Docket Management
Docket: 02D-0324 - Draft Guid.: Drugs, Biologics & Medical Devices Derived from Bioengineered Plants
Comment Number: EC -49

Accepted - Volume 9

Comment Record
Commentor Mr. Dave Nelson Date/Time 2003-01-10 12:02:01
Organization Iowa Corn Growers Association
Category Association

Comments for FDA General
Questions
1. General Comments January 10, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5600 Fishers Lane Room 1061 Rockville, Maryland 20852 Re: Docket number 02D-0324 To Whom It May Concern: The Iowa Corn Growers Association (ICGA) represents over 6,000 farmers in Iowa who grow corn. We want to take this opportunity to comment on the guidance document for growing and manufacturing plant-made pharmaceuticals. The ICGA has a biotech committee that is looking at policy and technical issues that impact the development of new traits in corn. This committee has investigated the opportunity and the risk of growing plant-made pharmaceuticals in Iowa. We believe that there is long-term opportunity for Iowa farmers to grow value-added products derived from biotechnology and extracted from plants. Pursuit of this new technology platform holds great promise for society. The Iowa Corn Growers Association, in conjunction with the National Corn Growers Association, will continue to work responsibly to position growers to capture value from these new proteins in ways that ensure the safety of the food supply. Some biotechnology products require extensive management. Trained and certified Iowa growers have the skills and ability necessary to produce these crops with proper audits. Containment and isolation of biotechnology products are critical issues that must be resolved in order to realize the promise of this technology. Each protein should be grown and handled differently based on a scientific risk assessment and therefore each product should have specific requirements for regulatory approval. If the protein occurs naturally or poses little risk to society, then tolerances should be established for these proteins. Tolerances would facilitate development of these new and novel products in plants. We encourage EPA, FDA and USDA to distinguish and differentiate products developed through biotechnology by means that are appropriate for the trait and based on a risk assessment of that trait. We urge that federal policy not force abandonment of the progress that has already been made to develop novel products in corn. Most importantly, we urge that federal policy not prevent or exclude the opportunity to develop and grow these new products in Iowa. Thank you for the opportunity to present our views on the development of this important issue. Sincerely, Dave Nelson President




EC -49