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Rise And Fall Of Biotech Potatoes: Why And Where Next?
Dr. George Kennedy
Department of Entomology, North Carolina State University

Transgenic potato varieties expressing the Cry 3A δ-endotoxin of Bacillus thuringiensis tenebrionis (san diego) were commercialized for control of Colorado potato beetle in 1996 by NatureMark, Inc. (owned by Monsanto) under the trade name Newleaf® . Newleaf® varieties provided excellent control of insecticide resistant Colorado potato beetle populations and their introduction was greeted with high expectations. However, planting of Newleaf® varieties peaked at 20,000 hectares in 1998 and by March of 2001 NatureMark removed them from the market. Despite their effectiveness in controlling the potato beetle, they were at a competitive disadvantage against the newly introduced insecticide imidacloprid (Admire® ), which was equally effective in controlling Colorado potato beetle and, unlike the Newleaf® varieties, also controlled aphids and leafhoppers. The willingness of potato growers to embrace the Newleaf® varieties was further dampened by reports of sporadic occurrences of reduced yields with some lots of the Newleaf® variety 'Atlantic' and delayed maturity and variable tuber quality in the Newleaf® variety 'Superior.' The death knell for Newleaf® potatoes sounded when the largest potato buyers/processors announced that they would not buy genetically modified potatoes in 2001 due to public relations concerns associated with marketing genetically modified foods.
The experience of Bt-potato clearly indicates that efficacy against a key pest is not sufficient to ensure success in the marketplace. Successful varieties have to compete effectively with conventional varieties in terms of yield and quality and with conventional pest management measures in terms of overall cost and efficacy. Before transgenic pest protected potatoes can succeed, public concern over the environmental, health and ethical issues relating to genetically modified foods must be resolved so that public relations and international marketing issues can be satisfactorily addressed.

Slow, Uncertain, but Steady Rise of Biotech Sweet Corn.
Dr. Doug Plaisted
Sweet Corn Research Manager, Syngenta Seeds Inc, Nampa ID

ATTRIBUTE® insect tolerant sweet corn was commercially introduced by Syngenta Seeds to the food processing industry in 1998 and 1999. The products perform very well in the field and growers are impressed with the product. Adoption by large processing corporations stalled due to concerns over export restrictions, labeling issues and potential negative publicity like the Starlink episode. Syngenta has since received food approvals for ATTRIBUTE in several export countries and expects more in the near future. The product is now gaining acceptance among fresh market growers who supply regional and local markets and is actually preferred as an IPM product. Adoption in both the processing and fresh market segments should increase once food safety clearances are obtained in key European countries (EU).

Potential of Bt Brassica Vegetables
Dr. Anthony Shelton
Department of Entomology, Cornell/NYSAES

Cruciferous vegetables are annually harvested from approximately 5 million ha of small and large scale production. These vegetables are a dominant part of the Asian diet, as well as other nationalities such as India and Russia. The chief insect pest of crucifers, the diamondback moth (DBM), occurs wherever crucifers are grown and it has been estimated to cost growers $1US billion annually. There is interest in developing Bt crucifers for field crops (e.g. canola) as well as vegetables (e.g. cabbage). Because some populations of DBM have developed resistance to some Bt proteins contained in foliar sprays of Bt, these populations can be used in conjunction with Bt crucifer plants to study resistance management strategies that apply broadly to other crops/insects. Through over 10 years of research in the DBM/Bt crucifer system, we now have more a priori knowledge about resistance management for Bt crucifers and DBM than for any other crop that has been developed. Now projects should be developed that can utilize Bt crucifer vegetables to help reduce the use of more hazardous insecticides.

Shedding Light On Biotech Mushrooms For Pest Management
Dr. Charles Peter Romaine
Department of Plant Pathology, Penn State University
Abstract not available, but PowerPoint is available

Controlling Aphid-Transmitted Viruses Through Biotechnology
Dr. Dennis Gonsalves
USDA/ARS, Hilo, Hawaii

Papaya ringspot virus (PRSV) causes the most important viral disease of papaya worldwide and papaya is Hawaii’s second most important fruit crop. In 1992, PRSV was discovered in Puna on Hawaii Island where 95% of Hawaii’s papaya were being grown. By 1995 PRSV was widespread in Puna, causing severe damage to papaya orchards. By 1991, we had developed a transgenic papaya line that showed resistance to PRSV in greenhouse tests. Field tests that were started in 1992 confirmed its resistance. Two cultivars, SunUp and Rainbow, were developed from the original transgenic line and showed excellent resistance to PRSV in a field test that was started in Puna in 1995. Both cultivars were deregulated and seeds were distributed to growers in 1998. Rainbow is now widely planted in Puna and has had a substantial impact in increasing papaya production in Puna. In 1992 when PRSV was discovered in Puna, that area was producing 53 million pound of fresh papaya per year; by 1998 annual production in Puna was down to 26 millions pounds. After release of the transgenic papaya seeds, production increased and came up to 40 million pounds in 2001. Transgenic papaya is also being used as a tool to produce nontransgenic papaya in Puna. In this approach, surrounding solid blocks of nontransgenic papaya with plantings of transgenic papaya reduces virus pressure.

