . . . . . 21

Criminal prosecution . . . . . . . . . . . . . . . . . . . . . . . 1

SOURCE: General Accounting Off Ice, complied from the Agricultural Marketing Service.

must be denatured and destroyed or otherwise handled

to preclude their use as human food.

AMS has cooperative agreements with all 50 States,

Puerto Rico, and the Virgin Islands. AMS uses State

inspection personnel to make unannounced quarterly shell

egg surveillance visits to shell egg-packing establishments. AMS provides Federal oversight for State programs, and reimburses States for performing surveillance

inspection work. In 1989, approximately 1,500 shell eggpacking plants and 500 hatcheries were subject to, and

received, quarterly inspections by USDA or cooperating

State agencies ( 18).

Egg products may be imported only from countries

with egg products inspection systems that meet the standards of the U.S. system. As of September, 1989 only

Canada and the Netherlands met this requirement. AMS

monitors incoming products and routinely tests products

for Salmonella and various environmental contaminants.

Shell eggs are imported for use in producing egg products

and are processed under continual inspection. Table 10-

10 summarizes AMS enforcement activities for 1989.

APHIS Inspection Activities

The Animal Plant Health Inspection Service (APHIS)

has few legal responsibilities to protect or promote food

safety and quality unless the organisms or chemicals of

concern to public health are also of concern to animal or

plant health. Programs designed to protect the animal

industry against pathogens or diseases that can also pose

foodborne risks to humans improves food safety. In 1990,

for example, APHIS instituted an emergency program to

combat Salmonella enteritidis in poultry. APHIS tests

and monitors all egg type breeding and multiplier flocks

as well as controls the interstate movement of poultry,

eggs, and material from known culture positive flocks

and exposed flocks. APHIS also conducts programs to

prevent communicable disease of foreign origin from

entering the United States, diagnoses foreign animal

diseases should they enter the country, and prevents the

spread of disease through interstate shipments of livestock.

APHIS also regulates animal biologics under the VirusSerum-Toxin Act (21 U.S.C. 15 I-158) A veterinary biologic is any natural or synthetic virus, serum, toxin, or

microorganism intended for use in the diagnosis, treatment, or prevention of animal diseases. USDA and FDA

have a standing committee to determine whether a new

animal product is a drug or a biologic. Under FDCA (21

U.S. C. 351 -360b, 1982) FDA has jurisdiction to regulate

new animal drugs that are not biologics.

Outside Input Into the USDA Decision

Process

Statutory authority for USDA food safety regulatory

activities does not require public notification and comment, except for new food additives used in meat and

poultry products that are subject to notice and comment

procedures with FDA. USDA (most notably APHIS) has

undertaken a voluntary notification program for the environmental release of genetically modified organisms.

USDA does use advisory committees to provide outside

expertise to aid their regulatory decisions ( 16).

THE ENVIRONMENTAL

PROTECTION AGENCY

The Environmental Protection Agency (EPA) is responsible for regulating all pesticide products sold or

distributed in the United States. For the purpose of regulation, EPA defines a pesticide as any substance or

mixture of substances intended for preventing, destroying, repelling, or mitigating any pest, and any substance

or mixture of substances intended for use as a plant regulator. defoliant, or desiccant. A pest is defined as 1 )

any insect, rodent, nematode, fungus, weed, or 2) any

other form of terrestrial or aquatic plant or animal life

or virus, bacteria, or other microorganism (except viruses, bacteria, or other microorganisms on or in living

man or other living animals) that the administrator declares a pest (7 U.S. C. 136(2)(t)).

Statutory Authority for EPA Food Safety

Regulations

Statutory authority for the regulation of pesticides are

provided by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) of 1947 (7 U.S.C. 136 et seq),

and the Federal Food, Drug, and Cosmetic Act (21 U.S.C.

301 et seq).
284 . A New Technological Era for American Agriculture

Under FIFRA, EPA registers new pesticide products,

reregister existing pesticides, specifies the terms and

conditions of their use, and removes hazardous pesticides

from the market. (See ch. 7.) Under FIFRA, EPA can

register a pesticide only if it determines that the pesticide,

when used according to directions, will perform its intended function without causing any unreasonable risk

to humans or the environment, taking into account the

economic, social, and environmental costs and benefits

of the pesticide’s use.

Under FDCA, EPA has responsibility for determining

the safety of pesticide residues in or on food for humans,

or feed for domestic food animals. Before a pesticide

can be registered for use on a food or feed crop, a tolerance, or an exemption from the requirement of a tolerance, must be established. A tolerance is the maximum

level of pesticide residues that can be present in or on

raw agricultural commodities, food, or feed transported

in interstate commerce. Tolerances, or exemptions from

the requirement of a tolerance, must be established for

each active and inert ingredient contained in the pesticide, and for each raw commodity, processed commodity, and livestock species that might contain residues of

the pesticide.

Any person applying for a pesticide registration may

file a tolerance petition. Appropriate data must be submitted so that EPA can define a safe and realistic tolerance level, or grant the exemption. These data include

information on the pesticide’s toxicity (potential to cause

adverse health effects), the residues that may remain in

or on food or feed, and an analytical method that can

detect the chemical and any metabolizes of concern in

the commodity ( 19).

In addition, EPA has discretionary authority to establish tolerances and exemptions on its own initiative or

in response to a request of any interested person. EPA

can set a tolerance, grant an exemption from tolerances,

or amend a current tolerance if the current pesticide registration is changed. At the request of FDA or USDA,

EPA also recommends enforcement levels (action levels)

for residues that may occur in food and feeds resulting

from other than direct application of the pesticide to the

crop. For example, a pesticide may persist in the environment even after a pesticide registration has been

canceled.

Section 408 of the Federal Food, Drug, and Cosmetic

Act (FDCA) provides the authority to establish tolerances

for raw agricultural commodities, and section 409 provides the authority for processed products. Section 408

was first passed in 1954, and section 409 was passed 4

years later. Initially, tolerances for pesticide residues were

established by the Food and Drug Administration, but

with the creation of the Environmental Protection Agency

in 1970, these pesticide regulatory responsibilities were

transferred to the EPA.

Raw agricultural commodities are considered to be

fresh fruits, vegetables, grains, nuts, eggs, raw milk, and

meats. The term excludes foods that have been processed, fabricated, or manufactured by cooking, freezing, dehydration, or milling among other processes (40

CFR 180. l(e)). When establishing pesticide residue tolerances on raw agricultural commodities, EPA must not

only consider the safety of the product, but also the

necessity of the pesticide to produce an adequate, wholesome, and economical food supply; other ways that the

consumer may be affected by the pesticide; and the usefulness of the pesticide. Under FDCA, raw agricultural

commodities that contain pesticide levels above established tolerance levels are considered adulterated (21

U.S.C. 346a (a)(b)).

The tolerance established for the raw commodity also

applies to the processed food product if the pesticide

residue level in the processed product is less than that

tolerance level. If, however, the processing concentrates

the pesticide residue such that levels contained in the

processed food exceed the established tolerance for that

pesticide in raw commodities, then a separate tolerance

must be established for the pesticide in the processed

food. The tolerance that then must be established for the

processed food is considered a food additive under FDCA.

Food additive petitions do not include an assessment of

the benefits that may result from the pesticide, The Delaney Clause of the food additive amendment prohibits

the use of carcinogenic food additives.

Outside Input Into EPA Decision Process

Under FIFRA, EPA is required to publish notice of

the receipt of a pesticide registration application or of

any Experimental Use Permit (EUP) that is of regional

or national significance. EUP’s are required before pesticides can undergo field trials. Trials involving less than

10 acres of land or 1 surface acre of water, and for which

the crop is destroyed or used only for research (i.e., it

is not used for food or feed) are generally not required

to file an EUP, however. Notifications are published in

the Federal Register and the public has 30 days to provide

written comments. EPA also publishes the issuance of

pesticide registrations and EUP’s. If public comments

indicate that there is sufficient interest or that it would

otherwise be in the public interest, EPA can hold a public
Chapter 10—Regulatory Agencies and Their Statutory Authority ● 285

Table 10-1 l—Selected State Pesticide Enforcement

Activities, 1988-1990

1990

Activity 1988 1989 (est)

Use inspections . . . . . . . . . 12,639 19,308 18,829

Producer establishment

inspections . . . . . . . . . . . 1,488 1,662 2,509

Marketplace inspections 5,662 8,032 4,035

lmport inspections . . . . . . . 273 431 475

SOURCE: General Accounting Office, compiled from the Environmental

Protection Agency.

hearing concerning an application. EPA can also use

advisory committees and generally tries to include public

representatives on these committees. EPA tries to draw

a distinction between private citizens and representatives

of public interest groups (40 CFR 25 .7(c)(1)(i and ii).

EPA can also utilize its FIFRA Scientific Advisory Panel

as a forum for scientific peer review and comment. Panel

meetings are public and allow an opportunity for public

comment.

EPA Enforcement Activities

EPA does not enforce tolerances; that is the responsibility

of USDA and FDA, and State enforcement agencies. USDA

has monitoring and enforcement responsibilities for pesticide residues in meat, poultry, and egg products. FDA is

responsible for monitoring the rest of the Nation’s food

supply. These agencies test samples of food to determine

if the food contains residues for which no tolerance has

been set or residues exceeding tolerance levels, rendering

the food adulterated. Food commodities with residues in

excess of tolerance levels or residues for which no tolerance

has been set are subject to seizure. EPA has cooperative

agreements with the States to perform enforcement activities. State agencies conduct use inspections, inspect pesticide-producing establishments, maintain marketplace

surveillance, inspect imports, and inspect dealers and users

of restricted-use pesticides. They also complete analyses

of pesticide samples collected during inspections (table 10-

11) (18).

Similar to other Federal agencies, resources devoted

to food safety activities at EPA declined during the 1980s.

EPA had 17 percent less staff and 8 percent less funding

in 1989 compared to 1980 ( 17).

OTHER FEDERAL AGENCIES

Other Federal agencies also carry out activities that

have some effect on food safety. The National Marine

Fisheries Service (National Oceanic and Atmospheric

Administration (NOAA), U.S. Department of Commerce) conducts voluntary seafood inspection programs.

The Agricultural Marketing Act of 1946(7 U.S.C. 1621

et seq) authorized the Secretary of Agriculture to establish a voluntary inspection and certification program for

agricultural products including fish and shellfish traded

in interstate commerce. The act also required the Secretary to conduct research and development on methods

of processing, packaging, handling, storing, and preserving products, and to develop and improve standards

of quality, condition, quantity, grade, and packaging to

encourage uniformity and consistency in commercial

practices. The Fish and Wildlife Act of 1956(16 U.S.C.

742a et seq) transferred USDA functions and authorities

pertaining to commercial fisheries, including the voluntary seafood inspection program, to the U.S. Department of the Interior in 1958. Reorganization Plan No. 4

of 1970 transferred the functions described in the Fish

and Wildlife Act to NOAA. The National Marine Fisheries Service (NMFS) conducts the National Seafood Inspection Program and the Product Quality, Safety and

Identity Research Program ( 18).

The seafood inspection program is voluntary and fee

based. Plants and fishing vessels are inspected for sanitation and certified. Seafood products are analyzed for

microbial and chemical contamination, for decomposition, and for species identification. NMFS has cooperative agreements with the States and provides training to

State inspectors who are certified to perform inspection

activities. NMFS also monitors State inspection activities. NMFS does not provide Federal grants to States for

providing inspection services, but does reimburse States

for costs incurred at an agreed on hourly rate ( 18).

In February, 1991 the FDA established a new Office

of Seafood (within CFSAN). This office will cooperate

with NMFS and will increase FDA responsibilities for

seafood inspections. The office will oversee seafood inspection programs by FDA in cooperation with NMFS

and State agencies, oversee the development of training

programs for FDA, State, and local inspectors, and increase research and develop methods to detect and evaluate the effects of microbial and chemical contaminants

in seafood that might pose public health hazards (11).

As of January 1990, there were 144 NMFS inspectors,

63 NMFS cross-licensed Federal (USDA) inspectors, and

74 NMFS cross-licensed State inspectors. It is estimated

that there are approximately 1,878 fish processing plants

in the United States, and about 141 of those contracted

for inspection services (table 10-12) ( 18). FDA has about

300 people engaged in various seafood safety programs
286 . A New Technological Era for American Agriculture

Table 10-12—National Marine Fisheries Inspection

Activities, 1981-1989

The Federal Grain Inspection Service (USDA) inspects

corn, sorghum, and rice for aflatoxin contamination.

Laboratory testing

Year Microbial Chemical Physical Total

1981 ... , ... , . . . . . 75

1982 . . . . . . . . . . . . . 69

1983 . . . . . . . . . . . . . 70

1984 . . . . . . . . . . . . . 71

1985 . . . . . . . . . . . . . 39

1986 . . . . . . . . . . . . . 43

1987 . . . . . . . . . . . . . 51

1988 . . . . . . . . . . . . . 68

1989 . . . . . . . . . . . . . 33

35

28

6

7

9

23

20

22

25

5

7

2

6

11

5

14

15

8

115

104

78

84

59

71

85

105

66

SOURCE: General Accounting Office, compiled from the National Marine

Fisheries Service.

and is expected to add another 270 scientific and inspection positions within 2 years ( 1 1).

Other Federal agencies with some food safety activities

include the Agricultural Research Service (USDA-ARS),

which conducts food safety research primarily to develop

methods to detect and control bacterial and parasitic contamination of meat and poultry and their products. ARS

develops methodologies to detect chemical residues in

meat and poultry and their products, and methods to

detect and prevent mycotoxins in plant commodities.

The Public Health Service Act (42 U.S.C. 201 et seq)

authorizes the Center for Disease Control (Department

of Health and Human Services) to conduct research on,

and monitor and control foodborne diseases.

The Federal Trade Commission Act (15 U.S.C. 51 et

seq) authorizes the Federal Trade Commission (FTC) to

investigate advertising claims that may result in unfair

competition and unfair or deceptive acts and practices in

commerce. Under this Act, the FTC has investigated

claims of companies that test fresh produce for pesticide

residues, health claims for food products, and home test

kits for food impurities.

The U.S. Customs Service assists FDA, USDA, and

EPA in their import inspection duties. It makes sure that

documentation is in order and, via a memorandum of

understanding with FDA, delivers samples of imported

food products to FDA on request.

The Bureau of Alcohol, Tobacco, and Firearms (BATF)

regulates production and distribution of alcohol and tobacco products. FDA has responsibility for safety of

alcoholic beverages; however, a memorandum of understanding with BATF gives most of that responsibility

to BATF.

FOOD SAFETY COORDINATION

AMONG FEDERAL AGENCIES

Given that so many agencies are involved in various

aspects of food safety, coordination between the agencies

is imperative. In general, this coordination involves notifying appropriate agencies of findings that may indicate

that regulations have been violated, and trying to avoid

inspection duplication when products or facilities are under the jurisdiction of more than one agency. In 1989,

FDA had 27 memorandums of understanding relating to

food safety and quality with other Federal agencies, primarily USDA.

EPA, FDA, FSIS, and AMS all have agreements to

notify each other in the event that residues from drugs,

pesticides, or environmental contaminants exceed tolerance levels. EPA is to notify FDA and USDA of any

pesticide use it encounters that may have resulted in

residues that adulterate human food or animal feed. FDA

is to notify EPA of possible misuse of pesticides or chemical substances that may indicate a violation of EPA laws;

and to notify USDA of illegal residues of drugs, pesticides, or environmental contaminants in human food or

animal feed. USDA is to notify FDA of findings of illegal

residues in edible meat, poultry, or egg products and to

keep FDA and EPA informed of all FSIS and AMS

sampling and testing programs for illegal residues ( 18).

FSIS, AMS, and FDA try to avoid duplicating inspections and exchange information on violative conditions concerning food manufacturers whose facilities are

under the jurisdictions of more than one agency. For

example, the Egg Products Inspection Act gives AMS

authority over egg product plants, egg producers and

packers, other firms engaged in marketing eggs including

hatcheries, and imported egg products. FDA has jurisdiction over restaurants, institutions, food manufacturing

plants, and other similar establishments that break and

serve eggs or use them in their products. The National

Marine Fisheries Service covers fishery products plants

that are under NMFS voluntary inspection contracts and

also subject to FDA inspection. NMFS is to apply to

these plants FDA regulations concerning good manufacturing practices, labeling, food additives, tolerances,

standards of identity, minimum quality, and fill of container. NMFS also cross-licenses FDA and USDA inspectors for seafood inspections. The agencies notify each

other of violations ( 18).
Chapter 10—Regulatory Agencies and Their Statutory Authority ● 287

INTERPRETATION OF FEDERAL

FOOD SAFETY LAWS WITH

RESPECT TO PRODUCTS

PRODUCED WITH

BIOTECHNOLOGY

None of the laws used to regulate food safety contain

specific provisions for products derived using biotechnology. However, based on the Coordinated Framework

(see ch. 7), all of the Federal agencies involved in food

safety regulation feel that current laws are adequate to

cover products created with biotechnology techniques

and that no new regulation is needed for such products.

The broad interpretation of the existing statutory authority allows for the agencies to extend their regulatory

authority to cover genetically modified products.

FDA Regulation of Biotechnology-Derived

Food Products

The application of the Federal Food. Drug, and Cosmetic Act to the regulation of food products produced

with biotechnology is complex. FDA must choose a regulatory course that ensures public safety, however, unnecessary over-regulation could damage agricultural

competitiveness and deny new products to consumers.

FDA’s statutory authority should be implemented in a

manner consistent with past actions, with the goals of

the Coordinated Framework, and with FDA’s own stated

policy that it will regulate the product and not the process.

FDA must apply its authority to biotechnology products

in such a way that they capture those foods for which

there are safety concerns. but it is important that it do

so in such a way that a regulatory structure that requires

review of all new food crop varieties is not established.

Finding an appropriate balance is a complex task.

As discussed earlier, FDA has the legal authority to

take action against foods adulterated with poisonous or

deleterious substances that would ordinarily(for inherent

natural substances ) or may (for added substances) render

the food injurious to health. Action can also be taken

against foods containing an additive(s) for which no regulation exists or that is not GRAS for its intended use.

Because FDA does not generally conduct a premarket

safety evaluation of food. only of food additives. some

groups (e. g., the Environmental Defense Fund) feel that

use of the adulteration clauses to remove marketed food

products made from biotechnology is inadequate to ensure the safety of these foods and have proposed that

essentially all food products produced with biotechnol -

ogy be classified as food additives. FDA is faced with

the challenge of deciding whether new biotechnologyderived food products are GRAS or whether they are

food additives that require premarket approval.

The types of food products likely to be developed using

biotechnology include

●

●

●

●

single compounds (e. g., flavors, enzymes, colors)

produced by genetically modified organisms (e. g.,

bacteria, cell culture) and added to goods,

genetically modified organisms (e. g., yeast and bacteria) that become part of the food itself (e. g., dairy,

meat, and vegetable starter cultures),

simple mixes of compounds added to food, and

whole foods (transgenic crops) (8).

Biotechnology-derived food products in the first three

categories generally fit the standard interpretation of a

food additive and thus may be regulated in the same

manner as additives produced by conventional means.

Thus. genetically modified starter cultures and single and

simple mixture compounds derived from genetically

modified organisms may be treated as food additives it

the modification alters the ingredient in such a way that

it is no longer GRAS (8, 9. 12).

The primary difficulty FDA will have in applying its

statutory authority to food products produced with biotechnology will be with respect to whole foods (e. g..

transgenic crops). New varieties of crops have generally

been regarded as safe (GRAS) by FDA. and thus have

not required pre,arket approval as a food additive. FDA

has the option of similarly allowing biotechnology-derived

whole foods to be marketed, relying on its seizure procedures to remove products for which safety risks arise.

or of applying the food additive definition to whole foods

produced with biotechnology. In the latter case. biotechnology products either would be affirmed as GRAS

or declared a food additive requiring premarket approval.

The question that arises with biotechnology is does the

process alter the food in such a way that it is now adulterated or is no longer GRAS’?

Use of the Seizure Procedures

It is possible to use biotechnology to create transgenic

crops that contain completely novel gene products. However, it is also quite possible to use biotechnology to

create transgenic crops essentially equivalent to new varieties produced by traditional means. New varieties produced by conventional methods do not undergo premarket

evaluation. Rather. FDA relies on their ability to seize

products should a food safety problem arise. FDA could
288 ● A New Technological Era for American Agriculture

apply a similar approach to whole foods produced with

biotechnology.

As is currently the case, whole foods produced with

biotechnology that contain poisonous or deleterious substances could be considered adulterated if the substance

is in sufficient quantities that it would ordinarily render

the food injurious to health (inherent natural substances)

or may render the food injurious to health (added substances). Added substances include those present as a

result of human intervention (e. g., mercury in fish).

Broadly interpreted, added substances could include inherent naturally occurring substances whose levels have

been significantly altered as a result of human intervention. Such an interpretation could include new crop varieties produced by conventional breeding procedures, as

well as whole foods produced with biotechnology methods. The use of traditional breeding methods to develop

new crop varieties have generally not been found to alter

the product in such a way that they would be considered

adulterated. Given that many biotechnology products will

be essentially equivalent to new products produced conventionally, the application of seizure standards to whole

foods derived from biotechnology must be implemented

in a manner that captures products for which there are

safety concerns without establishing a regulatory structure that requires the review of all new food crop varieties

(7, 9).

An advantage of using the seizure procedure to remove

biotechnology-derived whole foods from the market is

that this procedure does not a priori impose an extensive

regulatory process and premarket approval for all foods

for which biotechnology has been used. Action is initiated against those products that clearly pose a health risk

to society. This procedure is the one currently applied

to whole foods produced with conventional methods.

Like biotechnology, conventional breeding can alter the

levels of toxic substances or nutrients in whole foods.

A disadvantage of relying on seizure procedures to

remove biotechnology-derived whole foods from the

market, is that action is not initiated until a product poses

a health safety risk, and/or someone is adversely affected.

This is no different than what occurs now with conventionally produced whole foods, but given that biotechnology is a new procedure, and there appears to be public

apprehension concerning this technology, removal of an

unsafe biotechnology product from the market could be

very damaging to public acceptance of biotechnology in

food production.

Use of the Food Additive Definition

FDA could choose to apply the food additive definition

to whole foods, including those produced by biotechnology or conventional methods. Recall that a food additive is any substance whose intended use may be

reasonably expected to directly or indirectly become a

component or otherwise affect the characteristics of any

food, unless the substance is GRAS or subject to some

other exemption of the food additive amendment (e. g.,

pesticides, color additives, etc.).

Application of the food additive definition to whole

foods requires a specification of what food ingredient

actually is the food additive. A whole food could be

classified as a food additive if that food is used as an

ingredient in another food product. For example, carrots

used in beef stew could be considered a food additive if

the carrots are not GRAS. Alternatively, some trait or

constituent of the food could be designated as a food

additive, if that constituent is not GRAS.

Because of a long history of safe use prior to 1958

when the food additive amendment was enacted, most

whole foods have been considered GRAS. Likewise, FDA

has generally not required a formal review to establish

GRAS status of new varieties of crops produced after

1958 because changes resulting from traditional breeding

have generally been felt not to result in traits that are

sufficiently different to warrant such a review. A significant issue with respect to whole foods produced with

biotechnology methods is whether these procedures alter

the food in such a way that these products cannot now

be viewed as GRAS.

Alternatively, constituents of whole foods could be

designated as food additives if these constituents are not

GRAS. Thus, for example, gene products resulting from

biotechnology procedures could be classified as food additives. It is possible to transfer truly novel genes to

whole foods. These genes may produce proteins that have

previously not been part of the food system. Such expression products would not have been previously designated

as GRAS, and would be good candidates for designation

as food additives. However, many genes transferred between crops may code for proteins that are currently

consumed. Under what circumstances will these proteins

be deemed sufficiently different from those being consumed to warrant a formal review of GRAS status”? FDA

could describe the kinds of traits that might be different

enough to warrant review. Minor alterations of previously consumed proteins or the addition of common kinds

of nontoxic proteins could potentially be viewed as not
 Chapter 10—Regulatory Agencies and Their Statutory Authority . 289

raising sufficient concerns to warrant a formal review of

GRAS status.

An advantage of declaring whole foods or traits contained in whole foods as food additives is that this affords

an opportunity to examine these products prior to marketing. A disadvantage is that in some cases it may be

technically difficult to actually conduct the safety assessment (see ch. 11). Additionally, if most or all biotechnology-derived whole foods are declared food

additives, and conventionally produced products are not,

it would behoove FDA to explain the scientific justification for such a distinction. Otherwise it could appear

that FDA is regulating by process, which it has stated it

will not do.

Other analysts have suggested different interpretations

of the food additive amendment with respect to whole

foods derived from biotechnology. One proposal is to

apply the food additive definition to gene products that

would have been classified as food additives if added to

foods, and to exclude from the definition gene products

that result in changed agronomic traits (8). As noted

above, others have suggested that all whole food produced with biotechnology be classified as food additives

with the possible exception of transgenic crops that could

have been developed using traditional means rather than

biotechnology (i.e., the genes transferred come from species that are sexually compatible with the host plant) (3).

Still others have suggested that legal difficulties may

arise in developing an approach to regulating whole foods

produced with biotechnology that is risk based and not

process based, without simultaneously establishing regulations that require formal review of all new crop varieties produced by conventional means (7).

Current Status of FDA Regulations

Given the complexities involved, and the controversial

nature of genetically engineered food products, FDA policy has been a long time in the making. A clear policy

statement and guidelines have been needed. The lack of

a clear policy has been confusing to industry and the

public. Many biotechnology-derived food products, including whole foods, are no longer in the preliminary

stages of development; products are rapidly approaching

commercialization. FDA no longer has the luxury of

delaying a decision on whether or how they intend to

regulate food products produced with biotechnology.

In May 1992, FDA released a preliminary policy statement regarding new varieties of crops produced with

biotechnology (5). The policy statement is not final; public comments are being solicited. Some public interest

groups oppose the policy and are threatening to take legal

action to stop it. Thus, policy regarding the food safety

regulation of transgenic crops is still evolving.

FDA policy states that it is the characteristics of the

product, not the method used that will be of most concern. The FDA will not a priori require a food additive

petition for all genetically modified whole foods. Rather,

FDA will require an assessment of the expression products of the genetic modification and any unexpected or

unintended effects that may result from genetic modification. Expression products that differ substantially in

structure, function, or composition from substances found

currently in the food supply may require a food additive

regulation. New products that are not substantially different from foods currently consumed may, like new

varieties conventionally produced. be considered as GRAS.

FDA policy emphasizes safety assessment guidelines

that focus on determining whether the new plant varieties

are as safe and as nutritious as their parental varieties.

FDA is concerned that new toxicants not be introduced

into the food supply, that the level of toxicants inherently

present in foods is not unintentionally increased to levels

exceeding those already consumed, that the composition

or bioavailibility of nutrients is not significantly altered,

and that compounds that are known to cause allergic

responses in sensitive individuals are not transferred between crop varieties. Effects of processing on the composition of the food product must also be considered.

Decision trees are provided in the policy statement to

assist firms in assessing the safety of genetically modified

varieties. Characteristics of the genetically modified varieties are based on the characteristics of the host and

donor species, the identity and function of the newly

introduced substances, and any unexpected or unintended

effects that may accompany the genetic change are emphasized. The safety assessment focuses on:

. toxicants known to be characteristic of the host and

donor species,

. potential that food allergens will be transfered from

one food source to another,

. concentration and bioavailibility of important nutrients for which the food crop is ordinarily consumed,

. the safety and nutritional value of newly introduced

proteins, and

. the identity, composition, and nutritional value of

modified carbohydrates, fats, and oils (5).

FDA states in their preliminary policy that if genetic

modification does not result in the introduction of new
290 . A New Technological Era for American Agriculture

toxicants to the food supply, does not alter the level of

toxicants already present, does not alter the composition

or bioavailability of nutrients in new varieties, and does

not result in the transfer of allergenic components to new

varieties, then the new variety can be considered as

equivalent to traditional varieties when used in a similar

manner. If that traditional variety is classified as GRAS,

then the new variety would also be GRAS. Modifications

that result in varieties that contain new toxicants or significantly elevated levels of inherent toxicants are unacceptable. Modifications that result in nutritional changes

or potentially increase the possibility of allergic reactions

must be further evaluated by FDA. Such varieties may

require a food additive petition and a complete premarket

safety assessment.

FDA is also not requiring generic labeling of all new

crop varieties produced with biotechnology methods. Approved products that may have altered nutritional composition or that contain compounds that are potentially

allergenic may need to be labeled as such. Prior to commercialization, many transgenic crops will undergo field

trials. Permits for such trials are granted by USDA and

EPA and require an environmental assessment. FDA intends to coordinate with these agencies to prevent duplication in FDA’s efforts to comply with NEPA.

FDA has not yet formally been petitioned to review a

transgenic plant, although it has been asked to give an

advisory opinion on the use of the kanamycin resistance

gene as a marker in transgenic tomatoes, cotton, and

rapeseed (6). FDA has also been asked to give an advisory opinion on the use of the antisense technology to

delay softening in tomatoes. The agency has recently

provided for public comment its response to this request.

FDA has ruled on an enzyme (chymosin) produced by

a genetically modified bacteria, and used to clot milk in

cheese production. Chymosin will be used to replace

rennet, a GRAS enzyme extracted from the forestomachs

of cattle. The manufacturers of chymosin sought a formal

affirmation of the GRAS status of this enzyme. After

reviewing the structure, function, and purity of the enzyme, and published information, FDA affirmed GRAS

status for chymosin (4).

FDA Regulation of Biotechology-Derived

Animal Drugs

All new animal drugs, whether administered directly

to livestock or added to their feed, are required to receive

premarket approval. Thus, biotechnology-derived drugs

will undergo a premarket evaluation similar to that required for their traditionally developed counterparts. There

is no difficulty in interpreting FDCA with respect to these

products.

Transgenic crops used to feed livestock will face many

of the same ambiguities as transgenic crops used as human food as discussed above. Transgenic animals that

produce human or animal drugs may also raise questions

concerning the safety of food products produced from

these animals.

FSIS Regulation of Biotechnology-Derived

Meat and Poultry Products

FSIS will regulate biotechnology in meat and poultry

products. Food additives produced by fermentation using

genetically engineered organisms and added to the meat,

and genetically engineered meat starter cultures are classified as GRAS or food additives and are regulated as

such. FDA is the agency responsible for approving the

safety of these products and all food additives; FSIS will

then consider approval of their use in meat and poultry

products. These classes of biotechnology products will

be handled in the same way that their conventional counterparts are (i.e., as food additives unless granted GRAS

status). FSIS will also enforce the tolerances of biotechnology-produced pesticide and animal drugs in meat and

poultry products as established by EPA and FDA.

Application of the Federal Meat Inspection Act and

the Federal Poultry Inspection Act to transgenic animals

is a little more ambiguous. FSIS is in the process of

developing guidelines regarding transgenic animals. They

are expected to issue guidelines concerning the slaughter

of experimental livestock in which the attempts to insert

foreign genes failed. Development of guidelines for

transgenic livestock are in the preliminary stages and are

not likely to be available any time soon. FSIS has indicated that it regards transgenic animals as new breeds,

rather than new species, and thus they are amenable to

inspection (1, 13, 15).

EPA Tolerances for Biotechnology-Derived

Pesticides

EPA is responsible for establishing pesticide tolerance

levels for, or exempting from the requirement of tolerances, any pesticides used in food and feed products.

When an application is made under FIFRA to register a

pesticide that will be used on agricultural commodities
Chapter 10—Regulatory Agencies and Their Statutory Authority ● 291

marketed as food or feed, the applicant must also submit

to EPA a petition proposing either the issuance of a

regulation establishing a tolerance or an exemption of

the pesticide from the requirement of a tolerance as required by FDCA (21 U.S. C. 346a). The trigger for establishing a pesticide tolerance for biotechnology products

will be whether or not the biotechnology product is classified as a pesticide under FIFRA and has food or feed

uses. Thus, EPA’s role in food safety issues involving

biotechnology products hinges on its interpretation of

FIFRA with respect to these products (see ch. 7).

Responsibility for Transgenic Finfish

and Shellfish

Finfish and shellfish have been identified that produce

toxins highly poisonous to humans. Additionally, several

species of seafood consumed by humans are known to

concentrate environmental toxins and microbial toxins

that may pose food safety risks to humans. At present it

is not known how genetic engineering might affect these

characteristics. Fish and seafood consumption in the United

States has increased significantly, and transgenic finfish

and shellfish are in varying stages of development. The

FDA Office of Seafood has claimed food safety responsibility for transgenic fish and seafood products.

INTERNATIONAL

COORDINATION

Because food is internationally traded and several nations are developing the capability of producing biotechnology-derived foods, there is a need to develop acceptable

international standards for these food products. Several

European countries as well as Canada and Japan are

developing regulatory guidelines for the safety assessment of foods produced with biotechnology. Additionally, international organizations such as the Food and

Agricultural Organization (FAO), the World Health Organization (WHO), and the Organization for Economic

Cooperation (OECD) among others, are exploring the

issues involved. The FAO and the WHO jointly consulted

on the issue of food safety. They stated that any food

safety assessment of biotechnology-derived foods should

be based on sound scientific principles, that the extent

of the evaluation should be based on potential risks, and

that the evaluation should be multidisciplinary and include all steps in the production process.

Building on the FAO-WHO approach, the OECD, a

group of industrial nations including Europe, the United

States, Canada, Japan, Australia, and New Zealand, has

established various working groups to discuss issues surrounding the development of products produced with biotechnology. With respect to food safety, OECD has

established a group of international experts in the area

of biotechnology safety to address issues related to food

safety. Issues to be addressed include:

1.

2.

3.

4.

5.

the scientific principles that underlie the definition

of a new food or food component,

identification of methods to distinguish between

new foods or food components and their conventional counterparts,

establishing whether conventional food and food

components and their associated safety judgments

are good benchmarks for assessing the safety of

new foods or food components,

determining methods for establishing the substantial equivalence of the new foods or food components as compared to their conventional counterparts,

and

identifying methods to establish the safety of new

foods or food components when there are no conventional counterparts.

It is hoped that these and other international groups

can both develop principals that are acceptable for new

biotechnology products and help harmonize international

regulations to facilitate international trade of biotechnology products. Preliminary FDA policy is consistent

with the concept of substantial equivalence of new foods

discussed in the OECD working papers and with the

safety assessment procedures discussed in the FAO-WHO

reports.

1.

2.

3.

4.

5.

6.

CHAPTER 10 REFERENCES

Crawford, Lester M. and Clark, Denise L., “Biotechnology and Food Safety, ” Agricultural Biotechnology, Food Safety and Nutritional Quality for

the Consumer, National Agricultural Biotechnology

Council Report 2, 1990, pp. 161-166.

Degnan, Frederick H., “An Introduction to FDA

Advisory Committees, ” Food Drug Cosmetic Law

Journal, vol. 45 ( 1990), pp. 709–7 16.

Environmental Defense Fund, “Mutable Harvest, ”

1991.

Flamm, Eric L., “How FDA Approved Chymosin:

A Case History, “ Biotechnology” vol. 9, April 1991,

pp. 349–35 1.

Food and Drug Administration, “Statement of Policy: Foods Derived From New Plant Varieties; Notice , Federal Register. 57,22984-23005, 1992.

Food Chemical News, Dec. 24, 1990, p. 10.
292 ● A New Technologicul Era for American Agriculture

7.

8.

9.

10.

11.

12.

Frank, Steven W., “Food Additive Models for the

Regulation of Recombinant DNA Technology Under

the Federal Food, Drug, and Cosmetic Act, ” Food

Drug Cosmetic Law Journal, vol. 45, 1990, pp.

169–202.

International Food Biotechnology Council, Biotechnologies and Food: Assuring the Safety of Foods

Produced by Genetic Modification, 1990.

Jones, Daniel D. and Maryanski, James H., “Safety

Considerations in the Evaluation of Transgenic Plants

for Human Food, ” Risk Assessment in Genetic Engineering, Morris A. Levin and Harlee S. Strauss

(eds. ) (New York, NY: McGraw-Hill, Inc., 1991,

pp. 64-82.

Lakshmanan, Joseph L., “Nontechnical Representation on the FDA’s Advisory Committees: Can There

Be More, ” Food Drug Cosmetic Law Journal, vol.

44, 1989, pp. 181–194.

Miller, Roger W., “Get Hooked on Seafood Safety, ”

FDA Consumer, June 1991.

Munro, Ian, Pariza, Michael, and Stewart, Kent,

‘ ‘Scientific Information and Methodologies for

13.

14.

15.

16.

17.

18.

Assessing the Safety of Genetically Modified Foods

and Feeds, commissioned background paper prepared for the Office of Technology Assessment,

1991.

Norcross, M. et al., USDA, FSIS, “Food Safety of

Animals Produced by Biotechnology, ” 1990.

Office of Science and Technology Policy, Coordinated Framework for Regulation of Biotechnology,

Federal Register, 51, 23302, 1986.

Regulatory Information for Food Safety, FSIS Handout, 1989.

Shapiro, Sidney A, “Administrative Conference of

the United States: Biotechnology and the Design of

Regulation, ’ Administrative Conference of the United

States, 1989.

U.S. Congress, General Accounting Office, “Food

Safety and Quality: Who Does What in the Federal

Government, RCED-91-19B, December 1990.

U.S. Environmental Protection Agency, “General

Information on Applying for Registration of Pesticides in the United States, ” USEPA, Office of Pesticide Programs, June 1989.
Chapter 11

Scientific Issues in Food Safety
contents

Page

FDA ASSESSMENT OF FOOD AND FEED ADDITIVES AND ANIMAL DRUGS ......... 295

Quality Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ....297

Animal Safety Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ...297

Environmental Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 297

EPA ASSESSMENT OF RESIDUE TOLERANCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ....298

POTENTIAL FOOD SAFETY CONSIDERATIONS INVOLVING BIOTECHNOLOGYDERIVED FOODS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...300

Potential To Affect Microbial Contamination of Foods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ....300

Potential To Affect Nutritional Content of Foods . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ..............300

Potential To Affect Toxic Constituents of Foods . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...........301

APPLICABILITY OCCURRENT SAFETY ASSESSMENT METHODOLOGIES TO THE

PRODUCTS OF BIOTECHNOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ................307

Knowledge of the Genetic Modification and Inferences . . . . . . . . . . . . . . . . . . . . . . . . . . ... ........308

Assessment of Potential Unexpected Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...............310

RESEARCH NEEDS . . .,.,... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 311

SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .............313

CHAPTER 11 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 314

Box

Box Page

11-A. FDA Safety Review of a Food Enzyme Derived From a Genetically

Modified Bacterium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...............309

Table

Table Page

11-1. Naturally Occurring Toxins in Foods That Have Been Documented To Have Acutely

Toxic Affection Humans Consuming Normal Diets . . . . . . . . . . . . . . . . . . . . . . . . . . . ... .......305
Chapter 11

Scientific Issues in Food Safety

In an ideal world, the food products we eat would

contain no hazardous components and would be completely safe. We do not live in an ideal world. It is

impossible to eliminate all potential food hazards, but

food risks can be minimized by controlling microbial

hazards, toxic constituents, and the nutritional value of

foods. Scientists generally agree that when it comes to

food safety, the number one concern is the problem of

microbial contamination, followed closely by the effects

of nutritional imbalance. The risks posed by toxic constituents such as pesticide residues, environmental contaminants, natural toxins, and chemical food additives,

viewed as most important by the public, are generally

considered by scientists to present lower risks (19, 28,

37).

It is impossible to precisely measure the number of

foodborne illnesses that occur as a result of microbial

contamination each year in the United States. Hundreds

of thousands of cases are documented, including thousands of deaths. Due to underreporting, these documented cases represent only a fraction of the number of

actual cases that occur. The Centers for Disease Control

and the Food and Drug Administration (FDA) estimate

that up to 33 million cases of foodborne illnesses occur

annually, and some studies have placed the estimate as

high as81 million (27, 55). This staggering number costs

the U.S. economy billions of dollars in lost productivity

each year. Some of the major genera of bacteria responsible for foodborne illnesses include Salmonella, Shigella, Campylobacter, Listeria, Escherichia, Bacillus,

Staphylococcus. Vibrio, and Clostridium (botulism) (4).

The nutrient composition of foods affects their safety

both directly and indirectly. Diets high in saturated fat,

cholesterol, salt, sugar, and calories may be associated

with an increased risk of cardiovascular disease and cancer. Failure to eat an appropriate diet indirectly may

affect health by diminishing the body’s capacity to prevent certain diseases such as cancer ( 17, 33). Additionally, the fad diets followed by many Americans can be

dangerous.

Toxic constituents are either inherent to the food (produced naturally by plants and animals, particularly marine animals), result from microbial infections, or result

from human activities such as environmental pollution

or chemicals used in the production and processing of

whole foods and food products. Public attention focuses

primarily on toxins arising from human activities, and it

is not surprising that the public views these constituents

as posing the most severe risks. However, scientists generally feel that the levels of these constituents present in

foods are generally low enough that the risks posed by

them are less than those posed by microbial contamination, nutritional imbalances, and natural toxicants ( 19,

28, 37).

In part, this situation results from the extensive regulation of toxic constituents. Indeed, the food safety laws

place heavy emphasis on the premarket approval of food

additives and pesticide use. These laws also seek to minimize microbial contamination via extensive inspection

of food establishments and sampling and laboratory analysis of foods for microbes. However, there are numerous

ways in which a food may become contaminated, and it

is an ongoing battle to try to minimize these occurrences.

The development of new technologies used to produce

food products has raised new public concerns about food

safety. This chapter will present some of the scientific

issues pertinent to those concerns. The chapter will begin

with a discussion of how conventional food products are

assessed for safety. A discussion of issues raised by new

food products produced with biotechnology will follow.

The chapter will close with a discussion of the applicability of traditional safety assessment procedures to these

new products.

FDA ASSESSMENT OF FOOD

AND FEED ADDITIVES AND

ANIMAL DRUGS

As discussed in chapter 10, FDA does not perform

premarket evaluations on whole foods, only on food,

feed, and color additives and new animal drugs. The

FDA has the responsibility of assessing the safety of

substances added to food and livestock feed and of drugs

administered to animals used for human food. The FDA

assesses the safety of food additives for human consumption and for quality control. Feed additives are evaluated for safety to the animal. Residue levels of feed

additives or metabolizes related to the additive in edible

animal products must be determined and assessed for

their safety to humans. Animal drugs are treated in a

similar manner to feed additives—they must be safe and

effective for the animal, and any residues left in edible

animal products must be safe for human consumption.

-295-
296 ● A New Technological Era for American Agriculture

For products that might have an environmental impact

(animal drugs in particular), an environmental impact

assessment is also needed.

The basis for a safety assessment of additives and

drug residues for humans relies on determining the

toxicity of the additive or drug and the likely levels of

human exposure to the substance. Human safety assessments require attention to the levels of toxic substances present. In 1564, the physician Paracelsus stated

“Everything is poison. There is nothing without poison. Only the dose makes a thing not a poison. This

concept of dosage still underlies toxicity assessments

today.

Ingestion of excessive quantities of any substance,

even one necessary for survival, can lead to death.

Vitamin A is a necessary nutrient in small quantities,

but is highly toxic in large quantities (24). Sometimes

the acceptable consumption range is narrow as is the

case with vitamin A. Therefore the dose is a fundamental determinant of toxic potential. The dose that a

human is likely to consume will depend on the toxicity

of the compound for the individual consuming the food,

the level of the compound in food, and the levels of

intake of the food. Exposure levels will vary by individual and by cultural, economic, and geographic

factors. People have the ability to detoxify and/or excrete a large variety of potentially toxic compounds

(10, 58, 59). However, in the elderly, children, and

infirm those abilities may be compromised, raising their

susceptibility to toxins in foods.

Firms seeking the approval of a food additive must

submit a petition that contains information about the

chemical identity of the substance, the anticipated level

of consumption of the additive, and documentation of

the efficacy of the additive for its intended use. Firms

must also provide analytical methods to detect the additive and any related metabolizes that might result from

use of the additive in food. Firms must also submit toxicity testing data.

Toxicological testing is conducted to ensure that the

product is safe for its intended use and is required not

only for the substance itself, but for any other substance

that may form in and on food as a result of the use of

the additive. Metabolic and pharmacokinetic studies are

required to assess the fate of the test substance in the

body. These studies help to identify metabolizes that might

pose toxic risks.

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service

Microbiologist checks growth medium for visual evidence

of harmful foodborne bacteria.

The extent of testing required depends on the chemical

structure of the ingredient, and on its intended level of

use and consequent human exposure. Compounds whose

chemical structures are such that they are unlikely to pose

toxicological risks and those with low human exposure

potential require only limited toxicological testing.

Full toxicological testing is required for high-use substances, especially when the chemical structure is judged

not to lend itself to rapid and complete metabolism to

innocuous end products. Full toxicological testing of food

ingredients includes acute, subchronic, and long-term

(including carcinogenicity) testing; impacts on reproduction; teratogenicity (ability to cause birth defects) testing;

and genotoxicity (ability to mutate genetic material) testing. These tests are performed in multiple species.

Toxicology testing of additives is conducted by administering large doses of the test substance to an animal.

The amount administered to animals is in increments so
Chapter n-Scientific Issues in Food Safety .297

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service

Fluorescent light illuminating colonies of bacteria in

growth medium aids researchers in counting organisms

present in studies that help ensure food safety.

that it can be determined what maximum daily dose can

be administered without producing evidence of toxicity

(i.e., the no observed effect level or NOEL). To be

acceptable for inclusion in the diet of humans, food additives must have a margin of at least 100-fold between

the highest estimated human exposure and the NOEL

(20, 30).

If the product is intended for use in a food-producing

animal, it must also be tested for human safety in a

manner similar to food additives. The manufacturer must

develop analytical methods to detect and measure feed

additives, drug residues, and other potential metabolizes

related to the additive or drug, in edible animal products.

Residue levels are usually determined for muscle, liver,

kidney, and fat, and where applicable, in skin, milk, and

eggs (yolk and egg white). The length of time required

for residues to be eliminated from animal products must

also be determined (54).

The extent of testing required is tied to the degree of

concern (anticipated hazard). This provides a flexible and

scientifically valid procedure for assessing the safety of

food ingredients, and allows for the safety evaluation of

a wide range of food additives. It can be used to evaluate

chemically synthesized or microbially derived additives,

and drug residues resulting from medicated feeds or direct application to livestock. However, this method is

not appropriate to evaluate the safety of whole foods,

because toxicity is determined by feeding test animals

large quantities of the ingredient. It is not possible to

feed large quantities of whole foods needed to induce

toxicity without so radically changing the metabolism of

the test animal as to invalidate the results of the test.

This constraint has not been a problem in the past, primarily because whole foods have traditionally been viewed

as Generally Recognized as Safe (GRAS), and have not

undergone formal toxicity testing. This situation may

change with the development of new biotechnology products (20).

Quality Control

The FDA requires manufacturers to submit an extensive dossier of information pertaining to the method of

manufacture of food or feed additives and of animal

drugs. Detailed studies of the chemistry and purity of

substances under the proposed conditions of manufacture, and information pertaining to their intended use is

required. Petitions must include a description of the

methods, facilities, and controls used to manufacture,

process, and package the new product in sufficient detail

to demonstrate that the methods will preserve the identity, strength, quality, and purity of the ingredient. Methods used in the synthesis, extraction, isolation, or

purification must be described. Analytical procedures must

be available that are capable of determining the active

components with reasonable accuracy and of assuring the

identity of such components, These procedures must have

adequate sensitivity to determine the amount of the new

ingredient in the final product.

Animal Safety Assessment

If the new product is a veterinary drug or feed additive

used for livestock, the safety and efficacy of the product

for the animal must be documented. Evidence must be

provided that the drug or additive performs as claimed

under the conditions of use specified in the petition.

Animal drugs and feed additives must be tested for toxicity in all species of animals for which they will be used.

Similar to food additives, the level of toxicity testing

depends on the perceived risk of the substance. Drugs

and additives may require acute, subacute, and chronic

toxicity testing. Drug side effects must be evaluated.

Reproductive effects may also be examined.

Environmental Assessment

The National Environmental Policy Act (NEPA) of

1969 requires Federal agencies to prepare a statement of

the environmental impact of every major Federal action

that significantly affects the quality of the human environment. Typically, the environmental review begins when

industry submits a food additive petition, although FDA

has the responsibility to evaluate any action within its

jurisdiction that may significantly affect the environment.
—

298 ● A New Technological Era for American Agriculture

Firms must either file for categorical exclusion from the

requirements or submit an environmental assessment (EA).

Categorical exclusions include any actions under FDA

authority that do not result in the production, distribution,

or introduction of substances into the environment. Such

actions might include inspection requests, changing labels, etc. Additionally, some additive and drug petitions

seeking GRAS affirmation may also be excluded from

the EA requirement. Examples would include products

already marketed for the use for which the affirmation

is sought and which are not toxic to organisms in the

environment at expected levels of exposure (21 CFR

25.24(b)(7)).

Environmental assessments include, for example, data

concerning the identification of the substances, physical

containment procedures, waste stream treatment procedures, fate of the substance in the environment, and any

special precautions taken to minimize release as a result

of nonroutine or accidental situations. Information on

traits that would limit survival, growth, or activity of

organisms if released into the environment should be

included. Verification of compliance with State and local

requirements is needed (21 CFR 25.3 la). If the EA indicates that there might be adverse environmental impacts, then a full environmental impact statement may

be required.

EPA ASSESSMENT OF RESIDUE

TOLERANCES

The Environmental Protection Agency (EPA) has responsibility for determining the safety of pesticide residues in or on food for humans, or feed for domestic

animals that are used for human food. Before a pesticide

can be registered for use on a food or feed crop, either

a tolerance or an exemption from the requirement of a

tolerance must be established. A tolerance is the maximum level of pesticide residues that can be present in or

on raw agricultural commodities, food, or feed transported in interstate commerce. Tolerances or exemptions

from the requirement of a tolerance, must be established

for each active and inert ingredient contained in the pesticide and for each raw commodity, processed commodity, and livestock species that might contain residues of

the pesticide.

In a manner similar to FDA risk assessments of food

additives, the EPA conducts a risk assessment to establish, or exempt from the requirement, a pesticide residue

tolerance in food and feeds. This assessment includes

identifying the existence and type of hazards that may

be caused by pesticides; evaluating the relationship between the amount of the pesticide administered and the

incidence of any adverse effects; and determining probable human exposure to the pesticide (53).

For pesticides used on raw agricultural commodities, ’

EPA tries to determine whether or not the pesticide can

be used in such a manner that it is reasonably certain

that no injuries will result in humans even after a lifetime

of exposure. The risk assessment is based on the toxicology and residue data submitted by the petitioner.

Several kinds of data must be included when a petition

is submitted for the establishment of a tolerance or exemption from a tolerance (21 U.S. C. 346a (d)). Required

data include:

1.

2.

3.

4.

5.

6.

7.

the name, chemical identity, and composition of

the pesticide chemical;

the amount, frequency, and time of application of

the pesticide chemical;

full reports of investigations made with respect to

the safety of the pesticide chemical;

the results of tests on the amount of residue remaining, including a description of the analytical

methods used;

practicable methods for removing residue in excess

of any proposed tolerance;

proposed tolerances for the pesticide chemical if

tolerances are proposed, and

reasonable grounds in support of the petition.

Petitioners also may be required to submit an analytical

grade standard sample of the pesticide so that the adequacy of the residue detection method can be evaluated.

Residue chemistry data are designed to provide the

information necessary to determine the site, nature, and

magnitude of residues in or on food or feed. The purpose

of the data is to identify what chemical residues are

present and in what quantities. These data, along with

information on use patterns of the pesticides, are used

to determine dietary exposure levels. Information required includes qualitative data on the metabolism and

degradation of the pesticide, quantitative data on the

1Raw agricultural commodities are considered to be fresh fruits, vegetables, grains, nuts, eggs, raw milk, and meats as opposed to foods that

have been processed, fabricated, or manufactured by cooking, freezing, dehydrating. or milling among other processes (40 CFR 180. I(c)).
Chapter 11—Scientific Issues in Food Safety ● 299

magnitude of the residue in plant or animal tissues, and

analytical methods to detect residues.

Residues present when a crop is harvested may not be

identical to the applied pesticide. Environmental and host

plant factors can degrade or metabolize an applied pesticide to form a variety of metabolizes. Plant metabolism

data is collected to identify any types of pesticide residues

that actually remain in agricultural crops as a result of

these transformations. Field trials are conducted to determine the magnitude of the identified residues under

conditions that simulate the way the pesticide will be

used commercially. These data provide information about

the kinds of residues likely to be present in raw agricultural commodities, as well as the amount of residues

expected after pesticides are used in an approved manner.

Pesticide residues, degradation products, and metabolites all are tested for toxicity. Acute toxicity testing is

required of all residues and provides information on the

health hazards likely to arise from a single exposure to

any toxic components associated with the pesticide.

Changes in behavior, body weight, clinical symptoms,

mortality, and tissue pathology among other symptoms

are noted. Additional subchronic and chronic toxicity

testing, oncogenicity testing, teratogenicity testing, neurotoxicity testing, and reproductive and fertility testing

may be required depending on the pattern of use for the

pesticide, its physical or chemical properties, the expected exposure of nontarget organisms, and the results

of the acute toxicity testing.

As with FDA testing of pesticides, EPA toxicity testing

involves feeding test animals large quantities of the pesticide to determine the dosage level at which the pesticide

shows no observable or measurable effects in treated

animals when compared to control animals (the no observed effect level, NOEL). Because of uncertainty in

extrapolating data from test animals to humans, the NOEL

is divided by a safety factor to determine the maximum

levels considered safe for human consumption. The safety

factor may vary depending on the type of data submitted

and the chemical evaluated, with a factor of 100 the

minimum generally used.

The EPA calculates a total amount of residues that a

person can be exposed to in the daily diet. Based on

residue data obtained from field testing, a petitioner may

propose a safe tolerance level for humans. This proposed

tolerance is multiplied by the number of commodities

treated with the pesticide and the average consumption

of the commodity by the general public. Similar exposure

levels also may be calculated for specific groups that

may be particularly sensitive to a pesticide, such as pregnant women and infants.

The EPA then compares the maximum level of residues considered safe with the total theoretical exposure

level. If the maximum level considered safe is greater

than the total theoretical exposure level, then usually the

proposed tolerance level is established as the tolerance

level of the pesticide in raw agricultural commodities.

If, however, the maximum level considered safe is less

than the total theoretical exposure level, EPA may reject

the proposed tolerance level, or request further review.

With raw agricultural commodities, it maybe possible

to establish a tolerance for pesticides that are carcinogenic. Additional risk assessments to determine the additional cancer risk will be conducted. Usually, if the

additional cancer risk is less than 1 in a million, the

proposed tolerance for the pesticide will be accepted.

Livestock feeding studies are required whenever residues result in or on crops used as feed items. Animal

metabolic studies are conducted to determine the types

and levels of residues present in edible animal tissues,

such as meat, poultry, milk, or eggs.

Processing studies are required to determine whether

residues in raw agricultural commodities can concentrate

or degrade when those commodities are processed. If

residues do not concentrate on processing, the tolerance

established for the raw commodity applies to all processed food or feed derived from the commodity. If,

however, residues concentrate on processing, a pesticide

tolerance level must be established for the processed

product (51).

Exemptions from the requirement of a tolerance can

be granted if it appears that no hazard to public health

will result from residues of a pesticide. Data that may

be required to support an exemption include residue

chemistry, product chemistry, and toxicology data, including subchronic toxicity, teratology, and mutagenicity

studies.

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA regulates microbial pesticides

used in food and feed crops as well as chemical pesticides. To register a microbial pesticide, toxicity testing

is required. Such testing might include acute oral, pulmonary, dermal, and intravenous administration. Additional subchronic and chronic toxicity testing may be

required, as well as oncogenicity, mutagenicity, teratogenicity, and pathogenicity studies. The EPA has established protocols for such testing (57). Generally, however,
300 . A New Technological Era for American Agriculture

microbial pesticides -have been exempted from the requirement of a tolerance.

POTENTIAL FOOD SAFETY

CONSIDERATIONS INVOLVING

BIOTECHNOLOGY-DERIVED

FOODS

Currently, there is no evidence that whole foods, food

or feed additives, animal drugs, or pesticides produced

with biotechnology methods create greater food safety

risks than these same products produced with traditional

methods. However, biotechnology results in a new class

of products, with which we have little experience. This

lack of experience, combined with the novelty of the

types of genes that can potentially be transferred, has

raised concerns about the safety of such products.

Speculation about the potential food risks associated

with biotechnology products has focused on the same

general areas of concern as apply to traditional food products—namely, microbial contamination, nutritional imbalances, and presence of toxic constituents. The major

new concern is whether or not the new technologies increase the potential for microbial contamination, whether

or not they could lead to nutritional imbalances, and

whether or not they might add new toxins or increase

the levels of existing naturally occurring or synthetic

toxins in food.

Potentiul To Affect Microbial Contamination

of Foods

Several factors play a role in the growth of microbial

organisms in food. Factors such as pH, type and concentration of acid, water activity, concentration of sodium chloride and other electrolytes, availability of

nutrients and growth factors, and the levels of microbial

growth inhibitors all function to inhibit or enhance the

potential for microbial contamination and growth. Any

change in the composition of a food that affects one or

more of these factors will influence the chances of that

food causing illness (37).

Products produced using biotechnology could potentially alter some Qf these factors in ways that could increase the potential for microbial contamination. For

example, the development of low-acid fmits and vegetables might increase the possibility of botulism. Most

tomatoes have a pH of 4.5 or lower, but some low-acid

varieties are pH 5 or greater. When canned or processed,

such low-acid foods are more likely to support the growth

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service

C/ostridiurn botu/inurn is a toxin-producing food spoilage

organism and dangerous human pathogen. The sac-like

dormant spores can survive conditions that are lethal for

the rod-shaped bacterial cells. Magnification is about

8,500 times.

and toxin production of Clos/ridium botulinum than are

high-acid varieties.

Removal of substances that act as microbial growth

inhibitors may also increase the potential for contamination. For example, there is some evidence that caffeine

in coffee beans may suppress aflatoxin production (3 1).

Suppression of caffeine production in coffee beans could

increase the potential for contamination. It may also be

possible to introduce nutrients into foods previously lacking in sustenance. If the introduced nutrient is a required

growth factor for a particular microbe, its introduction

might enhance the potential for infection by the microbe.

Changes in factors that affect microbial growth might

also be in the direction that inhibits the growth of pathogens. For example, delayed softening of tomatoes may

decrease the potential for mold and bacterial growth. Nor

is the potential for such events to occur limited to foods

produced with biotechnology. Low-acid tomatoes produced with traditional methods are currently being marketed. But new technologies do warrant an awareness of

the potential to enhance microbial contamination.

Potential To Affect Nutritional

Content of Foods

Whole foods are compositionally highly complex. They

contain carbohydrates (e. g., starches, sugars, gums, cellulose, etc.), fats, proteins, minerals, vitamins, enzymes,

genetic materials (e.g., DNA, RNA), waxes, plant pig-
Chapter 11—Scientific Issues in Food Safety .301

ments, essential (volatile) oils (e.g., peppermint and citrus oils), alkaloids, and many other compounds. The

levels and types of these constituents present vary significantly between species due to different genetic composition, but even within the same species, or even variety,

the levels can vary substantially as result of different

environmental factors. Different soil types, sunlight,

rainfall, temperature, and agricultural practices such as

irrigation, planting date, maturity at harvest, and storage

conditions substantially can alter the level of food constituents present (20).

Information is available concerning the normal levels

of major nutrients in several food products. In general,

levels of nutrients vary by two- to three-fold in foods,

although higher levels of variation are seen. For example,

the level of beta-carotene (a precursor of Vitamin A) in

carrots ranges from O to 370mg per 100 grams of tissue

(42). In general, such nutrient variation does not pose

severe problems for humans, because humans eat a wide

range of food products, even in situations where there is

heavy dependence on one source of food for most of the

calories in the diet. Thus, diet quality is measured by

the sum total of everything eaten, and is not generally

based on a single crop or product. Decreases in the nutritional value of one crop may not be significant unless

that one product is the major or only source of that nutrient for the population. Likewise, increases in a nutrient

compound may not be significant unless the population

eats large quantities of the food containing the compound

and/or the compound has a narrow range of toxicity acceptability (35).

Because of the diversity of food products available in

the United States, alternative sources of major nutrients

are available. However, some foods do constitute the

major source of particular nutrients. For example, Americans rely on milk and milk products as the major food

source of calcium, on oranges and orange juice to provide

most of the vitamin C consumed, and on carrots to provide the precursors of vitamin A. Furthermore, some

nutrients (e. g., vitamins and minerals) can be toxic in

high levels, and a significant increase could potentially

pose some risks. Thus, an evaluation of the levels of

nutrients in individual food types and the amount of the

different food types eaten will determine if there is likely

to be a nutritional impact.

Nutritional impact depends not only on the amount of

the nutrient present in the food, but also on how much

of the food is consumed by an individual, and the individuals physiological state. If technological changes

significantly alter the types or amounts of foods eaten,

nutritional risks could result from this changed behavior.

For example, technological changes that alter the growing season or geographical region where foods are grown

could alter the seasonal or quantitative availability of

some foods such that consumers may eat more or less of

that particular food. Technology could change the quality

of the food (e. g., decreased fat in meats, altered taste of

the food) such that consumption patterns would change.

Uncertainty about technologies used to produce some

foods may cause some consumers to avoid that food. For

example, surveys have indicated that if bovine somatotropin (bST) is used to produce milk, some consumers

will decrease their consumption of milk and milk products, potentially with a consequent reduction in calcium

consumption. Thus, use of technologies that result in

significant changes in consumption patterns may also

create nutritional risks.

Whereas some biotechnology research is conducted for

the purpose of altering the nutritional composition of

foods (i.e., efforts to decrease the fat content in meat

products and to increase lysine in corn), potential may

also exist to inadvertently alter a critical nutrient biosynthetic pathway. If an important nutrient like vitamin

C was inadvertently reduced in oranges, this potentially

could have significant nutritional implications. Some nutrients are needed in small quantities but are toxic in

large quantities. Increases in the levels of these nutrients

could be significant from a food safety standpoint. Nutrient levels in normal foods differ significantly. Additionally, changes in acidity or solidity, for example, may

alter the ability of food constituents to be utilized as

nutrients. Similar to the development of new varieties

using traditional breeding practices, which can also alter

the level of important nutrients, careful attention should

be paid to whether there are significant changes in the

level of important nutrients between a biotechnologyderived food and its traditional counterpart, or whether

the change is within the normal range of nutrient variation

for foods.

Potential To Affect Toxic

Constituents of Foods

In addition to the potential impacts of biotechnology

on microbial contamination and nutrient composition of

foods, there is concern that new biotechnology-derived

food products may have new and/or increased levels of

toxic compounds. Postulated mechanisms for this increased toxicity include:
302 . A New Technological Era for American Agriculture

1.

2.

3.

4.

5.

the transferred gene(s) code for toxic compounds,

the transferred gene stimulates the production of

secondary compound(s) that are toxic,

the marker genes used for identification of transformed cells code for toxic compounds,

the production of naturally occurring toxins increases unexpectedly as a result of the undirected

insertion of the transferred gene into the host genome (the so-called pleiotropic effects), or

plants unexpectedly accumulate environmental toxins (e.g., heavy metals) in edible tissues (likely

only to be a problem for plants developed to grow

in contaminated soils) (16, 20, 30, 44).

When transferring genes into host organisms, a genetic

construct consisting of the gene to be transferred, marker

sequences to identify those organisms that have been

genetically transformed, and regulatory elements such as

promotors and enhancers that control the operation of

the transformed gene are all inserted into the new organism. Additionally, in many transformations, vectors

are used to insert the gene construct, and it is possible

that some of the vector DNA could also be inserted into

the host organism. Some groups have expressed concerns

that the expression products coded for by these genes

may be toxic.

Primary and Secondary Gene Products

When a gene is transferred into a host organism it

produces a gene product (protein). This gene product

may be the final active product, or it may act as an

enzyme or hormone that mediates the production of other

compounds. Gene products may therefore have direct,

primary effects and indirect, secondary, or compensatory

effects. Most proteins are generally nontoxic, and no

known proteins exhibit mutagenesis or carcinogenesis.

A few highly specialized proteins (i.e., cytotoxins, enterotoxins, and neurotoxins) are acutely toxic, but these

proteins are generally well characterized as to their source

and mode of action. Proteins, unlike some chemicals,

are constantly being degraded in an organism and do not

accumulate in tissues (21, 22).

Most proteins are readily degraded during digestion

but a few do not. These exceptions are characterized by

fairly well-understood chemical interactions that stabilize

parts of the protein molecules, thereby enabling them to

survive digestion partially intact. Most of these protein

fragments are excreted in the feces, but some enter the

blood stream where they may elicit immunological reactions. Allergic reactions have been documented to protein products found in many common foods including

nuts, peanuts, chocolate, barley, rice, wheat, citrus, melons, bananas, tomatoes, spinach, corn, potatoes, and

soybeans. In some cases, the immunological agent is

known to be a protein, while in other cases a glycoprotein

(a compound containing both a carbohydrate and a protein) is involved. With glycoproteins, it is not known

whether it is the protein portion or the carbohydrate portion that is causing the immune response. Both components could be affected by genetic modification (21, 22).

In cases where a gene product mediates another chemical reaction, indirect effects from gene transfers may

occur. For example, the primary gene product might be

an enzyme that catalyzes production of another product.

Alternatively, the gene product might be a protein hormone that itself produces biological effects as well as

stimulates production of other compounds that have biological functions. As an example, somatotropins (growth

hormones) are protein hormones that elicit several physiological responses in the body, such as enhancing protein accretion in immature animals. Somatotropins also

stimulate the production of other compounds such as

insulin-like growth factors (IGFs), which also elicit physiological responses. Thus, in this example, the primary

gene product would be somatotropin and the secondary

gene product would be IGF.

Unlike the primary gene expression product which is

a protein, secondary products do not necessarily have to

be proteins. Enzymes can catalyze the production of other

proteins or the production of other classes of chemicals

such as carbohydrates, fats, etc. Protein hormones may

also stimulate the production and release of steroidal

hormones. Concern has been expressed that these nonprotein secondary metabolizes may be chemically more

stable, may accumulate in body tissues (most notably fat)

and may be easier to absorb through the digestive system

than protein products. Thus, indirect effects of gene transfer

may be an important food safety consideration if the

organism compensates for, or responds to, the primary

gene product by producing increased levels of a compound that displays oral toxicity (22). Food safety evaluations must include an assessment of both primary and

secondary products.

Marker Genes

Various marker genes, including antibiotic resistance

genes, are used in biotechnology as a means of distinguishing between cells that have been genetically transformed and those that have not—only the transformed

cells will contain the resistance gene. Many first-generation transgenic plants use as a marker the gene for
Chapter n-Scientific Issues in Food Safety .303

neomycin phosphotransferase, an enzyme that converts

the antibiotic kanamycin to an inactive form. Some groups

have expressed concern over the inclusion of such marker

genes in genetic constructs. Possession of a particular

antibiotic resistance gene allows an organism to grow in

the presence of normally toxic levels of the particular

antibiotic the enzyme deactivates. Thus, the organism is

resistant to that antibiotic.

The primary issues raised with respect to the use of

antibiotic resistance genes as markers are not those of

toxicity per se. Rather, the issues focus on whether or

not potential exists for the transfer of antibiotic resistance

from food products to intestinal bacteria during digestion

(thus creating a strain of intestinal bacteria resistant to

kanamycin) and whether the presence of these genes will

interfere with therapeutic antibiotic administration.

Evidence to date does not suggest that naturally occurring antibiotic resistant organisms transfer resistance

in the intestinal environment. Usually DNA rapidly degrades in the presence of acids and enzymes contained

in the gastro-intestinal tract, significantly decreasing the

likelihood of an intact gene being transferred. Additionally, the promoter sequences used with the kanamycin

resistant gene are plant promotors rather than bacterial

promotors; plant promotors do not function in bacteria

so there is some question as to whether the gene would

be active even if transferred. Additionally, kanamycin

resistance is relatively common among soil microorganisms, and thus it is likely that humans are already consuming the gene. The likelihood of the transfer of

kanamycin resistance seems remote.

A more pertinent concern with respect to the use of

antibiotic resistance markers is the possibility that they could

interfere with therapeutic antibiotic administration if the

food containing the resistance enzyme is ingested with antibiotic administration. This may not be significant for kanamycin, but the issue must be addressed. The FDA has

been petitioned for an advisory opinion concerning the use

of the kanamycin resistance marker in transgenic plants.

