u.s. agricultural biotechnology: status and prospects

NORTH- HOLLAND

U.S. Agricultural Biotechnology: Status and Prospects

S U S A N N E L. H U T T N E R , H E N R Y I. MILLER and PEGGY G. L E M A U X

ABSTRACT

Agricultural applications are extending the already impressive record of biotechnology's contributions to medicine. In many ways, agriculture offers a more ready fit for modern genetic techniques, as single gene methods extend directly from traditional breeding techniques. This article describes how the new genetic tools are being applied to enhance many aspects of the food production system. Crop protection through genetic resistance to insects and disease is among the earliest, significant agronomic contributions. Food characteristics, including nutrient composition, fat content, ailergenicity, texture, and flavor, are being modified through selectively targeted metabolic changes. Raw materials for food processing and fermentation are similarly modified and improved. New genetic techniques also present opportunities for introducing products of commodity crops into entirely new markets, including industrial oils, plastics,and pharmaceuticals. Taken together, biotechnology's value-added products, improved food and feed, and enhanced agronomic crop performance bolster the economic competitiveness of American farmers. There are also environmental advances, including biological control strategies and the use of microorganisms and plants to remove heavy metals and other contaminants from soil and agricultural run-off and ground waters.

The ultimate impact of agricultural biotechnology, however, is far from certain. Several factors, some well defined and others less transparent, affect the directions and pace of development. These include public funding for basic research and for R&D, governmental regulation of research and products, and enhancement of linkages between the research and agriculture sectors. Compared to public investment in human and microbial genetics, federal support for the plant sciences has been dismal. USDA and EPA have proposed and implemented new regulatory requirements that are remarkable both for their lack of focus on genuine biosafety risks and for their unequivocal anti-innovation and anti-competitiveness effects.

The relatively short history of U.S. policy on agricultural biotechnology may provide a microcosm view both of the introduction of technological innovations, more generally, and of emerging patterns of dominance of major agricultural firms in the worldwide economic arena. The analysis of that history suggests that a new paradigm for technological advancement is needed.

Introduction Biotechnology is the use of living organisms or parts of organisms, such as deoxyribonu-

cleic acid (DNA) or enzymes, to make or modify products. It is as ancient and familiar

SUSANNE L. HUTTNER is director of the Systemwide Biotechnology Research and Education Program, University of California, Berkeley.

HENRY I. MILLER is a fellow at the Hoover Institution and a professor in the Institute for International Studies, Stanford University, Stanford, CA.

PEGGY G. LEMAUX is Cooperative Extension Specialist in the Department of Plant Biology and Associate Director of Systemwide Biotechnology Research and Education Program, University of California, Berkeley.

Address reprint requests to Professor Susanne L. Huttner, Biotechnology Research and Education Program, University of California, Berkeley, 345 Giannini Hall, Berkeley, CA 94720-3100.

Technological Forecasting and Social Change 50, 25-39 (1995) © 1995 Elsevier Science Inc. 655 Avenue of the Americas, New York, NY 10010

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26 S.L. HUTTNER ET AL.

as using yeast to leaven bread and as modern as genetic engineering. Today, the term "biotechnology" is most often used synonymously with the latter--genetic engineering techniques that selectively modify individual genes or transfer genes from one organism to another. However, the term also encompasses another important set of techniques derived from our knowledge of the immune system that provide highly sensitive diagnostics and other products. Taken together, the new biotechnology is best viewed as a set of tools that exploit the molecular systems of the living world. As our knowledge of genetics, biology, and physiology increases, these tools find broader applications.

The most familiar applications of biotechnology are in medicine. In the past two decades, biotechnology has given us life-saving drugs like human insulin and clot-dissolv- ing TPA (tissue plasminogen activator), effective new vaccines for hepatitis, and precise genetic diagnostic tools for muscular dystrophy and acquired immune deficiency syn- drome (AIDS). The new tools have supported the emergence of a new business sector, comprised principally of small, entrepreneurial firms driven by venture capital and public stock offerings. The biotechnology industry has largely been focused on biomedical applications, including drug design and formulation, DNA-probe and monoclonal antibody- based diagnostics, and immunotherapy. In 1993, drugs produced by these firms achieved total sales of $7.7 billion [7].

