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Executive Summary and Recommendations A national strategy for biotechnology in agriculture must fo- cus on solving important scientific and agricultural problems, ef- fectively using the funds and institutional structures available to support research, training researchers in new scientific areas, and efficiently transferring technology. This report assesses the status of biotechnology in agricultural research and suggests approaches toward a more effective national strategy for biotechnology in agri- culture. Thus far, government at both the state and federal levels has responded with short-term, Shoe management approaches; it has not addressed the long-term needs and policy concerns of in- tegrating biotechnology into agricultural research and technology. Short-term management approaches jeopardize the fragile U.S. competitive advantage in biotechnology. Such approaches and un- certain funding create an environment that does not attract the best minds to agricultural research. This report points to policy changes that are needed in funding patterns and in the operation and organization of agricultural research institutions. THE INTERNATIONAL DIMENSION Agriculture has moved from a resource-based to a science- based industry as science and technology have been substituted for 1

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2 AGRICULTURAL BIOTECHNOLOGY land and labor. This transition, which began in the United States, now affects agriculture and food producing systems throughout the world. Technology has driven this change toward more effec- tive and efficient production practices. Yet current political and economic policies governing agriculture neither fully recognize nor take these changes into account. The adoption of new technologies has improved the efficiency of agricultural production practices; the causes of current agricultural surpluses lie elsewhere. Agri- cultural systems throughout the world continue to adopt new and better technologies that enable them to become more efficient and competitive in developing new markets and capturing old markets for their agricultural products. The future leadership and com- petitiveness of the U.S. agricultural enterprise is dependent on the health and effectiveness of the agricultural research system in our country and its ability to translate better technologies into prac- tice. Research must make American farming a more profitable, reliable, and durable business able to compete in both domestic and international markets. Innovation is crucial to enhance pro- ductive efficiency and environmental acceptability. Biotechnology is key to this innovation. American agriculture has achieved its preeminence through in- novation and substitution of knowledge for resources. This trend must continue. Yet technological innovations cannot revitalize American agriculture unless farm business management, farm pol- icy, the U.S. Department of Agriculture (USDA), land-grant uni- versities, extension services, and private sector businesses that serve agriculture are innovative. Leadership in technology development and utilization is the role the United States has, can, and should play for the world. American farmers can take the lead in adopting new biotechnolo- gies. These technologies should emphasize maximizing economic yield rather than total production. That is, they should increase the efficiency of production by reducing the costs of production. Such technologies become increasingly important as support prices are removed and world competition stiffens. A focus on increasing profit by reducing costs requires aug- menting our knowledge in the agricultural sciences, especially those fundamental disciplines that underlie biotechnology devel- opment. For example, how can one design crops that grow more efficiently and yield more nutritional food? Research will open the

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13XECUTIVE SUMMARY AND RECOMMENDATIONS 3 door to ever better technologies and products. In both research and development, our USDA laboratories, land-grant universities, and other public and private institutions have a critical role to play. THE POWER OF BIOTECHNOLOGY The power of biotechnology is no longer fantasy. Biotechnolo- gy the use of technologies based on living systems to develop commercial processes and products now includes the techniques of recombinant DNA, gene transfer, embryo manipulation and transfer, plant regeneration, cell culture, monoclonal antibodies, and bioprocess engineering. Using these techniques, we have be- gun to transform ideas into practical applications. For instance, scientists have learned to genetically alter certain crops to increase their tolerance to certain herbicides. Biotechnology has also been used to develop safer vaccines against viral and bacterial diseases such as pseudorabies, enteric colibacillosis (scours), and foot-and- mouth disease. Yet we have barely scratched the surface of the many potential benefits the tools of biotechnology will bring. Biotechnology offers new ideas and techniques applicable to agriculture. It offers tools to develop a better understanding of living systems, of our environment, and of ourselves. Yet continued advances will take a serious commitment of talent and funds. Biotechnology offers tremendous potential for improving crop production, animal agriculture, and bioprocessing. It can pro- vicLe scientists with new approaches to develop higher yielding and more nutritious crop varieties, improve resistance to diseases and adverse conditions, or reduce the need for fertilizers and other ex- pensive agricultural chemicals. In animal agriculture, its greatest immediate potential lies in therapeutics and vaccines for disease control. Bioprocessing-the use of living systems or their com- ponents to create useful products-offers opportunities to man- ufacture new products and foods, treat and use wastes, and use renewable resources for fuel. Biotechnology could also improve forestry and its products, fiber crops, and chemical feed stocks.

