Plant Derived Biologics (PDBs)

Date: 7/07
Position Number: I-A-2
Expires: 3/08

Background: We believe that there is long-term opportunity for farmers to grow value-added products derived from biotechnology and extracted from plants. Pursuit of this new technology platform holds great promise for society. NCGA will continue to work responsibly to position growers to capture value from these new products while ensuring the safety of the food supply.

Some biotechnology products require extensive management. Trained and certified growers must have the skills and ability necessary to produce these crops with proper audits. Containment and isolation of PDBs are critical issues that must be resolved in order to protect traditional markets, and realize the promise of this technology.

Supports the following:

1. Federal policy should allow the opportunity to develop and grow these new products based upon scientific risk assessment(s).
2. Each class of compounds should be grown and handled based on the scientific risk assessment.
3. Each class of compounds should have specific requirements for regulatory approval.
4. We agree the following requirements should be followed when growing PDBs:
   1. Isolation from commodity corn through the use of:
      1. Non-transgenic pollen or male sterile corn;
      2. Dedicated production systems;
      3. Third party verification;
      4. A process that ensures plants containing an unapproved trait be 100% detasseled;
      5. A fallow system where appropriate;
      6. Temporal separation by using growing degree-days; and
      7. The development of technology protection systems in all pharmaceutical and industrial enzyme corn.
   2. A grower training, testing and auditing program to implement standard operating procedures.
5. Recommend a review of the following procedures used by the PDB industry for:
   1. Seed production and handling;
   2. Grain production and handling; and
   3. Utilization and handling of by products.