Biomedicine was the first wave in the commercialization of biotechnology. Agricul- ture is the second. The third will include environmental monitoring and remediation, as well as natural resource characterization and conservation. The directions and rate of applications of the new tools to any of these fields is affected by at least three critical factors: (1) the level of knowledge of the genetics and biochemistry of target organisms (i.e., humans, livestock, plants, insects, and microorganisms); (2) the availability of funding for basic research in public institutions and for R&D in private firms; and (3) governmental regulations on basic research, R&D, and marketing.

The diffusion of new biotechnologies into medicine was facilitated tremendously by the effects of all three factors. A sophisticated knowledge base has been built over more than three decades of federal funding for basic research in human genetics, biochemistry, and molecular biology. Venture capital was relatively abundant during the critical decade in which most biotechnology firms were being established, and public stock offerings were relatively successful. Moreover, the Food and Drug Administration (FDA) announced as early as 1980 that new biotechnology products would be treated the same as other, similar products. No additional regulatory hurdles would be imposed on the R&D process or on product marketing. Based on the experiences described below, the biomedical model is not fully applicable to the commercialization of agricultural biotechnologies. This paper provides both a brief introduction to certain applications of the new biotechnology in agriculture (specifically, in plant breeding) and a discussion of key issues that will determine its ultimate impact.

Agricultural Biotechnology: The Second Wave Biotechnology is being used in nearly every aspect of the food-production system--

from the field to the grocer. The majority of research is currently on plants, but animal research is progressing as well. Targeted single gene changes are improving both agronomic and postharvest characteristics of crops. The nutrient composition, solids content, fats, texture, and flavor of foods are enhanced through discrete modifications of plant metabolic processes. Modern genetic techniques are also creating novel strategies for biological control of insects and disease.

AGRICULTURAL BIOTECHNOLOGY 27

Improvements in food crops currently fall into four familiar categories: (1) enhanced food quality and food processing traits, (2) disease or pest resistance, (3) environmental stress tolerance, and (4) weed management. The new tools complement and extend traditional plant-breeding techniques by providing the means for making selective, single-gene changes. The difference lies principally in precision and speed. Moreover, because DNA is biochemically equivalent in all organisms, the new techniques enable scientists to take advantage of the full spectrum of genes present in nature. For example, crop scientists can now in theory seek beneficial t ra i t s - l ike pest and disease resistance, drought and salt tolerance, and factors that enhance the nutritional quality of fruits and vegetables- wherever they exist in nature. Although the goals of traditional and molecular breeding are s imi la r - the new technologies greatly expand the realm of possible strategies by elimi- nating the interspecies barriers presented by sexual reproduction.

The new tools will thus affect agriculture and food production in at least five important ways that enhance the efficiency of production and the value of farm products. They are being used to: (1) add value to U.S. crops and livestock; (2) provide sensitive diagnostics for early detection of disease and infestation; (3) create biological mechanisms to combat crop losses due to pests and disease; (4) improve food processing and fermentation through enhanced raw materials, microorganisms, enzymes, bioreactors, and diagnostics; (5) open new markets in plastics, industrial oils, and pharmaceuticals for U.S. agricultural products. A very brief and selective overview of plant applications is provided here and illustrated in Figure 1.

CROP IMPROVEMENT Genes for a variety of proteins are being introduced into rice, corn, and other staple

grains to make them more nutritionally balanced and to improve the quality of protein. Genes for enzymes involved in starch metabolism are used to increase the starch levels in potatoes and thereby reduce fat absorption during frying. Genes for enzymes affecting the sugar and solids content of tomatoes are used to improve the flavor and processing quality of canning tomatoes. Other genes involved in the natural metabolic pathways that cause fruit softening and ripening have been genetically controlled to improve harvesting, shipping and shelf-life characteristics of tomatoes, such as the Calgene (Davis, CA) FLAVR SAVR ® tomato. Canola (rapeseed) oil is modified to reduce the levels of saturated fats and improve its thermal stability.

