1. The U.S. Sugarbeet Industry
2. Sugarbeets and the Implications of Biotechnology
3. Current Status of Plant Biotechnology and the Sugarbeet Industry in the U.S.
4. Background on Plant Biotechnology
5. Global Regulatory Policies on Plant Biotechnology
6. Conclusion

ADDENDUM Commonly Asked Questions About Plant Biotechnology and the Sugarbeet Industry Literature Cited

This paper was complied by the Beet Sugar Development Foundation, Denver Colorado. The Beet Sugar Development Foundation is a non-profit 501(c)(3) Corporation. It represents the Beet Sugar Processing Companies and Sugar Beet Seed Companies doing business in North America.

Food producers in the United States rely heavily on the U.S. sugarbeet industry for approximately half of their annual supply of sugar. In fact, the United States Department of Agriculture, Economic Research Service estimates that the 1998 sugarbeet crop will reach a record 32.6 million tons, producing approximately 4.01 million tons of white sugar. (1)

Over 10,000 growers produce sugarbeets on more than a million acres in the United States. Sugarbeets are grown in scattered geographic pockets, including California, Colorado, Idaho, Michigan, Minnesota, Montana, Nebraska, North Dakota, Ohio, Oregon, Washington and Wyoming.

However, sugarbeets are a challenging crop to produce. Beet cultivation is highly sensitive to insects, diseases and weed competition and requires continuous monitoring and management for control of these pests. Insects, diseases and weeds begin attacking the sugarbeet crop from the time of planting and continue through harvest.

As a result, sugarbeet growers must work diligently to control these pests with hand labor, mechanical weed removal and pesticide applications. The industry continually looks for ways to enhance pest control and ultimately improve yields and sugar content. For more than 60 years, plant developers have worked with the genetic material of sugarbeets through conventional plant breeding (hybridization) to provide the strongest and most disease-resistant plant possible. The next step in the evolution is to improve pest control through plant biotechnology.

This paper will address the implications of plant biotechnology in the US sugarbeet industry.

Plant biotechnology is different from hybridization because it involves isolating and transferring a single gene trait from a plant or other organism – rather than crossing one plant’s entire genetic makeup with another. Plants developed through this science have a number of beneficial traits. Some examples include disease protection, insect protection, herbicide tolerance to a specific herbicide, and improved food quality.

Plant biotechnology was recently introduced in commercial corn, potato, canola, cotton and soybean production. The resulting plants are called genetically enhanced, or transgenic. New sugarbeet plants are available that are genetically enhanced to tolerate specific herbicides, a trait that offers both economic and environmental benefits to growers and processors.

The new plants allow growers more flexibility in timing their herbicide applications and the option to use fewer and/or more desirable herbicides. Fewer applications mean fewer trips across the field, resulting in less soil erosion and less compacting of the soil.

Sugarbeets are biennial and have a two-year life cycle. (2) In the major production areas sugarbeets are grown for only the first year of the life cycle. During this time they are in a non-reproductive stage and produce large storage roots that are harvested for sugar extraction. Generally, sugarbeets are not allowed to develop seed or cross-pollinate with other plants. This greatly reduces the chance of genetically improved sugarbeets transferring herbicide-resistant qualities to other plants or weeds.

Sugarbeet seed is generally planted in April or May and harvested in the fall. After growers harvest the crop, sugarbeet processors recover three products from the sugarbeet root: sucrose (or sugar), molasses and beet pulp. The processor first extracts sugar from the beets, purifies the juice using lime and carbon dioxide, then crystallizes the sugar.

The sucrose derived from these plants is highly processed and has the same chemical composition as sugar processed from conventional sugarbeets. (3) Both genetically enhanced and conventional sugarbeets are processed the same way.

During extraction, beets are washed, sliced and placed in a diffuser. The diffusion process exposes the beets to temperatures of approximately 72 degrees Centigrade (161°F) (4) and levels of sulfur dioxide in the range of 50 to 100 parts per million (5), or other micro biocide agents.

