Statement for Senate Committee on Agriculture, Nutrition, and Forestry

October 6, 1999

Ralph W. F. Hardy, President

National Agricultural Biotechnology Council

Boyce Thompson Institute for Plant Research, Inc.

Tower Road

Ithaca, NY 14853-1801

It is a pleasure to participate in this hearing on agricultural biotechnology and this panel focused on the science, its applications, and the opportunity for U.S. and world consumers to be major benefactors. Potential U.S. consumer benefits include increased security and sustainability in our food supply but also our health, energy, environment, and economy. Food will be more healthful, nutritious, and even safer. The relationship between food, health, and medicine will become more seamless as will be documented by examples presented by this panel. Agricultural crops will become major sources of economically competitive energy, chemicals, and materials significantly replacing fossil based products that can have negative health, environmental, and economic consequences. The consumer needs to be informed of these potential products in the research pipeline so they can balance the benefits to them versus the fears generated by undocumented risks currently dominating public media. Although the consumer may be led to believe that foods from genetically engineered sources are more risky to the environment and their health than traditional sources there is no evidence to support this view and the nature of the genetic engineering process supports less risk.

Let me introduce myself. I am President of the National Agricultural Biotechnology Council (NABC), a consortium of most of the leading not-for-profit agricultural research and educational institutions in the United States and Canada. There are twenty-eight U.S. members and two Canadian members. The council members are senior management of their institutions. NABC was formed in 1989 to provide an open forum to address in a timely way critical issues regarding the safe, efficacious, and equitable development of agricultural biotechnology. NABC has held eleven fora since 1989 on the following topics hosted by the indicated institutions sustainable agriculture (Iowa State University), food safety and nutritional quality (Boyce Thompson Institute and Cornell University), socioeconomics (University of California, Davis), animal biotechnology (Texas A&M University), risk (Purdue University), public good (Michigan State University), gene discovery, ownership, and access (University of Missouri), novel products and partnerships (Rutgers University), challenged environments (University of Saskatchewan), environmental quality gene escape and pest resistance (Clemson University), and industrial consolidation and world food security and sustainability (University of Nebraska). Biobased industrial products (University of Florida) will be the topic in May 2000. These combined presentation /workshop meetings are attended by a broad range of stakeholders from farmer/growers to industry to activist groups to government and academe. The meetings increase understanding and identify specific issues and, most importantly, build trust across stakeholders. About 7,000 copies of these books compiling the results of these open fora are distributed annually to leaders and interested individuals.

I am also a board member of the AARC Corporation of USDA, which makes venture capital investments for early stage commercialization of biobased industrial products made from plant or animal materials. Previously, I have been President/CEO of the Boyce Thompson Institute for Plant Research, Inc. at Cornell University, President/COO of BioTechnica International, and Director of Life Sciences at E. I. DuPont.

The Biobased Economy

The NABC recognized the need for a vision statement for agriculture and agricultural research and development in the 21st century. They envisioned a major expansion of the role of agriculture beyond food, feed, and fiber to include the emerging biobased industrial product area. They proposed that agricultural research and development should take the lead in providing technology for the biobased economy of the 21st century. They noted that the biobased economy would be rooted in life science and its application technology, biotechnology, the current dominant science and technology coupled with engineering processes and supported by the physical sciences, information technology, and economics. A copy of the 1998 NABC Vision for Agricultural Research and Development in the 21st Century with the signed support of 26 senior managers of public-sector agricultural research is attached. This vision statement identified multiple benefits of the biobased economy to U.S. society and consumers. It identifies increased security and sustainability in food, health, energy, environment, and national and rural economies. The National Research Council (NRC) Report on Biobased Industrial Products issues in 1999 outlines in some detail the opportunity for the biobased economy and targets for expanded agricultural research and development. The NABC Vision and NRC Report are consistent with S.935 and the President's Executive Order of August 12, 1999 on Developing and Promoting Biobased Products and Bioenergy. Today's panel will focus on food, health, and chemical examples in the biobased economy.