BIOLOGICAL CONTROL Biological control strategies for pests are likely to be among the earliest and most

important contributions of the new biotechnology. Plants can be made resistant to insects or pathogens through single gene changes. For example, the bacterium, Bacillus thurin- giensis (Bt), is a common biological control agent used in the U.S. for decades. Bt produces a family of protein endotoxins that selectively kill certain types of insects, including lepidoptera. The genes for these endotoxins have been identified and cloned. When introduced into plants by recombinant DNA (rDNA) techniques, they confer protection by delivering the toxin directly to the insect through its "meal," and overcome limitations presented by bacterial spray techniques. Bt genes have been successfully introduced into cotton, walnut, apples, and other important crops.

The ability to overcome reproductive barriers enables researchers to develop other creative new approaches to pest management. A particularly striking example can be found in efforts to control plant viral diseases, that are generally untreatable except through chemical control of vector insects. Transferring a single virus gene (that encodes


What we can expect from plant biotech:

New Products

(Cumulatlve)

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C~HEMICALS AND POLYMERS (plastics from starch)

/ N~UUTRITION AND HEALTH (nutrients; pharmaceuticals)

OOD PROCESSING TRAITS (solids, starch, water content)

GRONOMIC TRAITS (improved production; consumer acceptance)

J t - - I - - J - - -- I

1990 1995 2000 2005 2010 2015

Fig. 1. A conceptual representation of the likely timecourse for the introduction of major agricultural biotechnology product groups (taken from Roger Beachy, September 24, 1993). The entry of each set of new products in the marketplace is dependent on the rate of development of fundamental knowledge on the genetic and biochemical bases of the specific traits involved. Every set is already well represented in research underway in U.S. laboratories.

a coat protein found on the exterior of the virus) effectively protects plants against subse- quent viral infection. Viral coat protein-mediated protection has been conferred to potato, cucumber, squash, melons, papaya, and legumes. It is expected to be broadly applicable to many viral pathogens and crop species. Alternative strategies utilizing other viral genes have also been shown to be efficacious.

PLANT DISEASE DETECTION Early treatment, often an excellent strategy for reducing inputs, requires early detec-

tion. The new biotechnology offers highly sensitive and selective diagnostic tools that can detect very low levels of infection or infestation. Field kits based on monoclonal antibodies are already in use for soybean root rot and certain bacterial diseases of tomato and grape. DNA fingerprinting-- famous for its use in forensics-- is useful in characteriz- ing plant diseases and infestations. It is an important new tool for plant breeders and facilitates plant variety characterization and protection.

WEED CONTROL Genes encoding enzymes that metabolically degrade chemical herbicides protect

plants against their destructive effects. Herbicide tolerance genes have been a major focus


of R&D efforts in the private sector and could both significantly reduce herbicide inputs and encourage the use of more environmentally benign herbicides.

NOVEL PLANT PRODUCTS Knowledge of the metabolic pathways involved in starch metabolism has enabled

the development of plants that produce starch-based polymers. These polymers can be used to produce plastic-like materials. They may prove to be helpful in reducing reliance on petroleum-based polymers. Plant oil metabolism has also garnered interest. Not only are plants tailored to produce more healthful oils for cooking, they are also being designed to serve as a source for industrial oils used in machining and other applications. Farmers' fields are also envisioned as future pharmaceutical factories. For example, preliminary research has demonstrated that plants are efficient producers of proteins valuable as drugs or vaccines for humans and animals. For example, genes encoding protein components of the cholera toxin that are known to confer immunological protection against cholera, have been introduced into plants with encouraging early results as a source of cholera vaccine. These strategies would deliver vaccines through food and feed.