The beet residue, called beet pulp, is pressed and dried for cattle and other animal feeds. The conventional process exposes the pulp to temperatures of 650 to 1000 degrees Centigrade (1202 to 1832°F). It is dried for approximately 15 to 20 minutes. (6)

The juice that is extracted in the diffusion process is heated and exposed to a liming process reaching temperatures of 95 degrees Centigrade (203°F) and pH values of 12 for approximately 20 minutes. (7) This process removes 20 to 35 percent of the impurities from the juice. The juice is then filtered, concentrated at temperatures of 120 to 135 degrees Centigrade (248 - 275°F), and sent through the crystallization process. (8)

The juice is further concentrated to a density that supports the formation of crystals. The crystallized sugar (now 99.5 percent sucrose, the remainder being moisture and inorganic salts) is dried and sent to storage. (9) The extreme temperatures and the crystallization process ensure the purity of the final product, whether the sugar is from genetically enhanced sugarbeets or conventional sugarbeets.

The portion of the juice that will not crystallize because it contains too many impurities is molasses. Molasses is used for cattle feed, yeast manufacture and various other industrial applications.

The majority of sugar produced from U.S. sugarbeet crops is sold within the country for domestic use. Much of the sugarbeet pulp is exported to Japan and/or Europe. Molasses is sold primarily domestically, occasionally abroad.

III. CURRENT STATUS OF PLANT BIOTECHNOLOGY AND THE SUGARBEET INDUSTRY IN THE U.S.

Seed production of genetically enhanced sugarbeets is currently underway. There are two different types of herbicide-tolerant sugarbeet being developed, and planting may begin in the spring of 2000 in the United States.

One type of plant is tolerant to Roundup Ultra® herbicide. It includes several commercially available varieties and has completed the U.S. regulatory review by the Food and Drug Administration (FDA), Environmental Protection Agency (EPA) and the United States Department of Agriculture (USDA).

The other type of herbicide-tolerant sugarbeet is tolerant to Liberty® herbicide. As of this writing, regulatory review is in process. Both FDA and USDA have completed their reviews. EPA registration for the use of Liberty® herbicide on Liberty Link® sugarbeets is expected soon.

U.S. regulatory agencies, FDA and USDA, agree that these genetically enhanced sugarbeets are substantially equivalent to conventional sugarbeets and pose no threat to humans, animals or the environment. (10,11,12,13) Monsanto Company and AgrEvo, makers of the Roundup Ready® gene and the Liberty Link® gene, have submitted data to the FDA, substantiating that sugar produced from both forms of genetically enhanced sugarbeet, contains no detectable level of the respective proteins.

Makers of the genetically enhanced sugarbeets have applied or will apply for clearance by other international regulatory agencies: the European Union (EU), which includes 15 member states; the Ministry of Health and Welfare in Japan; and Health Canada. For detailed information on global regulation policies, see Global Regulatory Policies on Plant Biotechnology on page 9 of this document

Biotechnology is the application of living organisms to develop new products. Although the term, biotechnology, has gained widespread recognition in recent years, the science has been with us for centuries. For example, in 1800 BC, with the use of fermentation, man first harnessed organisms to produce wine, beer and leavened bread.

Plant breeders have employed these same principles in crop hybridization for the past 60 years. Crop hybridization combines genes from a plant with desirable traits (such as increased yield or resistance to insects or disease) with a commercial variety to produce an improved plant. For example, Rhizomania- and Cercospora-resistant varieties are hybrids developed to confer disease protection on sugarbeet plants.

Plant biotechnology isolates and transfers a single genetic trait from a plant or other organism – rather than crossing one plant’s entire genetic materials with another. This allows the transfer of a selected, desirable trait in a more controlled manner than with traditional plant breeding.

Genetically enhanced plant seed available today offers growers options to convert to no-till and low-till farming practices and to decrease their use of pesticides, reduce labor and allow more timely management of crop production. The plants grown from these seeds offer processors and consumers cleaner products with fewer complications caused by trash or foreign debris.