To date, FDA has not issued that opinion.

In addition to the kanamycin resistant marker, other

marker genes can and are being used. Such genes include

those that code for herbicide tolerance and the lacZY

color marker. Concerns have been expressed that these

markers might also create novel gene products or associated secondary metabolizes. Once again, the expression

products and the genes coding for these markers are well

characterized and have been studied for many years, so

it seems unlikely that they would cause safety problems.

In general, the marker genes currently used code for

gene products that are well characterized and have been

part of the food system for many years. Use of such

markers significantly reduces the potential for food safety

problems. Additionally, new research showing that these

genes can be successfully removed from transgenic crops

may eliminate many of the concerns associated with the

use of marker genes.

Vector Material

Viral or bacterial plasmid vectors are sometimes used

to transfer genes from one organism to another. Some

groups have expressed concern that these vector sequences may code for toxic substances. The likelihood

of this occurring is significantly decreased by using vectors derived from microbes that do not produce toxic

substances or that are not closely related to microbes that

produce toxic substances. Additionally, use of plasmids

from bacteria that have a long history of use in food

products decreases the likelihood that the vector used

will code for toxic substances. It is a commonly accepted

practice to use vectors with these characteristics in genetic engineering (e. g., the Ti plasmid of Agrobacterium

tumefaciens). Thus, the probability of vector toxin production is low.

Unexpected Pleiotropic Effects

A primary concern raised with respect to biotechnology products is the potential for pleiotropic effects. Pleiotropic effects are secondary changes in metabolism (i.e.,

phenotypic alterations) that result from a single genetic

change (50). Genetic material contained in cells is composed of sequences of DNA that code for gene product

(the coding regions), sequences of DNA involved in controlling gene expression (regulatory sequences), and sequences of DNA for which there is no readily apparent

function (the noncoding regions). The majority of the

plant genome consists of this noncoding DNA.

As discussed in chapter 2, when genes are introduced

into a plant, there is little control over where the gene

is inserted. The new gene can be inserted into the coding

regions of a host gene, into the noncoding regions of a

host gene, or within regulatory regions of a host gene.

This undirected insertion of the gene raises the possibility

that

● the site of insertion will affect the level of expression

of the introduced gene itself,

● the site of the insertion is such that host organism

genes will be activated or inactivated, or
304 . A New Technological Era for American Agriculture

. the site of insertion will be such that there will be

no inadvertent effects on the host organism (20).

Gene expression levels (i.e., the amount of gene product actually produced) vary depending on a number of

factors, including the number of copies of the gene incorporated into the host and the position of the gene

within the host genome. The mechanism by which insertion site affects expression levels is not fully understood; however, the insertion site and expression levels

are passed on to the offspring in a consistent manner (20,

41). Expression levels of the gene may be too high or

too low or absent altogether. Depending on the nature

of the gene, overexpression may be detrimental to the

host organism itself, or pose food safety risks for human

consumption. Underexpression, and particularly no

expression, may pose no technical safety issues, but may

still raise concerns among a public uncertain about the

process of biotechnology itself. This situation has arisen

with transgenic animals in which the gene was incorporated into the host genome, but not expressed. Some

consumer groups have opposed the slaughter of these

experimental animals. The Food Safety and Inspection

Service (FSIS) is in the process of formulating guidelines

for the slaughter of these types of animals.

Insertion of the foreign gene into noncoding regions

of the host DNA may cause no disruption of any of the

host genes. These regions do not code for gene expression

products, so disruption of these sequences is unlikely to

result in the activation or inactivation of host genes. The

more likely consequence would be production of the

expression product of the inserted gene itself, rather than

any unexpected pleiotropic effects (20, 21).

The third, and likely most significant possible pleiotropic effect of gene transfer, involves the activation or

inactivation of host organism genes as a result of undirected insertion of the foreign gene. The foreign gene

may insert into the coding sequences of a host organism

gene or into the regulatory sequences of a host organism

gene.

Insertion of foreign genetic material into a regulatory

sequence of the host organism could destroy the ability

of the regulatory sequence to control the expression of

host organism gene(s). The foreign gene construct that

is inserted into the regulatory sequence of the host gene,

moreover, contains a regulatory sequence itself, which

could affect the expression of the host gene(s). The foreign regulatory sequence may be activated under different

circumstances than the host organism’s regulatory sequence, thus altering the expression of the host organism

genes in terms of amount, timing, and/or tissue location.

The significance of this occurrence may, in part, be influenced by whether or not the promotor sequence used

is inducible (controlled by specific stimuli) or constitutive

(turned on all the time) (20, 21, 56).

If the foreign gene is inserted into the coding region

of a host gene, then the most likely outcome would be

the inactivation of the host gene. This is because the

foreign gene must be inserted in the proper place and in

the proper direction (i. e., the sense direction) for activation to occur. Insertion into improper sites (even if in

the proper direction) or in the backwards direction (i.e.,

the antisense direction) will cause the gene to be deactivated. The probability that the foreign gene will be

inserted in the improper position or wrong direction is

higher than the probability that the gene will be inserted

into the proper position and direction (20).

Host gene inactivation could present food safety risks

if, for example, it led to decreased levels of nutritional
Chapter 11 —Scientific Issues in Food Safety ● 305

components. Inactivation of enzymes or hormones that

play key roles in biosynthetic pathways could lead to the

use of alternate pathways and the potential buildup of

some secondary metabolizes.

If the insertion of foreign genetic material is such that

host organism genes are activated (i.e., the insertion is

in the regulatory rather than coding region), several possible outcomes could result, some of which could pose

food safety risks. Activation of host genes could result

in increased levels of naturally occurring toxins or the

appearance of those toxins in plant tissues where they

do not normally appear. For example, a toxin normally

produced only in the leaves of a plant now may be produced in the seeds as well. Other possibilities include

the increased uptake and concentration of environmental

contaminants by the organism (6, 11, 14, 23, 30, 32,

36). It is more probable that foreign gene insertion will

lead to host gene deactivation rather than activation, although the probability of host gene activation is not zero.

Ten times more DNA is contained in the coding regions of genes than in the regulatory regions. Therefore,

if gene insertion is truly random, gene inactivation by

insertion into a coding region of a gene is about 10 times

more likely to occur than gene activation by insertion

into a regulatory region of a gene. However, it is possible

that gene insertion may occur preferentially in selected

areas of the genome (e. g., in active genes) rather than

in a completely random fashion. If this is the case, host

gene activation might occur with a higher probability.

The potential activation of genes that code for natural

toxins in the organism is of particular concern. Plants

are known to contain hundreds of toxic compounds, and

it is likely that they contain many more that have not

been identified. For example, roasted coffee is known to

contain at least 826 volatile compounds that could potentially have toxic effects ( 1). At least 148 naturally

occurring food compounds have been demonstrated to

have acutely toxic effects in experimental animals, livestock, or humans when consumed.

In humans, most of the toxic effects of food have

occurred as a result of abnormal diets or substance abuse,

but at least 14 food compounds can be acutely toxic under

certain circumstances even when consumed in quantities

within the range of normal dietary intake (table 1 l-l).

For example, the solanine content of white table potatoes

normally ranges from 2 to 20 mg/10Og of tissue, but

abnormal weather conditions can raise the concentration.

Just 100 mg of solanine is enough to evoke death in some

individuals. Low cyanogen varieties of cassava, if improperly prepared, are capable of yielding 20 to 40 mg

Table n-l-Naturally Occurring Toxins in Foods

That Have Been Documented To Have Acutely Toxic

Effects on Humans Consuming Normal Diets

Toxic compound Food source

Acetylandromedol . . . . . . . . . . . . .

Andromedol . . . . . . . . . . . . . . . . . . .

Anhydroandromedol . . . . . . . . . . .

Desacetylpieristoxin . . . . . . . . . . . .

Gelsamine . . . . . . . . . . . . . . . . . . . .

Tutin . . . . . . . . . . . . . . . . . . . . . . . . .

Hyenanchin . . . . . . . . . . . . . . . . . . .

Cicutoxin . . . . . . . . . . . . . . . . . . . . .

Hypoglycin A . . . . . . . . . . . . . . . . . .

Linamarin . . . . . . . . . . . . . . . . . . . . .

Lotaustralin . . . . . . . . . . . . . . . . . . .

Solanine . . . . . . . . . . . . . . . . . . . . . .

Curcurbitacin E . . . . . . . . . . . . . . . .

Nitrates . . . . . . . . . . . . . . . . . . . . . .

Honey

Honey

Honey

Honey

Honey

Honey

Honey

Milk (19th century America

from water hemlock)

Ackee fruit

Lima beans and Cassava

Lima beans and Cassava

Potatoes

Squash, Cucumber

Spinach, and other green

Ieafy vegetables -

SOURCE: International Food Biotechnology Council, 1990.

of hydrogen cyanide per kilogram of cassava. However,

some varieties of cassava can yield 20 times that much

hydrogen cyanide, which is enough to be deadly. Increased levels of these known naturally occurring toxins

as a result of biotechnology would certainly present food

safety risks (20, 23, 26, 30, 32, 60).

Sufficient knowledge has accumulated regarding naturally occurring acutely toxic plant toxins to provide

assurance that the food supply contains either safe levels

of these toxins or can be processed in a way that minimizes or eliminates their acute health effects. However,

much less is known regarding the role in chronic disease

of naturally occurring plant toxins currently consumed

(30). A large number of naturally occurring compounds

frequently found in foods appear to be mutagens and

possible carcinogens. For example, of the 826 volatile

compounds contained in coffee, only 21 have been tested

for chronic effects, and 16 of them were found to be

carcinogenic in rodents (1, 2, 3). Potentially, the number

of such substances could reach into the thousands, we

know neither their identities, their normal concentrations,

nor their long-term impacts on human health (1, 2, 3,

20).

Compared to plants, substantial literature on microorganisms and their toxins relative to foodborne illness

exists. Considerable information concerning the genetic

and/or environmental determinants of microbial toxin

expression is also available. This information could be

used to structure strategies for determining the safety of

microbially derived food products (7, 20, 30, 38). The

microbial toxins of primary concern are those that are
306 ● A New Technological Era for American Agriculture

’

.

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service

Microbiologist obtains samples for microbial analysis

from carcass, Production of toxins by animals consumed

for food purposes is rare.

active orally and are known to be produced by organisms

related to those used in food processing.

The production of toxins by animals consumed for

food purposes is rare and is generally limited to a few

marine species such as the puffer-fish (6, 23, 32). Severe

insertional effects are likely to be uncommon because

such impacts would probably lead to the death of the

embryo. Insertional effects could potentially affect the

manner in which an environmental toxin is detoxified,

or could increase the accumulation of contaminants such

as heavy metals, pesticides, or orally active compounds

in edible tissues. A significant change in the accumulation of such compounds is likely to be detrimental to

the animal itself; thus, the health of the animal serves as

a preliminary screen for toxic effects (5).

Plietotropic effects might also result from using tissueculture techniques to regenerate genetically transformed

cells. When the genetic material is transferred into a cell,

the cell must first be regenerated into a whole plant using

tissue-culture techniques before additional breeding can

occur. Plants regenerated from cell tissue culture have

sometimes shown striking differences among themselves

and from the parent cells from which they were regenerated. The process of separating mature plants cells and

regenerating those cells into whole plants releases a pool

of genetic diversity inherent in the plant. This process is

referred to as somaclonal variation, and it is being used

in traditional breeding programs to identify new traits

that might be of agricultural interest. Because transgenic

cells are regenerated into whole plants, it is possible that

some unexpected gene products might be expressed in

the mature plant. Frequently, the gene expression of these

somaclonal variants is not stable, and they are not inherited by subsequent generations, but this does not hold

in all cases (34).

For whole foods that rely almost exclusively on the

use of tissue culturing in the breeding program, these

effects might be significant. For many transgenic plants

(i.e., grain crops), however, they may not be. Transgenic

crops will not immediately go from the laboratory to the

dinner table. In some cases, backcrossing with traditionally bred lines may be needed. Even if the gene is transferred to a well-adapted parent line, the stability of the

gene and the agronomic performance will need to be

determined. Thus, if a key enzyme is deactivated, an

essential pathway disrupted, or detrimental somaclonal

variants occur, it is likely that the crop will not perform

well in field trials and will be screened out and never

commercialized. Likewise, as a result of the Lenape incident, screening has improved for compounds known to

be acutely toxic to humans if consumed in high enough

quantities. While these methods do not guarantee that all

unexpected and undesirable effects will be detected prior

to commercial release, it is likely that many of the more

significant ones will be.

Unexpected results can and do happen frequently as a

result of traditional breeding. This situation is not unique

to biotechnology. Indeed, many of the issues raised today

concerning biotechnology are the same concerns raised

in the 1970s with respect to the development of new crop

varieties by traditional breeding and the use of chemicals

and irradiation to mutate microorganisms. The majority

of these unexpected effects that occur have not been

demonstrated to cause severe food safety risks, although

on rare occasions there are exceptions. Unexpectedly

high levels of toxic compounds have occurred as a result

of traditional breeding. The classic example is the development of a new potato variety (Lenape) in the 1970s.
Chapter 11—Scientific Issues in Food Safety ● 307

This new variety had better processing characteristics and

enhanced disease resistance over traditional varieties. It

also had significantly elevated levels of solanine, which

were fortunately discovered before any illnesses resulted

(20, 30, 61). However, this example involves a crop that

contains a known, acutely toxic compound. Most crops

do not have such compounds. Therefore, even if unexpected effects do occur as a result of biotechnology, they

may not present significant food safety risks just as they

do not when they occur during traditional breeding. Clearly,

particular attention should be paid to those crops known

to produce highly toxic compounds.

APPLICABILITY OF CURRENT

SAFETY ASSESSMENT

METHODOLOGIES TO THE

PRODUCTS OF

BIOTECHNOLOGY

The FDA does not routinely review for the safety or

toxicity of food, only for food additives. Food additives

generally are synthetically produced in batch quantities

and added to foods. Because of the way these compounds

are produced, a safety assessment approach has been

established that administers large quantities of the additive to animals to determine at what level any toxic

effects may occur. Concentrations of additives must be

well below the level at which any toxic effects may have

occurred. This type of approach will be difficult to apply

to genetically modified whole foods.

Whole foods are complex mixtures of chemicals, not

single chemicals. It is not possible to feed whole foods

in quantities sufficient for toxicity assays without simultaneously producing gross disturbances in the nutrient

balance and physiology of the test animal, which invalidates the results of the test. Experiments involving whole

foods fed at the levels approximating the intended use

for humans lack the sensitivity to detect anything but the

most potent toxins. Thus, conventional procedures of

toxicological investigation lack the sensitivity necessary

to ensure the safety of genetically modified whole foods

under chronic use conditions. It is for these reasons that

the safety evaluation of genetically modified whole foods

requires that innovative new approaches be developed.

Many first-generation transgenic crops involve the

transfer of a single gene, often derived from a different

species than the host (transformed) plant. The foreign

gene may or may not significantly alter inherent biosynthetic pathways in the transformed plant. In the future,

however, genetically engineered crops will likely be more

sophisticated. Multiple genes will be transferred. Host

plant biosynthetic pathways may be significantly altered

such that the levels of several naturally occurring compounds in the transformed plant will be altered.

Recently, for example, it was announced that the first

protein plant hormone has been identified ( 13). This hormone mediates several metabolic reactions within the

plant. Research is being conducted to identify additional

plant protein hormones and to possibly clone and transfer

the genes that code for these hormones. Thus, future

transgenic plants may display significant compositional

differences from those available today. Current safety

assessment methods that rely on testing individual components will be increasingly inadequate as a method to

assess the safety of these more complex genetically engineered plants.

Finally, as discussed above, the potential food safety

risks that may result from the use of biotechnology in

food production fit two general categories—those that

can be anticipated based on the structure and known

metabolic activity of the gene product, and unexpected

results, such as the enhanced production of naturally

occurring toxic substances, that might result from the

undirected insertion of the gene.

For all these reasons, a new approach to safety evaluations is needed in the era of biotechnology. The new

approach has two key elements:

1. knowledge of the genetic modification practices

used and the inferences this has for product safety,

and

2. compositional studies designed to evaluate whether

changes in composition of food products might lead

to safety concerns under the intended conditions of

use (30).

Understanding the genetic modification practices used

and the inferences this has for product safety provides

information concerning the types and nature of gene

products likely to be present. Compositional studies yield

information on any unexpected effects that may occur as

a result of the genetic modification. Since the effects are

unexpected, one does not know what kinds of gene products to evaluate for toxicity. The way to obtain this information is to compare the transgenic organism to its

conventional counterpart and note any significant changes

in the amounts of common constituents associated with

the foodstuff and for identifying any new constituents

that may have been introduced by the genetic modification process (30). Knowing what these changes are
308 ● A New Technological Era for American Agriculture

provides a basis on which to conduct a safety evaluation

of the new food product.

Knowledge of the Genetic Modification

and Inferences

An analysis of the safety of the gene products will

require understanding the type and nature of products

expressed, any toxic effects of these products, and the

levels at which they occur in the food. These are the

same issues that must be addressed when evaluating the

safety of conventional food additives. As with the safety

assessment of traditional food additives, the assessment

of biotechnology-derived foods must begin with the identification of the types and nature of gene products present.

Such information can be obtained by evaluating the genetic construct itself and understanding the metabolism

of the product of the inserted gene.

Evaluating the genetic construct itself includes analyzing both the product of the newly transferred gene

and the products of any other genetic material transferred

with the desired gene (e. g., marker sequences, regulatory

sequences, vector sequences). The information needed

to evaluate the genetic construct includes:

●

●

●

●

This

the physical size, structure, and functional limits of

the coding region;

the physical extent and functional properties of the

regulatory DNA regions (e. g., where the regulatory

sequence occurs relative to the coding sequence, the

relative strength of the regulatory sequence;

the starting signal for transcription of the gene); and

the structure and function of the marker sequences

(20).

information is needed whether the host organism is

a microorganism, a plant, or an animal. In some cases,

this information is already available in the public literature, but if it is not, it usually becomes available as a

result of the genetic engineering process itself, or it can

be obtained relatively easily with genetic engineering

techniques.

An understanding of how the inserted gene functions

in the plant is also needed. An ideal situation is to have

stable and predictable gene expression. Information useful in determining gene expression in the plant includes

an estimate of the number of gene copies inserted, whether

they are inserted into the chromosomes or other organelles that contain genetic material (i.e., the mitochondria

or chloroplasts), and whether gene expression is inducible or constitutive (turned on all the time). Tissue location (plant part) and concentration of gene expression

products during the plant’s life cycle should be determined. And any evidence of the gene moving to other

locations within the genetic material should be evaluated

(56).

The mode of action of the gene product also should

be assessed. In general, with food additives and pesticides, these compounds and any degradation products

are traced in the plant by radioactively labeling the compounds. Such an approach may not be adequate to identify metabolic products inherently produced in a plant as

a result of genetic engineering. New analytical methods

and greater understanding of basic plant metabolism will

be needed to identify endogenous plant metabolizes that

result from genetic engineering.

Once the gene products have been characterized, their

potential to produce toxic effects must be addressed. The

material used for the toxicity testing should represent as

closely as possible the expression product as it actually

occurs in the plant. It is preferable to develop methods

that could assess the toxicity of the whole food, i.e., the

form in which it is eaten. However, such methodology

is not currently available. An alternative approach is to

isolate and purify the gene product from the plant in

sufficient quantities to conduct traditional toxicity testing

(i.e., administering large doses of the substance to a test

animal). Isolating sufficient quantities of primary and

secondary gene products from whole foods, however,

may be difficult in some cases. The gene product must

be extracted from the food. In some cases, methodology

for such extraction may not be available, and new analytical techniques will need to be developed.

If the gene product does not undergo significant posttranslational modifications in the plant, an alternative

approach to obtaining sufficient quantities of the gene

product for toxicity testing might be to produce and purify

the product from a microbial system. Even if post-translation modifications occur, knowledge of the sequence

of the gene allows for the use of computer algorithms to

identify other proteins with related sequences, taking into

account any post-translational processing that might occur to alter the protein. Once the protein family has been

identified, it may be possible to establish a history of

safe consumption of closely related proteins in other foods.

This does not guarantee the safety of any specific protein,

but each new case does not have to be treated as being

entirely novel; the relationship of a protein to other proteins with a similar function provides additional information that can sharpen the focus of the safety evaluation

(5).
Chapter 11—Scientific issues in Food Safety ● 309

Box II-A—FDA Safety Review of a Food Enzyme Derived From

a Genetically Modified Bacterium

Rennet, an enzyme preparation isolated from the forestomach of calves is used to clot milk in the cheesemaking

process. The principal enzyme contained in rennet is chymosin. The FDA affirmed rennet as GRAS for use in food

in 1983. However, this source of the chymosin enzyme is expensive for food processors, and an appropriate

substitute would be beneficial to the industry.

In February 1988, Pfizer Central Research (Pfizer Co.) petitioned FDA to affirm as GRAS, a chymosin preparation obtained from genetically inserting a chymosin gene into a bacterium. This genetically modified bacterium

was then used to bacterially ferment large quantities of chymosin, which could be used in place of rennet. Chymosin

was the first biotechnology-derived food additive reviewed by FDA.

During the review, FDA viewed the chymosisn preparation as a product consisting of an active enzyme plus

any impurities that may have been introduced during fermentation and processing. The FDA was interested in

determining whether the cloned chymosin gene yielded a protein enzyme of the same structure and function as is

contained in rennet.

The cloned gene was sequenced and other analytical tests performed to establish the chemical identity of the

resulting enzyme. This cloned chymosin enzyme was tested to determine if it had the same functional activity as

chymosin derived from rennet; its ability to clot milk was tested under various conditions of temperature, salt

concentration, and PH. This information was used to determine that the cloned chymosin enzyme was indistinguishable from that contained in rennet. The safety of the chymosin enzyme preparation was also tested by feeding

large quantities of the preparation to laboratory animals. No adverse effects were detected.

The FDA also examined the safety of the bacterium into which the chymosin gene was inserted. The bacterial

strain used has been used widely as a laboratory organism for at least 30 years without any reported incidents of

illness. The strain does not colonize the gut of man or animals, even when present in high concentrations; does

not produce toxins; and lacks the characteristics necessary for pathogenicity. Additionally, the process used to

purify the enzyme destroys the bacteria and removes most of the microbial material from the final product. Because

the bacterial strain used contained an antibiotic resistance gene as a marker, FDA also sought to ensure that this

gene was destroyed during purification and that there was no possibility of the gene being transferred to bacteria

contained in the human gut.

Chemicals used in the purification process were also evaluated to determine if they presented safety concerns.

Compounds used in processing were those already approved as food additives or were GRAS. The resulting

chymosin preparation was considerably purer than the rennet preparation currently in use.

After review of test data and published literature pertinent to the use of chymosin in food, FDA affirmed the

GRAS status of biotechnology-derived chymosin in March 1990.

SOURCES: Federal Register, vol. 55, No. 57, Mar. 23, 1990, pp. 10932-10936. Eric L. Flamm, “How FDA Approved Chymosin:

A Case History,” Bio/Technology, vol. 9, April 1991, pp. 349-351.

For microorganisms used as a source of simple chem- iatiom and control elements. The purity and identity of

ical additives, the safety assessment includes identifying:

the host organism, any evidence of pathogenicity or toxin

production, the function of the inserted gene, and the

identity of any organisms that contributed genetic material to the final construct. In addition, characterization

of the inserted genetic material is needed to ensure the

absence of sequences that may encode harmful substances. Insertional and genomic stability, chemical specifications, dietary use and exposure, and other relevant

information must also be evaluated. Safety evaluation of

the insert itself focuses on its expression product. In

addition, the fermentation process is evaluated for varthe final product should be maintained throughout the

production process. This approach was taken with the

FDA review of chymosin, the first chemical additive

produced by genetically modified bacteria to be approved

(box 1 l-A).

In keeping with the approach that chemicals with the

highest potential risks must undergo the most extensive

toxicity testing, the use of genetic elements that have a

safe history of use in food could require a less rigorous

evaluation than is necessary if genetic elements foreign

to the food supply are used. “Safe” genetic elements
310 ● A New Technological Era for American Agriculture

might consist of genetic material from nonpathogenic,

nontoxigenic microorganisms that are commonly associated with or found in foods; and genetic elements,

characterized or uncharacterized, used as source material

for the genetic modification of food species via conventional breeding procedures (20).

Assessment of Potential Unexpected Effects

While some of the traditional safety assessment practices may be used to identify the toxicity of primary and

secondary gene products, the evaluation of the potential

impacts of gene insertion effects will require a different

approach. The major difficulty encountered is documenting the effects of undirected insertion since one does

not know what compounds could be produced or what

expression levels could be enhanced.

The way to determine whether unexpected expression

products or nutritional deficiencies have in fact occurred,

is to compare the compositional changes of a genetically

modified organism with that of a traditional organism,

or a selected reference organism. Bacteria commonly

used in food production are generally well characterized,

and the possibility of production of toxic compounds is

very low if the host bacterium does not normally produce

toxins. Demonstration of unexpected results in more

complex organisms, such as plants, will be complicated

by the large size of the genome and the fact that toxic

products may only be produced under special conditions

(38).

To compare transgenic plants to traditional or reference

plants requires knowing the normal range of the latter’s

nutritional components, and identifying any naturally occurring toxic compounds that have significantly increased

levels in genetically modified plants. The inadequacy of

the information concerning whole food composition of

traditional foods limits the ability to make such comparisons at the present time (30).

While knowledge concerning the normal range of toxic

compounds in raw foods is limited, even less is known

about the normal range of such toxins in processed foods.

While food processing and cooking often lowers the levels of toxic factors, sometimes this processing and cooking has the opposite effect. For example, high temperature

that kills organisms also can thermally transform normal

components of foods, such as proteins, carbohydrates,

and lipids into toxic materials (45, 46, 47). Thus, pyridines, which are mutagenic compounds, can be formed

by cooking meats. Acid and alkali treatment and fermentation processes also can result in toxic compound

production (23). Data collected on toxin levels usually

consists of determining whether or not particular regulatory limits have been reached. This type of data is not

the type needed to predict levels of toxins that may occur

during processing. Additionally, the methods used are

generally not sensitive enough to detect and quantify

extremely low levels of toxicants in foods (30).

In addition to the issues of toxicity and nutritional

deficiencies, genetic modification has raised the issue of

allergenicity of the gene product. The possibility exists

to alter the structure of endogenous proteins or introduce

new proteins into foods ( 16). One approach to determining allergenicity is to allow limited distribution and

carefully monitor for allergic response (29). Other possibilities might be to use double antibody screening procedures, in which food materials (or extracts) are used

as antigens to which human blood plasma (containing

antibodies) is added. Complexes formed by the interaction of antibodies and antigens are detected using a

second antibody labeled with fluorescent materials to

bind to the initial antigen-antibody complex. This method

can be used as a general means of detecting potential

allergenic effects of food products ( 12). This approach

is most useful for proteins to which sensitive individuals

have already been exposed; it is not particularly useful

for new proteins.

Similar to the FDA, the EPA may face analytical

difficulties in their attempts to develop tolerances for

pesticidal products created using the new tools of biotechnology. Historically, EPA has worked with chemical

rather than biological substances. Biological pesticides

have heretofore been restricted to microbial pesticides,

not whole plants. Whole plants are considerably more

complex than microbial pesticides, which in turn are

much more complex than chemical pesticides. Identifying, isolating, and assessing the toxicity of endogenously produced pesticides creates new analytical

challenges. Identifying the appropriate test material for

toxicology testing, and synthesizing radioactively labeled

materials to conduct metabolism studies will require the

development of new methodologies.

EPA guidelines for establishing a tolerance level for

transgenic plant pesticides have not yet been developed.

Determining the type, nature, and level of residues in

whole plants, and then testing those residues for toxicity

will create analytical challenges. EPA has indicated that

its assessment will focus on the pesticide product and its

active ingredient, although at present, it has not clarified

whether that means that EPA will regulate the gene itself,

the gene product, or both. EPA also has not yet clarified
Chapter n-Scientific Issues in Food Safety ● 311

whether regulations will be applied to the seed or the

whole plant.

EPA has suggested that for the purposes of product

assessment, pesticidal products produced in transgenic

plants might be divided into two categories—proteinaceous products and nonproteinaceous products. EPA expects that the information and data needed to assess the

safety of proteinaceous products will, in general, be less

than that required for nonproteinaceous products, because proteins are susceptible to acid and enzymatic

digestion (56).

An example of the types of problems that may be

encountered with whole plants genetically engineered to

contain pesticidal compounds is illustrated by some of

the technical difficulties encountered with the registration

of plant extracts as pesticides. Plant extracts contain many

chemical compounds, several of which maybe pesticidal.

Additionally, the quantities and types of these compounds can vary substantially depending on soil type,

temperature, rainfall, etc. To register plant extracts, EPA

requires composition and product chemistry data for all

chemical compounds in the extract. Toxicology tests representing the entire range of possible compositions must

be conducted and tolerances may need to be established

for all compounds (9). Needless to say, it can be time

consuming, expensive, and difficult to register plant extracts as pesticides.

It is reasonable to expect that in the future, fundamental biosynthetic pathways in plants will be altered

such that several potential pesticidal compounds may be

present, a situation that may be analogous to plant extracts. Because EPA has not clarified its policy with

respect to these types of products, it is speculative how

EPA will address such products. However, if EPA does

treat these biotechnology products similarly to plant extracts, this may create significant obstacles to the development of many of these types of biotechnology

products.

RESEARCH NEEDS

New analytical methodology must be developed to

measure the normal range of toxic and nutritional components in foods needed for comparison with biotechnology-derived foods. Whole food composition analysis

is a complex task due to large numbers of potentially

toxic materials that may be present in raw foods and the

constantly changing nature of the processed food market.

Monitoring levels of key toxic components will require

a large number of assays for many different compounds,

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service

Chemist evaluates a screening assay for residues. New

analytical methodology will need to be developed for

biotechnology-derived foods.

sometimes at quite low levels. Many traditional analytical

methods, such as titrations and calorimetry, can be used

to assay classes of compounds, such as reducing sugars

or proteins, but by themselves these methods cannot be

used to quantify individual members of those classes in

mixtures of compounds. Food safety assays for determining individual compounds in complex mixtures are

needed (30).

The analytical process starts with the preparation of

the food sample followed by extraction by chemical class.

Most modern analytical separation and detection techniques require clean samples free of interfering compounds. Most food samples are mixtures of multiphase

materials with extremely complex chemical compositions, and the quantitative extraction of a given chemical

class can be quite difficult. The development of adequate

plant extraction techniques has lagged behind the other

analytical techniques of food analysis. Those wishing to
312 ● A New Technological Era for American Agriculture

use modem analytical separation and detection tools often

find that the companion sample extraction techniques are

inadequate, untested, or nonexistent. For example, the

present methods of determining amino acid composition

of foods with high sugar and starch contents is unsatisfactory-sugar and starches cause extensive losses of the

amino acids in the sample preparation step (hydrolysis).

The lack of proper extraction techniques is frequently

the primary bottle neck to obtaining good data on the

levels of the components in foods and feeds. In most

cases the compounds of interest must be separated from

other similar components in foods and feeds before they

can be quantified. Once the extraction and separation of

chemical classes has been accomplished, techniques and

instrumentation for the analytical separation and detection of individual compounds are available (30).

New assay procedures must be validated before they

can be widely used for food safety analysis. Validation

has been defined as the process of determining the suitability of methodology for providing useful analytical

data (48). Validation generally consists of 1) estimating

acceptable performance parameters in a laboratory, 2)

demonstrating successful performance in limited interlaboratory studies, and 3) demonstrating successful performance in collaborative studies. Performance parameters

assessed include accuracy (how well the methodology

measures true values), reproducibility, specificity, sensitivity (lowest levels detected), and scope (number of

analytes to which the procedure can be applied (8).

New analytical methodology is needed not only to

determine the initial safety of food products, but to conduct follow-up regulatory compliance and monitoring.

For example, with pesticides, the toxicity of the pesticide

initially must be determined. Once a pesticide is approved, methods are needed to verify that it does not

exceed tolerance levels in marketed food products. Conditions under which new products are developed differ

significantly from the routine conditions that exist in the

day-to-day and year-to-year production and processing

of foods. Genetic drift of new genetically modified species; changes in cultivation conditions or in processing

conditions; and transportation or storage conditions might

alter levels of toxic materials. Routine quality assurance

measures should be developed. Often quick, inexpensive, and reliable analytical techniques are not available

for widescale sample testing (30).

There is often a significant delay in the development

of new analytical methods and their general use in food

safety regulation. Nonselective, insensitive, and timeconsuming assays for which validation protocols are inadequate or unavailable may be the only assays available

for some compounds. New assay procedures are being

developed, but they must be validated before they can

be widely used for food safety regulation. Additionally,

new developments in automated chemical analysis can

help reduce the time and expense of manual assays. These

new methods have not been rapidly adopted for food

analysis, however (18, 25, 30, 43, 49, 52, 53).

Quality control and regulatory compliance personnel

may work under less-than-ideal conditions, have less formal analytical training, and use less sophisticated instrumentation than food scientists working in research. The

assays developed need to be rugged (i.e., require minimal

training and skill on the part of the analyst and give good

results even when there are small deviations from the

assay protocols), completed quickly at low unit cost, and

provide the necessary accuracy. Assays need to generate

low levels of false positives (i.e., doesn’t identify a compound as being present when it is not) and yet not have

high levels of false negatives (i.e., doesn’t miss compounds that are present). Assays must be accepted by

the professional analytical community, regulatory community, and legal community. Formal validation usually

will be required (30). In addition, compliance monitoring

of genetically modified organisms may require the development of statistical sampling methods that differ for

those used for pesticides and other chemical additives.

Compliance assays are particularly pertinent in that

there exist no analytical techniques capable of identifying

whether a food or feed crop has been genetically modified. Nor is it clear that any such methodology can be

developed on a generic level. Development of assays for

selected genetic alterations may be possible (i.e., if a

given genomic sequence is known to always be present

or absent in a given species, then its loss or appearance

would be reasonable evidence that genetic modification

had occurred). Probe technologies do exist to determine

the existence or absence of specific DNA or RNA sequences and proteins, but the types of DNA sequences

that conceivably could be engineered into plants is potentially great, and this procedure may not be very efficient (30).

The absence of a means of identifying if a food or

feed crop has been genetically modified is made more

significant by the fact that the United States imports large

quantities of food and feeds yearly. The United States is

by no means the only country capable of genetically

modifying food crops. If the United States enacts standards that are more strict than other countries, then the

general population may not feel that the assurances of
Chapter 11 —Scientific Issues in Food Safety ● 313

other countries is sufficient proof that the crops they are

exporting are not genetically engineered. A verification

methodology may be needed.

The lack of analytical systems for quality control and

regulatory compliance assays of genetically modified foods

and the lack of sufficient numbers of adequately trained

analysts could pose major problems in the assessment of

the safety of genetically modified foods. Furthermore,

the training of food analysts lags far behind that of other

fields (30).

Although this chapter has focused on potential food

safety risks that might arise from using biotechnology to

produce food products, it should be pointed out that biotechnology itself can be used to develop analytical methodologies that might improve the safety of foods.

Biotechnology products can be used to monitor plant and

animal products for food safety. Nucleic acid probes and

monoclinal antibodies can be used to analyze raw materials, ingredients, and finished products for pathogenic

organisms, bacterial or fungal toxins, chemical contaminants (i.e., pesticides, heavy metals), and biological

contaminants (i. e., hormones, enzymes). Detection kits

to monitor several pesticide and antibiotics, and some

microorganisms such as Salmonella, are commercially

available. Additionally, animal cell cultures may partially replace whole animal systems to test for acute toxicity. Biosensors may be used to monitor food processing,

packaging, transportation, and storage (15, 39).

New analytical methodologies still are needed to assay

the safety of genetically engineered foods. Such methodologies also could be used for other food-related issues, such as current attempts to analyze the anticancer

properties of certain food ingredients that occur in foods

such as garlic, broccoli, etc. (i.e., the designer foods

project currently in progress) (40). Much research is needed

to develop new methodologies. Primary attention should

be given to:

The development of acceptable alternatives to animal feeding tests for safety assessment. Because of

the inability to feed high levels of whole foods to

animals to determine toxicity, in vitro tests and

chemical/biochemical assays need to be developed.

The development of rapid, accurate methods for

assaying food components of particular interest.

The development of comprehensive food composition databases. It will not be possible to determine

acceptable limits of variation in composition of new

foods without knowing what kind of variation now

exists in traditional foods.

297-937 0 - 92 - 11 QL 3

. A greater understanding of basic molecular biology of plant development. This information will

be helpful in designing genetic strategies to improve composition or food characteristics. Greater

knowledge of the organization of plant genomes

would be helpful in assessing the positional effects

if any, Improved methods of toxicological assessment of proteins and/or whole foods would constitute an important advance in the safety review

of foods.

. The development of fixed algorithms for computations and report generation to reduce the human

error in food safety assessments and research.

Research must be conducted in many areas to develop

the analytical methodology needed to assess the safety

of food products produced with biotechnology. The regulatory agencies responsible for assuring safety must set

priorities for their own in-house research programs. Additionally, it would be useful for these agencies to work

with the major research funding agencies (i.e., NIH,

NSF, and USDA) to support the research and training of

food analysts needed to assess the safety of biotechnology

food products.

SUMMARY

The key scientific issues raised by the genetic modification of foods are with respect to the activity of the

inserted gene and the site of insertion of the gene into

the host genetic material. Assessment of the activity

of the inserted gene includes assessing the safety of

the gene product itself and any secondary products

whose production might be stimulated by the presence

of the gene product (e. g., if the gene product is an

enzyme or hormone that mediates the production of

other compounds).

The gene product itself is a protein. Proteins are generally nontoxic, readily degradable in the host organism,

and easily digestible by humans. The major concern with

respect to the gene product itself may be that it results

in increased allergenic responses rather than toxic effects.

Secondary products stimulated by the presence of the

gene product, however, may not be proteins. An increased understanding of plant physiology, the physiological impacts of the inserted gene, and the possible

development of new analytical techniques is needed to

identify any secondary compounds produced so they can

be assessed for safety.

Other genetic material inserted into a

in addition to the selected gene might

host organism

include vector
314 ● A New Technological Era for American Agriculture

material and marker genes used to identify those cells

that incorporate the selected gene. The current use of

vectors and marker genes that are well characterized,

nontoxic, and already widely present in the food system

is not expected to result in significant food safety problems when used to genetically modify foods.

At present, researchers cannot completely control the

location where a selected gene inserts into the host’s

genetic material. There is a possibility that the insertion

site of the selected gene will be such that it activates or

deactivates host organism genes (possibly resulting in

pleiotropic effects). Some host organisms used as food

(e.g., most food crops, some microorganisms, and some

marine animals) naturally produce compounds that could

potentially display toxic effects in humans if consumed

in sufficient quantity. If the insertion site of the selected

gene in the host organism is such that it increases the

production of these potentially toxic compounds, food

safety issues could arise.

Because these insertional effects would not be predicted based on the knowledge of the physiological activity of the selected gene, one approach to detecting

whether or not any of these effects have in fact occurred

would be to compare the composition of the genetically

modified organism with its traditional counterpart. However, our understanding and knowledge of the identity

and normal levels of toxic compounds in the foods we

currently eat and extraction methodologies are insufficient to perform an extensive comparison. Comparison

of the levels of major nutrients and some widely known

acutely toxic compounds between biotechnology-derived

foods and their traditional counterparts could probably

be made. But plant compounds have never been identified nor evaluated to determine if they cause long-term

toxic effects in humans.

A question that must be decided is whether or not

those comparisons that cannot currently be made are significant from a food safety standpoint. The development

of new crop varieties using traditional breeding and cell

culture techniques can also result in similar pleiotropic

effects. To date, no evidence exists that the development

of new crop varieties has significantly decreased the safety

of the food supply. It may also be the case that new food

products produced with biotechnology will present no

food safety risks greater than those already generated by

the foods we eat every day. It will be the task of the

agencies responsible for food safety to identify those

biotechnology-derived food products that may present

increased food risks.

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

13.

14.

15.

CHAPTER 11 REFERENCES

Ames, B.N. and Gold, L. S., “Chemical Carcinogenesis: Too Many Rodent Carcinogens, ” Proceedings of the National Academy of Science, vol. 87,

1990, Pp. 7772-7776.

Ames, B. N., Profet, M., and Gold, L. S., “Dietary

Pesticides (99.99% All Natural, Proceedings of ?he

National Academy of Science, vol. 87, 1990, pp.

7777–7781 .

Ames, B. N., Profet, M., and Gold, L. S., “Nature’s

Chemicals and Synthetic Chemicals: Comparative

Toxicology, ’ Proceedings of the National Academy

of Science, vol. 87, 1990, pp. 7782–7786.

Bennet, J.V. et al., “Infectious and Parasitic Disease, ’ Closing the Gap: the Burden of Unnecessary

Illness, R.W. Amler and H.B. Dull (eds. ) (New

York, NY: Oxford University Press, 1987), pp. 102–

114.

Berkowitz, D. B., “Food Safety of Transgenic Animals, ” Biotechnology, vol. 8, 1990, pp. 819–815.

Cheeke, P. R., Toxicants of Plant Origin (Boca Raton, FL: CRC Press, 1989).

Cliver, D.O. (cd.), Foodborne Diseases (San Diego,

CA: Academic Press, Inc., 1990),

Conacher, Henry B. S., “Validation of Analytical

Methods for Pesticide Residues and Confirmation of

Results, ” background paper for U.S. Congress, Office of Technology Assessment, Pesticide Residues

in Food: Technologies for Detection, OTA-F-398

(Washington, DC: U.S. Government Printing Office, October 1988).

Conner, John D. Jr. et al., Pesticide Regulation

Handbook (New York, NY: Executive Enterprises

Publications Co., Inc., January 1991).

Debethizy, J,D. and Hayes, J. R., “Metabolism: A

Determinant of Toxicology, ” Principles and Methods of Toxicology, second edition, A. Wallace Hayes

(cd.) (New York, NY: Raven Press, Ltd., 1989).

Falco, S. C., “Herbicide Resistant Crops, ” Genetically-Engineered Plants: Scientific Issues in Their

Regulation for Animal Feed and Human Food Uses,

Workshop at Boyce Thompson Institute for Plant

Research and Cornell university, Ithaca, NY, May

1-3, 1989.

Fong, Harry, Professor of Pharmacognosy, University of Illinois at Chicago, personal communication,

July 1991.

Freiberg, Bill, “WSU Scientists Discover First

Polypeptide in Plants, ” AgBiolechnology News,

September/October, 1991.

Friedmann, T., “Progress Toward Human Gene

Therapy,” Science, vol. 244, 1989, pp. 1275.

Harlander, Susan, “Biotechnology in Food Processing in the 1990’ s,” commissioned background

paper prepared for the Office of Technology Assessment, 1991.
Chapter 11—Scientijlc issues in Food Safety ● 315

16. Health and Welfare Canada, “Approaches to Assessing the Safety of Crops Developed Through Wide–

Cross Hybridization Techniques, ” Proceedings of a

Food Directorate Symposium, Nov. 22, 1989, Ottawa, Canada.

17. Health and Welfare Canada, Nutritional Recommendations, the Report of the Scientific Review

Committee, Ottawa, Canada, 1990.

18. Holden, J.M. et al., “A System for Evaluating the

Quality of Published Nutrient Data: Selenium, a Test

Case, ’ Food Composition Data: A Users Perspective, Food and Nutrition Bulletin, Supplement 12,

W.M. Rand, C.T. Windham, B.W. Wyse and V.R.

Young (eds. ), United Nations University, Tokyo,

Japan, 1987.

19. Hotchkiss, Joseph H., “Food Related Risks: A Food

Scientists Perspective, ” Agricultural Biotechnology, Food Safety, and Nutritional Quality for the

Consumer, National Agricultural Biotechnology

Council Reports, June Fessenden MacDonald (cd.)

(Binghamton, NY: Union Press, 1990).

20. International Food Biotechnology Council, “Biotechnologies and Food: Assuring the Safety of Foods

Produced by Genetic Modification, ” 1990.

21. Jones, Daniel D. and Maryanski, James H., “Safety

Considerations in the Evaluation of Transgenic Plants

for Human Food, ” Risk Assessment in Genetic Engineering, Morris A. Levin and Harlee S. Strauss

(eds. ) (New York, NY: McGraw–Hill, Inc., 1991),

pp. 64-82.

22. Li, A. P., “Protein Toxicology Applied to Biotechnology Products, ” Genetically–Engineered Plants:

Scient@c Issues in Their regulation for Animal Feed

and Human Food Uses, Workshop at Boyce Thompson Institute for Plant Research and Cornell university, Ithaca, NY, May 1–3, 1989.

23. Liener, I. E., Toxic Constituents of Plant Foodstu#s,

second edition (New York, NY: Academic Press,

1980.

24. Lu, F. C., “Basic Toxicology, “ Fundamentals, Target Organs, and Risk Assessment (Washington, DC:

Hemisphere Publishing Corporation, 1985).

25. Merchandise, H., “Accuracy in the Analyses of Biological Materials, ’ Fresenius Zeitschrift fur Analytishce Chemie, vol. 326, 1987, pp. 613–617.

26. McMillan, M. and Thompson, J. C., “An Outbreak

of Suspected Solanine Poisoning in Schoolboys: Examinations of Criteria of Solanine Poisoning, ”

Quarterly Journal of Medicine, vol. 48, 1979, pp.

227–243.

27. Miller, Sanford A., “Food Safety–An International

Concern, ’ Food Microbiology, 7:81-88, 1990.

28. Miller, Sanford A., Food Chemical News, Oct. 21,

1991, p. 46.

29. Ministry of Agriculture, Fisheries and Food, “Memorandum on the Testing of Novel Foods, Incorporating Guidelines for Testing for the Advisory Committee on Irradiated and Novel Foods, ’ Department

of Health and Social Security, Ministry of Agriculture, Fisheries, and Food, Scottish Home and Health

Department, Welsh Office, and Department of Health

and Social Services, Northern Ireland, 1984.

30. Munro, Ian C., Pariza, Michael, and Stewart, Kent

K., “Scientific Information and Methodologies for Assessing the Safety of Genetically Modified Foods and

Feeds,” commissioned background paper prepared for

the Office of Technology Assessment, 1991.

31. Nartowicz, V. D., Buchanan, R. L., and Segall, S.,

“Aflatoxin Production in Regular and Decaffeinated

Coffee Beans, ” Journal of Food Science, vol. 44,

1979, p. 446.

32. National Academy of Sciences, Toxicants Occurring

Naturally in Foods, Printing and Publishing Office,

National Academy of Sciences, Washington, DC,

1973.

33. National Academy of Science, “Diet, Nutrition, and

Cancer, ” Committee on Diet, Nutrition, and Cancer, Assembly of Life Sciences, National Research

Council, National Academy Press, Washington, DC,

1982.

34. National Academy of Science, “Genetic Engineering of Plants: Agricultural Research Opportunities

and Policy Concern s,” Board on Agriculture, National Research Council, Washington, DC, 1984.

35. Nesheim, Maiden C., “Food Related Risks; A Nutritionist’s Perspective, ” Agricultural Biotechnology, Food Safety and Nutritional Quality for the

Consumer, National Agricultural Biotechnology

Council Reports, 1990, pp. 90-95.

36. Nriagu, J. O., and Simmons, M. S., Food Contamination From Environmental Sources (New York,

NY: J. Wiley and Sons, 1990).

37. Pariza, Michael W., ‘‘Evaluating the Relative Safety

of Biotechnologically Produced Foods. Agricultural Biotechnolog~’, Food Safe~~, and Nutritional

Quality for the Consumer, National Agricultural

Biotechnology Council Reports, June Fessenden

MacDonald (cd. ) (Binghamton, NY: Union Press,

1990).

38. Pariza, M. W., and Foster, E. M., ‘‘Determining the

Safety of Enzymes Used in Food Processing, ’ Journal of Food Proteins, vol. 46, 1983, pp. 453–468.

39, Parson, George, “Biotechnological Diagnostics for

the Detection of Microbial Contamination of Food,

Agricultural Biotechnology, Food Safety, and Nutritional Quali~~ for the Consumer, National Agricultural Biotechnology Council Reports, June

Fessenden MacDonald (cd. ) (Binghamton, NY: Union

Press, 1990).

40. Pierson, Herbert, National Cancer Institute, Designer Foods Program, personal communication, June

1991.
316 . A New Technological Era for American Agriculture

41.

42.

43.

44.

45.

46.

47.

48.

49.

50.

51.

Pursel, Vern, “Prospects for Genetic Engineering

of Swine, ” commissioned background paper prepared for the Office of Technology Assessment, 1991.

Senti, F. R., “Agricultural Practices Influencing Vitamin-Mineral Content of Foods and Biological

Availability, ’ Nutrients in Processed Foods–Vitamins, Minerals, American Medical Association,

Publishing Sciences Group, Acton, MA, 1974.

Stepany, R.W. and Van Ginkel, L. A., “Quality

Criteria for Residue Analysis and Reference Materials: Relationship Between Legal Procedures and

Materials, ” Fresenius Journal of Analytical Chemistry, vol. 338, 1990, pp. 370–377.

Stotzky, G. and Babich, J., “Fate of GeneticallyEngineered Microbes in Natural Environments, ”

Recombinant DNA Technical Bulletin, vol. 7, 1985,

pp. 163–188.

Sugimura, T., ‘‘Studies on Environmental Chemical

Carcinogenesis in Japan, ” Science, vol. 233, 1986,

pp. 312-318.

Sugimura, T., “New Environmental Carcinogens in

Daily Life, ” TIPS, vol. 9, 1988, pp. 205–209.

Sugimura, T. et al., “Mutagenes and Carcinogens

Formed by Cooking Meat and Fish-Heterocyclic

Amines in Maillard Reaction in Food Processing, ”

Human Nutrition and Physiology, 1990.

Taylor, J. K., Analytical Chemistry, 55:600A, 1983.

Taylor, J. K., Quality Assurance of Chemical Measurements, Lewis Publishers, Chelsea, Michigan,

1987.

Tiedje, J.M. et al., “The Planned Introduction of

Genetically Engineered Organisms: Ecological Considerations and Recommendations, ” Ecology, vol.

70, 1989, pp. 289–315.

Trichilo, Charles L. and Schmitt, Richard D., “Federal Pesticide Monitoring Programs: Analytical

Methods Development, ’ background paper for U.S.

Congress, Office of Technology Assessment, Pes52.

53.

54.

55.

56.

57.

58.

59.

60.

61.

ticide Residues in Food: Technologies for Detection,

OTA-F-398 (Washington, DC: U.S. Government

Printing Office, October, 1988).

U.S. Congress, General Accounting Office, “FDA

Surveys Not Adequate to Demonstrate Safety of Milk

supply,” GAO/RCED-91-26, November 1990.

U.S. Congress, Office of Technology Assessment,

Pesticide Residues in Food: Technologies for Detection, OTA-F-398 (Washington, DC: U.S. Government Printing Office, October 1988).

U.S. Department of Health and Human Services,

Food and Drug Administration, Center for Veterinary Medicine, Addendum to the New Animal Drug

Application, Form FDA 356V.

U.S. Department of Health and Human Services,

Center for Disease Control, Foodborne Disease Surveillance: Annual Summary, various years.

U.S. Environmental Protection Agency, Office of

Pesticide Programs, ‘‘Final Report of the Transgenic

Plant Workshop, ” College Park, MD, Jun. 18-20,

1990.

U.S. Environmental Protection Agency, Office of

Pesticide and Toxic Substances, Subdivision M Pesticide Testing Guidelines–Microbial and Biochemical Pest Control Agents.

Weisburger, E. K., Progress in Predictive Toxicology, D.B. Clayson, I.C. Munro, P. Shubik, and J.A.

Swenberg (eds. ), Elsevier, Amsterdam, 1990.

Weisburger, J.H. and Williams, G. M., “Chemical

Carcinogens, ’ Casarett and Doull’s Toxicology: the

Basic Science of Poisons, second edition, J. Doull,

C.D. Klaassen, and M.O. Amdur (eds. ) (New York,

NY: Macmillan Publishing Co., Inc., 1980).

Willimott, S. G., “An Investigation of Potato Poisoning, ” Analyst, vol. 58, 1933, pp. 431-439.

Zitnak, A., and Johnston, G. R., “Glycoalkaloid

Content of B5141–6 Potatoes, ” American Potato

Journal, vol. 47, 1970, p. 256.
Chapter 12

Public Perceptions of Food Safety

Photo credit: DNAP
Contents

Page

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ........319

CONCERN ABOUT THE REGULATORY PROCESS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ...321

PERSONAL PERCEPTIONS OF RISK . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 323

Consumer Perceptions of Adverse Outcomes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324

Consumer Willingness To Pay . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324

Consumer Perceptions of Risk Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 324

Perceptions of the Probability of Harrn . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325

IMPLICATIONS FOR CONSUMER BEHAVIOR AND WILLINGNESS TO PAY FOR

IMPROVED FOOD SAFETY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 325

IMPLICATIONS FOR NEW AGRICULTURAL TECHNOLOGIES . . . . . . . . . . . . . . . . . . . . . . . . . . 329

Food Scares . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .................331

Food Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 332

SUMMARY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............. 335

CHAPTER 12 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 336

Tables

Table Page

12-l. Food Marketing Institute Consumer Food Safety Survey Responses, 1989 and 1990 ...319

12-2. Summary of Consumer Food Safety Surveys . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...........320

12-3. Specific Food Safety Concerns by Consumers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 320

12-4. Consumer Response to New Agricultural Technologies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 321

12-5. Consumer Confidence in Regulatory Agencies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ........322

12-6. Consumer Perceptions of the Likelihood That a Food Contains Pesticide Residues ... ..325

12-7. Consumer Perceptions of the probability of Health Problems Occurring Because of

Pesticide Residues in Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 326

12-8. Consumers Who Have Purchased Organic Produce . . . . . . . . . . . . . . . . . . . . . . . . . . . ... .......327

12-9. Frequency of Purchase of Organic Produce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 327

12-10. Estimated Consumer Willingness To Pay To Reduce Pesticide Residues Under

Specified Market Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... .....328

12-11. Estimated Consumer Willingness To Pay for Pesticide Residue Reductions

Under No Specified Market Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .................328

12-12. Consumers Indicating Purchase lntentions of Milk Produced With Bovine

Somatotropin Under Specified Conditions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 330

12-13. Consumers Indicating Purchase Intentions of Meat Produced With Porcine

Somatotropin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...........331

12-14. Consumer Confidence Following Alar and Cyanide Scare . . . . . . . . . . . . . . . . . . . . . . . . . . . ...332
Chapter 12

Public Perceptions of Food Safety

INTRODUCTION

Public acceptance or rejection of new food products

produced via biotechnology will determine the commercial success of these products. Public concerns about the

food products themselves and the level of confidence in

the agencies responsible for ensuring the safety of the

products will be of paramount importance. Consumer

demand for food safety is a relatively new research topic.

Most available information consists of responses to general survey questions. Extensive empirical or statistical

analyses are rare, and those that exist generally focus on

issues involving pesticides. Consumer food surveys have

been conducted for many years, but only recently have

they included questions about food safety. The Food

Marketing Institute, for example, began conducting annual opinion polls on supermarket trends in 1974, but

did not include questions on food safety until 1982.

Comparisons among surveys are complicated because

sampling methods, wording of the questions, and response

categories provided can differ widely. Thus, direct comparisons between surveys generally is not possible. And

not surprisingly, surveys that ask respondents about a specific risk report higher levels of concern about that risk

than surveys that merely ask respondents to list their concerns. For example, in 1989 and 1990 the Food Marketing

Institute asked consumers what they felt were the greatest

risks to food safety, and also asked them to identify items

they considered serious from a specified list. When asked

to list food safety concerns, less than 20 percent of respondents named pesticide residues, but more than 80 percent said pesticides were a serious health hazard when

specifically asked. Thus, conclusions must be viewed within

the context of the questions asked (table 12-1).

The lack of commonly accepted frameworks and methods used in consumer food surveys makes it nearly impossible to arrive at many definitive conclusions concerning

public perceptions of food safety. What can be reasonably deduced, however, is that over time, general concern about food safety seems to have increased (table 12-

2), and the types of food risks perceived to be a problem

have broadened (table 12-3). Historically, food safety

concerns were commonly associated with the handling,

processing, and packaging of food. These concerns still

remain; however, concerns over the risks associated with

the way food is grown have been added (22).

Only a handful of surveys have asked people whether

new agricultural technologies, specifically those derived

Table 12-1—Food Marketing Institute Consumer

Food Safety Survey Responses, 1989 and 1990

Category Open-ended

specified question

Food safety category 1989 1990 1989 1990

Spoilage and germs ., . . . . . . . . .

Tampering . . . . . . . . . . . . . . . . . . .

Improper packaging and canning

Pesticide residues . . . . . . . . . . . .

Chemicals . . . . . . . . . . . . . . . . . . .

Unsanitary handling by

supermarket employees . . . . .

Additives (nonspecific) . . . . . . . . .

Preservatives . . . . . . . . . . . . . . . . .

Unsanitary handling by

supermarket shoppers . . . . . . .

Processing and preparations of

foods . . . . . . . . . . . . . . . . . . . . . .

Pollution and environmental

pollution . . . . . . . . . . . . . . . . . . .

Bugs, pests, and rats ... , . . . . . ,

Artificial coloring . . . . . . . . . . . . . .

Antibiotics . . . . . . . . . . . . . . . . . . . .

Radiation . . . . . . . . . . . . . . . . . . . .

Other . . . . . . . . . . . . . . . . . . . . . . . .

None . . . . . . . . . . . . . . . . . . . . . . . .

Not sure . . . . . . . . . . . . . . . . . . . . .

Additives and preservatives . . . .

Nitrites . . . . . . . . . . . . . . . . . . . . . . .

NA

NA

NA

82

NA

NA

NA

NA

NA

NA

NA

NA

28

61

42

NA

NA

NA

30

44

Percent

NA 36

NA 20

NA 17

80 16

NA 11

NA 10

NA 7

NA 7

NA 6

NA 4

NA 3

NA 3

21 2

56 1

42 1

NA 6

NA 2

NA 11

26 NA

37 NA

29

14

16

19

16

11

6

8

3

4

3

3

2

1

10

6

12

NA

NA

NA = Not applicable.

NOTE:

These are Food Marketing Institute (FMI) surveys of 1989 and 1990. 1989

respondents were only those that in earlier questions indicated that they were

not completely confident of the food supply. 1990 respondents included everyone initially surveyed. Respondents were asked “What, if anything, do you

feel are the greatest threats to the safety of the food you eat” (open ended

question) and “I’m going to read a list of food items that may or may not

constitute a health hazard, For each one please tell me if you believe it is a

serious health hazard, somewhat of a hazard, or not a hazard at all “

SOURCE: Food Marketing Institute, TRENDS: Consumer Attitudes and

the Market P/ace, Washington, DC, 1989 and 1990,

from biotechnology, cause any food safety concerns. While

a significant percentage of consumers expressed concern

about the safety of new biotechnology-derived products, a

comparable percentage also expressed concern about other

food safety issues, such as pesticide residues (table 12-4).

It is important not to overinterpret the results of such

surveys; virtually all food contaminants are perceived as

potential risks to at least some degree by the majority of

consumers. However, the surveys do not ask consumers,

for example, how likely it is that the contaminant is at

hazardous levels in the food supply, or the probability that

the level of contaminants present will result in impaired

health or death to them or their family. These questions

are more pertinent to assessing how concerned consumers

-319-
320 . A New Technological Era for American Agriculture

Table 12-2—Summary of Consumer Food Safety Surveys

FDA FMI FMI FMI FMI FMI FMI VANR

1980 1982 1983 1986 1988 1989 1990 1991

Percent

Fully confident . . . . . . . . . . 47 NA NA 58 55 23 10

Mostly confident . . . . . . . . . 14 89 88 34 38 58 56

Somewhat concerned . . . . 28 9 11 5 5 15 18 23

Very concerned . . . . . . . . . 10 NA NA 2 1 2 2 4

Not sure/No answer . . . . . 2 2 1 0.5 0.5 2 0.5 6

NA = Not applicable.

NOTES:

Food and Drug Administration (FDA) survey consisted of 1,570 respondents and asked “How do you feel about the safety of food and its effect on your

health? Do you feel confident that your food is safe or do you worry about it, or what?” Response categories provided include fully confident, basically

confident with some doubt, concerned about one or two specific problems, very worried, not sure.

SOURCE: James T. Heimbach, Yesterday, Today and Tomorrow: consumer Perceptions of Food Safety, Washington, DC, Division of Consumer Studies,

Bureau of Foods, U.S. Food and Drug Administration, 1981.

The Food Marketing Institute (FMI) surveys of 1982 and 1983 consisted of 1,003 and 1,001 respondents, respectively, and asked the question “Please tell

me whether you agree strongly, agree somewhat, disagree somewhat, or disagree strongly with the following statement-the food in supermarkets is safe

to eat?” The results of the survey are presented in aggregate form such that the 89 and 88 percent somewhat confident figure includes both strongly agree

and somewhat agree responses. Likewise, the percentages reported for somewhat concerned include the responses for both the disagree somewhat and

disagree strongly categories.

SOURCE: Surveys conducted by Louis Harris Associates for the Food Marketing Institute, January 1982 and February 1983.

The Food Marketing Institute (FMI) surveys of 1986 and 1988 consisted of 1,004 and 1,019 respondents, respectively, and asked the question “The following

are statements that people have made. For each one, please tell me how close it comes to describing you—very close, somewhat close, not very close,

or not close at all—1 feel the food in supermarkets is wholesome and safe to eat.”

SOURCE: Food Marketing Institute, TRENDS: Consumer Attitudes and the Market Place, Washington, DC, 1986 and 1966.

The Food Marketing Institute (FMI) surveys of 1969 and 1990 surveyed 1,031 and 1,005 respondents, respectively, and asked the question “How confident

are you that the food in your supermarket is safe? Would you say you are completely confident, mostly confident, somewhat doubtful, or very doubtful?”

SOURCE: Food Marketing Institute, TRENDS: Consumer Attitudes and the Market Place, Washington, DC, 1989 and 1990.

The van Ravenswaay and Hoehn (VANRAV) survey consisted of 906 respondents and asked the question “How confident are you that the food your

household eats is safe?” Response categories provided include completely confident, mostly confident, somewhat doubtful, and very doubtful.

SOURCE: Eileen O. van Ravenswaay and John P. Hoehn, “Contingent Valuation and Food Safety: The Case of Pesticide Residues in Food,” Michigan

State University staff paper No. 91-13, 1991.

Table 12-3—Specific Food Safety Concerns by Consumersa

FMI Mich

1984 1985 1986 1987 1988 1989 1990 1990

Pesticide residues . . . . . . . . .

Antibiotics and hormones . . .

Nitrites . . . . . . . . . . . . . . . . . . .

Wadiation . . . . . . . . . . . . . . . .

Additives and Preservatives

Artificial colors ., . . . . . . . . . .

Tampering . . . . . . . . . . . . . . . .

Handling . . . . . . . . . . . . . . . . .

Improper processing . . . . . . .

Natural toxins and bacteria

77

x

x

32

26

x

x

x

x

73

x

x

36

28

x

x

x

x

75

x

37

33

26

x

x

x

x

Percent

76 75

61 61

38 44

43 36

36 29

24 21

x x

x x

x x

x x

82

6?

44

42

30

28

x

x

x

x

80

56

37

42

26

21

x

x

x

x

68

53

37

36

57

19

71

68

67

50

‘Respondents Indicating Serious Health Hazard

x = Not asked

NOTES:

Food Marketing Institute (FMI) surveys asked “I’m going to read a list of food items that may or may not constitute a health hazard. For each one please

tell me if you believe it is a serious health hazard, somewhat of a hazard, or not a hazard at all.”

SOURCE: Food Marketing Institute, TRENDS: Consumer Attitudes and the Market Place, Washington, DC, 1964-1990.

Michigan (Mich) survey asked “Now I’m going to read a list of factors that mayor may not constitute a health hazard to food products. For each one, please

tell me if you believe the item is a serious health hazard, somewhat of a health hazard, or not at all a health hazard.

SOURCE: Charles Atkin, “Consumer Attitudes About Food Issues in Michigan,” Michigan Department of Agriculture, March 1990.
Chapter 12—Public Perceptions of Food Safety ..321

Table 12-4-Consumer Response to New Agricultural Technologies

bST Transgenic organisms

VA MO WI pST Vegetables and fruit Dairy and meat

Percent

Yes . . . . . . . . . . . . . . . . . . . . 44 93 71 33 82

No . . . . . . . . . . . . . . . . . . . . . 19 8 NR 67 7 7 NR

Don’t know . . . . . . . . . . . . . 37 5 NR NR NR NR

NR = Not reported

NOTES:

Surveys for bovine somatotropin (bST):

Virginia (VA) survey. Because only 20 percent of respondents had heard of it, they were given descriptions of the technology and conclusions of scientists

concerning safety. They were also told that it was under development and pending FDA approval. Respondents were asked if the agreed with the statement

that approval of bST will make milk unsafe.

SOURCE: W.P. Preston, A.M. McGuirk, and G.M. Jones, “Consumer Reaction to the Introduction of Bovine Somatotropin,” paper presented at the Economics

of Food Safety Workshop, Alexandria, VA, June 1990.

Missouri (MO) survey. Respondents were asked if they would probably or definitely have concerns about the safety of milk.

SOURCE: Barbara J. Slusher, “Consumer Acceptance of Food Production Innovations-An Empirical Focus on Biotechnology and bST,” paper presented

at the Second International Conference on Research in the Consumer Interest, Snowbird, UT, Aug. 9-11, 1990.

Wisconsin (Wl) survey. About 90 percent of the respondents were aware of bST. Respondents were asked if they have concerns that future studies might

reveal that bST might harm human health.

SOURCE: Robin Douthitt, “Biotechnology and Consumer Choice in the Market Place: Should There Be Mandatory Product Labelling? A Case Study of

Bovine Somatotropin and Wisconsin Dairy Products,” paper presented at the Second International Conference on Research in the Consumer

Interest, Snowbird, UT, Aug. 9-11, 1990.

Porcine somatotropin (pST) survey was conducted in 1986 in Atlanta, New York City, and Philadelphia. Respondents were given a description of PST and

asked if they would eat less pork due to its use in production.

SOURCE: Catherine Halbrendt et al., “Public Attitudes in the Northeast Region Toward Recombinant Porcine Somatotropin,” Journal of Food Distribution

Research, February 1989, pp. 153–163.

Transgenic vegetables and fruit and poultry and meat survey was conducted in North Carolina. Respondents were asked if they would be very or somewhat

concerned with eating genetically engineered products.

SOURCE: Thomas Hoban. “Public Attitudes Toward Bovine Somatotropin,” paper presented at the 39th Annual DairyConference, Winston-Salem, NC,

Feb. 27–28, 1990.

really are about the safety of the food supply. These types

of information are needed to help define what consumers

mean when they say a problem is serious. Thus, surveys

that report that significant percentages of consumers view

a risk as serious may create the impression that consumers

see huge risks from contaminants. However, this could be

an erroneous conclusion. The information needed to make

that type of assessment is lacking (22).

The survey information presented suggests that consumers do have food safety concerns, but it does not

provide many insights into the cause(s) of these concerns.

Consumer concern could be based on a real or perceived

impression that the food regulatory system is inadequate.

Consumers may feel that standards for safety are too

lenient, have become obsolete, or are impossible to establish because of scientific uncertainty. It is possible

that consumers are satisfied with the standards, but are

concerned that they are not adequately enforced.

The extent of concern expressed by consumers will be

influenced by their personal perceptions of risks. Risk

perceptions involve assessments of the probability that

loss or harm will occur as well as assessments of the

type, severity, duration, and timing of the harm. Such

perceptions are highly variable. Even if consumers do

perceive risks, the question arises as to how much they

are willing to pay to reduce or avoid a risk. Consumers

are constantly evaluating these tradeoffs, and the willingness to pay to reduce risks is highly variable among

the population. These issues must be understood in order

to determine what food safety policy changes consumers

might prefer (24).

CONCERN ABOUT THE

REGULATORY PROCESS

As indicated, consumers maybe concerned that safety

standards are not stringent enough, or that they are not

adequately enforced. Information concerning how consumrs view safety standards is particularly pertinent as

Congress debates possible changes in how the Environmental Protection Agency (EPA) sets pesticide residue

tolerances. Unfortunately, definitive studies simply are

not available.