Projecting the Economic Impact of Agricultural Biotechnology Biotechnology has been widely heralded as an economic development vector. The

rate of development and commercial application has been remarkable in medicine, where more than 1000 new biotechnology products have been approved by the FDA and clini- cians have proceeded with more than 100 trials of human gene therapy. Exciting bench- marks have also been achieved in agriculture, as described above, but overall the rate of development has been substantially slower. Perhaps more than for other technologies, the rate and directions of seminal'biotechnology developments in agriculture have been strongly affected by governmental actions that affect how these effective new tools are used in research and product development.

From an historical perspective, much of the past progress in biotechnology derives from academic research that has greatly extended and refined our ability to manipulate genes. Biomedical research has been significantly better funded by the federal government than basic research in the agricultural sciences. Moreover, in contrast to human genetic research, agricultural research must address fundamental questions in over 300 different species. A National Research Council report [12] found that, on average, competitive grants for plant biology have been 33 070 smaller and only 25 07o-5007o as long as biomedical research grants. As a result, plant scientists must truncate their research goals and spend more time writing grants and renewals. Continuity of research is also often lost due to inadequate and unstable funding. As a result, knowledge of plant genetics, host-pathogen interactions, and other fundamental biochemical and metabolic processes have been a rate-limiting factor in the application of biotechnology in agriculture.

Regulatory policies have played an equally important role. Regulation of biomedical applications has been more reasonable, judged by similar regulatory policies for analogous technologies and products. In contrast, entirely new regulatory requirements have been created just for agricultural biotechnology-and they have targeted the earliest stages of field research. In the mid-1970s, all rDNA research at federally funded institutions was strictly overseen by National Institutes of Health guidelines and related biosafety commit- tees. By 1982 more than 9507o were exempt from review as the guidelines were focused more narrowly on pathogens, toxigens, and human gene therapy. Encouraged by these changes and by FDA's positive response to new biotech products, investors and companies fueled robust activity in biopharmaceuticals and diagnostics.

The U.S. Department of Agriculture (USDA) and the Environmental Protection Agency (EPA) took a very different course than FDA, proposing entirely new regulatory

30 s.L. HUTTNER ET AL.

schemes specifically targeting the use of the new genetic techniques in research. These regulatory schemes conflict with worldwide scientific consensus that rDNA techniques and rDNA-modified organisms are not inherently dangerous or unpredictable [5, 10, 11, 13, 19, 20, 21, 23]. There is no valid conceptual distinction regarding safety between modern and older genetic methods. The scientific community has found from millions of laboratory experiments and thousands of field trials that the precision of rDNA techniques actually enhances determinations of safety and risk. This confidence is not, however, reflected in EPA and USDA regulations on field research.

USDA REGULATION OF PLANT BREEDING Under the Plant Pest Act, USDA's Animal and Plant Health Inspection Service

(APHIS) promulgated new regulations in 1987 [22] that essentially equated plant pest risk with plants that had been manipulated with rDNA techniques and that contained any substance derived from a plant pest. As implemented by APHIS, this policy is interpreted strictly to require permits without distinguishing between those plants that actually express pest traits and those that do not. By focusing on the source of the DNA rather than on the potential pest characteristics of the modified plant, the APHIS approach captures the vast majority of rDNA-modified plants. This results from the fact that the most common technique for introducing genes into plants involves disarmed plasmids from Agrobacterium tumefaciens (a plant pathogen) and genetic regulatory sequences from cauliflower mosaic virus (another plant pathogen). These DNA sequences ensure the efficient delivery and expression of introduced genes. There is no reasonable scenario by which they could convert a crop plant into a pathogen [4]. The 1987 APHIS regulations effectively disconnect the Plant Pest Act from a clear definition of what constitutes a plant pest and create an historically significant change in the agency's regulatory approach to plant breeding.