Other ways plant biotechnology can improve crops include:

• Instilling built-in tolerance to a specific herbicide, thus affording growers more flexibility in timing herbicide treatments, choosing more desirable herbicides, or reducing overall herbicide use;
• Instilling built-in protection against a specific insect or plant disease that could cut yield or even destroy a crop;
• Building in vital additives to animal feed;
• Allowing improvements in processing efficiency;
• Improving nutritional value;
• Improving flavor.

In 1998 a broad range of genetically enhanced plants were made available to growers in a number of countries worldwide. Some of the companies commercializing these plants included AgrEvo, Calgene, Du Pont, Dow/Mycogen, Monsanto, Zeneca/Petoseed, Asgrow, and Novartis, to name a few. The following is a sample of the transgenic plants available:

• Herbicide-tolerant corn, canola, cotton, soybean, oil seed rape
• Virus-resistant squash, tomato, tobacco, papaya
• Insect-protected potato, cotton, corn
• High oleic acid soybean
• Laurate canola

According to the International Service for the Acquisition of Agri-biotech Applications (ISAAA), between 1996 and 1998, eight countries contributed to a more than fifteen-fold increase in the global acreage of genetically enhanced crops, resulting in a total of nearly 70 million acres. Growers in the United States, Argentina, Canada, Australia, Mexico, Spain, France and South Africa planted genetically enhanced seed, primarily soybean, corn/maize, cotton, canola/rapeseed and potato. The rank-order of the principal transgenic traits in the planted seed is: herbicide tolerance; insect-protection; stacked (combined) herbicide tolerance and insect protection; and quality traits. (14)

Once growers harvest and ship genetically enhanced commodity crops to food producers, the products of these crops are incorporated into scores of foods. For example, over one-third of the corn planted in the United States in 1999 was genetically enhanced. (15) After harvest, as in previous years, this corn will be processed with traditionally grown corn and will help meet the demand for products ranging from animal feed to corn syrup sweeteners.

In addition to grower satisfaction, genetically enhanced foods will help meet the growing global food demands. According to a 1998 report of the Word Health Organization (WHO), the global population of about 5.8 billion will increase to about 8 million by the year 2025. (16)

The accelerating world population taxes an already strained agricultural base. In order to produce enough food, farmers worldwide will need higher-yielding plants that require fewer inputs, like pesticides and fertilizers. Because plant biotechnology offers plants with beneficial traits not possible before, the science holds great hope for agriculture.

Scientists worldwide are studying many ways they can develop plants that offer the advantages made possible through plant biotechnology. Although there often is collaboration and consensus within the scientific community, each country continues to operate its own regulatory systems that govern the development, planting and commercialization of genetically enhanced crops.

There are two types of herbicide-tolerant sugarbeet plants that have been reviewed or are being reviewed. The genetically enhanced sugarbeet tolerant to glyphosate (marketed under the name Roundup Ready®) has been reviewed and cleared by all three of the U.S. regulatory agencies: the Environmental Protection Agency (EPA), the Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA). Roundup Ultra® has been registered for use over the top of Roundup Ready® sugarbeets by the EPA. These sugarbeets have been cleared after consultation with the FDA, and granted non-regulated status by the USDA. (10,11,12,13) The sugarbeet resistant to glufosinate (marketed under the name Liberty Link®) has been cleared by two of the three agencies, FDA and USDA; as of this writing, EPA registration of Liberty® herbicide for use on Liberty Link® sugarbeets is pending. Makers of both genetically enhanced sugarbeets are awaiting clearance from regulatory agencies in various world markets.

The U.S. Food and Drug Administration (FDA) completed its review of the new sugarbeet plants with a built-in tolerance to specific herbicides and confirmed their food and feed safety. (12,13)

FDA is the primary agency responsible for ensuring the safety of food and feed products. FDA establishes guidelines to evaluate a new plant for "substantial equivalence" with the plant’s traditionally grown counterpart. "Substantial equivalence," or "equivalence," in this context means there is no meaningful change in the nutritional value or composition of the food.

