3.1 Introduction
Humankind has used the traditional techniques of “biotechnology” – breeding and selection – for thousands of years to domesticate wild species for large-scale production and to change plants, animals, and microorganisms to create hybrids which produce higher yields, enhanced flavors and textures, increased resistance to pests, and a host of other desirable traits. Modern techniques of polyploidization, embryo rescue, mutagenesis and cell fusion don’t occur naturally, and yet, they have been employed safely for decades. As a result, the genetic “parents” of many common foods we eat would be virtually unrecognizable as the foods we know today.

Advances in molecular biology resulting in what is known as recombinant DNA (rDNA) technology or genetic “engineering” are the latest in plant and animal husbandry. This technology, which applies the science of biology, offers the opportunity to move more quickly, precisely selected, well-characterized genetic material between organisms than could be done through the traditional techniques.

The term “biotechnology” refers to the latest, most modern husbandry technique to modify plants, animals, or microorganisms by introducing into their genetic code genes for specific desired traits, often from different species. The tools of biotechnology, such as polyploidization, embryo rescue, mutagenesis and cell fusion don’t occur naturally, but yet have been employed safely for decades. The potential benefits to the world from future discoveries in biotechnology are almost too vast to comprehend. The products derived from rDNA technology can significantly enhance our quality of life from the medicines we use, to the food we eat, to the environment in which we live.

3.2 Biotech’s Impact On Agriculture
Adoption of rDNA technology by the farm sector is an accomplished fact, particularly so in the United States. In 2000, 13 nations, including the United States, allowed biotechnology-enhanced crops to be grown commercially. Of those, five are in the developing world: Argentina, China, Mexico, South Africa and Uruguay. In fact, China and Argentina now rank among the top four growers, alongside the United States and Canada, in number of acres planted. Between 1999 and 2000, the amount of genetically-enhanced crops planted world wide (100 million acres) increased by 10.75 million acres. While industrial nations – mainly the United States and Canada – still produce three-quarters of the world’s biotech crops, 84 percent of the 10.75 million-acre increase occurred in developing countries – mainly Argentina, China, and South Africa. According to the United States General Accounting Office, in 2000, biotech varieties accounted for about 25 percent of the corn, 54 percent of the soybeans, and 61 percent of the cotton planted in the United States. Clearly, agricultural biotechnology is here to stay.

However, the issues surrounding agricultural biotechnology are complex and varied. The USDA’s Economic Research Service summed them up this way:

“The complexity of issues stems from the creation and management of the science, the ownership of intellectual property, the economic nature of the industry undertaking the research, the interaction between public and private research and the marketing of the products. Adding to the complexity are concerns about the implications of biotechnology for new agricultural products, markets and contractual arrangements between producers, processors, and marketers.

The acceptance of the technology depends critically on the perceptions and attitudes of consumers, both domestic and foreign, and on the expected impacts on food safety, health, and the environment. The degree of foreign acceptance can significantly affect international trade and may create the need to segregate and identify genetically engineered products.

3.3 Production and Marketing
The presence of biotech products in the marketplace, coupled with the disparate status of regulatory approvals in major world markets and changing patterns of consumer acceptance, has introduced great complexity and poses a huge management challenge to the U.S. bulk commodity handling system. No longer can farmers plant seed and assume the harvested product will be accepted universally by all buyers or under traditional terms and conditions. Meanwhile new biotech events must be approved for general production only after international customer acceptance has been achieved.

The impact on the industry clearly illustrates the urgent need to develop an internationally accepted certified marketing system based on sound-science and consumer preferences that can assure all biotechnology-enhanced products will reach appropriate markets. As new varieties become available, it will become more important to have instituted prior to commercialization of these products a proven channeling/segregation/certification program guaranteeing that tolerance levels are met. This will be necessary to provide customers with the products they desire while supporting the development, production and promotion of additional biotech crops that are acceptable to domestic and foreign customers. Until such a system is clearly established, new biotech events should only be approved after international customer acceptance has been achieved.

The tools necessary to implement such a system are:

• A standardized definition of biotechnology
• Standardized tests and methodology for detecting biotechnology-enhanced products within the food chain.
• A threshold or tolerance for adventitious or accidental inclusion of biotechnologically-derived traits consistent with sound science and commercial reality.
• Ensure the availability of pure seed to meet internationally accepted tolerance.
• A “stewardship program” consisting of biotechnology and seed companies working together with producers to ensure that crops are grown in accordance with recommended practices and marketed through appropriate channels and certification systems.
• Effective regulatory oversight to assure integrity of marketing system. This includes sampling protocols and the testing of equipment that needs calibration, such as NIR machines.

3.4 International Trade and Market Access
The United States must work toward the goal of internationally accepted, science-based standards for trade in biotechnology-enhanced products. These science-based standards must include testing methodologies, sampling protocols, and tolerance levels. Given the novelty of agricultural biotech products, harmonized regulatory oversight by major trading countries will be a work in progress for quite a while. Indeed many countries have no approval process for these products at all. The U.S. government must participate in all appropriate international, multilateral and bilateral forums to ensure that all international standards, guidelines or recommendations for commodities and food developed through the use of biotechnology, are based on sound science and prudent risk analysis and result in fair trade practices that allow for the unrestricted shipment of such commodities and products in international markets.

The international bodies established to administer the sanitary and phytosanitary agreement of the World Trade Organization should continue to have the authority to regulate the international trade of genetically enhanced agricultural products. The United States should use all available means to improve international understanding of the science-based processes used by U.S. agencies when approving products that have been developed through biotechnology. The Codex Alimentarius Commission of the United Nations is currently developing international guidelines for analyzing the risks of foods derived from biotechnology that countries may use in establishing their own product approval regulations. Many countries simply adopt the Codex standards as their own. For this reason, the Codex Alimentarius Commission of the United Nations should fast-track this process.