By 1992 more than 350 field research permits and 1000 movement permits had been issued by APHIS, the former following thorough environmental assessments. Each of the plants involved contained new genes that conferred agronomically familiar traits or simply benign marker substances. Not surprisingly, each environmental assessment concluded with a finding of no significant environmental impac t - a conclusion that could have been reached by a paper exercise that considered the nature of the genetic modification made in the plant [4, 9, 10, 11]. Extensive documentation of the environmental assessments of field trials conducted worldwide have confirmed what the scientific community already knew-plants modified using rDNA techniques present no unusual or unex- pected behaviors compared to plants modified using older genetic methods [6, 8]. The common practices of plant breeders would be fully adequate to manage potential risks associated with plants modified with rDNA or older methods.

The field-research regulations, focused as they are on the use of the new genetic techniques rather than on tangible risks, have been estimated to increase the price of a field trial, on average, as much as 100 times that of a trial with a similar, conventionally bred plant. Under pressure from the academic research community and the Bush Adminis- tration, USDA modified the regulations in 1993 to provide a streamlined notification process but only for field research with six crops on which the agency had completed hundreds of environmental assessments. Since the new notification process was enacted the number of approved field trials has grown dramatically--but only within the six crop species and only for a very narrow spectrum of traits. Figures 2 and 3 illustrate the types of crops and traits that have been tested in approved field trials. Although more than 90 crop species have been successfully modified using the new genetic methods, fewer than 25 have been field tested and most of them in only a few trials.

A G R I C U L T U R A L B I O T E C H N O L O G Y 31

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EPA REGULATION OF PEST RESISTANCE IN PLANTS E P A recently proposed new regulations [2] under the Federal Insecticide, Fungicide,

and Rodent icide Act (F IFRA) that would, in essence, equate chemical pesticides with those protective biological substances introduced into plants through certain kinds of genetic modification. The direct effect o f the rule would be to regulate more stringently than common chemical pesticides those plants that are made more biologically pest- resistant through modern genetic methods. By focusing on methods rather than on specific risks associated with introduced traits, the rule places the regulator and the plant breeder in the posi t ion of treating virtually identical products differently depending on whether they are produced by modern or older genetic techniques. This will lead to increased product ion costs, unnecessary confusion for the consumer, and no assurance of greater safety.

Genetic strategies for protecting crops from insects and disease have played an historically impor tant role in maintaining efficient and environmental ly sound product ion. There isn't a fruit or vegetable in the American food supply that does not contain protective substances introduced genetically through evolution or breeding programs. E P A has not

previously regulated pest resistance breeding programs, and since 1982, the agency has expressly exempted from F I F R A requirements all small scale field trials with biological control agents (including plants but excepting certain microbes). The proposed regulations present an abrupt change that stands in conflict with the impressive record of pest resistance traits introduced through classical breeding.

A joint committee of the Crop Science Society of America , the American Society of Hort icul tura l Science, and the Amer ican Phytopa tho logy Society commented [19] on the likely economic impact of the proposed regulations:

The economic lifetime of most varieties, especially crop varieties, is relatively short (i.e., about 5 years). Limited returns on investments for any one particular variety/hybrid (especially self-pollinated crops) are not unusual . . . . The committee isn't convinced the EPA has adequately addressed these concerns in their Regulatory Impact Analysis, especially as it would affect the numerous small plant improvement programs throughout the United States.

FDA REGULATION OF FOODS FROM GENETICALLY ENGINEERED PLANTS In keeping with the agency's earlier approach to biotechnology drugs and devices,

F D A announced [3] that it would treat food from plants the same regardless o f the genetic method used to modify them. The agency described the central criteria that producers should consider in judging the safety of new foods (i.e., allergenicity, toxigenicity, and nu t r ien t / fa t composi t ion) and emphasized there was no need for special regulatory oversight for substances introduced into plants that were substantially equivalent to substances common to the food supply that have a history of safe use. That is, if a gene is t ransferred f rom corn into tomato it will not normal ly require special considerat ion.

On the other hand, the agency announced for the first t ime that it considered genetic modification as adding substances to food. This is a conservative policy f rom the point o f view of public health. I f an introduced substance is new to the food supply, it would be considered a food addit ive and subject to the premarket ing approval requirements of the Food , Drug, and Cosmetics Act.