FDA does not require any special handling or labeling of the food and feed produced from genetically enhanced crops that are equivalent to traditional crops. Genetically enhanced crops are mixed, or co-mingled, with traditionally grown crops. Since 1996 the United States has harvested millions of acres of crops grown with genetically enhanced seed and processed these crops with their traditionally grown counterparts. The processed portions of such crops then are distributed and used in end products in the food and feed industries.

In 1998, the Animal and Plant Health Inspection Service (APHIS) – a division of the U.S. Department of Agriculture (USDA) – completed its review of the new herbicide-tolerant sugarbeet plants, and confirmed their agricultural and environmental safety. (10,11)

The USDA regulates agricultural products and research – including the development of new plants. APHIS’s role is to ensure that new plants pose no threat to production agriculture or the environment. APHIS regulates research development by requiring permits for field-testing, shipping and delivery of any seed or plants modified through biotechnology.

In March 1999, the U.S. Environmental Protection Agency (EPA) completed its review of Roundup Ultra® herbicide for use over Roundup Ready® sugarbeet plants and registered the new use of this herbicide. (17) Use of Liberty® herbicide currently is being reviewed by EPA for use on Liberty Link® sugarbeets.

EPA regulates any pesticide that may be present in food and sets tolerance levels to provide a high margin of safety for consumers. As part of this responsibility, EPA regulates new uses of herbicides, such as the use of a new or existing herbicide on a new plant that is tolerant to that specific herbicide.

If a plant developer wishes to introduce a genetically enhanced food product into Europe, the developer must prepare extensive data and submit it to one of the European Union (EU) member states. The data must follow the submission requirements of the Directive 90/220, the Novel Foods Regulation, or both. In the case of the 90/220, the member states must tally at least 62 affirmative votes of the possible 87 to confirm the data’s safety conclusion and allow the product into the EU. The EU follows a similar procedure for products reviewed under the Novel Foods Regulation. However, under this regulation, if one EU member approves the product, a simple notification of the other member states confirms approval.

Although the EU has adopted a regulation requiring labeling of food products derived from genetically enhanced organisms, the guidelines for labeling are not yet available. However, the law indicates there will be types of products that will be exempt from labeling. The EU has not yet issued this product list.

Currently, no beet sugar is exported to Europe from the United States, although U.S. sugarbeet pulp for animal feed is sold in Europe. The EU has no regulations governing the use of animal feed derived from genetically enhanced plants. However, some European countries – the United Kingdom, Switzerland and the Netherlands – have a formal review process for genetically enhanced animal feed.

Japanese Regulatory System

The Ministry of Health and Welfare regulates food safety in Japan. The Ministry of Agriculture, Forestry and Fisheries (MAFF) regulates the feed and environmental safety in Japan.

Both Japanese agencies accept applications for approval only at specific times. For example, they are expected to announce acceptance of applications for review in August 1999. At this time, plant developers can submit their data to gain acceptance into Japanese commerce.

Although the United States does not export beet sugar to Japan, a significant amount of the industry’s sugarbeet pulp is sent to Japan for use as animal feed. Because of this, Japan is a very important world market for the developers of genetically enhanced sugarbeet plants. Developers of the new herbicide-tolerant sugarbeets fully expect regulatory clearance in Japan by mid-2000.

Canadian Regulatory System

Canada’s regulatory system governing new plants is similar to that of the U.S., in many ways paralleling the three U.S. agencies.

Health Canada oversees food safety in Canada. Agriculture and Agri-Food Canada regulate feed and environmental safety, as well as registration of specific plant varieties for certain crops. The Pesticide Management Regulatory Agency regulates pesticide use in Canada.

Roundup Ready® sugarbeets as novel food are in the review process and regulatory clearance is expected in early 2000. Roundup Ready® sugarbeets as novel feed were submitted in June.

Application for Liberty Link® sugarbeets as novel food was made in February 1999. Approval is expected by the end of 1999.

Application has been made to the Pesticide Management Regulatory Agency for registration of the use of Roundup® and Liberty® over the top of the respective transgenic sugarbeets.

