Public Information Issues Statement (The Food and Drug Administration Public Meeting)

Thank you for inviting the Biotechnology Industry Organization (BIO) to provide a statement on the Food and Drug Administration's policy on information issues related to products developed through agricultural biotechnology. I am Michael J. Phillips, Executive Director for Food and Agriculture of 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. BIO commends FDA for conducting these public meetings to explain the agency's policy and experience regarding the safety evaluation and labeling of food products derived through agricultural biotechnology and to solicit views from consumers, industry, and academia on the policy.

BIO supports the consumer's right to know information regarding biotechnology foods so that they can make more informed choices regarding the foods they eat. We believe that FDA's 1992 labeling policy for biotechnology foods and ingredients is appropriate and that the Food, Drug and Cosmetic Act currently allows food producers to provide choice through voluntary label statements as long as labels are truthful and not misleading. We agree with FDA's implementation of the 1992 policy that requires labeling for significant changes including nutrients or the introduction of allergens, and specifically that the common or usual name for the ingredient should identify the change.

There are two key aspects that must be considered in how a voluntary labeling process should work. First, FDA would need to establish guidelines or criteria to ensure that consumers could rely on labels like GMO-free or non-GMO. Second, the public must not be misled by packaging or advertising that would in any way suggest or imply that these products are less safe.

FDA has posed a series of questions to be addressed in its public meetings regarding public information issues. The remainder of this statement directly addresses those questions.

1. Should FDA's policy requiring labeling for significant changes including changes in nutrients or the introduction of allergens, be maintained or modified?

FDA's policy should be maintained. We agree that FDA should require labeling of foods or food ingredients from genetically modified plants if there are: important changes in the nutritional content such that the nutrition statement on the food label needs to be modified; if there is a change in the safety of the ingredient or food, such as the presence of an allergen which would not be anticipated in that food; or if there is a change in the common and usual name of the food or food ingredient. Where biotechnology-enhanced food is not materially different from other foods and as safe as foods from conventional plant varieties, we agree with FDA's policy that there is no need for mandatory labeling. However, voluntary labeling, which is truthful and not misleading, provides an opportunity to provide additional information to the consumer.

2. Should FDA maintain or revise its policy that the name of the new food be changed when the common or usual name for the traditional counterpart no longer applies?

FDA should maintain its policy. Food manufacturers and consumers need to be informed if there has been a significant change in the product so that the common and usual name no longer applies. This has already been implemented in the case of foods from biotechnology derived plants with improved nutritional or health benefits, which are, by definition, not compositionally equivalent to traditional foods. Following FDA's existing "decision tree" approach, these foods were assessed for safety and the consultation completed confirming the safety of these foods. However, because they were nutritionally altered such that the common and usual name no longer applied, two examples of food products derived through biotechnology have been labeled to communicate the fact the common and usual name was changed: laurate canola oil and soybean oil with higher oleic acid. In both cases, FDA confirmed the safety of these food ingredients and appropriately required labeling to communicate a new name for these ingredients to inform consumers and food companies that these ingredients were not compositionally equivalent to their conventional counterparts.

3. Have these policies regarding the labeling of these foods served the public?

These policies have served the public very well. Labels provide a consumer's first impression of most packaged food products. Labels list ingredients, describe features, give instructions, explain benefits and deliver advisories and warnings. Information considered essential to health and safety is mandated by law to appear on the label.

In addition to the mandatory labeling discussed above, FDA permits voluntary labeling, as long as the label is truthful and not misleading, to provide additional information to those consumers who desire more information. It is critical that voluntary labeling be truthful and not misleading; that such labeling does not infer that there are any differences in the safety of the food derived from crops improved by biotechnology. The safety of all the food products derived from biotechnology enhanced plants have been assessed by the FDA during their consultation process. These foods have been shown to be as safe as foods derived from conventional plant varieties. Therefore, it would be false and misleading if a label, in any way, communicated that such food differed in safety compared to foods derived from conventionally bred plants. The consumer deserves clear, accurate and truthful information.