There is limited information that consumers have decreased confidence in the institutions responsible for food

safety. Once again, much of the information available

comes from general consumer surveys (table 12-5). How-
322 . A New Technological Era for American Agriculture

Table 12-5—Consumer Confidence

in Regulatory Agencies

Pennsylvania bST PST

1964 1984 VA MO Atl NY/Phil

Percent

Yes . . . . . . . . . 94 49 54 51 76.7 75

No . . . . . . . . . . NR NR 35 31 NR 25

Don’t know . . . NR NR 12 18 NR o

NR = Not reported

NOTES:

Consumers in Pennsylvania were asked if they thought that the “government does an adequate job of inspection. ”

SOURCE: Carolyn Sachs, Dorothy Blair, and Carolyn Richter, “Consumer

Pesticide Concerns: A 1965 and 1984 Comparison,” Jounal of

Consumer Affairs, vol. 21, 1987, pp. 96-107.

bST (VA): Consumers in Virginia were asked if “the government will make

sure milk supplies are safe and wholesome.”

SOURCE: W.P. Preston, A.M. McGuirk, and G.M. Jones, “Consumer Reaction to the Introduction of Bovine Somatotropin, ” paper presented at the Economics of Food Safety Workshop, Alexandria,

VA., June 1990.

bST (MO): Consumers in Missouri were asked if they agreed with the

statement “if a government agency such as FDA or USDA says a production process is safe then it is okay to eat foods produced that way.”

SOURCE: Barbara J. Slusher, “consumer Acceptance of Focal Production

Innovations-An Empirical Focus on Biotechnology and bST,” paper presented at the second International Conference on Research in the Consumer Interest, Snowbird, UT, Aug. 9-11, 1990.

PST (ATL): Consumers in Atlanta were asked if they would believe Federal

agencies concerning the safety of pST.

SOURCE: W.J. Florkowski, C.L. Huang, and Brian Goggin, “Attitudes Towards Porcine Somatotropin: A Consumer Survey of the Atlanta

Metropolitan Area,” The Georgia Agricultural Experiment Station, College of Agriculture, The University of Georgia Research

Report 570, August 1989.

pST (NY/Phil): Consumers in New York and Philadelphia were asked if they

would be inclined to believe Federal agencies concerning the safety of PST.

SOURCE: Catherine Halbrendt et al., “Public Attitudes in the Northeast

Region Toward Recombinant Porcine Somatotropin,” Journal

of Food Distribution Research, February 1989, pp. 153–163.

ever, these surveys provide little information about what

is causing public skepticism.

In an empirical analysis that might shed some light on

this issue, van Ravenswaay and Hoehn evaluated consumer willingness to pay for pesticide labeling in apples.

Using a methodology that economists call a contingent

valuation study, the authors simulated market conditions

by establishing a specified set of circumstances, and then

asked consumers about their purchase intentions. Values

obtained using this approach are contingent on, and must

be interpreted in light of, the market circumstances specified. The reliability and validity of the approach depends

critically on developing clear and meaningful choice

scenarios, including clear descriptions of the product and

conditions under which it will be offered for sale. Vague

or unfamiliar choices make it difficult for respondents to

predict how they would actually act, and the answers

Photo credit: Grant Heilman,

Some consumers are concerned that food safety

standards are not stringent enough, or that they are not

adequately enforced.

Inc.

given are likely to be a poor predictor of subsequent

behavior ( 10).

The authors of the study evaluated willingness to pay

for three types of product labels—no pesticide residues,

no detectable pesticide residues, and no pesticide residue

levels above Federal limits. Participants in the study were

provided a description of pesticides and information on

Federal pesticide limits. They were also informed of the

circumstances under which the apples would be marketed, including the assumption that only apples would

be labeled, that only one type of apple label would be

available, that labeled apples would be marketed and

displayed in stores as they are currently, and that the

prices of substitute fruits were the prices currently prevailing at the time of the study. Consumer willingness

to pay for different product labels was calculated (23).

The results indicate that on average, consumers were

willing to pay 23.6 cents per pound more for apples

certified and tested to have no residues above Federal

limits as compared to apples with no labels. Interestingly,

no statistically significant difference was found in the

willingness to pay for the Federal limit label and the no

detectable residue label. It was estimated that consumers

were willing to pay an average of 37.5 cents per pound

more for apples with the “no pesticide” label than for

unlabeled apples (23).

The estimates of willingness to pay for labels provide

information about how, on average, consumers value
Chapter 12—Public Perceptions of Food Safety .323

pesticide residue reduction, and given the constraints of

the methodology, the estimates represent an upper bound

of willingness to pay. However, they do not tell us how

many consumers would actually purchase a particular

label in the market because actual purchase decisions

will depend on whether or not the market conditions

specified in the study prevail, and on the total price of

the apples (i. e., base price of the apples plus the added

price of the label) (23).

While one must be careful not to stretch the interpretation of the results too far, they do raise some interesting

questions concerning how consumers feel about Federal

standards and enforcement of standards. It is illegal to

sell apples containing pesticide residue levels higher than

Federal specifications, and as such, all apples marketed

should contain residue levels that are less than the Federal

limit. Yet consumers certainly demonstrated a willingness to pay for the information that the particular apple

they were purchasing met Federal standards. This suggests that there is concern about the enforcement of Federal standards (23).

It is interesting that consumers were not willing to pay

more for apples certified to have no detectable residues

than for those that met Federal limits. Presumably, the

apples with no detectable residues could have considerably lower residue levels than those that meet Federal

limits. It appears that consumers are viewing these two

situations as being very similar. This again suggests that

consumers do not view the standards as being inadequate,

but do question whether most apples actually meet the

standards (23).

Consumers were willing to pay most for the “no pesticide residue” label; however, the “premium” on the

“no residue’ label compared to that on the ‘‘meets Federal standards” label was much lower (13.9 cents) than

the premium on the ‘‘meets Federal standards’ label in

comparison to no label at all (23.6 cents). Intuitively one

would suspect that if consumers were extremely concerned that the standards were too lax, that there would

be a small willingness to pay for assurance that the standards were met, and a much larger willingness to pay

for no residues (i.e., the differences should be the reverse

of what they were calculated to be). It is possible that

the difference between the ‘‘no residues’ and the ‘‘meets

Federal limit” labels are simply a reflection of people’s

willingness to pay more for a sure thing rather than for

something that still contains some degree of uncertainty;

and that in general, consumers are not unduly concerned

that standards are not appropriate.

The study also found that consumer willingness to pay

for labeled apples was not explained by respondents’ risk

perceptions. Respondents were willing to pay more for

the labels when they perceived little risk as well as when

they perceived large risks from pesticide residues. A

potential explanation suggested for this finding is that

the method used to elicit risk perceptions measured what

people think the risks are most of the time but not the

level of accuracy of that assessment. People may think

the regulatory system works most of the time, but that

it may break down occasionally, and consumers may be

willing to pay to reduce their uncertainty about these

errors. This analysis implies that it is the uncertainty

about risks rather than the average perception of risk that

is most important to consumers. If this is so, then it

implies that policy that reduces uncertainty about risks

(e.g., greater sampling and testing) rather than tougher

standards may be more important in alleviating consumer

concerns over food safety (22).

Clearly this study does not definitively reveal the extent of consumer concern about the process of setting

standards or about the enforcement of those standards.

The study does, however, present insights into the kinds

of information and approaches that will be needed to

begin answering those questions.

PERSONAL PERCEPTIONS

OF RISK

Consumer concerns about food safety will be influenced by personal perceptions of food-related risks. Risk

is defined as a chance of loss or harm. The chance of

occurrence can be high or low, and the potential loss or

harm constituting risk can vary in type, severity, duration, and timing. A severe, lengthy, and immediate harm

or loss would be viewed with greater alarm than a mild,

short-term, and delayed harm or loss. This perhaps explains why consumers, in contrast to scientists and food

regulatory personnel, seem to view pesticide residues as

a more serious food safety risk than microbial contamination. Consumers likely associate microbial agents with

an upset stomach, and possibly diarrhea, which may be

inconvenient and immediate, but which is likely to be a

short-term, relatively minor problem. Pesticide residues,

however, are viewed as causing cancer, certainly a catastrophic illness, even though its onset may be delayed

(3, 17, 23).

The concept of personal risk is further complicated by

the fact that consumers can choose to take risks, or may

face imposed risks (17). Risks can be avoided, but gen-
324 . A New Technological Era for American Agriculture

erally at some cost. If the cost of avoiding the risk is

high (e.g., because there are few good substitutes available) or if a person’s resources are limited, then the risk

will probably cause greater distress than if the risk were

easily avoided. Risks that are beyond the control of an

individual may be under the control of others. If it is

believed that those who do have control over risks are

not seeking to minimize the risks, distrust, doubt, and

suspicion could result. This may explain why some heavy

smokers still become upset over any potential cancer risks

associated with pesticide residues in food. Smokers choose

cigarettes, but don’t have much direct control over how

food is produced (24).

Public understanding of risks also varies. If the probability or the type of loss involved is not clearly understood,

it is more difficult for people to make decisions about

whether and how to avoid a risk. A higher level of uncertainty about risks and/or the ways and costs of avoiding

risks will result in a greater level of concern (24).

Thus, the possibility exists for consumers to have very

different perceptions concerning food safety risks. Variation in perceptions arise primarily from four different

sources. First, consumers may have different perceptions

of the types, severity, duration, or timing of any adverse

outcomes that may result from a risk. Second, consumers

may value the same outcome differently and thus may

be willing to pay different amounts to reduce the probability of that outcome occurring. Third, consumers may

have different views of how likely they are to be exposed

to a risk. And fourth, consumers may have a different

perception of the probability that the risk will cause harm

(24).

Consumer Perceptions of Adverse Outcomes

Few studies have evaluated the types of adverse outcomes consumers feel might result from food-borne risks.

The little information available comes from studies that

have evaluated perceived health risks associated with

pesticide residues. These studies indicate that consumers

do have different perceptions of the types of harm that

may result from consuming pesticide residues in food.

One study that compared perceptions of organic and conventional produce purchasers found that the former associated a greater number of adverse health effects with

pesticide residues than did purchasers of conventional

produce (6). A second study of organic produce purchasers found that these consumers considered pesticide

residues responsible for a wide range of adverse health

effects in addition to cancer (16). van Ravenswaay and

Hoehn (22) also found that consumers differed in terms

of their perceptions of the types of harms caused by

pesticide residues. Thus it seems likely that consumers

do have different perceptions of the types of harm that

might result from food hazards.

Consumer Willingness To Pay

The types of harm consumers associate with food safety

hazards are varied, and include allergic responses, intestinal

disorders, reproductive problems, cancer, and possibly death.

There is little information available as to how consumers

value these potential outcomes, or how much they would

be willing to pay to reduce the possibility of these outcomes

occurring. The limited evidence that exists for how consumers value harmful food safety outcomes is obtained

from studies that have analyzed conventional and/or organic

food purchases. (6, 16, 23). These studies estimated the

willingness to pay to reduce the annual risk of death from

pesticide residues by one in a million. The estimated willingness to pay to reduce mortality by this amount was

similar in all studies and for both conventional and organic

produce purchasers (6). Furthermore, this estimated willingness to pay was similar to the estimated willingness to

pay to achieve a one in a million reduction in mortality

due to occupational hazards, or by using seat belts and

installing home fire alarms (4). Thus, it appears that the

willingness to pay for a reduction in mortality is similar

for many consumers and is consistent for several different

potential causes of death.

Consumer Perceptions of Risk Exposure

Survey data indicate that consumers do have different

perceptions of the likelihood that different food items will

contain pesticide residues, and generally believe that fresh

produce is more likely to have residues than processed food

(table 12-6). However, in the study that evaluated conventional and organic purchasers of fresh produce, the participants did not feel that different types of fresh produce

presented significantly different risks (6).

Exposure to risk also depends on the cost and ability

to avoid the risk. The 1989 scare over Alar in apples

presents a good example. Alar was reported as posing a

small additional risk of cancer particularly in children.

Because there are many good substitutes for apples, consumers could easily avoid any potential risks from Alar

simply by purchasing other types of fruit regardless of

whether or not they believed the purported risks to be

significant. Thus exposure to a risk will depend on how

easily that risk can be avoided, and will vary for different

individuals and food safety hazards.
Chapter 12—Public Perceptions of Food Safety ● 325

Table 12-6-Consumer Perceptions of Likelihood

That a Food Contains Pesticide Residues

USDA van Ravenswaay

Fresh fruits and vegetables . . . . . 88

Apples . . . . . . . . . . . . . . . . . . . . . . NA

Lettuce . . . . . . . . . . . . . . . . . . . . . NA

Tomatoes . . . . . . . . . . . . . . . . . . . NA

Oranges . . . . . . . . . . . . . . . . . . . . NA

Frozen fruits and vegetables . . . . 32

Canned fruits and vegetables . . . . 28

Processed fruits and

vegetables (frozen and

canned) . . . . . . . . . . . . . . . . . . . NA

Fruit/vegetable juices . . . . . . . . . NA

Dried foods (flour, cereals, rice) 46

Cereals, flour and uncooked

grains ... , ... , . . . . . . . . . . . . NA

Bread and baked goods . . . . . . NA

Meat and poultry . . . . . . . . . . . . . . . 41

Fresh fish . . . . . . . . . . . . . . . . . . . NA

Fresh meat . . . . . . . . . . . . . . . . . . NA

Dairvmoducts . . . . . . . . . . . . . . . NA

Percent

5.8

5.5

5.4

5.2

4.8

NA

NA

4.1

4.1

NA

3.8

3.8

NA

4.3

4.2

3.1

NA = Not applicable.

NOTES:

USDA survey (1974): An in-person interview with homemakers in 2,503

households. Asked the question “Which of the types of food listed, if any,

do you believe could carry traces of chemicals to kill insects and other

pests?” Percentages reported are the number of respondents indicating

the possibility.

SOURCE: Judith Lea Jones and Jon P. Weimer, “Food Safety: Homemakers’ Attitudes and Practices, ” U.S. Department of Agriculture, Economic Research Service, Agricultural Economic Report

No. 360, January 1977.

van Ravenswaay and Hoehn survey (vanRav) (1990): Number of respondents was 906. Asked the question “What do you think the chances are

that there are any pesticide residues in each of the following types of food

that you might buy when you do the grocery shopping?” Respondents

were asked to assign scores ranging from O (O = percent chance) to 10

(91 to 100-percent chance). Scores reported are the average scores for

each category.

SOURCE: Eileen O. van Ravenswaay and John P. Hoehn, “Contingent

Valuation Safety: The Case of Pesticide Residues in Food,”

Michigan State University staff paper No. 91-13, 1991.

Perceptions of the Probability of Harm

Evidence exists that different consumers view the

probability of harm occurring very differently. The Hammitt study of organic and conventional food purchasers

found that organic food consumers had a significantly

higher estimation of the likelihood of developing cancer

or other health problems than did consumers of conventional foods. This study found that organic consumers

estimated that the additional risk of dying from consuming conventional produce for 1 year was 8.5 in 10,000.

Conventional food purchasers estimated the additional

risk of dying from consuming conventional produce for

1 year was 8 in 10,000,000. Thus, organic consumers

perceive the probability of dying as being three orders

of magnitude higher than conventional produce consumers. Similarly in the Rae study, organic produce purchasers estimated the additional lifetime chance of getting

cancer if only organic food was eaten was 1 in 4, as

compared to 1 in 2 if conventional food was eaten.

The van Ravenswaay and Hoehn study also examined

consumer perceptions concerning the probability of harm.

This study asked consumers to estimate the probability

that current levels of pesticide residues will cause health

problems to someone in your household (table 12-7).

The perceptions of how likely pesticide residues are to

cause health problems vary widely. When compared to

worst case estimates of the cancer risks associated with

pesticide residues, 

] at least half of the respondents perceived the health risks to their household as being less,

approximately 30 percent view the risks as being the

same, and about 15 percent consider the risks to be much

higher. At least a quarter of the population perceives the

risks associated with pesticide residues to be very serious,

while another quarter believes them to not be serious at

all. These two polar positions imply that there may be

very different preferences for changes in food safety policy among consumers (24).

IMPLICATIONS FOR CONSUMER

BEHAVIOR AND WILLINGNESS

TO PAY FOR IMPROVED FOOD

SAFETY

The food safety surveys discussed above indicate that

at least 80 percent of consumers consider pesticide residues to be a ‘‘serious’ hazard; however, while data are

1

The worst-case scenarios of lifetime additional cancer risks for an average household are estimated at 3.8 per 1,000 by the Environmental

Protection Agency (EPA) and 1.6 per 100 by the National Research Council (NRC). These scenarios are based on lifetime additional cancer risks

for anaverage household of 2.7 persons. For EPA, the worst-case estimate is that there would be 6,000 extra cases of cancer per year or a rate of

2 in 100,000. Assuming a 70-year lifespan and a linear dose-response function, this would be a lifetime risk of 1.4 in 1,000 persons. For a household

of 2.7 persons, the household risk would be 3.8 per 1,000. Similarly, the NRC worst-case estimate of extra lifetime cancer risk from pesticide

residues in food is 5.8 in 1,000. For a household of 2.7 persons, the household risks would be 1.6 in 100. The worst-case estimates and study

results are not completely comparable because the worst-case scenarios looked only at cancer risks. as compared to the broader issue of health

problems examined in the study. U.S. Environmental Protection Agency, “Unfinished Business: A Comparative Assessment of Environmental

Problems, ” 1987 and National Research Council, Board on Agriculture, Committee on Scientific and Regulatory Issues Underlying Pesticide Use

Patterns and Agricultural Innovation, ” Regulating Pesticides In Food, National Academy Press, Washington, DC, 1987.
326 . A New Technological Era for American Agriculture

Table 12-7—Consumer Perceptions of the

Probability of Health Problems Occurring Because

of Pesticide Residues in Food

Percent

No chance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.1

1 in a million . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19.5

1 in 100,000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16.4

1 in l0,000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13.4

1 in 1,000 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15.6

1 in 100 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.1

1 in 10 .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.1

1 in . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3.2

1 in 2 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1.0

Certain to happen . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4.4

No answer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5.2

NOTE:

The study asked the question “What do you think the chances are that

someone in your household will have health problems someday because

of the current level of pesticide residues in their food?”

SOURCE: Eileen O. van Ravenswaay and John P. Hoehn, “Contingent

Valuation and Food Safety: The Case of Pesticide Residues in

Food;’ Michigan State University staff paper No. 91-13,1991.

skimpy, it would appear that no more than 5 to 10 percent

of consumers could be classified as purchasers of organic

foods (tables 12-8 and 12-9).

Given that so many consumers seem to be concerned

about pesticide residues, why do so few buy organic

produce? Several factors are undoubtedly involved. Organic produce may not be available in the supermarkets

where consumers regularly shop. Even if available, the

choice of varieties may be limited orthe organic produce

maybe marketed or advertised differently from conventional produce. Another explanation may be the lackof

national definitions and standards for organic produce,

leaving consumers unsure about what they are actually

purchasing. However, cost and quality factors also play

a critical role in consumer purchasing decisions. Consumers are constantly faced with tradeoffs. For food safety

concerns, a major consideration is how much it will cost

to avoid or reduce perceived risks.

Because food safety is a public good required by law,

consumers face few actual food safety choices in the

marketplace. Consequently there are few opportunities

to observe the choices and tradeoffs consumers actually

make. Even if these tradeoffs could be observed, actual

market choices still may not reflect willingness to pay

for safety, because safety is a characteristic embodied in

goods and not a separate good itself. Methodologies have

been developed to overcome some of these problems so

that estimates of consumer willingness to pay to reduce

food risks can be made.2 These estimates tell us how

consumers value the food safety benefits of regulatory

control, and what tradeoffs they are willing to make

between food safety and income.

Four studies have attempted to estimate willingness to

pay for reduced pesticides based on data of actual purchases or purchase intentions under specified market conditions (table 12-10). Three studies asked consumers how

much they would generally be willing to pay to reduce

pesticide residues without specifying market conditions

(table 12-1 1). The results from the different approaches

are relatively consistent with each other, and suggest that

many consumers are willing to pay to reduce risks from

pesticide residues, however, not all are willing to pay

the same amount. Approximately one-quarter to onethird of the consumers surveyed indicate that they are

unwilling to pay anything. About 5 to 10 percent of

consumers, primarily those who now purchase organic

foods, appear to be willing to pay premiums of up to 50

percent over conventional foods. In between are the majority who may be willing to pay 5 to 10 percent more

for reduced pesticide residues (22).

Estimates of willingness to pay for reduced pesticide

residues indicate what consumers may be willing to pay

to reduce pesticide residues, but do not indicate whether

or not consumers will actually purchase a product in the

marketplace. Many factors affect the final purchase decision, including the perception of risk, total product

price (price of product plus willingness to pay for added

risk reduction), quality, and other factors associated with

the product, such as environmental concerns, small farm

issues, etc. (24).

Total price of a product will affect the quantities of

the product purchased regardless of the willingness to

pay for safety. For example, in the study that evaluated

the willingness to pay for labeled apples, given a total

price of apples of $0.79 per pound, the probability of

purchase was 0.59 for no-label apples, 0.69 for Federallimit apples, and 0.74 for no-residue apples. As total

2 TW0 methods are commonly used to estimate willingness to pay. One method seeks to IWeal prefe~nCeS for ch~actefistics of g~s based on

examining how changes in that characteristic affect purchases of the good (a method that economists call the hedonic approach). The other method

simulates the market and ascertains purchase intentions under specified circumstances (the contingent valuation method discussed previously). A

third method is to simply ask consumers how much they would pay for a product improvement without describing the specific market setting or

quantities involved (10).
Chapter 12—Public Perceptions of Food Safety .327

Table 12-8—Consumers Who Have Purchased

Organic Produce

Fresh Trend California Michigan

Percent

Yes . . . . . . . . . . . . . . 11 62 45

No . . . . . . . . . . . . . . . 89 38 48

Don’t know . . . . . . . 0 0 7

NOTES:

Fresh Trend Survey, October 1989, asked 1,260 households nationally if

they sought or bought organically grown produce in previous 12 months.

SOURCE: The Packer Focus: Fresh Trends 1990, B. Jones and T. Zind

(ads.), Vance Publishing Corp., Lindolnshire, IL, 1990, pp. 37-69.

California survey, California counties of Marin, Sacramento, and San Diego,

August 1989, asked 946 households if they purchase organic products,

SOURCE: Desmond Jolly, “Consumer Willingness to Pay Price Premiums

for Organic Apples and Peaches,” Department of Agricultural

Economics, University of California, Davis, March 1989.

Michgan survey was 600 households, 1990, and asked if they had ever

purchased organically grown foods,

SOURCE: Charles Atkin, “Consumer Attitudes About Food Issues in Michigan,” Michigan Department of Agriculture, March 1990.

price of apples increased, the probabilities of apple purchase decreased in all three scenarios (23).

Quality of the product is a major concern to purchasers

of organic products. Organic products frequently have

more pest damage than conventional products. Three

studies have looked at how pest damage affects consumer

purchases. The study that estimated consumer willingness to pay for pesticide labels in apples also estimated

the amount of pest damage that would be acceptable

under different label scenarios (22, 23, 24). This study

presented consumers with photographs portraying apples

that varied only in terms of pest damage. Four levels of

damage were presented ranging from no damage to damTable 12-9—Frequency of Purchase

of Organic Produce

California Michigan

Percent

Total purchasing organic produce. . . . . . 62 45

16–30 times/month . . . . . . . . . . . . . . . . . . 2 NA

5–15 times/month . . . . . . . . . . . . . . . . . . . 9 NA

1–4 times/month . . . . . . . . . . . . . . . . . . . . 23 NA

less than once/month . . . . . . . . . . . . . . . . 28 NA

very often . . . . . . . . . . . . . . . . . . . . . . . . . . NA 7

occasionally . . . . . . . . . . . . . . . . . . . . . . . . NA 23

seldom . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NA 15

NA = Not applicable

NOTE: Times/month is the number of times that any organic foal was

purchased.

SOURCES: Desmond Jolly, Howard Schutz, Jagit Johal, and Kathy Diaz

Knauf, “Marketing Organic Foods in California,” Sustainable

Agricultural Research in Education Program, University of California, Davis, CA, August 1989; Charles Atkin, “Consumer

Attitudes About Food Issues in Michigan,” Michigan Department of Agriculture, March 1990.

age of 24 percent of the surface area of the side of the

apple shown in photo. Respondents were asked what their

purchases would be under different labeling conditions

and prices. It was estimated that when the ‘‘meets Federal

limits” label was available, consumers were willing to

accept damage in lieu of paying a higher price. The

maximum level of damage acceptable under these conditions was estimated to be 7.5 percent of the surface

area on the apple shown in the photo. For the ‘‘no pesticide residue” level, acceptable levels of pest damage

was 11.9 percent of the surface area of the apple in the

photo. Since the surface area of a real apple would be

larger, the acceptable level of damage is small.

In another study, Bunn et al. ( 1 ) presented consumers

in California with three photographs of oranges. One

photo presented a perfect orange, one presented an orange with 10 percent of the surface area scarred as the

result of insect damage, and one presented an orange

with 20-percent scarring. Seventy-eight percent of the

respondents said they were less willing to buy the orange

with 10-percent scarring than the perfect orange, and 87

percent were less willing to buy the orange with 20-

percent scarring. When informed that the damaged oranges were grown with 50 percent less pesticide, 63

percent of respondents indicated that they were more

willing to buy the orange with 10-percent scarring than

the perfect orange, and 58 percent indicated they were

more willing to buy the orange with 20-percent scarring.

A survey in Georgia found that 62 percent of consumers were unwilling to accept cosmetic damage to obtain

pesticide-free fresh produce and 88 percent were unwilling to accept insect damage ( 11, 12).

Overall, these studies suggest that consumers are generally willing to accept a small amount of pest damage

if they also feel that risks are reduced. However, the

amount of damage acceptable is not likely to be very

high (24).

Hammitt (6) found that organic-produce purchasers

perceived higher risks from conventional produce than

organic produce and are willing to pay higher prices for

reduced pesticides (i. e., organic foods) than are conventional produce purchasers. The Van-Ravenswaay and

Hoehn study that examined willingness to pay for labels,

however, found that there is no strong correlation between willingness to pay and risk perception (23). This

study found that consumers are willing to pay more for

labels whether or not they perceived high or low risks

resulting from pesticide residues. This finding suggests

that even consumers that do not feel that low levels of

pesticide residues pose significant risks, may have some
328 ● A New Technological Era for American Agriculture

Table 12-10—Estimated Consumer Willingness To Pay To Reduce Pesticide Residues Under

Specified Market Conditions

Hammitt Rae JoIIy vanRav

Percent willing to pay above conventional food prices

Organic consumers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 49 NA NA

Peaches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NA NA 69 NA

Apples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NA NA 37 NA

Conventional consumers . . . . . . . . . . . . . . . . . . . . . . . . . 5 NA NA NA

Labeled apples.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . NA NA NA 47

NA = Nonapplicable

NOTES:

The Hammitt study assumes that conventional and organic versions of products differ only in terms of risk, a very strong assumption. Data was collected

from shoppers patronizing two food cooperatives, one health food market, and two supermarkets in West Los Angeles and Santa Monica, CA, 1985,

Estimates were based on focus group studies involving two groups each of organic and conventional produce purchasers. The values reported are the

median willingness to increase expenditures over conventional produce prices to avoid a one part per million of residues. The actual observed premiums

paid in the market were 45 percent higher for organic produce.

SOURCE: James Hammitt, “Organic Carrots: Consumer Willingness to Pay to Reduce Food Borne Risks,” The RAND Corp., R-3447-EPA, 1986.

The Rae study was conducted in 1987 at four Bread and Circus stores in Boston. Organic produce purchasers were asked if they would be willing to

support a referendum requiring EPA to eliminate the use of most pesticides if they knew it would increase the cost of food by X (20,40,50,60,80) percent.

SOURCE: Douglas Rae, “Risks of Consuming Pesticide and Fungicide Additives: Perceptions and Behavior of Organic Food Consumers,” Final Report to

the U.S. Environmental Protection Agency Benefits Staff, 1987.

The Jolly study involved organic fruit purchasers in Marin, Sacramento, and San Diego, CA counties in August, 1989. The estimated willingness to pay for

organic apples and peaches was based on the price of conventional apples of $0.68/lb and of conventional peaches of $0.49/lb.

SOURCE: Desmond Jolly, “Consumer Willingness to Pay Price Premiums for Organic Apples and Peaches,” Department of Agricultural Economics,

University of California, March, 1989.

The van Ranvenswaay and Hoehn study was a 1990 nationwide survey. The estimate reported is for the percent increase consumers were willing to pay

for apples with no label and those certified and labeled to contain no pesticide residues, given a conventional apple price of 79 cents/pound, and given

that only apples (and not other produce) were labeled (thus it represents an upper bound).

SOURCE: Eileen O. van Ravenswaay and John P. Hoehn, “Willingness to Pay for Reducing Pesticide Residues in Food: Results of a Nationwide Survey,”

Michigan State University staff paper No. 91-18, 1991.

Table 12-1 l—Estimated Consumer Willingness To Pay for Pesticide Residue Reductions Under

No Specified Market Conditions

Atlanta Georgia Michigan

No . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Yes ., . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Don’t know . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

How much more

50/0 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

10% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

0.10% . . . . . . . . . . . ... , . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Don’t know . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Percent willing to pay above conventional food prices

34 26 29

66 45 66

0 29 5

56 24 23

10 15 23

NA 6 17

NA NA 5

NA = Not asked

NOTES:

The Atlanta survey was administered to 313 shoppers at 9 supermarkets in Atlanta, Georgia suburbs in 1988. The survey asked if the shoppers were

willing to pay more for certified pesticide-free fresh produce.

SOURCE: Stephen L. Ott and Arlyn Maligaya, “An Analysis of Consumer Attitudes Toward Pesticide Use and the Potential Market for Pesticide ResidueFree Fresh Produced,” Paper Presented at the Southern Agricultural Economics Meetings, Nashville, TN, January, 1989.

The Georgia survey involved 389 members of the Georgia Consumer Panel maintained by the Department of Agricultural Economics at the Georgia

Experiment Station in 1989. The survey asked the respondents if they were willing to pay more for certified pesticide-free fresh produce.

SOURCE: Stephen L. Ott, C.L. Huang, and S.K. Misra, ‘(Consumer Risk Perceptions About Pesticide Use in Fresh Produce Production,” Paper Presented

at the Economics of Food Safety Workshop, Alexandria, VA, June 1990.

The Michigan survey was a telephone survey of 600 households in Michigan in 1990. The survey asked respondents what they would be willing to pay for

food products grown without the use of pesticides and/or chemicals.

SOURCE: Charles Atkin, “Consumer Attitudes About Food Issues in Michigan,” Michigan Department of Agriculture, March 1990.
Chapter 12—Public Perceptions of Food Safety ● 329

questions about the certainty of that perception or that

the apples they are consuming may contain much higher

levels of pesticides than anticipated. Thus, it would appear that consumers are willing to pay more for additional

information on which to base purchase decisions.

Consumers may be willing to purchase organic foods

for reasons unrelated to their perceived risks from pesticide residues. For example, purchasers of organic produce generally indicated that they bought organic products

primarily for their family’s health, although some consumers indicated that they bought organic products due

to political or ecological concerns, concerns about small

farms, and because they thought organic food was more

nutritious and tasted better (6, 8, 9, 16).

IMPLICATIONS FOR NEW

AGRICULTURAL

TECHNOLOGIES

Unlike the development of some technologies that enhance food safety, such as refrigeration, the benefits of

many biotechnology products may not be obvious to the

consumer or may accrue to someone other than the consumer. For example, genetically modified enzymes may

allow a food company to produce a food product at a

reduced cost, but unless that reduced cost of production

results in a noticeable price reduction to consumers, the

benefits of the technology will not be obvious to them.

Consumers may only see real or perceived increases in

risk without any offsetting benefits resulting from biotechnology. If important changes in the food supply are

to be introduced, industry and government regulators will

have to demonstrate that risks are not going to be increased, or that there are consumer benefits that offset

any added risks (14).

Risks that are uncontrollable, invisible, unfamiliar, not

well understood, or involuntary will also elicit greater

public concern than those that are readily identified and

potentially avoided by individuals. Risks that may have

catastrophic effects, affect particular groups such as children, or involve particularly dreaded diseases such as

cancer will cause the most alarm. Consumers often differentiate between risks of natural and synthetic origin

(21), although this distinction may not be based on any

sound scientific rationale.

Industry and government regulators can help alleviate

consumer fears by explaining what steps are taken to

reduce any risks that exist. Additionally, offering choices

to consumers can help diminish fears. Organic foods are

an example. As noted, many consumers indicate that they

are not willing to pay substantially higher prices for pesticide-free foods (e.g., one-quarter to one-third of consumers indicate they are unwilling to pay any price, while

nearly two-thirds of consumers indicate a willingness to

pay 5 percent and possibly 10 percent higher food prices).

About 5 to 10 percent of consumers appear willing to

pay premiums of up to 50 percent over conventional

foods to reduce pesticide residues (23). Development of

an organic foods market, even if prices are higher, provides consumers who can afford these prices with a choice

concerning the amount of pesticide residues they are exposed to. A similar scenario may be possible with food

products produced with biotechnology. Niche markets of

biotechnology-free food products could be developed to

satisfy those consumers whose concerns are so great that

they are willing to pay potentially higher food prices to

avoid biotechnology, without burdening all consumers

with these potentially higher food prices.

The lack of standard frameworks and methods to analyze how consumers think about food risks, how those

perceptions are affected by new information, and the

tradeoffs consumers are willing to make to reduce risks,

makes it difficult to assess how consumers will react to

new biotechnology products. Assessments are further

complicated by the fact that few consumers have heard

of many of the technologies. Furthermore, of the few

surveys available, the purchase scenarios given to consumers were generally ambiguous about the conditions

under which the consumer would know if the product

had been produced with biotechnology, what the price

would be, and how the quality characteristics of the product would be affected (tables 12-12 and 12-13).

Definitive conclusions concerning how consumer purchases will be affected by the use of biotechnology in

food products cannot be reached, but a few tentative

conclusions are suggested by these studies. At least onequarter of the respondents are resistant to the idea of

using milk or pork produced with the use of somatotropin. However, the data also indicate that consumers revise their perceptions in light of new information regarding

risks. For example, learning that the government had

approved the safety of bovine somatotropin (bST) substantially reduced the percentage of consumers who said

they would not purchase bST-produced milk, Price and

quality characteristics also affect consumer purchase intentions. With knowledge that the price of bST- and

porcine somatotropin (pST)-produced products is less than

that of conventional products, a greater percentage of

consumers said they would increase purchases of milk

and pork produced with bST and pST. Learning that pST
330 . A New Technological Era for American Agriculture

Photo credit: Terry Etherton, Pennsylvania State University

At least 50 percent of consumers surveyed are willing to pay higher prices for PST produced

pork if it is leaner.

Table 12-12—Consumers Indicating Purchase Intentions of Milk Produced With Bovine Somatotropin Under

Specified Conditions

Virginia Missouri Wisconsin

10¢ price 40@ price No price FDA No price

decrease decrease change bST approved change

Percent

No change in amount purchased . . . . . . 79 72 82 NA NA NA

Reduce or stop purchases . . . . . . . . . . . 16 15 16 NA NA NA

Increase purchases . . . . . . . . . . . . . . . . . 4 11 NA NA NA NA

Probably would purchase milk . . . . . . . . NA NA NA 28 49 NA

Probably would not purchase milk . . . . . NA NA NA 44 28 NA

Don’t know . . . . . . . . . . . . . . . . . . . . . . . . . 2 2 2 28 23 NR

Prefer milk not treated with bST . . . . . . NA NA NA NA NA 77

NA = Not applicable.

NOTES:

The Virginia study asked consumers about their purchase intentions of milk after bST was approved. Consumers were not told whether all milk or only

some would be produced with bST or whether consumers would be able to identify that milk produced with bST.

SOURCE: W.P. Preston, A.M. McGuirk, and G.M. Jones, “Consumer Reaction to the Introduction of Bovine Somatotropin,” paper presented at the Economics

of Food Safety Workshop, Alexandria, VA, June 1990.

The Missouri study asked consumers if they would purchase milk produced with bST. They were then asked if they would purchase milk produced with

bST if bST is approved by FDA. No price scenarios were given nor was it indicated whether consumers would be able to identify milk produced with bST.

SOURCE: Barbara J. Slusher, “Consumer Acceptance of Food Production Innovations-An Empirical Focus on Biotechnology and bST,” paper presented

at the Second International Conference on Research in the Consumer Interest, Snowbird, UT, Aug. 9-11, 1990.

The Wisconsin study asked consumers if they would prefer milk from untreated herds if milk from bST treated herds were labeled and there was no price

difference.

SOURCE: Robin Douthitt, “Biotechnology and Consumer Choice in the Market Place: Should There Be Mandatory Product Labeling? A Case Study of

Bovine Somatotropin and Wisconsin Dairy Products,” presented at the Second International Conference on Research in the Consumer Interest,

Snowbird, UT, Aug. 9-11, 1990.

makes pork significantly leaner resulted in more con- surveyed in Atlanta said they would pay 5 to 10 cents/

sumers indicating that they would increase purchases of lb extra, and 21 percent would pay even more. About

pork produced with pST. half of the consumers surveyed in New York and Philadelphia indicated that they are willing to pay higher

When asked if they are willing to pay more to purchase prices for pST produced pork if it is leaner. In contrast,

leaner pork produced with pST, 32 percent of consumers of the consumers in Wisconsin who said that they prefer
Chapter 12—Public Perceptions of Food Safety .331

Table 12-13—Consumers Indicating Purchase Intentions of Meat Produced

With Porcine Somatotropin

New York/ Atlanta/Chicago/Los Angeles

Atlanta’ Philadelphia New York/Philadelphia3

Question: Would you eat less pork if PST were used? (no price or quality information provided)

Less likely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1570 2 2 % NR

More Iikely/yes . . . . . . . . . . . . . . . . . . . . . . . . . 129’0 230/. 330/0

No change/no . . . . . . . . . . . . . . . . . . . . . . . . . . 420/o 550/0 670/.

Don’t know . . . . . . . . . . . . . . . . . . . . . . . . . . . . 300/0 NR NR

Question: Would you eat more pork if pST were used and the pork is leaner?

New York/ Atlanta/Chicago/Los Angeles/

Atlanta Philadelphia New York/Philadelphia

Less Iikely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14% 22% NR

More Iikely/yes . . . . . . . . . . . . . . . . . . . . . . . . . 27% 320/o 46%

No change/no . . . . . . . . . . . . . . . . . . . . . . . . . . 40% 460/o NR

Don’t know . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19% NR NR

Question: Would you eat more pork if PST were used and the pork was cheaper?

New York/ Atlanta/Chicago/Los Angeles/

Atlanta Philadelphia New York/Philadelphia

Less likely . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17Y0 240/. NR

More Iikely/yes . . . . . . . . . . . . . . . . . . . . . . . . . 21% 1 9% 4 4 %

No change/no . . . . . . . . . . . . . . . . . . . . . . . . . . 43% 57% NR

Don’t know . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19% NR NR

NR = Not reported

SOURCES:

1 W.J. Florkowski, C.L. Huang, and Brian Goggin, C

"Attitudes Towards Porcine Somatotropin: A Consumer Survey of the Atlanta Metropolitan Area, ” The

Georgia Agricultural Experiment Station, College of Agriculture, The University of Georgia Research Report 570, August 1989.

2 Catherine Halbrendt et al., “Public Attitudes in the Northeast Region Toward Recombinant Porcine Somatotropin,” Journal of Food Distribution Research,

February 1989, pp. 153-183.

3 Catherine Halbrendt et al., “Socioeconomic Determinants of Attitudes Toward the Use of Bioengineered Products in Food Production,” Department of

Food and Resource Economics, University of Delaware, 1990.

milk that is not produced using bST, 67 percent said they

are willing to pay at least 5 cents more per half gallon

to obtain bST-free milk.

Perhaps the feature that stands out the most in these

surveys is the large number of consumers who are unfamiliar with these new technologies. Given this lack of

familiarity, there is a great deal of consumer uncertainty.

The greatest awareness of a new technology was for

technologies that had generated controversy and media

coverage in a region. Thus, 80 percent of the consumers

in Wisconsin were aware of bST, while fewer than 20

percent of those surveyed in Virginia had heard of it.

This implies that consumer perceptions concerning these

new technologies will be affected by media coverage and

controversy. The Alar scare of 1989 provides another

example of how consumer perceptions can be affected

by media attention. The significance of media attention

and controversy is substantial given that some opponents

of biotechnology have demonstrated a willingness to exploit food safety issues in their attempts to stop biotechnology.

Food Scares

Food scares can affect consumer food demand and

shake the public confidence in regulatory institutions. In

early 1989, reports3 highly critical of the use of Alar (a

growth regulator) in apples, followed by an alert of potential cyanide poisoning in imported grapes, lead to

significant public fears over the safety of the food supply

(table 12-14). Nearly a year later, the level of confidence

had not recovered to previous levels.

One study isolated the effects of the Alar controversy

on apple purchases by determining what the purchases

would have been in the absence of the controversy (23).

This difference provides an estimate of the willingness

to pay for the removal of Alar. The study found that

3~e ~ub]lc intere~t group Natural Resources Defense Council (NRDC) ( 18) and the television program 60 Minure.$ concurrently released rePofis.
332 . A New Technological Era for American Agriculture

Table 12-14—Consumer Confidence Following Alar and Cyanide Scare

FMI CPQ

Jan. Apr. Apr. June Aug. Jan. Jan. Mar.

1989 1989 1989 1989 1989 1990 1989 1989

Percent

Completely confident . . . . . NA NA NA NA NA NA 25 21

Mostly confident . . . . . . . . . 81 67 73 65 67 79 56 49

Somewhat doubtful . . . . . . 15 24 19 27 24 18 14 23

Very doubtful . . . . . . . . . . . 2 7 6 6 6 2 4 6

Not sure , . . . . . . . . . . , . . . . 2 2 2 2 3 0 NA NA

NA = Not applicable.

NOTES:

The Food Marketing Institute (FMI) surveys were conducted in January, the second week of April, the fourth week of April, June, and August of 1989 and

in January, 1990, Respondents numbered greater than 1,000 in each survey. The question asked was “HOW confident are you that the food in your

supermarket is safe?” Response categories provided were completely or mostly confident, somewhat doubtful, very doubtful, not sure.

SOURCE: Food Marketing Institute, Consumer Confidence in Food Safety, an Update, Sept. 28, 1989 and Food Marketing Institute, “Trends: Consumer

Attitudes and the Market Place,” 1989 and 1990.

The Center for Produce Quality (CPQ) surveys were conducted in January and March of 1989 and consisted of 1,008 and 1,004 respondents, respectively.

The question asked was “How confident are you that fruits and vegetables available to consumers are safe to eat?” Response categories provided were

very, somewhat, not very, and not at all.

SOURCE: Center for Produce Quality, “Tracking Survey to Identify Changes in Consumer Concern about Pesticide Residues on Fresh Fruits and Vegetables,”

Produce Marketing Association, Newark, DE, April 1989.

consumers were willing to pay 21 cents per pound (a 27-

percent increase) more for Alar-free fresh apples in 1989.

On an annual basis and based on the average annual perperson consumption of fresh apples, this finding implies

that the average consumer is willing to pay about $2.35

per year to avoid the risks of Alar. Estimates of consumer

willingness to pay for a one in a million reduction in

annual mortality risks were approximately the same as

those calculated for other risks such as occupational hazards, seat belt use, etc. Thus consumers react to Alar in

much the same way as they do to other risks, and the

estimated willingness to pay to reduce Alar gives an

indication of what consumers may be willing to pay to

reduce pesticide risks given an unusual situation when

the risks of pesticides were probably perceived to be well

above what people normally believe them to be (23).

Food Labeling

Labels can be used to provide consumer information,

and indeed, that is the primary purpose generally attributed to them. Labels as well as brands, however, are

also used by the food industry to differentiate their products and to establish market niches. Labels are most

frequently used for this purpose when the product is

technically complex, when nutritional and food safety

attributes are enhanced by processing or combining of

ingredients, when advertising is important in establishing

and maintaining the value of the product, and when convenience, packaging, and style are important to establishing the image of a product. When characteristics such

Photo credit: DNAP

Freshworld, a joint venture between DNA Plant

Technology and DuPont, has been marketing VegiSnax

brand carrot and celery sticks produced by plant tissue

culture technology.

as these are important, sellers use advertising and new

product introductions to distinguish their products rather

than price rivalry.

Labels may also play a role in defining public values

(i.e., the choice and emphasis of information contained

in labels reflects those nutritional and safety attributes

considered important). Debates over the types of information that should be contained in food labels provide

a forum to reach expert consensus concerning important

nutrition and safety issues. Information provided on food
Chapter 12—Public Perceptions of Food Safety .333

labels is regulated by several Federal and State agencies,

and this regulation provides some public surveillance

over food safety and nutrition claims (13).

Consumer surveys indicate that consumers prefer that

foods derived from biotechnology be labeled as such (2,

15, 19). Consumers also prefer that foods containing

pesticide residues are labeled, but studies show that even

though consumers prefer labeling, they are not willing

to pay significantly higher prices to get labeling. if consumers react to biotechnology products in a similar manner, then it may be reasonable to expect that they also

will be unwilling to pay significantly higher prices for

those labels. In general, the costs of labeling will play

a significant role in consumer demand for labels. Labeling costs are born by the food industry itself (e.g.,

the actual costs of implementing the label), and by society

as a whole (e.g., in the form of potentially higher food

prices, higher taxes, fewer food choices, and a changed

food industry structure).

Implementing a label change can be expensive for the

food industry. Costs include administrative costs and the

actual printing costs of the label itself. The cost of any

analytical assays necessary to support the information

contained on the label (e. g., verification of cholesterol

content) and any marketing costs incurred as a result of

the label change (e. g., if the label change resulted in the

reformulation of a food product) must also be included

in the label’s cost. Additionally, any losses incurred as

a result of a firm having a large inventory of products

with the old label must be included (5).

Administrative costs will vary by firm size, the scope of

the label change, the significance of the change, and the

length of time allowed for the labeling change to occur.

The scope of the labeling change can be limited (e.g.,

inclusion of a saccharin warning statement), or it may be

comprehensive (e.g., major changes in nutrition labeling).

Additionally, the number of products, firms, and industries

affected will influence whether the scope of the label change

is major or relatively minor. The significance of a label

change can be measured, in part, by the impact it will have

on the functionality of the product (e.g., the label change

causes a reformulation of the product that affects the taste,

texture, smell, and appearance) and on consumer perceptions of the product (5).

Analytical costs are a function of the analytical test

being performed and the number of products affected.

Analytical testing is the step that most frequently concerns small companies faced with a mandated label change.

Large companies generally maintain their own analytical

databases or contract with independent analytical testing

companies to obtain lowest cost. Small companies usually produce only a few products and are often not equipped

to perform analytical testing in-house (5).

Marketing costs are similar to analytical costs in that

they are a function of the market test performed and the

number of products tested. Firms do not regularly initiate

market testing in response to labeling changes, unless a

mandated label change results in a reformulation of the

product that affects the characteristics of, or the public

perception of the product. If major reformulations are

needed as a result of a mandated label change, firms may

choose to discontinue the product altogether (5).

Printing costs are a function of the printing process,

the frequency with which the label must be redesigned,

the complexity of the label changes, the length of time

needed to implement the change, and the number of units

in stock that must be changed. Label changes range from

minor one-color changes to completely redesigned labels

requiring extensive artwork, photography, stripping, and

engraving (5).

The primary inventory cost associated with a label

change is the inventory loss of old labels (i. e., products

with old labels may have to be disposed of’). Many variables influence the probability and magnitude of inventory losses for a particular firm, including the average

size of the inventory containing the old label, the length

of the compliance period allowed for mandated label

changes, the significance of the change, the size of the

firm, and the type of the label (i.e., if it’s a label that is

added after the product is packaged, or if it is a significant

part of the packaging itself). Shorter compliance periods

may not be as significant for products that have short

shelf lives and rapid market turnover, in contrast to products that sell more slowly in the market (5).

Mandatory changes in food labels can affect product

formulation. Proponents of mandatory labeling of certain

ingredients (e. g., pesticide residues) push for such labeling in the hopes that rather than stating that their

product contains such an ingredient, a food processor

will redesign their product so that the ingredient is not

used at all. Indeed, this is one of the primary goals of

Proposition 65 in California. Proposition 65 contains provisions that consumers be warned about potential exposure to certain carcinogens or reproductive toxins.

Proponents hope that such labels will result in the reformulation or discontinuation of products containing ingredients requiring labels ( 13). Some groups have proposed

that any food product that contains ingredients produced

with biotechnology should be required by law to state

this fact on the label (7). Many opponents of biotech-
334 ● A New Technological Era for American Agriculture

nology hope that by requiring biotechnology labeling,

food producers will avoid the use of biotechnology.

Such avoidance, in the absence of banning all agricultural biotechnology products, may be difficult to

achieve. Biotechnology is not like pesticides, which are

limited in number and whose residues in food, at least

in theory, can be analytically verified. The numbers of

genes that could be manipulated and the types of food

products that could be produced using biotechnology are

enormous, and at present, it is not clear if it is even

theoretically possible to develop a generic assay to determine if biotechnology has been used to produce a food

ingredient.

Thus, the only mechanism of verification may be intense monitoring of every step (i.e., from farm to dinner

table) in the food production process. Such monitoring

may be feasible in some food industries where a significant amount of vertical integration already exists (e. g.,

some fruits and vegetables, and poultry). For food industries that are highly decentralized (e.g., grains and

oilseeds), monitoring requirements may provide significant incentives for the vertical integration of these industries. Generally, small farmers do not fare well in

food industries that are highly vertically integrated. Thus,

a mandatory labeling program could result in significant

structural changes in agricultural production.

The record keeping and oversight needed to monitor

all aspects of food production will be expensive for the

food industry. Additionally, mandatory labeling programs will require State or Federal oversight, the maintenance of which will require a reallocation of personnel

and tax dollars. Given that the food industry involves

over two million farmers alone, in addition to millions

of food haulers, processors, and retailers, effective oversight of a mandatory labeling law for all biotechnology

products used in foods will not be easy to accomplish,

and significant potential for abuse of the labeling requirements can exist.

Regulated voluntary labeling is an alternative to mandatory labeling of all food products containing biotechnology-derived food products. Such a policy could provide

for the establishment of niche markets for biotechnologyfree products. This would provide a choice to consumers

who are substantially concerned about the use of biotechnology in food without unduly burdening consumers

who are indifferent to the use of biotechnology in food

production. As with mandatory labeling, voluntary labeling programs would require industry monitoring of

the entire food production process; however, with a voluntary program, the number of firms involved could be

substantially fewer than with a mandatory program (choices

of food products available also may be limited). Administration of such a program would be more manageable

as compared to a mandatory program, although considerable difficulties would still exist. Industry can compensate costs incurred by charging higher prices for labeled

food items (i.e., similar to organic foods).

Federal or State resources will still be required to establish guidelines, provide certification or permits for

participants, and to provide oversight, but these inputs

will be lower than they would be under a mandatory

program. Additionally, while a voluntary program is also

likely to provide incentives for vertical integration, because the number of participants may be considerably

less than with a mandatory program, the extent of the

impact on the structure of the agricultural industry would

likely be less. A regulated voluntary program would substantially shift the cost of the program to those who are

most concerned about biotechnology food products, rather

than requiring all of society to pay the higher prices likely

to occur with a mandatory labeling program.

Alternatively, the status quo can be maintained concerning labels, with all labeling at the discretion of the

food industry-hence, completely voluntary. Unlike the

regulated voluntary labeling program, Federal or State

regulatory agencies would not establish guidelines other

than those currently in existence for food products, would

not establish a certification or permit procedure, and would

not conduct oversight procedures specific to biotechnology. Enforcement would be limited to the same misbranding (see ch. 10) provisions that currently exist for

food products. The cost of such a program would be

minimal, and it is likely that producers will limit the

biotechnology information provided to consumers.

The need for information concerning biotechnology in

food could be eliminated, of course, by banning the use

of biotechnology in agriculture. Such a step is not without

consequences, however, and even if enacted, is no guarantee that biotechnology will not be used in the food

products eaten by U.S. consumers. Banning biotechnol4Fim~ am “enlca]ly integrated when [hey control two or more levels of the production-marketing System for a product. For examPle, a ve~icallY

integrated fruit industry could control the conditions under which the fruit is produced (i.e., varieties grown and inputs used in production) and the

manner and price in which the fruit is distributed and marketed. Control of the two levels may be exercised by contractual w-rangements with

producers or by ownership.
Chapter 12—Public Perceptions of Food Safety ● 335

ogy would greatly diminish the competitive position of

U.S. agriculture, which could result in significant social

costs. Some products may have significant cost advantages to farmers and processors, and if such products are

available elsewhere in the world, the development of a

black market trade in such products cannot be ruled out.

Additionally, the United States is by no means the only

country developing biotechnology for use in the food and

agricultural industries. The United States annually imports billions of dollars worth of food products and seeds.

Given that it may not be possible to develop verification

procedures for biotechnology-derived imported foods, it

is not clear how one will be able to control the importation

of genetically modified food products short of banning

the importation of all imported food products.

In short, contrary to the claims of proponents for mandatory labeling of biotechnology food products, such a

regulation is not likely to be very low cost (7). Indeed a

recent study conducted by the Wisconsin Department of

Agriculture concerning a mandatory labeling program for

fluid milk only (milk products such as cheese, ice cream,

and yogurt were not included) produced with bovine somatotropin (bST) found that such a policy would be difficult

and costly for Wisconsin to implement, and would require

considerable changes in modes of operation for milk producers, haulers, processors, and distributors. Considerable

funding and personnel would be needed to oversee the

program. No assay methodology currently is available to

detect bST in milk, making effective enforcement extremely difficult. Additionally, even if Wisconsin adopted

labeling, it would be nearly impossible to control milk

imported from other States. A regulated voluntary control

mechanism would have some of the same problems, but

they were likely to be on a smaller scale, and therefore

more manageable and less costly (20).

The argument for mandatory labeling is that the consumer has the right to know whether or not biotechnology

was used in the production of the food, and presumes

that a high level of consumer concern will persist indefinitely. This is a possibility. It is also possible that consumers will be concerned when these products are first

introduced, but as they become more familiar with the

products, anxieties may decrease and the demand for

labels may decline. Mandatory labeling could not accommodate this scenario; a regulated voluntary program

would be more flexible in this respect.

Although a small subset of the population undoubtedly

will be willing to pay higher prices to avoid products

produced with biotechnology, most people will not, if

they react to biotechnology as they do

idues.

to pesticide resSUMMARY

Attempts to study food safety issues are relatively new

and do not share a standard methodology. No definitive

answers to questions about public perceptions of food

safety are available, but some tentative conclusions can

be reached. For example, there appears to be increasing

and broadening concern about food safety issues, and a

general skepticism about the ability of public institutions

to maintain food safety. It is not clear whether the public

feels that Federal agencies establish inadequate standards

of safety or inadequately enforce the standards, although

some research suggests that enforcement might be the

major concern. Consumer perceptions of the harm that

will come from food safety risks vary extensively. While

most consumers value the same harm or loss similarly,

they have widely divergent views of the types of harm

that might occur as a result of food safety risks, and

differ significantly in their views of the probability that

the risk will result in harm to them.

Because of these differences in perceptions, consumers

may not be equally willing to pay for food safety precautions. For example, perhaps as many as one-third of

consumers surveyed are unwilling to spend any amount

to reduce risks from pesticide residues, while 5 to 10

percent of consumers surveyed appear willing to pay

premiums of up to 50 percent over conventional food

prices to reduce the risks of pesticides. The majority of

the consumers appear willing to pay a premium of 5 to

10 percent to reduce pesticide residues. There is also

evidence that consumers do consider new information

about risks and change their perceptions accordingly.

Additionally, when considering how much consumers are

willing to pay to accept or reduce a risk, other factors,

such as total product price and quality are also important

decision variables. Thus, it is too early to determine how

consumers will perceive food products derived from biotechnology, but it is likely that the same factors that

influence their perception of the safety of conventional

foods will also influence their acceptance of foods produced with new technologies. That is, the extent of safety

concerns about new technologies will depend on how the

potential risk is perceived, how much confidence consumers have in government food safety guarantees, how

costly it is to avoid the technology, and what benefits

consumers perceive will accrue to them from eating or

not eating biotechnology-derived food products.
336 . A New Technological Era for American Agriculture

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11.

12.

CHAPTER 12 REFERENCES

Bunn, David et al., The Journal of Consumer Affairs

24:268-279, 1990.

Douthitt, Robin, “Biotechnology and Consumer

Choice in the Market Place: Should There Be Mandatory Product Labeling? A Case Study of Bovine

Somatotropin and Wisconsin Dairy Products, ” paper presented at the Second International Conference

on Research in the Consumer Interest, Snowbird,

UT, Aug. 9–1 1, 1990.

Fischoff, B. et al., “How Safe is Safe Enough? A

Psychometric Study of Attitudes Towards Technological Risks and Benefits, ’ Policy Sciences 9: 127–

152, 1978.

Fisher, A., Chestnut, L. G., and Violette, D. M.,

“The Value of Reducing Risks of Death: A Note

on New Evidence, ’ Journul of Policy Analysis and

Management 8(1):88–100, 1989.

French, Michael T. and Neighbm, Dierdre M., “The

Costs of Food Labeling Regulations, ” The Economics of Food Safety Workshop, Alexandria, VA, Jun.

4–6, 1990.

Hammitt, James, ‘‘Organic Carrots: Consumer Willingness to Pay to Reduce Food Borne Risks, ” The

RAND Corporation, R-3447-EPA, 1986.

Hopkins, D. Douglas, Goldburg, Rebecca J., and

Hirsch, Steven A., “A Mutable Feast: Assuring Food

Safety in the Era of Genetic Engineering, ” Environmental Defense Fund, New York, NY, Oct. 1,

1991.

Jolly, Desmond, “Consumer Willingness to Pay Price

Premiums for Organic Apples and Peaches, ” Department of Agricultural Economics, University of

California, Davis, March 1989.

Jolly, Desmond et al., “Marketing Organic Foods

in California, ’ Sustainable Agricultural Research in

Education Program, University of California, Davis,

CA, August 1989.

Mitchell, Robert C. and Carson, Richard, Using Surveys to Value Public Goods: The Contingent Valuation Method (Washington, DC: Resources for the

Future, 1989).

Ott, Stephen L. and Maligaya, Arlyn, “An Analysis

of Consumer Attitudes Toward Pesticide Use and

the Potential Market for Pesticide Residue-Free Fresh

Produced,” paper Presented at the Southern Agricultural Economics Meetings, Nashville, TN, Jan11~ 1989.

Ott, Stephen L., Huang, C. L., and Misra, S. K.,

“Consumer Risk Perceptions About Pesticide Use

in Fresh Produce Production, ’ paper Presented at

13.

14.

15.

16.

17.

18.

19.

20.

21.

22.

23.

24.

the Economics of Food Safety Workshop, Alexandria, VA, June, 1990.

Padberg, Daniel I. and Caswell, Julie A., “Toward

a Theory of Food Labeling”, The Economics of

Food Safety Workshop, Alexandria, VA, Jun. 4–6,

1990.

Pape, Stuart M., ‘‘Regulation of New Technologies:

Is Biotechnology Unique, ” Food Drug Cosmetic

Law Journal, vol. 44, pp. 173–179.

Preston, W. P., McGuirk, A. M., and Jones, G. M.,

“Consumer Reaction to the Introduction of Bovine

Somatotropin, ’ paper presented at the Economics

of Food Safety Workshop, Alexandria, VA., June

1990.

Rae, Douglas, “Risks of Consuming Pesticide and

Fungicide Additives: Perceptions and Behavior of

Organic Food Consumers, ” Final Report to the U.S.

Environmental Protection Agency Benefits Staff,

1987.

Rescher, Nicholas, Risk: A Philosophical Introduction to the Theory of Risk Evaluation and Management (New York, NY: University Press of America,

1983).

Sewell, Bradford H. and Whyatt, Robin M., “Intolerable Risk: Pesticides in Our Children’s Food, ”

Natural Resources Defense Council, Washington,

DC, 1989.

Slusher, Barbara J., “Consumer Acceptance of Food

Production Innovations-An Empirical Focus on Biotechnology and bST, ” paper presented at the Second

International Conference on Research in the Consumer Interest, Snowbird, UT, Aug. 9–1 1, 1990.

State of Wisconsin, Department of Agriculture, Trade

and Consumer Protection, Office of Policy and Program Analysis, “Regulation of Supplemental Bovine Somatotropin in Wisconsin: An Evaluation of

Dairy Product Labeling, ” March 1991.

Stenzel, Tom, Food Chemical News, Oct. 28, 1991.

van Ravenswaay, Eileen O., and Hoehn, John P.,

“Contingent Valuation and Food Safety: The Case

of Pesticide Residues in Food, ” Michigan State University Staff Paper No. 91-13, 1991.

van Ravenswaay, Eileen O. and Hoehn, John P.,

“Willingness to Pay for Reducing Pesticide Residues in Food: Results of a Nationwide Survey, ”

Michigan State University Staff Paper No. 91-18,

1991.

van Ravenswaay, Eileen O., “Public Perceptions of

Food Safety: Implications for Emerging Agricultural

Technologies, ’ commissioned background paper

prepared for the Office of Technology Assessment,

1991.
Chapter 13

Food Safety Issues

and Policy Options

Photo credit: Michael Jenkins
Page

ISSUE: ESTABLISHMENT OF FEDERAL REGULATIONS AND GUIDELINES FOR

BIOTECHNOLOGY FOOD PRODUCTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ............339

Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 339

Policy Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 340

ISSUE: PUBLIC CONFIDENCE IN THE DECISIONMAKING PROCESS ... ................343

Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ...343

Policy Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ................344

ISSUE: TRADEOFFS BETWEEN INDUSTRY COMPETITIVENESS AND SOCIETY’S

RIGHT TO REINFORMED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 346

Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 346

Policy Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 346

ISSUE: SAFETY ASSESSMENT METHODS AND REGULATORY ENFORCEMENT ..... 347

Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 347

Policy Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 348

ISSUE: LABELING FOOD PRODUCTS IN WHICH BIOTECHNOLOGY HAS BEEN

USED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .... ............348

Findings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 348

Policy Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 348

INTERNATIONAL COORDINATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349

CHAPTER 13 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 349
Chapter 13

Food Safety Issues and Policy Options

Biotechnology rekindles many of the same scientific

issues concerning food safety raised by previous agricultural technologies. What is substantially different,

however, is the climate in which this new class of technologies is being introduced. Society in general is more

skeptical of the need for new technologies. Scientific

illiteracy combined with a lack of knowledge about agriculture leads some people to misunderstand how and

why biotechnologies will be used. Scandals involving

institutions that develop and regulate these technologies

have shaken the public’s confidence in the ability of these

institutions to carry out their activities responsibly. These

factors lead to a high level of uncertainty among the

public, and a desire for a high level of scrutiny in the

development and use of new technologies. Consumers

generally are willing to accept some risk if it is accompanied by a clear benefit to them. New biotechnologies

that appear to or are perceived to put consumers at risk,

but whose benefits accrue to someone else, are likely to

meet with more consumer resistance.

The extent to which the public accepts or resists these

new technologies will be influenced greatly by its confidence in the ability of the Federal regulatory agencies

to protect public health and safety. Public confidence

will decline if people feel that safety standards are too

lax, cannot be adequately established due to scientific

uncertainty, or arise through a process that is flawed or

corrupt. Even if consumers have confidence that the established safety standards are adequate, they may worry

about adequate enforcement. Enforcement may become

more difficult if labels cannot be verified, imports increase, or if fewer or inappropriate resources are allocated to enforcement.

In addition to public confusion, uncertainty exists within

industry as to how new food technologies will be regulated. After considerable delay, the Food and Drug Administration (FDA) in May 1992, released preliminary

guidelines with respect to new biotechnology-derived food

products. The Environmental Protection Agency (EPA)

has yet to establish guidelines on data requirements needed

to determine residue tolerances for pesticidal plants, and

the Food Safety Inspection Service (FSIS) has not established guidelines concerning the slaughter of transgenic animals. Genetically engineered products, plants

in particular, are approaching the commercialization stage

at a faster rate than anticipated even 5 years ago. These

agencies no longer have the luxury of long timeframes

with which to articulate policy.

Uncertainty over how these products will be regulated

must end. Additionally, there is a general need to regain

public confidence in the regulatory agencies responsible

for determining the safety of new biotechnology products.

●

●

●

●

As a result of this study, OTA concludes that:

At present consumers and producers are in limbo.

Clear federal regulatory policies are needed. Preliminary FDA guidelines just released are still subject to

public comments and possible revisions before receiving final approval. EPA, FSIS, and Agricultural

Marketing Service (AMS) have not yet published regulations and guidelines concerning how they intend

to address biotechnology food products. Both FDA

and EPA need to establish scientific criteria needed

to assess the safety of those products they decide to

regulate.

Public confidence in Federal regulatory institutions

has been shaken. There is a general need to reestablish

the credibility of these agencies so that the public will

have confidence that Federal regulatory decisions concerning new biotechnology products are appropriate.

Three areas that need to be addressed include: 1) public input into the decisionmaking process, 2) evaluation of the tradeoffs between industry competitive

positions and the public’s right to be adequately informed about health and safety issues that affect them,

and 3) improved enforcement of regulations.

Traditional approaches to food safety assessment are

inadequate to assure the safety of biotechnology food

products. A new food safety approach is needed. New

analytical techniques must be developed.

The United States imports billions of dollars worth of

food products each year. The United States is not the

only country capable of genetically engineering foods.

International coordination on regulatory issues dated

to biotechnology food products is imperative.

ISSUE: ESTABLISHMENT OF

FEDERAL REGULATIONS AND

GUIDELINES FOR

BIOTECHNOLOGY FOOD

PRODUCTS

Findings

In the first half of the 1980s, it was anticipated that

animal biotechnologies would be developed more quickly

–339-
340 . A New Technological Era for American Agriculture

than plant biotechnologies because more was known about

animal physiology than plant physiology. Several major

scientific breakthroughs were considered necessary to

speed the development of transgenic plants. Those breakthroughs have occurred, and now FDA and EPA no longer

have the luxury of continuing to delay the establishment

of final regulations and guidelines. Several transgenic

plants are in various stages of field testing, and Federal

regulatory agencies are being asked to provide advisory

opinions concerning the regulatory status of these products. Transgenic plants are approaching commercialization, and scientific guidelines for assessing the safety

of these plants, where required, will be needed. Continued delay in finalizing these regulations will slow the

commercialization of new biotechnology products, putting American industry at a competitive disadvantage,

while continuing to undermine public confidence in the

ability of regulatory agencies to establish a clear policy

concerning biotechnology.

As discussed in chapter 10, FDA is wrestling with

whether or not to classify transgenic plants as food additives. In May 1992, FDA published a preliminary proposal regarding the regulation of new varieties of

genetically modified crops. This policy states that FDA

is concerned with the characteristics of the food product

and not with the method used to produce the product.

Thus, new genetically modified crop varieties will not

automatically be required to obtain a food additive regulation. New varieties that do not contain new toxicants,

elevated levels of inherent toxicants, altered nutrient

composition or bioavailability, or enhanced allergenic

potential may be regarded as not significantly different

from conventionally produced new varieties that are generally regarded as safe. These varieties could be marketed

without premarket oversight by FDA. The adulteration

clauses of the Federal Food, Drug, and Cosmetic Act

could be used to remove these varieties from the market

if FDA disagrees with a firm’s safety evaluation. Varieties that contain substances (either gene expression products or unintended products) that differ significantly in

structure, function, and composition from substances

currently contained in foods may be required to obtain

a food additive regulation.

The lack of a priori oversight of some new varieties,

however, may still leave considerable uncertainties in the

minds of the public, at least for the first generation of

products developed. Public confidence in the process

may still require at least a minimum review of the product

prior to commercial release. Such review may consist of

notifying FDA of the development of a transgenic crop

and provision of a minimum level of data so that FDA

can make a determination as to whether a food additive

petition will be needed. Such a notification process could

be open to the public so that any significant concerns

can be identified. Additionally, public interest groups

have expressed opposition to the policy and have threatened legal action to prevent its implementation. The policy is currently open to public comment, and could be

subject to revision. Congress may yet be required to

intervene in the development of food biotechnology regulations if differences cannot be resolved in a timely

fashion. If such action is needed, several options are

available to Congress.

Policy Options

Option: Congress could monitor the development of

regulations and conduct oversight hearings of FDA and

EPA to determine why final regulations and guidelines

do not exist and to have them report back to Congress

with recommendations in these areas within a specified

period of time.

This would be a strong signal to the executive branch

that Congress is concerned about the delay in providing

guidance to the private sector for these new technologies.

