1. Nanotechnology - USDA - 18 Nov 2002 REGULATORY CONSIDERATIONS FOR NANOTECHNOLOGY IN PUBLIC HEALTH FOOD AND DRUG ADMINISTRATION Norris E. Alderson, Ph.D. Senior Associate Commissioner for Science

2. Nanotechnology - USDA - 18 Nov 2002 FDA REGULATES 20 percent of the consumer purchases $50 billion of medical R&D 8 million import shipments/year Food, drugs, biologicals, devices, cosmetics, blood Counter terrorism products

3. Nanotechnology - USDA - 18 Nov 2002 FDA’S PUBLIC HEALTH MISSION Safety Efficacy Good Manufacturing controls Risk analysis Be a force in counter-terrorism

4. Nanotechnology - USDA - 18 Nov 2002 FDA ORGANIZATION Center for Biologics Evaluation and Research Center Drug Evaluation and Research Center for Devices and Radiological Health Center for Food Safety and Applied Nutrition Center for Veterinary Medicine Office of Regional Operations National Center for Toxicological Research

5. Nanotechnology - USDA - 18 Nov 2002 PUBLIC HEALTH IMPLICATIONS FOR NANOTECHNOLOGY New materials and manufacturing processes All FDA regulated areas are likely affected –drugs, medical devices, biologicals, food The science is new to the Agency –Risk management is our job Education of the Public will define its acceptance

6. Nanotechnology - USDA - 18 Nov 2002 NATIONAL NANOTECHNOLOGY INITIATIVE Examples of fundamental research that will be regulated by FDA –Biological assembly of nanostructures –Using DNA molecules to construct nanoscale devices –Artificial genetic system –Modeling and simulation of biological ion channels to cure diseases –Nanoscale film serves as molecular filter

7. Nanotechnology - USDA - 18 Nov 2002 NANOTECHNOLOGY AND COMMERCIALIZATION OF PUBLIC HEALTH PRODUCTS Education & training of FDA Education of the Public – Developing the public perception Education and training of industry sectors unfamiliar with FDA Demonstrate the safety of products Demonstrate the efficacy of products Establishment of standards of manufacturing, performance, and approval Risk analysis and management

8. Nanotechnology - USDA - 18 Nov 2002 CHALLENGES!! New technology – Unknown risks Education – A bad job here can minimize the utility Stakeholder involvement –Early involvement of all parties –Risk communication FDA guidance development – Help us.