1. Low Acid Canned Foods Dennis M. Dignan, Ph.D. Center for Food Safety and Applied Nutrition November 7, 2003 U.S. Food and Drug Administration College Park, MD

2. Food Drug and Cosmetic Act Misbranded Adulterated 402 (a)(1) - Bears or contains poisonous or deleterious substance 402 (a)(3) - Consists of whole or in part filthy, putrid, decomposed substance or otherwise unfit for food 402 (a)(4) - Prepared, packed or held whereby it may be contaminated or injurious to heath

3. Food Drug and Cosmetic Act Emergency Permit Control - Section 404 When food contaminated with microorganisms may be injurious to health and the injurious nature cannot be determined, regulations provide for the issuance of permits

4. 21 CFR 108 - Emergency Permit Control 108.25 - Acidified Food 21 CFR 114 Register File Processes 21 CFR 114 Report Spoilage Recall Plans BPCS Keep Records Detention 108.35 - LACF 21 CFR 113 Register File Processes 21 CFR 113 Report Public Health Deviations & Spoilage Recall Plans BPCS Keep Records Detention

5. HUMAN ERROR PROCESS DELIVERY PROCESS DESIGN PROCESS RECORDS FDA’s LACF PROGRAM CONTAINER INTEGRITY RISK TO PUBLIC HEALTH FROM IMPROPERLY PROCESSED LACF BETTER PROCESS CONTROL SCHOOLS

6. ACTIVE REGISTRATIONS FY 2003

7. SCHEDULED PROCESS FILING FY 2002

8. Low-Acid Canned Food pH > 4.6 Water Activity > 0.85 Thermally Processed Hermetically Sealed Container Non-refrigerated

9. Low acid food pH > 4.6 water activity > 0.85 Acid(s) or acid foods are added equilibrium pH = or < 4.6 Non-refrigerated Acidified Foods

10. Examples of LACF/AF Product Salmon Tuna in oil Lentil soup Asparagus in brine Marinated artichokes Roasted peppers Salsa Tinned biscuits Green olives Mandarin oranges Canned ham Register & File? Yes - LACF Yes - AF No - Water activity No - Fermented No - Acid food No - USDA

11. Avoiding LACF/AF Delays at Import Knowledge of product Register File scheduled processes in advance container types and sizes product name pH water activity

12. FIRM REGISTRATION and SCHEDULED PROCESS FILING Must Each Plant Register? Who Registers? Low-Acid or Acidified? Products Not Covered? When to File? What to File? Approval? Certificate?

13. BATCH ORIENTED LACF/AF FIRM REGISTRATION, PROCESS FILING & EVALUATION SYSTEM RECEIVE BATCH TRACK TECHNICAL EDIT PROCESS EVALUATION FDA FORMS 2541a 2541c FCE DATA ENTRY FILE UPDATE FDA FORMS 2541 2541a 2541c FDA

14. ON-LINE LACF & AF REGISTRATION & PROCESS FILING

15. Foreign Inspections New LACF processing systems Aseptic processing and packaging No or little inspection history

16. How to Stay Informed http://vm.cfsan.fda.gov/list.html http://vm.cfsan.fda.gov/~comm/lacf- toc.html Regulations Inspectional Guides Registration and Filing Forms http://www.foodsafety.gov/

17. DON'T EVER GIVE UP!