Docket Management
Docket: 02D-0324 - Draft Guid.: Drugs, Biologics & Medical Devices Derived from Bioengineered Plants
Comment Number: EC -89

Accepted - Volume 9

Comment Record
Commentor Ms. Carla West Date/Time 2003-02-07 16:55:10
Organization AgBiotech Planning Committee
Category Other

Comments for FDA General
Questions
1. General Comments AgBiotech Planning Committee 655 15th Street, NW Suite 700 Washington, D.C. 20005 (202)660-0608 February 7, 2003 Dockets Management Branch (HFA-305) Food and Drug Administration 5630 Fishers Lane Room 1061 Rockville, MD 20852 RE: Docket No. 02D-0324 Dear Docket: The AgBiotech Planning Committee (ABPC) appreciates the opportunity to respond to the Food and Drug Administration’s request for comment to the draft document “Guidance for Industry: Drugs, Biologics, Medical Devices Derived from Bioengineered Plants for Use in Humans and Animals” published in the Federal Register on September 12, 2002 (67 Fed Reg 57828). The ABPC is a coalition of agriculture producers, processors and merchandisers, food processors and manufacturers and biotechnology providers that support the continued availability and marketability of agriculture and food biotechnology. Individual member organizations of the ABPC will provide more detailed comment to the FDA regarding issues that specifically affect their business operations and interests. In addition, as a food chain coalition, the ABPC strongly supports the following fundamental principles to ensure that U.S. government policy that regulates food crops, used to produce traits not intended for food or feed use, are stringent and sufficiently restrictive to protect human health, the food supply and the environment. 1. The draft guidance primarily and appropriately addresses issues relating to the safety, purity and efficacy of vaccines and drugs. The environmental and confinement section, which is of great interest to ABPC, is not comprehensive in the FDA guidance and should be addressed by USDA’s Animal and Plant Health Inspection Service (APHIS). We strongly encourage the U.S. Department of Agriculture (USDA), in coordination with other agencies as appropriate, to issue regulations and guidance addressing the containment, confinement and production of food crops, intended for uses other than food or feed, including both plant-made pharmaceuticals (PMPs) and plant-made industrial products (PMIPs). 2. PMIPs, not intended for food or feed use, raise most of the same environmental and food safety issues as those developed for PMPs. USDA should require that PMIPs, not intended for food or feed use, be grown only under permit during field testing and commercialization. 3. Applicants should be required to provide validated, rapid testing methodologies for PMP and PMIPs to allow regulatory authorities to detect both the presence of the target gene and the protein in field testing and in raw agricultural commodities. 4. Systematic, well articulated procedures outlining how the PMP or PMIP crop will be grown, harvested, transported, processed, and disposed of should be included as conditions of the permit. The production procedures should include, but not be limited to, a grower certification program, standard operating procedures focused on critical production activities, and details regarding use of dedicated equipment and land use requirements in the year subsequent to the production of the non-food use crop. Permit conditions must assure protection of health and environmental safety associated with the use of food crops to produce non-food PMPs or PMIPs. 5. APHIS should articulate in a regulatory statement the protocol for ensuring appropriate oversight and inspection of crops used to produce traits not intended for feed or food use. The protocol should include mandatory audits and inspections at critical production points during the entire production process. Again, we appreciate the opportunity to provide input regarding the regulatory oversight of these products. We look forward to continuing the dialogue with FDA and other regulatory agencies as more specific requirements and guidance are announced. Sincerely, American Farm Bureau Federation American Feed Industry Association American Soybean Association Biotechnology Industry Organization CropLife America Corn Refiners Association National Association of Wheat Growers National Corn Growers Association National Cotton Council National Oilseed Processors Association North American Millers Association USA Rice Federation U.S. Grains Council Wheat Export Trade Education Committee




EC -89