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FDA/HHS Technical Assistance on Senate Agriculture Committee Draft Legislation to Establish a National Disclosure Standard for Bioengineered Foods

These comments are intended only to provide technical assistance on the draft bill and are by no means to be interpreted as any kind of approval or endorsement of the proposed legislation by HHS and its agencies or the administration.

General Comments

The bill would give USDA alone certain regulatory authorities over claims on human food labeling that the food is bioengineered. Those authorities would apply to any food that is subject to labeling requirements under the Federal Food,  Drug, and Cosmetic Act (FD&C Act) and to certain foods that are subject to labeling requirements of the Federal Meat Inspection Act or the Egg Products Inspection Act. Thus, the bill would give USDA these authorities over food labeling that is otherwise under FDA's sole regulatory jurisdiction (as well as over certain other foods).

FDA has a long-held policy position that the use of genetic engineering (GE) in the production of food has not presented any safety concerns for such foods as a class, and therefore the use of GE techniques in the production of food is not a material fact that must be disclosed on the labeling of food products. Since FDA's key responsibilities and focus with respect to food are for safety, any issuance by FDA of regulations governing labeling of foods as bioengineered could be understood by the public as reflecting on the safety of such foods. In the absence of reliable data indicating any safety concerns with bioengineered foods as a class, FDA has not expressed a desire to be the responsible agency for any such regulatory program.

We note that provisions to allow information regarding the GE content of food to be presented only in an electronically accessible form and not on the package label would be in tension with FDA’s statute and regulations, which require disclosures on food labels. For example, under FDA's provisions, information such as Nutrition Facts and the list of ingredients must be displayed directly on the label. To avoid potential conflicts, the drafters could make clear in this bill that it will not affect FDA’s labeling requirements in the future.

We are concerned that USDA’s regulations implementing the mandatory standard under this bill could conflict with FDA’s labeling requirements. For example, depending on what USDA requires for small packages, it is possible that a manufacturer would not be able to fit both FDA’s required statements and USDA’s required information on the label. Here also, to avoid conflicts, the drafters could amend the bill to state clearly that it shall not be construed to authorize a regulatory requirement that would supersede or conflict with any labeling requirement under the FD&C Act.