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4 AGRICULTURAL BIOTECHNOLOGY STRATEGIES FOR NATIONAL COMPETITIVENESS It is important to develop a national strategy for biotechnol- ogy in agriculture because biotechnology offers opportunities for increased sustainability, profitability, and international competi- tiveness in agriculture. Such a strategy should address improving the full spectrum of activities, from the quality and direction of research to the realization of the benefits of this research in agri- cultural production. Research Emphasis The potential benefits of biotechnology will not be realized without a continued commitment to basic research. Six research areas merit emphasis. 2. 1. Gene identification-locating and identifying agricultur- ally important genes and creating chromosome maps. Gene regulation understanding the mechanisms of reg- ulation and expression of these genes and refining the methods by which they may be genetically engineered. 3. Structure and function of gene products understanding the structure and function of gene products in metabo- lism and the development of agriculturally important traits. 4. Cellular techniques developing and refining techniques for cell culture, cell fusion, regeneration of plants, and other manipulations of plant and animal cells and em- bryos. 5. Development in organisms and communities under- standing the complex physiological and genetic interac- tions and associations that occur within an-organism and between organisms. 6. Environmental considerations-understanding the behav- ior and effect of genetically engineered organisms in the environment. The Research System Funding and institutions provide the foundation for progress in biotechnology. A Tong-term commitment of adequate support

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EXECUTI VE SUMMARY AND RECOMMENDA TIONS 5 is critical because biotechnology requires a substantial initial in- vestment to acquire and build upon basic knowledge. Applying biotechnology to agriculture will put new demands on existing relationships among research institutions, will influence patterns of funding, and will alter established pathways between research discoveries and commercial developments. The USDA and the land-grant university system have been the keystones of our national agricultural research system, and they will continue to play an important role in developing biotech- nologies. Yet the emergence of biotechnology has brought a variety of new actors in particular, non-land-grant universities and pri- vate companies- into agriculturally related research. An alliance is emerging between public sector basic science and private sector technology development, which should be exploited and enhanced in the area of biotechnology. A variety of federal, state, and private institutions support agriculturally relevant research. The current total annual expen- diture for agricultural research by these institutions is roughly $4 billion. Private industry spends about $2.1 billion annually, mostly on proprietary technology development. The federal-state agricultural research system spends about $1.9 billion annually. The current agricultural research system depends on basic re- search, applied research, technology development, and technology transfer (which includes extension). Basic and applied research overlap in biotechnology to perhaps a greater extent than in tra- ditional areas of agricultural science. In realigning the system to promote biotechnology, communication is essential among basic researchers, applied researchers, and farmers and private compa- nies, the end users of technology. For the agricultural research system to be most effective, links among the disciplines of science that support agriculture as well as links between basic and ap- plied research and technology development and transfer must be strengthened. Peer review must be a key component of any step taken to strengthen and improve the agricultural research system. Peer re- view, which in its broadest form is also called merit review, is one of the most effective mechanisms available to ensure that federal dollars are invested in high-quality research and that judgments made in allocating research funds are equitable and discerning.

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6 AGRICUlTU~L BIOTECHNOLOGY Careful attention to the objectivity, quality, and breadth of ex- pertise represented on review panels is necessary to ensure sound ~ . cleclslons. New Talent Implementing advances in biotechnology in agriculture will require a work force of highly skilled scientists who can apply molecular biological techniques to agricultural problems. Be- cause biotechnology research spans a continuum from basic science through practical application, its practitioners must be conversant with the general biology of an organism, with the biochemical and genetic details of its life cycle, and with the needs of modern agriculture. There is an increasing demand for scientists competent with the tools of biotechnology in academic, government, and indus- trial laboratories. Yet insufficient federal training programs exist to fulfill these needs, and the few programs currently in place are continually in jeopardy because of budget cuts. Increased federal support for graduate education and postdoctoral training in rel- evant areas is necessary to ensure the supply of scientists. Four types of programs merit increased federal support: pre- and post- doctoral fellowships, training grants, career development awards, and retraining opportunities. As with other effective national programs, these should be adrn~nistered on a peer-reviewed, com- petitive basis. Applications and Commercialization The goal of technology transfer has always been implicit in U.S. science policy: Federally funded research should benefit the public, and such benefit includes the development and transfer of technologies from public laboratories to private industry. Trans- lating basic research discoveries into commercial applications and social benefits requires a complex set of interactions involving many types of people and institutions. Universities as well as state and federal agencies are expanding their relationships with the private sector as they explore ways to increase scientific com- munication and the flow of technology. The rapid rate of breakthroughs in molecular biology and biotechnology and their potential commercial applications have led

