Docket Management
Docket: 02D-0324 - Draft Guid.: Drugs, Biologics & Medical Devices Derived from Bioengineered Plants
Comment Number: EC -3

Accepted - Volume 6

Comment Record
Commentor Dr. Walter R. Fehr Date/Time 2002-12-18 14:57:22
Organization Iowa State University
Category Academic

Comments for FDA General
1. General Comments December 18, 2002 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane, Room 1061 Rockville, MD 20852 Re: Docket No. 02D-0324: Guidance for Industry - Drugs, Biologics, and Medical Devices Derived From Bioengineered Plants for Use in Humans and Animals Thank you for the opportunity to comment on the guidance document. My comments reflect my own opinion and do not necessarily reflect the position of Iowa State University. The authors of the guidance document and their agencies are complimented for addressing a very difficult and important topic. The document provides excellent guidance for maintaining the integrity of plant-made pharmaceuticals (PMP) and other novel proteins, while protecting food and feed. My primary concern about the proposed regulation of PMP is the apparent lack of a risked-based assessment of each novel protein. As currently written, it seems that all PMP are judged to have the same risk for consumption in food and feed. No tolerance of PMP in food and feed would be allowed. This is not consistent with other genetically engineered traits that are used in crop production. For example, all Bt events for insect control are evaluated individually for the risk they pose to food and feed. Some Bt events have not been approved, while others are widely used. Given the regulatory approval process for Bt events, it does not seem appropriate to consider all PMP to be equivalent. The assessment of risk for PMP will not be a trivial undertaking. It also will be difficult to establish science-based tolerances for the presence of PMP in food and feed. Nevertheless, the work that is done now to address the issue of tolerances is important because of the numerous PMP that will be candidates for genetic engineering in the future. There is concern that the presence of PMP in food and feed may be unacceptable to consumers. I share this concern, but would not want consumer acceptance to become a criterion for regulatory review. Whether or not consumers accept PMP in their food is a matter that industry will have to consider in their commercialization programs, but should not be a matter for the regulatory agencies to address. My compliments to the USDA and FDA for their concern about the safety of food and feed. The confidence of the consumers in the regulatory agencies has been very important for the acceptance of genetically engineered products. Your vigilance is appreciated. Thank you for the opportunity to make these comments. Walter R. Fehr, Charles F. Curtiss Distinguished Professor in Agriculture and director of the Office of Biotechnology, 1210 Molecular Biology Building, Iowa State University, Ames, IA 50011

EC -3