Language and Process

I will make some comments on the language and process of biotechnology. This panel will focus on the molecular techniques of agricultural biotechnology. These molecular techniques are sometimes referred to as genetic engineering and produce genetically engineered organisms (GEOs). These organisms may be microorganisms, plants, or animals. In some cases they are referred to as genetically modified organisms (GMOs) but this terminology is confusing since traditional plant and animal breeding utilizing organismal techniques also produces genetically modified organisms with improved traits, as does genetic engineering. These molecular techniques or genetic engineering permit the directed movement of one or more specific genes, the units of genetic information from one organism to another. The movement may be within a genus as in traditional breeding, but also includes movement between genera. Molecular movement of genes from one organism to another produces what scientists call a transgenic organism. The product from the transferred gene is called a transgenic product. Often a marker gene is included along with the desired gene(s) in the directed movement so as to facilitate the easy identification of the organism with the desired added gene(s). The objective of traditional breeding is to improve the traits (genes) of a plant or animal such as improved yield or quality or disease and pest resistance. The parallel objective of genetic engineering is to improve the trait genes of a microorganism, plant, or animal such as improved yield, or qualities, or disease and pest resistance. Plant breeding uses massive transfer of genes - about 30,000 different genes in the case of plants - and subsequent sorting, while genetic engineering selects and transfers only those genes - two or a few in most cases to date - for the desired benefit and identification. The massive sorting required for traditional breeding is eliminated in genetic engineering.

Molecular methods of genetic improvement in especially crop plants are enabling a powerful directed-design approach. Our improved understanding of biology is leading to principles or laws e.g., genes are the units of genetic information; DNA/RNA are the elements of genes; DNA double helix structure, and its self replication; DNA (top management molecules) directs RNA formation (middle management molecules) directs protein formation (worker molecules); and protein folding for its cellular function. The information base of biology such as genomic sequences is exploding with a predicted 100X increase in the next decade. The tools for gene identification and use for improved organisms, e.g. plants, are available but will see major improvement with replacement of antibiotic-resistant marker genes and development of site-specific introductions of genes. The combination of laws/principles, information, and tools will improve our ability to do directed designed improvements of agricultural organisms and to make products even safer through the asking and answering of the key risk questions. However, no guarantee of absolute safety can ever be made for anything.

Relative Risk

The inherent risk to the environment and human health in genetic improvement has declined as we have progressed from the highly random whole organism process of traditional breeding to the directed molecular process of genetic improvement. The ability to ask and answer the important risk questions is key to minimizing risk. This ability is much greater for the molecular than the whole organism process. For example, selection of plants from the wild in the emerging days of agriculture was highly risky because there was only crude ability to ask and answer risk questions.

Plant breeding enables much improved but still somewhat limited ability to ask and answer risk questions. For example, plant breeding may use a wild relative of a highly domesticated crop to provide a disease resistance trait to the domesticated plant. In simple terms, the about 30,000 different genes of the wild plant with only a very few of those genes providing the disease resistance trait are mixed with the about 30,000 different genes in the domesticated plant. A major sorting process follows to retain the few desired genes for disease resistance and eliminate especially those genes from the wild relatives that will produce an undesirable outcome such as reduced yield, quality, or any other outcome that is agronomically or consumer undesirable. However, one does not know all the important risk questions to ask to assure that all the undesirable genes have been eliminated from the improved domesticated plant. An example of a failure to ask the right risk questions is male-sterile cytoplasm (MSC) corn. MSC corn was useful in hybrid corn production eliminating the need for physical detasseling. In the early 1970s, the MSC trait dominated hybrid corn production. However, the MSC trait was also accompanied by an unrecognized trait of susceptibility to southern corn blight disease. About 15 percent of the U.S. corn crop in the early 1970s were lost to this disease because the knowledge to ask the risk question about the disease trait did not exist. Inspite of the incomplete ability to ask the right risk questions the overall experience with plant breeding has been relatively low in risk.

An example of asking and answering the important risk question occurred in the molecular effort to genetically engineer soybeans with a high content of the amino acid, methionine, whose content is limiting in soybeans. A gene that produces a high methionine content in Brazil Nuts was used. It was known that Brazil Nuts could be allergenic. Dr. S. Taylor, an expert in allergenicity at the University of Nebraska was asked to assess the high methionine protein for allergenicity. The protein was found to be allergenic and the project terminated.

The commercialized products of agricultural and food biotechnology involve minimal compositional change with, for example, the use of a single gene producing a protein with minimal change. The nutrients available for absorption by our body following digestion of a specific food product made from, for example, a herbicide-tolerant soybean crop and its genetic mate that is not herbicide tolerant are essentially identical and less different, on average, than the nutrients available from consumption of different cultivars of soybean. A similar statement could be made for a Bt insect-resistant crop and its non-Bt crop mate. The modest and known changes in the molecularly improved crops to date are correctly viewed as substantially similar to their non-improved genetic mates.

Experience to Date

The commercialized agricultural and food transgenic products to date include chymosin for cheese making, bovine somatotropin for increased milk productivity, and herbicide-tolerant and insect-resistant crops. The favorable experience with these products to date is informative.

