Scientific and Food Safety Issues Statement (The Food and Drug Administration Public Meeting)

The Biotechnology Industry Organization (BIO) is pleased to be invited by the Food and Drug Administration (FDA) to participate on the Food Safety Panel for this public meeting. I am L. Val Giddings, Vice President for Food and Agriculture at the Biotechnology Industry Organization. BIO represents more than 850 companies, academic institutions, and state biotechnology centers in 47 states and 26 nations involved in research and development of health care, agricultural, industrial and environmental biotechnology products. We applaud the FDA for holding these public meetings to explain its policy and relate its experience regarding the safety evaluation and labeling of food products derived from agricultural biotechnology and to solicit the views of consumers, industry, and academia on FDA's policy. Agricultural biotechnology has undergone significant research and development over the last fifteen years with the first products introduced in the U.S. in 1992 and the first commodity products in 1996. U.S. farmers receive significant benefits from current agricultural biotechnology crops including:

1. improved insect and weed control,
2. improved crop yields and seed and feed quality,
3. reduced labor and pesticide costs, 4) reduced time spent in the field, and
4. increased profitability and competitiveness.

There are also important environmental and consumer benefits from current agricultural biotechnology crops including:

1. reduced pesticide usage against some pests,
2. reduced soil erosion through conservation tillage techniques,
3. more efficient use of agricultural land,
4. reduced mycotoxins in grains, and
5. improved food quality.

Agricultural biotechnology also offers these important benefits for developing countries where food security and productivity are especially important.

Universities, research institutes, and agricultural biotechnology companies currently are conducting research leading to numerous important new products with additional benefits for consumers and the environment. These new products will provide foods with enhanced nutritional content and improved quality as well as renewable fuel sources to meet growing energy needs. Some of these products include:

• Rice with increased levels of vitamin A and iron.
• Soybean and corn oil with more favorable fatty acids for cardiovascular health or increased levels of vitamin E.

• Corn with increased levels of methionine and lysine, which are limiting amino acids in conventional varieties.
• Corn with decreased levels of phytate which decreases water pollution from animal waste.

The FDA plays a central role in the regulation of products derived from agricultural biotechnology. In order to obtain feedback about how the regulatory process is working, FDA in announcing these meetings posed two series of questions concerning scientific/safety and public information issues pertaining to products derived from bioengineered plant varieties. The remainder of this statement focuses on FDA's questions related to the scientific and safety issues.

1. Has FDA's consultation process achieved its intended purpose? Based on experience to date, should this regulatory approach ``sunset,'' continue in its current state, be made mandatory, or otherwise be revised?

The FDA consultation process has achieved its intended purpose by providing clear policies and decision-trees (FDA flow charts) to ensure that all relevant scientific, safety and regulatory issues are resolved prior to commercial distribution of foods produced from biotechnology-derived plant varieties. FDA has provided numerous opportunities for public comment and input over the past 15 years to assure the concerns of all stakeholders have been heard and addressed. Under the Federal Food, Drug and Cosmetic Act (FFDCA), agricultural biotechnology developers have an obligation to ensure that the commodities utilized and the foods available to consumers are safe and in compliance with applicable legal requirements.

The success of this policy and consultation process is based on its design. The FDA flow charts provide a decision tree approach that focuses on key safety considerations. The decision trees are consistent with over ten different authoritative bodies' international guidelines and recommendations (FAO/WHO/OECD/ILSI/IFBC). It begins with full public input and participation over the past 15 years which included implementing the Coordinated Framework, effectively using the advice of the FDA Food Advisory Panel, and holding numerous public meetings such as you are doing today.

FDA has shown that it is committed to an interactive consultation process. The process is flexible to enable a case-by-case assessment that anticipates new products and methods. It also has leveraged the experience gained in completing consultations on over 40 products to date. All BIO member companies are aware that FDA has full legal and regulatory authority under the FFDCA and its amendments to remove food from the market if it is determined to be unsafe or incorrectly labeled.

The agricultural biotechnology industry is totally committed to developing safe and nutritious crops that are trusted and valued by consumers, farmers and food companies. The FDA consultation process, together with the regulatory reviews conducted by EPA and USDA, are critical to establishing and maintaining this trust.

The agricultural biotechnology industry fully understands FDA's legal authority under the FFDCA which gives the agency the power to block commercialization of any food product that is considered unsafe. Industry also recognizes the value of this process to ensure that all obligations have been met prior to placing foods on the market.

