In 1996, Zeneca launched a biotech processing-tomato product that from 1999 to 2000 was the best-selling tomato paste in the United Kingdom. The paste reduced processing costs and resulted in a 20% lower price. However, despite their consumer benefits and initial market acceptance, none of these tomato products were financial successes and none are being sold today. In the first instance, production and distribution costs of the Flavr Savr proved prohibitive. In the second case, Zeneca decided not to continue growing the tomatoes in California and shipping the paste to the United Kingdom. When Zeneca ran into the European moratorium, they were unable to get approval for growing the tomatoes in Europe. Once the supply of the tomato paste was exhausted, the product disappeared from the grocery store shelves. These early products of horticultural biotechnology are often overlooked because of the huge successes of biotech field crops such as feed corn, soybeans and cotton. Since their introduction in 1996, biotech field crops have quickly gained wide acceptance by farmers and were grown on more than 167 million acres worldwide in 2003, primarily in the United States, Canada, Argentina, Brazil and China . India recently approved biotech cotton and Brazil approved biotech soybeans, for a total of 18 countries that have approved commercial field production of biotech crops. All of these crops are designed for pest and weed control, with either insect or herbicide resistance. As a result,vertical farming tower for sale sales of conventional agricultural pesticides declined 7.4% in 2000, while biotech-based varieties jumped 12.9% .

The worldwide value of all seed business rose from $15.3 billion in 1996 to $16.7 billion in 2001, but the value of conventional seed fell during the same period from $14.9 billion to $13.4 billion, indicating a healthy value of $3.3 billion in 2001 for biotech seed worldwide. Although the European Union moratorium on new registrations has affected introduction of the newest biotech field crops, the utilization of current products is increasing. The success of biotech field crops is in sharp contrast to restricted commercial opportunities for biotech fruits and vegetables. There are few examples of transgenic horticultural crops that are currently being grown and marketed successfully: virus-resistant squash is planted on a small acreage in the southeast United States, and virus-resistant papaya has been grown in Hawaii since 1998 . Whereas Zeneca was able to obtain food approval for its tomato in the United Kingdom in 1995 , no food approvals have been allowed in the European Union since an unofficial moratorium was imposed in 1998, in effect stopping the import or cultivation of any new biotech crops. Japan has also restricted imports of biotech foods, requiring suppliers to obtain food and environmental approvals prior to importation. Commodity organizations, shippers-packers and grocery chains in the United States have also been reluctant to introduce new biotech varieties and foods because of logistical difficulties in segregating food for export markets to Europe and Japan. For example, even though it resulted in a significant reduction in insecticide use, Monsanto’s insect- and virus-resistant New Leaf potato is no longer available because a major processor and fast-food chain prohibited their suppliers from using this variety . Gianessi et al. calculated that there would have been 1 billion pounds of yield gain in 2001 and a reduction of1.5 million pounds of pesticide active ingredients applied if growers had widely planted the New Leaf potato . Research activities with horticultural crops have also been cut back, with the number of field trials conducted declining since 1999 . Together, the E.U. moratorium, the failure of the European Union to establish tolerances for the adventitious presence of biotech crops in food and seed, labeling issues and the reluctance of the marketing chain to accept new biotech foods have virtually halted commercialization of new biotech fruits and vegetables.

Despite initial consumer acceptance, biotech horticultural products are virtually absent from today’s market. Are U.S. consumers concerned about the safety of these products? They do not appear to be, and in general seem to trust the U.S. government’s oversight. The regulatory requirements to demonstrate food, feed and environmental safety of biotech crops are well established in the United States. The U.S. Department of Agriculture Animal and Plant Health Inspection Service regulates the field testing and commercial release of genetically engineered plants; the U.S. Environmental Protection Agency ensures the safety and safe use of pesticidal and herbicidal substances in the environment; and the U.S. Food and Drug Administration governs the safety and labeling of the nation’s food and feed supply.In general, it takes dozens or hundreds of transformation events, each of which must subsequently be regenerated into a transgenic plant, to identify one or two that will be used for commercialization. This compares to the hundreds or thousands of plants that may be evaluated in a traditional breeding program to identify a single commercial line. However, unlike with traditional breeding, each commercial transformation event must have its own dossier of safety assessments and meet key data requirements, including toxicity, nutritional data, allergenicity and environmental impacts . Companies have conducted these studies for all biotech products commercialized to date, and U.S. and international regulatory agencies have granted approvals . No case has been documented to date of harm to humans or the environment from the biotech crops currently being marketed, although “genetic drift” from transgenic to conventional crops has occurred as it has for millennia between conventional crops. Now some Mexican growers have expressed concerns under the North American Free Trade Agreement about preserving the biodiversity of their maize due to gene flow from transgenic corn . Certainly, information of this type is needed to identify potential hazards and ensure the food and environmental safety of crops developed using biotechnology. Despite the track record of currently approved biotech crops,many opponents continue to demand that additional safety studies be conducted due to concerns such as genetic drift, out-crossing with wild species and food safety.