VI. CONCLUSION

In summary, as the sugarbeet industry moves into the next century, the introduction of desirable genetic traits through plant biotechnology holds great promise for the industry’s continued growth and success. Herbicide-tolerant sugarbeets demonstrate significant agronomic advantages. Growers will realize economic benefits with enhanced weed control. Sugarbeet processors can look forward to an excellent, consistent product with less weed debris delivered at harvest. The environment will benefit by the result of using lesser amounts of herbicides, making fewer trips across the field, and conserving our vital agricultural soils. And, because these plants ultimately will result in the same pure, refined sugar product as conventional sugarbeets, food producers can rely on an abundant supply of beet sugar for their products. Finally, consumers worldwide will continue to enjoy food products sweetened with sugar produced from sugarbeet.

ADDENDUM COMMONLY ASKED QUESTIONS ABOUT  PLANT BIOTECHNOLOGY AND THE SUGARBEET INDUSTRY

1. Are there any genetically enhanced sugarbeets planted in the United States today?

There are currently no genetically enhanced sugarbeets planted for commercial use. However, experimental trials are currently underway and transgenic sugarbeets are expected to be planted commercially in spring 2000 in the United States.

2. Will genetically enhanced sugarbeets adversely affect the environment?

Herbicide-tolerant sugarbeets can use lesser amounts of herbicide and require fewer herbicide applications than conventional sugarbeets. They also allow growers more flexibility in timing their herbicide applications and the potential for fewer applications. Fewer applications mean fewer trips across the field, resulting in soil conservation, reduced soil compaction and decreased fuel usage. In addition, the herbicides planned for use over the two types of genetically enhanced sugarbeets in most cases offer environmental advantages as good as, or better than, herbicides currently used on conventional sugarbeets. The use of Roundup Ultra® on Roundup Ready® sugarbeets is environmentally responsible because the herbicide’s active ingredient, glyphosate, does not volatilize and binds tightly to soil particles, which prevents leaching and undesirable residual activity. Liberty® herbicide breaks down rapidly in the soil into naturally occurring elements, eliminating any concern for herbicide carryover. Both herbicides represent a low environmental risk for both organisms and groundwater.

Plant biotechnology is different from hybridization because it involves isolating and transferring a single gene trait from a plant or other organism, rather than crossing the entire genetic material of one plant with another.

Sugar from the two types of herbicide-tolerant sugarbeets has the same chemical composition as sugar processed from conventional sugarbeets. The Food and Drug Administration and United States Department of Agriculture agreed that varieties of these genetically enhanced sugarbeets are substantially equivalent to conventional sugarbeets and pose no threat to humans, animals or the environment.

The review process for new products can take several years. The international agencies have not rejected the use of genetically enhanced sugarbeets, they are simply reviewing the products. Developers of the new herbicide-tolerant sugarbeets expect regulatory clearance in various world markets.

6. How will genetically enhanced sugarbeets impact industrial and retail consumers of beet sugar?

Retail consumers will not notice any change in sugar processed from genetically enhanced sugarbeets. Genetically enhanced sugarbeets are processed exactly the same way as conventional sugarbeets.

Genetically enhanced plant seed available today offers growers options to convert to no-till and low-till farming practices and to decrease their use of pesticides, reduce labor and allow more timely management of crop production.

In addition, the ability to use certain herbicides over the plants results in cleaner products for processors with fewer complications caused by trash or foreign debris.

Herbicide-tolerant sugarbeets enhance weed control, sometimes use lesser amounts of herbicide, offer effective control even when herbicides are applied later, and require fewer herbicide applications than conventional sugarbeets.

Sugarbeets (genetically enhanced and conventional) have a two-year or biennial life cycle. The commercial production of sugarbeets is in the non-reproductive phase. In most growing areas, they do not develop seed or cross-pollinate with other plants. This greatly reduces the chance of genetically enhanced sugarbeets transferring herbicide-resistant qualities to other plants.