Cheese making until 1990 used mainly rennin, a preparation from animal stomachs, to coagulate the milk proteins. The active natural chemical in the animal stomach is a protein/enzyme called chymosin. The product, usually from a slaughtered calf stomach, is only about two percent chymosin. The lack of a consistent and reliable supply of this crude product encouraged the isolation of the animal gene for chymosin and introduction of that gene into bacteria and yeast. The transgenic bacteria or yeast are grown in highly controlled fermentors, and a product that is highly purified-98+ percent pure chymosin-is produced. The generic name for this product is fermentation-produced chymosin or FPC. The chymosin in FPC is chemically identical to that in the calf stomach but is highly pure, consistently available, and highly effective in cheese making. FPC was approved by FDA in 1990 and is the first transgenic product used in food making. By 1994 FPC was approved as kosher, halal, and vegetarian and had about 60 percent market share in cheese making. This year the estimated market share for FPC in cheese making in Canada and the U.S. is 80 to 90 percent. This very high market share of FPC demonstrates efficacy in cheese making, and the broad approvals indicate its acceptance. We have almost ten years of favorable experience with this food product made by a genetically engineered organism. Any person who eats cheese in Canada and the U.S. has been eating a food whose processing involves a transgenic food product. I personally like to think that my cheese is being made with a highly pure product, made under highly controlled conditions rather than an extremely crude product obtained from a slaughterhouse source. This is the premier story and major consumer experience base in food biotechnology.

The next product of agricultural biotechnology was bovine somatotropin (BST) approved by FDA for increased milk productivity in 1994. This product has maybe only 30 percent U.S. market penetration in contrast to chymosin's 80-90 percent market share. Canada has not approved the product, expressing a concern about dairy-cow health and at the same time finding no identified concern about human health. Much controversy has surrounded this product, and this controversy has been used by opponents to question all of agricultural and food biotechnology.

The more recent product introductions include herbicide-tolerant soybeans, corn, and canola and Bt-containing cotton, corn, and potatoes for protection against certain pest insects - agronomic advantages. The approval of these transgenic crops began in the mid 1990s. Rapid market penetration of the transgenic soybean, corn, cotton, and canola products occurred with 50 percent or more of the U.S. and Canadian acreage of these crops now transgenic, suggesting that farmers/growers see advantages to these crops. These transgenic crops are benefiting the agribusiness companies that own and market them and the farmers/growers who use them; another major benefactor in several cases is the environment including the agroecosystem. Herbicide-tolerant crops allow the use of highly effective herbicides with a field-activity duration of days versus most traditional herbicides with a field activity of months and in some cases years. Thus, the agroecosystem has the advantage of the use of short-lived herbicides, which increases the ability to practice crop rotation and removes any possible consumer concern that the herbicide might remain in the harvested product. I am amazed that public-interest groups with their major interest in environmental protection are opposing rather than aggressively promoting herbicide-tolerant crops. The issue of the possibility of escape of the transgenic herbicide-tolerant gene to wild and weedy relatives is raised, but in the case of soybeans and corn, wild and weedy relatives do not occur in the U.S. thereby eliminating that risk. The same statement could not be made for sorghum and, to my knowledge, there is no herbicide-tolerant sorghum product in the pipeline. Industry is being environmentally responsible in its selection of commercial targets.

Crops such as corn, soybeans, and canola are the sources for a large number of food products. There is a minimal change in genes (only two of about 30,000 different genes in the transgenic crops to date). As a result, there will only be minimal change in proteins mimicking that in the genes. The building blocks of these introduced genes and resultant proteins are similar to those in the large number of genes and proteins already in the crop. The amount of any of these introduced genes or resultant proteins in the food product is exceedingly small and these genes and proteins are digested to the same basic chemical nutrients as any other gene or protein.

Consumer Benefits

The consumer, to date, does not perceive a direct benefit from agricultural biotechnology. Some of this may be the failure to communicate the positive story to the consumer of FPC chymosin, and use of short-lived herbicides. Also the historic fact that improved agricultural technology initially provides economical benefits to the farmer/grower but ultimately the consumer receives the major benefit in reduced prices of food staples.

There are a number of potential products in the research pipeline where the consumer will easily relate to the benefits. Today's panel will describe several of these. Dr. Charles Arntzen's laboratory at the Boyce Thompson Institute for Plant Research, Inc. is developing edible vaccines in transgenic plants. Clinical trials of a hepatitis vaccine in potatoes were initiated earlier this summer. These edible vaccines could be attractive as oral rather than injection-delivery systems in the developed world and possibly the only broadly workable delivery system in the developing world where refrigerated vaccine storage and injection is not broadly available. Dr. Dean Della Penna from the University of Nevada will describe transgenic plants with increased vitamins for improved health. Oil seeds with increased amounts of the antioxidant vitamin E may be beneficial to cardiovascular and other areas of health. Rice with increased beta-carotene/vitamin A could be very important in reducing blindness due to inadequate vitamin A in the developing world where rice is the major food crop.