In a customer-driven market, the terms of product acceptability may change rapidly. There is additional risk in this kind of marketplace that can be managed only if there is good communication at every level of the food chain. If the United States does not have a system that can reliably and consistently deliver products that the customer wants, U.S. agriculture may lose part of its customer base.

3.5 Regulation and Oversight
The Coordinated Framework for Regulation of Biotechnology, prepared by the Office of Science and Technology Policy (OSTP) and published June 1986, is the comprehensive U.S. policy for ensuring the safety of biotechnology research and resulting products. It explains the coordination among federal agencies and the basis for regulation. Under the Framework, the United States applies existing food safety and environmental protection laws and regulations to biotech products and makes decisions on approvals based on characteristics of products rather than whether they are derived from biotechnology. The “products, not process” scheme is objective, transparent, and scientifically sound.

It is appropriate to periodically review federal regulatory oversight in order to ensure comprehensive, efficient regulatory review of new genetically modified crops and foods. Governments, biotech companies, producers, processors, and the scientific community must work to maintain a responsive regulatory system in which the public has confidence. Oversight of agricultural biotechnology should continue to be a careful, objective, science-based evaluation of technologies and products through continuous testing, safety assessments for reasonably foreseeable risks, continued implementation of appropriate biosafety and environmental controls, frequent review of safety evaluation procedures, and economic assessments. The basis for regulation should continue to be the characteristics of the organism, its intended use, and the environment into which it is to be introduced, and not the method used to produce it.

It is critical that federal and state agencies be informed, knowledgeable, and work as partners in all phases of the ongoing biotechnology regulatory policy process. State agencies should be active partners, sharing oversight responsibilities with federal agencies, while carrying out their responsibilities to the state’s agricultural community, the environmental community and the consuming public at large. As new advances are made in plant and animal production, it is critical to ensure that private and public issues are adequately reviewed. Providers of seeds and biotech-enhanced ingredients should provide adequate information in a timely fashion to ensure that new products do not create new or unexpected concerns.

Government has a vital role in the commercialization of biotechnology products for the future. Regulation and oversight should include:

• Periodic review of the federal biotech regulatory system in an effort to maintain a responsive system and public confidence.
• Evaluation of the technologies and products through science-based continuous testing, safety assessments for reasonably foreseeable risks, continued implementation of appropriate biosafety and environmental controls, frequent review of safety evaluation procedures, and economic and benefits assessments.
• Oversight based on the characteristics of the organism, its intended use, and the environment into which it is to be introduced, not by the method used to produce it.
• Support for state agencies as active partnerships, sharing oversight responsibilities with federal agencies, on biotech issues.
• Establishment of a regulatory system that can enforce the tolerance levels and established certification/channeling process, testing protocols, and equipment testing.
• Enforcement of and support for humane animal care in research and prosecute acts of terrorism on research and research facilities of any kind.
• Monitor strategic actions, both vertical and horizontal, of biotechnology firms so that new practices and products are competitive and do not unfairly burden producers or restrict fair and free market activities.
• Protect agricultural producers from liability for damages resulting from biotech-enhanced product use if recommended practices and procedures have been followed.
• Provide clear identification and aggressive communication of export approval status of hybrid-specific seed and the approval status of all seed varieties.
• Provide significant investment in publicly-funded biotech research to establish independent verification of privately-owned information.

NASDA should play a key leadership role in the following issues:

• Work with the U.S. Trade Representative, USDA, and others to establish tolerance levels for biotechnology products that is accepted domestically and internationally.
• Lead a coordinated effort with the U.S. seed industry and ensure that “pure seed” is made available to producers.
• Coordinate and lead work with EPA, FDA, and USDA, to establish standardized testing methodologies and equipment standardizations and calibrations.
• Coordinate state efforts to establish grain production/handling/marketing/process-ing/food industry supply chain channeling/segregation/certification programs that can enforce the tolerance levels.
• Advocate the rights of U.S. farmers and producers in the world marketplace.

3.6 Food Safety and Labeling
While industry has the legal duty to ensure the safety of foods it puts on the market, government oversight of foods and food ingredients, whether produced by biotechnology, conventional or organic means, is necessary to ensure and maintain a safe and stable food supply. The evaluation of food, food ingredients, and animal feed obtained from organisms developed using rDNA technology does not require a fundamental change in established principles of food safety; nor does it require a different standard of safety. The science that underlies biotechnology-derived foods does not support more stringent safety standards than those that apply to conventional foods. Current FDA policy reflects this view.

Numerous authoritative groups worldwide have concluded that modern gene transfer technologies offer no unique risk to human or animal health or the environment. These groups include official commissions, scientific bodies, and international organizations, such as the OECD, and the Codex Alimentarius, which are staffed with experts from all relevant disciplines.

Federal law requires specific labeling on food products to inform consumers of the existence of material facts that are significant and relevant to the issues of safety, efficacy, and purity. Any changes to a food product that alter the chemical or nutritional composition, or allergenicity of the product must be disclosed to the consumer. Under this requirement, if a food derived from modern biotechnology affects any of these aspects, FDA requires that the food be so labeled. If the product is not materially different from its conventional counterpart, it does not require special labeling.

NASDA supports the role and responsibility of FDA to determine appropriate food labeling and to provide regulatory guidance to the food industry on the voluntary labeling of products to meet consumer preferences. The agency should communicate a clear definition as to what constitutes genetically modified food or food products, should establish criteria for “GM Free” and “non-GM ingredient” labeling, and require that voluntary labeling claims can be substantiated by identity-preserved supply chains based on a clear and factual certification process. The Federal Trade Commission should develop comparable guidelines for advertising claims about food biotechnology.