FDA TSE Advisory Committee Meeting July 17, 2003 U.S. Market Dynamics for Bovine Bone Gelatin George E. Masson Preside

1. FDA TSE Advisory Committee Meeting • July 17, 2003 • U.S. Market Dynamics for • Bovine Bone Gelatin • George E. Masson • President/CEO Rousselot Inc. • President, Gelatin Manufacturers Institute of America (GMIA)

2. GMIA – Gelatin Manufacturers Institute of America • Founded 1956 • Association of Gelatin Manufacturers • 6 Members, NAFTA-Based • 8 Working Committees: Technical Regulatory Environmental Safety Raw Materials Tariff & Trade Public Relations Audit TSEAC July 2003

3. GMIA – Gelatin Manufacturers Institute of America • Represents 22% of Global Gelatin Production • Represents 96% of NAFTA Gelatin Production • 3 Members are GME Member Affiliates TSEAC July 2003

4. GMIA Objectives • Monitor and inform members of regulations affecting gelatin • Serve as industry liaison with regulatory authorities • Gather and distribute technical information to members • Promote broader knowledge of gelatin and encourage wider consumption • Provide discussion forum and liaison on technical, environmental and safety issues • Facilitate the exchange of technical information with gelatin associations in other parts of the world TSEAC July 2003

5. Use of bovine bone gelatin in the US • Photographic use • Dietary supplements • Drugs • Cosmetics • Food • All grades are made using the same basic manufacturing processes to assure the safety of the final product TSEAC July 2003

6. Global Gelatin Production (2002) (metric tons) TSEAC July 2003

7. TSEAC July 2003

8. TSEAC July 2003

9. (1) (3) (3) (2) (4) (5) (5) • Excluding PRC • In EU, removal of vertebrae mandatory for ruminants over 12 months; all bovine bones used for gelatin manufacturing are vertebrae-free. • According to GME and auditable; all skulls and vertebrae removed; might be more, used by non-GME members • Meets EMEA Guidance provided alkaline process exclusively • No vertebrae / spines or other SRM’s per EU definition TSEAC July 2003