Farmers, our customers, need the assurance that these products are safe and nutritious when they make decisions on planting and marketing. Our industry also understands that food companies need the assurance that these crops and derived food ingredients are safe; the FDA consultation provides this assurance.

Most importantly, we understand that consumers require FDA oversight of their food supply. As a result, FDA's consultation process is de facto mandatory.

We believe the current process should continue and at this time should not be subject to any "sunset" provision. To continue providing assurance to the public that FDA is conducting sufficient oversight in the regulation of these new products, FDA should continue implementing its current policy well into the future.

BIO urges FDA to continue providing the public with information about its policy and defend its policy when it comes under attack and is misrepresented. We also urge the FDA to provide more information to the public about the implementation of its policy. For example, once a company has completed the consultation process, information could be posted on FDA's web site describing the new product, listing the numerous tests routinely conducted and summary results, results of any review of the product by FDA advisory committees, and information provided to the company that the consultative process has been completed. We strongly urge FDA to make its process as transparent as possible while of course being careful to respect confidential business information.

2. What newly emerging scientific information related to the safety of foods derived from bioengineered plants is there, if any? Are there specific tests which, if conducted on such foods, would provide increased assurance of safety for man or animals consuming these foods?

International consensus documents from FAO, WHO, OECD and ILSI conclude that the risk and safety concerns associated with foods derived from biotechnology are not unique to the process of biotechnology and are of the same nature as those associated with foods derived through conventional breeding. The same safety standards that apply to foods derived from conventionally bred plants apply to foods derived from plants improved through biotechnology i.e., a reasonable certainty of no harm.

Those tests deemed most relevant to food safety by food safety authorities and scientific experts are conducted by companies, universities, and research institutes and the results are reviewed by FDA. Based on a thorough safety analysis performed on biotechnology products, the FAO/WHO concluded that "this approach provides equal or greater assurance of the safety of food derived from genetically modified organisms as compared to foods or food components derived by conventional methods."

This thorough safety assessment of foods derived from biotechnology includes establishing: 1) the nutritional and compositional equivalence of the food and feed derived from biotechnology compared with food and feed currently on the market, and 2) the safety of the protein(s) encoded by the introduced DNA. Proteins expressed by the gene are extensively analyzed to assure safety, including allergenic potential. Foods produced from new genetically enhanced plant varieties are more thoroughly tested than foods produced from new plant varieties derived by traditional plant breeding. This testing, which compares the composition and nutritional quality of foods produced by biotechnology to their traditional counterparts, has actually added to the general knowledge of the quality of the foods we eat.

Food and feed products produced from over one hundred million acres of new genetically enhanced plant varieties have been marketed for the past several years. In fact, field studies conducted over the past four years have shown that insect-protected corn varieties can actually result in higher quality grain with lower levels of certain mycotoxins that are potentially harmful to farm animals and humans. There is no credible evidence relevant to current products to raise questions of food safety.

Industry is continually pursuing new methods to improve assessments, especially in the area of allergenicity. As technology continues to develop, any new tests which provide increased assurance of food or feed safety should be evaluated. As with any new methodology, these tests must be validated before they are used to assess safety. We continually research and evaluate methods to improve the safety assessment of our products.

3. What types of food products derived from bioengineered plants are planned for the future? Will these foods raise food safety issues that would require different approaches to safety testing and agency oversight? If so, what are those approaches?

The first products of plant biotechnology have focused on agronomic or "input" traits such as insect resistance or herbicide tolerance. The traits have generally been introduced by the insertion of one or a few genes and result in food products that are substantially equivalent.

As the technology develops, researchers will be able to introduce quality traits into plants resulting in foods with higher nutritional quality and other health benefits. Examples include soybean and corn with healthier oils, canola oil with higher levels of beta-carotene to reduce night blindness, rice with higher iron content, and bananas that contain vaccines against childhood and other diseases. Many of these products are aimed at addressing problems in developing countries, where a safe, adequate food supply and preventative medical care are often not currently available.

Foods with improved nutritional or health benefits are, by definition, not compositionally equivalent to traditional foods. The FDA's existing "decision tree" approach provides a mechanism to assess the safety of these improved foods. There have been two cases of these types of products: high laurate canola and high oleic acid soybean. In both cases, FDA confirmed the safety of these food ingredients but appropriately required labeling to communicate a new name for these ingredients in order to inform consumers and food companies that these ingredients were not compositionally equivalent to their conventional counterparts.

The current FDA policy and consultation accommodates new products. If a product has not been established as safe, the FDA has full authority to require a pre-market approval or to block its commercialization.