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EXECUTIVE SUMMARY AND RECOMMENDATIONS 7 to more formal and aggressive transfer of biotechnology. The shift has promoted collaborative research relationships between pub- licly supported scientists in universities and federal laboratories and those in the private sector. Consultancies, affiliate programs, grants, consortia, research parks, and other forms of partnership between the public and private sectors foster communication and technology transfer. The scientific advances that made biotechnology possible came out of basic research funded mainly by the federal government and carried out primarily at universities. Research in other nations has also made valuable contributions to this area of science. In contrast, industry's support for basic research is quite limited and cannot be expected to compensate for a reduction in federal funding. Thus, continued research efforts at universities remain highly dependent on federal and state governments for support. Patenting, licensing, and regulatory issues are all areas that affect the rate and cost of technology transfer. In agricultural biotechnology, technology transfer has been hindered by federal government delays in implementing a mechanism to regulate en- vironmental testing of the products of biotechnology. Although patent policy has been modified at the federal level to overcome obstacles that had kept government- and university-sponsored re- search from being commercially exploited, many government and university institutions retain policies that inhibit the transfer of technology to industry. Of particular importance in technology transfer from federal laboratories will be implementation of the Federal Technology Transfer Act of 1986. RECOM1~:NDATIONS Biotechnology offers both challenge and tremendous opportu- nity. The Committee on a National Strategy for Biotechnology in Agriculture recommends the following actions as constructive steps in developing and implementing a strategy to utilize biotech- nology to improve U.S. competitiveness in agricultural production. Such a strategy addresses not only the science aspects of biotech- nology, but also the policy areas of funding and institutions, train- ing, and technology transfer. ,i

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8 AGRICULTURAL BIOTECHNOLOGY Scientific Aspects INCREASED EMPHASIS ON BASIC RESEARCH Basic research programs in physiology, biochemistry, genet- ics, and molecular biology within agricultural disciplines such as agronomy, entomology, and animal science need to be strengthened and in many cases redirected to questions of identifying genes and understanding the regulation of their expression. Just as an enor- mous information base has provided a substructure for sweeping advances in biomedical science, a similar foundation of knowledge is now needed about the basic biochemistry, physiology, and ge- netics of such agricultural subjects as host-pathogen interactions, plant and animal developmental responses to environmental stim- uli, enzymes and metabolic pathways, and molecular constituents and their patterns of organization in subcellular organelles. Ac- quiring such knowledge will affect the rate at which agriculturally valuable genes can be identified, isolated, and characterized, and is a prerequisite for anolvinF the tools of hint.~rkn~l~`r t.n z.~rir,~l tural problems. Or r -a -ice ~_ O ~O IMPROVED TECHNIQUES AND APPLICATIONS The repertoire of molecular biology and cell culture techniques needed to implement advances in genetic engineering is incomplete. Methods for gene transfer in many plants, animals, and microbes; plant cell culture and regeneration; and animal embryo culture and manipulation are inadequate to support the goal of improving agricultural productivity. Increased efforts are needed to apply techniques developed for laboratory organisms to those plants, animals (including insects), and microbes relevant to agriculture. A national effort should be mounted by both public and pri- vate sectors to apply techniques of biotechnology to problems in the agricultural sciences. This effort should include research on: . Gene identification locating and identifying agriculturally important genes and creating chromosome maps. . Gene regulation understanding the regulation and expres- sion of these genes and refining methods by which they may be genetically engineered.

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EXECUTIVE SUMMARY AND RECOMMENDATIONS 9 . Structure and function of gene products-studying the struc- ture and function of gene products in metabolism and the development of agriculturally important traits. . Cellular techniques developing and refining techniques for cell culture, cell fusion, regeneration of plants, and other ma- nipulations of plant and animal cells and embryos. Development in organisms- using the new technology to study cell and organismic biology in intact organisms. . Development in communities understanding the complex as- sociations and interactions that occur among organisms. INCREASED ATTENTION TO THE ECOLOGICAL ASPECTS OF BIOTECHNOLOGY Both the public and private sectors should increase their ef- forts to develop an extensive body of knowledge of the ecological aspects of biotechnology in agriculture. In particular, studies must be done to further our understanding of the behavior and effects of genetically engineered organisms. In addition, the public must be educated about biotechnology. These efforts are essential to support future applications of biotechnology and to adequately inform regulators and the public about both the benefits and pos- sible risks involved. Fending and Institutions LINKING AND INTEGRATING RESEARCH The tools and approaches of biotechnology are equally rele- vant to science-oriented research and technology-oriented research. Biotechnology can strengthen as well as benefit from improved linkages between basic scientific research and research to adapt technology to agricultural problems. Equally important, differ- ent disciplines within biology and agriculture can collaborate to integrate knowledge and skills toward new advances in agriculture. New approaches to agricultural research are needed to estate fish productive linkages between basic science and its applications as well as interdisciplinary systems approaches that focus a num- ber of skills on a common mission. Just as biochemistry, genetics, molecular biology, and fields of medicine have successfully joined