Some of our major foods such as milk, wheat, peanuts, etc. have major allergenicity problems for a fraction of the U.S. population. It is my understanding from Dr. Taylor that hypoallergenic rice has been made in Japan using molecular biotechnology. Other scientists are focusing on peanut allergy. Dr. Robert Buchanan at the University of California-Berkeley, is modifying the three-dimensional structures of allergenic proteins to reduce their allergenicity. Dr. Roger Beachy of the Danforth Center for Plant Research has been a leader in developing viral-resistant crops. Papaya, a consumer crop grown in Hawaii, has benefited from his technology as well as other crops in developing countries.

Physical and chemical stresses are major limitations in crop productivity especially in parts of the world where there is severely limited food supply. Dr. Walter Hill of Tuskegee University will describe a novel new program involving universities and government to genetically engineer crops with increased stress tolerance. Dr. John Ohlrogge of Michigan State University will provide examples of plant modification to improve their value as oils for biobased industrial products. Dr. Ray Bressan of Purdue University will describe molecular approaches for drought tolerance. The need for such tolerance in the Eastern U.S. was great this year. Dr. Brian Larkins will discuss proteins with improved nutritional value and relevance to improved health.

In addition, there are other research stage biotechnology products that will directly benefit consumers. Antibodies (plantabodies) to dental-decay organisms are being produced in plants for use in dental health. Brushing with these plantabodies reduces decay. Genes from Jerusalem artichoke have been placed into sugar beets that then produce fructans rather than sucrose. Fructans are not digestible. Short-chain fructans taste sweet and may have use as low-calorie sweeteners. Long-chain fructans form emulsions with the mouth-feel of fat but are not digestible - the desirable fat taste without caloric consequences! A genetically modified tomato is being used to make an improved puree in Europe. This marketed product is identified as coming from a genetically engineered tomato. Model experiments with transgenic mice produced milk with a 50-80 percent reduction in lactose; similarly transgenic dairy animals might produce low-lactose milk that would be attractive to people with lactose intolerance. A plant-produced vaccine has shown early effectiveness against a cancer. A transgenic pig produces phytase, thereby enabling increased use of phosphorus in feed and reducing the need for additional phosphate and thereby reducing phosphate-producing pollution by manure. There are many examples where pharmaceuticals are being produced in transgenic plants or animals and potential efficacy is being shown. The consumer will receive many direct benefits of agricultural biotechnology.

The 21st Century could and should be the golden era of agriculture. Science will use the expanding laws/principles of biology, the exploding information base, and improved tools to design products with value to the agri-input industry, the food-processing and delivery industry, the biomedical industry, and the energy, chemical, and materials industries, the farmer/grower, and ultimately, in all cases for the end-user, the consumer. Genetic improvement of microorganisms, plants, and animals using molecular approaches that are variously identified as genetically engineered organisms, transgenic organisms, or genetically modified organisms, or molecularly modified organisms have received and continue to receive extensive scientific examination regarding risks to the environment and to humans. These risks must be evaluated relative to those of existing products that they would replace. Genetically engineered crops are inherently less risky because of the ability to better ask and answer the important risk questions than for existing processes. In some cases, such as herbicide tolerance, the products are much more favorable to the environment than the products/procedures they are replacing - use of herbicides that last days, not months or years. We must continue to aggressively ask and answer the risk questions such as was done in the early identification of the allergenicity of the high-methionine Brazil-nut protein and the discontinuation of the development of this product long before it reached the consumer. Many are understandably concerned about foods from transgenic crops because they are perceived as new and different. Comfort will grow as the consumer has favorable experiences. The use of FPC chymosin in cheese making represents about a decade of favorable experience with a food product. The overall compositional changes in genetically engineered crops to date are very, very, very small - two in 30,000 -and on average much less than that between some different cultivars of the same crop. The products in the pipeline provide consumer benefits from more nutritious food to more healthy food to consumer products, e.g. polymers, from sunlight and green plants rather than fossil fuels and industrial plants. The future will be exciting and beneficial for the consumer.

___________________________________________________________

National Agricultural Biotechnology Council (NABC)

Jane Baker Segelken, Executive Coordinator

419 BTI, Tower Road e-mail NABC@cornell.edu

Ithaca, NY 14853 phone 607-254-4856

fax 607-254-1242

http//www.cals.cornell.edu/extension/nabc

Save the Date

NABC 12th Annual Meeting - May 11-13, 2000

Hosted by University of Florida in Orlando, Florida

The Bio-Based Economy of the Twenty-First Century Agriculture Expanding Into Health, Energy, Chemicals and Materials