What's In The Pipeline: The Next Generation Of Molecules
Dr. Graham P. Head
Monsanto Company

Transgenic crops expressing insecticidal proteins have been available commercially since 1996, and were in development and testing for 10 years prior to that. They have broadly adopted in North and South America, Australia, and Asia. However, these products all employ similar insecticidal proteins. Current commercial products all express crystalline proteins (Cry proteins) derived from the bacterium Bacillus thuringiensis (Bt), and all of these proteins are from Classes 1, 2, and 3. Products that are now in development will continue primarily to utilize Bt proteins but will use many novel classes of Cry proteins, as well as other sorts of insecticidal proteins from Bt such as VIPs. The natural diversity of Bt proteins is proving to be very useful in this respect, and this has been enhanced using modern molecular genetic techniques such as domain swapping. The reasons for the continued focus on Bt proteins include their diversity, efficacy, specificity, and demonstrated safety.

Development And Commercialization Of Biotech Vegetables Outside The US
Dr. Peter Gregory and Rob Potter
Dr. Orlando de Ponti
Nunza Seeds

Most biotechnology research and development focuses on major agricultural crops but large potential markets exist for biotech vegetables, especially in developing countries where the economic, health and environmental benefits could be huge. In India, losses of cabbage and cauliflower due to diamondback moth ( Plutella xylostella L. ), or DBM, can reach 90% if not sprayed and 35% even if sprayed. Massive applications of chemical insecticides are required, posing serious health risks to the millions of ‘small’ farmers who grow these crops as well as to the consumer. The environment is also threatened. These problems are escalating because DBM has developed resistance to almost all insecticides and no plant-based resistance to DBM has yet been found. A new collaborative project between Cornell University and Nunza B.V. aims to develop a sustainable solution to DBM management in cabbage and cauliflower in India and beyond. Our scientific approach is to enhance integrated crop management strategies by developing cabbage and cauliflower varieties with durable resistance to DBM. We will use dual constructs of Bt genes that have not been exposed to strong DBM selection pressure. The new varieties will be accessible to farmers and to breeders. Tight linkage of the dual Bt genes will prevent accidental segregation. This is a novel arrangement in which Nunza is responsible for making the product and Cornell is working with public sector donors and other public partners to facilitate product release. To date, private companies have typically made technologies available to public sector recipients who then develop the products themselves.

Consumer Acceptance of Agricultural Biotechnology: A Market Experiment with Conventional and Biotech Sweet Corn
Dr. Jennifer Jones (lead author),
Shelby Fleischer, Dave Johnson, Bradley Schwab, John Lord, Anthony Resh, Michael Villa, and Jo Anna Hebberger
Department of Agricultural Economics and Rural Sociology, Penn State

Consumer acceptance of agricultural biotechnology could be an important determinant of its future. While most of the current knowledge about the attitudes of U.S. consumers about biotechnology is based on telephone survey data, this type of data may not accurately reflect consumer behavior in the marketplace. A market experiment was conducted to measure actual consumer choices between conventionally grown sweet corn and sweet corn developed using modern biotechnology. Two similar varieties were grown at a Penn State farm, delivered to nine participating stores in the Philadelphia area, clearly labeled as either "Biotech" or "Conventional" and sold side-by-side. Relative prices of the two varieties were varied, and an informational brochure was available to consumers at the corn display. While sales data are fairly imprecise, they indicate that approximately 25 to 35 percent of the sweet corn sold was the biotech variety. Survey data were collected from over 700 consumers who purchased sweet corn at participating stores to gather consumer characteristics that may be linked with particular choices. Preliminary analysis of survey data indicates that 35 percent of respondents did not realize that there were two types of corn for sale. Among those who noticed the two types of corn, 38 percent bought some biotech, while 40 of those who did not notice bought some. When asked about the most important things they considered when choosing their corn, 64 percent of consumers said it was the corn's appearance, 20 percent said price, and only 16 percent mentioned biotechnology as influencing their choice (3 percent said they wanted biotech, and 13 percent said they didn't). In addition, the majority of respondents spent less than a minute making their sweet corn choice. Based on these preliminary results, it appears that whether or not this particular product was developed using biotechnology was not a major influence on the choice of most consumers. It is one of several corn characteristics that busy consumers may or may not take the time to notice or to factor into their decision-making process.

Biotech Vegetables: World Market Implications
Mr. Tom Facer
Birdseye Foods

In the past several years there has been significant advancement in Biotechnology as it relates to plant varietal development. The majority of the development that has made the leap from science to mainstream agriculture has been in the commodity grain and fiber industries. While there has been considerable science in the fruit and vegetable arena little has been commercialized in the processed fruit and vegetable marketplace. The technology has been proven to work commercially but to date has not offered the consumer an advantage over conventional methods. Cost reduction alone is not significant enough to offset any potential perceived risk associated with Biotech in this market area. Fruits and Vegetables will follow the lead of grain and fiber agriculture in the Biotech area over time. Providing the consumer a product improvement benefit that is not available conventionally will speed the adoption.

