Low Acid Canned Foods

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

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. 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 21 CFR 108 - Emergency Permit Control

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

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

10. 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 - LACF Yes - LACF Yes - LACF Yes - AF Yes - AF Yes - AF No - Water activity No - Fermented No - Acid food No - USDA Examples of LACF/AF

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 REGISTRATIONandSCHEDULED PROCESS FILING • Must Each Plant Register? • Who Registers? • Low-Acid or Acidified? • Products Not Covered? • When to File? • What to File? • Approval? Certificate?

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

14. ON-LINE LACF & AFREGISTRATION & 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!