Despite calls from certain activist groups for labeling of all genetically engineered foods, F D A has decided to require labeling only where consumers can benefit f rom informat ion related to the nutr i t ional or safety characteristics of the food. Foods con- taining a substance derived from commonly allergenic sources will be labeled to indicate the presence of that substance, unless the producer can demonstra te that the substance


Commercial 87%

Non-Commercial 13%

Academia, State Agricultural Units,

and Non-profit Foundations

Fig. 4. Relative percentage of field trial permits and notifications approved by USDA Animal and Plant Health Inspection Service to applicants in commercial and noncommercial institutions. Source: Data provided by USDA.

is not allergenic. Foods will not be labeled to indicate that they were produced through genetic engineering or biotechnology. The contrary decis ion-to require broad labeling for all genetically engineered foods-undoubtedly would adversely impact the food- production system. Labeling would require special handling to keep biotechnology products separate from other products at all stages, from the field to the market. The added costs would be vertically transmitted, resulting ultimately in a substantially more expensive consumer product. Calgene Corporation is using voluntary point-of-purchase labeling and has created a comprehensive production system to deliver the FLAVR SAVR ® tomato from the field to the fresh market. The success of such strategies will depend on the products garnering premium prices.

Recently, FDA prepared and circulated for clearance within the government a pro- posal for premarket notification applicable only to genetically engineered foods. This approach represents a departure from the basic tenet of more than a decade of successful, science-based FDA regulation-- that oversight shall focus on the characteristics of products, not on the use of certain techniques.

WHO'S FILLING THE COMMERCIAL PIPELINE? Information from APHIS field-trial applications provides a preview of the kinds

of genetically engineered products that are potentially entering the commercialization pipeline. The vast majority of field trials have involved six major commodity crops and a relatively small array of introduced traits. Much less field research is underway in another 20 or so crops and other traits. It is particularly striking to find (Figures 4, 5, 6, and 7) that publicly funded research institutions, both academic and Agricultural Research Stations, have conducted very few field trials since 1987. Yet, the field trials that have been conducted at publicly funded institutions present much greater breadth in both crops and traits tested than those at companies (Figure 5).

One can conclude at least two things from this information. First, the private sector involvement is limited to a relatively small number of companies, and those are generally

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large, established agricultural firms. This is quite different from the history of the biomedical sector of the biotechnology industry, where the majority of firms are small, entrepreneurial entities [7]. Second, it appears in general that the only crops and traits that are being tested are those for which there is significant market potential, such as herbicide-related products or high value-added tomatoes.

One might speculate that the APHIS or EPA regulatory requirement for a full environmental assessment, which includes extraordinary design, monitoring, and reporting requirements, presents a serious disincentive to researchers working in less well-funded institu- t i ons - such as universities or small companies. These regulatory requirements constitute unwarranted burdens on already strained research budgets and schedules. That regulations have discouraged some researchers from conducting field trials has been documented elsewhere [ 17, 18]. That publicly funded institutions are grossly underrepresented in field research is illustrated in Figure 6.

The costs, paperwork, and delays associated with the USDA and EPA policies on field research and with the proposed food policies on premarket approval, taken together, discourage the broad use of modern genetic techniques. Thus far, it appears that the technologies and products are becoming sequestered among a small number of companies (Figure 7), and are diffusing only slowly (if at all) through the broader traditional commercial agriculture sector that includes plant breeders, farmers, food manufacturers, and retailers.

Access to these new tools may be particularly constrained when a new product presents a tangible but incremental improvement over existing products. For example, the solids content of tomatoes has been increased through a single gene change, producing tomatoes with less water and better processing characteristics. Although this is a useful improvement, it is not one that will garner high market prices. Costs imposed on early stages of development added to enhanced government scrutiny has apparently discouraged


commercial interest in all but those products that present sufficiently valuable "improvements" to garner market prices that offset the added development and production costs.