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10 AGRICULTURAL BIOTECHNOLOGY forces to solve medical problems, integration of these scientific disciplines for agricultural research must be promoted and sup- ported by appropriate recognition and reward through university, industry, and government channels. First, universities should establish graduate programs that cut across departmental lines; recognize and reward faculty contri- butions to cooperative research programs; promote collaborative projects and exchanges between researchers in land-grant univer- sities, non-land-grant universities, industry, and government lab- oratories; and recruit faculty to create interdisciplinary research programs that can attract competitive funding. Faculty should be selected by departments or groups representing two or more disci- plines (e.g., genetics and entomology or biochemistry and botany). Second, federal and state governments should support the establishment of collaborative research centers, promote interdis- ciplinary conferences and seminars, support sabbaticals for gov- ernment scientists and other exchange and retraining programs with universities and industrial laboratories, and provide funding for interdisciplinary-program project grants. PEER AND MERIT REVIEW A peer and merit review process must be used to assess and guide the development of the agricultural biotechnology research system, including all steps from basic science to extension. The participants and procedures in the review process should be organized to match the nature of the tasks and programs re- viewed and must include individuals outside the organization as well as experts from relevant disciplines and from basic and applied research programs. Efforts must be made to broaden the expertise represented on review panels in order to best examine the quality and relevance of work with minimal bias. The benefits of peer and merit review- properly done and heeded-are continuous monitoring of research advances; more efficient, relevant, and higher quality research; and increased communication and respect among scientists. THE F EDERAL G OVERNMENT ' S ROLE It is logical that primary funding for agricultural biotechnol- ogy should be achieved through the USDA. Unfortunately, funding

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EXECUTIVE SUMAI4RY AND RECOMMENDATIONS 11 for both intramural and extramural basic research within USDA is well below that of other federal agencies. USDA has recognized the need to support basic research and is attempting to do so, albeit not as rapidly as might be optimal. Funding increases are needed. Allocation of new and even redirected funding should be based principally on competitive peer and merit review. Any increase in funding at USDA should not come at the expense of appropriations to other federal agencies that support biological research relevant to agriculture. This is because it is not always clear where innovation applicable to agricultural biotech- nology might arise. However, some existing research program funds should be redirected within USDA to heighten the prior- ity given to biotechnology. USDA should also emphasize related fundamental research on animals and plants, the lack of which is impeding the application of biotechnology to livestock and crop improvement. Funding for competitive grants through USDA must be of a size and duration sufficient to ensure high-quaTity, efficient research programs. The recommended average grant should be increased to $150,000 per year for an average of 3 years or more. This level of funding is consistent with the current average support per prin- cipal investigator used by industry and the USDA's Agricultural Research Service (ARS) intramural research programs. The dura- tion of these competitive grants is also in accord with the recent recommendation: Of equal importance with the level of funding is the stabilization of federal support to permit more effective use of financial and human resources.... Federal agencies "should] work toward an average grant or contract duration of at least three, and preferably five, years. (White House Science Council, 1986) The committee recommends that competitive grants by all agencies in the federal government for biotechnology research re- lated to agriculture total upwards of $500 million annually, a level that could support 3,000 active scientists. This level of support should be achieved by 1990, primarily through competitive grants administered by USDA and the National Science Foundation.

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12 AGRICULTURAL BIOTECHNOLOGY T HE S TAT E G OVERNMENTS ' ROLE States should continue to strengthen their already major role in agricultural research and training through their support of uni- versities and research stations that conduct regional research. They should continue to focus on identifying regional interests and on supporting the training of personnel needed in agriculture. The states should also evaluate programs in agricultural biotech- nology and the role such programs can and will play in each state's economy. THE PRIVATE SECTOR'S ROLE The private sector's traditional emphasis on product devel- opment is not likely to change, even though there has been a dramatic increase since 1980 in private sector investment in high- risk basic research in agricultural biotechnology. Because public sector investment provides skilled manpower and the knowledge base for innovation, industry should act as an advocate for publicly supported training and research programs in agricultural biotech- nology. Industry can also support biotechnology research through direct grants and contracts to universities, cooperative agreements with federal laboratories, and education to inform the general pub- lic about the impacts of agricultural biotechnology. Foundations should be encouraged to support innovative sci- ence programs in order to maximize their potential for having sub- stantial influence in important areas. The McKnight Foundation's interdisciplinary program for plant research and the Rockefeller Foundation's efforts to accelerate biotechnology developments in rice are noteworthy examples. Other foundations should address equally important experiments in technology transfer and exten- sion for agricultural biotechnology. Training Scientists, administrators, faculty, and policymakers in all sectors should be aware of the importance of state-of-the-art ed- ucation and training to the future development of agricultural biotechnology. Specifically, the committee makes the following recommendations.