4. Should additional information be made available to the public about foods derived from bioengineered plants? If so, what information?

Providing Information About the Safety of the Food

Consumers need to be better informed about foods derived through agricultural biotechnology. More and better information on the use of biotechnology in food production should be made available. Consumers need to be made aware of the data and experience showing that these foods are as safe as, and in many cases safer than, foods derived through traditional methods.

Industry, universities and the developers of these products need to and are working to provide more information via a numbers of different approaches. Numerous Internet web sites have been established by universities, regulatory agencies and other governmental organizations, BIO, food companies and other industry organizations as well as by many of the developers of the products of agricultural biotechnology. In addition to web sites, information should be provided by toll free numbers, by brochures and other methods which enable consumers to have the information they need to make informed choices of the food they purchase.

In addition, FDA needs to be more proactive in explaining its regulatory policy to consumers and its rationale for the policy. We urge the FDA to be more transparent in how it implements 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 tests conducted and summary results, results of any review of the product by FDA advisory committees, and information provided to the company once the consultative process has been completed. We strongly urge FDA to make its process as transparent as possible while being careful not to divulge confidential business information.

Providing Information About Biotechnology

A question one might ask is whether information about modern biotechnology is so essential that it must appear on every label of a food produced with it.

Some critics of FDA's labeling policy are urging the government to mandate the disclosure of genetic techniques used in the development of a product, even if the food that results is substantially equivalent to its traditional counterpart and even though it presents no demonstrated health or safety risk to the population.

Labeling policy based on this rationale is not only unnecessary but detrimental to consumers. It is unnecessary, because competitive markets will give consumers the products they want and the information they need to find them. Consumers who desire to purchase traditional or specialty foods create opportunities for companies eager and able to serve them. Consumers today may choose from a bounty of "organic", "natural", or "kosher" offerings. Manufacturers voluntarily identify and actively promote goods that meet these and other descriptions.

5. Who should be responsible for communicating such information?

In general, consumers may wish to obtain additional information about: 1) the safety assessment of foods derived from biotechnology; 2) the intended purpose and benefits of these plants; and 3) those points in the food or feed chain where these biotechnology plant products are utilized.

Information of food, feed and environmental safety should be provided by the appropriate regulatory agencies, the companies who have developed the products and, to a lesser extent, by the food and feed companies who use these products. In this regard, we encourage the FDA to be more transparent in how it implements its policy as noted above.

Information on the products and product benefits should be provided by the biotechnology companies who develop these products, the seed company affiliates and groups representing the growers, food and feed manufacturers and others who benefit directly from these products. Governmental agencies such as the USDA's Agricultural Research Service can also play a role in documenting the benefits to US agriculture. For products which provide direct benefit to the consumer, food manufacturers and retailers will also play an important role in communicating directly to the consumer.

The food manufacturers and food retailers should provide relevant information on the food products. The majority of consumers will want to know about the use of biotechnology in the food chain only when the products they purchase and consume are substantially different from their traditional counterpart. In these cases, labeling will provide that information. For other information, the alternative information systems discussed above could be used to provide the consumer with the information they need to make informed food choices.

6. How should additional information be made available to the public: e.g. on the Internet, through food information phone lines, on food labels, or by other means?

Clearly more use could be made to provide additional information through the Internet, toll free numbers, and displays/brochures at point of purchase. Voluntary labeling can also provide an opportunity to provide additional information. Such labeling must be truthful and not misleading. The FDA should develop appropriate criteria for voluntary labeling to assure that these labels are clear, accurate and not misleading. Given that the safety of the foods is reviewed by FDA during the consultation process, voluntary labeling must not imply that the foods derived from biotechnology differ in safety from the foods derived from conventional plant varieties. We urge the FDA to work closely with the food industry to develop standards that the food industry could use in providing voluntary labels indicating the use or non-use of biotechnology in producing the labeled food product.

A sound labeling policy can and should recognize the rights of consumers to a safe and nutritious food supply, while facilitating consumer choice based on clear, meaningful, truthful and non-misleading information about the product.