An oversight hearing would provide the agencies with

an opportunity to explain their rationale and concerns in

establishing regulations for these new products and allow

Congress the opportunity to provide guidance and direction to the agencies.

Congress and the executive branch through EPA,

FDA, and USDA have a number of options for regulating transgenic organisms. The following illustrates options available.

Option: Congress or FDA could establish categorical

exclusions to the requirement of a food additive regulation for certain transgenic organisms and require a

case-by-case approach for the remaining products.

Essentially, this is the policy chosen by FDA. Transgenic organisms that involve gene products that are widely

present in the current food supply, and do not introduce

new toxicants, elevate levels of existing toxicants, alter

the composition or bioavailability of nutrients, or transfer

allergenic components, and that use safe marker and promoter sequences can be excluded from the need for a

food additive regulation. These products do not introduce

new food compounds into the food supply and they have

no unintended effects. Therefore, FDA states that they

can be classified as GRAS because they are equivalent

to traditional new varieties that historically have been

given GRAS status. Only products that contain compo-
Chapter 13—Food Safety Issues and Policy Options .341

nents that are significantly different in structure, function, and composition may be required to obtain a food

additive regulation on a case-by-case basis. This option

is a risk based option that requires extensive safety testing

for products that are not normally found in the food

supply, and less testing for products that contain substances already widely consumed. It places responsibility

for the initial food safety assessment with industry. Lack

of FDA oversight, especially for the first generation of

biotechnology-derived food products, may raise public

concerns. A number of public interest groups have indicated their opposition to this policy.

Option: Congress or FDA could establish a policy

similar to the preliminary policy articulated by FDA,

and include a formal notification procedure.

Such a policy would require the establishment of a

system for notifying FDA when a new transgenic crop

is marketed. As currently outlined, FDA policy allows

firms to determine if a new variety contains components

that are already widely consumed. Thus, firms can make

a determination about the GRAS status of new biotechnology products without consulting FDA. In the beginning, it is highly probable that most firms will consult

FDA prior to marketing a new biotechnology-derived

variety, but they are not required to do so. This situation

is likely to create considerable apprehension among the

public. Thus, a formal system of notification may be

desirable.

The notification process could include safety data the

company used to determine that the product was GRAS.

Such data includes the identity of the host and donor

organisms, information on the genetic construct, and information on the physiology of the gene product. Additional information required could include compositional

data. A comparison of nutrient and toxic component levels in transgenic and counterpart traditional crops could

be included, as well as data on allergens. This type of

information will be available in the development of transgenic organisms and is required for a company to make

its determination of the regulatory status of the product.

Thus, requiring this information to be on record with

FDA should not present undue burdens on industry.

However, requiring FDA to review and act on this information for all transgenic crops will place a strain on

the agency’s resources. Most likely FDA will need additional resources to implement this policy.

The notification process could be open to the public

so that they can raise concerns and issues regarding transgenic organisms. It may also be useful for FDA to use

an advisory committee to comment on the data presented.

If an advisory committee is used, representatives from

the public could be included along with technical representatives.

Such a policy might be effective for the safety assessment of the first biotechnology food products developed. It would allow FDA to provide at least minimal

oversight over all biotechnology food products, assure

the public that scientific information is available, and

thus, might alleviate some public concern. In the short

run, such a policy may appear to result in unnecessary

regulation of these products. However, it may be the

price industry must pay to have their products accepted

by the public, at least in the initial stages of commercializing biotechnology food products.

Option: Congress or FDA could require a food additive petition for all transgenic crops.

This policy would force all transgenic food products

to undergo a premarket safety approval process. Such a

process would be tantamount to regulating the process

rather than the product. It would not be based on the

risks involved with the product itself, but rather would

reflect a categorical determination that the process of

genetic engineering is inherently risky, an assumption

not established by scientific data. This policy would likely

delay commercialization of transgenic crops already being

developed and possibly could inhibit the development of

additional transgenic crops. Such a policy, however, would

not be inconsistent with a broad interpretation of the food

additive definition. It probably would soothe some consumer fears and uncertainties about these products.

Option: Congress or FDA could establish some categorical exclusions of transgenic food products from the

requirement of a food additive petition, and require all

other biotechnology products to meet the requirements

for a food additive petition.

Once again categorical exclusions might include transgenic crops that do not contain components that are significantly different from those currently present in the

food supply and for which unsafe, unintended components have not been introduced. This policy would be

more risk-based than requiring all transgenic organisms

to meet the rigors of a food additive petition, because

transgenic organisms that are essentially the same as

products that have historically been viewed as safe would

not be required to undergo premarket approval. This policy would ease some of the burden on industry. There

may still be public apprehension with respect to those

products that have been excluded.
342 ● A New Technological Era for American Agriculture

Option: Congress or FDA could establish a policy in

which the gene expression product is classified as a food

additive if it would have been classified as such if added

during the processing stages, and excluding from the

food additive definition gene products that would not

have been classified as a food additive if produced by

traditional means.

A policy similar to this has been recommended by a

group of food manufacturers (i.e., the International Food

Biotechnology Council). Gene products that might be

excluded as food additives are those that would code for

agronomic functions such as drought resistance. Genes

products that might be classified as food additives are

those that would be considered a food additive if added

during the processing stage, such as natural preservatives. However, this policy seems to be based more on

the intended use of the gene product rather than any safety

risk that that gene product may pose. Such a policy may

be consistent with how FDA has historically interpreted

the food additive amendment, but would be difficult to

justify on scientific grounds.

Option: Congress or FDA could establish a policy that

the need for a food additive petition be determined on a

case-by-case basis for each transgenic organism.

Such a policy would allow FDA to provide oversight

of all biotechnology products. This would provide the

public with an assurance that all transgenic organisms

would be reviewed by FDA. However, continuation of

this type of policy indefinitely could overwhelm FDA,

since the number of products that could be developed is

large. At some point, FDA will likely need to categorize

some products as GRAS, just as it does with chemical

additives.

FDA is not alone in slowly establishing regulations

regarding biotechnology food products; EPA has also

failed to provide guidelines for establishing or exempting

pesticidal biotechnology products from the requirements

of residue tolerances. EPA generally exempts microbial

pesticides from the requirement of a pesticide tolerance,

and it is possible that microbial pesticides produced by

genetic engineering techniques will also be exempted.

EPA however, has not clarified how it will handle pesticidal whole plants with respect to the need to establish

tolerances. Clarification is needed. Pesticidal transgenic

plants are already in advanced stages of field testing, and

applications to register some of these products will soon

be forthcoming. Guidelines outlining what substances

(e.g., the whole plant, plant extracts, single gene products) require a tolerance are needed. Additionally, because State agencies, FDA, and USDA rather than EPA

enforce the tolerances, EPA needs to work closely with

the appropriate agencies in establishing tolerances. EPA

does meet with officials from FDA and United States

Department of Agriculture (USDA). However, EPA has

not adequately worked with States in establishing these

tolerances.

Option: EPA may wish to hold workshops with State

regulators to clarify and establish its policy position with

respect to biotechnology food products.

State laws may not be compatible with EPA regulations, and some States may lack the authority or expertise

to carry out EPA regulations with respect to pesticidal

biotechnology products. New laws may need to be passed

or old laws amended. Personnel and laboratory assay

methods may need to be changed. States cannot plan for

new contingencies because EPA has not kept the States

informed about its intentions. In fact, it is only recently

that EPA has even contracted to compile a list of contact

persons in State agencies. This lack of cooperation and

coordination with the States could easily lead to significant delays and difficulties with State implementation

of EPA regulations with respect to pesticidal biotechnology products. Congressional hearings and oversight

may be necessary if EPA does not rectify this situation.

FSIS’s food safety responsibilities with respect to biotechnology products lies primarily with animal inspection. FSIS will be responsible for inspecting transgenic

livestock. Transgenic livestock will not be commercially

available for several years. However, transgenic research

is proceeding. Given the high cost and the inefficiency

of the research, many researchers would like to be able

to slaughter experimental animals in which attempts to

insert genes failed. FSIS plans to release guidelines in

the near future concerning the slaughter of these experimental animals. Of particular interest will be guidelines

concerning the slaughter and potential food use of transgenic animals that produce pharmaceuticals.

Option: Congress or EPA could establish guidelines

for the safety evaluation required to establish pesticide

tolerances for whole plants.

Currently, EPA does have guidelines for transgenic

pesticidal microorganisms, but has yet to establish such

guidelines for whole plants. Transgenic plants producing

pesticidal compounds, such as Bt producing plants, are

completing small-scale field trials. Guidance from EPA

for dealing with such plants can no longer be delayed.

Establishment of safety guidelines will require a new

assessment paradigm (discussed later). Additionally, be-
Chapter 13—Food Safety issues and Policy Options ● 343

cause States, FDA, and USDA enforce pesticide tolerances, EPA needs to work closely with appropriate agencies

in establishing tolerances. EPA’s work with States needs

improvement in this area. Only recently has EPA even

begun to compile a list of contact persons in State agencies. This ignoring of States could easily lead to State

laws that are incompatible with Federal regulations, or

to gaps in State authority or expertise to carry out Federal

regulations. Congressional hearings and oversight may

be necessary if EPA does not improve this situation.

Option: Congress or USDA -FSIS could establish

guidelines concerning transgenic animals.

USDA-FSIS plans to release guidelines in the near

future concerning the slaughter of experimental animals

in which gene transfer attempts failed. Guidelines concerning the slaughter of transgenic livestock are still in

early draft form. Of particular interest will be guidelines

concerning the slaughter and potential food use of transgenic animals that produce pharmaceuticals. FSIS and

FDA have established a joint committee to deal with

issues that jointly affect the two agencies. Careful monitoring of how successful this committee is may be required.

Option: Congress may wish to monitor the development of guidelines established for the slaughter of transgenic livestock that produce pharmaceuticals.

The first transgenic livestock to be available may well

be animals engineered to produce pharmaceuticals. FDA

and FSIS will share food-safety responsibilities for these

animals, and the two agencies have established a joint

committee to deal with issues that jointly affect them.

Careful monitoring of how successful this committee is

may be required.

ISSUE: PUBLIC CONFIDENCE

IN THE DECISIONMAKING

PROCESS

Findings

One method of enhancing public confidence in the

regulatory process is to make that process more open and

accessible to the public. Decisions made in secret and

not explained to the public often are greeted with distrust.

Opponents of increased public input in regulatory processes argue that citizens lack the training needed to

understand complicated scientific and technical issues,

and as such their participation only delays the agency’s

decisionmaking without offering any offsetting benefits.

Critics also fear that public representatives may act in

emotional and irrational ways and make unreasonable

demands. Those who support increased public input argue that such input is invaluable in establishing the legitimacy of regulatory decisions. Indications also exist

that public participation can encourage agencies to focus

on a wider range of issues and values than they normally

would. And, it is hard to deny public participation in

regulatory processes in a democratic society.

The public will not make regulatory decisions—that

is the responsibility of the State and Federal agencies

whose statutory authority requires them to ensure a safe

and wholesome food supply. However, public confidence that these agencies are fulfilling their responsibilities will be enhanced if there are mechanisms available

for public questions and concerns to be heard and addressed prior to decisions by the regulatory agency. At

present, public input into the regulatory process consists

of notification and comment procedures and participation

on advisory committees.

The rationale for using advisory committees is to provide expert knowledge to agencies and to enhance the

credibility of their final decisions. Including public representatives in addition to technical experts and possibly

industry representatives not only ensures that a broader

range of issues will be addressed, it also may forestall

public outcry about issues that, if aired, are not likely to

raise public concerns. If the public accepts decisions

because the solutions appear valid and the process was

fair, industry is likely to lose less money, time, and

credibility than if the decision was made based solely on

industry views. Even for highly technical committees,

public members force experts to express their answers in

terms and concepts understandable to most people (3).

However, “the public” may also include special interests

who can use their membership on advisory bodies to

promote private concerns. A real danger exists in allowing special interest groups to exercise undue influence

on the government or to dominate advisory committees

that deal with matters in which they have vested interests

(3).

With these dangers in mind, Congress passed the Federal Advisory Committee Act in 1972 (5 USC app 2),

which generally stipulates that the need for advisory committees must be reviewed and substantiated, that the public must have access to advisory committee meetings and

all records and documents relied on by committee members, that the membership on all advisory committees be

fairly balanced with respect to viewpoints and functions,
344 . A New Technological Era for American Agriculture

and that committees act only in an advisory capacity and

be independent of agency influence. Closed sessions can

be held when trade secrets or confidential commercial

information is considered, for matters involving the review of investigative files, or for review of matters that

would constitute an invasion of privacy. Public notice is

required and public participation is encouraged. Minutes

and reports must be available for public inspection (3).

The FDA uses notification and comment procedures

for decisions concerning food additives and advisory

committees for decisions concerning drugs. Any person

may petition FDA to establish a regulation to approve

the use of a food additive (21 U.S.C. 409(b)(l)). If FDA

concurs that a regulation is required, it must publish a

notice of that decision in the Federal Register. Any person who might be adversely affected by the proposed

decision has 30 days to request a hearing. Additionally,

FDA relies on input from scientific organizations, such

as the National Academy of Science (NAS) and the Federation of American Societies for Experimental Biology

(FASEB), and consultants for issues concerning food

additives.

FDA is not required to publish the notification of the

receipt of a new drug petition, except in the case of some

veterinary drugs. Administration of veterinary drugs may

involve release of organisms into the environment. Under

such circumstances, FDA may be required to comply

with National Environmental Policy Act (NEPA) requirements for public notification and comment.

Public participation in the drug approval process comes

primarily from the use of advisory committees, although

public participation in these committees is limited. Advisory committees advise and recommend policy, but do

not make regulations themselves. Congress mandated the

use of advisory committees for drugs, and currently FDA

has 38 standing advisory committees most of which are

concerned with human drugs and medical devices. There

is one veterinary drug advisory committee. Only technical experts can be voting members of FDA advisory

committees. However, industry and public representatives serve on such committees also but as non-voting

members (l).

The Federal Insecticide, Fungicide, and Rodenticide

Act (FIFRA) requires EPA to publish a notice of receipt

of any pesticide registration that involves a new ingredient or new use. EPA must also publish a notice of the

receipt of any Environmental Use Permit (EUP) that is

of regional or national significance. EUP’s are required

before pesticides can undergo field trials of greater than

10 land acres or 1 surface acre of water. Notifications

are published in the Federal Register and the public has

30 days to provide written comments. EPA also publishes

a notice of the issuance of pesticide regulations and EUP’s.

If public comments indicate that there is sufficient interest or that it would otherwise be in the public interest,

EPA can hold a public hearing concerning an application.

EPA may seek additional advice concerning petitions

that raise significant issues via intra- or interagency reviews and advisory committees. EPA has established a

standing committee for biotechnology, the Biotechnology Science Advisory Committee (BSAC) which is composed of 9 scientists and 2 persons from the public. EPA

tries to draw a distinction between truly private citizens

and representatives of public interest groups (40 CFR

25.7(c)(l)(iand ii)).

The Poultry Products Inspection Act; the Federal Meat

Inspection Act; and the Virus, Serum, Toxin Act do not

require public comment concerning agency regulations.

USDA (primarily Agricultural Plant Health Inspection

Service [APHIS]) has voluntarily notified State agencies

and the public when environmental releases might occur.

The USDA has established a standing advisory committee for biotechnology = mthe Agricultural Biotechnology

Research Advisory Committee (ABRAC), which is composed of 11 scientists and 2 lawyers. This committee

advises on regulatory matters as well as research issues.

Policy Options

Option: Congress could direct agencies (FDA, USDA)

to establish a mechanism to allow for increased public

participation and to report its results to Congress.

This option sends a clear message to the agencies that

Congress is concerned about the public’s view of regulatory agencies and that the public should be more involved in the decisionmaking process. It gives maximum

flexibility to the agencies to determine the method of

incorporating the public’s input.

A number of mechanisms are available. For example,

Federal agencies could establish criteria by which local

agencies can be notified any time significant risk or unique

questions arise that are pertinent to them. Agencies may

wish to adopt a procedure similar to that used by FIFRA,

i.e., notification of petitions received, and if public interest warrants, an informal hearing. Increasing public

participation will require increased resources and risk

politicizing decisions, but could also enhance public confidence in the regulatory process. It might cost less in

the long run.
Chapter 13—Food Safety Issues and Policy Options ● 345

Option: Congress could direct the agencies to increase

the use of advisory committees for decisions involving

biotechnology and to change the composition of their

membership to increase the number of nontechnical public representatives.

For FDA, advisory committees could help establish

GRAS and the minimum information needed for food

additive applications of genetically engineered whole foods.

These committees could be used as a first screening

mechanism to see if a food additive petition is actually

needed. Public meetings help assure the scientific validity

of the process. EPA might also use advisory committees

to establish tolerances for genetically engineered plants

with pesticidal properties. This might be helpful since

in-house expertise to handle this responsibility seems to

be lacking. Advisory committees might also prove useful

to USDA in establishing a policy on transgenic animals.

The credibility of any advisory committee will be enhanced if it includes public representatives.

FDA may need to consider granting current nonvoting

members of its advisory committees the right of full

voting membership. And they may need to expand the

list of technical fields beyond MDs from which experts

are drawn.

Use of advisory committees presents some logistical

problems and requires additional resources, but provides

expertise that currently may be missing. Additionally,

the possibility that nontechnical representatives will pursue political agendas and unnecessarily delay committee

decisions exists. However, used properly, such representatives can focus the attention of the committee on

issues that might otherwise be overlooked and provide

legitimacy to committee decisions.

Option: Congress could direct the agencies (EPA, FDA,

USDA) to change the notification procedures for advisory

committee meetings.

The standard method of notification involves publication in the Federal Register. Few members of the public

know what the Federal Register is, much less read it

regularly. Also, notices published are written by and for

those knowledgeable in the field and, thus, the general

public might not recognize what the issue is. Additionally, most meetings are held in Washington, DC. Agencies could have committees convene in different cities

and publish announcements, other then the Federal Register, that are more likely to be noticed by a wider public.

Such activities are likely to be more expensive than current ones, however; but make the decision-making process more accessible to the public.

Option: Congress could direct agencies (EPA, FDA,

USDA) to establish a mechanism to allow for public

input, even if not required by law.

Agencies may wish to establish criteria by which local

agencies and the public can be notified anytime significant risk or unique questions arise that are pertinent to

them. Agencies may wish to adopt a procedure that publishes notification of petitions received, and where comments are such to indicate that there is sufficient public

interest or unique questions, an informal hearing can be

held.

Option: Congress could direct agencies (EPA, FDA,

USDA) to increase the use of advisory committees for

decisions involving biotechnology.

For FDA, advisory committees could be helpful in

helping establish GRAS status and minimum information

needed for food additive applications of genetically engineered whole foods. These committees could be used

as a first screening mechanism to see if a food additive

petition is actually needed. Also, if the meeting is public,

greater assurance of the scientific validity of the process

would be provided. The EPA might also use advisory

committees to establish tolerances for genetically engineered plants with pesticidal properties. This might be

particularly helpful since in-house expertise to handle

this responsibility appears to be lacking. Use of advisory

committees might also give greater credibility to USDA

policy on transgenic animals, since its expertise lies mainly

with inspection for microorganisms and disease rather

than toxicology assessments. However, the credibility of

these advisory committees will be enhanced if they include public representatives.

Option: Congress may wish to appoint a task force to

study the role of independent safety testing of biotechnology products.

Independent testing is unlikely to be popular with industry. However, there is a growing perception that companies are withholding negative data, and the safety review

conducted by regulatory agencies is not made using accurate and complete data. Enhanced subpoena data by

the regulatory agencies, most notably FDA, could be

useful. Additionally, it may be worthwhile to consider

establishing independent testing of products. FDA, for

example, rather than companies could choose outside

investigators to perform selected safety assessments, and

these contractors could report results directly to FDA

rather than companies. A study to consider the broad

range of implications of such a change would be warranted before implementation.

297-937 0 - 92 - 12 QL 3
346 ● A New Technological Era for American Agriculture

ISSUE: TRADEOFFS BETWEEN

INDUSTRY COMPETITIVENESS

AND SOCIETY’S RIGHT TO

BE INFORMED

Findings

Public interest groups argue that industry claims too

much scientific data as confidential business information

(CBI), thereby limiting the amount of health and safety

data available to the public. Industry feels that there is

too little protection of proprietary data, and this situation

adversely affects their competitive position. Achieving

the proper balance between protecting proprietary rights

and disclosing health and safety data to the public is a

delicate undertaking.

Disclosure practices are regulated by the Trade Secrets

Act and the Freedom of Information Act. The Secrets

Act (18 U.S.C. 1905) of 1982 subjects government employees to criminal penalties for the disclosure of proprietary data unless authorized by law. The Freedom of

Information Act (5 U.S.C. 522(b)(4)) of 1982 permits

agencies to protect trade secrets and commercial and

financial information that is privileged or confidential.

Both laws seek to protect information that would be of

commercial value to a firm’s competitor.

The FDA has restrictive CBI policies. Although Congress has mandated that health and safety testing data for

new drugs can be released after another manufacturer

becomes eligible to sell the drug unless extraordinary

circumstances are shown (Drug Price Competition and

Patent Term Restoration Act, 1984; PL98-417), little data

is actually released. FDA defines extraordinary circumstances to include any claim that the data is CBI, including a claim that it could be used by competitors in

foreign countries (3).

While FDA usually does not release safety data, in

the case of bovine somatotropin (bST) it did. For the

first time in FDA history, FDA published an article in a

peer reviewed scientific journal (Science) detailing how

FDA reached its conclusion that bST was safe for human

consumption. Specific safety data was presented. Additionally the National Institutes of Health (NIH) and

FDA hosted a scientific meeting with public participation

to discuss food safety concerns of bST. Thus, FDA has

shown that it can release such information when it is in

the public interest.

FIFRA protects CBI, but allows release of health and

safety testing data to be disclosed for registered pesticides. Also, data concerning production, distribution,

sale, or inventories of a pesticide may be released in

connection with a public proceeding if disclosure is in

the public interest (7 U.S. C. 136h). Thus, FIFRA permits

the release of health and safety data after the decision is

made but not during the process.

After notification of a food additive or pesticide registration petition has been published, requests for safety

data can be made under the Freedom of Information Act

(FOIA). However, sometimes it is not possible for agencies to determine whether or not information is CBI in

the time allotted to them to make a regulatory decision.

Attempts to mitigate these problems include requesting

that companies restrict their CBI claims and that they

justify their claims of confidentiality at the time they

submit a petition.

Currently, biotechnology firms have limited the availability of CBI involving environmental release to those

public interest groups needing current information in order to participate in EPA cases. However, this condition

exists because of voluntary cooperation of the firms, and

this cooperation could be withdrawn at any time.

Decisions to disclose CBI focus on whether or not

such disclosure will be harmful to the company. No attempt is made to weigh this harm against the public’s

right to be informed about health and safety issues that

might affect them. Other countries, most notably Canada,

have taken the approach that disclosure of health data is

authorized if it is in the public interest as it relates to

public health, public safety, or protection of the environment and if it clearly outweighs in importance the

financial loss to the competitive position of a company

or person (Access to Information Act, Canada Statute

3324).

Policy Options

Option: Congress could encourage FDA to publish

more scientific review articles and hold public meetings

in cases that generate public interest.

Clearly it is possible for FDA to release health and

safety information to the public as they have done for

bST. The public controversy surrounding this product

apparently outweighed any competitive disadvantage that

disclosure of this information imposed on the firms producing bST. Such a policy might prove useful in re-
Chapter 13—Food Safety Issues and Policy Options .347

sponding to public concerns about other biotechnology

products and potentially could enhance the accountability

and credibility of FDA decisions.

Option: Congress could conduct oversight to provide

increased guidance to regulatory agencies attempting to

encourage firms to reduce CBI voluntarily.

Congress could monitor whether health and safety data

are being made available as products approach commercialization or if firms withdraw their voluntary cooperation and claim more data as CBI. If firms increase CBI

claims, Congress could direct Federal agencies to require

firms to justify CBI claims when a petition is submitted

rather than waiting until a FOIA request is made. Currently, firms realize that it takes regulators longer to

determine the validity of CBI claims than the time allotted

to make regulatory decisions. This could encourage some

firms to make CBI claims of data that in fact are not

confidential.

Congress could also direct agencies to facilitate reconsideration of a decision if CBI data are released after

a regulatory decision is made and causes public concern.

Currently, firms can avoid disclosure of data during the

regulatory process simply by claiming confidentiality and

know that the regulatory decision will not be reconsidered. If the decision is allowed to be reconsidered, firms

may reduce their CBI claims.

Industry will oppose increased disclosure of safety data

because it will erode their competitive position. On the

other hand, with the current climate of public skepticism

of new technologies and regulatory agencies, increased

industry accountability and public disclosure of safety

data may be required of business.

Option: Congress could liberalize the CBI policy.

Congress could direct FDA to release data it is currently authorized to release but generally does not. Congress could consider adopting a regulatory policy similar

to that used in Canada which would weigh any harm to

the “company against the public’s right to be informed

about safety concerns. Current policy considers only the

harm to firms. As a last resort, Congress could force the

disclosure of health and safety data. Once again the potential harm to the competitive position of companies

must be weighed against the public’s right to be aware

of potential safety risks and to regain public confidence

in the regulatory process. Industry probably will object

to an easing of CBI policy. Public support, on the other

hand, may be equally strong for disclosure.

ISSUE: SAFETY ASSESSMENT

METHODS AND REGULATORY

ENFORCEMENT

Findings

Traditional food safety assessment approaches As

discussed in chapter 11, are inappropriate for the assessment of whole foods because large enough quantities of the food cannot be fed to test animals without

invalidating the results of the test. Thus, a new food

safety approach will be required. New assay and testing

methods will need to be developed and additional data

concerning the normal levels of toxic compounds in

foods will be needed. Additional funding will be needed

to develop new testing procedures applicable to genetically modified foods.

Preliminary research indicates that a significant

component of the public’s lack of confidence in regulatory agencies stems from concerns that regulations

are not being adequately enforced. For example, research shows that consumers are willing to pay for

labels that indicate that Federal pesticide tolerances are

in fact being met in apples. For Federal regulatory

agencies to regain public credibility and for the public

to accept biotechnology products, enhanced enforcement of regulations will need to be an integral component of the regulatory process.

Enhanced enforcement will be difficult. The regulatory agencies do not have the resources to significantly increase enforcement activities. A GAO study

found that the regulatory agencies involved in food

safety had less staff and funding and a larger workload

in 1989 as compared to 1980. Available resources are

being stretched.

In addition to the lack of available resources, the food

safety regulatory agencies will need to develop new assay

procedures and sampling methodologies to track genetically modified organisms. Again, studies show that FDA,

for example, has not been quick to develop or adopt new

practices in dealing with current food safety problems

such as pesticide residues and antibiotics in milk (4, 5).

Unlike pesticide residues and antibiotics, multiresidue

assays methods for genetic engineering do not exist and

may not be possible to construct. Generic verification

that a plant has been genetically engineered will be difficult if not impossible. This creates problems in verifying the safety of imported food products unless these

products are accompanied by compositional data.
348 ● A New Technological Era for American Agriculture

Policy Options

Option: Congress could fund the development of new

analytical methodologies and assay procedures through

the National Institutes of Health (NIH).

New analytical methods for whole food assessments

must be developed not only to determine the safety of

genetically modified crops, but to monitor foods once

they are marketed commercially. NIH, in coordination

with FDA, could provide funding to develop food analytical technologies. These new technologies and

assessment procedures would not only be useful in determining the safety of genetically engineered foods, but

could also enhance several other research programs such

as the designer foods project (cancer research) and nutritional programs.

Option: Congress could provide funds to NIH for the

development of databases detailing the normal range of

nutritional and toxic components of food.

Major nutrients and toxic substances in food have been

identified, but more information is needed to assess these

food components, such as the quantities at which these

components are normally present in foods and their chronic

impacts on humans. Assessment of such information will

be needed to determine if genetically modified foods

present greater safety risks than do foods currently consumed.

Option: Congress could provide additional resources

to the regulatory agencies to carry out their duties.

In the absence of additional staff and funding, FDA

will have a difficult time increasing enforcement activities to cover genetically modified products.

Option: Congress could direct FDA and EPA to request that assay procedures developed by firms to detect

additives be readily adaptable for use under field conditions.

Currently, when firms submit a food additive petition

or a pesticide registration they are required to provide an

assay method to detect the residues or additive in the

food. Generally, the method provided requires highly

sophisticated instrumentation and is generally not compatible with multiresidue assays (i.e., the methods developed usually are single residue only). Agencies might

require multiresidue assay methods that are more readily

usable under field conditions than they are today. The

residues would have to have some similar characteristics

for a multiresidue technology to work. Development of

such assay methods may create technical difficulties and

are likely to create added costs to industry. However,

they would improve monitoring and enforcement activities of regulatory agencies, an issue of particular importance to the public.

ISSUE: LABELING FOOD

PRODUCTS IN WHICH

BIOTECHNOLOGY HAS

BEEN USED

Findings

Many consumers have expressed a desire for food that

includes products developed with biotechnology to be so

labeled. However, while consumers express a desire to

have such labels, many of them are not willing to pay

much for those labels. (See chapter 12. ) For example,

approximately one-third of consumers surveyed do not

seem willing to pay anything for labels whereas another

5 to possibly 10 percent of consumers seem willing to

pay as much as 50 percent higher food prices for labels.

The remaining consumers appear willing to pay 5 to

possibly 10 percent more for labels. Clearly a labeling

proposal that is very expensive will not be popular with

most consumers. Additionally, there is the problem of

verification. Consumers want labels, but they want those

labels to be accurate and verifiable. This is entirely consistent with the desire of consumers that current regulations be enforced. Labeling is not a substitute for an

adequate safety assessment, rather it is to provide information to consumers. Labeling, unlike safety, is not a

public good. The approach may be to make labeled biotechnology food products available to those willing to

pay the added price of the label rather than forcing all

consumers to pay higher food prices to incorporate labeling.

FDA has stated in its preliminary policy that generic

labeling of biotechnology food products will not be required but selected products may require labeling. Such

products may include those for which nutritional composition has been altered or potential allergens introduced. Other options are possible however.

Policy Options

Option: Congress could mandate that all food products

containing constituents derived from biotechnology be so

labeled.
Chapter 13—Food Safety Issues and Policy Options .349

This certainly would satisfy public desire to be aware

that the food they are eating contains products derived

using biotechnology. It is also likely to be very expensive

and difficult to verify that food products do not contain

constituents that have been derived using biotechnology.

No generic means exist to identify whether a food constituent, such as a kernel of corn that will be ground into

meal, has been genetically engineered or not, and it is

unlikely that such a method can be developed. Thus,

unlike for pesticides and antibiotics, there is no simple

assay method that can be used to determine if the plant

from which the corn was derived is a transgenic plant.

Thus, to assure that genetically modified products are

not used will require that the markets for agricultural

commodities be segregated. That is not how many bulk

commodities, such as grains, are currently marketed.

Entirely new marketing structures will need to be developed. To guarantee the quality control of the crops

will require producer oversight, which will be expensive

for food processors. That added expense will be passed

along to consumers. Thus, the difficulty involved in determining that a product does or does not contain any

ingredients derived from biotechnology could become

quite expensive. It is not clear that consumers would be

willing to pay that added expense.

Option: Congress, through research and extension

agencies, could encourage niche markets to be established to satisfiy the concerns of those willing to pay high

prices for labeled food signifying that it does not contain

genetically engineered food.

An alternative to passing the high cost of verification

along to all consumers is to establish a higher priced

niche market for biotechnology-free foods that would

satisfy the needs of consumers who are concerned enough

about biotechnology to be willing to pay higher prices

for products not produced with biotechnology. Such a

market would be similar to the current organic food market. Organic produce is higher priced than traditionally

produced produce but provides an alternative product to

consumers who are willing and able to pay higher food

prices. Recent legislation has been enacted to help resolve some problems involved with organic produce, such

as a lack of a standard definition, grower certification

and oversight procedures, etc. Such a policy might also

work for biotechnology-free food products, and would

have the advantage of passing the extra costs along only

to consumers willing to bear them.

INTERNATIONAL

COORDINATION

The United States annually imports billions of dollars

worth of food products. The United States is not the only

country capable of producing biotechnology food products. If U.S. food safety regulations concerning biotechnology substantially differ from other country’s regulations,

several difficulties could arise. For example, if U.S. policy is substantially stricter than other countries, enforcement will be difficult. As already stated, no generic

methods exist to determine genetic modification. Reliance on the word of other countries that their products

contain no biotechnologically derived constituents may

or may not be acceptable. Likewise, if U.S. regulations

are substantially more stringent than other countries, then

U.S. producers will likely be at a competitive disadvantage. If U.S. regulations are substantially less stringent

than other countries, then exporting U.S. agricultural

products could prove difficult. Agricultural commodities

are a major export of the United States. Thus, international coordination will be an important issue. Preliminary FDA policy is consistent with the concept of the

substantial equivalence of new foods discussed in the

Organization for Economic Cooperation and Development (OECD) working papers and with safety assessment

procedures discussed in World Health Organization

(WHO)/Food and Agricultural Organization (FAO) reports.

1.

2.

3.

4.

5.

CHAPTER 13 REFERENCES

Degnan, Frederick H., ‘‘An Introduction to FDA Advisory Committees, Food Drug Cosmetic Law Journal, vol. 45 (1990), pp. 709–716.

Lakshmanan, Joseph L., “Nontechnical Representation on the FDA’s Advisory Committees: Can There

Be More?” Food Drug Cosmetic Law Journal, vol.

44, 1989, Pp. 181-194.

Shapiro, Sidney A, “Administrative Conference of

the United States: Biotechnology and the Design of

Regulation, ” Administrative Conference of the United

States, 1989.

U.S. Congress, General Accounting Office, “FDA

Surveys Not Adequate to Demonstrate Safety of Milk

supply,” GAO/RCED-91-26, November 1990.

U.S. Congress, Office of Technology Assessment,

Pesticide Residues in Food: Technologies for Detection, OTA-F-398 (Washington, DC: U.S. Government Printing Office, October 1988).
Chapter 14

Food Quality: The Relevance

of Food Grades

PhotoCredit: Grant Heilman, Inc
Page

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ........353

THE PORK GRADING SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 354

USDA Grade Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ....354

Changing Public Concerns and Expectations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...............355

New Technologies and Implications for Pork Grading . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ....356

Potential Parameters for Alternative Grading System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ......359

Options for unimproved Grading System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 360

Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 365

THE FRUIT AND VEGETABLE GRADING SYSTEM . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ...366

Fruit and Vegetable Production and Consumption . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ...........366

USDA Grade Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ....367

Conceptual Considerations of Grade Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ............369

Nutritional Attribute Measurement . . . . . . . . . .

Nutrient Attributes Variation . . . . . . . . . . . . . . . .

Assessing the Relationship Between Nutrient

Chemicals and the Grading System . . . . . .

Chemical Residue Grading Standard . . . . .

Options for unimproved Grading System

Conclusions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

CHAPTER 14 REFERENCES . . . . . . . . . . . . . .

...

..,.

. . .

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. . .

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 369

and Sensory Characteristics . . . . . . . . . . . . . . . . . . 372

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Box

14-A. Technology

14-B. Technology

To

for

Boxes

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Evaluate Pork Carcasses or Products . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ......362

Nutrient Attribute Measurement of Fruits and Vegetables .. .............370
Chapter 14

Food Quality:

The Relevance of Food Grades

INTRODUCTION

Many consumers are expressing concerns over the safety

and the quality of food, and these concerns extend to the

use of new agricultural technology in food production.

Information about food quality can be provided through

labeling, brand names, price, and grades. Food grades,

for example, are used to classify products according to

certain quality characteristics.

The objective of a grading system is to sort a population with heterogeneous characteristics (i. e., a group

of foods) into lots of more uniform or homogeneous

characteristics. An effective grading system uses personal observation and testing to provide information

that reduces user-perceived risks associated with product quality. Grading also aims to improve product uniformity within a particular grade and serves as the basis

for price. Grading facilitates an equitable incentive

system stimulating farmers to produce commodities in

response to consumer preferences. As a consequence,

grading transaction costs are lowered and overall marketing efficiency is enhanced. Sorting via grades also

facilitates trade because many consumers are likely to

lack the expertise or time to identify meaningful qualit y

characteristics from heterogeneous lots of any particular commodity.

Grades for beef, fruits, and vegetables are used

throughout the marketing system, i.e., by farmers, processors, wholesalers, retailers, and consumers. However, grades for some commodities (i.e,, pork) are used

almost entirely at the producer-processor level. At least

70 percent of pork is cured, smoked, or further processed before it reaches the consumer, whereas most

beef reaches the consumer in the fresh form; this can

explain the greater need for beef quality grades at the

consumer level. Pork is also more uniform from a quality point of view than beef. Most hogs are marketed

at about the same age after being fed a high-concentrate

diet. Beef cattle, on the other hand, may be marketed

as ‘‘grass fat” or after being fed high-concentrate rations for varying lengths of time, and are slaughtered

at a wide range of ages. Both factors influence tenderness and appearance of fresh beef.

The use of grades as a proxy for quality is criticized

heavily for at least two reasons. First is the concern

about the usefulness of current grading systems, especially for the livestock industries. The criticism focuses on the relevance of the criteria used and on the

accuracy of measurement, and the value differentiation

for users.

Second is the concern about the attributes on which

grading is based and resulting economic incentives.

For example, fruit and vegetable grades are based on

characteristics that affect consumers’ senses, such as

touch, sight, and taste, and on shelf-life considerations

or some combination of these factors. These current

sensory-based grade attributes, critics argue, indirectly

may encourage the use of chemicals during the production process. For example, when the top grade of

a fruit or vegetable is based on sensory characteristics,

it provides economic incentive to apply chemicals so

as to ensure minimal blemishes and vibrant skin color.

If the standards were shifted away from sensory characteristics, fewer chemicals probably would be used

because less economic incentive would exist to use

chemicals.

Consumers are increasingly aware of and dubious

about the use of chemicals, or chemically based ingredients, in the production and preservation of the

food supply. In addition to concern that chemicals used

in the production process may be deleterious to the

environment, concern exists that chemical ingredients

in or on food maybe injurious to human health, perhaps

in ways yet unknown to the scientific community.

However, grading standards and the process of grading should not be confused with food safety. Food

safety is a question of determining whether or not the

ingestion of a particular food or food ingredient may

be injurious to human health. Only food items already

determined to be safe are graded.

This chapter focuses on two concerns 1) the usefulness of current grades and 2) the potential for alternative grade attributes. An exhaustive analysis of all

grading systems is beyond the scope of this report.

Instead, a case approach is used to focus on these

issues. The first case study focuses on the livestock

industry —specifically pork. The second focuses on the

fruit and vegetable industry.

-353-
354 . A New Technological Era for American Agriculture

THE PORK GRADING SYSTEM1

USDA Grade Standards

Background

Grade standards for pork were established by the U.S.

Department of Agriculture (USDA) in the early 1930s.

Barrows and gilts are the primary market animals. Grades

for barrow and gilt carcasses, i.e., U.S. No. 1, No. 2,

No. 3, and No. 4 are based on two general considerations:

1) quality—which includes characteristics of lean and

fat, and 2) expected yield (i.e., in proportion to total

weight) of the four lean cuts (ham, loin, picnic shoulder,

and Boston butt).

Two general levels of quality are recognized: 1) acceptable and 2) unacceptable. Presently, the quality of

lean cuts is best evaluated by a direct observation of its

characteristics on a cut surface. Standards indicate that

when a cut surface of a major muscle is available, quality

determination shall be based on the characteristics of the

loin eye muscle at the 10th rib. When this surface is not

available, other exposed major muscle surfaces can be

used for comparable quality determinations. Generally,

packers do not elect to reduce the value of a loin by

cutting the loin at the 10th rib or to expose any of the

major muscle surfaces. When a major muscle cut surface

is not available, the quality of the lean is to be evaluated

indirectly based on quality-indicating characteristics of

the carcass. These include firmness of the fat and lean,

amount of feathering (fat streaking in tissue) between the

ribs, and color of the lean. While current standards employ feathering as a quality indicator, there is no scientific

evidence that feathering is related to quality.

A barrow or gilt carcass with acceptable lean quality

and belly thickness is placed in one of four grades, depending on the backfat thickness over the last rib, and

the degree of muscling (thickness of muscling in relation

to skeletal size). These two factors together indicate the

expected carcass yields of the four lean cuts. These yields

are based on cutting and trimming methods used by the

U.S. Department of Agriculture in developing the standards (table 14-1). Other cutting and trimming methods

may result in different yields.

Adoption of USDA Grades

Use of USDA grade standards is voluntary. However,

if a packing plant decides to use grade standards and

designate the U.S. grade on a package label, they must

use USDA’s grade standards.

A USDA study of 12 packers in 1981 and 1982 found

that none of the plants used the USDA grading system

(66). This may be attributable in part to the fact that

USDA grade standards had not changed since 1968,

whereas the characteristics of the market hog population

had changed significantly. In 1981–82, 71.7 percent of

the market hogs were graded U.S. No. 1, and 24.4 percent were graded U.S. No. 2; these USDA standards

were not effectively discriminating among hogs varying

significantly in value. Most packers developed their own

grading systems in order to differentiate among pork

carcasses (one plant had no grading system). Because

each packer’s grade and evaluation system was individually designed, grade criteria, descriptive terms used for

grades, and evaluation methods varied among packers.

Among the factors used to determine grading standards

were backfat, muscling, percentage of carcass weight

consisting of primal cuts, and conformation. Packer employees primarily used visual appraisal for grading. In

1985 the USDA changed the backfat standards for its

grades (table 14-1), but a study of market hog characteristics from five plants in the South and Midwest predicted that 98 percent of the pigs would be in the U.S.

No. 1 or No. 2 grade (52). Thus, USDA grades still do

not adequately differentiate carcass quality. Overall, pork

carcass characteristics have improved to where most meet

the standards for the top USDA grades.

Packer grading and evaluation systems also have evolved

over the past decade and now have little in common with

the USDA grading system. A 1990 Iowa State University

survey of 12 of the largest pork slaughter firms found

that all large packers now are using carcass weights in

their evaluation procedure. Four of the largest packers

indicated that actual backfat measurements were the primary basis for their internal evaluation system and their

carcass merit buying systems (though the grade could be

modified by extremes in muscling noted by visual evaluation). Where backfat measurements were employed,

the top grades often had much lower backfat thresholds

than USDA grades currently do, with one at 0.6 inches

of backfat or less, and two at 0.8 in. or 0.75 in. or less.

Seven firms reported currently using or switching soon

to the use of the Fat-o-Meter, which calculates percent

lean in the carcass from the backfat measurement (taken

21⁄2 inches off the midline of the carcass at the 10th rib)

l~i~ analysis is based on the OTA commissioned background Paper “An Analysis of the Pork Grading System: Needed Adjustments, ” by

James Kieibenstein, Marvin Hayenga, Lauran Christian, Kenneth Prusa, Robert Rust (all associated with Iowa State University); and John Forrest,

AlIan Schinckel and Max Judge with Purdue University (31).
Chapter 14—Food Quality: the Relevance of Food Grades ● 355

Table 14-1—Expected Yields of the Four Lean Cuts,

by Grade, Based on Chilled Carcass Weighta

Grade Yield

U.S. No 1 . . . . . . . . . . . . . . . . . . . . . . . . 60.4 percent and over.

U.S. No 2 . . . . . . . . . . . . . . . . . . . . . . . . 57.4 to 60.3 percent.

U.S. No 3 . . . . . . . . . . . . . . . . . . . . . . . . 54.4 to 57.3 percent.

U.S. No 4 . . . . . . . . . . . . . . . . : . . . . . . . less than 54.4 Percent.

*These yields will be approximately 1 percent lower if based on hot carcass

weight.

SOURCE: U.S. Department of Agriculture.

and the loin muscle depth at that location. The percent

lean in the carcass then serves as the basis for grading.

In summary, the current USDA pork carcass grading

system already is significantly out of step with industry

systems: changes in pork carcass composition brought

on by new growth promotant technologies may cause

further divergence of government and industry grading

systems. The USDA pork grades are primarily employed

in Federal-State market news and price reporting for live

hogs rather than in packing plants. This contrasts with

the USDA beef grading system, which is used extensively by beef packing plants for price reporting. In 1989,

the American Meat Institute reported that 56 percent of

the beef produced was quality-graded, and 65 percent

was yield-graded using USDA standards.

Changing Public Concerns and Expectations

Annual per capita consumption of red meat has been

declining (figure 14-1) as poultry and fish have been

substituted for red meat. The dramatic increase in poultry

consumption reflects the aggressive marketing of poultry

Figure 14-1—Per Capita Pork, Beef, and Poultry

Consumption, United States, 1970-1989

100Pounds per person

I

products, their lower relative price, and the response of

consumers to fat and cholesterol concerns. Consumption

of all meat has trended upward overtime. Total per capita

consumption of red meat and poultry reached a record

level in 1989 of 220 lbs. per capita, compared with 200

lbs. in 1970 and 170 lbs. in 1960 (figure 14-1). While

annual per capita consumption of pork varies cyclically

in the United States, there has been little change in pork

consumption levels over the long term. Annual per capita

consumption of beef, however, has declined dramatically; from 94.2 lb. in 1976 to 71.0 lb. in 1989.

Consumer preferences and attitudes regarding meat

products have a major influence on meat and meat product demand. Consumer perceptions of product quality

and healthfulness, product convenience, cultural or ethnic background, household age composition, lifestyle,

and price all impact purchase decisions. Health concerns

related to fat and cholesterol levels can affect some consumers’ attitudes and preferences regarding pork and beef.

These have likely led to changes in demand for meat

products. These shifts are difficult to measure accurately,

and their impact on purchase patterns are not well documented; it seems likely, however, that health and diet

issues will be major factors influencing the future demand

for pork and beef. In addition, the need for better nutritional labeling on food products is receiving attention.

Healthfulness of food products may be a major driving

force in future food policy and consumer purchasing

decisions.

A series of Food Marketing Institute ( 18, 19, 20) consumer surveys document the evolution of factors influencing consumer food purchases. Taste is clearly the

leading factor, with 90 percent of consumers surveyed

in 1991 considering it very important, and 8 percent

somewhat important. Nutrition, product safety, and price

ranked high, with 71 to 75 percent of shoppers considering each very important.

At various times nutrition has not been so important

to consumers. In 1983, 64 percent of supermarket shoppers were very concerned about nutrition, whereas in

1987, 54 percent indicated this level of concern, and 40

percent were somewhat concerned. In 1991, 75 percent

of shoppers surveyed considered nutrition very important, with 22 percent considering it somewhat important

in food selection. In food selection decisions, concern

about overall nutritional issues is being replaced by concern for specific nutritional components, such as (in order

of decreasing importance) fat content, cholesterol level,

salt content, calories, vitamin/mineral content, and pre-
356 . A New Technological Era for American Agriculture

servatives (20). Some of those specific concerns were

evident in the 1983 survey as well.

Preservatives and chemical additives used in food

preparation have emerged as a major consumers concern

in recent years. In 1991, 80 percent of shoppers surveyed

considered chemical residues in foods a serious hazard

(20). The presence of antibiotics and hormones in poultry

and livestock feeds was ranked as the second most serious

hazard (56 percent). Irradiation was viewed as a serious

hazard by 42 percent of the respondents, closely followed

by nitrites at 41 percent.

A recent National Research Council report indicates

that Americans consume too much fat with consequential

nutrition-related health problems (41). A common method

to reduce fat in meat products is trimming. Perhaps a

more efficient method is the production of leaner animals

(41). The pork industry has attempted to reduce the fat

content in fresh pork significantly through selective

breeding (genetics) and diet and management practices

(58). Technological advancements, such as growth promotants and application of genetic engineering, offer the

opportunity to markedly improve body composition of

pigs before slaughter.

Consumers also are increasingly desirous of product

uniformity. While level of desired quality varies among

consumers, an individual consumer typically prefers

products of uniform quality, as exemplified by the success of many fast-food establishments such as McDonald’s, Wendy’s, Kentucky Fried Chicken, etc. A

visit to the local meat counter, on the other hand, illustrates the lack of uniformity in pork products—present

grading systems do not directly reflect product quality.

New Technologies and Implications

for Pork Grading

A young animal develops lean muscle more rapidly

than fat; but as the animal matures, fat accumulates more

rapidly than lean. With increasing consumer concerns

about fat, it is advantageous for pork producers to shift

the growth pattern away from fat accumulation to lean

tissue accumulation, particularly during the finishing phases

of production. In pork production, recombinant porcine

somatotropin (pST) and beta-agonist administration (discussed in ch. 3), shifts the growth response from fat

accumulation in pigs to deposition of lean tissue.

Porcine Somatotropin

As discussed earlier, carcass characteristics such as

backfat thickness and carcass weight currently determine

Table 14-2—influences of pSt or Ractopamine on

Production and Carcass Characteristics of Pigsa

pSTb Ractopaminec

(in percent) (in percent)

Feed efficiency . . . . . . . . . . . +21 .1 + 12.7

Average daily gain . . . . . . . . + 15.2 + 8.4

Average backfat . . . . . . . . . . – 24.8 – 15.3

Loin eye area . . . . . . . . . . . . . + 18.5 + 16.3

Muscle mass . . . . . . . . . . . . . + 9.9 + 9.3

Carcass yieldd . . . . . . . . . . . . -2.4 + 1.4

‘Expressed as an increase or decrease as compared with controls,

bSummary of 20 research trials.

cSummary of up to 17 research trials.

dHot carcass weight divided by live weight X 100.

SOURCE: D. Zimmerman, “Growth Enhancers,” Proceedings on New Swine

Growth Enhancers, lowa State University, 1989.

USDA carcass grade. Thus, changes in the carcass composition that result from use of pST or beta agonists can

impact the present grading standards.

Zimmerman (70) summarized the available studies that

evaluated the impact of pST administration on lean meat

production and feed efficiency (table 14-2). The magnitude of response of pST administration varies from

study to study and depends on frequency of administration, pST dose level, time of administration, genotype,

gender, energy intake, and protein and amino acid intake.

In 20 research trials evaluated by Zimmerman, pST

was injected daily at dosages from 15 to 100 ug/kg body

weight. Pigs weighed 40 kg or more at the beginning of

the treatment period and were fed a diet containing at

least 16 percent protein. In many cases diets were supplemented with additional lysine. The average daily gain

of pST-treated pigs was 15.2 percent higher than that of

controls. Feed efficiency was 21.1 percent higher.

The use of pST has a positive impact on most carcass

characteristics. Average backfat thickness decreased by

24.8 percent, loin eye area increased by 18.5 percent,

and quantity of muscle mass increased by 9.9 percent

with pST administration. In general, the carcass percent

lean, which was 52 percent for control pigs, was 64

percent for pST pigs (4); the actual differential depended

on the level of pST administered. Studies have shown

percent lean increases of 15 to 25 percent. Dressing percentage (carcass yield) decreased by 2.4 percent when

pST-treated pigs were compared with controls.

A rapidly accumulating body of data indicates that

administration of pST to finishing pigs alters the yield

and distribution of wholesale cuts in the carcass. Weight

and percentage of lean cuts are significantly increased

(ham, 12 percent; loin, 11 percent; Boston butt, 12 per-
Chapter 14—Food Quality: the Relevance of Food Grades ● 357

Photo credit: Terry Etherton, Pennsylvania State University

Comparison of pork loins that show the effect of pigs treated with porcine somatotropin (pST). The

loin-eye area of the loin treated with pST is 8 square inches; the control is 4.5 square inches.

cent; picnic, 9 percent) whereas weight and percentage

of fatty cuts are reduced significantly (belly, 13 percent;

jowl, 32 percent) (6, 12).

Proximate composition of the skeletal muscle exhibits

a dose-dependent decrease in lipid concentration and a

small but significant increase in protein concentration

with pST administration (5, 6, 39, 47, 48). Cholesterol

concentration of the loin muscle is not altered, and only

minor increases in percentage of polyunsaturated fatty

acids are observed in the subcutaneous or intramuscular

fat of pST-treated pigs (6).

Although data are sparse, little indication exists of any

change in mineral concentrations (22) or vitamin content

of muscle (46) with administration of pST. Therefore,

the most significant effects of pST on nutrient composition of edible tissues is reduction of neutral lipid concentration. Several investigations indicate that cooking

loss and sensory characteristics of fresh pork are not

adversely affected by pST administration, unless very

high doses are administered (5, 6, 15, 22, 47, 64).

In a study that evaluated consumer reaction to pork from

pigs treated with pST, nearly 1,200 consumers sampled

broiled loin chops from pST-treated and control pigs. Pork

from pST-treated pigs was favored by 58.8 percent of the

participants for its tenderness, by 60.6 percent for its juiciness, and by 53.7 percent for flavor (49).

In another study, members of 114 Des Moines households (414 people) compared boneless loin roasts from

pigs treated with and without pST (17). Overall, no difference was noted in how individuals liked the two roasts.

Roasts from pST-produced pigs were judged larger and

leaner than control roasts.

pST On-Farm Study

Most studies of pST’s effects on pork production and

carcass characteristics have been conducted within an

experimental and control setting. The expected production responses to pST under normal farm conditions were

studied on 15 Iowa pork production operations (50) at

Iowa State University. Some pigs were grown to the

normal market weight (109 kg) while others were taken

to 131 kg before marketing.

The administration of pST had a dramatic positive

effect on packer-determined carcass grades (table 14-3).

Only 18 percent of control carcasses graded No. 1, whereas

41 percent of the pST (109 kg) group and 69 percent of

the pST (131 kg) group graded No. 1. Over 90 percent

of the pigs administered pST graded a No. 3 or better,

versus only 75 percent of the control hogs. Even though

allowances were made for increased backfat with heavier

weight pigs a substantial improvement in grade was noted

with pST use. However, dressing percentage (hot carcass

weight as a percent of live weight) was depressed slightly

due to pST administration (table 14-4).

Beta-Agonists

Zimmerman (70) also summarized the large number

of research trials that have involved the use of ractopamine in finishing pigs (table 14-1). As with pST, re-
358 ● A New Technological Era for American Agriculture

Table 14-3—Effect of Porcine Somatotropin (pST)

Administration on Pig Growth Performance

Control/

109 kg pST/109 kg ST/131 kg

Treatment a

(n = 15) (n = 12) (n = 13)

Start weight (kg) . . . . 69.3 69.0 69.3

Final weight (kg) . . . . 109.3 111.5 126.3

Gain (kg) . . . . . . . . . . . 40.0 42.6 57.4

Feed (kg) . . . . . . . . . . 144.3 125.6 173.5

Feed/Gain . . . . . . . . . . 3.6 3.0 3.0

Average daily feed

(kg) .....,,..,,.. 2.7 2.4 2.4

Average daily gain

(kg) . . . . . . . . . . . . . 0.76 0.81 0.79

a

control/109 kg targeted for slaughter at 109 kg, a summary of 15 farms

averaged over 533 pigs; pST/109 kg targeted for slaughter at 109 kg, a

summary of 12 farms averaged over 373 pigs; pST/131 kg, targeted for

slaughter at 131 kg, a summary of 13 farms averaged over 437 pigs.

SOURCE: K. Prusa et al., ‘Influence of Porcine Somatotropin (pST) on

Carcass Characteristics of Pigs—A Summary of 15 Producer

Trials,” Journal of Animal Science 69:344, 1991.

sponses were found to vary from study to study. In general

the trials utilized 20 ppm of ractopamine and at least 15

percent protein in the diet, and all experiments were

based on starting weight of approximately 60 kg and

ending weights of 105 kg body weight. Averaged over

all trials, ractopamine increased average daily gain by

8.4 percent and feed efficiency by 12.7 percent when

compared with control pigs. Research of Veenhuizen et

al. (67) and Anderson et al. ( 1 ) shows feeding betaagonists increases growth rate and feed efficiency, decreases backfat, and increases loin muscle size of pigs.

The use of ractopamine also has a positive effect on

carcass characteristics. Backfat was decreased by 15.3

percent, loin eye area increased by 16.3 percent, and

muscle mass increased by 9.3 percent. In general, carcass

percent lean increased from 51 percent to 57 percent

when 20 ppm of ractopamine were administered (69).

When lower levels were administered, response rates

were lower. Similarly to pST, ractopamine increases the

weight and percentage yield of trimmed wholesale cuts

(ham, 7 percent; loin, 6 percent) (36).

In contrast to pST, ractopamine increased carcass yield

by 1.35 percent; and beta-agonist use did not significantly

reduce the amount of intramuscular fat in lean tissue.

Animals fed cimaterol (68) or ractopamine (36) had the

same intramuscular fat contents in their loin muscle as

control pigs. Lee et al. (33) found that ractopamine feeding had only a minor effect on fatty acid profiles in

adipose tissues of finishing pigs, and Walker et al. (68)

found no differences due to cimaterol treatment in the

total saturated-unsaturated fatty acid ratio of the subcutaneous fat. These researchers also reported that cimaterol had no affect on carcass fat firmness scores or

intramuscular fatty acid profiles.

Little information about the sensory quality of pork

from beta-agonist-supplemented pigs is available. Greater

Warner-Bratzler shear values (toughness) of the loin increased in pigs that received cimaterol treatment in the

range of 0.50 to 1.0 mg/kg (28, 68). Effects of betaagonists on pork quality may be compound specific (36)

because ractopamine feeding had no effects on the tenderness, juiciness, or flavor of fresh or cured pork.

In summary, pST and beta-agonist administration improves feed efficiency and average daily gain reduces

Table 14-4-Effect of Porcine Somatotropin (pST) Administration on Carcass Grades at a Major

Commercial Packer

Control/109 kg PST/109 kg pST/131 kg

Number Number Number

Commercial gradesa

of pigs (percent total of pigs (percent total) of pigs (percent total)

No. . . . . . . . . . . . . . . . . . 80 (18) 117 (41) 295 (69)

No. 2 . . . . . . . . . . . . . . . . . 115 (26) 83 (29) 76 (18)

No. 3 . . . . . . . . . . . . . . . . . 142 (32) 65 (23) 39 (9)

No, 4 . . . . . . . . . . . . . . . . . 76 (17) 15 (5) 11 (3)

No. 5 . . . . . . . . . . . . . . . . . 34 (8) 2 (1) 4 (1)

Total . . . . . . . . . . . . . . . . . 447 282 425

aCommercial packer grades based on live weight and tenth rib backfat thickness:

No. 1 = 0.80 in. or less (95-113 kg); 1.00 in. or less (1 14–122 kg); 1.20 in. or less (123 kg and up)

No. 2 = 0.81-1.00 in. (95-113 kg); 1.01-1.20 in. (1 14-122 kg); 1.21-1.40 in. (123 kg and up)

No. 3 = 1.01–1.20 in. (95-113 kg); 1.21–1.40 in. (1 14-122 kg); 1.41-1.60 in. (123 kg and up)

No. 4 = 1.21-1.40 in. (95-113 kg); 1.41-1.60 in. (114-122 kg); 1.61-1.60 in. (123 kg and up)

No. 5 = Over 1.40 in. (95-113 kg); over 1.60 in. (114–122 kg); over 1.80 in. (123 kg and up)

NOTE: Percents may not add to 100 because of rounding.

SOURCE: K. Prusa et al., “Influence of Porcine Somatotropin (PST) on Carcass Characteristics of Pigs—A Summary of 15 Producer Trials,” Journal of

Animal Science 69:344, 1991.
Chapter 14—Food Quality: the Relevance of Food Grades ● 359

backfat thickness, and increases the carcass percent lean

and the weight of the major boneless pork cuts. Carcass

dressing percentage increases with beta-agonist use, but

decreases with pST administration. Both growth promotants show promise as methods to produce leaner pork

cuts more efficiently. These changes have implications

for present pork carcass grading and payment systems.

Potential Parameters for Alternative

Grading System

USDA grades and grading criteria are rapidly becoming irrelevant for at least two reasons. First, the industry

does not use USDA grades because they do not measure

characteristics deemed important by industry. Second,

advancing technologies, such as pST, will significantly

change the composition of pork cuts to leaner products

desired by consumers. Current USDA grading criteria

based on backfat thickness and degree of muscling will

not be relevant since there will be little, if any, difference

in these characteristics among products produced with

the new technology. For a grading system to be useful

new criteria will be needed.

In determining potential criteria for use in alternative

grading systems, it seems logical to focus on those characteristics considered most important by the ultimate consumer of pork products, with some consideration of the

intermediate customer and the pork processor. The goal

of an evaluation scheme as it pertains to pork quality is

to predict from characteristics of fresh meat the general

merit and value of the cooked product. In purchasing

high-value products, consumers will consider price as

well as such product characteristics as amount of lean

versus fat and bone in the pork product; cholesterol levels; flavor, tenderness, texture, and firmness; degree of

marbling; juiciness; color of the lean and fat; and aroma

of the product. Moisture holding capacity is important

for products to be cured or smoked.

External Fat

Both USDA and packer grades of pork are influenced

largely by the amount of subcutaneous (external) fat,

which accounts for approximately 70 percent of total

carcass fat (8). Until recently, external fat was trimmed

to approximately 1⁄4 inch on pork cuts at the retail level.

The Pork Market Basket Study completed in 1990 at the

University of Wisconsin revealed that pork currently is

trimmed to an average of only 1/8 in. of external fat.

Although trimming away undesirable external fat is

one method of improving product quality and increasing

consumer appeal, it is less appealing to the retailer who

Photo credit: John Forrest, Purdue University

Grades for pork carcasses are based on a combination

of subjective visual appearance and measurement of fat

thickness (by simple ruler) and carcass weight. Fat

thickness will not be a relevant criteria in the future.

suffers the trim loss. Fat is perhaps viewed even less

favorably by the producer who stood the consequences

of inefficient gains of his animals (fat requires more

calories than lean). Furthermore, carcasses with excessive external fat are likely to contain more intermuscular

or seam fat, which is difficult to locate and remove,

particularly in large roasts. Intermuscular or seam fat

levels in excess of 20 percent are common in pigs; on

average that type of fat represents 15 percent of carcass

weight. Thus, trimming away of external fat deposits is

a less than satisfactory solution to the fatness issue.

Lean-Fat Ratios

An accurate method of determining directly the total

fat percentage or lean-fat ratio of carcass products would

be valuable for both consumers and packers. Present

measurement procedures will be described in a later section. These techniques do not adapt well to the modern-
360 ● A New Technological Era for American Agriculture

day rapid slaughter line. The Anyl-Ray procedure for

assessing fat content of ground fresh meat samples is

widely used in meat processing and has a relatively high

degree of accuracy; however, it cannot assess fat content

of the intact carcass.

Intramuscular Fat

The relative importance of marbling (intramuscular

fat) to product acceptability is not clearly established.

Malphrus et al., (34) reported a closer relationship between marbling and juiciness than between marbling and

tenderness, although both exhibit a positive relationship.

Further, marbling seems to be more important to palatability in fresh than cured pork and more important in

chops than in pork roasts. However, marbling or intramuscular fat generally is considered a factor affecting

palatability (7, 11, 53).

Cholesterol and Unsaturated Fatty Acids

Reduction of caloric content (fat content) of meat can

contribute to reduction of obesity in humans and possibly

improved health. The fat component of meat (particularly

saturated fatty acids and cholesterol content) has been

implicated in cardiovascular disease (23). More recently,

red meat consumption has been linked to higher rates of

colon cancer.

Muscle Quality

Problems of poor muscle quality continue to plague

the pork industry. Pale, soft, and exudative (PSE) and

dark, firm, and dry (DFD) muscle have been reported

for 3 to 25 percent of carcasses in U.S. packing plants.

Exudative pork has the tendency to lose water. It is important to monitor this problem if our foreign markets

(particularly that of color-conscious Japan) and our domestic market are to be maintained or expanded.

Tenderness

Objective muscle shear measurements such as the Warner-Bratzler shear have been positively correlated with

palatability (tenderness) of cooked pork as well as other

meats (7). While there may not be a practical approach

to obtaining this measurement on fresh carcasses, there

may be a need to include some measure of tenderness in

the grading process. In Denmark, shear force values have

increased significantly with reduction in backfat and increased lean content. These changes have been significantly associated with a reduction in intramuscular fat.

To date, there is no practical direct method of evaluating

tenderness in fresh meat or in the meat animal carcass.

Indirect indicators of meat tenderness such as color and

texture of lean are questionable, at best.

Nutrient Content

Nutrient content variation in pork cuts with a similar

lean-fat ratio primarily reflects the PSE condition and

the extent to which nutrient-containing juices are exuded.

For example, many nutritional elements are water soluble

and may be lost during retail storage or cooking. Meyer

et al. (37) examined B vitamin content and found greater

losses from PSE muscle than from normal muscle. Niacin, however, was found to be higher in the final cooked

PSE muscle. Biochemical differences in muscle metabolism were postulated as the reason for these differences.

Collection and analysis of the drip from normal and PSE

chops showed losses of protein, potassium, calcium, and

magnesium per unit weight of lean were higher in PSE

chops (16). Nutrient concentration of the drip was similar

for the PSE and normal chops, but twice as much drip

from PSE chops meant greater nutrient losses from the

PSE product. Such losses, however, represent a very

small portion of total nutrients present in a pork chop,

and the differences observed did not appreciably change

the nutritive value of PSE chops.

Flavor

Flavor is the most difficult to define of all the sensory

traits. The lipid composition and metabolism of fat primarily are responsible for flavor (56). However, lean is

also known to have important flavor components (9).

Minimum quantities of fat necessary for “typical” flavor

are not clearly defined, perhaps because juiciness becomes a palatability factor at low fat levels before loss

of flavor occurs. The lipid component of pork can lead

to the development of off-flavors. The high degree of

unsaturated fatty acids in pork fat is the major reason for

the potentially greater rancidity of pork relative to beef.

There are no commercially feasible technologies currently available for measuring flavor. The primary technique utilized presently is sensory panels.

Options for an Improved Grading System

There are a number of alternatives to the current USDA

pork grading system that warrant consideration. A few

observations about the current situation and imminent

changes in the pork industry will lay the background for

consideration of possible changes in the pork grading

systems. The current USDA pork grading system is not

effectively differentiating between carcasses that vary

widely in value. Packers are not currently using the USDA

grading system for evaluating or pricing hogs. The packer
Chapter 14—Food Quality: the Relevance of Food Grades ● 361

grading systems in use vary in the extent to which they

differ from the USDA system. The inadequacy of the

USDA grading system will become more apparent as

producers begin using new growth promotant technology

such as pST or beta-agonists.

Product characteristics valued by the consumer are only

partially reflected in current grading systems. Fat content

of pork products is a key factor for consumers, and external

backfat thickness is a key factor in current packer and

USDA grading systems. Fat content is related to calorie

content, so calories are indirectly considered. While there

currently are no grades for retail pork products, the labeling

systems on a limited number of branded, processed products listing percent fat-free and calories serve the same

purpose. Cholesterol and saturated fatty acid content, and

muscle quality traits (color, tenderness, texture, etc. ) considered important by consumers are not reflected in current

grading systems. Technologies to measure these variables

are not curently available or cannot be economically incorporated into the fast line speeds, etc., of the modem

packing plant. (See box 14-A.)

Ideally, grading systems should provide recognizable

homogeneous groups of products based on highly valued

consumer characteristics that are accurately and efficiently measured. This would facilitate better informed

purchasing and pricing decisions, and market feedback.

Making producers and processors aware of value differences via the grading and pricing and market information

system should improve industry resource allocation.

New growth promotants being developed for use in

pork production are likely to change the compositional

relationships within the pork carcass and the resulting

consumer products. These changes will primarily impact

lean/fat/bone relationships rather than sensory properties

or eating quality. The compositional changes will necessitate further adjustments in current grading systems

to provide accurate grading, equitable pricing, and accurate price reporting of pigs and their products or the

elimination of grades altogether.

Several changes in the grading system that might improve industry performance are considered. Potential

benefits and costs to consumers and industry participants

are briefly analyzed.

Option l—Status Quo

Maintain the status quo in the USDA grading system,

with a single measurement of backfat depth as the primary indicator of grade. This would be the least expensive alternative for the government and pork industry.

Since packers currently do not use the USDA grading

system, the impact on industry performance would be

limited to the market information system that relies on

USDA grades for price reporting. The Federal-State market price information based on USDA grades will become

gradually less discriminating and useful, as an increased

proportion of carcasses varying widely in value would

be graded U.S. No. 1. The Federal-State Market News

service has already deviated from using the USDA grading system by splitting their U.S. No. 1 grade carcass

price reports into separate price reports for hogs with less

than 0.8 inches of backfat and more than 0.8 inches of

backfat.