Roundup Ultra® and Roundup Ready® are registered trademarks of Monsanto Company. Liberty® and Liberty Link® are registered trademarks of Hoechst Schering AgrEvo GmbH.

ADDENDUM LITERATURE CITED

1. Sugar and Sweetner Situation and Outlook. Economic Research Service, United States Department of Agriculture, May 1999, SSS-225, p.49. Washington D. C.
2. Elliot, M. C. and G. D. Weston. 1993. Biology and Physiology of the Sugar-beet Plant. In: Cooke, D. A. and R. K. Scott, editors. The Sugar Beet Crop. London: Chapman and Hall. p. 37.
3. Klein, J., J. Altenbuchner and R. Mattes. 1998. Nucleic acid and protein elimination during the sugar manufacturing process of conventional and transgenic sugar beets. Journal of Biotechnology, vol. 60, p. 145-153.
4. J. Vetter. 1998. Extraction. In: van der Poel, P. W., Schiweck, H. and T. K. Schwartz., editors. Sugar Technology. Berlin: Verlag Dr. Albert Bartens KG. p. 335.
5. Ebell, H. O. and M. Storz. 1982. Diffusion. In: McGinnis, R. A., editor. Beet Sugar Technology. 3^rd ed. Denver: Beet Sugar Development Foundation. p.128.
6. J. Vetter. 1998. Pressed and Dried Pulp. In: van der Poel, P. W., Schiweck, H. and T. K. Schwartz., editors. Sugar Technology. Berlin: Verlag Dr. Albert Bartens KG. p.405.
7. R. F. Madsen. 1998. Juice Purification. In: van der Poel, P. W., Schiweck, H. and T. K. Schwartz., editors. Sugar Technology. Berlin: Verlag Dr. Albert Bartens K G. p. 482-486.
8. K. Urbaniec. 1998. Evaporation, Heating and Heat Economy. In: van der Poel, P. W., Schiweck, H. and T. K. Schwartz., editors. Sugar Technology. Berlin: Verlag Dr. Albert Bartens KG. p.606.
9. R. A. McGinnis. 1982. Beet-Sugar Technology 3^rd ed. Denver: Beet Sugar Development Foundation. p.545.
10. United States Department of Agriculture. Novartis Seeds and Monsanto Co., Availability of Determination of Nonregulated Status for Sugar Beet Genetically Engineered for Glyphosate Herbicide Tolerance. Federal Register, January 8, 1999, vol.64, no.5, p. 1177-1178.
11. United States Department of Agriculture. AgrEvo USA Co., Availablity of Determination of Nonregulated Status for Sugar Beet Genetically Engineered for Glufosinate Herbicide Tolerance. Federal Register, May 7, 1998, vol.63, no. 88, p. 25194-25195.
12. U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Premarket Approval. Foods Derived from New Plant Varieties Derived through Recombinant DNA Technology, Final Consultations under FDA’s 1992 Policy. MonsantoCo. and Novartis Seeds, Glyphosate Tolerant Sugar Beet. (http://vm.cfscan.fda.gov/~lrd/biocon.html)
13. U. S. Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Premarket Approval. Foods Derived from New Plant Varieties Derived through Recombinant DNA Technology, Final Consultations under FDA’s 1992 Policy. AgrEvo, Inc., Glufonsinate Tolerant Sugar Beet. (http://vm.cfscan.fda.gov/~lrd/biocon.html)
14. (14) C. James. 1998. Global Review of Commercialized Transgenic Crops. 1998. ISAAA Briefs. No.8. ISAAA. Ithaca, NY.
15. Remarks by the Honorable Dan Glickman, Secretary of Agriculture, National Press Club. "New Crops, New Century, New Challenges: How will Scientists, Farmers and Consumers Learn to Love Biotechnology and What Happens if They Don’t". Washington DC. July 13, 1999.
16. World Health Organization. Executive Summary, The World Health Report, 1998. Life in the 21^st Century – A vision for All. p.2.
17. Federal Register: April 14, 1999, vol. 64, no.71, p. 18360-18367.