FINANCING INNOVATION AND COMMERCIALIZATION

Research financing is, itself, a problem. The availability of venture capital for biotechnology pursuits is more limited than in the 1980s when many of the biomedical firms were founded [7]. Moreover, as shown in Figure 8, the rate of investment in the biopharma- ceutical and agbiotech stock market sectors of biotechnology has been markedly different. Although the pharmaceutical sector has consistently outperformed the Standard and Poor's (S&P) 500, the agricultural sector has consistently underperformed. Sluggish investment in stock offerings coupled with limited venture capital makes small companies particularly vulnerable to the burdens of excessive and unwarranted regulatory requirements. Similarly, limited federal support for basic research discourages academic researchers from pursuing early stage field validations of new plant varieties that help attract private sector interest.

The rate at which the agronomic performance of rDNA-modified plants is being validated through small-scale field tests can also affect the climate for commercialization. The current rate may prove too slow to generate the enthusiasm needed for farmers, food manufacturers, and retailers to adopt the new technologies and products on a large scale. Indeed, a slow pace can actually foster disincentives to commercialization when a new technology or product faces public controversy. As products trickle out of the development pipeline, one at a time, they are easy targets for negative campaigns. The high competition and narrow profit margins that characterize the food-production industry provide little buffer against even small potential losses in market share that may result from threatened or actual consumer boycotts and negative advertising campaigns.

Whether for early stage research or for premarket assessment, special regulatory requirements that are not scientifically justified put new biotechnology products in the spotlight for public scrut iny-for better or worse. "The bottom line is that regulated products such as pharmaceuticals, agricultural chemicals, food additives, and now genetically altered crops can be monitored and their market entry anticipated. The step that discloses the emergence of a new genetically modified crop is the requirement for an environmental release permit" [1]. Although this may be seen as an advantage for stock brokers and other industry analysts, it can also provide a mechanism for targeting products for negative campaigns at early stages of development, often before the agronomic or potential market performance has been demonstrated. Moreover, special regulatory requirements that are intended to reassure while providing no actual safety enhancements are confusing to consumers and may actually jeopardize public acceptance of new biotechnology products. Regulation is a costly and ineffective substitute for consumer education.

Conclusions Given resource and regulatory challenges and the demise of plant breeding as a core

emphasis in land grant institutions, the potential for achieving agricultural biotechnology's full potential may require the development of a new paradigm. New kinds of public- private partnerships are needed. These can ensure that publicly funded basic research advances in plant sciences are stewarded through early validations so that their value may be identified and captured by private sector firms that can then commercialize them for public benefit.

Novel partnerships must provide more than funding, however. Although there is insufficient space to consider the issue here, the plant breeding and distribution system

38 S . L . H U T T N E R E T A L .

400

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vs. the S&P 500 Index

350

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Fig. 8. Re la t ive p e r f o r m a n c e on the s tock m a r k e t o f c o m p a n i e s in var ious sectors o f the b i o t e c h n o l o g y industry . T h e sectors inc lude b i o p h a r m a c e u t i c a l (principal ly drugs) and agricul ture . Source: D a t a prov ided by Dr . Y u h a n g Z h a o , P a i n e W e b b e r .

has been challenged by rulings on plant variety protection and on intellectual property rights associated with plant breeding and the new biotechnology. Thus, capturing the full value of the new tools and products involves access as well as utilization, so that the benefits o f improved cultivars and breeding lines are kept within the financial reach of farmers, retailers, and food processors.

In summary, the potential benefits of biotechnology applied to agriculture are broad-- encompassing virtually the entire food-production system. Achieving those benefits will require thoughtful stewardship involving the traditional agricultural sector, the research community, and biotechnology companies. Immediate targets for improvement in this arena include increased federal support for essential basic research and training in the agricultural sciences, risk-based regulation of early stage field research that is needed to refine and validate the performance of new products, and new public-private partnerships to ensure efficient, timely, and fair technology transfer.

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A G R I C U L T U R A L B I O T E C H N O L O G Y 39

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Received 23 March 1995

u.s. agricultural biotechnology: status and prospects

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