Use of growth promotants will further widen the current disparity and variability between carcass grade and

carcass value, especially in the highest grade. Differences

between packer grading standards and USDA grading

standards will likely continue to widen if packers continue to adapt their grading and evaluation systems to

the changing characteristics of the market hog population. Several different packer grading and evaluation systems will continue to coexist, with differences in method

and accuracy of evaluation. Producers will continue to

have difficulty comparing alternative packer price quotations based on different grading systems. This would

primarily affect producers’ abilities to assure getting the

best price for their hogs, and would have a small impact

on resource allocation decisions by pork producers. Grades

will continue to offer no useful information on lean quality or fat content to consumers, but individual packer

grades and pricing systems likely will continue to offer

some incentives for leaner hogs. However, many packer

grading systems may have to be changed to reflect more

accurately the changes in carcass composition from pigs

produced using new growth promotants. The USDA grades

will be even less able to reflect relationships between

value characteristics and value. At the extreme, USDA

grades could be rendered highly ineffective.

Option 2—Develop Grades Based on Lean-Fat

Composition and Quality

Develop pork grades designed to reflect lean-fat composition as well as product characteristics most highly

valued by the consumer. Use these grades for consumer

products as well as at the packer level. Such grades might

distinguish product groups differing in eating quality

(tenderness, texture, freedom from PSE, freedom from

odor, and color) and composition (percent lean, calories

per ounce, etc.). There could be a separate quality grade,

or a minimum quality standard for each composition grade.
362 ● A New Technological Era for American Agriculture

Box 14-A—Technology To Evaluate Pork Carcasses or Procuts

Some 50 years of research and development has gone into the grading and classification of pig carcasses.

Along with visual assessment and direct measurement of various fat and lean parameters with grids and metal

rulers, the industry now has several highly sophisticated electronic techniques with which to measure economically

Important characteristics of pork carcasses or products. Some of these await only the final stages of development

before they can be applied commercially.

Subjective Visual Assessment and Ruler/Grid Measurements

Currently, grades for pork carcasses are based on a combination of subjective visual appraisal of muscle

thickness and objective measurements of fat thickness and carcass weight. In reality, most carcasses that are

graded are subjectively evaluated by trained personnel However, actual measurementt of fat thickness at some

point on the midline of the split carcass often is done with a simple ruler. the correlation of 10th rib backfat depth

with quantity of fat-free lean mass is generally low (-0.27), but the measure is much more highly correlated with

percentage fat-free lean mass (-0.56) (42). Combining measurements of the cross-sectional area of the loin muscle

at the 10th rib with measurement of fat depth at the 3/4 point over the loin muscle significantly improves the

prediction of either fat-free lean mass or percentage fat-free lean mass.

Carcass and cut Dissection

The standard to which most techniques for carcass

evaluation are compared is the complete dissection of

at least one side of the carcass into lean, fat, bone,

and skin followed by chemical analysis of the soft tissues to calculate either a fat-free lean mass or a fatstandardized lean mass. In many instances the major

primal cuts (ham, loin, belly, shoulder) are dissected

individuality in order to determine changes in composition within the carcass that could be due to breed, or

the utilization of growth stimulants or repartitioning

agents. This is not practical in current commercial

slaughter plants.

Carcass and cut Grinding and chemical Analysis

Grinding of the whole side or entire carcass followed by chemical analysis is sometimes utilized to

determine composition under research conditions. while

this technique reduces the labor that would be required

for full dissection, it is very costly because none of the

tissues can be salvaged for human consumption. Another disadvantage of this technique is that the com- Photo credit John Forrest, Purdue University

position of the edible soft tissues and the skeletal The Fat-0-Meter is an optical probe that directly senses

structures cannot beseperately determined. Like car- reflected light to determine tissue boundaries.

cass and cut dissecttion, this too is not practical for

commercial slaughter plants.

Optical and Mechanical Fat-Lean Probes

The Hennessy Grading Probe, Fat-o-Meter, Anatech PG-1OO, and Tecpro PG-200 are optical probes that

directly sense reflected light to determine tissue boundaries. Accuracy levels of the grading probes in predicting

percentage lean vary depending on the probe sites and combinations of parameters.

Mechanical-Pneumatic Assessmentt of Confirmation

An electro-pneumatic mechanical system measures the width of hams and loin. These measurements are

combined with fat depth determined on the midline. This system is considerably more complex and expensive than

an optical probe.
Chapter 14—Food Quality: the Relevance of Food Grades .363

Potent/a/ Technology for Measuring Composition of Pork Carcasses and Pork Products

Magnetic Resonance Imaging and Nuclear Magnetic Resonace Spectroscopy

Magnetic resonance imaging (MRI) utilizes electromagnetic signals induced by a strong magnetic field

to map and image fat and lean tissues. This technology

is currently very expensive to purchase ($225,000 or

more) and requires special shielding. It is slow and not

currently adaptable to modem day slaughter plants.

The high correlations with lipid (0.965), water (0.995)

and protein (0.995) content from MR spectroscopy and

the high resolution obtained from MRI images suggest

that this technology could be used in research to replace time consuming and expensive carcass dissection. To be effective in commercial application, further

research and development to reduce the cost and increase the speed of operation would be required.

x-ray computed Tomography

CAT scan or X-ray Computed Tomography produces a two-dimensional cross-sectional image of the

carcass. A CAT scan of live animals has been shown

to give highly accurate predictions of pork carcass composition without significant biases with respect to gender, breed, or live weight (55). The Norwegian Meat

Marketing Board plans to use this technology to replace

carcass dissection in the validation of other live animal

and carcass grading instruments. High cost and the

slow rate of data capture make this technology currently

impractical for consideration in online applications.

Photo credit: John Freest, Purdue University

Magnetic Resonance Imaging is a potential technology

for measuring pork carcass composition by using

electromagnetic signals to map and image fat and

lean tissue.

Video Image Analysis of Conformation and Fat Depth

Video image analysis offers the possibility of objectively measuring the shape and thickness of pork carcasses,

and could be combined with lean-fat probe data to improve predictive accuracy. In Denmark, a classification center

has been developed for beef carcasses that uses video image analysis combined with an optical probe system.

Tecpro, a company in Germany, is developing a similar system for porkcarcasses. Costs for this system are difficult

to determine at this point. Speed of operation should be limited only by computer capability for image processing.

Bioimpedance Analysis

Bioimpedance analysis (BIA) exploits the conductivity differential between the fat-free mass and fat to measure

carcass fatness. As carcass fatness increases, the impedance to the flow of electricity increases. BIA has been shown

highly accurate in predicting the fat-free soft tissue content of Iamb caresses (27). Swantek and coworkers (61) reported

that BIA accounted for 64 percent of the variation in fat-free mass in chilled pork carcasses. This system, as currently

structured, would be difficlt to use in the context of current Iine speeds of many packing plants.

Ultrasound

Real-time ultrasonic imaging devices have the ability to produce cross-sectional images at various locations

in either the live animal or carcass. An image of the cross-section of the loin at the 10th rib can be used to obtain

measurements of fat depth and loin muscle area. From this a model can be developed to estimate either the weight

or percentage fat standardized lean mass. This technique may be useful in evaluating composition of seedstock

animals or for evaluation of market animals to determine optimal market weight. With proper engineering and

adaptation, ultrasound also may be useful in evaluating carcasses on the slaughter line.

SOURCE: Office of Technology Assessment, 1992.
364 ● A New Technological Era for American Agriculture

Including eating quality characteristics as grading criteria could make the pork grading system more useful at

the consumer level. Unfortunately, few such characteristics are amenable to reasonably accurate and efficient

measurement under commercial conditions. And it is not

clear what quality measures would reflect characteristics

consumers consider important but cannot visually evaluate themselves.

The cost and difficulty of implementing composition

or quality grades beyond percent lean in ground pork

might be particularly oppressive for small processors or

retailers who do a small amount of meat processing.

Mandatory label or grade information thus could have

some undesirable structural implications. On the other

hand, providing that information could level the playing

field between small processors and larger retailers and

processors with advertised brands. Further, reducing consumer uncertainty regarding any important quality characteristics by having a grade carry through to the consumer

level could enhance consumer demand for pork products,

and provide signals regarding undesirable quality to hog

producers and pork merchandisers, which could stimulate

quality improvements.

The technical feasibility of quality grading is a critical

issue. Without a clear, pressing quality problem adversely affecting domestic or export demand, the potential benefits may not be large enough to justify this option

even if the technical problems could be overcome. The

price reporting system necessarily would become more

complex as quality and composition differences would

have to be reflected in price reports, requiring significant

administrative costs and education of marketing system

participants.

Option 3—Require Standardized Grading and

Measurement Systems

Require packers to use standardized grading systems

and a standardized effective measurement technology.

Use that system for market price reporting.

This would be unpalatable for packers who usually are

extremely independent and negative toward more government intervention in their operations. Standardized

grading systems would make price reporting easier and

more accurate, and facilitate comparisons of grade-related packer bids or hog prices for producers. However,

this approach would not allow individual packers to adjust to any special considerations relevant to their customers or suppliers. Moreover, USDA grading systems

have been notoriously slow to change when conditions

warranted it, and the same might be true of any standard

grading system. Small packers may find it difficult to

compete if needed changes are expensive to implement.

Greater equity among producers may be facilitated by

these changes. Other economic benefits are in the form

of faster industry adjustment to consumer wishes and

improved resource allocation and efficiency in the long

run. The costs would be incurred in the short run, primarily by packers (especially small packers) and producers of “poor quality” hogs. Establishing a mandatory

system would involve significant research and development costs by the USDA and packers (and subsequent

processors and merchandisers of pork products if the

quality and composition grades would be carried through

to the consumer level). The added operating costs could

also be significant. Standardization across all packers and

merchandisers would certainly improve the accuracy and

ease of acquiring price reports related to the USDA grading system, but the complexity of the system would also

be increased significantly.

Option 4—Use Percent Lean as USDA Grade

Criteria

More extensive use of lean-fat probes to predict carcass

lean percent suggests that percent lean (based on loin

muscle depth and backfat thickness, off-midline) rather

than the current percent-lean cuts (primarily based on

midline backfat thickness) is a grading criterion more in

tune with the measurement technology becoming dominant in the pork industry. If the USDA simply based

grades on percent lean without tying particular backfat

or loin depth measures to any numerical grades (e. g., 52

to 53 percent lean rather than U.S. No. 1) the grade

relationships would be less apt to lag behind changes in

the hog population.

The percent-lean measure, which is the common standard for carcass evaluation by meat scientists today, has

one flaw. It does not reflect the fact that lean from a loin

or ham has a different market value than lean from another part of the animal. If the hog population has significant variability in the proportion of carcass lean coming

from various parts of the animal, those differences in

value would not be accounted for in a grading and pricing

system based on (total) percent lean.

However, this system might be superior in value discrimination to some packer systems now in use, and

would be compatible with the probe technology currently

used by several large packers. Further, the percent-lean

criterion at the carcass level would be consistent with

the lean-fat composition information that many consumers demand for pork products.
Chapter 14—Food Quality: the Relevance of Food Grades ● 365

Significant administrative costs would be required to

establish new grades and to implement the price reporting

system. Price reporting might be difficult for packers not

using probes, but current measurement systems could be

adapted to the percent-lean criterion. If slightly less accuracy in grade reporting is acceptable, it probably would

not be necessary to require use of probes for this system

to be workable. If probes were required, this would involve significant transition costs for many packers.

Option 5—Abolish the USDA Pork Grading

System, and Use Percent-Lean Descriptive

Terms for Classes of Market Hogs in

Government Price Reporting

Currently, the USDA grading system is used only by

the Federal-State Market News Service in providing the

market classes for price reporters to use. Many packers

already are using the percent carcass lean as their basis

for market hog grading and evaluation; others have not

adopted that system, often because of perceived problems

with the probe measurement system or because their own

system is considered adequate. Asking packers to shift

to a new USDA grading system would involve significant

transition costs to packers not using a percent-lean probe

system, and more market costs for packers currently using those systems. If packers do not use USDA grades

now in their grading and evaluating systems, a high likelihood exists that they would continue to use their own

systems, which they have tailored to their specific needs,

even if the USDA system was improved. In addition,

USDA grades require significant time and administrative

costs to promulgate, and may in the future lag behind

practices used in the industry. These costs can be avoided

by eliminating official grades. Instead, prevalent industry

terminology (weight and percent-lean classes) could be

used to report prices by government price reporting agencies, in consultation with the users of the price reports.

This could be done with much less administrative cost,

and retain greater flexibility to change with industry practices and technology. Since many hog producers may not

be familiar with the percent-lean terminology, price reporters could use percent-lean ranges and corresponding

backfat ranges with which farmers are familiar in price

reporting for a transition period.

The benefits of this system would be the lower cost

and greater adaptability to changes in the market hog

population and measurement technologies, due to reduced bureaucracy involvement; and a better basis for

government price reporting. It would encourage the

movement by many packers to have their prices more

accurately reflect carcass merit. The costs would include those necessary for government agencies to develop

comparable percent-lean and backfat measurements for

use in translating prices paid on the basis of nonconforming grading systems into prices for the percentlean equivalent classes. Also, the lack of uniformity

of packer grading and evaluation systems would continue, with attendant problems for producers in comparing packer bids based on different systems. However,

the increased use of percent-lean systems should gradually lead to easier comparisons.

Conclusions

Many packers are shifting to probe measurement systems where their grades and prices are based on estimates

of carcass lean percentages. Since these estimates are not

based solely on backfat, the USDA could shift to carcass

lean percentage as the basis for both grade and price

reporting. However, it does not seem likely that such a

change will prompt many pork slaughter processors to

adopt the USDA grading system, since many of them

have their own system already developed and adapted to

their needs. Moreover, changing internal evaluation systems is costly.

Grading or labeling the quality of lean would appear

desirable in pork products and carcasses. However, this

seems impractical at this time due to the absence of

commercially feasible measurement technology. Nutrient

composition or similar labeling of fat content, calories,

fatty acid profiles, or cholesterol content for pork products at the consumer level would provide information

that could enhance demand or provide clearer signals to

producers and processors regarding consumer preferences. Some branded pork processors currently are providing some of this information. In addition, some industry

consumer information programs are beginning to move

in this direction. Unfortunately, the commercially available technology for meat-quality evaluation is primarily

adaptable to ground meat, and fat content is more easily

measured than some other characteristics. Adapting this

approach to highly variable intact fresh and processed

pork products could add relatively significant capital and

labor costs, especially in small processing and merchandising operations. If effective quality measurement technology were developed, the quality measurements and

information provided would need to be incorporated into

product evaluation and pricing throughout the marketing

system. Then, consumer reactions to differences in quality would be effectively transmitted through the system

and affect prices paid to producers.

Several promising technologies that might provide accurate estimates of lean/fat composition of carcasses or
366 . A New Technological Era for American Agriculture

pork products, including products affected by the new

growth promotants, are in the research and development

stage. This research could be encouraged. These technologies, when commercially feasible, could be incorporated with grading programs that focus on carcass percent

lean. Classifying pork carcasses via carcass lean percentages could be initiated with the view toward adding

lean-quality information at a later date. When a commercially feasible lean-quality measurement becomes

available, pork carcass grades could be determined by

carcass percentage lean and quality of the lean. Dramatic

adjustments in reporting of pork prices would not be

needed to incorporate quality information with carcass

percent-lean information.

Finally, the descriptive terms (currently primarily USDA

grades) used in government price reporting could be

changed to percent-lean classes, with related backfat

measures reported for a transition period. In the longer

term, quality information can be added when commercially feasible. When fully implemented, price would be

reported by percent-lean and lean-quality classes or measurements. If there is a need for a USDA grading system,

it could be based on carcass percent lean, measurements

(not grades), with lean-quality information added when

it becomes commercially feasible to do so. However,

packers are unlikely to use an improved voluntary system. Price reporting agencies should be able to adopt

percent-lean ranges for reporting prices with less bureaucratic cost and more flexibility than would be the

case for changes of grading systems. Consequently, a

strong argument can be made for abolishing the USDA

pork grading system. This is essentially what has been

happening de-facto in the pork industry over the last

decade.

THE FRUIT AND VEGETABLE

GRADING SYSTEM2

The U.S. Department of Agriculture has a long-established system for fruit and vegetable grades. Standards

used to determine a grade include “attributes,” such as

size, quality, and condition, and their related “tolerances. ” For example, one attribute for fresh market potatoes is “free from sunscald. ” The tolerance for this

attribute is “no more than 10 percent defects at the point

of shipping. ” This attribute and its tolerance are used

along with other attributes and tolerances to designate

grade. Attributes are based on sensory characteristics,

such as touch, sight, and taste, as well as shelf-life considerations, palatability considerations, or some combination of these factors.

Challenges have been raised to the Federal grading

system. Some question grades that do not explicitly include health and nutritional factors. Others argue that the

current sensory-based grade attributes indirectly encourage the use of chemicals in production, so as to minimize

blemishes and ensure vibrant skin-color.

Consumers are increasingly concerned about the use

of chemicals or chemically based ingredients in the production and preservation of our food supply, both for

environmental and health reasons. There is concern that

chemicals used in the production process may damage

the environment and that chemical ingredients in or on

food may impair human health, perhaps in ways yet

unknown to the scientific community.

Consumers increasingly want to be more fully informed about choices available in the marketplace. Given

such information consumers will, through their purchases, indicate levels of nutrition they want, what levels

of pesticide residue they are willing to tolerate, and what

level of blemishes they are willing to accept.

Thus, some alternative or revised set of grade attributes

might be more socially desirable than current sensorybased attributes. The natural question that arises is whether

it is more feasible and desirable to incorporate additional

or modified attributes, such as nutrition information or

other “nonsensory “ information, into current standards;

or to identify conceptual alternatives to the current sensory-based standards. This case study focuses on the use

of sensory and potential alternative grading attributes for

fruits and vegetables.

Fruit and Vegetable Production and

Consumption

The U.S. fruit and vegetable industry accounts for 8.7

percent of the market value of all agricultural products

sold in the United States (table 14-5). Fruits, nuts, and

berries account for 5.2 percent of the market value whereas

vegetables account for 3.5 percent of the market value.

Reflecting their high market value per acre of production,

fruits, nuts, berries, and vegetables account for only 1.8

percent of total U.S. acreage.

zmi~ ~dy~is is b-on the OTA co~ssion~ paFr “Assessing Federat Grade Criteria for Fruits and Vegetables, ” by Thomas Sporleder) Rebecca

Boerger, Mark Bemett, James Hoskins, Eugene Jones, Timothy Rhodus, Kuti Wiese. and Carl Zulauf, all associated with the Ohio State University

(59).
Chapter 14—Food Quality: the Relevance of Food Grades ● 367

Table 14-5—Market Value of Agricultural Products Sold and Total Acreage, United States, 1987

Total fruits,

nuts and % of % of

U.S. total berries total Vegetables total

Market value

of agricultural

products sold . . . . . . . . . . . . . . . . . . . . 136,048,516 7,084,818 5.2 4,698,083 3.5

($1 ,000)

Acreage (acres) . . . . . . . . . . . . . . . . . . 282,223,880 4,404,946 1.56 3,467,563 1.23

SOURCES: 1987 Census of Agriculture AC87-A-51, U.S. Department of Commerce, Bureau of the Census, November 1989 and Fruits and Nuts Situation

and Outlook Report Yearbook, U.S. Department of Agriculture, Economic Research Service, Washington, DC, November 1990,

Table 14-8-Top 12 Commercial Shipping Point

Commodities, Fresh Inspected Shipments, Fiscal

Year 1990

(Reported in cwt.)a

Commodity Tonnage

Potatoes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Tomatoes . . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . . .

Apples . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Onions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Grapefruit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Grapes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Oranges . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Cantaloupes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Pears . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Lettuce . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Peaches . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Plums . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

100,805,477

25,645,867

19,313,891

15,667,916

13,628,587

9,166,998

7,976,860

7,483,463

6,790,235

6,751,039

6,071,965

5,179,140

a

lnspected fresh product only.

SOURCE: Fresh Products Branch, Annual Report for Fiscal Year 1990,

AMS, U.S. Department of Agriculture, Washington, DC, 1990,

and ”Fruit and Vegetable Shipments:Market News, AMS, USDA.

In terms of tonnage at commercial shipping points,

the most significant commodity among fruits and vegetables for fiscal year 1990 was potatoes (table 14-6).

Tomatoes were second in volume but with only about

one-fourth the volume of potatoes. Apples were the third

largest commodity volume-wise with about three-fourths

the volume of tomatoes.

Apples, oranges, potatoes, and tomatoes were chosen

here for specific case analysis. These commodities were

selected because they represent a wide variety of grade

standards, have relatively high per capita consumption,

and figure significantly in today’s food markets. Annual

value of production for these commodities ranges from

$1 billion for apples to nearly $3 billion for potatoes.

Annual consumption per capita for the four commodities

ranges from about 15 pounds for oranges to over 127

pounds for potatoes. Since 1970, per capita consumption

of all fruits and vegetables in the United States has trended

upward.

Table 14-7—Number and Type of USDA Grades for

Fruits and Vegetables

Number of

grade

Category standards

Fruits for fresh market:

Wholesale market . . . . . . . . . . . . . . . . . . . . . . .

Raw products for processing . . . . . . . . . . . . . .

Fruits for processing . . . . . . . . . . . . . . . . . . . . . . .

Canned fruits . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Dried and dehydrated fruit ., . . . . . . . . . . . . . . . .

Frozen fruits , . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vegetables for fresh market:

Wholesale market . . . . . . . . . . . . . . . . . . . . . . .

Consumer retail market . . . . . , . . . . . . . . . . . .

Vegetables for processing . . . . . . . . . . . . . . . . . .

Canned vegetables . . . . . . . . . . . . . . . . . . . . . . . .

Frozen vegetable . . . . . . . . . . . . . . . . . . . . . . . . . .

29

15

15

36

14

21

58

12

24

39

26

SOURCE: U.S. Department of Agriculture, Agricultural Marketing Service

USDA Grade Standards

Current grade standards for fruits and vegetables are

administered by the U.S. Department of Agriculture

(USDA) under authority of The Agricultural Marketing

Act of 1946. The purpose of these sensory-based grade

standards is to encourage uniformity and consistency in

commercial practices related to the quality, quantity, and

condition of agricultural products shipped in interstate

commerce.

Use of USDA grade standards is voluntary. However,

if a firm decides to use grade standards and designate

the U.S. grade on a package label, they must use USDA’s

grade standards.

Fruit and vegetable USDA standards can be grouped

into categories (table 14-7). Most grade standards for

fresh fruit and vegetables pre-date 1960. Grade standards

for processed fruit and vegetables generally are of more

recent vintage.

At the commercial shipping point nearly 90 percent of

fresh potatoes and approximately 77 percent of fresh
368 ● A New Technological Era for American Agriculture

Photo credit: Grant Heilman, Inc.

Voluntary sensory-based grades encourage uniformity

and consistence of agricultural products. At least 75

percent of fresh tomatoes are graded.

tomatoes are graded. Only about one-third of fresh apples

and around one-fifth of the fresh oranges are graded.

At the raw product processing stage, nearly 80 percent of potatoes were graded while only about 5 percent

of the tomatoes were graded. Approximately 86 percent of the oranges and nearly 30 percent of apples are

graded.

Grading attributes can be broadly divided into three

categories: size, quality, and condition. Size of a commodity can be described by diameter, length, weight,

and uniformity (65). Quality factors are defined as “the

combination of the inherent properties or attributes of a

product which determines its relative degree of excellence” (26). In general, quality factors refer to the attributes of a commodity that remain permanent once the

commodity is harvested. Examples include variety,

cleanliness, shape, and maturity. Defects in quality can

be divided into four classes:

1.

2.

3.

4.

fungal injuries,

insect injuries,

mechanical injuries, and

other defects (ill shaped, undesirable color, sunburn, growth cracks, and dirt) (65).

Condition refers to

the relative degree of soundness of a product that may

affect its merchantability and includes those factors that

are subject to change after harvest. Condition (i.e., ripeness or freshness) may reflect age, improper handling,

storage or lack of refrigeration. . . . (10).

Along with attributes, tolerances are used to determine

grade. Tolerances are legal limits of acceptable size,

quality, and condition attributes. They generally are stated

in percentage terms, and can vary by product, use, or

size of the individually packaged product. The tolerances

for U.S. No. 1 apples illustrate the variety of forms that

tolerances can take:

1. no more than 10 percent of apples with quality and

condition defects including no more than 2 percent

of apples with decay, 2 percent with internal breakdown and 5 percent with wormholes; and

2. the apples cannot be further advanced in maturity

than generally firm ripe.

Size, quality, and condition attributes, as well as tolerances, differ for different commodities, they also vary

with market destination. In general, attributes and tolerances are more strict for fresh produce destined for the

fresh market than for fresh produce destined for the processing market. For example, U.S. Extra No. 1 fresh

potatoes at the wholesale level must be firm, a condition

attribute. In contrast, U.S. No. 1 potatoes for processing

at the wholesale level have a comparable condition attribute of moderately firm. Similarly, the retail consumer

grade for fresh produce tends to be more strict than the

wholesale standard, To illustrate, for U.S. No, 1 tomatoes at the wholesale level, defects can total no more

than 10 percent at shipping points or no more than 15

percent en route or at the destination point. On the other

hand, defects can total no more than 5 percent for U.S.

Grade A fresh tomatoes at the consumer retail level.

Most sensory attributes are measured by inspectors

using their sense of touch, sight, and smell. Many technologies, however, have been developed to measure sensory attributes of foods. A considerable amount of

automation and computerization is occurring in this area.

For example, up-to-date mechanical harvesters used in

the harvest of processing tomatoes are computer equipped

and give a preliminary objective color assessment that is

more accurate than previous human, subjective evaluation. Advancements in computer technology are leading

to fully automated color and size measurements that will

permit accurate sensory evaluation of products from the

field to the retail store, with perhaps the need for only

limited human spot-checking (38). One large fruit pack-
Chapter 14—Food Quality: the Relevance of Food Grades ● 369

Photo credit: Grant Heilman,

Most sensory attributes are measured by inspectors

using their sense of touch, sight, and smell. Inspectors

grade nearly 90 percent of all fresh potatoes.

Inc.

ing house in Florida recently added computerized equipment that weighed, optically scanned for dimensions,

and used an infrared camera to determine fruit size. Used

together, the processes are able to determine density and

cull fruit that is internally damaged by freezing (63).

Conceptual Considerations of Grade

Standards

A grade is assigned to fruits and vegetables by applying

prespecified standards to a random sample of the commodity being graded. Three conditions must be met for

an attribute to serve as a grade standard. First, the quality,

condition, and size attributes stated in the standards must

be observable or measurable. If an attribute cannot be

observed or measured, then it is not possible to include

it in a grading standard. Second, information about the

attribute must exist and be available to the public.

Third, the attribute must vary among individual specimens of the commodity. If the attribute does not vary,

then including it in the grading standard would provide

no information. The use of tolerances on quality, condition, and size attributes reflects this variability. Tolerances allow for a sample to obtain a given grade even

though not all specimens in the sample have the same

quality, condition, and size attributes.

Basing grades on the presence and quantity of chemical

residues and nutrient value, for example, mandates

knowledge about chemical residues and nutrient values.

If these two attributes vary among samples of a commodity, and are measurable, they can be incorporated

into or substituted for existing grade standards. The next

two sections address the measurement and variability of

nutrient and chemical residue attributes in fruits and vegetables. Their purpose is to introduce the conceptual basis

for two different fruit and vegetable grade standards—

one based on nutritional content, the other on chemical

residues.

Nutritional Attribute Measurement

Cost-effective techniques that provide information on

a timely basis do exist for several nutrients (box 14-B).

The willingness of consumers to pay for this information

could broaden the range of cost-effective techniques for

nutrient analysis. An alternative approach is to determine

if sensory characteristics also convey information about

nutritional characteristics. In other words, can sensory

grade attributes be used to evaluate the nutritional characteristics of fruits and vegetables? This question is addressed in the next section.

Nutritional Attriutes Variation

Knowledge Gaps

While much is known about the nutritional value of

fruits and vegetables, inadequate data exist in many

key areas (3). (See tables 14-8 and 14-9. ) Little or no

data exist for 9 nutritional components of fresh fruits,

14 nutritional components of frozen or canned fruits,

18 nutritional components of fresh vegetables, and 12

nutritional components of frozen and canned vegetables. This lack of information is due in part to the

minute quantities of some nutritional components of

fruits and vegetables, and uncertainty as to the exact

nature of these components’ contribution to human nutrition. For example, the fat soluble vitamins (A,D,E,

and K) can be accurately assayed and quantified in

most samples. However, quantities of these vitamins

may be present in bound form or other forms not utilizable or under-utilized in human physiological processes. Thus, their overall role in human nutrition is

uncertain. Additional research on nutrition of fruits and

vegetables is needed before all nutritional attributes

can be included in a grading standard.
370 . A New Technological Era for American Agriculture

B0X 14-B-Technology for Nutrient Attribute Measurement of Fruits and Vegetables

Nutritional attribute of food in general cannot directly be sensed by consumers. Consequently, scientific

methods and instruments are needed to measure these attributes. Currently available methods and instruments

are numerous and sophisticated.

Currrent Methods for Determining Nutrient Content

In addition to water, fruits and vegetables usually contain significant amounts of most or all types of carbohydrates, such as sugars, starches, and fiber. They also contain vitamins (notably vitamins A and C) and smaller,

but nutritionally significant, amounts of minerals and protein. Specific methods of analysis exist for each nutrient

category. These methods have varying degrees of accuracy, simplicity, and cost.

For carbohydrates, analytical methods indclude observing color changes, microbial assays, enzymatic assays,

and chromatography. Chemical extraction procedures will use one of these methods to extract and differentiate

simple sugars, complex sugars, starch, and dietary fiber for analysis. A technique recently developed for quantifying

fiber is enzymatic degradation.

Protein composition generally is determined by empirical techniques. Proteins are decomposed into constituent

amino acids by hydrolysis (a decomposition procedure using water). These amino acids are isolated by chromatography (a technical procedure that separates substances based on factors of size, electrical charge, or affinity

for another compound).

Analysis of mineral components in plants is challenging because minerals generally are present only in minute

quantities. Traditionally, quantification of mineral has involved analysis of the inorganic ash residue obtained from

burning a plant sample. Mineral ash from fresh fruits ranges from 0.2 to 0.8 percent of the weight of the entire fruit,

and the quantity of ash generally is inversely related to moisture content. Mineral content in vegetables is usually higher,

at about 1 percent. The oldest analytical techniques applied to mineral ash forms of spectroscopy (xray fluorescence

absorption.) Spectroscopy is the observation and measurement of radiation emitted from chemical elements after their

atoms have been excited in a certain way. Each element has a characteristic pattern of wavelengths following excitation

(45).

Assessment of Current Techniques and Methods

Beecher and Vanderslice have cattegorized methods of nutrient analysis based on their level of accuracy and other

attributes as adequate, substantial, conflicting, and lacking. Their criterion for accuracy is the production of an

analytical value within 10 percent of a true value when a nutrient is present in food at a nutritionally significant level,

defined as greater than 5 percent of the Recommended Daily Allowance (RDA) per standard serving or daily intake,

whichever is greater. Many methods fail to meet this criterion (45).

Adequate and “substantial” methods are highly accurate, Speedy, and modest in cost-defined as less than

$100 per test. “Conflicting” and “lacking” methodologies are unlikely to render valid results under conditions of

routine analysis.

Although problems exist with accurate assessment of nutritional components of fresh fruits and vegetables, analysis

of fresh produce is less Problematic than is analysis of processed foods. Adequate and substantial methods of analysis

already exist for many nutrients in fresh fruits and vegetables.

Developments in Nutrient CompositionMeasurement

Technological advances are improving the ability to accurately and expeditiously measure nutrient components.

An example is flow injection chromatography (60). it permits numerous rapid sequential analyses and is appropriate

for constituents other than proteins, including vitamins, and carbohydrates. Similarly, a new advance in spectroscopic

analysis is Simultaneous Multielement Atomic Absorption Spectrometry (SIMAAC). It is a furnace atomization

technique that compares analytic signals to known calibration standards. Simultaneous Muitielement Atomic Absorption Spectrometry, which permits simultaneous analysis of up to 16 elements, has important implications for

more rapid sample turnout in nutrient analysis of foods. However, careful sample preparation and accurate instrument

calibration is required to avoid erroneous results (60).

Other new techniques in food analysis Include use of bioindicators, mass spectroscopy, delayed light emission,

xray diffraction, supercritical C02 chromatography, microbial assays, and computerization. Although the list is not

all inclusive, it suggests some of the directions food analysis will follow. Last, advances in computer technology

point toward further miniaturization of techniques as well as improved speed and accuracy.

SOURCE: Office of Technology Assessment, 1992.
Chapter 14—Food Quality: the Relevance of Food Grades ● 371

Table 14-8-Knowledge of Nutrient Composition of Fresh Fruits

Little or Substantial Inadequate Not

Nutritional component no data data data applicable

Individual sugars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Starch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Nutrient fiber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Total fat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Fatty acids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Sterols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Iron . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Phosphorous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Sodium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Magnesium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Potassium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Zinc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Total protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Individual amino acids . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Folacin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vitamin D....... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vitamin E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Biotin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Choline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Pantothenic acid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vitamin A . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Vitamin B1 (Thiamin) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Vitamin B6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Vitamin B12.... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Vitamin C...... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Niacin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Tables from: G.R. Beecherand J.T. Vanderslice, “Determinationof Nutrients in Foods: Factors That Must Be Considered:’ Modern hfethods ofFood

Ana/ysis, K. Stewart and J. Whitaker (eds), 1984, pp. 34-41. Tables prepared from USDA, Nutrient Data Research Branch, Consumer Nutrition Division

of the Human Nutrition Information Service research publications.

Variation in Nutrient Attributes

To ascertain whether the nutritional value of a fruit or

vegetable varies among individual samples of the fruit

or vegetable, relevant information for potatoes, tomatoes, apples, and oranges was collected by examining

the past 10 years of International Food ScienceandTechnology Abstracts.

Nutritional variation was found to exist among samples

of fruits and vegetables in several published studies. For

example, protein, niacin, and thiamin increased in potatoes

while ascorbic acid as well as starch decreased when nitrogen fertilizer was applied. Sandy soils increased the

amounts of protein, ascorbic acid, riboflavin, niacin, sodium, and iron in potatoes but decreased the amounts of

thiamine, magnesium, and calcium (2). One study (35)

indicated that samples of a single potato cultvar may differ

widely in sugar content after 9 weeks of storage. Incorporating phosphorus or potassium to the soil had no effect

on protein or nonreducing sugars, but phosphorus increased

the starch and sugar content of the potatoes.

Environmental factors influence the sugar-acid ratio,

beta-carotene, and nitrogen content and quality of toX

x

x

x

x

matoes (24). Nitrogen and potassium ratios also influence

dry matter, soluble dry matter, and beta-carotene of fruits

as well as their keeping quality. Maturity of the tomato

affects total sugars and the ratio of reducing to nonreducing sugars as well as the percentage of total soluble

solids. Mineral content and composition in tomatoes are

influenced by location and growth but do not vary among

cultivars. However, cultivar and fertilizer both affect the

amount of ascorbic acid in tomatoes (25, 44).

In apples, seasonal variation affects anthocyanin, total

phenol content, diameter and weight, total soluble acids,

acidity, and Magnes-Taylor puncture values. Bruising and

softening rates in cool storage varied by cultivar (13, 32).

Vitamin C in oranges was found to be influenced by

variety, cultural practice, maturity, climate, fresh fruit

handling, and processing factors such as packaging and

storage. Percentage of juice, Brix, acidity, and total sugars varied with orange cultivar (40, 54).

In summary, the nutritive composition of fruits and

vegetables varies due to factors of climate, geographical

location, cultivar, soil variables, irrigation practices, fer-
372 . A New Technological Era for American Agriculture

Table 14-9—Knowledge of Nutrient Composition of Fresh Vegetables

Little or Substantial Inadequate Not

Nutritional component no data data data applicable

x

x

Individual sugars . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Starch . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Nutrient fiber . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Total fat . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Fatty acids . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Cholesterol . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Sterols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Calcium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Iron . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Phosphorous . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Sodium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Magnesium . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Potassium . . . . . . . . . . . . . . . . . . . . . . . . 4 . . . . . . . . . . . . . x

Zinc . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Total protein . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Individual amino acids . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Folacin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vitamin D...... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Vitamin E . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Biotin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Choline . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Pantothenic acid... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Vitamin A....,.. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Vitamin B1 (Thiamin) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Vitamin B2 (Riboflavin) . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Vitamin B6 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Vitamin B12, ... . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Vitamin C....... . . . . . . . . . . 4 . . . . . . . . . . . . . . . . . . . . . x

Niacin . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Tables from: G.R. Beecher and J.T. Vanderslice, “Determination of Nutrients in Foods: Factors That Must Reconsidered;’hfodemhfethodsof Food

Ana/ysis, K. Stewart and J. Whitaker (eds.), 1984, pp. 34-41. Tables prepared from USDA, Nutrient Data Research Branch, Consumer Nutrition Division

of the Human Nutrition information Sewice research publications.

x

x

x

x

tilization practices, and seasonal and annual variation.

Post-harvest physiology and handling introduces additional sources of variation in the nutritional composition

of fruits and vegetables.

Conclusion

Available evidence suggests that intracommodity

variation in nutritional value does exist. Thus, one

requirement for developing a grade standard based on

nutritional characteristics is fulfilled. However, the lack

of adequate data on several nutritive components of

fruits and vegetables remains a problem. This deficiency needs to be rectified before nutritive attributes

can be included in grade standards incomprehensive

manner.

Assessing the Relationship Between Nutrient

and Sensory Characteristics

Concept

Whether it makes sense to change from sensorybased grading to nutrient-based grading depends on the

extent to which nutrition and sensory characteristics

are related. To illustrate, consider the extreme case.

Suppose all criteria contained within the sensory characteristics base for grade standards were positively correlated at 1.0 with whatever criteria were chosen for

nutrition-related grade standard. This would imply little or no impact from a change to an alternative base.

Obviously, however, it is more likely that some (but

not all) sensory criteria are correlated with some (but

not all) nutrition-related criteria.

As discussed earlier, current grade criteria for fruits

and vegetables are based on three main considerations—

quality, condition, and size. In general, the quality criteria involve maturity, cleanness, shape and form, color,

and quality defects. The condition criteria generally involve firmness, condition defects, and color.

A matrix relating current sensory grade criteria to

nutritional characteristics is presented in table 14-10.

The current grade standards, generalized across all fruits

and vegetables, appear as rows in the table. The columns are various nutrition-related characteristics. Some
Chapter 14—Food Quality: the Relevance of Food Grades .373

Table 14-10-A Method for Conceptualizing the Relationship Between Sensory Characteristics and

Nutrition Characteristics

Current grade criteria, Conceptual nutrition-related characteristics

generalized across all Enzymes & Carbo- Fats &

fruits and vegetables Vitamins Minerals Calories proteins hydrates oils Sodium Calcium Fiber

Quality

Maturity

Cleanness

Shape/Form

Color

Quality defects

Fungus injury

Insect injury

Mechanical injury

Otherb

Condition

Firmness

Condition defects

Decay

Bruising

Freezing

Discoloration

Ground color/color

Size

aThe OSU study team believes that this list accurately portrays the criteria which predominate across all fruits and vegetables. However, there are some

criteria in the current standards for a specific fruit or vegetable not reflected in this list. Such omissions have scant consequence for the present assessment.

%)ther is defined as ill-shaped, undesirable color, sunburn, growth cracks, and/or dirt.

SOURCE: Office of Technology Assessment, 1992.

cells of the matrix are not expected to be of equal

relevance. For example, one might expect positive correlation between maturity and calories per gram, whereas

the fiber-insect injury cell might not have any correlation or importance. Similarly, if a nutrition-related

base for standards were ever adopted, one would not

expect all the criteria listed as columns in the table to

be included in a standard. At this point, however, there

are no compelling reasons to exclude cells formed by

the matrix from examination, except for the cells involving cleanness and shape and form. These two current sensory grade criteria are not related to nutrition

attributes. Therefore, these two rows are shaded to

indicate no correlation is expected.

Each of the 126 relevant cells of the matrix, in effect,

defines a specific topic where knowledge is desired.

A task of the assessment of the nutrition-related base

for grade standards was to carefully review existing

scientific literature for each of the relevant cells for

the four commodities chosen for analysis—potatoes,

tomatoes, apples, and oranges. The past 10 years of

volumes of the International Food Science and Technology Abstracts have been examined for research literature relevant to the matrix and the case study

commodities.

Current Information

A summary of the findings is presented in table 14-

11. A letter for each of the investigated commodities (A

for apples, O for oranges, P for potatoes, and T for

tomatoes) is placed in a cell if information existed about

the nutrition-sensory relationship.

As is evident from the summary table, no scientific

literature was found for many of the cells. For only

about 8 percent of the 504 total cells (126 for each

commodity) does at least one research article exists.

No studies were found that investigated the relationships between current sensory grade characteristics and

sodium while only one study examined calories. The

inevitable conclusion is that much is unknown about

the relationship between sensory characteristics and

nutrition-related characteristics.

Nonetheless, some knowledge is available. The relationships between maturity and nutrition, especially

with respect to vitamin C and carbohydrates, are the

most researched. The concentration of vitamin C increases with maturity in potatoes and tomatoes, but

decreases dramatically in oranges and potatoes the longer

these commodities are held in storage. Carbohydrates

in apples and tomatoes are positively related to ma-
374 ● A New Technological Era for American Agriculture

Table 14-1 l—Summary Table of Scientific Literature on the Relationship Between Sensory Characteristics and

Nutrition Characteristics for the Four Study Commodities.

Current grade criteria, Conceptual nutrition-related characteristics

generalized across all Enzymes & Carbo- Fats &

fruits and vegetables Vitamins Minerals Calories proteins hydrates oils Sodium Calcium Fiber

Quality

Maturity . . . . . . . . . . . . . A,O, P,

A, O, P, T T T o A, O, P, T O, T A,O,T A, T

Cleanness . . . . . . . . . . .

Shape/form . . . . . . . . . .

Color . . . . . . . . . . . . . . .

Quality defects . . . . . . .

Fungus injury . . . . . .

Insect injury . . . . . . .

Mechanical injury . .

Other c 

. . . . . . . . . . . .

Condition

Firmness ., . . . . . . . . . .

Condition defects . . . .

Decay . . . . . . . . . . . . 0

Bruising . . . . . . . . . . . P

Freezing . . . . . . . . . . P, T

Discoloration . . . . . .

Ground colorl/color . . .

Size . . . . . . . . . . . . . . . . . . P

P

o

P T

A, T

A

aKey: A = apples, O = oranges, P = potatoes, T = tomatoes

b% OSU study team believes that this list accurately portrays the criteria which predominate across all fruits and vegetables. However, there are some

criteria in the current standards for a speeific fruit or vegetable not refleeted in this list. Such omissions have scant consequence for the present assessment.

Oher is defined as ill-shaped, undesirable mlor, sunburn, growth cracks, and/or dirt.

SOURCE: Office of Technology Assessment, 1992.

turity. In potatoes, starch is more readily converted to

sugars after harvest. Conversely, oranges show a decrease in glucose and fructose during storage and as

they decay.3

Chemicals and the Grading System

Current Pesticide Usage in the United States4

Herbicides, insecticides, and fungicides comprise the

three major components of the $4 billion-a-year U.S.

agricultural pesticide market. Herbicides surpassed insecticides in the late 1960s to become the most utilized

pesticide class. With $2.5 billion in sales, they accounted

for 90 percent of the total pesticide pounds applied in

1986. The insecticide agriculture market was second with

$1.0 billion in sales, followed by fungicides with sales

of about $265 million.

In 1982, slightly more than 500 million pounds of

pesticide active ingredients were utilized in American

agriculture. Pounds of pesticide active ingredients were

170 percent higher than in 19&l, while acres under cultivation remained essentially constant. By 1987, pounds

of active ingredients had declined to about 430 million

pounds. Ninety percent of all herbicides and pesticides

are applied to four crops: corn, cotton, soybeans, and

wheat.

Fungicides account for about 10 percent of all pesticides applied in agriculture and are the most significant

pesticide product used in production of fruits and vegetables. Insecticide use is also significant in fruit and

vegetable production, however, its use has declined in

recent years through the adoption of new, more effective

products and innovative strategies such as crop rotations

and Integrated Pest Management.

Most new pesticide products introduced since 1980

have been herbicides. Thirty-seven herbicides have been

registered with the Environmental Protection Agency

(EPA) since 1980 as compared to 10 fungicides. This

3Note that mmy of these ~ic]es address ~St-hmest changes. These changes are not a maturity issue; however, they do ilhIstrate the imprtance

of post-harvest storage and handling techniques to the nutritional value consumers ultimately derive from a stored fruit or vegetable.

gInformation in this ~ction comes from pages 43 through 49 of Alternurive Agriculture, a report by the Committee on the Role of Alternative

Farming Methods in Modem Production Agriculture, Board of Agriculture, National Research Council, 1989.
Chapter 14—Food Quality: the Relvance of Food Grades ● 375

Photo credit: Grant Heilman, Inc.

Chemicals applied during production of fruits and

vegetables may affect certain grade criteria. Enhanced

grade quality is one of many reasons for using

pesticides.

disparity reflects differences in the size of the market

and the higher profitability of the herbicide class, which

encourages new product innovation. Development of new

fungicides is tricky due to a tendency for the development

of pest resistance. Finally, fungicides have faced significant regulatory problems due to high carcinogenicity or

oncogenicity. Although important to the production of

fruits and vegetables, introduction of a new fungicide

product can be a financial risk for the developing company.

Production of processing tomatoes in California and

fresh market tomatoes in Florida and Ohio are discussed

to highlight patterns of fruit and vegetable fungicide use.

About 1.3 million tons of active ingredients are applied

to the 304,000 acres devoted to these crops. California,

which has 240,000 acres in processing tomatoes, uses

784 tons of fungicide active ingredient. On a pound-peracre basis, however, the State uses only 6.5 lb per acre,

compared to 11.5 lb per acre in Ohio and 17.9 lb per

acre in Florida. The higher application rates in Ohio and

Florida are due in part to the more rigid cosmetic requirements needed for fresh market production. More

importantly, the more humid Midwestern and Southern

climates necessitate increased levels of fungicide use.

The fungicide use pattern of tomatoes is representative

of most fruits and vegetables. California uses less per

acre because of its dry, favorable climate. But because

it produces over half of the Nation’s fruits and vegetables,

California utilizes the largest share of fungicide products

applied nationwide.

Pesticides and the Current Grading System

Chemicals applied during production may affect certain grade criteria in the current USDA grade standards

for fruits and vegetables. An assessment of the relationship among various chemicals and current grade criteria

was completed for apples, potatoes, and tomatoes. Tables

14-1 2–14- 14 summarize current, recommended cultural

practices and the relationship of the chemical to current,

selected USDA grade criteria. An ‘‘X’ is placed in each

cell where the chemical’s use affects the particular grade

criterion. The summary reveals that chemical use primarily is relevant to three general grade criteria—fungus

injury, insect injury, and decay. Thus, chemicals are used

primarily to protect potatoes and tomatoes from fungal

or insect damage.

While relationships between pesticide usage and grade

criteria have been found, it is not clear whether or not

current grade criteria encourage use of pesticides. Probably, improved grade quality is only one reason for using

pesticides. Other reasons would likely include higher

yield, better harvesting conditions, and reduced pest preserves on subsequent crops.

Chemical Residue Grading Standard

For an attribute to serve as a portion of a grade standard, variation in the attribute is necessary. Two recent

surveys of chemical residues in food suggest that individual samples of fruit and vegetables are likely to exhibit

differences in chemical residues. In 1989, the State of

California sampled 9,403 food samples for pesticide residues (43). The following distribution was found:

Percent

of

Residue distribution samples

No detectable residues . . . . . . . . . . . . . . . . . . . . . . . . . . . 77.9

Residues 10% or less of tolerance level . . . . . . . . . . . . 13.0

Residues between 1O%. and 50% of tolerance level . . . 7.4

Residues from 50% to 100% of tolerance level . . . . . . 1.0

Exceeded tolerance level . . . . . . . . . . . . . . . . . . . . . . . . . 0.7

FDA annually tests about 20,000 samples of fresh

and processed foods for residues exceeding tolerances

established for 10,000 food additives and 300 pesticides (51 ). Foreign food imports make up a large proportion (36 percent) of the samples. In 1988, no residues

were found in 60 percent of the samples tested. The

remaining 40 percent contained detectable residues,
376 ● A New Technological Era for American Agriculture

Table 14-12-Relationship Among Selected USDA Grade Criteria and Chemicals Approved for Use

on Apples, Ohio, 1991

Selected generic grade criteria

Chemical (Scientific Name) Maturity Fungus injury Decay Insect injury Sizea

Growth regulator

Fruitone N (1-Naphthalene-Acetic Acid) . . . . . . x

Herbicides

Gramoxone (Paraquat) (Bipyridylnium) . . . . . .

Sinbar (3-tert-Butyl-5-chloro-6-methyluraciI) . .

Karmex (Substituted Urea) . . . . . . . . . . . . . . . . .

Fungicides

Captan (Cis-N-trichloromethylthio-4-

cyclohexene-2 1,2-dicarboximide) . . . . . . . . . x

Benlate (Methyl-1 (butylcarbamoyl)-2-benzimidazolecarbamate) . . . . . . . . . . . . . . . . . . . . . . . x

Dithane (Ethylene bisdithiocarbamate) . . . . . . . x

Insecticides

Oil (Oil solutions) . . . . . . . . . . . . . . . . . . . . . . . . . x x

Guthion (Organophosphorous-Pesticide

family) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x x

Vendex (Organotin) . . . . . . . . . . . . . . . . . . . . . . . x x

Imidax (N-(Mercaptomethyl) phthalimide S-O,

O-dimethylphosphorodithioate) . . . . . . . . . . . . x x

x

x

x

x

x

x

aVery poor weed mntml can result in smaller size because of competition between weeds and the commercial crop.

SOURCES: Office of Technology Assessment, 1992, compiled from Ohio Crop Errtefptise Budgets, 1989: Speciahy Crops, The Ohio State University,

Columbus, OH, p. 30 and Farm Chemicals Handbook, Meister Publishing Co., 1991.

but less than 1 percent of the samples exceeded EPA

tolerances. 5

EPA regulations exclude from the human food supply any commodity for which safe chemical residue

levels are exceeded. This is not a grading question,

but a food safety concern. However, assuming that the

safe level for detectable residue is greater than zero,

a grading standard hypothetically could be established ‘

on the basis of detectable levels of a specific chemical

residue. The degree of detectable residue denotes a

particular grade category. A hypothetical example appears in table 14-15.

Table 14-15 indicates that, if the level of detectable

chemical residue were the only attribute used for grading,

higher grades would be assigned to foods with successively lower residue levels.

Conceptually, each type of chemical would constitute

a separate attribute. The set of chemicals deemed appropriate would then compose the standard. Another possibility would be to develop a summary index or weighted

average measure for chemical residue. Such a summary

index could allow the resultant grade to be assigned on

the composite or summary score.

Conclusions

Implementation of a chemical residue attribute standard

for fruits and vegetables would require decisions concerning

which chemicals would form the standard. This task would

be controversial and would require participation from a

broad array of interested parties. It is reasonable to assume

that some potentially usable chemicals would not be admitted to form the standards.

If a chemical residue grading system were implemented,

lack of inclusion of naturally occurring toxic substances

would be controversial. Naturally present phenolic compounds in fruits and vegetables have been found to be

carcinogenic. Flavinoids tuercetin and campherol are present in many fruits and vegetables. Acetaldehyde, found in

apples, is reported to be mutagenic. Aflatoxin is a fungal

toxin and known carcinogen that can and does occur in

virtually every fruit and vegetable from the fresh to processed state. Thus, a grading standard based on residues

of chemicals ideally should include naturally occurring as

S~ the samples that exceeded to]e~ce ]eve]s, 84 Pereent involved cases for which there wss no established EPA tolerance. hck of ~ EPA

tolerance level generally means that any residue deems the commodity to be “adulterated” and subject to regulatory action. Exceptions include

“Unavoidable Pesticide Residues, ” which result unavoidably in certain processes under “good” agricultural and manufacturing procedures, and

EPA “Emergency Exemptions, ” which are granted for use of nonregistered pesticides under certain emergency situations.
Chapter 14—Food Quality: the Relevance of Food Grades ● 377

Table 14-13—Relationship Among Selected USDA Grade Criteria and Chemicals Approved for Use on

Potatoes, Ohio, 1991

Selected generic grade criteria

Chemical (Scientific Name) Maturity Fungus injury Decay Insect injury Sizea

Vine Killer Dessicant

Diquat (1,1 ’-ethylene, 2,2’ bipyridyliomion)b . . . . . . . . . . . . . x

Herbicides

Lorox (Linuron & Chlorimuron Ethyl) . . . . . . . . . . . . . . . . . . .

Dual (Chloracetanilise) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

Eptam (S-Ethyldipropylthiocarbamate) . . . . . . . . . . . . . . . . . .

Sencor-Lexone (Triazinone) . . . . . . . . . . . . . . . . . . . . . . . . . . .

Fungicides

Bravo (Chlorohalonil) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x

Ridomil (Metzlaxyl & Mancozeb) . . . . . . . . . . . . . . . . . . . . . . . x

/insecticides

Di-Syston (Organophosphorous) . . . . . . . . . . . . . . . . . . . . . . . x x

Sevin (Carbamate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x x

Phorate (Organophosphate) . . . . . . . . . . . . . . . . . . . . . . . . . . x x

Guthion (Organophosphorous) . . . . . . . . . . . . . . . . . . . . . . . . x x

Cygon(Carbamate) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . x x

Werypoorweecfcontrol canresultin srnallersize becauseofeompetition betweenweedsandthe commercial crop.

bD@atls alwwp~edto S.etpotatoskins.

x

x

x

x

x

x

SOURCE:Officeof Technology Assessmen~ 1992, cx)mpiled from Ohio Crop Enterprise Budgets, 1989: Specialty Crops, The Ohio State University,

Columbus, OH, p. 16 and Farm Chemica/s Handbook, Meister Publishing Co., 1991.

Table 14-14-Relationship Among Selected USDA Grade Criteria and Chemicals Approved for Use on Staked

Fresh Market Tomatoes, Ohio, 1991

Selected generic grade criteria

Chemical (Scientific Name) Fungus injury Insect injury Decay Sizea

Herbicide

Treflan (3,3,3-trifluoro-2,6-dinitro-N, Npropyl-p-toluidine) . . . . . . . . . . . . . . . . . . . . . . . x

Fungicides

Bravo (Chlorothalonil) . . . . . . . . . . . . . . . . . . . . x x

Benlate (Methyl-1 (butylcarbamoyl) -2-

benzimi-dazolecarbamate) . . . . . . . . . . . . . . . . x x

Insecticides

Sevin (Carbamate) . . . . . . . . . . . . . . . . . . . . . . . x x

Thiodan (Chlorinated Bicyclic Sulfite) . . . . . . x x

aVery poor weed control can result in smaller size because of competition between weeds and the commercial crop.

SOURCE: Office of Technology Assessment, 1992. Compiled from Ohio Crop Enterprise Budgets, 1989: Specia/fy Crops, The Ohio State University,

Columbus, OH, pp. 3–5 and Farm Chemica/s Handbook, Meister Publishing Co., 1991,

well as synthetic toxic substances. b Such a standard would has determined three requirements for an attribute to serve,

be complex and controversial. in whole or in part, as a grade standard. One requirement

is that the attribute must vary across the produce to be

Options for an Improved Grading System graded. A second requirement is that information on the

attribute must exist so that preferences can be assigned

The purpose of the case study to this point has been to gradations of an attribute. The third requirement is

that the attribute must be measurable. to introduce the conceptual basis for two different fruit

and vegetable grade standards—one based on nutritional The assessment of conceptual alternatives has estabcontent, the other on chemical residues. The investigation lished that both nutrition and chemical residue attributes

bAn argument can be made that humans have evolved over a long period of time eating these foods and have adapted to them and the chemicals

in them. But humans have not evolved with pesticides so the impacts can be different.

297-937 0 - 92 - 13 QL 3
378 ● A New Technological Era for American Agriculture

Table 14-15-Hypothetical Example of Grading

System Based on Chemical Residues

Level of detectable

chemical residue Resultant grade

Greater than EPA established residue No grade, excluded

tolerance level from human food

supply

<49% safety level . . . . . . . . . . . . . . . . . . . Grade C

50-90% safety level . . . . . . . . . . . . . . . . . Grade B

>90% safety level . . . . . . . . . . . . . . . . . . . Grade A

SOURCE: Office of Technology Assessment, 1992.

could be expected to vary across types of produce. Thus,

the first requirement is met.

The second and third requirements are more complex

and difficult to assess. The scientific literature review

contained in this chapter reveals substantial gaps in the

knowledge base required for either grading alternative.

Measurement, as a third requirement for an alternative

grade standard, is a special issue. Current standards that

primarily rely on sensory attributes mean that human

graders can gauge the presence or absence of the attribute

without mechanical assistance. Neither of the alternative

standards is sensory in nature, implying the need for

mechanical measurement. This, in turn, has significant

implications for the viability and cost effectiveness of

either alternative, given today’s technology.

Mechanical measurement or testing likely would be

slower and more costly than conventional grading by

humans. Lower efficiency and consequent higher grading

costs would probably occur for either the chemical residue or nutrition-based alternatives. This would raise consumer prices for fruits and vegetables.

The relative merit of implementing either alternative

for fresh versus processed fruits and vegetables bears

analysis. Consumers who purchase fresh produce at retail

for at-home consumption presumably would benefit the

most from information embedded in either alternative

standard. Processing firms and firms in the food service

industry (hotel, restaurant, and institutional away-fromhome market) already can and often do test produce they

purchase for nutrient or chemical residue characteristics.

In addition, since nutritional labels are on most processed

food products, a nutrition-based standard for processed

grades would be redundant and of little value to the

ultimate consumers.

OTA concludes that insufficient justification exists to

recommend shifting away from the current sensory standards to either of the alternatives discussed here for the

processed and food service markets. The argument for

alternative grading for the retail at-home (fresh) market

segment has more viability, and the ensuing discussion

is limited to that portion of the market.

The chemical residue concept for a grading system

combines the issue of food safety with that of food quality. The current food distribution system treats food safety

and quality separately. That is, the current distribution

and marketing system essentially assigns grades only to

food determined safe for human consumption. The ‘‘mixing’ of these issues distinguishes the chemical residue

attribute from the existing system.

The objective of implementing such a standard would

be to provide consumer information on the amount of

detectable residue below some “safe” level. Presumably

this would allow consumer choice among various levels

of ‘‘safe for human consumption residue’ at alternative

prices. However, the chances for consumer misinformation from such an attribute probably would be quite

high. Consumers could easily misconstrue the information to mean that some foods on the market are not safe.

Because of these problems, the chemical residue base

for standards is dismissed as a viable alternative by OTA,

even for the retail at-home fresh fruit and vegetable market segment.

Thus, three viable policy options arise from this analysis: abolishing current retail grades and standards, relying on point-of-sale (POS) nutritional labeling, and

modifying the current Federal standards to reflect some

information on nutrient content. An evaluation of each

policy option follows.

Option l—Abolishing Grades

Consumer grade standards exist, but seldom are used.

Explanations that might account for the limited use of

consumer grade standards include the following:

. retail grades are not useful as a merchandising device, and

. retail grades do not convey any additional information beyond that embodied in wholesale grades.

Regardless of the reasons for lack of use of retail grades,

it is clear that abolishing them would not have a direct

and significant impact on the marketing of fruits and

vegetables.

Because grade standards are used extensively for

wholesale trading, abolishing wholesale grades would

have significant economic consequences for the fruit and
Chapter 14—Food Quality: the Relevance of Food Grades ● 379

vegetable industry. Some immediate and obvious consequences would result:

●

●

●

●

transactions costs associated with trades would

increase.

marketing efficiency would decline.

marketing information would become less meaningful because price differentials by quality would

be less accurate, and

fewer buyers would be available for a given seller

(i.e., geographical area of trades would diminish).

Without the impartial information conveyed through

grade standards, fruit and vegetable marketing would

experience a significant decline in overall efficiency.

Commodities previously bought by grade descriptions

would require inspection by buyers, producing a decline in the efficiency with which fruits and vegetables

are shipped from production areas to consuming areas.

Such inspection also would reduce the area over which

commodities could be traded, thereby limiting market

competition and raising commodity prices at the wholesale and retail level. Moreover, while the current grading system facilitates grading at the shipping point level,

abolishing grades would encourage trade consummation at terminal markets. Previous experience has already shown that terminal market transactions are less

efficient than the current geographically dispersed system (i. e., most produce bypasses terminal markets because chain stores buy direct from shipping point

markets).

Although grade standards primarily are used to facilitate wholesale trading, abolishing them is likely to have

significant impact at the consumer level. For example,

one reason grades might not be used at the consumer

level is that their use at the wholesale level captures the

relevant attributes for consumers. That is, attributes such

as color, maturity, shape, and size, which facilitate

wholesale transactions, are likely to be important for

consumer transactions. If these attributes are not used

for wholesale transactions, then consumer purchases at

the retail level that are based on these attributes are likely

to be impeded.

Option 2—Point of Sale Nutritional Labeling

The U.S. Congress in 1990 passed and the President

signed a fruits and vegetables nutritional labeling law.

The law stipulates that the content, format, and delivery of fruit and vegetable nutritional labeling is to be

determined by the Food and Drug Administration (FDA).

In general terms, the bill will require the posting of

point of sale (POS) signs that detail the nutritional

content of the 20 most frequently consumed fruits and

vegetables. During an 18-month period following signing of the law, compliance is voluntary. Should compliance be deemed insufficient, a provision in the law

enables the FDA to then make in-store nutritional labeling mandatory.

The bill had the general support of industry trade associations such as the United Fresh Fruit and Vegetable

Association, the Produce Marketing Association, and the

Food Marketing Institute. The final compromise legislation proved to be less onerous than earlier versions of

the bill, which would have called for labeling of virtually

all produce sold in stores. The trade associations view

labeling as positive because of the opportunity to present

information highlighting the nutritional benefits of produce. The conclusion drawn by the produce industry, in

terms of labeling’s potential impact on sales, is that to

the extent that consumers are better informed about the

nutritional quality and healthful benefits of fruits and

vegetables, overall sales of fruits and vegetables should

go up. These indusry groups, however, do not support

the idea of mandatory labeling and therefore are working

to assure high voluntary compliance. Additionally, they

seem to be advocating simplified labeling with information on calories, carbohydrates, fiber, vitamin A, and

vitamin C.

The production of nutritional labels (signs) that presumably would be posted in every retail food store in

the country under this legislation will entail significant

startup costs. Once the labeling system has been put into

place, maintenance costs should be modest. The nutritional components of the produce to be displayed in the

labeling will come from government published data, and

the signs (or labels) themselves will become permanent

fixtures within produce departments. Open to question

is the extent to which implementation costs may be passed

on to consumers. Little direct cost will be incurred by

produce retailers. The labeling will be provided by various industry trade associations, and the signs and labels

should be freely available in the 18-month “voluntary”

initial phase of the law as the various industry groups

are interested in bolstering participation to stave off mandatory labeling.

The final form nutritional labeling will take is still being

worked out between the FDA and interested industry and

consumer advocacy participants. The produce industry perceived several years ago that nutritional labeling was an

inevitability. By becoming involved with nutritional labeling in its early stages, the industry can exert influence on

the form nutritional labeling would take.
380 . A New Technological Era for American Agriculture

A survey by Opinion Research Corp. commissioned

by the National Food Processors Association in late 1989

found that 4 of 10 consumers say that the first time they

buy a food product they read the labels for general nutritional information and make purchasing decisions based

on their comparisons. The survey results report that the

more nutritionally sound a food product is (e. g., breakfast food v. snack food), the more likely consumers are

to buy it. Other research has revealed that perceived

negative food attributes such as high sodium or cholesterol contents are just as important as positive attributes

in formulating consumer decisions to buy one food product over another. Significantly, the proposed produce

labeling is limited to nutritional attributes perceived by

consumers to be positive.

The final form that nutritional labeling will take may

favor some fruits and vegetables over others in marketplace competition. First, determining which are the top

20 fruits and the top 20 vegetables by consumption is

difficult: there seems to be some jockeying for a place

among positions 15 through 20. In these lower ranking

categories, consumption statistics do not indicate clear

winners. Foods that do carry nutritional labels probably

will attract consumers and lead to sales increases at the

expense of the lower rated foods. A second important

implication of nutritional labeling in terms of marketplace

competition relates to display of the nutritional information. Will labeling take the form of presentation of

aggregate data at a centralized location, with the 40 produce products ranked on attributes; or will each produce

bin have a unique sign with nutritional attributes displayed solely for that product? Research indicates that,

for aggregate data, sequencing would have an impact on

consumer purchase decisions. If, for example, ranking

occurred on a positive (negative) nutritional attribute,

then consumers would be steered toward (away from)

purchase of the higher ranked food.

The nutritional labeling law will present the FDA with

another program area to administer. Therefore, some

governmental costs will be incurred. After FDA’s initial

involvement of writing provisions of the legislation, however, its involvement will be limited to measuring compliance. Should the labeling legislation become mandatory,

then it is possible that administrative costs related to

enforcement could rise.

Option 3—Modifying Grades

Basing Federal fruit and vegetable grades for the athome retail market in part on nutrient characteristics

presents an interesting and plausible option. The scientific knowledge base for this option is relatively adequate though not comprehensive in scope. The

possibility of combining some nutrient attributes with

existing sensory characteristics appears feasible. For

example, the relationship between maturity in the current standards and several nutrient attributes is fairly

well established.

The economic impact and cost of adjustment to some

nutrition-based grade standards, especially if they were

mandatory, would be substantial. Transactions costs would

increase for some period of time during adjustment to

the new standards. Costs of grading would increase, especially if destructive testing for nutritive content were

necessary. Consequently, during the adjustment period,

prices for fresh fruits and vegetables at retail likely would

be higher and producer prices lower.

After some period of adjustment, nutrition-based grading standards would become customary for all firms involved in the marketing channel-producers, wholesalers,

and retailers. At this point, transaction costs of using the

new system should not be significantly different from

the previous sensory standards; however, grading costs

would be higher because nutrition-analysis requires the

use of instruments and experts. These increased transactions costs would be passed on to consumers in the

long run.

The distribution of costs to various industry participants would be different during the adjustment period

than in the long term. Initial uncertainty about the new

standards would increase transaction costs to users of

the new standards. If use of the new standards were

voluntary, relatively higher transaction costs would

discourage use of the new system by wholesalers and

retailers. Instead, they would use the former standards

or rely on trade associations or comparable groups to

define standards similar to the old system. Furthermore, over the longer term, the higher transaction costs

would result in higher costs to consumers and/or lower

prices for producers.

The shift to a grading system based in part on nutrition

criteria would probably diminish the historic role the

Agricultural Marketing Service has played in grading and

enhance the role of FDA. The food science component

of FDA would be a more natural focal point for regulatory

and compliance activities.

Conclusions

A summary table of the conclusions concerning the

potential viability of the alternative conceptual bases ex-
Chapter 14—Food Quality: the Relevance of Food Grades .381

Table 14-16—Summary Conclusions on Potential Viability of Conceptual Grading Alternatives

Market segment Chemical base Nutrient base

Fresh Costly to implement Costly to implement

At-Home Sparse scientific knowledge base Inadequate current scientific knowledge base

May impart misleading information Advantage lessened by recent nutritional information point-of-sale program

Relatively most viable

Away-from-Home Marginal value to consumers Marginal value to consumers

Costly to implement Costly to implement

Processed Marginal value to consumers Marginal value to consumers

Costly to implement Costly to implement

SOURCE: Office of Technology Assessment, 1992

amined is presented in table 14-16. Before either the

nutrient or chemical base could be implemented on a

cost-effective basis, advances in measurement technology would need to occur. This is on the horizon, but

until advances occur, the wisdom of adopting an alternative base seems marginal from a societal perspective.

At the current time, neither the scientific information

base or the technology for measurement permits nutrient

attributes to be an exclusive grade standard for fruits and

vegetables.

1.

2.

3.

4.

5.

6.

CHAPTER 14 REFERENCES

Anderson, D.B. et al., “Effect of Ractopamine on

Nitrogen Retention, Growth Performance and Carcass Composition of Finisher Pigs, ’ J. Anim. Sci.

65( Suppl. 1):130, 1987.

Baerug, R., Roer, L., and Tjomhom, T., “Amino

Acid Composition of Potato Tubers as Influenced

by Nitrogen and Potassium Fertilization, Year, Location and Variety, ” Meldinger fra Norges Landbrukshogskole 58(40), 1979, 24 pp.