Food Safety Of Vegetables Engineered For Insect Management
Dr. Bruce Chassy
Biotechnology Research & Outreach, University of Illinois

Insect protected crops produced through genetic engineering have been required to demonstrate their food and environmental safety before entering the market. In the US, the USDA, EPA, and FDA all play a role in regulating the safety. The food safety assessment requires evaluation of: 1) the newly added DNA, 2) the safety of the newly introduced gene product, and 3) the overall safety of the balance of the food including any unintended effects that might have been introduced. The principal food safety issues for new varieties crops are: 1) potential toxicity of the newly introduced protein(s), 2) potential changes in allergenicity, 3) changes in nutrient composition, 4) unintended effects giving rise to toxicity, and 5) the safety of antibiotic resistance marker-encoded proteins included with the transgene. All of these must be taken in the context of predicted range of dietary exposures. The evaluation is strongly influenced by the findings that the new crops are indistinguishable from their conventional counterparts in every aspect of form, function and composition. Assessment must point to establishing that there is a “reasonable certainty of safety” and that new varieties are as safe as, or safer than crops produced by traditional methods. Absolute safety is not and cannot be expected of any food or crop. After extensive safety testing and some seven plus years of experience with such crops in the marketplace, there is not a single report that would lead to questions the safety of such transgenic crops now in use.

Regulatory History And Future For Biotech Vegetables
Dr. Sharlene Matten
USEPA Headquarters

The U.S. Environmental Protection Agency (EPA) regulates plant-incorporated protectants (PIPs) under the primary auspices of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Federal Food Drug and Cosmetics Act (FFDCA), and the Food Quality Protection Act (FQPA). A PIP is defined as the pesticidal substance and the genetic material necessary for its production in a living plant. EPA has ten currently registered PIPs expressed in sweet corn, potato, cotton, and field corn. Several other PIPs have been given tolerance exemptions for use as viral protectants in a number of crops. EPA's risk assessment for PIPs considers the hazard, exposure, and risk of a particular PIP as expressed in a crop plant. At present, EPA requests the following types of information to assess the risk of PIPs: product characterization (e.g., source of the gene and/or expression system, nature of the pesticidal substance, modifications to the introduced trait, biology of the recipient plant and stability of the introduced trait, mode of action), human toxicology (acute testing), allergenicity screening (amino acid homology, heat stability, and in vitro digestibility), test substance equivalency, non-target ecotoxicological studies, environmental fate (gene flow and its impacts, soil degradation, expression data), and insect resistance management (IRM) for all Bt crops to date. IRM requirements for Bt potato have evolved since it was first registered in 1995. However, there are no longer any commercial sales of Bt potato in the U.S. There are no specific refuge requirements for Bt sweet corn because of when it is harvested and requirements for crop destruction and double-cropping that minimize survival of any resistant insects. If one is interested in registering a PIP expressed in a vegetable crop, one should consider the following aspects: (1) Talk to the Agency, (2) Market acceptance, (3) Appropriate data requirements and cost, (4) Potential data waivers, (5) Data compensation, (6) Tolerances (or exemptions from the requirement of) and tolerance fee waivers, (7), Collaborations with IR-4, grower groups, (8) Research grants, and (9) Published Agency information.

Consumer Advocates’ Perspective On Biotech Vegetables
Mr. Greg Jaffe
Center for Science in the Public Interest

If consumers are going to accept fruits and vegetables produced with agricultural biotechnology, four issues must be addressed by the developer or the government. First, the product must provide some benefit to the consumer, preferably a personal benefit (such as a better tasting product). If the product does not provide a tangible benefit to the individual, then it must provide a societal benefit that is important to the consumer, such as a significant
reduction in pesticide use. Second, the food must be found safe by the Food and Drug Administration (FDA). Any new biotech crop must obtain a mandatory safety approval by FDA before it is marketed. Currently, developers only voluntarily consult with FDA before marketing a biotech crop. A recent survey by the Pew Initiative on Food and Biotechnology confirms that consumers want FDA to regulate biotech crops with a mandatory pre-market approval process.
Thirdly, consumers care about the environment and want to be assured that crops produced with agricultural biotechnology do not cause environmental harm. The government should assess all biotech crops before they are released into the environment and ensure that any restrictions put in place to manage possible environmental risks are adhered to by the developer and farmers. Finally, if consumers are going to accept biotech crops, they need information about agricultural biotechnology. Consumers need to understand how agricultural biotechnology works, how it compares to current agricultural practices, what benefits it provides, and who benefits from particular products. They also need to know which specific foods contain genetically engineered ingredients so they can purchase those beneficial products.
In conclusion, the key to consumer acceptance of fruits and vegetables produced with agricultural biotechnology is to market products that have consumer benefits and that have been determined safe by the federal government.