1. What constitutes the legal authority of USDA to regulate biotechnology products (your response must include a statement of the legislative authority/authorities with complete and accurate citation of the primary source for full credit)
2. Distinguish between the regulatory functions of the Licensing and Policy Development unit and the Inspection and Compliance unit in the approval process for Veterinary Biologics. If you feel their functions are the same in this process, say so and explain your response.