Beecher, G.R. and Vanderslice, J. T., “Determination of Nutrients in Foods: Factors That Must

Be Considered, ” Modern Methods of Food Analysis, Kent K. Stewart and John R. Whitaker (eds. )

(Westport, CT: Avi Publishing Co., Inc., 1983),

pp. 29-53.

Beermann, D. H., “Implications of Biotechnologies

for Control of Meat Animal Growth, ” Reciprocal

Meat Conference Proceedings, vol. 43:87, 1990.

Beermann, D.H. et al., ‘‘Comparison of the Effects

of Two Recombinant Forms of Porcine Somatotropin (PST) on Pork Composition and Palatability, ”

J. Anirn. Sci. 66( Suppl. 1):281, 1988.

Beermann, D. H., Thiel, L. F., and Prusa, K. J.,

‘‘Dose-response effects of porcine somatotropin

on yield, distribution and nutritional composition

of edible carcass tissue, presented at the symposium, Biotechnology for Control of Growth and

7.

8.

9.

10.

11.

12.

13.

14,

15.

16.

Product Quality in Meat Production: Implications

and Acceptability, Session 11, Washington, DC,

December, 1990.

Bereskin, B., Rough, D. K., and Davey, R. J., “Some

Factors Affecting the Evaluation of Pork Quality, ”

J. Anim. Sci. 47:389, 1978.

Boggs, D.L. and Merkel, R. A., Live Animal Carcass Evaluation and Selection Manual, Third Edition (Dubuque, IA: Kendall/Hunt Publishing Co.,

1990).

Chang, S.S. and Peterson, R. J., “Recent Developments in the Flavor of Meat, ” J. Food Sci. 42:298,

1977.

Code of Federal Regulations, Title 7, Parts 51 and

52, January 1990.

Davis, G.W. et al., “Relationship of Quality Indicators to Palatability Attributes of Pork Loins, ’ J.

Anim. Sci. 41 :1305, 1975.

Demeyer, D. et al., ‘‘Effect of recombinant porcine

somatotropin on carcass and meat quality of Belgian

and Dutch pigs, ‘‘ Biotechnology for Control of Growth

and Product Quality in Swine—Implications and Acceptability, P. van der Wal, G.J. Nieuwhof and R.D.

Politick (eds. ), Pudoc Wageningen, Wageningen,

Netherlands, 1989, pp. 191–199.

D’Souze, M.C. and Ingle, M., “Effect of Delayed

Cooling on the Poststorage Flesh Firmness of Appies, ” Journal of Food Science 54(2)493–494,

1989.

Eikelenboom, G. and Nanni Costa, L., ‘‘Fibre Optic

Probe Measurements in Landrace Pigs of Different

Halothane Phenotypes, ’ Proceedings of the 34th International Congress of Meat Science and Technology, Workshop on Pig Meat Quality, Brisbane,

Australia, 1988, p. 30.

Evock, G.M. et al., ‘‘Pituitary Porcine Growth Hormone (pGH) and a Recombinant pGH Analog Stimulate Pig Growth Performance in a Similar Manner, ’

J. Anim. Sci. 66: 1928-1941, 1988.

Ewan, R. C., Topel, D. G., and One, K., “Chemical

Composition of Chops from Pale, Soft, Exudative
382 . A New Technological Era for American Agriculture

17.

18.

19.

20.

21.

22.

23.

24.

25.

26.

27.

28.

29.

30.

31.

(PSE) and Normal Pork Loins,” J. Food Sci. 44:678,

1979.

Fedler, C. A., Prusa, K. J., and Meisinger, D., “InHome Consumer Evaluation of Pork Loin Roasts

Form Pigs Administered Porcine Somatotropin, ” J.

Anim. Sci. 69:347 (abstract), 1991.

Food Marketing Institute, Trends: )983 Consumer

Attitudes and the Supermarket, Washington, DC,

1983.

Food Marketing Institute, Trends: 1987 Consumer

Attitudes and the Supermarket, Washington, Washington, DC, 1987.

Food Marketing Institute, Trends: )991 Consumer

Attitudes and the Supermarket, Washington, DC,

1991.

Fortin, A. and Raymond, D. P., “The Use of the

Electrical Characteristics of Muscle for the Objective

Detection of PSE and DFD in Pork Carcasses Under

Commercial Conditions, ” Can. Inst. Food Sci.

Technol. J. 21:260, 1988.

Goodband, R.D. et al., “The Effects of Porcine

Somatotropin and Dietary Lysine on Growth Performance and Carcass Characteristics of Finishing

Swine, ” J. Anim. Sci. 68:3261-3276, 1990.

Grundy, S.M. “Cholesterol and Coronary Heart

Disease: A New Era, ” J. Amer. Med. Assoc.

256:2849, 1986.

Gull, D.D. et al., “Stability Differences Among

Fresh-Market Tomato Genotypes: II. Fruit Quality, ” Journal of the American Society of Horticultural Science 114(6)950-954, 1989.

Hardh, K., Murmann, T., and Seppala, J., “Effects of Chemical Constituents of Tomato on its

Keeping Quality, ” Acta Horticultural 93, 387-

393, 1979.

Harl, D. Neil, Agricultural Law, Sections 78.01 and

78.02, 1990.

Jenkins, T. G., Leymaster, K. A., and Burlington,

L. M., “Estimation of Fat Free Soft Tissue in Lamb

Carcasses by Use of Resistance Impedance Measurements,” J. Anim. Sci. 66:2174, 1988.

Jones, R.W. et al., “Effect of the Beta-Adrenergic

Agonist Cimamterol (CL 263, 780) on the Growth

and Carcass Characteristics of Finishing Pigs, ” J.

Anim. Sci. 61:905, 1985.

Kauffman, R. G., ‘‘Value Pricing Systems—Pricing To Stimulate Change, presented at Pork

Strategies 2000, University of Wisconsin, Madison, WI, 1990b.

Kleibel, A., Pf&zner, H., and Krause, E. “Measurement of Dielectric Loss Factor, A Routine Method

of Recognizing PSE Muscle, ” Fleischwitischaft

63:1183, 1983.

Kleibenstein, James et al., “An Analysis of the

Pork Grading System: Implications of New Growth

Promotants, commissioned background paper

32.

33.

34.

35.

36.

37.

38.

39.

40.

41.

42.

43.

44.

45.

46.

prepared for the Office of Technology Assessment, 1991.

Kubo, Y. et al., “Color Development of 4 Apple

Cultivars Grown in the Southwest of Japan, With

Special Reference to Fruit Bagging, Journal of the

Japanese Society for Horticultural Science 57(2) 191–

199, 1988.

Lee, K.O. et al., “Does Ractopamine Affect Fatty

Acid Profiles in Lipid Depots of Finishing Pigs?”

J. Anim. Sci. 67( Suppl. 1):151, 1989.

Malphrus, L. D., Skelley, G. C., and Johnston, W. E.,

“Consumer Preference for Pork Cuts with Varying

Degrees of Marbling,” South Carolina Agricultural

Experiment Station, Bulletin No. 583, 1975.

Marwala, R. S., “Nutritional Composition of Commonly Cultivated Potato Varieties Grown Under Short

Day Conditions, ” Indian Journal of Plant Sciences

5(1/2) 44-51, 1989.

McKeith, F.K. et al., ‘‘Palatability and Visual Characteristics of Hams and Loin Chops from Swine Fed

Ractopamine Hydrochloride,” J. Anim. Sci. 66(Suppl

1):306, 1988.

Meyer, J.A. et al,, “Niacin, Thiamin, and Riboflavin in Fresh and Cooked Pale, Soft, Watery vs.

Dark, Firm, Dry Pork Muscle, ” Food Technol.

17:485, 1963.

Mohri, K., Umeda, S., and Tsurumi, G., “Basic

Study on Color Sorting of Fresh Market Tomatoes, ’

Bulletin of the University of Osaka Prefecture, B.

(39), 85-90, 1987.

Mourot, J. et al., “Effects of Exogenous Porcine

Somatotropin (pSt) Administration on Pork Meat

Quality, “ Meat Science, 1990.

Nagy, S., ‘‘Vitamin C Contents of Citrus Fruits and

Their Products: A Review, ’ Journal of Agricultural

and Food Chemistry 28(1)8–18, 1980.

National Research Council, “Designing Foods, Animal Product Options in the Marketplace, ” National

Academy Press, Washington, DC, 1988.

Orcutt, M. W. et al., ‘‘Practical Means of Estimating

Pork Carcass Composition,” J. Anim. Sci. 68:3987,

1990.

Parnell, Jack C., “Food Safety: Some Changes are

Needed, ” Choices, American Agricultural Economics Association, vol. 5, No. 3, 1990, pp. 4–11.

Petro-Turza, M. et al., “Study on Taste Substances

of Tomato. 1. Analytical Investigations into the Sugar,

Organic Acid and Mineral Contents, ” Acta Alimentaria 18(1)97–106, 1989.

Pomeranz, Yeshajahiu and Clifton E. Melsan, Food

Analysis: Theory and Practice, Second Edition, Van

Norstrand Reinhold Company, New York, 1987,

p. 612.

Prusa, K. J., “Nutritional and Sensory Characteristics of Pork from Pigs Administered Somatotropin,

Biotechnology for Control of Growth and Product
Chapter 14—Food Quality: the Relevance of Food Grades ● 383

47.

48.

49.

50.

51.

52.

53.

54.

55.

56.

57.

Quality in Swine-Implications and Acceptability, P.

van der Wal, G.J. Nieuwhof, and R.D. Politick (eds. ),

Pudoc Wageningen, Wageningen, Netherlands, 1989,

pp. 183-189.

Prusa, K. J., Love, J. A., and Miller, L. F.,

“Composition and Sensory Analysis of Rib Chops

from Pigs Supplemented with Porcine Somatotropin

(pST),” J. Food Quality 12:455-465, 1989a.

Prusa, K. J., Love, J. A., and Miller, L. F., “Composition, Water-Holding Capacity and pH of Muscles from Pigs Supplemented with Porcine

Somatotropin (pST), ” J. Food Quality 12:467–474,

1989b.

Prusa, K. J., Fedler, C. A., and Christian, L. L.,

‘‘Consumer Acceptability of Pork from Pigs Treated

With Porcine Somatotropin,” J. Anim. Sci. 68( Suppl.

1):338 (abstr.), 1990.

Prusa, K.J. et al., “Influence of Porcine Somatotropin (pST) on Carcass Characteristics of Pigs—A

summary of 15 Producer Trials, ” J. Anim. Sci. 69:344

(abstract), 1991.

Reeves, Tim, ‘‘1s Our Food Supply Safe?” The Ohio

Farmer, Sept. 15, 1990, pp. 84-85.

Rothschild, M. R., Meeker, D. L., and Healy, M.,

“Large Scale Survey of Electronically Collected

Swine Carcass Data,”J. Anim. Sci. 68 (Suppl. 1):474,

1990.

Rust, R.E. et al., “Pork Loins: The Effects of Selection on Cutout Yields, Cooked Edible Portion

Yield and Organoleptic Superiority, ” J. Food Sci.

37:222, 1972.

Saifur, Rehman et al., “Qualitative Aspects of Various Cultivars of Sweet Oranges (Citrus sinensis),

Pakistan Journal of Agricultural Research 4( 1)22–

28, 1983.

Sehested, E. and Vangen, O., “Computer Tomography, a Non-Destructive Method of Carcass

Evaluation, ” Proceedings of the EAAP Symposium:

New Techniques in Pig Carcass Evaluation, EAAP

Publication No. 41, 1989, p. 98.

Sink, J. D., “Symposium on Meat Flavor: Factors

Influencing the Flavor of Muscle Foods, ” J. Food

Sci, 44:1, 1979.

Sorensen, S. et al., ‘‘Utilization of On-Line Methods

for Measuring Quality Parameters in Carcasses—

Future Possibilities and Challenges, ” Proceedings

of the 35th International Congress of Meat Science

and Technology, Copenhagen, 1989, p. 16.

58.

59.

60.

61.

62.

63.

a.

65.

66.

67.

68.

69,

70,

Speer, V. C., “Altering Carcass Measurements and

Composition of the Pig, ” Designing Foods, Animal

Product Options in the Marketplace, National Academy Press, Washington, DC, 1988, p. 273.

Sporleder, Thomas et al., ‘‘Assessing Federal Grade

Criteria for Fruits and Vegetables, ” commissioned

background paper prepared for the Office of Technology Assessment, 1991.

Stewart, Kent K., “Flow Injection Analysis: A New

Tool for the Automation of the Determination of

Food Components, Modern Methods of Food Analysis, Stewart and Whitaker (eds. ), op. cit., 1984,

pp. 369-379.

Swantek, P.M. et al., “Bioelectrical Impedance: A

Noninvasive Procedure to Estimate Fat-Free Mass

of Market Swine, ’ J, Anim, Sci. 67( Suppl. 1):225,

1989.

Swatland, H. J., “Objective Measurement of Physical Aspects of Meat Quality, ” Proceedings of the

42nd Annual Reciprocal Meat Conference, 1989,

p. 65.

The Packer, “Upgrades Aid Efficiency, ” Dec. 1,

1990, p. 5B.

Thiel, L.F. et al., “Effects of Somatotropin on Sensory Characteristics and Composition of Boneless

Pork Loin Chops, ” J. Anim. Sci. 68( Suppl. 1): 199

(abstr.), 1990.

U.S. Department of Agriculture, Agricultural Marketing Service, Fruit and Vegetable Division, FPB,

General Market Inspection instructions, Washington, DC, July 1966.

U.S. Department of Agriculture, Packers and Stockyards Administration, “Grade and Yield Marketing

of Hogs, unpublished, 1982.

Veenhuizen, E.L. et al., “Lipolytic, Growth, Feed

Efficiency and Carcass Responses to Phenethanolamines in Swine, ” J. Anim. Sci. 65( Suppl. 1):130,

1987.

Walker, W.R. et al., “Evaluation of Cimaterol for

Finishing Swine Including A Drug Withdrawal Period,” J. Anim. Sci. 67: 168, 1989.

Watkins, L.E. et al., ‘‘The Effect of Various Levels

of Ractopamine Hydrochloride on the Performance

and Carcass Composition of Finishing Swine, ’ J.

Anim. Sci. 68:3588, 1990.

Zimmerman, D., “Growth Enhancers, ” Proceedings on New Swine Growth Enhancers, Iowa State

University Extension Conference, Ames, IA, December 1989.
—.

Part V

Institutions
Chapter 15

Intellectual Property Rights

for Biotechnology and

Computer Software

Photo credit: Steven Bent
Page

INTRODUCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 389

INTELLECTUAL PROPERTY PROTECTION AND BIOTECHNOLOGY ................... 389

Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 389

Trade Secrets . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .................390

The Chakrabarty Decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 391

INTELLECTUAL PROPERTY PROTECTION FOR PLANTS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 391

Plant Breeders’ Rights . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... .......391

Plant Patents v. Plant Variety Protection Certificates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 392

Plant Patents v. Utility Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ..393

Plant Variety Protection Certificates. Utility Patents . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ........394

Trade Secret Law . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 394

INTELLECTUAL PROPERTY PROTECTION FOR ANIMALS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 394

Federal Regulation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .................394

Economic Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ..........396

Ethical Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ..........397

Deposit Considerations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 397

INTERNATIONAL PROTECTION FOR PLANTS AND ANIMALS . . . . . . . . . . . . . . . . . . . . . . . . . 398

ISSUES AND POLICY OPTIONS FOR BIOTECHNOLOGY . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 398

INTELLECTUAL PROPERTY PROTECTION AND COMPUTER SOFTWARE ............. 399

Copyright . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 399

Patent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 400

Trade Secret . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 401

INTERNATIONAL PROTECTION FOR COMPUTER SOFTWARE .........................403

ISSUES AND POLICY OPTIONS FOR COMPUTER SOFTWARE ..........................403

Copyright and Patent Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ...403

Liability Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. ................404

User Issues . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 404

Box

15-A,

15-B.

15-C.

Table

15-1.

15-2.

Boxes

Page

What Can Be Patented? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ..389

International Union for the protection of New Varieties of Plants . . . . . . . . . . . . . . . . . . . . . . . 393

Patent Number 4,736,866-The “Harvard Mouse” . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ...395

Tables

Page

Types of Intellectual Property Protection for Plants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ....392

Member Countries of the Union for the Protection of New Varieties of Plants ... .......393
Intellectual

Chapter 15

Property Rights for Biotechnology

and Computer Software

INTRODUCTION

Biotechnology and advanced computer technologies

have the potential to carry the productivity record of

agriculture into the 21st century. Biotechnology can

increase food production by lowering the costs of agricultural inputs and by contributing to the development of new high-value-added products to meet the

needs of consumers and food processors. These potential products include seeds, pesticides, veterinary

diagnostics and therapeutics, food additives and food

processing enzymes, more nutritious foods, and crops

with improved food processing qualities. Advanced

computer technologies can enhance management

capabilities in the agriculture and food industry. These

technologies include knowledge-based systems, networks, information retrieval systems, sensors, and robotics.

Thus far, biotechnology research and development

(R&D) has focused on those crops and traits that are

easiest to manipulate, particularly single-gene traits in

certain vegetable crops. As technical roadblocks are lifted,

however, R&D likely will lead to a wide range of agricultural products. Likewise, computer software R&D

and further advances in networks, sensors, and robotics

will spawn numerous computer-related technologies for

food and agricultural use. A critical incentive for R&D

efforts in biotechnology and information technology is

adequate intellectual property protection for these emerging processes and products.

Intellectual property law, which protects works of

the mind as personal property, is of increasing importance to those who create new products and processes

using biotechnology and computers. Intellectual property involves several areas of the law: patent, copyright, trademark, trade secret, and plant variety

protection. All affect emerging high-technology industries and can help bring important technological

information and products into commerce. This chapter

examines intellectual property rights for inventions

created through the use of biotechnology (with particular focus on plants and animals) and computer-related

technologies.

INTELLECTUAL PROPERTY

PROTECTION AND

BIOTECHNOLOGY

Intellectual property protection encompasses several

areas of statutory and common law: patent, copyright,

trademark, trade secret, and plant variety protection; other

laws discourage unfair competition. Patents, trade secrets, and plant variety protection

portant to biotechnology.

Patents

United States patent law has its

are particularly imroots in the Constitution, which gives Congress broad powers to ‘‘promote the Progress of Science and useful Arts, by securing

for limited times to authors and inventors the exclusive

right to their respective writings and discoveries’ (article 1, section 8). The first patent act was enacted by

Congress in 1790 and, though amended several times,

still allows broad scope as to what can be patented.

(See box 15-A).

A patent is a grant issued by the U.S. Government

that gives the patent owner the right to exclude all others

from making, using, or selling the invention within the

United States, its territories, and possessions during the

term of the patent (35 U.S. C. 154). There are three types

of patents. The most common type is the utility patent.

To qualify for utility patent protection in the United States,

an invention must meet several requirements:

Box 15-A—What Can Be Patented?

One section of the U.S. patent law, 35 U.S.C.

101, defines what constitutes a patentable invention:

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful

improvement thereof, may obtain a patent

therefore, subject to the conditions and requirements of this title.

This section of the patent code has changed little

since it was first enacted in 1790, and its broad

language has made possible the issuance of more

than 5 million patents.

SOURCE: Office of Technology Assessment, 1992.

-389-
390 . A New Technological Era for American Agriculture

The U.S. Constitution provides that “Congress shall

have the power. . . . To promote the Progress of

Science and useful Arts, by securing for limited Times to

Authors and Inventors the exclusive Right to their

respective Writings and Discoveries.”

●

●

●

A

 it must be a process, machine, manufacture, or composition of matter (35 U.S.C. 101);

it must be new, useful, and not obvious (35 U.S.C.

101-103); and

it must be disclosed in sufficient detail to enable a

person skilled in the same or the most clearly related

area of technology to construct and operate it (35

U.S.C. 112).

second category, patents for plants, includes cultivated sports, mutants, hybrids, and newly found seedlings. A third category, patents for designs, is not relevant

to biotechnology-related inventions.

Patents serve two important policy objectives:

● by rewarding successful efforts, a patent provides

inventors and their backers with incentive to risk

time and money in R&D; and

● by requiring disclosure of the manner and process

of making an invention, a patent encourages public

disclosure of otherwise secret information, so that

others are able to use it.

Although a patent gives the inventor the right to exclude others from making, using, or selling the invention

for 17 years, it does not grant the inventor any affirmative

right to make or use an invention. Commercial use of a

patented invention, just like other products, can be regulated by Federal, State, or local law.

Once obtained, a patent has a term of 17 years, assuming that maintenance fees are paid (35 U.S. C. 154).

One exception to the 17-year term is relevant to biotechnology: patents on a human drug product, medical

device, food, or color additive that have undergone regulatory review prior to FDA approval for commercial

marketing or use may be eligible for an extension of up

to 5 years, if certain conditions are satisfied (35 U.S.C.

156).

Recent revisions in Federal patent policy have encouraged increased patent activity from federally funded

researchers. Prior to 1980, 26 separate patent policies

promulgated by various government agencies existed for

such research (9). Recognizing that a uniform patent

policy would encourage cooperative relationships and

commercialization of government-funded inventions,

Congress passed the Patent and Trademark Amendments

of 1980 (P. L. 96-5 17) and amendments in 1984 (P. L.

98-260). The law allows nonprofit institutions (including

universities) and small businesses to retain title to patents

arising out of federally funded research, with the Federal

agency retaining a nonexclusive, worldwide license. Universities are required to share royalties with the inventor

and to use any net income for research and education

(35 U.s.c. 202).

The law, which gave statutory preference to small

businesses and nonprofit organizations, was extended by

executive order to larger businesses in 1983 (6). The

Technology Transfer Act of 1986 (P. L. 99-502) granted

Federal authority to form consortia with private concerns.

Executive order 12591, issued in 1987, further encouraged technology transfer programs, including the transfer

of patent rights to government grantees.

Trade Secrets

Trade secrets extend protection to information used in

one’s trade or business, that is maintained in secret by

its owner, and provides a competitive business advantage

over those not having the information. A plan, process,

tool, mechanism, recipe, chemical compound, customer

list, or formula all are examples of information that can

be maintained as trade secrets.

Unlike patents (which are governed exclusively by

Federal law), trade secrets are the subject of State law.

Trade secret law promotes not only commercial morality

and fair dealing, but also research and innovation. Unlike

patent law, however, trade secret law discourages rather

than encourages public disclosure of technical information.

Trade secret rights require that a trade secret be disclosed in confidence only to those having a reasonable

need to know (e. g., employees). Measures must be taken
Chapter 15—intellectual Property Rights for Biotechnology and Computer Software ● 391

by the owner of the trade secret to prevent disclosure of

the trade secret to the public or to competitors (e.g.,

expressly identifying the information as a trade secret

and prohibiting its disclosure).

The Chakrabarty Decision

During the 1980s, two events in the United States

shaped the application of intellectual property law to

biotechnology. First, the Supreme Court was called on

to determine whether a living organism could be patented. Second, Congress and the executive branch took

actions making it easier for federally funded inventions

to become commercialized. These actions ignited a flood

of biotechnology patent activity. By 1989, an examining

unit specifically for biotechnology was established at the

Patent and Trademark Office (PO).

The development of rDNA technology in the 1970s

led to debate regarding what constitutes a patentable invention. Although patents on biotechnological processes

had been issued since the 1800’s, PTO did not permit

patents on living products created by the technology on

the grounds that such matter were ‘‘products of nature’

and not statutory subject matter as defined by 35 U.S. C.

101 (see box 15-A). Although proposed patent claims to

living organisms were rejected by PTO, patent protection

had been granted for many compositions containing living things (e. g., sterility test devices containing living

microbial spores, food yeast compositions, vaccines containing attenuated bacteria, milky spore insecticides, and

various dairy products) (8).

The issue of whether a genetically engineered organism itself could be patented was addressed by the Supreme Court in 1980, in Diamond v. Chakrabarty 2).

In this case, the patent applicant had developed a genetically engineered, but not recombinant, bacterium capable of breaking down multiple components of crude

oil. Because no naturally occurring bacterium possessed

this property, Chakrabarty’s bacterium was thought to

have significant value for the cleanup of oil spills.

Chakrabarty filed a patent application with 36 claims.

Process claims for the method of producing the bacteria

were allowed by the PTO; but claims for the bacterium,

itself, were rejected on two grounds: 1 ) microorganisms

are “products of nature, ” and 2) as living things, microorganisms are not patentable subject matter under 35

U.S.C. 101. The case was eventually heard by the Supreme Court; the justices, in a 5-4 ruling, held that a

live, human-made microorganism is patentable subject

matter under section 101 as a ‘‘manufacture’ or ‘ ‘composition of matter. ”

The Chakrabarty decision provided a judicial framework for subsequent PTO decisions to issue patents under

35 U.S.C. 101 for plants and nonhuman animals. The

decision also provided great stimulus for the economic

development of biotechnology processes and products in

the 1980s.

INTELLECTUAL PROPERTY

PROTECTION FOR PLANTS

Plant Breeders’ Rights

No intellectual property rights relevant to new plant

varieties existed prior to 1930. Plant breeding and research were conducted primarily by federally funded agricultural experiment stations and, to a limited extent,

by amateur breeders. Private breeders had few financial

incentives—their sole financial reimbursement was through

high sales prices of comparatively few reproductions during the first 2 or 3 years after the variety’s initial availability. Once the plant left a breeders’ hands, it could be

reproduced in unlimited quantity by anyone.

Proprietary protection specifically for plant varieties

has evolved in the United States over the last 60 years

and now is based on several statutes, a Federal decision,

and recognized trade secret and contract law. (See table

15-1. ) Although in the United States an exclusive right

to an invention is as old as the Constitution, until the

late 1920s the sentiment was largely held that plant varieties were not patentable under the general patent statute. In deciding to expressly provide intellectual property

protection for asexually reproduced plants, Congress

concluded that the work of the breeder was an aid to

nature and thus the resulting plant was a patentable invention.

Two Federal statutes specifically confer ownership rights

to new plant varieties: the Plant Patent Act (PPA) of

1930 (35 U.S.C. 161-164) and the Plant Variety Protection Act (PVPA) of 1970 (7 U.S.C. 2321 et seq.). The

PPA extended patent protection to most new and distinct

asexually propagated varieties. It was the first, and to

date, only law passed by Congress specifically providing

patent protection for living matter. Since then, more than

6,500 plant patents have been issued by PTO covering

flowering plants, ornamental and fruit trees. nut trees,

grapes, and vegetable crops. Plant patents cannot be obtained for seeds, tubers, biotechnology processes, recombinant DNA (rDNA), or genes (5). On average, more

than 225 plant patents are issued each year ( 10).
392 . A New Technological Era for American Agriculture

Table 15-1—Types of Intellectual Property Protection for Plants

Type Citation Subject matter

Plant patent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 U.S.C. 161-164 Asexually reproduced varieties

Plant variety protection certificate , ... , . . . . . . . . . . . . . 7 U.S.C. 2321 et seq. Sexually reproduced varieties

Utility patent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 735 U.S.C. 101 et seq. Process, machine, manufacture,

composition of matter

Trade secret . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . State law Information used in trade or business

that is kept secret

SOURCE: Office of Technology Assessment, 1992

Commercial and international developments between

1930 and 1970 encouraged the United States to consider

protecting sexually reproduced plants as well. Plant

breeders had developed new sexually reproducing plants

that could replicate ‘‘true-to-type’ but that could not be

patented under the PPA. In 1961, several European countries formed the International Union for the Protection

of New Varieties of Plants (UPOV) to protect breeders’

rights. (See box 15-B. ) At the time, U.S. breeders had

no law protecting their inventions, other than the PPO

for asexually reproduced plants.

The PVPA was enacted by Congress in 1970 to provide

patent-like protection for certain types of new, sexually

reproduced plant species. It is mainly of interest to breeders and farmers of sexually reproduced varieties of crops

such as: wheat, alfalfa, soybeans, cotton, corn, lettuce,

soybeans, and watermelon (1).

Although PVPA is not a patent statute, the protection

it provides to breeders of new plant varieties is similar

in concept to patent protection. The act is administered

by the U.S. Department of Agriculture (USDA). Upon

application to USDA and examination by this agency, a

plant variety protection certificate may be issued on any

novel variety of sexually reproduced plant—other than

fungi, bacteria, or a first-generation hybrid. The novel

variety must have distinctiveness, uniformity, and stability. Amendments in 1980 (P. L. 96-574) added protection for six vegetable crops and extended coverage to

18 years so the PVPA would be consistent with UPOV

provisions.

Under PVPA, the breeder can exclude others from

selling, offering for sale, or reproducing (sexually or

asexually) the variety; producing a hybrid from the variety; and importing or exporting the protected variety.

PVPA contains two important exclusions to this protection:

. A research exemption that precludes a breeder from

excluding others from using the protected variety to

develop new varieties; and

● a farmers’ exemption that allows an individual

whose primary occupation is growing crops for sale,

for other than reproductive purposes, to use protected seed on his or her farm or to sell it to people

whose primary occupation, also, is growing crops.

From 1970 through 1988, 2,783 applications for plant

variety protection certificates were filed with the USDA

for some 100 different crops. By December 31, 1988,

2,133 certificates had been issued and 274 applications

were pending. Another 376 applications had been abandoned, withdrawn, declared ineligible, or denied ( 10).

The Supreme Court decision in Diamond v. Chakrabarty (2), coupled with a 1985 ruling of the PTO Board

of Appeals (3), affords individuals the additional option

of seeking a utility patent (35 U.S.C. 101 ) to protect a

novel plant variety. In 1985, the PTO Board of Appeals

and Interferences ruled, in Ex parte Hibberd (3) that a

corn plant containing an increased level of tryptophan,

an amino acid, was patentable subject matter under 35

U.S.C. 101. To summarize, federally credentialed protection of plants encompasses three forms: plant patents,

plant variety protection certificates, and utility patents.

Recognized trade secret law provides further protection

for inventions that constitute plant life. Each of these

four methods of protection differs from the others in some

respects, as described below.

Plant Patents v. Plant Variety Protection

Certificates

PPA provides rights, through plant patents, to plant

breeders who discover or develop new distinct plant varieties and propagate them by asexual reproduction. In

contrast, Plant Variety Protection Certificate (PVPC)

holders under PVPA are granted protection for discovering or developing new, uniform, stable, and distinctive
Chapter 15—Intellectual Property Rights for Biotechnology and Computer Software .393

Box 15-B—International Union for the Protection of New Varieties of Plants

With the development of plant sciences came the realization that the rights of plant breeders were entirely

overlooked in many countries. The patent laws of many countries, for example, specifically excluded the patenting

of any type of Iifeform. An international conference in 1957 led to the drafting of the International Union for the

Protection of New Varieties of Plants (UPOV); it was signed by several nations in 1961 and entered into force in

1968. Currently, 19 nations are members of UPOV (see table 15-2).

Table 16-2-Member Countries of the Union for the Protection of New Varieties of Plants

Australia The Netherlands

Belgium New Zealand

Denmark Poland

France South Africa

Germany Spain

Hungary Sweden

Ireland Switzerland

Israel United Kingdom

Italy United States

Japan

SOURCE: Office of Technology Assessment 1992.

The International Union for the Protection of New Varieties of Plants was designed “to recognize and to ensure

the breeder of a new plant variety. . . the right to a special title of protection or of a patent.” The goal was to provide

a model for the adoption of breeders’ rights statutes in individual countries and to assure reciprocity between

countries in the convention.

To obtain protection in each member country, it is currently necessary to file a separate application in each

country. There is no central filing system, nor is international protection available by filing in only one member

county. While both sexually and asexually reproduced plants can be protected, the UPOV convention requires

that each protected variety have a specific, unique name for registration purposes. In all member nations except

the United States, new varieties are subject to official inspection establishing that conditions for protection are

satisfied.

The UPOV convention presently is under consideration for revision. A recent diplomatic conference, held in March

1991, may lead to revision of Article 2, which currently does not allow both patent and breeders’ rights for the same

botanical species or genus (14).

SOURCE: Office of Technology Assessment, 1992.

plant varieties that are propagated by sexual reproduc- Advantages of obtaining a utility patent for an asex

tion. Protection under PPA and PVPA complement each

other in providing protection for all new varieties of

plants—asexually reproduced by plant patents and sexually reproduced by PVPCs.

Plant Patents v. Utility Patents

Utility patents provide protection for plants, including

asexually reproduced plants such as those included within

PPA, as well as plant parts (e.g., flowers, fruits, and

nuts) and hybrids, which are excluded from PPA. Also,

seeds and plants with defined physical traits can be protected through utility patents. Utility patents for plants,

when the requirements can be satisfied, offer broader

coverage than would be available for the same plant under

PPA.

ually reproduced plant are many. A plant patent is limited

to a single claim; a utility patent need not be so limited.

Perhaps the most significant advantage of the utility patent is that it provides broad protection for inventions

that can affect more than a single variety and can cover

plant parts including flowers, nuts, fruits, and cuttings

that do not asexually reproduce a plant. Further, no requirement exists for utility patents that an infringing plant

be reproduced asexually from the patented plant, hence

sexual reproduction of the protected variety is also covered.

One disadvantage of utility patents is that the description requirement is more stringent than it is for a plant

patent. To satisfy this requirement for utility patents,
394 ● A New Technological Era for American Agriculture

placing the plant or seed on deposit may be necessary

(depending on whether or not the production of the plant

can redescribed by words alone).

Plant Variety Protection Certificates v.

Utility Patents

Compared to PVPCs, several aspects of utility patent

coverage for sexually reproduced plants appear advantageous to plant breeders. A utility patent is not limited

to the specific variety described; it can protect the specific

variety, as well as other varieties having the same traits

and functional properties. Hybrids are specifically excluded from plant variety protection but are fully protectable by utility patents. Extensive scope of coverage

is another significant advantage of utility patents over

PVPCs. Utility patents can protect the plant, seed, plant

parts, genes, plants having a specific physical trait, and

processes for developing new varieties and hybrids.

Another key difference is that utility patent statutes do

not provide for a farmer’s exemption. Consequently, if

anyone other than the patent owner makes, uses, or sells

the seed for reproductive purposes, it is an infringement

of the utility patent, subject to judicial enforcement. Utility patents also do not allow research exemptions (i. e.,

it is an infringement of the utility patent to use the patented plant or variety in developing a new variety or

hybrid). Finally, compulsory licensing cannot be mandated by any Federal agency for a utility patent. In compulsory licensing under PVPA, the Secretary of Agriculture

directs the PVPC holder to grant a license to a third party

if the Secretary determines that such a license is in the

public interest. The owner receives a reasonable royalty

but has no option and must grant the license.

An advantage of PVPCs over utility patents is that the

latter have stringent description requirements that may

necessitate the deposit of the plant or seed, such that it

is publicly available when the utility patent issues. The

present Plant Variety Protection Office (PVPO) policy

is not to make most deposited seed available to the general public. One other advantage of PVPCs is that protection is afforded to the new variety before the issuance

of the certificate ( 10).

Trade Secret Law

While patents and protection certificates have been

applied successfully to plants, they are ill-suited to trade

secret protection. Plants often cannot be easily confined

to an enclosed space, thus making them susceptible to

theft by outsiders. Some plants are easily grown from

only a portion of the parent or, if the plant is an inbred,

from a seed—if someone obtains inbred seeds, plants

from those seeds can be easily reproduced. Theft of secret

plant varieties jeopardizes producers’ potential compensation for their investment of creative effort, time, and

dollars. Nevertheless, some inventors within the agricultural and horticultural industries successfully employ

trade secret protection by not releasing the parents of

hybrids that they sell.

INTELLECTUAL PROPERTY

PROTECTION FOR ANIMALS

in April 1987, the Board of Patent Appeals and interferences ruled that it would henceforth consider nonnaturally occurring, nonhuman, multicellular living

organisms, including animals, to be patentable subject

matter under general patent law. This statement initiated

broad debate and the introduction of legislation concerning the patenting of animals. The first—and, to date,

only—animal patent was issued in April 1988 to Harvard

University for mammals genetically engineered to contain a cancer-causing gene (see box 15-C). Exclusive

license to practice the patent went to duPont Co., which

was the major sponsor of the research. The patented

mouse was genetically engineered to be unusually susceptible to cancer, thus facilitating the testing of carcinogens and of cancer therapies. Specifically, the patent

covers

. . . a transgenic nonhuman eukaryotic animal (preferably

a rodent such as a mouse) whose germ celIS and somatic

cells contain an activated oncogene sequence introduced

into the animal . . which increases the probability of the

development of neoplasms (particular] y malignant tumors )

in the animal.

The 1987 PTO policy and the 1988 issuance of the first

patent on a transgenic animal spurred public debate on

scientific, regulatory, economic, and ethical issues.

Federal Regulation

Several Federal agencies currently use transgenic animals. The National Institutes of Health is currently the

largest user of such animals for biomedical research projects. USDA has conducted research on the genetics of

animals for many years. USDA’s Agricultural Research

Service reported projects involving the use of growth

hormone in sheep and swine, and chickens engineered

by recombinant DNA technology to be resistant to avian

leukosis virus. USDA’s Cooperative Research Service is

in the early stages of supporting extramural research proj-
Chapter 15—Intellectual Property Rights for Biotechnology and Computer Software ● 395

Box 15-C—Patent Number 4,736,866-The ‘Harvard Mouse”

Photo credit: Ira Wyman/Sigma

On April 12, 1988, the U.S. Patent Office issued the first patent of a living animal to Harvard Professor Philip

Leder and Timothy A. Stewart of San Francisco, California. The patent was assigned to the President and Fellows

of Harvard College. The patent claims “a transgenic nonhuman eukaryotic animal (preferably a rodent, such as a

mouse) whose germ cells and somatic cells contain an activated oncogene sequence.” The claim cited a mouse

into which had been inserted a gene that causes an increased propensity for the mouse to develop cancerous

tumors. Such mice can be used to test materials suspected of being carcinogens. These tests “can be extremely

sensitive” and “will permit suspect materials to be tested in much smaller amounts . . . used in current animal

carcinogenicity studies.” The patent points out that this “will minimize one source of criticism of current (testing)

methods, that their validity is questionable because the amounts of the tested material used is greatly in excess

of amounts to which humans are likely to be exposed.”

Such transgenic mice “can also be used as tester animals for materials. . . thought to confer protection against

the development of “cancerous tumors (e.g., antioxidants such as beta-carotene or Vitamin E).

The precise language of the patent described several similar lines of laboratory mice that had been engineered

by the insertion of an activated oncogene sequence, specifically, the mouse “myc” myelocytomatosis) gene under

control of a promoter or regulatory gene sequence derived from the mouse mammary tumor virus (MMTV LTR).

Gene fusions of the myc and MNITV LTR genes were created and inserted into fertilized one-cell mouse eges via

microinjection. The treated eggs were then implanted in receptive female mice and the offspring were raised, used

to establish laboratory populations, and then analyzed for incorporation and expression of the inserted genes.

The actual patent coverage is broad, embracing virtually any species of “transgenic nonhuman mammal all of

whose germ cells and somatic cells contain a recombinant activated oncogene sequence introduced into said

ammmal, or an ancestor of said mammal, at an embryonic stage.”

SOURCE: U.S. Patent and Trademark Office, U.S. Patent No. 4,736,666 (1966).
396 . A New Technological Era for American Agriculture

ects involving genetically engineered animals. The National Science Foundation (NSF) currently funds research

involving transgenic animals in a range of laboratory

experiments. With the use of transgenic animals becoming central to whole lines of investigation, NSF expects

that work with such animals will increase. The Agency

for International Development (AID) funds research involving conventional and transgenic animals at international research centers that are only partially funded by

the United States. Accordingly, AID has only partial

control over such research activities. Several Federal

agencies regulate the experimental use or commercial

development of genetically altered animals. Because current statutes regulate various uses and protections for

animals, no single Federal policy governs all uses of

genetically altered animals. In the absence of a single

policy, Federal agencies will rely on existing statutes,

regulations, and guidelines to regulate transgenic animal

research and product development. Current federally

funded research efforts could lead to patents on animals.

The patentability of an animal, however, does not affect

the manner in which the animal would be regulated by

any Federal agency.

Economic Considerations

Economic considerations will influence the order in

which different transgenic animals are produced for commerce. Transgenic animals used for biomedical research

are likely to be developed first, primarily due to extensive

research in this area. Transgenic agricultural animals are

also likely to be produced, although large-scale commercial production of such livestock and poultry is unlikely in the near future (5 to 10 years). The largest

economic sectors likely to be influenced by animal patents are the different markets for agricultural livestock,

and possibly some sectors of the pharmaceutical industry.

The principal agricultural markets involve poultry, dairy,

and red meat. These markets are organized quite differently, and they are subject to different degrees of economic concentration. Poultry is the most concentrated

(though still diffuse by the standards of other industries,

such as automobiles) and the dairy and red meat sectors

are more diffuse. Different economic forces are important

in these three markets as well: Federal price supports are

of major importance in the dairy market, while the market

for poultry is more open and competitive. It is difficult

to predict the manifold consequences of any particular

approach to protecting intellectual property, especially

across so wide a range of economic activity as may make

use of patentable animals. In addition to the diverse sectors of the agricultural livestock markets, and pharmaPhoto credit: Kevin O’Connor

The economics of patenting, such as for these

transgenic pigs, will be determined by the potential use

of the animal, its market, reproduction rate, and relative

value.

ceutical and other chemical production, there are academic

research or industrial testing activities to consider.

The economics of patenting and the effect on inventors

and consumers will be determined by the potential use

of the animal, its market, its reproduction rate, and its

relative value. The existence of animal patents and the

degree to which they are employed in the different markets may introduce some new economic relationships. It

is not now clear that these are likely to have any substantially adverse effects on the major markets or existing

market forces. The same types of pressures that have

driven economic choices in the past are likely to continue

to dictate them in the future. If an innovation increases

costs (e. g., if a patented animal costs more than the

unpatented alternative) it is unlikely to be adopted unless

it commensurately increases output or product values. It

therefore seems that although cost savings can be anticipated to follow from animal patenting in some areas

(e.g., pharmaceutical production or drug testing), innovations attributable to patented animals are likely to

advance more slowly in low-margin operations such as

raising beef cattle. In some cases, efficient alternatives

to protection of intellectual property via patents are feasible. Trade secrets or contractual arrangements might

serve well where the animals involved have a high intrinsic value and are limited in number, e.g., animals

used for pharmaceutical production. When faced with

the complexity of the markets for pork or beef production, however, such alternatives are clearly less practical.

However, the same complexity must be accommodated
Chapter IS—intellectual Property Rights for Biotechnology and Computer Software ● 397

by any scheme for enforcement or royalty collection associated with patenting animals per se.

Ethical Considerations

A number of ethical issues have been raised in regards

to patenting animals. Many of these arguments focus on

the human health or environmental consequences that

could occur subsequent to the patenting of animals. Other

arguments focus on religious, philosophical, spiritual, or

metaphysical grounds. These grounds have been used by

different parties to support and oppose the concept of

animal patenting. Many arguments relating to the consequences of animal patenting are difficult to evaluate

since they are speculative, relying on hypothetical scenarios or on as yet unproven assertions. Arguments based

largely on theological, philosophical, spiritual, or metaphysical considerations are likewise difficult to resolve,

since these may not be acceptable or relevant to other

persons holding opposing beliefs. Most arguments that

have been raised for and against the patenting of animals

concern issues that would be materially unchanged whether

patents are permitted or not. Most arguments center on

issues that existed prior to the current patenting debate

(e.g., animal rights, the effect of high technology on

American agriculture, the distribution of wealth, international competitiveness, the release of novel organisms

into the environment). It is unclear that patenting per se

substantially would redirect the way society uses or relates to animals. Many concerns about the consequences

of patenting can be addressed by appropriate regulations

or statutes, rather than by amendments to patent law.

Other arguments, particularly those of theological, philosophical, spiritual, or metaphysical origin, need to be

debated more fully and articulated more clearly.

Deposit Considerations

In 1949, the PTO began recommending that patent

applications for inventions involving microorganisms

should include the deposit of the pertinent microorganism

in a culture depository. A culture depository accepts,

maintains, and distributes cultures of microorganisms,

viruses, cells, or other genetic-type material. The deposit

of seeds and plant tissue culture has become established

practice. A depository maybe public or private, nonprofit

or for profit. The main function of a public culture depository is the preservation and distribution of reference

cultures that serve as standards for users in the scientific

and educational communities.

Although not a formal requirement, patent examiners

advised applicants that in cases where words alone were

not sufficient to describe the invention adequately, a deposit was advisable. Currently, patent applications for

inventions involving microorganisms, plasmids, vectors,

cells, plant tissues, seeds, and other biological materials

that are not generally available or reproducible are often

supported by a deposit in a recognized patent depository.

A deposit is employed in many cases to meet the requirement that a patent provide ‘enablement’ or the best

mode of practicing an invention.

The PTO first published guidelines on the deposit of

microorganisms in 1971. In 1977, establishment of the

Budapest Treaty required contracting States that allow

or require the deposit of microorganisms as part of their

patent procedure to recognize the deposit of a microorganism with any International Depository Authority. In

1985, the Court of Appeals for the Federal Circuit held

that the enablement provision of the patent statute did

not require a deposit in a recognized depository by the

filing date of the patent application, but only before the

issuance of the patent. In 1988, the PTO published proposed rules for deposit of biological materials for patent

purposes. These rules, if adopted formally by the PTO,

will assist the inventor and the depository in defining the

position of the PTO on deposits.

The new patentable status of animals raises the possibility that the PTO will encourage or require the deposit

of animal forms to support certain patent applications.

To date, no animal has been deposited with a depository.

In the case of the first animal patent granted (U.S.

4,736,866), the deposit requirement was satisfied not by

deposit of a mouse or other animal, but by deposit of the

DNA plasmids bearing the cancer-causing genes intended

for transfer into an animal. In the patent, the inventors

provide detailed instructions for inserting those genes into

mouse embryos to produce transgenic mice.

The patenting of animals could be problematic if deposit of the animal is required. Currently no depository

is willing to accept the deposit of animals because the

cost of facilities and expertise needed to maintain animals

would be prohibitive. A depository maintaining animals

for patent purposes might be subject to adverse publicity.

If it were necessary to maintain the animal, a depository

might need to grow another sample to prove the replication of the animal. After growth of the animal, disposal

might not be acceptable and, therefore, maintenance of

progeny would be necessary. It is not clear how a depository would make samples of an animal available or

how it would create more animals. Maintenance of many

kinds of short-lived animals for the current required period of 30 years would not be possible.
398 ● A New Technological Era for American Agriculture

The deposit of animal embryos may not present the

same difficulties as long as the embryos can be successfully frozen and recovered. To date, at least 13 species

of animal embryos (cattle, mice, rats, rabbits, hamsters,

sheep, goats, horses, cats, antelopes, and three species

of nonhuman primates) successfully have been frozen

and recovered.

INTERNATIONAL PROTECTION

FOR PLANTS AND ANIMALS

Intellectual property protection of microorganisms,

plants, animals, and biological processes is of increasing

concern to the world community. International patentability is one element of the current debate in the United

States regarding the scope of patentable matter. For example, those who favor patenting of animals point out

other countries that either permit or do not expressly

exclude the possibility of such patents. Opponents of

patenting of animals can point to other nations that expressly exclude or have yet to issue patents on animals.

Several international treaties and agreements relevant

to biological inventions seek to harmonize various procedural and substantive elements of international patent

practice. However, the patenting of animals is not the

subject of any existing treaty. Of the existing agreements,

the European Patent Convention (EPC) is most relevant

to the substantive issue of patenting plants and animals.

Article 52( 1) of the EPC defines patentable subject matter

as inventions that are susceptible to industrial application,

are new, and involve an inventive step. This definition

is extraordinarily general. Rather than providing a precise, positive definition of patentable subject matter, the

EPC instead narrows this broad definition by explicitly

specifying negative restrictions. One such exclusion is

article 53(b), which stipulates that European patents will

not be issued for plant or animal varieties and essentially

biological processes for the production of plants and animals (with the exception of microbiological processes

or the products thereof): Although plant varieties are

specifically excluded, there is no general exclusion for

plants. According to the Technical Board of Appeal of

the European Patent Office (EPO), article 53(b) of the

EPC prohibits only the patenting of plants that are in the

genetically fixed form of a plant variety, i.e., a specific

variety such as the rose “Peace” or the wheat cultivar

“Chinese Spring. ” Thus, EPO will grant utility patent

protection for a plant that has had a gene inserted (e.g.,

corn having gene X), if it is not a specific plant variety

(e.g., corn inbred A having gene X). Similarly, a process

for transforming a plant to insert a desired gene would

be patentable because human intervention played a greater

role in the final result than biological forces. This viewpoint has been adopted by the Swiss Patent Office as

well as by the European Patent Office, which in early

1988 granted a patent on a technique for increasing the

protein content of forage crops such as alfalfa and for

the plants produced with the aid of the technique. This

decision arguably opens the door for plant and animal

patenting in Europe, subject to the specific treatment of

European patents on a country-by-country basis.

Differences do exist between nations regarding intellectual property protection of biotechnological inventions, including the issue of what constitutes patentable subject

matter. Patent protection is widely available for microorganisms, as are various forms of patents and breeders’

certificates for plant life. Analysis of the laws of other

nations indicate that patent protection on animals is permissible or theoretically possible in a number of nations.

Any projection of the number of nations permitting animal

patents must be speculative in the absence of additional

activity in this area. To date, only the United States has

announced a policy permitting patents on animal life forms

and issued a patent on an animal invented through biotechnological techniques. It is likely that other nations will

issue such patents in the future. The Japanese patent office,

for example, recently issued an internal notice announcing

its intention to grant patents on nonhuman animals if they

meet the requirements of their patent law.

ISSUES AND POLICY OPTIONS

FOR BIOTECHNOLOGY

Intellectual property is one of the most important assets

for a company attempting to commercialize biotechnology-related processes and products. Patents often are used

by start-up companies to lure crucial financing and to

gain access to new markets. Patent protection has played

a major role in the development of biotechnology-based

pharmaceuticals. Patents and other forms of intellectual

property (plant breeders’ rights, trademarks) are similarly

important to the commercial development of a range of

agricultural products.

Under United States law, patents may be issued for

any new, useful, unobvious process, machine, manufacture, composition of matter, or new and useful improvement of these items. Under this broad umbrella, U.S.

law has permitted the patenting of micro-organisms, plants,

and nonhuman animals. The patenting of nonhuman animals has led to legislative debate regarding whether such

patents should be granted. Options for congressional action—including discussion on issues such as deposit con-
Chapter 15—Intellectual Property Rights for Biotechnology and Computer Software ● 399

siderations and exemptions from infringement for certain

classes of users—were presented in an earlier OTA report

(New Developments in Biotechnology: Patenting Life)

and are incorporated here by reference ( 10).

In terms of the breadth of patentable items, U.S. patent

law is the most inventor-friendly statute in the world; it

is unique in that it makes no exceptions to patentability

found in the statutes of many other countries (e.g., animal

and plant varieties, public order or morality, products

such as pharmaceuticals, and foods). If Congress takes

no action regarding patentable subject matter, broad protection for inventions created by biotechnology will continue. Laws created by Congress to regulate interstate

commerce would be relied on to govern the development,

approval, sale, and use of such inventions. Congress

could, either through moratorium or prohibition, specifically bar patents from issuing for nonhuman animals or

human beings. Such action would clarify congressional

intent regarding the limits of subject matter protection,

but it would also create a precedent of using patent law,

rather than laws regulating commerce, to discourage certain types of inventions.

To date, only one patent on an animal has been issued.

Since this occurred ( 1988), no further patents have been

issued, and the backlog of such patent applications now

numbers over 160. Since the status of specific patent

applications is, by law, confidential, there is no way to

ascertain when, or if, the PTO will issue subsequent

animal patents; and further, if issued, whether such patents will have agricultural applications. Congress could,

through its oversight powers, ask PTO to explain the

present status of such patent applications.

The need to harmonize U.S. patent law with the laws

of other nations is likely to come to Congress’ attention

as a result of several ongoing efforts: the General Agreement on Tariffs and Trade (GATT), the World Intellectual Property Organization (WIPO), amendments to the

Union for the Protection of New Varieties of Plants

(UPOV), and other bilateral and multilateral trade discussions. It is too early to predict specific options arising

from each of these forums. In all cases, the goal of

harmonization should be the creation of consistent laws

addressing substantive and procedural issues in patent

practice.

INTELLECTUAL PROPERTY

PROTECTION AND COMPUTER

SOFTWARE

As with biotechnology, the merging of intellectual

property law and computer software represents the joining of old law with new technology. Computer software

can be protected under copyright, patent or trade secret

law, or some combination of these. This section briefly

reviews these forms of protection for computer software

and discusses some issue areas for agricultural software

use.

Copyright

The current copyright law is enacted in the Copyright

Act of 1976, as amended. A 1980 amendment made

explicit provisions for computer programs as (literary)

works of authorship (P. L. 96-5 17). Copyright protects

‘‘original works of authorship’ from unauthorized uses

including reproduction (copying), making derivative works

(adaptation), public distribution, public performance, and

display. Generally, the term copyright for new works is

the life of the author plus 50 years, or 75 years for works

made for hire (e. g., by an employee of a firm).

Copyright has been the form of software protection

favored by most nations and will be the most widely used

for agricultural software. Obtaining a copyright is easy,

inexpensive, and quick compared to the requirements for

a patent. And since a copyright is administered under

Federal law, unlike trade secret protection, it is uniform

in all the states. The duration of copyright protection is

very long, compared to the expected economic or technical lifetimes of computer programs.

The doctrine of fair use is one of several statutory

limitations on copyright holders’ exclusive rights. Under

this doctrine, certain unauthorized uses, such as copying

for the purposes of teaching, scholarship, or research,

may be considered ‘‘fair use, ” not copyright infringements. Whether an instance of copying is a fair use instead of an infringement is determined by the courts.

Another statutory limitation on the rights of software

copyright holders is contained in the 1980 amendment.

It states that it is not an infringement for the owner of a

copy of a computer program to make or authorize the

making of a copy or adaptation of that computer program

provided that such new copy or adaptation is created as

an essential step in utilizing the program or that it is for

archival purposes only and that all archival copies are

destroyed in the event that continued possession of the

computer program should cease to be rightful. This limitation clarifies the right of a user who legitimately owns

a software product to make “backup’ copies of the software to protect against damage or loss, to load the software onto the hard disk of a computer for easier or more

efficient use, and to make any necessary adaptations to

make the program usable on a computer. It does not
400 ● A New Technological Era for American Agriculture

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service

There is disagreement over what features of a computer

program are copyrightable. The distinction between idea

and expression can be difficult to determine.

permit, for example, the making and distributing multiple

copies for school or office use.

Copyright does not confer rights over ideas—only the

expression of an idea is protected, not the underlying

idea itself. This could be considered a disadvantage by

the software developer because the copyright will not

preclude a competitor from creating a new work embodying the same idea, so long as the competitor does

not incorporate copyrighted expression from the first program into the second program. For software, copyright

may also allow reverse engineering practices. This means

that one team of software developers studies the code of

a copyrighted program to extract the underlying ideas.

A second team then creates a new program, based on

the first team’s functional specifications. The extent to

which these are protectable expressions, as opposed to

uncopyrightable ideas, is the focus of recent court cases.

Considerable disagreement exists over what features

of a computer program are copyrightable. The distinction

between idea and expression can be quite difficult to

determine, even for some traditional literary works like

books and plays. For software, which is intrinsically

functional, idea and expression are closely interwoven.

It is difficult to separate which elements of a program

are the expression and which are the underlying idea.

There is substantial disagreement among legal scholars

and among software developers and computer scientists

as to whether copyright should protect only against literal

or near-literal copying or should also protect a program’s

structure, sequence, and organization and user interfaces

as well. For example, some argue that a program’s ‘‘look

and feel” (e.g., computer program screen displays) should

not be protected by copyright;1 instead protection for

“look and feel” is better suited by a patent. Others are

critical of the patent protection for computer programs

(1 1).

Patent

As discussed earlier, a patent protects an invention

including the expression of an underlying idea, from

copying and from independent creation for a period of

17 years. It protects against literal infringement (making,

using, or selling the claimed invention) and also against

infringement by equivalent inventions, whether or not

the infringing inventor had prior knowledge of the patented invention. The subject matter of a patent is limited

to a process, machine, article of manufacture, or composition of matter that is novel, nonobvious, and useful,

or to new and useful improvements to these classes of

patentable subject matter. However, the following generally cannot be patented: ideas, scientific principles,

phenomena of nature, and mental processes. For a knowledge-based system, obviously it may be difficult to patent

the knowledge in the system if it is common knowledge

associated with the profession (4), Patents probably will

be of little value to applications of advanced computer

technologies, although they should be of value to a basic

computer scientist who develops domain-independent tools

(e.g., inference engines).

The requirements for a patentable invention are relatively stringent; patents do not reward hard work per se.

I couti~ have ~ddre~~ed ~opyrlght issues in disputes relating to computer program screen displays, distinguishing copyrightable eXPreS~ion from

unprotected elements in the text, menu hierarchies, command structure, key sequences, and other aspects of a program’s ‘‘interface’ with the user

(12).
Chapter 15—Intellectual Property Rights for Biotechnology>’ and Computer Software . 401

The patent requirements for novelty and nonobviousness

are more difficult to satisfy than the ‘‘originality’ criterion of copyright. (All “original” software is eligible

for copyright, as with any other work of authorship, and

copyright inheres in a work as soon as it is created. )

Although patents are being granted for software-related

inventions, only a small fraction of these inventions is

likely to contain a computer process meeting the tests of

novelty and nonobviousness.

An advantage of patent protection for the discoverer

of a software-related invention is that the patent will

protect all the claims for the invention as a whole. In

contrast, many of the processes underlying a software

invention would likely not be protectable under copyright

because they would be considered part of the unprotected

‘‘idea. A single computer program may consist of a

number of patentable processes and algorithms. At the

same time, the claimed invention might be executed by

a number of copyrighted programs. Depending on how

carefully claims are constructed, the computational logic

and processes and even the algorithm itself can be patent

protected.

The availability of patent protection for software-related inventions was unclear until the early 1980s. During

the 1980s patents were issued for software-related inventions such as linear-programming algorithms, spellchecking routines, and logic-ordering operations for

spreadsheet programs.

Some patent lawsuits concerning software-related inventions and controversies concerning patents for algorithms became highly visible in the late 1980s. These

lawsuits have focused concerns over the appropriateness

of patent protection for software-related inventions and

algorithms. Some argue that patents on computer-program processes do not encourage technological progress

and point to the practical problems of administering the

patent system for software-related inventions.

One such problem is the incomplete “prior art” available to patent examiners in evaluating patent applications

for processes involving computers, especially those involving software and algorithms. 2 The published literature does not completely represent developments in the

fields of software and computer science. In many cases,

important prior art exists only in product form and is not

described in print form such as articles in technical or

scientific journals. Another problem is the lack of special

classifications or cross-references to issued patents. As

a result, it is virtually impossible to find, let alone count

or profile, all software-related patents. Thus, patent examiners have no effective way of searching and studying

such patents.

Another problem is the long time lag between patent

application and issuance, compared to quick-moving

software life cycles. Patents under examination are not

disclosed, so a competitor may put considerable effort

into developing a program that unknowingly duplicates

computer processes for which one or more patents are

pending. Finally, the process of obtaining a patent is

expensive and lengthy, compared to copyright or trade

secret protection. Although turnaround time in the Patent

and Trademark Office (PTO) is decreasing, a patent still

may take years to issue in an industry where products

have short economic lifetimes (11 ).

Trade Secret

Trade secret protection, provided under individual State

laws, protects against use or willful disclosure of trade

secrets by others, but does not penalize independent discovery. Unlike copyright or patent, there is no limitation

on its duration. Trade secret has been the most-used form

of protection for mainframe and minicomputer software.

Its main advantages are that it protects a program’s underlying ideas, logic, and structure, not just expression

as in copyright. Trade secret avoids formalities of registration or application and lengthy waits for protection.

Enforcement is straightforward and injunctions or compensatory relief is available for those who can prove

misappropriation of trade secrets.

Trade secret protection, however, does not protect

against independent creation, reverse engineering, or accidental disclosure of the secret. For software protection

it is relatively weak and is best used in conjunction with

a copyright or patent (7). It can also be costly or impossible to maintain secrecy. Finally, the lack of uniformity in State laws can be frustrating.

If software is protected by trade secret, it maintains

that status so long as it is not publicly disclosed. This

can stifle the spread of knowledge about software stateof-the-art and in turn can adversely affect knowledge of

prior art for patent examinations as discussed earlier ( 11).

~ Prior m-t IS that which is krmwn Or available m a persm skilled in the relevant field d’ techml{~gy. Evidence of prim art (e. g., existing patents,

publicatims) is evaluated not Only ft}r what it expressly teaches, but iilw fm what it would fairly suggest to me Of Ordinary skill in the relevant

field of technology” ( I I).
402 ● A New Technological Era for American Agriculture
Chapter 15—Intellectual Property Rights for Biotechnology? and Computer Software ● 403

INTERNATIONAL PROTECTION

FOR COMPUTER SOFTWARE

The United States is a major international competitor

in computer software development and sales. In 1987,

about 40 percent of the U.S. software developers’ revenue came from foreign sales ( 13). Many multilateral

and bilateral treaties help protect the intellectual property

of software developers through patent and copyright.

Copyright is the predominant form of software protection in the United States and abroad. In most countries,

computer programs per se are not eligible for patent protection. However, in some countries, including the United

States, certain types of computer-implemented processes

and algorithms can be patented.

Copyright and patent protections abroad are very similar in form to those in the United States and have most

of the same advantages and liabilities. Copyright protection abroad is provided principally through the Berne

Convention and the Universal Copyright Convention. The

United States joined the Berne Convention in March 1989.

The treaty was first established in 1886 and is the primary

multilateral agreement in the world dealing with copyright.

The United States is also a member of the Universal

Copyright Convention (UCC), which was established and

adopted by the United States in 1955. UCC provides less

protection than the Berne Convention and has lower minimum standards. In nations that agree to both Berne and

UCC, Berne takes precedence.

The Berne Convention is recognized in 79 nations,

and gives U.S. software developers protection in 24

countries where there was no previous copyright agreement. The United States has bilateral agreements with

33 nations as well, often in addition to common Berne

or UCC membership. The procedures are simple: once

a copyright exists for a work in a member nation, it

applies in all signatory nations, according to their own

laws. Computer programs are not specifically mentioned

in either convention, but are commonly acknowledged

to be included.

Securing patent protection in foreign countries is a

difficult process. Patents for any invention are difficult

to obtain due to the rigorous standards of novelty and

nonobviousness. A patent must be applied for in each

country where it is to be valid—there is no universal

patent process.

in most countries, software per se is not considered

patentable. The United States is a member of the oldest

and most extensive patent treaty, the Paris Convention,

established in 1883. There is no requirement in the Convention that software-related inventions be considered

patentable.

Trade secret has been the traditionally favored method

of protection for mainframe and minicomputer software

developers in the United States. However, most countries

outside of the United States and Western Europe do not

recognize either domestic or international trade secret

protection. No international conventions for trade secret

exist.

International standards for intellectual property law are

important to encourage and to protect U.S. inventions.

The United States is attempting to include intellectual

property in the General Agreement on Tariffs and Trade

(GATT) treaty and is engaged in bilateral negotiations

as well (11).

ISSUES AND POLICY OPTIONS

FOR COMPUTER SOFTWARE

Copyright and Patent Issues

Rapid technological advances in computer software are

challenging the intellectual property laws in the United

States and internationally. Copyright law offers straightforward remedies for the literal copying of program code,

although enforcement remains a problem. especially

overseas. Functional aspects of computer programs pose

difficult questions for the application of copyright. The

traditional “fuzzy” line between idea and expression in

copyright is confounded by the need to determine an

appropriate scope of protection in light of the intent of

current law.

The protection of software-related inventions by patent

is a fairly recent and controversial development. The

PTO faces considerable challenges in examining applications for computer-related inventions. PTO has an incomplete data base of ‘‘prior art’ for computer-related

inventions. Much of what constitutes prior art historically

has been in the form of products, not literature or issued

patents. This makes it very difficult for examiners to

judge whether an application describes a “novel” and

‘‘nonobvious’ invention. Improving electronic search

and retrieval capabilities for PTO’s own database is critical since it is used by the patent examiners during the

application process. Currently, PTO is unable to provide

statistics on the number of patents issued for softwarerelated inventions except through time-consuming man-
404 ● A New Technological Era for American Agriculture

ual search, review, and selection from various large patent subclasses (12).

Options for congressional action are presented in the

OTA report Finding A Balance: Computer Software, Intellectual Property and the Challenge of Technological

Change and are incorporated here by reference. If Congress chooses not to act, the status quo is maintained but

uncertainty as to how current intellectual property law

applies to computer software remains. On the other hand,

taking action may reduce some uncertainties but add others, especially if additional bodies of case law or international agreements have to be developed. If Congress

chooses to take action, it must decide how comprehensively to act. Actions might take the form of measures

to address ongoing institutional problems (e.g. prior art

and examination quality issues facing PTO) or legislative

measures to amend current copyright and patent statutes

or to create sui generis (of its own kind or class) protection. Generally, congressional action might

1.

2.

3.

4.

5.

(See

explicitly affirm the status quo and course of case

law;

make small adjustments at the margins of copyright

and patent law possibly through procedural changes;

clarify or modify the scope of patent or copyright

but leave the basic paradigms unchanged;

introduce one or more complementary, sui generis

protection tailored specifically at certain aspects

software innovation; and

develop sui generis protection to substitute for

copyright and/or patent protection.

the above referenced OTA report for a discussion

of the issue areas in the context of these choices. )

Liability Issues

It has been said: “To make a mistake is human, but

to really mess things up requires a computer. Unfortunately, mistakes can occur in using advanced computer

technologies, and some mistakes can lead to personal

injury or financial loss. The liabilities associated with

such ‘ ‘torts’ ‘ need to be examined. This issue is not

specific to agriculture but applies to the computer industry in general.

The issue of personal injury arises in areas such as

medicine where a computer application is controlling a

patient’s treatment (e.g., the level of radiation in cancer

treatment) but is unlikely to arise in business applications

such as agriculture. Therefore, the main concern will be

with financial loss as a result of bad advice (4).

To recover in negligence, the plaintiff must show that

the defendant did not take sufficient care in developing

the system to prevent injury (4). The courts have not

established standards for adequate care, but developers

would be advised to maintain detailed records of knowledge sources, verification tests, and validation procedures. Inclusion of a disclaimer at the beginning of each

program has been suggested to insulate the developer

from such litigation. Gemignani (4) suggests the following:

SOFTWARE IS INTENDED TO BE USED BY LICENSED PROFESSIONALS ONLY. THE USER ASSUMES SOLE RESPONSIBILITY FOR DECISIONS

CONCERNING ADVICE OR TREATMENT. IF YOU

DISAGREE WITH THIS POLICY, YOUR LICENSE

FORBIDS YOU TO USE THIS SOFTWARE

The issue of liability has not been a major problem in

agricultural computer applications, possibly as a result

of the small amount of activity in knowledge-based systems. However, it is a topic frequently mentioned among

program developers. Stressing the view that these are

decision support systems that provide advice to professionals is important. In this light, such systems are similar

to a colleague who provides advice.

A related issue in software development is the lack of

regulation. Software must conform to standard regulations (e. g., patents, fraud, etc. ) but need not be approved

by any Federal agency. The medical field is a potential

exception. The Food and Drug Administration proposed

reviewing software that is the component of a medical

device or that is used in the clinical management of

patients. Therefore, it is likely that software that claims

to make medical decisions will be regulated (4). Government regulation is unlikely to protect a developer from

negligence claims; however, it may relieve some of the

paranoia that exists among developers.

User Issues

When advanced computer technologies are developed,

they will be available to agribusiness professionals and

agricultural producers. An interesting negligence liability

issue may exist if the consultant making the recommendation to a producer chooses not to use an available

technology (4). The argument stems from an historic case

where a tugboat lost the barges it was towing in a storm.

The situation might have been avoided if the tugboat had

a radio on board. The owner of the tugboat was held

liable because of failure to use an available technology—

even though radios were not yet standard equipment on
Chapter 15—Intellectual Property Rights for Biotechnology and Computer Software ● 405

tugboats. According to this case, three criteria must be

proven to establish negligence in not using a technology:

1. The technology must be readily available.

2. The technology must be reliable.

3. The cost of using the technology must bear a reasonable relationship to the harm that might be suffered in the absence of the technology.

Thus far, this precedent has not been tested with computer technologies. However, this suggests that for those

who advise farmers, such as Extension agents, consultants, input suppliers, processors, etc., they may be obligated to adopt these technologies.