Nonetheless, in the same report, the Royal Society recommended that more studies be conducted using the latest analytical techniques to test each and every compound produced by the biotech crops, including compounds released as volatiles. The Royal Society then recommended that post-marketing surveillance be conducted, “should GM foods be reintroduced into the market in the U.K.” Although it could not identify any specific safety hazards in current biotech products, the Royal Society did not recommend that such foods be allowed back into the United Kingdom. Regardless of the extent of safety testing and absence of evidence of harm, the bar may continue to be raised as new testing technologies are developed, making it increasingly expensive to meet regulatory requirements.In addition to safety assessments, there are a number of significant barriers to developing new biotech horticultural crops, including the added costs of variety development,hydroponic vertical farm regulatory approval, post-commercialization stewardship and the reluctance of the horticultural marketing industry to accept products grown from biotech varieties. Many of the hurdles faced by companies developing biotech varieties do not exist for traditionally bred varieties, including the following issues. Seed movement and field testing. Experimental biotech varieties can be moved interstate and tested in the field only under permit from the APHIS, to prevent mixing with non-biotech seed. During the experimental phase, it takes at least 10 days to obtain a permit for seed movement and 30 days to obtain one for field release.Adventitious mixing. Specific protocols must be developed, implemented and enforced to prevent adventitious mixing with other varieties. Such mixing can occur as a result of pollen movement from a biotech field to a conventional field or during seed harvest and cleaning. Adventitious mixing occurs when very small amounts of biotech seed mix with other non-biotech seed. Regulatory agencies in some countries establish “tolerances,” the maximum allowable amount of adventitious material . For biotech varieties at the experimental stage , the tolerances are usually zero in food and seed. For biotech varieties approved for commercial growing and consumption, the thresholds for adventitious presence vary from country to country, ranging from less than 1% to 5% for food ingredients, and 0.3% to 1% for seed. By comparison, conventional seed-purity thresholds are usually between 1% and 10%, depending on the crop and varieties. Handling procedures. Separate breeding and seed production programs are needed for biotech crops, with increased isolation and strict handling procedures to prevent cross pollination or adventitious mixing. Increased seed purity standards — over the standards for conventional seed — are also required throughout growing, harvesting, cleaning, milling, storage, coating, packaging and shipping. Tracking, training. In order to achieve tolerances an order of magnitude stricter for biotech varieties than is required for conventional varieties, biotech specific internal tracking and testing procedures must be implemented. Additional training on handling of biotech crops is required throughout the development and marketing chain — from molecular biologists and breeders to seed producers and distributors.

Each new employee who might be involved with biotech varieties at any level must be specially trained. Depending upon the type of product, grower training and post-commercialization stewardship programs may be required.These additional requirements have increased the cost of developing biotech varieties to at least $1 million per allele and more likely to $5 million or more per allele, depending on the number of countries in which approvals are required. An allele is a single transformation event, which contains the genetic trait of interest and expresses the desired phenotype in the crop. These additional costs and issues are the same for both field and horticultural crops. Due to the large acreage of field crops, the costs can be justified by the market size of the biotech varieties. The same is not true for horticultural crops because of the small acreage of each crop. One strategy has been to limit marketing of a biotech horticultural crop to just the United States. However, due to the international trade in horticultural commodities, there are few examples of products under development in which both the seed and the product could be contained solely in the United States. More likely, a biotech variety will need approvals in a number of countries to which the product might be exported. For example, biotech processing-tomatoes grown in California will end up being exported as tomato paste or other products to many countries around the world, each of which must give food approval prior to commercialization. And, if the processed product contains seeds that might be viable, environmental studies and approvals may also be required in the importing country, even if the importation is intended only for food consumption. Importing countries may also impose additional and unique requirements, such as labeling or the ability to trace the product back to the producing farm, as in pending E.U. regulations. The end-result of a successful biotech development program is a new allele that produces the intended effect, has passed the thorough safety testing and has received approvals and registrations from appropriate government agencies. In the 1990s, developers of biotech varieties assumed that once a biotech product was shown to be safe, it would be produced and marketed just like any other commodity. A biotech allele would be equivalent to a traditional allele, and there would be no need for product segregation, labeling or special handling. While this is largely the case in the United States, this assumption is no longer valid because of labeling requirements in the European Union and other countries. Another assumption was that product approvals could be achieved generically for a specific gene and crop. That is, once a particular gene product was shown to be safe, it could be introduced into additional varieties without retesting. Instead, approvals are based on specific transformation events. Consequently, if different varieties are transformed with a given gene to produce a range of biotech varieties, each is an independent transformation event subject to all of the regulatory requirements. Because this is prohibitively expensive, developers must transform just one variety, register that event, and then use traditional breeding methods to incorporate the transgene into other varieties. This greatly delays and increases the cost of developing multiple biotech varieties in a given crop.