Docket Management
Docket: 02D-0324 - Draft Guid.: Drugs, Biologics & Medical Devices Derived from Bioengineered Plants
Comment Number: EC -47

Accepted - Volume 9

Comment Record
Commentor Mr. Doug Getter Date/Time 2003-01-10 11:03:07
Organization Iowa Biotechnology Association
Category Association

Comments for FDA General
1. General Comments Submitted electronical Friday, January 10, 2003 The Iowa Biotechnology Association would like to offer the following comments regarding Docket Number 02D-0324. 1. The Association appreciates and welcomes the inter-agency and inter-departmental cooperation which is demonstrated in the draft guidance document. The emerging science of derived proteins from renewable plant products will have significant societal benefits. 2. As the collaborative group reviews comments and modifications to the draft, it is important a distinction be made from engineered proteins that are expressed solely in the seed of the plant versus the leaves, stalk or root system of the plant. Proteins that are expressed in the salk, leaves or root system will demand production processes different than those proteins which are solely expressed in the seed of the plant. 3. A distinction in the Guidance Document is needed to address co-mingling. For example, are the genetic enhanced attributes developed within a plant easily transferable through a cell wall? This distinction would also need to be addressed relative to the source of the expressed protein(s). To illustrate, if an applicable protein is only expressed in the plant seed, co-mingling of residue from the plant stalk, leaves or root system with potentially other food grade products should not create or constitute a risk to human or animal use. 4. The Guidance Document should be modified to include a risk assessment of the enhanced proteins. Those proteins determined to be generally available in society and safe to human and animal usage should be free of the terms and conditions outlined in the Guidance Document. Those proteins determined to carry significant human or animal risk should carry well-defined controlled production requirements. For those proteins which are determined to fall between a save or a significant risk additional research should be required for safety evaluation. 5. Geographic production guidance should be deleted from the Document. Production guidance needs to be based on a science-based risk assessment of the proposed proteins. For those proteins determined to carry significant risk to humans or animals, highly controlled environmental production procedures should be defined and required. The Iowa Biotechnology Association appreciated the opportunity to hear and share concerns with FDA & USDA representatives from the collaboration group at an informational session held at Iowa State University. Taking the Draft Guidance Document on the road for review and comments is an excellent way of developing public policy. Thank you for the opportunity to share our suggestions and recommendations. Sincerely, Doug Getter Executive Director Iowa Biotechnology Association

EC -47