1.

2.

3.

4.

5.

6.

CHAPTER 15 REFERENCES

Cooper, I. P., Biotechnology and the Luw (New York,

NY: Clark Boardman Co., Ltd., 1989).

Diamond v. Chakrabarty, 447 U.S. 303 (1980).

Ex parte Hibberd, 227 USPQ 443 (PTO Bd. Pat.

App. & Int. 1985).

Gemignani, M. C., “Some Legal Aspects of Expert

Systems, ” Expert Systems with Applications, vol.

2, No. 4, 1991.

Jondle, R. J., “Overview and Status of Plant Proprietary Rights, ” Intellectual Property Rights Associated With Plants (lMadison, WI: American Society

of Agronomy, 1989).

Memorandum dated Feb. 18, 1983, from the President to the Heads of Executive Departments and

Agencies on Government Patent Policy, 19 Weekly

Comp. Pres. Dec. 252.

7.

8.

9.

10.

11.

12.

13.

14.

Sumner, J.P. et al., A Legal Guide for the Sof?ware

Developer (Minneapolis, MN: Merchant and Gould,

1989).

Tanenholtz, Alvin E., “Genetic Engineering—

Technological Trends From the Perspective of a U.S.

PTO Examiner, Fourth Annual Biotechnology Law

Institute (Clifton, NJ: Prentice Hall Law & Business, 1988).

U.S. Congress, Office of Technology Assessment,

New Developments in Biotechnology: Ownership of

Human Tissues and Cells—Special Report, OTABA-337 (Washington, DC: U.S. Government Printing Office, April 1987).

U.S. Congress, Office of Technology Assessment,

New Developments in Biotechnology: Patenting Life—

Special Report, OTA-BA-370 (Washington, DC: U .S.

Government Printing Office, April 1989).

U.S. Congress, Office of Technology Assessment,

Computer Sofware andlntellectual Property, OTABP-CIT-61 (Washington, DC: U.S. Government

Printing Office, March 1990).

U.S. Congress, Office of Technology Assessment,

Finding A Balance: Computer Sof~are, [ntellectuai

Property and the Challenge of Technological Change,

OTA-TCT-527 (Washington, DC: U.S. Government

Printing Office, May 1992).

U.S. International Trade Commission, The E&ects

of Greater Economic Competition Within the European Community on the United States (Washington, DC: U.S. Government Printing Office, July

1989).

Van Horn, C. E., Patent Policy & Programs Administrator, U.S. Patent and Trademark Office, personal

communication, December 1990.
Chapter 16

Institutional Change Within the

Land-Grant System
Contents

Page

THE MISSION OF LAND-GRANT UNIVERSITIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .410

CHANGING ENVIRONMENT FOR AGRICULTURAL RESEARCH . . . . . . . . . . . . . . . . . . . . ....41 I

The Political Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ............ 411

The Resource Base . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 412

The Technology Base . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 415

The Legal Environment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 417

ISSUES RAISED BY THE NEW ENVIRONMENT . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ... ......419

RESEARCH TO EVALUATE IMPACTS OF THE NEW ENVIRONMENT .................. 421

POLICY OPTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 423

CHAPTER 16 REFERENCES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 426

Table

16-1.

16-2.

16-3.

16-4.

16-5.

16-6.

16-7

16-8

16-9

16-10

16-11

16-12

16-13

16-14

Tables

Page

Current Formulator Allocating Hatch Funds to States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 410

Number of Farms in the United States, Selected Years . . . . . . . . . . . . . . . . . . . . . . . . . ... .....411

State Agricultural Experiment Station Funds From Special Grants, Selected Years ... ..412

Research Funds for State Agricultural Experiment Stations, Selected Years .. ..........413

Distribution of Research Funds by Source for State Agricultural Experiment Stations,

Selected Years . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 413

Research Funds for 12 Largest State Agricultural Experiment Stations, 1989 . . . . . . . . . . 414

Doctoral Level Scientists by Employment Sector, 1985 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 414

Distribution of Applied Agricultural Scientists by Employment Sector and Doctorate

Field, 1985 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 414

SAES Resources Devoted to Biotechnology Research, Selected Years . . . . . . . . . . . . . . . . . 416

SAES Biotechnology Research Funds, Selected Years . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 416

Biotechnology Research Funds for 12 Largest State Agricultural Experiment

Stations, 1988 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 416

Universities Receiving the Most Patents, 1989 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 419

USDA Agricultural Research Service Technology Transfer Activities, 1987-1990.....419

Mean Values of Selected SAES Output by Grant Type . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 423
Chapter 16

Institutional Change Within the Land-Grant System

The U.S. agricultural research system is large and

diverse, employing some 23,000 doctoral level agricultural scientists and economists in academia, industry, and

government. For many years, funding of agricultural research was divided evenly between the public and private

sectors, but recent studies indicate that today this is not

the case—nearly 60 percent of the funding for agricultural research is in the private sector (9).

4 The public-sector agricultural research budget exceeded $2.2 billion for 1989; Federal funding for agricultural research, however, has been a shrinking proportion

of total Federal research funding. In 1955, for example,

the research budget for the U.S. Department of Agriculture (USDA) represented 13.4 percent of the total

Federal nondefense research funding, but was only 4.6

percent of the funding in 1988 (7).

The public agricultural research system nonetheless

plays a significant role in the American economy. Studies

have estimated high rates of social returns to public agricultural research investments, indicating that these investments have been a wise social investment.

Different types of research are conducted by the public

and private sectors and is determined by the extent of

externalities. Externalities exist when the action of a single entity (or firm) affects the environment (or decision)

of another. If they exist the private sector cannot capture

the full returns of its investment, and will not invest in

such research at socially optimal levels. The public sector

must fill in the gap. The private sector, for example,

conducts little agriculture-related social science research;

primarily the role of the public sector. Research that

creates easily transferable information is conducted by

the public sector, while research that creates information

embedded in a product is conducted by private sector.

For example, the public sector develops pure lines and

self-pollinated crop varieties that can be used by any seed

company while the private sector develops hybrid varieties that must be purchased annually by farmers if they

are to be productive.

The U.S. public sector agricultural research system,

a dual Federal-State system, had its origins in the 1860s,

but it was not until the late 19th century that the system

truly began to acquire the capacity to provide the scientific knowledge needed to deal with the problems of

agricultural development. Today the Federal agricultural

research system includes the USDA’s Agricultural Research Service (ARS), Economic Research Service (ERS),

and Forest Service; and the State Agricultural Experiment

Stations (SAES) located within the land-grant university

system.

The Agricultural Research Service, established in 1953,

conducts basic and applied research in six programs covering Natural Resources, Plant Science, Animal Science,

Commodity Conversion and Delivery, Human Nutrition,

and Integration of Systems. ARS employs approximately

2,670 scientists and engineers (of which about 2,500

have doctoral degrees) and had a fiscal year 1991 research

budget of $624 million. Research is conducted at some

127 domestic and 7 foreign locations, including 5 major

regional research centers located in Maryland, Pennsylvania, Illinois, Louisiana, and California. ARS has cooperative research agreements with other USDA agencies

and many of the ARS facilities are located at or near

academic institutions. Some ARS staff hold adjunct faculty appointments and participate in graduate teaching

(7, 17, 18).

The Economic Research Service was established in

1961 to provide economic and other social science information and analysis for improving the performance of

agriculture and rural America. ERS collects and maintains a number of historical data series on farm type,

size, and number; production and input levels; trade;

effects of farm policy; and socioeconomic characteristics

of rural areas of the United States. The ERS also performs

statistical and analytical research, and is organized into

four divisions covering Commodity Analysis, Agricultural and Trade Analysis, Resources and Technology,

and Agricultural and Rural Economy. ERS has limited

funds to contract for research in the academic sector but

is not authorized to administer a competitive grants program. The ERS budget for fiscal year 1990 was $51.3

million (7, 16).

The Forest Service is responsible for research on the

Nation’s forests and for technologies useful in the manufacture of pulp and wood-based products. Research topics cover a broad range, and the Forest Service also

manages 182 million acres of forest. The research budget

for fiscal year 1990 was $157.4 million.

The land-grant university system in the United States

was established in 1862 with the passage of the Merrill

Act. The impetus for establishing these land-grant schools

arose from both a populist reaction to the elitism of uni-

-409-

297-937 0 - 92 - 14 QL 3
410 ● A New Technological Era for American Agriculture

Table 16-1-Current Formula for Allocating Hatch

Funds to States

. . .

●

●

●

✎

20 percent of the funds are allocated equally to each experiment station.

At least 52 percent of the funds are allocated as follows: 1⁄2 in

an amount proportionate to each State’s share of the total rural

population of all States, and 1⁄2 in an amount that is proportionate to each State’s share of the total farm population of all

States.

Not more than 25-percent of the funds are allocated to States

for cooperative research in which two or more SAES cooperate

to solve agricultural problems that are of concern to more than

one State.

3 percent of the funds are for the administration of the Hatch

Act.

SOURCE: National Research Council, Board on Agriculture, “Investing in

Research: A Proposal to Strengthen the Agricultural, Food, and

Environmental System, ” National Academy Press, Washington,

DC, 1989.

versities in the eastern United States, and a perceived

need to provide higher education to the masses, with

particular emphasis on the children of farmers and industrial workers. The Merrill Act made grants of land

to States that were willing to create universities that would

fulfill this mission. Originally, education focused on agriculture and the mechanical arts, but subsequently the

educational focus has expanded to include all of the major

disciplinary fields.

The partnership between the State and Federal Government was extended to research with the Hatch Act of

1887, which provided Federal funding for the support of

agricultural experiment stations at land-grant universities. Before this, agricultural science was limited to the

activities of innovative farmers and inventors and the

industrial sector, and progress came primarily in the form

of mechanical technology. Few States provided significant funding for agricultural research. Eventually, however, agricultural output did not keep up with demand

and food prices began to rise. This set the stage for the

passage of the Hatch Act. It was not until the 1920s that

the land-grant system was fully functional. Today, there

are 57 experiment stations located in each of the 50

States, the District of Columbia, the Pacific Territories

(American Samoa, Guam, Micronesia, and the Northern

Mariana Islands), the U.S. Virgin Islands, and Puerto

Rico. Additionally, six historically black universities (the

1890 Universities) and the Tuskegee Institute also conduct publicly supported agricultural research (10).

The Hatch Act provides research funding to States

based on a formula that considers the importance of the

agricultural sector to the State’s economy. The formula

funding system (table 16-1) provides stable funding for

research programs that may have long gestation periods.

All formula funds must be matched by the State. The

current formula for funding designates 1955 as the base

year and the minimum amount to be allocated.

The structure of the current system was completed with

the passage of the Smith-Lever Act in 1914, which created the Cooperative Extension Service-a mechanism

to carry the results of the research system to the farmer.

Funding is provided by a formula mechanism somewhat

similar to that of the Hatch Act. Today there are extension

offices in nearly every county in the United States, employing approximately 9,650 county agents and 4,650

scientific and technical specialists; the extension budget

totals about $1.2 billion annually (31% Federal) (13).

THE MISSION OF LAND-GRANT

UNIVERSITIES

Land-grant universities are distinguished from other

universities by their legislatively mandated mission; the

Federal-State partnership embodied in the formula funding mechanism; and their integration of research, teaching, and extension. Academic departments within the

State Experiment Stations have three functional budgets,

one each for teaching, research, and extension; individual

professors tend to have joint appointments in one or more

of these functional endeavors.

The legislated mission of the system is to provide

higher level education to the masses; apply research

knowledge to the solution of society’s problems; and

provide outreach or extension programs for nonresident

instruction groups. Over time, the sense of institutional

mission has declined as research has become more basic

and more focused on increasing disciplinary knowledge

than on solving the problems of society. Less emphasis

has been given to the development and adaptive research

needed to apply basic research to solving social problems. When the system was first established, disciplinary

specialization had not yet progressed very far; it was easy

to obtain multidisciplinary cooperation among scientists

and to communicate the research results to lay people.

This is no longer the case.

Rapid post-World War II advances in knowledge and

increasing intellectual specialization has made interdisciplinary cooperation and extension increasingly difficult. Specialized language, compounded by the scientific

illiteracy of the public, has increased the difficulties in

communicating research results to the public. This situation will be even more problematic for research conducted with the tools of biotechnology. The lack of
Chapter 16—institutional Change Within the Land-Grant System .411

understanding of these technologies has raised public

concerns and in some cases a call for the end of this type

of research. University researchers will need to improve

their communication skills with the public if they wish

to enjoy the academic freedom to conduct this research.

The basic premise that the same faculty can efficiently

fulfill the multiple missions of the modem land-grant

university (research, teaching, and extension) still prevails, but tensions are growing in the system as it becomes more and more difficult to achieve these multiple

ends.

The research system must have public support and

funding to function. It also must have the flexibility to

reallocate scarce resources to new priorities, and to attract

highly qualified personnel that can keep abreast of changing technological opportunities. Despite high social returns to public sector agricultural investments, the system

has been the subject of criticism from internal and external sources. External critics focus primarily on the

heavy research emphasis on agricultural productivity and

the lack of research devoted to nutrition, rural problems,

and environmental concerns. Internal criticisms have focused on the perceived low quality of the research, on

the inadequate interaction of agricultural researchers with

the basic scientific disciplines that underlie agriculture,

and on the limited role of peer evaluation in project

formulation and review. In addition, public-sector budget

constraints have frozen funding. Thus, the public sector

agricultural research system is being challenged from

many directions. Whether the system can be revitalized

and renew its historical commitment to solve the problems of society, or whether it becomes isolated and loses

its credibility with the public remains to be seen. The

decade of the 1990s will be a period of significant change

within the agricultural research system.

CHANGING ENVIRONMENT FOR

AGRICULTURAL RESEARCH

The ability of the land-grant system to carry out its historic missions is becoming increasingly suspect. Internal

as well as external pressures could significantly alter the

structure and function of the system. Changing political

support, resource base, and institutional frameworks combined with the development of revolutionary new technologies will put presure on the system to change dramatically.

The Political Environment

Historically, political support for the agricultural research system has come primarily from the farm and rural

Table 16-2—Number of Farms in the United States,

Selected Years

Year Number of Farms

1900 . . . . . , . . . . . . . . . . . . . . . . . . . . . . . . .

1950 ., . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1960 . . . . . . . . . , ., . . . . . . . . . . . . . . . . . . .

1970 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1980 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1984 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1986 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

1989a . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5,737,000

5,382,000

3,963,000

2,949,000

2,433,000

2,328,000

2,214,000

2,172,920

a 1989 figures are preliminary.

SOURCE: U.S. Department of Agriculture, Agricu/tura/ Statistics, Washington, DC, various years,

population; as a result, agricultural research has placed

heavy emphasis on increasing the productivity of agriculture. However, agricultural’s traditional base of support has been eroding steadily. Farm numbers and

populations have been declining (table 16-2), and today

more than 75 percent of the total U.S. population resides

in metropolitan areas. Of the 435 members of the House

of Representatives, approximately 100 represent rural

districts and this proportion will decline with the new

redistricting in 1992 ( 12).

Public interest groups have become increasingly critical of the emphasis on productivity in agricultural research. Silent Spring (1) and Hard Tomatoes, Hard Times

(3) criticized the system for its failure to consider the

problems of rural communities, the environment, and

consumer needs. Environmental, consumer, and animal

welfare groups have become increasingly active in the

debates of recent Farm Bills. Additionally, these groups

have challenged the universities themselves by bringing

forward law suits on the use of public funds for productivity increasing research. For example, a law suit was

brought against the University of California system for

the development of a mechanical tomato harvester.

The changing demographics of the United States combined with the increased activism of a wider range of

constituents is indeed changing the climate in which the

land-grant system conducts research. The 1985 Farm Bill

contained several conservation measures, and many more

such measures were added in the 1990 Farm Bill. Several

environmentally oriented research initiatives, such as the

groundwater initiative and the low input sustainable agricultural initiative were also passed. Congress increasingly has earmarked agricultural research funds to help

the agricultural research system more quickly to adjust

to these new priorities. (See table 16-3. )

The political climate is changing at the State level as

well, as State agricultural income dwindles. In 1980,
412 . A New Technological Era for American Agriculture

Table 16-3-State Agricultural Experiment Station

Funds From Special Grants, Selected Years

(in millions of dollars)

Year Special grants

1982 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12.9

1984 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15.8

1986 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19.9

1987 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21.8

1988 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23.2

1989 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29.1

1990 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39.6

SOURCE: Cooperative State Research Service, Inventory of Agricultural

Research, U.S. Department of Agriculture, Washington, DC,

various years.

nearly 29 percent of nonmetropolitan counties received

at least one-fifth of their total income from farmingrelated industries. That number had dropped by 1986 to

21 percent and it continues to decline (2). During past

recessions, State support for the land-grant system generally has remained strong, but during the last 2 years,

as State budgets have become severely constrained, support for the land-grant system has wavered. Not only is

funding not increasing, in many States it is actually declining. Thus, for the first time since World War 11, the

University of Minnesota received a cut in its operational

budget; faculty salaries were frozen for 2 years. Additionally, proposals were introduced in the State legislature to have students pay the full cost of their resident

instruction (11 ). Other State universities are facing similar situations.

The Resource Base

Although total research funding for the State Agricultural Experiment Stations (SAES) has increased slightly

over the last decade (table 16-4), in general agricultural

research is underfunded. The States provide the majority

of the funding for research at the SAES, and through the

1980s, State support increased by 58 percent. (See tables

16-4 and 16-5.) However, the recession of the early 1990s

has constrained State budgets, resulting in few increases

and in some cases declining State support for agricultural

research.

The USDA is the second largest single contributor to

SAES research funding. Historically, USDA funding has

been in the form of a block grant formula funds. Decisions concerning allocation of these funds have been

made at the local level. USDA funding has basically

stagnated and barely keeps up with inflation. Increases

in USDA funding primarily reflect congressional earmarking of special grants for such areas as water quality,

nutrition, and integrated pest management and biological

control research.

In response to widespread criticisms of the agricultural

research system, a major new funding initiative was undertaken in 1977 to establish a USDA competitive grants

program. Competition for funding is open to researchers

from both the land-grant and non-land-grant universities

and research laboratories. Today, grants are awarded in

plant and animal systems; natural resources and the environment; human nutrition, food quality, and health;

markets, trade, and policy; and development of new

products. Funding for the program was $15 million in

1978, rising to $39.7 million in 1989. Partly as a result

of a National Research Council proposal to strengthen

agricultural research, allocations of the competitive grant

program rose to $97 million for 1992. However, funding

per grant is small relative to other Federal agency grant

programs.

Researchers within the SAES also can compete for

competitive grants from other Federal agencies such as

the National Institutes of Health (NIH) and the National

Science Foundation (NSF). Competitive grant funding

from such agencies to the SAES researchers and projects

increased by 83 percent between 1982 and 1989, and

now represents about 10 percent of total SAES research

funding.

Funding from the private sector has increased by 60

percent since 1982 (table 16-5). Private sector funding

comes from industry or from the sale of products by the

university. Currently these sources of income represent

less than 9 percent of the total funding. Analysts speculate that industry-supported research is not likely to

continue growing at such a high rate, as many researchintensive industries are reducing their own in-house research budgets. However, funding likely will be available

for selected research programs that are expected to yield

high payoffs. The product sales category also is a potentially lucrative source of funding for universities. Legal and institutional changes, which will be discussed

later in this chapter, have made it easier for universities

to capitalize on their research. Income from product sales

rose only 6 percent between 1982 and 1986, but increased

33 percent between 1986 and 1989.

Research funds are not evenly distributed to all experiment stations (table 16-6). The experiment stations

in 12 States (California, Florida, Iowa, Illinois, Indiana, Michigan, Minnesota, North Carolina, Nebraska,

New York, Texas, Wisconsin) account for nearly 49

percent of the total research funding available to the

SAES, nearly 69 percent of the USDA competitive
Chapter 16—Institutional Change Within the Land-Grant System ● 413

Table 16-4-Research Funds for State Agricultural Experiment Stations, Selected Yearsa

(in millions of dollars)

USDA Other Product

Year USDAb

competitive FederaldStatee

Industry sales Otherf Total

1982 . . . . . . . . . . 161.3 5.5 77.8 522.2 57.0 58.5 70.0 952.3

1984 . . . . . . . . . . 174.9 6.1 81.7 591.4 64.1 61.3 79.8 1,059.3

1986 . . . . . . . . . . 174.4 11.9 110.8 704.3 78.1 62.9 89.8 1,232,1

1987 . . . . . . . . . . 175.6 16.8 114.9 732.5 87.4 68.4 104.2 1,299.8

1988 . . . . . . . . . . 187.0 19.3 115.0 770.0 91.2 77.8 114.1 1,374.2

1989 . . . . . . . . . . 194.0 21.9 130.4 827.6 101.2 82.4 132.1 1,489,6

1990 . . . . . . . . . . 203.6 20.0 143,9 877.9 113.8 91.6 145.7 1,596.5

a Funds are for State Agricultural Experiment Stations only and do not include the 1890 universities, the Schools of Veterinary Medicine, or the Forestry

Schools. Funding is in current dollars.

bUSDA includes Hatch, Mclntyre-Stennis, Special Grants, Evans-Allen, Animal Health, and miscellaneous other funds administered by the Cooperative

State Research Service.

c USDA competitive is the USDA competitive grants program.

‘Other Federal includes funding from Federal agencies excluding USDA and includes funding from NIH, NSF, AID, DOD, DOE, NASA, TVA, HHS, PHS, etc.

‘State is State appropriations.

fOther includes funding from nonprofit organizations, and contracts and cooperative agreements administered by USDA.

SOURCE: Cooperative State Research Service, Inventory of Agricultural Research, U.S. Department of Agriculture, Washington, DC, various years.

Table 16-5—Distribution of Research Funds by Source for State Agricultural Experiment Stations,

Selected Yearsa

(in percent)

USDA Other Product

Year USDAb

competitive Federald

StateeIndustry sales Otherf Total

1982 . . . . . . . . . . 16.9 0.6 8.2 54.8 6.0 6.1 7.4 100

1984 . . . . . . . . . . 16.5 0.6 7.7 55.8 6.1 5.8 7.5 100

1986 . . . . . . . . . . 14.2 1.0 9.0 57.2 6.3 5.1 7.3 100

1987 . . . . . . . . . . 13.5 1.3 8.8 56.4 6.7 5.3 8.0 100

1988 . . . . . . . . . . 13.6 1.4 8.4 56.0 6.6 5.7 8.3 100

1989 . . . . . . . . . . 13.0 1.5 8.8 55.6 6.7 5.6 8.8 100

1990 . . . . . . . . . . 12.8 1.3 9.0 55.0 7.1 5.7 9.1 100

‘Due to rounding, the total figure may not add to 100 percent.

bUSDA includes Hatch, Mclntyre-Stennis, Special Grants, Evans-Allen, Animal Health, and miscellaneous other funds administered by the Cooperative

State Research Service.

c USDA competitive is the USDA competitive grants program,

‘other Federal includes funding from Federal agencies excluding USDA and includes funding from NIH, NSF, AID, DOD, DOE, NASA, TVA, HHS, PHS, etc.

e State is State appropriations,

fOther includes funding from nonprofit organizations, and contracts and cooperative agreements administered by USDA.

SOURCE: Cooperative State Research Service, Inventory of Agricultural Research, U.S. Department of Agriculture, Washington, DC, various years.

grants, 61 percent of all competitive funds obtained

from Federal agencies other than the USDA, and nearly

59 percent of all funding from industry support and

product sales. The State Agricultural Experiment Station system clearly contains ‘‘have and have not’ institutions. The ‘‘have not’ institutions rely primarily

on the traditional sources of funding (State and USDA

formula funds), while the “haves” have diversified

their funding sources.

The agricultural research system employs at least

23,000 PhD-level agricultural scientists, of which nearly

10,000 are employed in academia (table 16-7). Another

65,000 doctoral scientists who work in academia, may

be conducting research applicable to agricultural problems. Of those research scientists employed in academia in applied agricultural disciplines, approximately 27 percent received their PhDs in fields other

than applied agriculture. Sixteen percent received their

doctoral degree in an agriculturally related basic science such as molecular biology, plant pathology, genetics, microbiology, and biochemistry, and 6 percent

received their doctoral degrees in some natural science

field such as mathematics, computer science, chemistry, or physics (table 16-8). Approximately 5 percent

of academic researchers working in applied agricultural

fields received their doctoral degrees in the social sciences and engineering. The percentage of academic

agricultural researchers receiving their doctorate degrees in an agriculturally related basic science is lower

than for agricultural researchers employed by other

sectors of the economy.
414 . A New Technological Era for American Agriculture

Table 16-6—Research Funds for 12 Largest State Agricultural Experiment Stations, 1989

USDA Otherc

USDAacompetitive Federal Stated Privatee Otherf Total

Total funding for 12 SAESg

($ million) . . . . . . . . . . . . . . . . . 69.4 15.0 80.0 399.8 107.5 58.0 724.6

Percent of total funding by

source . . . . . . . . . . . . . . . . . . . . 9.6 2.1 11.0 55.2 14.8 8.0 100.0h

Percent of total SAES funding

captured by 12 SAES . . . . . . 35.8 68.5 61.3 48.3 58.5 43.9 48.6

0 USDA includes Hatch, Mclntyre-Stennis, Special Grants, Evans-Alien, Animal Health, and miscellaneous other funds administered by the Cooperative

State Research Service.

bUSDA competitive is the USDA competitive grants program.

Cother Federal includes funding from Federal agencies excluding USDA and includes funding from NIH, NSF, AID, DOD, DOE, NASA, TVA, HHS, PHS,

etc.

‘State is State appropriations.

e Private includes industry support and product sales.

‘Other includes funding from nonprofit organizations, and contracts and cooperative agreements administered by USDA.

9States include California, Florida, Iowa, Michigan, Minnesota, New York, North Carolina, Texas, Wisconsin, Indiana, Illinois, Nebraska.

‘Due to rounding, the total figure may not add to 100 percent exactly.

SOURCE: Cooperative State Research Service, Irwentov of Agricultural Research, U.S. Department of Agriculture, Washington, DC, various years.

Table 16-7—Doctoral Level Scientists by Employment Sector, 1985

Employment sector AcademiaaIndustryb Government Total

Applied agriculture . . . . . . . . . . . .

Animal . . . . . . . . . . . . . . . . . . . . .

Plant and soil . . . . . . . . . . . . . . .

Food . . . . . . . . . . . . . . . . . . . . . . .

Natural resources and

environment . . . . . . . . . . . . . .

Other . . . . . . . . . . . . . . . . . . . . . .

Agricultural economics . . . . . . . . .

Agricultural related

basic science . . . . . . . . . . . . . . .

Biological science . . . . . . . . . . . . .

9,900

2,500

3,200

700

2,000

1,500

1,900

31,300

34,600

7,000

1,100

1,300

1,800

2,000

900

300

9,600

10,700

3,800

300

800

200

2,100

300

400

5,000

5,300

20,600

3,900

5,300

2,700

6,100

2,700

2,700

45,900

50,600

aEmployment in academia does not include post doctorates.

bEmployment in i~ust~ includes those who are self-emPloYed.

cThe distinction between basic and applied is somewhat arbitrav in that scientists employed in applied agricultural fields may be conducting basic research

while those employed in agriculturally related basic science may be conducting applied research.

SOURCE: National Research Council, Educating the Next Generation of Agricultural Scientists, Washington, DC, 1988.

Table 16-8—Distribution of Applied Agricultural Scientists by Employment Sector

and Doctorate Field, 1985

(in percent)

Field of doctorate All sectors Academia industry Government

Applied agricultural sciencea . . . . . . . . . . . . . . . . . . . . . . 61 73 50 50

Agriculturally related basic scienceb . . . . . . . . . . . . . . . . 20 16 22 24

Other natural Sciencec 

. . . . . . . . . . . . . . . . . . . . . . . . . . . 13 6 8 10

Otherd . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 5 8 10

aAppliecf agricultural sciences include animal breeding and genetics; animal husbandry, science, and nutrition; veterinary science; agronomy and soil; plant

breeding and genetics; soil sciences; other plant sciences; horticulture and hydrobiology; food science and technology; fish and wildlife; forest~; environmental

sciences; hydrology; agricultural engineering; and general agriculture.

bAgflcultu@y re[at~ basic scien~s include bimhemistry; biophysics and biometrics; ecoiogy; Cytobgy and embryology; mOlecular biology; 9enetics;

bacteriology and microbiology; plant genetics; plant pathol~y; plant physiology; botany; immunology; nutrition and dietetics; animal physiology; and zoology.

@ther natural sciences include fields such as biological sciences not Ilsted above, health sciences, computer sciences, mathematics, chemistry, geology,

physics, meteorology, etc.

‘Other includes engineering; psychology, social scientists, humanities, and education.

SOURCE: National Research Council, Educating The Next Generation of Agricultural Scientists, Washington, DC, 1988.
Chapter 16—lnstitutional Change Within the Land-Grant System . 415

Concerns have been raised that the physical plant of

the universities has deteriorated. Many laboratories at

land-grant universities are old. Equipment, in many instances is obsolete and the cost of procuring new equipment to conduct new types of research, such as

biotechnology, is rising. This has been remedied to some

degree by the development of research centers. In addition to providing an environment for multidisciplinary

research, they allow for the sharing of expensive equipment and other laboratory needs for personnel conducting

similar types of research. Such centers, however, are not

the complete answer to this problem.

The Technology Base

To continue to perform high-level research, universities

need to keep abreast of new information and technologies.

New biotechnologies and information technologies in particular are yielding powerful research tools that can be

applied to questions in a wide range of scientific disciplines.

Effective use of these technologies will require new funding. or a reallocation of funding from traditional research

projects. The scientists who use these new research tools

will need a thorough grounding in the basic scientific disciplines that underlie biotechnology and information technology.

The allocation of resources (funding and research personnel) for research classified as biotechnology1 at the

SAES has been increasing (table 16-9). The primary

funding sources for such research are USDA and other

Federal agency competitive grants. and private industry

(table 16- 10). It is likely that significant funds also arise

from the licensing of technologies, royalties, and product

sales.

The same 12 SAES that capture most agricultural research funds also are able to capture the majority of the

resources devoted to biotechnology research (table 16-

1 1). Indeed, the concentration of resources in only a few

experiment stations is even more pronounced for biotechnology than for all agricultural research. Twelve experiment stations capture nearly 64 percent of all

biotechnology funding available to the SAES and more

than 65 percent of all competitive grant and private sector

funding. These same stations also receive more than 72

percent of the “other” funds, which includes product

sales. Additionally. the distribution of biotechnology

funding by source differs for these 12 stations relative

to the other SAES. They rely on competitive grants and

private-sector funding for at least 40 percent of their

biotechnology funding; only 17 percent of their total agricultural research funding comes from these sources.

Biotechnology research requires a thorough knowledge of agriculturally related biological and natural sciences. However, only about 16 percent of agricultural

scientists working in academia received their PhDs in

the basic disciplines underlying this new technology (i. e..

molecular biology. genetics, microbiology. etc. ) (See

table 16-8). Furthermore. most SAES do not include

many of these more basic disciplines as part of the training of agricultural scientists. Thus, many agricultural

researchers in academia lack formal training in the disciplines that underlie biotechnology. The same is true

for advanced computer technology research.

Advanced computer applications have been used in

agriculture for less than 10 years. Consequently, there

is a shortage of scientists who understand and are capable

of applying these technologies to agricultural problems.

Existing personnel with these attributes are recently graduated PhD students and faculty who have taken a sabbatical leave to study this area, and they number less

than 20 (4). Intensive training programs are needed to

prepare researchers for the public and private sectors.

Such training should consist of domain specific subject

matter, computer science topics, and system design. Universities with identifiable agricultural programs in advanced computer applications include: Cornell University,

Virginia Polytechnic Institute and State University. Purdue University, Texas A&M University, University of

Illinois, University of Idaho, University of Kentucky,

Pennsylvania State University, Mississippi State University, and North Carolina State University. However,

each of these programs is narrowly focused.

The development of advanced computer technology

relevant to agriculture is impeded by funding and a

professional reward system in SAES that does not support

the development of computer systems. Research in agriculture traditionally has been classical biological research whereby a researcher States a hypothesis and

1 Biotechnology is first and foremost a set of tools and techniques. It is sometimes arguwt that resources are being shifted from other discipliner}

activities into biotechnology research to the detriment of these other fields. Indeed, increased funding and \cienti\t years (full-time equitalent~) for

biotechnology could mean that those resources are being taken away from other research programs. Hwmrer, [hat is not the only plausIblc

explana[lon. Because biotechnology is a tool, rather than an end in itself. increased resources for biotechnology}’ research could also mean thtit the

tools of biotechnology rather than traditional tools are now being used to examine the same questions. Thu\, this rcwarch would now be cla~sificd

as biotechnology even though the research focus is the same. A much more extensive examination t~f how biotcchm~logy i~ being used is nwdtxi

to determine if resources are actually being shifted from other disciplines into biotechnology’.
——

416 ● A New Technological Era for American Agriculture

Table 16-9-SAES Resources Devoted to Biotechnology Research, Selected Years

Share of total FTE Funds Share of total funds

Year Projects FTEa

(percent) (million$) (percent)

1982 . . . . . . . . . . . . . . . . . . . . . . . . . 571 273.5 4.5 40.8 4.7

1986 . . . . . . . . . . . . . . . . . . . . . . . . . 1,043 487.5 8.0 89.6 8.2

1988 . . . . . . . . . . . . . . . . . . . . . . . . . 1,360 681.9 11,1 131.3 10.6

‘Full-time equivalent.

NOTES:Data is for 41 stationss responding to survey.

Stations not included are Alabama, Alaska, Connecticut, Delaware, District of Columbia, Idaho, Nevada, New Mexico, North Dakota, Pacific Territories,

Virgin Islands, Vermont, Wyoming.

The 1984 survey was different from the other three and not completely compatible.

SOURCE: National Association of State Universities and Land Grant Colleges, Division of Agriculture, Committee on Biotechnology, “Emerging Biotechnologies in Agriculture: Issues and Policies, ”Progress reports I thru Vlll, November, 1982–1989.

Table 16-10—SAES Biotechnology Research Funds, Selected Years

USDA Other

Year USDA competitive Federal State Private Other Total

1982 . . . . . . . . . . . . . . . . .

1986 . . . . . . . . . . . . . . . . .

1988 . . . . . . . . . . . . . . . . .

Funds by Source

(in million dollars)

5.1 NC 14.6 16.2 4.9 NC 40.8

0.6 7.1 20.9 38.0 9.5 3.5 89.6

8.3 10.0 27.6 55.2 14.0 6.2 31.3

Distribution of Funds by Source

(as percent of total SAES biotechnology funds)

USDA Other

Year USDA competitive Federal State Private Other Total

1982 . . . . . . . . . . . . . . . . . 12.5 NC 35.8 39.7 12.0 NC 100

1986 . . . . . . . . . . . . . . . . . 11.8 7.9 23.3 42.4 10.6 3.9 100

1988 . . . . . . . . . . . . . . . . . 13.9 7.6 21.0 42.0 10.7 4.7 100

NC = Not collected

NOTES: Data is for 41 States responding to the survey.

Stations not included are Alabama, Alaska, Connecticut, Delaware, District of Columbia, Idaho, Nevada, New Mexico, North Dakota, Pacific Territories,

Virgin Islands, Vermont, Wyoming.

The 1984 survey was different from the other three and not completely compatible.

SOURCE: National Association of State Universities and Land Grant Colleges, Division of Agriculture, Committee on Biotechnology, “Emerging Biotechnologies in Agriculture: Issues and Policies, ” Progress reprots I thru Vlll, November, 1982-1989.

Table 16-11—Biotechnology Research Funds for 12 Largest State Agricultural Experiment Stations, 1966°

USDA Other

USDA competitive Federal State Private Other Total

Total funding (million $) . . . . . . . . . . . 9.96 6.48 18.58 34.70 9.47 4.50 83.69

Distribution of biotech funds by

source (percent) . . . . . . . . . . . . . . . . 11.9 7.7 22.2 41.5 11.3 5.4 100.0

Share of total biotech funds (percent) . . . . . . . . . . . . . . . . . . . . . . . . . . 54.5 64.9 67.4 62.9 67.7 72.1 63.8

a

12 SAES include California, Florida, Iowa, Indiana, Illinois, Michigan, Minnesota, Nebraska, New York, North Carolina, Texas, Wisconsin.

Data for total funding does not include the stations of Alabama, Alaska, Cmwcticut, Delaware, Districe of Columbia, Idaho, Nevada, New Mexico, North

Dakota, Pacific Territories, Virgin Islands, Vermont, Wyoming.

SOURCE: National Association of State Universities and Land Grant Colleges, Division of Agriculture, Committee on Biotechnology, “Emerging Biotechnologies in Agriculture: Issues and Policies, ” Progress reports I thru Vlll, November, 1982-1989.

conducts an experiment to test it. Research in computer by domain experts and computer scientists and cannot,

systems does not easily lend itself to this approach and in general, be performed by a single scientist. Multidistraditional agricultural journals are reluctant to publish ciplinary development efforts currently cannot be adearticles on computer application. Research in advanced quately recognized solely through publications. In fact,

computer applications require a multidisciplinary effort the end result of most computer-related research projects
Chapter 16—Institutional Change Within the Land-Grant System ● 417

is a marketable product not a manuscript. And, advanced

computer applications are perishable. Once a system is

developed, it will generally require regular maintenance

to ensure that the information and knowledge are current.

Consequently, there exists a perception, especially among

conservative faculty, that advanced computer technology

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service

Biotechnology research requires a thorough knowledge

of agriculturally related biological and natural sciences.

Only 16 percent of agricultural scientists working in

academia received PhDs in basic disciplines underlying

this new technology.

Photo credit: U.S. Department of Agriculture,

Agricultural Research Service

Development of advanced computer technology relevant

to agriculture is impeded by funding and a professional

reward system in State Agricultural Experiment Stations

that does not support the development of

computer systems.

research does not represent an appropriate topic for academic professionals. This technology will challenge traditional institutional arrangements.

The Legal Environment

The legal environment in which the agricultural system

operates is changing. As discussed in chapter 15, Congress has for the past 60 years expressly permitted intellectual property protection of new plants. Since 1980,

the U.S. Patent and Trademarks Office has interpreted

patent laws to cover not only plants but also microorganisms and animals as patentable subjects ( 14). The

Patent and Trademark Amendments (Public Law 96-517,

1980 and amended in 1984) gave universities, other nonprofit organizations, and small businesses the option,

with few exceptions, to retain the title rights to any federally funded inventions that they developed. The same

rights were extended to large businesses by executive

order ( 14). Legislation has also been enacted to facilitate

technology transfer between Federal laboratories and industry. The Stevenson-Wydler Technology Innovation

Act of 1980 (Public Law 96-480) provides Federal laboratories with a mandate to undertake technology transfer

activities, while the Technology Transfer Act of 1986

(Public Law 99-502) created an organizational structure

to meet this mandate.

The changing legal environment in which the agricultural system operates is changing the system itself.

Universities are creating new structures to take advantage

of these “legislated” opportunities. Until recently, only

a few institutions (i. e., the Massachusetts Institute of

Technology and Stanford University) aggressively marketed the research of their faculty, primarily by licensing

their technology to the private sector. Now, however,

other universities are establishing venture capital pools,

technology development companies, and research companies with the goal of transferring technology and making money.

Universities have usually patented their inventions, so

patenting per se does not represent a significant change.

And not surprisingly, the universities receiving the most

patents are generally larger, research intensive institutions (table 16-12), Among those universities receiving

the most patents in 1989, six are land-grant universities.2

As discussed previously, the sale of products by the SAES

2

The six land-grant universities are Massachusetts Institute of Technology, which does not have a SAES, and the University of California, the

University of Florida, Iowa State University, the University of Minnesota, and the University of Wisconsin, which do have SAES. Patent figures

are for the whole university, and not exclusively the SAES.
418 ● A New Technological Era for American Agriculture

The patent awarded to Stanley Cohen and Herbert Boyer in 1980. This patent has since become Stanford

University’s top earning patent ($1.7 million annually).

United States Patent [191 [11] 4,237,224

Cohen et al. [45] Dec. 2, 1980

[54]

[75]

[73]

[21]

[22]

[63]

[51]

[52]

[58]

[56]

PROCESS FOR PRODUCING

BIOLOGICALLY FUNCTIONAL

MOLECULAR CHIMERAS

Inventors:

Assignee:

Appl. No.:

Filed:

Stanley N. Cohen, Portola Valley;

Herbert W. Boyer, Mill Valley, both

of Calif.

Board of Trustees of the Leland

Stanford Jr. University, Stanford,

Calif.

1,021

Jan. 4, 1979

Related US Application Data

Continuation-in-part of Ser. No. 959,288, Nov. 9, 1978,

which is a continuation-in-part of ser. No. 687,430,

May 17, 1976, abandoned, which is a continuation-inpart of ser. No. 520,691, Nov. 4, 1974.

Int. Cl. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .C12P 21/00

U.S. Cl. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 435/68; 435/172;

435/231; 435/183; 435/317; 435/849; 435/820;

435/91; 435/207; 260/1 12.5 S; 260/27R; 435/212

Field of Search . . . . . . . . . . . . . . 195/1, 28 N, 28 R, 112,

195/78, 79; 435/68, 172, 231, 183

References Cited

U.S. PATENT DOCUMENTS

3,813,316 5/1974 Chakrabarty . . . . . . . . . . . . . . . . . . . . . 195/28 R

OTHER PUBLICATIONS

Morrow et al., Proc. Nat. Acad. Sci. USA, vol. 69, pp.

3365-3369, NOV. 1972.

Morrow et al., Proc. Nat. Acad. Sci. USA, vol. 71, pp.

1743-1747, May 1974.

Hershfield et al., Proc. Nat. Acad. Sci. USA, vol. 71,

pp. 3455 et seq. (1974).

Jackson et al., Proc. Nat. Acad. Sci. USA, vol. 69, pp.

2904-2909, Oct. 1972.

Mertz et al., Proc. Nat. Acad. Sci. USA, vol. 69, pp.

3370-3374, NOV. 1972.

Cohen, et al., Proc. Nat. Acad. Sci. USA, vol. 70, pp.

1293-1297, May 1973.

Cohen et al., Proc. Nat. Acad. Sci. USA, vol. 70, pp.

3240-3244, NOV. 1973,

Chang et al., Proc. Nat. Acad. Sci, USA, vol. 71, pp.

1030-1034, Apr. 1974.

Ullrich et al., Science vol. 196, pp. 1313-1319, Jun.

1977.

Singer et al., Science vol. 181, p. 1114 (1973).

Itakura et al., Science vol. 198, pp. 1056-1063 Dec.

1977.

Komaroff et al., Proc. Nat. Acad. Sci. USA, vol. 75, pp.

3727-3731, Aug. 1978.

Chemical and Engineering News, p. 4, May 30, 1977.

Chemical and Engineering News, p. 6, Sep. 11, 1978.

Primary Examiner— Alvin E. Tanenholtz

Attorney, Agent, or Firm-Bertram 1. Rowland

[57] ABSTRAC T

Method and compositions are provided for replication

and expression of exogenous genes in microorganisms.

Plasmids or virus DNA are cleaved to provide linear

DNA having ligatable termini to which is inserted a

gene having complementary termini, to provide a biologically functional replicon with a desired phenotypical property. The replicon is inserted into a microorganism cell by transformation. Isolation of the transformants provides cells for replication and expression of

the DNA molecules present in the modified plasmid.

The method provides a convenient and efficient way to

introduce genetic capability into microorganisms for

the production of nucleic acids and proteins, such as

medically or commercially useful enzymes, which may

have direct usefulness, or may find expression in the

production of drugs, such as hormones, antibiotics, or

the like, fixation of nitrogen, fermentation, utilization of

specific feedstocks, or the like.

14 Claims, No Drawings

SOURCE: Office of Technology Liensing, Stanford Unversity
Chapter 16—institutional Change Within the Land-Grant Systerm ● 419

Table 16-12—Universities Receiving the Most

Patents, 1989

Massachusetts Institute of Technologya . . . . . . . . . . . . . . . 102

University of Californiaa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81

California institute of Technology . . . . . . . . . . . . . . . . . . . . . 59

University of Texas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57

Stanford University . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

University of Floridaa . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

University of Minnesotaa . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41

Iowa State Universitya . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

University of Wisconsina . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Johns Hopkins University . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

*Land-grant universities.

SOURCE: Association of University Technology Managers, 1991

increased from $58.5 million in 1982 to $83.4 million

in 1989.

What is different is that universities now have title to

the patent rights, even if the research was federally funded.

Thus, universities now own pieces of or are otherwise

involved with new ventures that invest in and commercialize the new technologies they developed. Universities, in some cases, seethe new ventures as a means of

establishing closer cooperation with private companies,

ultimately with the goal of inducing the private sector to

contribute research funding to the university, of facilitating the transfer of the technology, and of helping faculty to see the relevance of their work to real world

problems. In addition, the researchers who create the

new technology are now often given a share of the returns. Some examples help to illustrate the new arrangements.

Iowa State University has a research budget of over

$110 million annually and conducts over 2,500 research

projects. The goal of the university is to create new

businesses and generate new revenue and new jobs. Emphasis is being given to biotechnology. The university

keeps track of all research and helps obtain patents when

needed. It has even built a pilot manufacturing plant to

test a new innovation and eventually hopes to entice a

private company to provide capital for an expanded operation ( 1 1).

The Southwestern Medical Center at the University of

Texas has established a for-profit company with $12.5

million in equity from a private venture capital firm and

individual investors. The center retains a stake in the

company and expects to share any profits (11). Other

approaches include establishing joint projects with other

institutions. The University of Chicago and the Argonne

National Laboratory have created a not-for-profit corporation that will develop and market inventions produced by scientists at the two institutions. The Universities

Table 16-13—USDA Agricultural Research Service

Technology Transfer Activities, 1987-1990

1987 1988 1989 1990

Number of patents

awarded . . . . . . . . . . . 34 28 47 42

Royalties from licenses

(in thousand dollars) 85 97 418 567

Number of active

CRADAS , . . . . . . . . . 9 48 86 104

Value of active

CRADAS (in million

dollars) ... , ... , . . . . 1.6 8.7 15.6 18.9

SOURCE: Data provided by staff of USDA Agricultural Research Service,

Office of Cooperative Interactions, 1991.

of Texas and Chicago are not land-grant universities, but

the types of institutions described could serve as a model

for the development of similar institutions at the landgrant schools.

Federal research laboratories also are responding to

the new incentives, and to congressional wishes that they

do a better job of transferring their research results to

the private sector. The USDA Agricultural Research Service (ARS) has entered into 104 Cooperative Research

and Development Agreements (CRADAS) with private

industry valued at nearly $19 million. Additionally, ARS

patents its research findings and in 1990, received $567,000

from royalties on licenses issued (table 16-13).

ISSUES RAISED BY THE NEW

ENVIRONMENT

The changing environment in which the agricultural

research system operates raises three main issues for the

system:

1. What is the appropriate allocation of existing resources’?

2. Who decides what the appropriate allocation is?

3. How is the system to be structured to effectively

achieve the desired allocation’?

As indicated by the high rates of social return to agricultural research investments, the system as a whole

has not been funded at optimum levels, and there is a

general need for more research funding. However, increased research funding is not sufficient to achieve desired results. Funds also need to be reallocated from

current projects to research that reflects new needs. The

appropriate allocation of resources will depend primarily

on what society wants the system to accomplish. Resources cannot be allocated appropriately unless priorities

are determined and goals established.
420 ● A New Technological Era for American Agriculture

Land-grant universities differ from other universities

in that they have a legislated mission to address research

to the problems of society. Some argue that the landgrant system has, at least to some extent, already abandoned its mission, as researchers increasingly work for

the laurels of their disciplinary peers rather than society’s

benefit. Others argue that the system defines society’s

problems too narrowly and places too much emphasis on

increasing agricultural productivity and too little on nutrition, environmental, and rural problems. Some also

argue that too much attention is given to production agriculture and not enough on postharvest technologies,

value-added products, consumer preferences, and agribusiness problems.

There are no easy answers as to what types of research

should be conducted with public funds. What is clear,

however, is that as the traditional clientele (i.e., farmers)

continues to shrink, greater demands will be placed on

the system to address the needs of other groups. Difficult

choices must be made concerning the mix and prioritization of research.

Historically, decisions on how research funds were allocated were made at the local institutional level. This

approach was because most funds were awarded to institutions as block grant formula funds. The institution, with

input from local clientele, determined how the funds should

be administered. However, competitive grants, from USDA

and other Federal agencies are an increasing component of

total funding, and these grants are awarded to individual

researchers or projects. Project proposals reflect the individual researchers personal interests and views of social

needs. Decisions concerning which proposals are awarded

grants are made by peer review at the national level.

The shift toward greater reliance on project funding

(competitive grants) rather than institutional funding (formula funds) is an attempt to induce greater responsiveness of the State system to national priorities. Additionally,

the wider competition increases the pressure to perform

and be more productive. However, these goals must be

balanced against the potential losses that come from not

being part of a larger mission and attentive to local needs

and from the potential lack of continuity that might come

from a competitive grants program ( 11). Additionally, it

is argued that competitive grants may shift the research

focus from solving society’s problems to short-term projects, the results of which are more readily publishable

in peer reviewed journals.

An increase in research funds from the private sector

has raised a great many concerns. The actual extent of

private sector-public university collaboration is unknown, but university administrators suspect that it is

not yet extensive. Industry funding of research at the

SAES comprises about 6.5 percent of total funding, and

that share has not dramatically increased over the past

decade. Industry support of biotechnology research is

higher than for agricultural research in general, but even

in this area, funding from industry represents about 11

percent of total funding.

Industry support for university research is not expected

to continue growing rapidly. Private firms are decreasing

their own research budgets and may not have the money

to spend on university research. The biotechnology industry appears to be undergoing the long expected shakeout, with many smaller, dedicated biotechnology firms

consolidating, retrenching, or going out of business. The

large firms that likely will remain major players in the

area of biotechnology research have now developed their

own in-house research capacity. Industry financing of

university research will be directed toward specific fields

that industry feels will be most beneficial to them, and

may be leveling off.

The changes in the legal environment combined with

constrained research budgets provide many incentives for

universities to increase funding through product sales.

This potential privatization of public sector research raises

many issues. Product sales currently represent only 5.5

percent of total research funding, but whereas growth

potential in other sources of funding seem limited, there

is a possibility of high growth in revenue from the sale

of university inventions.

Incentives to privatize the benefits of university innovations for the benefit of the university rather than

society could conflict with the mandated mission of the

university. Using public resources to reap private gains

raises many ethical questions. The situation of allowing

individual researchers to share in the profits of their work,

even if it was publicly funded, and of encouraging universities to produce consumer products opens the door

to potential abuses.

Certainly there is potential for conflicts of interest if

universities and individual researchers are allowed to capture the returns of their innovations. To some extent, this

same issue is raised when researchers use public funds

to generate new knowledge that can be sold to the private

sector in the form of consulting fees. But there is a

distinction between providing expertise to potentially

multiple clients and having a vested interest in the development of one or several products by companies. The

credibility of a university may suffer if it is viewed as
Chapter 16—institutional Change Within the Land-Grant System .421

being too cozy with industry. An interesting dilemma

may arise for a university if its researchers identify significant hazards with a product or technology that generates profits for the university, or for a company with

which the university collaborates. If public universities

prioritize their own private good above the public welfare, the public may not maintain its support for the

university. On the other hand, given the underinvestment

in agricultural research as a whole, the additional revenue

from product sales could provide great benefits for the

university and society. Whether or not the funds are used

for desirable purposes will depend on how well university

administrators provide leadership to maintain a sense of

priority for the overall research and teaching mission,

and whether they have the administrative skills to allocate

resources to the proper ends.

Channeling more resources to innovative activities from

which private return can be reaped may alter the focus

of research. There could be a shift in the research mix

from research that is a public good to that which will be

attractive to industry. University research potentially could

shift from long-term research to more short-term projects

that are likely to have quick payoffs. There is also concern that changes in intellectual property rights will cause

universities to change the focus of their research. Results

of a preliminary analysis (5) suggest that intellectual

property rights do influence the amount of resources devoted to specific commodity research in universities (i. e.,

universities do allocate more resources to research on

commodities where they can get Plant Variety Protection

Act certificates and capture some of the returns to their

research). Results suggest, however, that universities do

not direct more public sector funding to commodity research supported by industry funding. The agricultural

research system often is criticized for focusing too much

attention on basic research and little on development and

adaptive research to solve social problems; a shift toward

practical technologies and products may be perceived by

some as a positive outcome.

One of the underlying principals of scientific research

is the free exchange of research results. Concern has

arisen that if research begins to generate income, it could

become more proprietary. The free exchange of germ

plasm between individual researchers and countries may

be inhibited as germplasm owners seek to profit from

that germplasm. Moreover, research results may be exchanged less freely, or exchanged only after the researcher, university, or industry supporting the research

attempts to patent the results or seeks additional privatesector funding. The growing tendency of researchers to

announce their results via press release rather than in

peer-reviewed journals may also, at least to some extent,

be an attempt to attract the attention of private industry

and to enhance the opportunity of obtaining private funding for further work. One unfortunate fallout of these

activities is to confuse a public that has little understanding of scientific issues, and thus to diminish the credibility of scientific research.

Concern also has been expressed that the potential for

financial rewards will lead to the exploitation of graduate

students by faculty advisers. If, for example, students

are directed toward research designed to benefit a particular company or are not allowed freely to publish their

research results, their future employment opportunities

could suffer.

Finally, it is likely that only some universities will

benefit from collaborations with the private sector. The

same universities that receive the bulk of the publicsector funding also attract the most private-sector funding, patent the most innovations, and receive the largest

revenue from the sale of products. As the costs of maintaining university programs continue to rise, then only

schools that can attract private revenue may be able to

continue to maintain a full research, teaching, and extension function. Smaller universities most likely will

need to reorganize and cooperate on a regional basis to

maintain research programs. Neither Federal formula funds

nor competitive grants nor State funding mechanisms are

designed to accommodate cooperative institutional arrangements.

RESEARCH TO EVALUATE

IMPACTS OF THE NEW

ENVIRONMENT

The above discussion has been based on possibilities

and speculation. There is little information available on

what changes actually are occurring at the SAES as a

result of the changing research environment. No comprehensive data exist on the present extent of collaboration between the public and private sector; on the nature

of existing arrangements; or on the amount and uses of

revenue generated from such arrangements and how that

revenue is being used. Data also do not exist on how

additional revenue is being used to support socially desirable but underfunded research, or to support teaching

activities. It is unknown to what extent existing university-private sector arrangements create additional economic activities. Any discussion of these issues is based

on speculation and anecdotes—u more rigorous analysis

is needed.
422 . A New Technological Era for American Agriculture

Likewise, little is known about how increasing reliance

on competitive grants is impacting agricultural research.

It is widely presumed that the research supported via a

competitive grant mechanism is of higher quality than

that funded by formula funds, and that greater reliance

on competitive grants increases productivity. However,

it is also possible that competitive grants distort the research mix favoring disciplinary research over problemsolving research.

Little research has been conducted to determine the

productivity of the different funding mechanisms. However, recent research completed by OTA and the University of Minnesota suggest that the most appropriate

policy is a mixture of formula and competitive grants,

with different funding mechanisms potentially more appropriate for different functions and goals of land-grant

universities ( 19).

The data set used to analyze the productivity of different funding mechanisms is a subset of agricultural

research at SAES. This subset is for fiscal year 1986

research projects that are receiving at least some funding

from USDA and at least some portion of the research

project involves using the tools of biotechnology. The

biotechnology data set was chosen because trends that

seem to be occurring within land-grant universities appear to be magnified in the area of biotechnology research. Therefore, whatever is occurring in that subset

of research may be indicative of future changes in other

fields of agricultural research. The data set includes research funded by Hatch grants, USDA Competitive grants,

and Other grants which include State grants, Evans-Allen

grants, Animal Health grants, and McIntyre-Stennis grants

(i.e., formula funds somewhat analogous to Hatch funds).

Data was obtained from the Cooperative Research Information System (CRIS) and includes publications as

reported by the principal investigators

Output is measured by publications including peer reviewed journal articles (published articles, abstracts, articles in press, and articles submitted), experiment station

bulletins, and graduate student degrees. These types of

publications were chosen because they can be used as

measurable proxies to represent the research, teaching,

and extension missions of the land-grant system. Quality

of published peer reviewed journal articles was measured

by the number of citations the article received. Citations

are not a perfect measure of quality, but are widely used.4

Findings from this research suggest that different types

of publications are more likely to be funded by different

sources. (See table 16- 14. ) The actual number of journal

articles per grant did not differ significantly by funding

source, however, articles published from research funded

by competitive grants were cited much more frequently

than research articles funded by other mechanisms. Also,

competitive grants provide funding for fewer years and

generally are for lower levels of funding than Hatch grants,

suggesting that for cutting-edge research, competitive

grants are more productive and of higher quality. However, Hatch funding supports more research students, and

generally produces a higher number of experiment stations bulletins, which are geared to be more useful to

farmers and others in the industry and may be more

representative of adaptive research than are many journal

articles.

The conclusion suggested by these results is that different funding mechanisms may be more appropriate for

different goals of the university system. If the goal is to

increase cutting-edge research, competitive grants might

best be emphasized. If the primary goal is to enhance

research applicable to problem solving (more development and adaptive research and technology transfer) or

to train future researchers, the more stable and locally

controlled Hatch funds may be the more appropriate

mechanism. The appropriate allocation of the two types

of grants depends on the priority given to the multiple

missions of the experiment stations. However, developing mission priorities is not a simple task. Research

‘The total number of grants have been normalized to account for the fact that while all projects were being funded in FY 1986, some projects

received their initial funding in that year while others had been funded for several years. For example, for Hatch grants and other grants, over 50

percent of the projects received initial funding prior to 1985. For competitive grants, only 25 percent of the grants had received initial funding prior

to 1985. Previous research has shown that it generally takes about four years of funding before significant levels of output can be expected (8).

However given the recent nature of biotechnology research, significant levels of funding did not exist prior to 1982. This is why 1986 and 1987

publications were chosen as the data set. However, for many of the projects funding had not occurred for four years. It is unreasonable to expect

a research project which has been funded for one year to produce as many articles as one which has been funded for several years and the grants

were normalized to account for this difference. (The actual normalization equation was as follows: (grants in 1982) + 4/5(grants in 1983) + 3/

5(grants in 1984) + 2/5(grants in 1985) + l/5(grants in 1986). )

4Citations indicate that other researchers have read and used the work. However, not all citations may be positive. Additionally, review articles

are likely to be sighted more often than other types of articles. It is also possible that an article is of high quality, but is in a field that not many

other researchers are working, and therefore the number of citations may not be a g~ measure of the quality of the afiicle. It may also be the

case that an article is cited only by the author of the article (self cites). One might argue that the research was useful in furthering the work of the

author, but that may not represent input into other researcher’s work. Citations were corrected by subtracting self-citations.
Chapter 16—Institutional Change Within the Lund-Grant System ● 423

Table 16-14—Mean Values of Selected SAES Output

by Grant Type

Hatch Competitive Other

Citations per articlea . . . . 1.70 3.98’ 1.82

Articles per grant . . . . . . 2.47 2.14 2.24

Weighted articles per

grantb 

. . . . . . . . . . . . . . 4.83 8.33f4.74

Journal publications per

grantc . . . . . . . . . . . . . . . 4.70 4.52 3.68

Weighted publications

per grantd

. . . . . . ... , 7.07 10.62g6.58

Degrees per grant . . . . . 0.45’ 0.18 0.25

Bulletins per grant . . . . . 0.35 0.09’ 0.28

a Articles are articles published m peer reviewed journals

b Weighted articles are pubhshed articles weighted by cltatlons

c Journal pubs are pubhshed articles, articles submitted, articles m press,

and abstracts in peer rewewed Journals.

d Weighted pubs are articles submitted, articles m press, and abstracts In

peer reviewed journals, and published articles weighted by cltatlons

e Slgniflcantly different from other two groups at 950/. confidence level

‘ Slgnlficantly different from other two groups at 940/0 confidence level

9 SlgfllflCafltly different from other two groups at 920/. confidence level.

SOURCE: Mane Walsh, “Factors Affecting the Cost and Productwlty of

Biotechnology Research at the State Agncuitural Experiment

Stations”, PhD thesis, Unwerslty of Minnesota, In progress.

is needed to analyze what sort of institutional structure

can best involve all relevant clientele in priority and goal

setting for SAES.

POLICY OPTIONS

ISSUE: The new partnership between the public- and

private-sectors potentially can revitalize agricultural research, but could also bias the overall research endeavor and destroy the credibility of

universities. Research and close monitoring will be

needed to understand the changes occurring within

the land-grant system and to ensure that they are

not undermining the system as a whole.

Option: Congress could require the U.S. Department

of Agriculture to monitor the increased private-sector

funding of agricultural research and to prepare an

annual report to Congress containing the data.

Currently, little is known about the extent of privatesector funding at land-grant universities and the nature

of the relationship between the universities and the private sector. Congress could provide oversight of this

situation by periodically conducting oversight hearings.

Furthermore, Congress could request that USDA collect

data from the land-grant universities on the extent of

public-private collaboration, prepare an annual report to

Congress containing the data, and provide guidelines on

the appropriateness of various public- private-sector research collaborations.

Option: Congress could direct USDA to require landgrant universities to establish an explicit policy with

regard to research sponsored by the private-sector

and report that policy to Congress.

The USDA would require each university using private-sector research funds for agriculture to establish a

policy as to how those funds are used. Establishing an

advisory board that includes members of the public in

setting spending priorities for the funding of research

from the private sector might be an effective mechanism.

This would help to increase the confidence of the public

that the university is using these funds to solve problems

that confront society.

Option: Public-sector support of social science research

could be increased.

Understanding the complex institutional changes occurring in the public agricultural research system will

require increased social science research. Currently, social science research is underfunded by the public sector,

and it is highly unlikely that the private sector will support

this kind of research. Lack of social science research

may constrain the ability of the land-grant system effectively to understand and the control the changes that are

occurring and to address the problems of society as its

mission dictates.

ISSUE: High rates of return to public-sector investments have been reported by numerous studies.

This a clear indication that public-sector research

funding is below socially optimum rates.

Option: Congress could increase public-sector support

of agricultural research.

Increasing public-sector support of agricultural research might help to lessen the pressure on land-grant

universities to try and obtain funds from the private sector. Given the high rate of return on public-sector funding

of agricultural research, increased funding is a good investment for the future.

Option: Congress could maintain or decrease publicsector funding for agricultural research.

Federal funding for agricultural research has been relatively flat for the last 30 years. As a consequence States

have picked up the increased costs of conducting agricultural research. It is difficult for States any longer to

take on an ever increasing share of public supported

research. If the Federal Government continues to shrink

from its partnership with the States in the funding of
424 ● A New Technological Era for American Agriculture

research, land-grant universities have no choice but to

look for alternative sources of funding. Private-sector

funding from specific industries or individual firms or

product sales from technologies developed by the university are the most likely sources of additional research

funds. The impact of this shift in support is unknown

and needs further analysis.

ISSUE: Land-grant universities have been and are

now rapidly developing into “have and have not”

universities. In this situation it is difficult for the

"have not" universities to individually fulfill their

historic responsibilities.

Option: Congress could increase Federal funding for

multiregional projects as opposed to institutional or

individual funding.

There is nothing magic about State Boundaries, yet

they have defined agricultural research problems since

the inception of the research system. Most cultural problems and solutions, however, are more appropriately defined within and across geographic regions. Universities

would be better able to collaborate on common agricultural problems or to specialize in certain areas for the

region where they have a critical mass of expertise. The

major disadvantage is State leaders accepting this concept

after so many years of expecting their university to provide the research, teaching, and extension to solve their

problems and provide education.

Option: Congress may wish to allow the States to find

their own solutions to this growing problem.

The States would have the major responsibility for

finding a solution. This could be in the form of increased

funding to the university to provide at least minimal

services in all traditional activities eliminating some activities and reallocating those funds to high priority activities or working with other States to jointly determine

activities suitable for cooperation. However, if the decision is to work with other States the Federal Government could be an obstacle by placing a constraint on the

proportion of Federal funds that can be used for regional

projects.

ISSUE: Recent research indicates that public sector

funding mechanisms should be goal oriented.

Option: Congress could appropriate funds for agricultural research through funding mechanisms based

on well-defined goals.

The land-grant system provides teaching, extension,

and research functions. Preliminary research indicates

that Hatch formula are more conducive to teaching

and extension activities and competitive grants more conducive to basic research. By appropriating funds via goals

to be achieved, Congress could improve the effective use

of public funds.

Option: Congress could maintain the current emphasis

of increased funds for competitive grants and level

or decreased funding of formula and intramural funds.

Implicitly, this would indicate that Congress places.

greater emphasis on basic research than on adaptive research, extension, and teaching activities. Evidence does

not exist that the lack of basic research is the primary

constraint to the ability of land-grant universities to fulfill

their historic mission of addressing research aimed at

serving societal problems.

Option: Congress could extend competitive grants to

extension and teaching curriculum development.

A strong case can be made for formula funding of

agricultural research. However, if politically the only

acceptable form of increased funds is competitive grants,

then expanding these grants to also include adaptive research, extension, and teaching could be considered. Balanced funding of basic research, adaptive research,

teaching, and extension would significantly strengthen

the land-grant universities and help them meet their multiple missions more effectively.

Option: Congress could award some competitive grants

to basic research that ties successfully into adaptive

research.

This would be a clear signal that Congress considers

the original mission of land-grant universities to be appropriate today. Currently, most grants for basic research

are not tied directly to adaptive research. Thus, it is

difficult to differentiate between funding provided by the

National Science Foundation (the major funding agency

for basic research) and the U.S. Department Agriculture

(a major funding agency for mission-oriented adaptive

research).

ISSUE: The public is increasingly losing confidence

in land-grant universities. Credibility needs to be

restored. Development of a more mission-oriented

system with increased public input would help to

restore confidence in the system.
Chapter 16—Institutional Change Within the Land-Grant System ● 425

The OTA report Agricultural Research and Technology Transfer Policies for the 1990s (15) addresses this

issue in some detail and provides specific options that

suggest changes in the system to make it more mission

oriented. Those options are incorporated here by reference. Some of the options were incorporated into the

1990 Food, Agriculture, Conservation, and Trade Act of

1990 (1990 Farm Bill).

ISSUE: Few professional benefits exist for conducting

adaptive and multidisciplinary research or to effectively communicate the purpose of university research to the public. Continuing focus on basic,

disciplinary research that is communicated only to

peers enhances the public’s perception that research is irrelevant and undermines the public willingness to support such research.

Option: Land-grant universities could develop professional rewards for researchers conducting adaptive

or multidisciplinary research.

A change at land-grant universities to reward researchers for adaptive or multidisciplinary research and those

that communicate well the purpose and results of research

to the public will be difficult to achieve. In many universities, determination of reward criteria goes beyond

research administrators to include faculty committees,

which in many cases have the last word on the university’s reward criteria. And, faculty who comprise these

committees are, for the most part, basic scientists. Until

such time that these committees’ composition is changed

or their power diminished, it will be difficult for any

change to occur. The only leverage available is through

those that control research funding. Thus, more strings

could be attached to Federal grants that provide incentives for adaptive research, multidisciplinary research,

and communication of results. This is especially crucial

for research in advanced computer technologies. This

promising area will continue to languish unless changes

are made to reward researchers in these other areas in

addition to basic research.

Option: Land-grant universities could maintain the status quo by continuing to provide the highest professional awards for basic research.

In the short run this option will be the path of least

resistance. But in many ways, it will be costly in the

long run. Following this course leads to the fundamental

question of the difference between a land-grant university

and any other university. Why should the public uniquely

support universities that provide a product no different

from other universities? If there is no difference then it

is difficult to provide a rationale for the special public

funding provided to land-grant universities. Indeed, such

funding is to be used by the university to provide a service

to society that is unique.

ISSUE: Advances in the application of advanced computer technologies require establishing this field of

research as a priority. Currently, research in this

area relies on ad hoc funding from numerous scientific disciplines and weak ties to basic computer

science and the private sector. Research for advanced computer systems requires a nontraditional

approach and multidisciplinary teams that include

computer scientists, traditional production-oriented scientists, business, marketing, and policy

specialists, and system designers.

Option: Congress could establish nationally recognized

centers of excellence for advanced computer technology research.