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EXECUTIVE SUNDRY AND RECOMMENDATIONS . 13 INCREASED FEDERAL SUPPORT FOR TRAINING Major increases in federal support for training programs are urgently needed to provide a high-quality research capability that ensures the future of U.S. agriculture and meets the growing need for scientists trained in agricultural biotechnology. Four types of programs must be supported: pre- and postdoctoral fellowships, training grants, career development awards, and retraining oppor- tunities. These approaches, used successfully in the biomedical sciences, have put the United States in the forefront of human medical advances. These programs should be administered on a peer-reviewed, competitive basis. USDA should support at least 400 postdoctoral positions at universities and within the ARS, which represents a quadrupling of the present number, and main- tain strong support for graduate-level training. INCREASED RETRAINING PROGRAMS For the short term, highest priority should go to increasing the retraining opportunities available to university faculty and federal scientists to update their background knowledge and provide them with laboratory experience using the tools of biotechnology. This retraining will expand the abilities of researchers experienced in agricultural disciplines. USDA should take the lead in adminis- tering a program to supply at least 150 retraining opportunities a year for 5 years, starting in FY89. Technology Transfer ROLES FOR UNIVERSITIES AND GOVERNMENT AGENCIES Universities and state and federal agencies are expanding both the nature and number of their relationships with the private sec- tor as they explore ways to increase scientific communication and the flow of technology. The federal government, granting agen- cies, and public and private universities should encourage interdis- ciplinary research, partnerships, and new funding arrangements among universities, government, and industry. The Federal Tech- nology Transfer Act of 1986 provides new incentives to federal scientists in this regard. Consultancies, affiliate programs, grants, consortia, research parks, and other for rns of partnership between

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14 A GRICULTUR~4L BIO TECHNOL OG Y the public and private sectors that foster communication and tech- nology transfer should be promoted. The USDA, State Agricul- tural Experiment Stations, and the Cooperative Extension Service (CES) should emulate other agencies such as the National Insti- tutes of Health and the National Bureau of Standards in forming innovative affiliations to increase technology transfer. COOPERATIVE EXTENSION SERVICE The CES should focus some of its efforts on the transfer of biotechnology research that will prove adaptable and profitable to the agricultural community. It should train many of its special- ists in biotechnology and increase its interactions with the private sector to keep abreast of new biotechnologies valuable to the agri- cultural community. Furthermore, CES should work to anticipate and alleviate social and economic impacts that may result from the application of biotechnologies. CES should also play a key role in educating the public about biotechnology. PATENTING AND LICENSING Patenting and licensing play necessary roles in advancing tech- nology transfer and assuring the commercialization of research re- sults, especially in capital-intensive fields such as biotechnology. Patenting and licensing by universities and government agencies should be encouraged as key instruments used to transfer tech- nology. Universities and government agencies should provide in- centives to their scientists to encourage patenting. Public policy should encourage state land-grant universities to confer exclusive licenses on patents to private companies with the resources, mar- keting, and product interests required to translate these discoveries into commercial products. REGULATION OF FIELD TESTING The government's uncertainty over appropriate regulatory steps has fueled public controversy over the assessment of possible environmental risks from genetically engineered agricultural prod- ucts. USDA, the Food and Drug Administration, and the Environ- mental Protection Agency must formulate, publish, and implement a research and regulatory program that is based on sound scientific

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EXECUTIVE SUMAL4RY AND RECOMMENDATIONS 15 principles. Initially, 5-10 selected, already-existing publicly owned field stations should be available as an option for environmental re- lease testing, professionally managed by an oversight committee of public sector scientists with expertise in agronomy, ecology, plant pathology, entomology, microbiology, molecular biosciences, and public health. This interim program should be designed to gain scientific information and practical experience with field testing and to protect the public safety. The current lack of adequate reg- ulatory procedures is halting progress in applying biotechnologies to agriculture.