March 13, 2001 - Premarket Notice Concerning Bioengineered Foods

The American Society for Microbiology (ASM) values greatly the opportunity the Food and Drug Administration (FDA) has provided for comment on its proposed rule that would require food developers to notify the FDA at least 120 days in advance of their intent to market a food produced through biotechnology and provide information to demonstrate that the product is as safe as its conventional counterpart. The ASM, which has a worldwide membership exceeding 42,000, has a particular interest in issues and policies relating to biotechnology research and development. The ASM membership includes scientists working in academic, governmental and industrial institutions with expertise in molecular biology and genetics as well as in environmental microbiology, medical microbiology, agricultural microbiology, and industrial microbiology - including the microbiology of food.

On November 30, 1999, in Washington D.C., at a public hearing conducted by the FDA, the ASM concluded that the voluntary consultation process instituted by the FDA had achieved its intended purpose of providing safe products for the marketplace. However, we recognize that there is considerable public interest in a mandatory process, and support the proposed FDA rule to make premarket notification and consultation for bioengineered foods and feeds obligatory. We also concur in the position that the FDA notification requirement should include bioengineered food derived from new plant varieties modified to contain pesticidal substances. It is our hope that this requirement will facilitate communication and consultation between the FDA and the EPA on scientific and regulatory issues. However, implementation will require patience and understanding. It will be necessary to guard against interagency conflict, since authority to regulate all pesticidal substances is assigned by the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA) to the EPA, and regulatory authority of the FDA is limited to bioengineered plant varieties which incidently may contain nonpesticidal substances that raise food or feed safety questions based on unexpected and/or unintended compositional changes.

We concur also in the position that the notification process should not extend to bioengineered food from plant varieties derived from a specific transformation event, provided that both the transformation process and the use of the bioengineered food were addressed satisfactorily in a consultation completed under the FDA 1996 voluntary program. Consultations in progress should be completed under the FDA 1996 procedures, but pending consultations should be administered under the January 18, 2001 rule change as and when enacted. We agree also that exclusions from the notification requirement include uses and applications of bioengineered food identical to those already addressed by the FDA in previously submitted applications that were complete and judged to be in compliance.

In response to the FDA request for comment on specific issues, we offer the following opinions:

Federal Register p. 4712-4713. The definition of bioengineered food and the scope of the proposed premarket notification may be expanded to accommodate specific mention of gene deletions which could result in unanticipated change/s in a bioengineered plant. Likewise, the scope of the proposed notification does not include a consideration of supplements. For example, would rosehips, which are included as supplements in some teas and some vitamin C preparations, be included in the present requirement if the parent rose plant had been bioengineered for resistance to a disease such as black spot?

Federal Register p. 4721. Although it appears efficient to require that a premarket notice for bioengineered food include methods by which the food can be detected, we suggest that the inclusion of methodology be optional. Detection methods are undergoing rapid change, with improvements in sensitivity and reliability, and to require use of current methods would be premature. Moreover, before a requirement for analysis is established, it is necessary to develop standards and tolerances based on nutritional and safety considerations.

The ASM will continue to strongly support the FDA in its efforts to modify science-based policy required to safeguard public health as recombinant DNA technology continues to evolve and give rise to more and different bioengineered foods.