The Federal Government, States, and the private sector

could jointly establish centers of excellence at various

land-grant universities. These centers would involve the

various university departments that comprise SAES,

computer science, the business school, etc. The center

concept has worked well in other major technological

areas such as biotechnology. It provides a focus for research with continuity. A drawback is the lack of incentive for faculty, especially young, untenured faculty, to

participate in multidisciplinary research.

Option: Congress could establish this area as a priority

with increased funding to land-grant universities.

Funding would be available through various types of

grants much like other scientific disciplines. To enhance

the multidisciplinary effort, grant applications could be

required to contain a strong adaptive component conducted by a multidisciplinary team. However, this is still

an ad hoc approach. A project investigator (PI) must

convince scientists in other disciplines that it is in their

best interest to be a part of the project. Even if the PI is

successful there is no guarantee of any continuity of

interest. Once the project is completed, team members

go back to their respective disciplines. Also, as mentioned above, it would be difficult to entice young, untenured faculty to participate. At best this approach is

only a step above the current situation.

297-937 0 - 92 - 15 QL 3
426 ● A New Technological Era for American Agriculture

1.

2.

3.

4.

5.

6.

7.

8.

9.

10.

11,

CHAPTER 16 REFERENCES

Carson, Rachel, Silent Spring (New York, NY:

Houghton-Miffin, 1962).

Hady, T. and Ross, P., “An Update: The Diverse

and Economic Structure of Nonmetopolitan America, ’ Staff Report No. AGES 9036, U.S. Department of Agriculture, Economic Research Service,

May 1990.

Hightower, Jim, Hard Tomatoes, Hard Times,

Schenkman, Cambridge, MA, 1973.

Jones, L., Cornell University, personal communication, December 1991.

Knudson, M. and Pray, C., “Plant Variety Protection, Private Funding, and Public Sector Research

Priorities, ” American Journal of Agricultural Economics, vol. 73, August 1991, pp. 882–886.

National Research Council, Educating the Next Generation of Agricultural Scientists (Washington, DC:

Board on Agriculture, National Academy of Sciences, 1988).

National Research Council, Investing in Research

(Washington, DC: Board on Agriculture, National

Academy of Sciences, 1989).

Pardey, P., “Public Sector Production of Agricultural Knowledge, ” unpublished Ph.D. Thesis, University of Minnesota, 1986.

Pray, Carl and Neumeyer, Catherine, “Impact of

Technology Policy on Private Research in the Agricultural Input Industry, ” American Journal of Agricultural Economics 71( December 1989).

Ruttan, Vernon W., Agricultural Research Policy,

The University of Minnesota Press, Minneapolis,

1982.

Schuh, E. G., “Privatization of Agricultural Research at Land Grant Universities, ’ commissioned

12.

13.

14.

15.

16.

17.

18.

19.

background paper prepared for the Office of Technology Assesment, 1991.

Scott, J., Rural Policy Research Institute, personal

communication, April 1992.

U.S. Congress, General Accounting Office, U.S.

Department of Agriculture, Interim Report on Ways

to Enhance Management, GAO/RCED-90- 19

(Gaithersburg, MD: U.S. General Accounting Office, October 1989).

U.S. Congress, Office of Technology Assessment,

New Developments in Biotechnology: Patenting L#e—

Special Report, OTA-BA-370 (Washington, DC: U.S.

Government Printing Office, April 1989).

U.S. Congress, Office of Technology Assessment,

Agricultural Research and Technology Transfer Policies: issues for the 1990s, OTA-F-448 (Washington, DC: U.S. Government Printing Office, March

1990).

U.S. Department of Agriculture, Cooperative State

Research Service, Inventory of Agricultural Research (Washington, DC: U.S. Government Printing

Office, 1991).

U.S. Department of Agriculture, Agricultural Research Service, Office of Cooperative Interactions,

data compiled by staff from budget reports for various years, 1991.

U.S. Department of Agriculture, Agricultural Research Service, Agricultural Research Service Program Plan, 1992–1998 (Washington DC: Government

Printing Office, 1992).

Walsh, M., “Factors Affecting the Cost and Productivity of Biotechnology Research at the State Agricultural Experiment Stations, ’ PhD Thesis,

University of Minnesota, in progress.
Appendixes
Appendix A

Glossary of Acronyms

ABRAC

AEAES

APHIS

ARS

BATF

BBEP

BITNET

BRS

BSAC

BSCC

CBA

CBI

CFSAN

COC

COMAX

CROPS

—Agricultural Biotechnology Research

Advisory Committee (USDA-OAB).

—Agricultural Financial Analysis Expert

System. A computer system combining

a spreadsheet, program calculator, and

expert systems to assist farmers with

financial planning and analysis;

developed by Texas A&M University

—Agency for International Development

—Agricultural Marketing Service

(USDA)

— . Animal and Plant Health Inspection

Service (USDA)

—Agricultural Research Service (USDA)

—Bureau of Alcohol, Tobacco and

Firearms

—Biotechnology, Biologics and

Environmental Protection Division

(USDA-APHIS)

—A national network of interlined

mainframe computers

—Biotechnology Research

Subcommittee (FCCSET); successor to

BSCC

—Biotechnology Science Advisory

Committee (EPA)

—Biotechnology Science Coordinating

Committee (interagency); succeeded by

BRS

-Committee on Biotechnology in

Agriculture (USDA-OAB)

-Confidential Business Information.

Protected information, the disclosure of

which could damage a firm’s

competitiveness

-Cooperative Extension Service (USDA)

-Center for Food Safety and Applied

Nutrition (FDA)

-Council on Competitiveness (executive

branch)

-Cotton Management Expert System.

An expert system developed by the

USDA that uses a simulation model of

cotton production to project when to

irrigate and fertilize to optimize

agronomic goals

-Crop Rotation Planning System. A

computer program developed at

Virginia Tech to assist with farm-level

or field-level planning

-Center for Veterinary Medicine (FDA)

DHI —Dairy Herd Improvement. A national

data recording system developed for

the dairy industry; provides centralized

databases from which expert systems

can be built

EA —Environmental Assessment

EBC —Environmental Biosafety Committee

(EPA)

EC —European Community

EPA —Environmental Protection Agency

ERS —Economic Research Service (USDA)

ESA —Ecological Society of America

EUP —Experimental Use Permit

FCCSET —Federal Coordinating Council on

Science, Engineering and Technology

FDA —Food and Drug Asministration

FD&C (FDCA) —Food, Drug and Cosmetic Act

FOIA

FONSI

FS

FSIS

GAO

GATT

GRAS

IBC

LISP

NAS

NEPA

NBIAP

NMFS

NOAA

NOEL

NRC

—Federal Insecticide, Fungicide, and

Rodenticide Act

—Federal Meat Inspection Act

—Freedom of Information Act

—Finding of No Significant Impact (from

an Environmental Assessment)

—Forest Service

—Food Safety and Inspection Service

(USDA)

-General Accounting Office

-General Agreement on Tariffs and Trade

-Generally Regarded as Safe. Status

granted to substances that are

acceptable as human foods or as

ingredients in human food, as

determined by qualified experts based

on a safe history of use in food prior to

1958; or based on published scientific

information

—Institutional Biosafety Committee

—List Processing. A high-level computer

programming language used in

artificial intelligence applications

—National Academy of Science

—National Environmental Policy Act

—National Biological Impact

Assessment Program (USDA-CSRS)

—National Institutes of Health

—National Marine Fisheries Service

—National Oceanic and Atmospheric

Administration

—No Observable Effect level (refers to

dosages of pesticide fed to test animals)

—National Research Council

429 -
430 ● A New Technological Era for American Agriculture

NSF

OAB

OECD

OMB

OPP

ORA

OSTP

OTS

PMN

—National Science Foundation

-Office of Agricultural Biotechnology

(USDA)

- -“on for Economic

Cooperation and Development

-Office of Management and Budget

-Office of Pesticide Programs (EPA)

-Office of Regulatory Affairs (FDA)

-Office of Science and Technology

Policy

-Office of Technology Assessment

-Office of Toxic Substances (EPA)

—Premanufacture Notice. Requested by

EPA for Commercial R&D involving

field-test releases of genetically

engineered microorganisms;

compliance is voluntary

PPA

PPIA

PVPA

RAC

SAES

TSCA

UCC

UPOV

USDA

WHO

—Plant Patent Act

—Poultry Products Inspection Act

—Patent and Trademark Office

—Plant Variety Protection Act

—Recombinant DNA Advisory

Committee (NIH)

-State Agricultural Experiment Stations

(USDA)

—Toxic Substances Control Act

—Universal Copyright Convention

—International Union for the Protetion

of New Varieties of Plants

—United States Department of

Agriculture

—World Health Organization
Appendix B

Glossary of Terms

Acetolactate Synthase (ALS): Enzyme essential for

plant growth; the target site in pest plants for many new

herbicides known as ALS inhibitors.

Algorithm: An unambiguous step-by-step procedure for

solving a problem or modeling a process; commonly

used as fundamental parts of computer programs.

Allelochemicals: Herbicides produced by plants.

ALS inhibitor: Herbicides that attack target plants by

binding to and inactivating the ALS enzyme essential

for plant growth.

Amino acid: Any of a group of molecules linked together

in various combinations to form proteins. Specific

sequences of amino acids makeup all known proteins,

with each unique sequence coded for by DNA.

Antibody: Protein produced by specific white blood cells

(i.e., B lymphocytes) in response to the presence of

foreign antigens in the body.

Antigen: Any substance that elicits a defensive (immune)

response.

Antisense technology: A technique for eliminating or

reducing the expression of a gene in an organism, thus

enabling scientists to study the organism’s physiology

and development.

Arthropods: A phyllum of invertebrate animals that

includes spiders, mites, and ticks; insects; centipedes

and millipedes; and crustaceans (shrimp, barnacles,

crabs).

Assay: Experiment, test or analysis.

Augmentation approach (to biological pest control):

Increasing an existing population of indigenous pest

enemies by periodically releasing small numbers of

these natural enemies, or by releasing large numbers of

these enemies at one time.

Bacillus thuringiensis (Bt): A spore-forming bacterium

that produces insecticidal proteins. Different strains of

Bt produce proteins toxic to different insects. Through

genetic engineering, the insecticidal genes from different Bt strains have been incorporated into other

organisms, including plants, which then produce the

corresponding Bt toxin.

Bacteria: A diverse and ubiquitous group of one-celled

organisms that lack a distinct nuclear membrane.

Bacteriophage: A virus whose host is a bacterium.

Beltsville pig: A pig, developed through research at the

USDA in Beltsville, MD, into which extra growth

hormone genes were inserted. The Beltsville pig

provides a clear example of biotechnology that compromised an animal’s well-being-the pig grew fast

but became lame and lethargic, developed degenerative joint disease and a variety of other disorders, and

clearly was under stress.

Biological control (of pests): Use of living natural

enemies to reduce pest populations.

Biopesticides: Organisms or products containing organisms that are pesticidal in nature; used for the

biological control of pests.

Biotechnology: Techniques, including recombinant DNA

techniques, that use living organisms or substances

from those organisms to make or modify a product, to

alter the characteristics of plants or animals, or to

develop microorganisms for specific uses.

Bolistic method (of gene transfer): A vectorless method

of transferring genes using a particle gun to shoot

high-velocity, DNA-coated microprojectiles into a

plant cell.

Bovine somatotropin (bST): See Somatotropin.

Broad leaf herbicides: Herbicides that attack broad leaf

plants or DICOTYLEDONS; will not harm grass

plants (monocotyledons) such as corn.

Broad spectrum herbicide: Herbicide that can kill

broad-leaf weeds as well as grasses.

Cell culture: The growth and maintenance of cells

derived from multicellular organisms under controlled

laboratory conditions. A sample of cells propagated in

this way.

Cellular techniques (for genetic modification of

plants): Use of tissue cell cultures to genetically

modify plants, e.g., hybridization of two sexually

incompatible plants via cell fusion.

Chromosome: A thread-like structure (of DNA molecules) carrying the genes that convey hereditary

characteristics; in mammals chromosomes are contained in cell nuclei.

Classical approach (to biological control of pests):

Generally involves searching the area of a pest’s origin

for its natural enemies and introducing these enemies

into the environment in which the pest is to be

controlled.

Classical techniques (for genetic modification of

plants): Generally refers to the use of traditional plant

breeding to develop plants with certain desired characteristics, such as insect or disease resistance, improved

harvestability, cold tolerance, etc.

Clone: A group of genetically identical cells or organisms

produced asexually from a common ancestor.

Community ecology: The study of the interactions of

populations of different species in a habitat.

Computer network: A system of interconnected electronic channels linking computers over a wide area;

allow rapid dispersal and sharing of information

among computer users on the network

Copyright: The exclusive statutory right of authors,

composers, playwrights, artists, publishers, and distributors to publish and dispose of their works for a

specified period of time.

Coordinated framework for the regulation of biotechnology: The fundamental document that outlines the

431 –
432 ● A New Technological Era for American Agriculture

roles, responsibilities, and policies of the Federal

Agencies involved in biotechnology and its regulation;

and that sets forth premises for guiding future policy

(49 FR 50856-50907).

Cross-hybridization: The crossing of two plants of

different species to produce fertile offspring; a rare

phenomenon in nature.

Cultivar: A strain or variety of cultivated plant that is

distinguished from others by one or more characteristics reproduced in offspring.

Deliberate release: Refers to the purposeful introduction

of genetically engineered organisms to the environment, either in a small-scale field test or on a

large-scale commercial basis.

Depository: A facility that accepts, maintains, classifies,

and distributes cultures of microorganisms, viruses,

cells, and other biological material.

Dicotyledon: The class of plants distinguished by having

two seed leaves within the seed.

DNA (Deoxyribonucleic Acid): The molecular building

block of genes; repository of genetic information in all

organisms. The information coded by DNA determines the structure and function of an organism.

Domain knowledge: The knowledge base of a computer

program.

Ecological risk assessment: In the context of biotechnology, a prediction, based on available scientific evidence and experience, of how a genetically engineered

organism will behave in the environment after its

release. See also Risk assessment.

Electrophoresis: Technique by which an electric current

is used to separate molecules in a mixture.

Enzyme: Any of a group of proteins that mediate the

chemical processes of organisms without themselves

being destroyed or altered.

Estrus: The period during which a female animal is most

receptive to sexual activity.

Estrus cycle: Reproductive cycle; includes ovulation,

egg maturation, and the preparation of the uterus to

receive fertilized eggs. The cycle is under hormonal

control.

Evolutionary biology: Study of the changes overtime in

genotype and phenotype of populations.

Exotics: Species accidentally or deliberately released into

a completely new environment.

Expert system: Two-component computer program that

mimics the reasoning process of a human expert. The

knowledge-base component contains the expertise for

solving a problem, often in symbolic rather than

numeric form; the inference engine component tells

the program how to combine domain knowledge to do

the task at hand. Expert systems are examples of

knowledge-based systems.

Food additive: Any substance that becomes a component

of food, or affects the characteristics of food; in the

broadest sense, the definition would include new crop

varieties developed either through traditional breeding

or with biotechnology.

Food grades: Standards used to classify food products

according to certain quality characteristics. Use of

USDA grade standards is voluntary.

Full-text retrieval systems: A human-computer interface by which users can search a collection of

documents for relevant information; especially useful

for accessing a collection of documents by different

authors who may use different wording to express the

same thing.

Fungi: A group of simple plants without chlorophyll.

Gene: A discrete segment of a chromosome, made up of

an ordered sequence of DNA molecules; the basic

fictional unit of heredity.

Gene flow: The movement of genes in the environment.

See Gene transfer.

Gene probe: A molecule of known structure and/or

function used to locate and identify a specific region of

a genome.

Gene stability: A measure of the effectiveness and

persistence of a gene artificially introduced into an

organism.

Gene transfer: The movement of a gene between

different organisms. Natural processes of gene transfer

include processes such as transformation (cellular

uptake of naked DNA); transduction (virus-mediated

transfer of a gene between bacterial strains); conjugation (direct genetic exchange between two bacterial

cells); and pollen-mediated gene transfer. Concern

exists that a gene artificially introduced into an

organism with biotechnology could be passed to other

organisms by one or more of these gene transfer

mechanisms.

Genetic engineering: See Recombinant DNA.

Genome: The complete set of genetic material possessed

by each organism, which is carried and passed to

offspring in the germ (reproductive) cells.

Genotype: The hereditary makeup (genetic constitution)

of an individual organism, as distinguished from its

physical appearance (phenotype).

Grass herbicides: Herbicides that attack grass plants

(monocotyledons); will not harm broad leaf plants

(dicotyledons) such as soybeans.

Hardware (computer): The electronic and mechanical

components of a computer, including keyboard and

other input devices, the central processing unit, etc. In

contrast to software.

Herbicide-tolerant crops: Crops that can grow in the

presence of herbicides that destroy or harm nontolerant plants.

Hypertext: A method of connecting related information

multidimensionally, allowing access in a nonlinear

fashion; analogous to footnotes.

Ice-minus: A bacterium from which a functional gene

coding for a protein that promotes the formation of ice

crystals has been deleted.
Appendix Glossary of Terms .433

Indigenous organism: Organism native to an area;

opposite of exotic.

Inference engine: See Expert systems.

Integrated pest management (IPM): A diverse array of

pest control strategies, the integrated use of which is

based on ecological principles and knowledge. IPM

can be thought of as a crop management system

whereby pest populations are maintained at levels

below those causing economic crop loss. May include

pest scouting, biological control strategies, chemical

controls, crop rotations, etc.

Integrated system: A software system that allows users

to access different decision support tools in the same

environment. The tools accessed might be operationally independent (lowest level of systems integration)

or logically linked, allowing the user to go from one

application to another with the same user interface.

Intellectual property law: Statutes that protect works of

the mind as personal property; examples include

patent, copyright, trade secret, and plant variety

protection laws.

In vivo: Within the living organism.

In vitro: Outside the living organism and in an artificial

environment such as a test tube.

Ketosis: A metabolic disorder that occurs in dairy cows

when the need for glucose exceeds the production of

glucose.

Knowledge-based systems: Computer programs with

the capability of dealing with symbolic data and/or of

mimicing an expert’s reasoning process. See Expert

systems.

Land-grant system: An educational system established

in 1862 with the passage of the Morrill Act, which

made grants of land to States for creating universities

that would fulfill the mission of providing higher

education to the masses, with particular emphasis on

the children of farmers and industrial workers.

Large-scale release: See Deliberate release.

Mainframe computers: Large, centralized computers

with millions of logic circuits.

Marker genes: Genes coding for specific characteristics,

the expression of which is used to distinguish genetically transformed cells or plants from untransformed

cells or plants (i.e., antibiotic resistance genre).

Mastitis: An infection of the udder, the most common

and one of the most important diseases affecting the

milk cow.

Mathematical modeling: Construction of a mathematical framework to describe a process and predicts its

outcomes.

Mesocosms: Contained walk-in chambers, the environmental parameters of which can be controlled to model

ecosystems.

Microbial contamination (of foods): The presence/

growth of microbial organisms in food; some foodborne organisms are toxic and may cause human

illness or death.

Microbial herbicides: Microorganisms, or products

containing microorganisms that are pathogenic to

plant pests; used for the biological control of pests.

Microcomputers: Personal computers, sized for tabletop use.

Microcosm (Soil): A laboratory-based model ecosystem

designed to mimic and used to study natural environmental processes.

Microinjection: A technique used to insert genes from

one cell into another cell.

Microorganisms: Organisms that can be observed only

with the aid of a microscope, e.g., bacteria, viruses,

protozoans, some algae and fungi.

Molecular techniques: Refers here to the use of biotechnology to transfer selected genes between plant

species.

Monitoring: Spatial and temporal tracking of an object or

process. Monitoring of genetically engineered organisms and of their introduced genes contributes to risk

assessment and management, and expands ecological

databases.

Monoclinal antibodies: Identical antibodieses that recognize a single, specific antigen and are produced by a

clone of specialized cells.

Monocotyledon: The class of plants distinguished by

having one seed leaf within the seed.

Natural language interface: A human-computer interface that allows users to query a database and retrieve

relevant information using natural language rather

than, for example, a hierarchical menu system.

Nematodes: A phyllum of invertebrate roundworms.

Object-oriented simulation system: A type of knowledgebased system that explicitly models the structure,

rather than the behavior of a real system; each

component of the real system is represented in the

simulation by a unit (object) consisting of selfdescriptive data and procedures for manipulating that

data.

Organic food: A term that generally designates foods

produced without manufactured chemical inputs such

as pesticides and synthetic fertilizers; however, no

precise definition exists.

Patent: A grant issued by the U.S. Government that gives

the holder right to exclude all others from making,

using, or selling the patented invention within the

United States, its territories, and possessions during

the term of the patent

Pest resistance: Characteristic of certain crop cultivars

allowing them to tolerate pests that harm or destroy

nonresistant cultivars.

Pesticidal plants: Plants that are pathogenic and hence

resistant to one or more plant pests.

Pesticide residue: Trace amounts of pesticides in food

products; foods with pesticide residues above federally

determined tolerances cannot be marketed.

Phenotype: The physical characteristics of an organism.
434 . A New Technological Era for American Agriculture

Plant pest: Defined in the Federal Plant Pest Act as any

living stage of: any insects, mites, nematodes, slugs,

snails, protozoa or other invertebrate animals; bacteria, fungi, or other parasitic plants or reproductive parts

thereof; viruses, or any organisms similar to or allied

with any of the foregoing; or any infectious substances

that can directly or indirectly injure or cause disease or

damage in any plants or parts thereof, or of processed

manufactured or other products of plants.

Plasmnid: A circular piece of DNA found in the cytoplasm

(rather than in the chromosomes), and able to replicate

independently of the chromosomes. Bacterial plasmids

are used as vectors in techniques of genetic engineering.

Pleiotropic effects: Multiple changes in metabolism that

result from a single genetic change.

Polymerase chain reaction: An enzymatic process for

rapidly generating large amounts of genetic material

from a trace amount.

Population ecology: The study of the dynamics and

growth of populations.

Population genetics: The analytical study of the properties of genes and changes in gene frequency overtime.

Porcine somatotropin (pST): See Somatotropin.

Primary gene product: A protein directly coded for by

a gene; may be the final active product or may act as

an enzyme or hormone that mediates the production of

secondary gene products.

Prior art: That which is already known or available; one

of the criteria used in evaluating patent applications.

Promotors: Regulatory genes that control the functioning of other genes.

Protozoa: A phyhun of unicellular or acellular microorganisms widely distributed in aquatic and wet terrestrial habitats; includes many parasites.

Recombinant DNA: Abroad range of techniques involving the manipulation of the genetic material of

organisms, including technologies by which scientists

isolate genes from one organism and insert them in

another organism. The term is often used synonymously with genetic engineering, and to describe DNA

sequences isolated from and transferred between

organisms by genetic engineering techniques.

Restriction enzymes: Certain bacterial enzymes that

recognize specific short sequences of DNA and cut the

molecule at these sites; used to isolate specific genes

of interest.

Restriction fragment length polymorphism (RFLP): A

technique for mapping approximately where on the

genome a specific gene(s) of interest resides.

Risk assessment: A scientific analysis of the potential

risks and risk levels (quantitative or qualitative)

associated with a particular action; includes estimates

of possible health, environmental and other effects,

and of the degree of uncertainty in these estimates. See

also Ecological risk assessment.

Risk management: In this report, scientific and agronomic methods used to minimize the ecological risks

potentially posed by deliberate releases of genetically

modified organisms into the environment.

Robotics: Computerized machines that can be programmed to perform a variety Of labor-intensive tasks 

i,e., harvesting in agriculture.

Science-based regulations: Regulations (for genetically

engineered organisms) based on scientific assessments

of the risks posed by releasing such organisms into the

environment.

Secondary gene product: A compound the production of

which is mediated by primary gene products.

Sensor technology: Means by which some electronic

systems monitor the environment combined with

knowledge-W decision support systems, a potentially important management tool for fanners.

Small-scale field tests: See Deliberate release.

Software (computer): The programs and data in a

computer. In contrast to hardware.

Somatotropin: A protein hormone produced by the

mammalian anterior pituitary gland that affects growth

and other physiological processes (i.e., lactation in

dairy cows). Species limited Examples include human

somatotropin, bovine somatotropin, porcine somatotropin, and ovine somatotropin. Natural levels of

Somatotropins in agricultural animals can be elevated

using genetic engineering techniques to increase

production.

Suicide genes: Genes that effectively cripple or kill

recombinant DNA-modified organisms following their

intended use; a means of containing such organisms

such that they cannot become established and spread.

Superovulation: The shedding of abnormally large

numbers of eggs.

Systematic: The analysis of variation of different levels

of taxonomic organization, with the ultimate goal of

taxonomic classification; also used to monitor biotic

diversity.

Tissue culture: A technique in which portions of a plant

or animal are grown on an artificial culture medium.

Trade secret: Protection for information used in one’s

trade or business that provides a competitive business

advantage over those lacking the information.

Transgenic animal (plant crop): Animal (plant, crop)

whose hereditary DNA has been augmented by the

addition of DNA from a source other than parental

germplasm using genetic engineering techniques.

Vector: A carrier or agent used to introduce foreign DNA

into host cells. Plasmids, bacteriophages, and other

forms of DNA commonly are used as vectors in genetic

engineering.

Veterinary biologics: Living organisms or their parts

used by veterinarians to prevent *disease and/or

promote animal health, e.g., sera, vaccines, veterinary

growth hormones.
Appendix C

Commissioned Papers and Authors

This report and the three reports that complete this series were possible in part because of the valuable information

and analyses contained in the background papers commissioned by OTA. These papers were reviewed and critiqued by

the advisory groups, workgroups, and outside reviewers. The papers are available through the National Technical

Information Service.1

Emerging Animal Technology

Genetic Engineering in Animal Agriculture

Howard Bachrach

Southhold, NY

Bovine Somatotropin: Review of an Emerging Animal

Technology

Dale E. Bauman

Cornell University

An Emerging Agricultural Technology: Porcine

Sornatotropin

Terry D. Etherton

Pennsylvania State University

An Emerging Technology: Poultry Somatotropin

Colin Scanes

Cook College, Rutgers University

Effects of Beta-Agonists on the Food Animal Industry

Edward Veenhuizen and D.B. Anderson

Eli Lilly and Co.

Reproduction and Embryo Transfer William Hansel

Louisiana State University

Transgenic Poultry

John Kopchick

Ohio University

Transgenic Fish

Dennis A. Powers (Stanford University) and

Thomas T. Chen (University of Maryland)

Transgenic Swine

Vernon Pursel

U.S. Department of Agriculture

Transgenic Ruminants

Caird Rexroad

U.S. Department of Agriculture

Animal Health

Bennie I. Osburn

University of California

Antibiotic Growth Promotants

Gary L. Cromwell and Karl A. Dawson

University of Kentucky

Steroid-Like Growth Promotants

Rodney Preston

Texas Tech University

Environment and Animal Behavior

Stanley E. Curtis

University of Illinois

Agricultural Animal Welfare Issues

Andrew Rowan

Tufts University

Emerging Plant Technology

Genetic Engineering in Crop Agriculture

Robert Fraley

Monsanto Co.

Genetic Technology for Resistance to Insect Pests

Michael Adang and Lois Miller

University of Georgia

Genetic Modification for Weed Control

Ganesh Kishore

Monsanto Co.

Genetic Modification for Disease Resistance

Sue Loech-Fries

Purdue University

I ~mco~wio~ Papn wiu be available in the f~ of 1992 fi-om the National lkchnical Information service, S@@cl& V-4 22161, @k@o=

(703) 4874650.

Volume 2: A New ‘lWmological Era for American Agriculturc+OTA Commis sioncd Background Papers:

Part A: Emerging Animal ‘Mmology

Par& B: Emerging I%nt ‘bcbnology

Part C: Emerging Computer Whnology

Part D: Agricultural Rcscarc h and khnology Transfer

Part E: Food Safety and Quality

Part F: Economic and Policy Analysis

-435-
436 . A New Technological Era for American Agriculture

Biocontrol for Weeds

Raghavan Charudattan (University of Florida) and

Lloyd A. Andreas (U.S. Department of Agriculture)

Pathogens for Insect Control

James Fuxa

Louisiana State University

Use of Parasites and Predators to Control Insect and

Mite Pests in Agriculture

Marjorie Hoy

University of California

Microbial Biocontrol of Plant Diseases

Christen Upper and Susan S. Hirano

University of Wisconsin

Temperature and Water Stress

John Burke

U.S. Department of Agriculture

Plant Disease Management

J.A. Browning

Texas A&M University

Insect and Mite Management

George Kennedy

North Carolina State University

Evolution of Resistance by Weeds and Pests to Herbicides

and Pesticides

Fred Gould

North Carolina State University

Exchange of Genetic Material Between Genetically

Engineered Crops and Close Relatives

Carol Hoffman

University of Georgia

Emerging Computer Technology

Knowledge-Based Systems for Crops

Nicholas D. Stone

Virginia Polytechnic Institute and State University

Use of Expert Systems in Animal Agriculture

Michael Tomaszewski

Txass A&M University

Expert Systems for Business Decision Making

Steven T. Sonka

University of Illinois

Networks, Telecommunications, and Multimedia

Information Bases for Agricultural Decision Support

Jerry R. Lambert

Clemson University

Emerging Agricultural Technologies in HumanComputer Interactions

Lawrence R. Jones

Cornell University

Sensor Technology

Gerald W. Isaacs

University of Florida

Robotics and Intelligent Machines

Gaines E. Miles

Purdue University

Agricultural Research and Technology

Transfer

The Changing Budget Environment for Agricultural

Research and Technology Transfer

Susan Offutt

Office of Management and Budget

The Changing Technology Environment

William Marshall

Pioneer Hi-Bred International, Inc.

Agricultural Research Issues for the 1990s

Terry B. Kinney

York, SC

Technology Transfer Issues for the 1990s

Jerome Siebert

University of California

The Competitive Environment for Agricultural Research

and Technology Transfer

Luther Tweeten

Ohio State University

Alternative National Agricultural Research and

Technology Transfer Policies

Ronald Knutson

Texas A&M University

Privatization of Agricultural Research at Land Grant

Universities

Edward Schuh

University of Minnesota

Food Safety and Quality

Biotechnology in Food Processing in the 1990s

Susan Harlander

University of Minnesota

Scientific Information and Methodologies for Assessing

the Safety of Genetically Engineered Foods and Feeds

Ian Munro (Canadian Centre for Toxicology), Michael

Pariza (University of Wisconsin), and Kent K. Stewart

(Virginia Polytechnic Institute and State University)

Public Perceptions of Food Safety Risks: Implications for

Emerging Agricultural Technologies

Eileen vanRavenswaay

Michigan State University
Appendix C-Commissoned Papers and Authors ● 437

An Analysis of the Pork Grading System: Implications of

New Growth Promotants

James Kliebenstein, Marvin Hayenga, Lauren Christian,

Kenneth Prusa and Robert Rust (Iowa State University);

John Forrest, Allan P. Schinckel, and Max D. Judge

(Purdue University)

Assessing Federal Grade Criteria for Fruits and

Vegetables

Thomas Sporleder, Carl R. Zulauf, Rebecca Boerger,

Mark Bennett, James Hoskins, Eugene Jones, Timothy

Rhodus, Kurt Wiese

Ohio State University

Economic and Policy Analysis

Adoption of Bovine Somatotropin: A National and

Regional Analysis

J. Thomas McGuckin

New Mexico State University

National and Regional Impacts of Bovine Somatotropin

Adoption Under Alternative Dairy Program Policies

Derrell S. Peel

Oklahoma State University

Farm Level Impacts of Bovine Somatotropin Introduction

and Adoption Under Alternative Farm Policies

James W. Richardson

Texas A&M University

Farm Level Impacts of Porcine Somatotropin

Introduction and Adoption on Representative Grain-Hog

Farms in the Midwest

James W. Richardson

Texas A&M University
Appendix D

Acknowledgements

OTA would like to thank members of the advisory groups who helped guide the direction of this study and who

reviewed drafts or chapters of this report. OTA also acknowledges the following individuals for reviewing background

papers, reviewing report chapters, or providing information or illustrations to the project staff:

L.G. Adamss

Professor

Department of Pathology

Texas A&M University

Lois Adams

Director, Congressional Affairs

Food and Drug Administration

Emerson Babb

Professor

Department of Food and Resource Economics

University of Florida

R.L. Baldwin

Professor

Departmentent Animal Science

University of California

David Barbano

Professor

Food Science Department

Cornell University

Pat Basu

Technology Transfer and Coordination Staff

Food Safety Inspection Service

U.S. Department of Agriculture

Howard Beck

Assistant Professor

Department of Agricultural Engineering

University of Florida

Gary Beecher

Chief

Nutrient Composition Laboratory

Agricultural Research Service

U.S. Department of Agriculture

Fred Betz

Office of Pesticide Program

Environmental Protection Agency

William Boehm

Vice President, Grocery Procurement

The Kroeger Corp.

Ken Bondioli

Research Scientist

Granada Biosciences Corp.

Robert A. Bosseti

Amgen Inc.

Amgen center

Drion Boucias

Professor

Department of Entomology

University of Florida

R.D. Boyd

Associate Professor

Department of Animal Science

Cornell University

R.A. Bressan

Professor

Department of Horticulture

Purdue University

Robert Brown

Director

Commodity Price Analysis

Wilson Foods

Floyd M. Byers

Professor

Department of Animal Science

Texas A&M University

Tom Carr

Professor

Department of Animal Science

University of Illinois

Jim Cate

Cooperative State Research Service

U.S. Department of Agriculture

Jerry Caulder

Mycogen

William Chalupa

Professor

New Boltan Center

University of Pennsylvania

Ken Clayton

Deputy Administrator

Agricultural Marketing Service

U.S. Department of Agriculture

-438-
Appendix D—Acknowledgements .439

Robert K. Colwell

Professor

Department of Ecology and Evolutionary Biology

University of Connecticut

Joseph Conlin

Professor

Department of Animal Science

University of Minnesota

James Cook

Professor

Department of Plant Pathology

Washington State University

Lyman Crittenden

Regional Poultry Research Laboratory

Agricultural Research Service

U.S. Department of Agriculture

Anita Daniels

Photojournalist

Agricultural Research Service

U.S. Department of Agriculture

James Davidson

Director

Agricultural Experiment Station

University of Florida

Robert Davis

Professor

Food Science Department

University of Arkansas

B.N. Day

Professor

Department of Animal Science

University of Missouri

Peter Day

Director

Center for Agricultural Molecular Biology

Cook College, Rutgers University

Robin Douhitt

Professor

School of Family Research and Consumer Science

University of Wisconsin

Donald Epp

Professor

Department of Agricultural Economics

Penn State University

Bob Fields

Meat Merchandising

The Kroger Co.

Neal First

Professor

Department of Meat and Animal Science

University of Wisconsin

David Fischhoff

Monsanto

Harry Fong

Professor

College of Pharmacy

University of Illinois

John Forrest

Professor

Department of Animal Science

Purdue University

George P. Georghiou

Professor

Department of Entomology

University of California

John B. Gerrish

Associate Professor

Department of Agricultural Engineering

Michigan State University

David Giamporcaro

Section Chief, Biotechnology Project

Office of Toxic Substances

Environmental Protection Agency

James Gillette

Director

ICET

Cornell University

David Glass

D. Glass Associates

Alan Goldhammer

Director of Technical Affairs

Industrial Biotechnology Association

Bob Granados

Boyce Thompson Institute

Cornell University

Temple Grandin

Assistant Professor

Department of Animal Sciences

Colorado State University

Kevin Guise

Professor

Department of Animal Science

University of Minnesota

Harold D. Hafs

Vice President

. Animal Science Research& Development

Merck Sharp & Dohme Research Laboratories

R.C. Harrell

Associate Professor

Department of Agricultural Engineering

University of Florida
—..——

440 ● A New Technological Era for American Agriculture

Kriton Hatzios

Professor

Department of Plant Pathology, Physiology,

and WA Science

Virginia Polytechnic Institute and State University

Don Holt

Director

Agricultural Experiment Station

University of Illinois

Kathy Hudson

Senior Policy Analyst

Department of Health and Human Services

John E. Hunter

Section Head Biotechnology

The Procter & Gamble Co.

Miami Valley Laboratories

Susanne Huttner

Director

University of California System-wide Biotechnology

Research and Education Program

Molecular Biology Institute

University of California

Chris J. Johannsen

Director

Laboratory for Applications of Remote Sensing

Purdue University

James Jones

Professor

Agricultural Engineering Department

University of Florida

N.A. Jorgensen

Associate Dean

College of Agriculture and Life Sciences

University of Wisconsin

Robert Kalter

Professor

Agricultural Economics

Cornell University

Robert Kauffman

Professor

Muscle Biology Labratory

University of Wisconsin

Kenneth Keller

Senior Fellow

Council on Foreign Relations

Robin Kline

Director of Consumer Affairs

National Pork Producers Council

Carol Kramer

Economic Research Service

U.S. Department of Agriculture

Brian Larkins

Professor

Department of Plant Sciences

University of Arizona

James Lauderdale

Director of Research

The Upjohn Co.

Homer LeBaron

Sr. Research Fellow

Ciba-Geigy

K.J. Leonard

Professor

Cereal Rust Laboratory

University of Minnesota

F.C. Leung

Adjunct Professor

Pacific Northwest Laboratory

Battelle

Irvin E. Liener

Professor Emeritus

Department of Biochemistry

University of Minnesota

Bernard J. Liska

Professor

Department of Food Science

Purdue University

Patrick Luby

Oscar-Meyer Foods

Laraw Maran

Director

Knowledge Base System Research Lab

Department of Agronomy

University of Illinois

Bill Martinet

Forecast and Economic Planningarming

Sunkist Growers, Inc.

James H. Maryanski

Biotechnology Coordinator

Division of Food and Color Additives

Food and Drug Administration

Mike McGilliard

Professor

Department of Dairy Science

Virginia Polytechnic Institute

James McGrann

Professor

Department of Agricultural Economics

Texas A&M University
Appendix Aknowledgements ● 4 4 1

Kenneth McGuffey

Research Scientist

Lilly Research Laboratories

Eli Lilly and Co.

Travis McGuire

Professor

Department of Pathology

Washington State University

Terry L. Medley

Director

. Animal and Plant Health Inspection Service

U.S. Department of Agriculture

David Meeker

Vice President

Research and Education

National Pork Producers Council

R.A. Merkel

Professor

Department of Animal Science

Michigan State University

H.J. Mersmann

Agricultural Research Service

U.S. Department of Agriculture

R.L. Metcalf

Professor

Department of Entomology

University of Illinois

Elizabeth Milewski

Special Assistant for Biotechnology-OPTS

Environmental Protection Agency

Kevin Miller

Maryland Institute for Agriculture and Natural Resources

Agricultural Experiment Station

F. Gordon Mitchell

Extension Pathologist

Pomology Department

University of California

Kirby Moulton

Extension Specialist

Department of Agricultural Economics

University of California

James Murray

Professor

Department of Animal Science

University of California

Lester Myers

Chief

Food Marketing and Consumption Economics Branch

Economic Research Service

U.S. Department of Agriculture

Merritt Nelson

Professor

Department of Plant Pathology

University of Arizona

Richard Nelson

Plant Biology Division

The Samual Roberts Noble Foundation

Nanette Newell

Research Scientist

The Synertech Group, Inc.

Michael Orzolek

Professor

Department of Horticulture

Pennsylvania State University

Colin J. Peel

Animal Scientist

Monsanto Co.

Derrell s. Peel

Assistant Professor

Department of Agricultural Economics

Oklahoma State University

Robert Petters

Associate Professor

Department of Animal Science

North Carolina State University

Carl Pinkert

Animal Biology Research Center

Innovation Center

Ohio University

Richard E. Plant

Professor

Department of Agronomy and Range Science

University of California

J.A. Proudman

Research Leader

Arian Physiology Laboratory

Agricultural Research Service

U.S. Department of Agriculture

John F. Reid

Assistant Professor

Department of Agricultural Engineering

University of Illinois

James Rhodes

Professor

Department of Agricultural Economics

University of Missouri

J.B. Russell

Associate Professor

Department of Animal Science

Cornell University
442 ● A New Technological Era for American Agriculture

Clarence Ryan H. Allen Tucker

Institute of Biological Chemistry Professor

Washington State University Michigan State University

William Schneider Henry Tyrrell

Biotechnology Coordinator

Office of Pesticides programs

Principle Ruminant Nutritionist

Environmental Protection Agency

Plant and Animal Sciences Staff

Cooperative State Research Service

John Schoss

Central Research and Development Dept.

Experimental Station

E.I. duPont de Nemours and Co.

Roy G. Smith

Merck Sharp & Dohme

Research Laboratories

Norman Steele

Agricultural Research Service

U.S. Department of Agriculture

Gerald Still

Director

Plant Gene Expression Center

Agricultural Research Service

U.S. Department of Agriculture

Maurice J. Tauber

Department of Entomology

Cornell University

George Templeton

Professor

Department of Plant Pathology

University of Arkansas

Richard Teske

William Uhrig

Professor

Department of Agricultural Economics

Purdue University

Glen VandenBerg

Agricultural Research Service

U.S. Department of Agriculture

David VanWert

President

Monfort Pork Division

L.T. Wilson

Professor

Department of Entomology

Texas A&M University

Glen W. Wolfrom

Physiology Research

Pitman-Moore, Inc.

Al Wood

Boyce Thompson Institute

Cornell University

Center for Veterinary Medicine Henry Wynn

Food and Drug Administration Professor

W.W. Thatcher Department of Agronomy

Professor Texas Tech University

Department of Dairy Science

University of Florida

Thomas Thompson

Professor

Agricultural Engineering Department

Purdue University

Gary Thorgaard

Professor

Department of Zoology

Washington State University

James T. Tiedje

Director

Center for Microbial Ecology

Michigan State University

Gregory Zeikus

Director

Michigan Biotechnology Institute

D.R. Zimmerman

Professor

Department of Animal Science

Iowa State University

Dwane R. Zimmerman

Professor

Department of Animal Science

University of Nebraska
Index
Index

Abscisic acid (ABA), 49

Academic research, TSCA and, 17-18

Acetolactate synthase (ALS) enzyme, 158

Advisory committees for biotechnology-related decisions, 25

Agribusiness

economic forces, 9-10

impact of new technologies, 144-146

impact of regulation, 214-216

use of expert systems, 7

Agricultural Biotechnology Research Advisory Committee (ABRAC), 189

Agricultural management technologies, 6, 10-11

expert systems, 101-102

skill requirements, 149

Agricultural Marketing Service (USDA) inspection activities, 282-283

Agricultural productivity

biotechnology and, 9, 133-139

research, 27-28

Agricultural research, 28

congressional policy options, 29-31,423425

funding, 28-30,409416

legal environment, 417,419

political environment, 411-412

traditional base of support, 27

Agricultural Research Service (USDA), 409

biocontrol research, 54

transgenic swim research, 85, 86

Agricultural support industries, computer use, 7

Agrobacterium radiobacter, 59,60

Agrobacterium tumefaciens, 39,60

Alar controversy, 331-332

Alfalfa weevils, 154

Allelochemicals, 46-47

American Cyanamid, 71

American Red Cross, 86

Anabolic steroids, 74-75

Anaplasmosis, 65

. Animal agriculture

impact of new technologies, 140-144

management, 10-11

. Animal and Plant Health Inspection Service (USDA),

184-185,260-261

biocontrol research, 54

EPA comparison, 262-263

inspection activities, 283

plants genetically modified for pest resistance, 15, 17

regulatory oversight, 12

regulatory purview, 13

. Animal disease vaccines. See Vaccines

. Animal health technologies

biotechnology and, 5-6

diagnostics, 6,90-92

early disease detection, 7

immunomodulators, 90

. Animal production

efficiency projections, 137-139

expert systems, 102-103

. Animal technologies. See also Animal health technologies; Reproduction technologies; Transgenic animals

growth promotants, 4-5,8

intellectual property protection, 11, 394-398

management issues, 167-173

potential for, 4,8

timing of commercial introduction, 135

USDA authority, 193

Animal well-being. See Farm animal well-being

Animals, transgenic. See Transgenic animals

Antifreeze proteins, 49

Antimicrobial agents, 72-74

Antisense technology, 4243,48

food processing industry use, 50

passive immunity provision, 90

APHIS. See Animal and Plant Health Inspection Service

(USDA)

Arcelin, 45-46

Arthropods

biological control by parasites and predators, 54-55

biological control by pathogens, 55-57

biological control of weeds, 57-59

feeding activity, 58

artificial intelligence, 107-108

Augmentation approach to biological control, 51,52-53,

55,59

Autographa californica, 56

Avian Leokosis virus (AI-Y), 88

Bacillus subtilis, 59,89

Bacillus thuringiensis, 4,45,55,61, 164-165

Bacteria

arthropod control, 55

plant resistance, 4

Bacterial vaccines, 88,89

Baculoviruses, 56-57

BBEP. See Biotechnology, Biologics, and Environmental

Program (APHIS)

Beta-agonists, 71-72

pork grading and, 357-358

Bioassay methods, 50

Biocontrol research, 53-54

Biological control

frost damage, 60

plant diseases, 59-60

tools and techniques, 50-60

weeds, 57-59

Biosensors, 92, 121

-445–
446 ● A New Technological Era for American Agriculture

Biotechnology. See also Biotechnology products; names

of specific biotechnologies

agricultural productivity and, 9

congressional oversight, 16-19,23-27, 339-349

definition, 3,38,65

food safety issues and options, 19-27

impact of new technologies, 8-12

intellectual property protection, 389-399

public sector research, 27-31, 409-410

regulation, 12-27

tools and techniques, 38-50

Biotechnology, Biologics, and Environmental Program

(APHIs), 12,17

Biotechnology products. See also Commercial introduction of biotechnology products

Federal regulations, 339-343

independent testing 25-26

safety assessment methodology, 307-309, 347-348

safety considerations, 300-307

Bovine sornatotropin, 69

consumer behavior and, 329-330

effects of, 4-5, 67

FDA review, 4,9

milk production and 9

moratoriums, 148

bST See Bovine somatotropin

Bt. See Bacillus thuringiensis

California, biotechnology regulation, 203

Callus culturing, 42

Canada

biotechnology regulation, 206

CBI policy, 22,26

Canola, 15, 16

Cattle. See also Bovine somatotropin

antimicrobial use, 73-74

reproduction technologies, 5

CBI. See Confidential business information

Cell fusion, 37

Cell suspension regeneration methods, 42

Cellular techniques, 37

Cereals

disease losses, 37

gene transfer methods, 39

Chemical residue grading standard, 375-377

Chicken-harvesting machine, 171-172

Cimaterol, 71

Citrus rust mites, 57

Class I Major Histocompatibility Complex, 86

Classical approach

biological control, 51,52

genetic engineering of plants, 37

Clavibacter xyli, 55-56

Clenbuterol, 71

Coding moth granulosis virus, 56

COLLEGO, 57

Commercial introduction of biotechnology products,

264-265

options for Congress, 18

risk assessment, 235-247,259-261

risk management, 15

timing, 133-137

Committee on Biotechnology in Agriculture (CBA), 189

Computer technologies

agricultural impacts, 8-12,99

agricultural management applications, 6-8

current state and future development, 123-124

integrated systems, 114-115

intellectual property protection, 11-12, 39942

interfacing technologies, 109-110

knowledge-based systems, 99-109

networks and telecommunications, 115-117

research, 28

Computers

use by agricultural support industries, 7

use by farmers, 7

Confidential business information (CBI), 186, 187,346-

347

new technology approval and, 21-22,26, 346-347

Congress

environmental safety oversight of biotechnology, 16-

19

food safety oversight of biotechnology, 23-27,339-349

patent oversight, 11

policy options, 29-31,267-270,423425

Conservation approach to biological control, 51-52,55,

59

Consumer market behavior, food safety and, 324,325-

329

Cooperative State Research Service (USDA), 189

Coordinated Framework, 13-14, 17, 184, 185, 191,

198-199

Copyright, computer software, 8, 11-12, 399-400

Corn, insect resistance, 163-164

Corn/soybean rotations, herbicide use, 158-159

Cotton

disease control, 59

herbicide use, 159-160

insect resistance, 163

Cotton bollworm, 56

Council on Competitiveness, 13

Crop agriculture

impact of new technologies, 139-140

integrated pest management strategies, 153-156

management, 10-11

robotics, 118-119

Crop Genetic International, 56

crop insurance payments, 37

crop losses, 37

Crop production

efficiency projections, 137-139

expert systems, 103-105
Index ● 447

rate of growth, 9

Crop rotation, 156

Crop technologies. See Plant technologies

crop-seed mimicry, 153

Cross-hybridization. See Gene transfer

Cryphonectria parasitic, 60

cST See Chicken somatotropin, 67-68

Dairy industry

bovine somatotropin and, 4-5

impact of new technologies, 140-142

mastits costs, 65

robotics, 118

DDT resistance, 153-154

Dedalenus siricidcola, 57

Developing countries

biotechnology regulation, 207

cross-hybridization risk, 16

DeVine, 57

Diamond v. Chakrabarty, 8,391

Dicotyledenous plants

gene transfer, 39

virus resistance, 4, 48

Disease control in plants, genetic engineering, 4,4748,

49

Displaced farm operators and workers, 149

DNX, 86

Double-nil restrainer conveyor systems, 172

Dutch elm disease, 235

Ecological risk of biotechnology, 231-235

Ecological Society of America, 12, 13

risk assessment report, 228-230,259

Economic Research Service (USDA), 409

Elcar, 56

Eli Lily and Co., 71

Embryo and sperm sexing, 77,79

Embryo cloning, 77

Enkephalins, 50

Environmental Protection Agency. See also names of

specific offices

advisory committees, 25

application of FIFRA, 196-197,261

application of TSCA, 200-201,261

authority of FIFRA, 193, 194-196

authority of TSCA, 193-194, 197-200

biocontrol research, 54

biotechnology oversight, 209-210

commercial v. research authority, 212-213

enforcement activity, 285

outside input, 284-285

pesticide residue tolerances, 290-291,298-300

regulation of commercialization, 18

regulatory delays, 262-263

safety of pest resistant plants, 24-25

statutory authority, 283-284

technical staff shortage, 16

virus registration, 56

Environrm ental safety, biotechnology regulation, 12-19

Erythopoietin, 87

Escherichia coli, 88,89,90,92

Estrous cycle regulation, 75-77

Ethics of farm animal well-being, 168-169

Europe, biotechnology regulation, 204-206

Expert systems

animal production applications, 102-103

crop production applications, 103-105

description, 100-101

farm and area-wide management applications, 101-102

research needs, 105-106

use by agribusiness, 7

Farm animal well-being

biotechnology and, 172-173

development of public concern, 167-169

electro-immobilization, 171

impact of biotechnology, 11

Judeo-Christian ethic, 16 8

learned helplessness, 170-171

market failure, 168-169

market model of free enterprise, 168

nestbuilding, 171

quality of space, 170

thermal comfort, 169-170

Farm labor, impact of new technologies, 10, 146-147

Farm management See Agricultural management

Farmers

adjustment to change, 149-150

computer ownership and use, 7

FDA. See Food and Drug Administration

Federal Food, Drug, and Cosmetic Act, 20, 193

Federal Insecticide, Fungicide, and Rodenticide Act

CBI, under, 21

ERA appliccation, 196-197, 261

EPA authority, 193, 194-196

review processes under, 12, 13

Federal Meat Inspection Act 185,280

Federal Plant Pest Act, 185,186,187,195

Federal Poultry Products Inspection Act, 280

Federal regulatory agencies, 275-291,339-343. See also

Coordinated Framework; names of specific agencies

animal technology, 394-396

CBI policies, 21-22,26,346-347

coverage, 210-213

enforcement, 22

impacts of, 213-216

jurisdiction and coordination, 207-210

product-based v. process-based approach, 260-261

public participation, 216-218

Federal Seed Act, 185

Field trials, 183-184,237-239
448 ● A New Technological Era for American Agriculture

FIFRA. See Federal Insecticide, Fungicide, and Rodenticide Act

Fish and Wildlife Act of 1956,285

Fish

antifreeze proteins, 49

fish somatotropin, 70

transgenic fish, 87,211,291

Food additives

FDA definition, 288-289

transgenic crops, 24

transgenic organisms, 24

Food, Agriculture, Conservation, and Trade Act of 1990,

31,149

Food and Drug Administration (FDA)

advisory Commmitties 2 5

anabolic steroid review, 74

bovine somatotropin review, 4

CBI policies, 21,26,346-347

enforcement activities, 279,280

food additive definition, 288-289

food safety assessment 26-27,295-298,348

genetically engineered rennet approval, 6,92,309

inspection activities, 278-279,280

labeling of biotechnology food products, 22,348-349

outside input, 277-278

porcine somatotropin review, 4

regulation, 19-27,201-202,287-288, 289-290

staffing levels, 278

statutory authority, 275-277

Food grading system. See Grading system

Food processing industry, biotechnology applications, 6,

49-50,61,92-93

Food safety

biotechnology, 6,287-291

biotechnology regulation, 19-27

CBI, 21-22

enforcement of regulations, 22

Federal agency coordination, 20,286

international coordination, 22-23

issues and options relating to biotechnology, 19-27

labeling, 22,27,332-335,348-349

monitoring, 6

policy options, 23-27,339-349

public perceptions, 319-335

scientific issues, 295-314

sensor technology, 122

Food Safety Inspection Service (USDA)

inspection activities, 281-282

regulation, 290

transgenic animal guidelines, 19,25

Food scares, 331-332

Foreign genes

promotors, 41

selectable markers, 41

transfer, 39,41

Forest Service (USDA), 409

Freedom of Information Act of 1982, CBI requirements,

21,26,187

Frost damage, biological control 60

Fruit

disease losses, 37

gradomg system, 366-381

postharvest pathogen control, 59

FSIS. See Food Safety and Inspection Service (USDA)

Full-text retrieval systems, agricultural applications, 7,

113

Fungi

arthropod control, 55

insect control, 57

mass production, 53

plant resistance, 4

Fungicides, resistant strains, 60

Gene deletion vaccines, 88

Gene identification, isolation, and purification

transgenic animals, 79-82

transgenic plants, 38-39,40

Gene product classification, 24

Gene stability, 241

Gene transfer. See also Transgenic animals; Transgenic

plants

crop-to-weed gene transfer, 160

genetically modified and wild plants, 16

prevention, 250

risk 241-243,266

transgenic animals, 82-85

Genetic engineering, 6

See also Genetic engineering of plants; Transgenic

.

animals; Transgenic plants

Genetic engineering of plants. See also Plants genetically

modified for pest resistance; Transgenic plants

APHIS oversight, 12

cellular techniques, 37

classical techniques, 37

disease control, 4,47-48,49

insect control, 4,4546, 162-164

molecular techniques, 38

policy implications, 166-167

risk 265-266

thermal and water stress, 48-49

weed control, 4,4647

Gene-detection viral vaccines, 5-6

Genome mapping, 88

Glaxo Animal Health, 71

Gliocladium virens, 57,59

Glyphosate tolerance, 159-160, 161

Grading system

fruit and vegetables, 366-381

pork 354-366

Grains. See Cereals

Growth hormone releasing factor, 70

Growth promotants, 4-5,8
Index ● 449

Hardware issues, 109-110

Herbicides

action, 46

antidotes, 46

microbial, 57,58

tolerant crops, 4,60, 157-160

use in corn/soybean rotations, 158-159

use in cotton, 159-160

weed resistance, 153-154, 157-160

Hessian flies, 154

Heterobasidion annosum, 60

Hirsutella thompsonii, 57

Human hemoglobin production, 86

Hypertext, 113-114

Immunomodulators, 90

Information retrieval systems

full-text retrieval, 113

hypertext, 113-114

natural language interfaces, 111-113

Information technologies. See Computer technologies

Inhibin, 75

insect control

fungi, 57

genetic engineering of plants, 4,4546, 162-164

nematodes, 57

protozoans, 57

viruses, 56-57

Insecticides. See Pesticides

Insulin-like growth factor (IGF-I), 66-67

Integrated Pest Management (IPM), 153-156

Intellectual property protection, 8, 14

animal technologies, 3%-398

biotechnology, 389-399

computer technologies, 11-12,39942

plant technologies, 391-394

Interferon, 90

Interleukins, 90

International coordination, 22-23,291,349

International regulation, 204-207

IPM. See Integrated Pest Management

Japan, biotechnology regulation, 206

kanamycin resistance gene, 41

Knowledge-based systems

expert systems, 100-106

knowledge acquisition, 107-108

object-oriented simulation systems, 106-107

operation, 99-100

report generation, 108-109

Kudzu vine, 235

Labeling of food products, 22,27,332-335,348-349

Laboratory testing, 236-237

Land grant universities

biocontrol research, 54

funding, 29

policy options for Congress, 29-31,423-425

research mission, 27,28-29,410411

research privatization, 29

Iectins, 45

Livestock

blood proteins production, 86

disease and reproductive losses, 65,67

feed and health Care Costs, 65

pregnancy detection, 76

Local government, approaches to regulation, 202-204

Lymphokines, 90

Lysostaphin, 90

Machine vision, 121

Marker genes, 302-303

Mastitis, 65

Meat and poultry products, USDA inspection authority,

280-283

Microbial contamination of food, 300

Microbial disease control, 59

Microbial herbicides, 57,58

Microinjection techniques, 82,83

Microorganisms

biological control of weeds, 57-59

EPA definition, 212

FIFRA authority, 195

monitoring, 245

oversight under TSCA, 13, 15

risk concerns, 16,226,265-266

Minnesota biotechnology regulation, 202-203

Molecular genetics

detection of pesticide resistance, 156-157

techniques for genetic engineering of plants, 38

Monoclonal antibodies, 6,4344

diagnostic kits, 50,91

passive immunity provision, 90

Somatotropin, 70-71

Monocotyledonous plants

gene transfer, 39

virus resistance, 4,48

NationalBiologicalInpact Assessment Program (NBIAP),

189-190

National Environmental Policy Act (NEPA), 183, 185,

187-188

National Institutes of Health (NIH)

food safety evaluation, 26-27

regulation, 201

Recombinant DNA Advisory Committee, 189

National Marine Fisheries Service, 285-286

National Oceanic and Atmospheric Administration, 285

National Research Council, 12, 13

risk assessment report, 228-230,259

National Science Foundation research tiding, 31
450 ● A New Technological Era for American Agriculture

Natural enemy pest control, 50-53,154

Naturalal language interfaces, 111-113

Near- infared (NIR) spectroscopy, 121

Nematodes, insect control, 55,57

Networks and telecommunications, 115-117

Neurotoxin genes, 65

New Jersey, biotechnology regulation, 203,204

NIH. See National Institutes of Health

North Carolina biotechnology regulation, 202

Nosema locustae, 57

Noxious Weed Act, 185,186

Nuclear magnetic resonance (NMR), 1 21

Nucleic acid hybridization, 6,91

Nutrient content, 300-301,369-372

Object-oriented simulation systems, 106-107

Office of Agricultural Biotechnology (OAB), 189

Office of Pesticide Programs (EPA), 1%-197, 261,262

Congress and, 18

oversight of pesticidal plants, 17

plants genetically modified for pest resistance, 13-15

review processes under FIFRA, 12, 13

Office of Science and Technology Policy (OSTP), 12,13

Office of Toxic Substances (ERA), 200,262

Congress and, 18

oversight of microorganisms, 13

regulation, 12-13, 16

Oncomouse, 395

OPP. See Office of Pesticide Programs (5A)

Organic Act, 185

Osmotin, 49

OSTP. See Office of Science and Technology Policy

OTS. See Office of Toxic Substances (EPA)

Ovine somatotropin, 69-70

Parasites

control of arthropods, 54-55

pest control, 51

production, 53

Patent and Trademark Office

animal patents, 11,395

computer-related patents, 11-12

Patents

animal patents, 11, 172,395

biotechnology products, 389-390

computer software protection, 400401,402

plant varieties, 8,391-394

Pathogen resistant crops, 160-161

Pathogenicity genes, 47

Pathogens. See also Bacteria; Fungi; Nematodes; Protozoans; viruses

arthropod control, 55-57

pest control, 51

resistance to biological control agents, 60

weed control, 57

Paylean, 71

Peniphora gigantea, 59,60

Peptides, natural and synthetic, 89-90

P@ adaptation, delaying strategies, 164-166

Pest control

Integrated Pest Management, 37,153-156

natural enemies, 50-53

Pest resistant plants. See Plants genetically modified for

pest resistance

Pesticidal plants. See Plants genetically modified for pest

resistance

Pesticide resistance

influence of genetically engineered crops, 157-166

molecular genetics for detection, 156-157

Pesticides. See also Fungicides; Herbicides; Pesticide

resistance

delivery systems, 53

grading and 374-375

usage, 374-375

Pharmaceuticals, transgenic animals and 5,8

Pigs. See Swine

Plant diseases

biological control, 59-60

revenue losses from, 37

Plant Patent Act, 391

Plant Quarantine Act, 185,186

Plant technologies. See also Plants genetically modified

for pest resistance; Transgenic plants

definition, 3-4

genetic engineering for disease control, 4,4748,49

genetic engineering for insect control, 4,4546

genetic engineering for thermal and water stress

tolerance, 48-49

genetic engineering for weed control, 4,4647

timing of commercial introduction, 136

Plant varieties, patent rights, 8,391-394

Plant Variety Protection Act, 8,391-394

Plants. See also Plants genetically modified for pest

control; transgenic plants

FIFRA authority, 195

intellectual property protection, 391-394

natural vs. genetically modified pest resistance, 13

USDA application, 188-191

USDA authority, 184-188

Plants genetically modified for pest resistance, 4546,155

ERA safety evaluation, 24-25

Federal review authority, 13-14

gene transfer or cross-hybridization, 16

large-scale introductions under APHIS, 17

OPP oversight, 17

regulatory oversight, 12

risk of becoming pests, 16

weediness, 166

Pleiotropic effects, 303-307

Polymerase Chain Reaction (PCR), 43

Porcine somatotropin, 6849,86, 142-144

consumer behavior and, 329-331
Index ● 451

effects of, 4

FDA review, 4

pork grading and, 356-357,358

Pork grading system , 354-366

Potatoes, insect resistance, 163

Poultry

antimicrobial use, 73

poultry somatotropin, 67-68

transgenic poultry, 85

USDA inspection authority, 280-283

Poultry Products Inspection Act, 185

Predators, control of arthropods, 54-55

Premanufacture notice (PMN), 199-200

Pristophora erichsonii, 154

Productivity, agricultural. See Agricultural productivity

Promotors

transgenic animals, 85

transgenic plants, 41,46

Property rights. See Intellectual property protection

Protoplasm culturing, 41

Protozoans

arthropod control, 55

insect control, 57

Pseudomonas, 55-56

Pseudomonas aeruginosa, 89

Pseudomonas fluorescens, 59,60

Pseudomonas solanacearum, 48

Pseudomonas syringae, 60, 196

Pseudorabies virus vaccine, 6,88

pST See Porcine somatotropin

PTO. See Patent and Trademark Office

Public confidence and concern

options for Congress, 18-19, 343-345

regulatory process and 20-21, 25, 321-323

technological innovation, 3

Pythium ultimum, 60

Ractopamine hydrochloride, 71

Recombinant DNA techniques. See Genetic engineering

Regeneration of transformed plants, 41-42

Regulatory agencies. See Federal regulatory agencies

Regulatory genes. See Promotors

Rennet, genetically engineered, 6,92,309

Reproduction technologies, 5

embryo and sperm sexing, 77, 79

embryo cloning, 77

estrous cycle regulation, 75-77

possibilities, 5,8

transgenic animals and, 5

Research, agricultural. See Agricultural research

Restriction Fragment length Polymorphism (RFLP)

mapping, 39,46,92

RFLP. See Restriction Fragment Length Polymorphism

Rhizoctonia solani, 60

Risk assessment

adequacy of knowledge base, 259-260

biotechnology ecological risk 231-235

concerns and postulated risks, 225-227

monitoring, 244

overview, 227-228

research needs, 244-247

Risk management

agronomic methods, 250-252

cost-benefit analysis, 248

generic v. case-by-case approach, 247,266-267

science-based regulations, 247

scientific methods, 249-250

Risk, personal perceptions of, 323-325

Robotics, agricultural applications, 7-8, 117-119

Rural communities, impact of new technologies, 10,

147-148

Salbutamol, 71

Salmonella, 91

Satellites, 115

Sensor technology, 119,121-122

silkworms, 154

Software

intellectual property protection, 39942

international protection, 403

issues and policy options, 110-111,403-405

Somaclonal variation, 37

Somatostatin, 70,83

Somatotropin. See also types of somatotropin

description, 66

mechanism of action, 66-67

related technologies, 70-71

Speech recognition, 109

St. Johnswort, 58

Staphylococcus aureus, 90

Starter cultures, 50,92

State Agricultural Experiment Stations (SAES), 412-417

States

approaches to regulation, 202-204

biocontrol research, 54

funding for agricultural research, 28

Steinernema carpocapsae, 57

Stem cell method, 83-85

Suicide genes, 249-250

Superovulation, 5,75,76

Swine. See also Porcine somatotropin

antimicrobial use, 73

growth hormone releasing factor, 70

impact of new technologies, 142-144

pseudorabies virus vaccine, 6

transgenic swine, 5, 85-86

Tansy ragwort, 58

Technological innovation. See also specific types of

innovation

impacts of, 8-12

policy issues, 148-150
452 . A New Technological Era for American Agriculture

public acceptance, 3

role in agricultural transformation, 3

Tennessee Wiley Authority, 54

testing of biotechnology products, 25-26

Theileria annulata, 89

Thermal stress tolerance, 48-49

Ti plasmid, 39

Tissue culturing techniques, 4142,49-50

Tissue plasminogen activator (TEA), 87

Tomatoes

antisense technology, 42,50

fungicide use, 375

Toxic constituents of food, 301-307

Toxic Substances Control Act (TSCA)

applicability to living organisms, 263-264

ERA application, 200-201,261

EPA authority, 193-194, 197-200

microorganisms oversight, 13, 15

policy options, 17-19,268-269

Trade secrets, 390-391,394,401

Trade Secrets Act of 1982: CBI requirements, 21

Transgenic animals. See also specific types of transgenic

animals

creation process, 65, 79-85

FSIS guidelines, 19,25

human medical implications, 5

intellectual property protection, 394-398

possibilities, 5

research needs, 87-88

Transgenic crops. See Transgenic plants

Transgenic fish, 87,211,291

Transgenic plants. See also Plants genetic-ally modified

for pest resistance

antifreeze proteins, 49

biotechnology techniques for creation, 38-49

commercial availability, 4

disease resistance, 60-61

FDA classification, 20

regulations and guidelines, 23

selectable markers, 41

Trichoderma, 60

Trypsin inhibitors, 4,45

TSCA. See Toxic Substances Control Act

U.S. Army Corps of Engineers, biocontrol research, 54

U.S. Congress. See Congress

U.S. Department of Agriculture. See also names of

specific USDA agencies

advisory committees, 25

application to plants, 188-191

application to veterinary biologics, 192-193

authority for animals, 193

authority for plants, 184-188

authority for veterinary biologics, 191-192

biocontrol research, 54

biotechnology oversight, 209-210

commercial v. research authority, 213,218-219,265

fruit and vegetable grading improvement options,

377-381

fruit and vegetable grading standards, 367-369

funding for agricultural research, 28,31

meat and poultry inspection, 280-283

outside input, 283

pork grading improvement options, 360-366

pork grading parameters, 359-360

pork grading standards, 354-355

regulation of commercialization, 18

statutory authority, 280-281

U.S. Department of Energy, biocontrol research, 54

U.S. Department of Interior, biocontrol research, 54

U.S. Environmental Protection Agency. See Environmental Protection Agency

U.S. Patent and Trademark Office. See Patent and

Trademark Office

Universities. See Academic research; Land grant universities

USDA. See U.S. Department of Agriculture

Vaccina virus, 89

Vacines, 5-6,8,65,88-90. See also names of specific

vaccines

Vanilla, 49

Vector material, 303

Vectored vaccines, 89

Vegetable grading system, 366-381

Veterinary biologics, 5-6

USDA application, 192-193

USDA authority, 191-192

Viral coat proteins, 4,48,89

Virus resistant plants, 4,48

Virus-Serum-Toxin Act (VSTA), 185, 191

Viruses. See also names of specific viruses

arthropod control, 55

mass production, 53

Water stress tolerance, 48-49

Weed control

biological control by microorganisms and arthropods,

57-59

genetic engineering of plants, 4,4647

Weed pathogens, 57-58

Weeds, herbicide resistance, 153, 157-160

Wheat, disease control, 59

Whole Earth Decision Support System (WEDS), 114

Wholesome Meat Act of 1967,280

Wholesome Poultry Products Act of 1957,280

Woodwasps, 57

Yeast strains, genetically engineered, 6