low acid canned foods dennis m. dignan, ph.d. center for food safety and applied nutrition november...
TRANSCRIPT
Low Acid Canned Foods
Dennis M. Dignan, Ph.D.Center for Food Safety and
Applied Nutrition
November 7, 2003
U.S. Food and Drug AdministrationCollege Park, MD
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
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
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
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
ACTIVE REGISTRATIONS
DOMESTIC
FOREIGN
0
1000
2000
3000
4000
5000
6000
7000 FY 2003
SCHEDULED PROCESS FILING
RECEIPTS
RETURNS
0
2000
4000
6000
8000
10000
12000
14000 FY 2002
Low-Acid Canned Food
• pH > 4.6
• Water Activity > 0.85
• Thermally Processed
• Hermetically Sealed Container
• Non-refrigerated
• 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
Examples of LACF/AF
ProductSalmon
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
Avoiding LACF/AF Delays at Import
• Knowledge of product
• Register
• File scheduled processes in advance
• container types and sizes
• product name
• pH
• water activity
FIRM REGISTRATIONand
SCHEDULED PROCESS FILING
• Must Each Plant Register?
• Who Registers?
• Low-Acid or Acidified?
• Products Not Covered?
• When to File?
• What to File?
• Approval? Certificate?
BATCH ORIENTED LACF/AF FIRM REGISTRATION,
PROCESS FILING & EVALUATION SYSTEM
RECEIVEBATCHTRACK
TECHNICAL EDIT
PROCESSEVALUATION
FDA FORMS 2541a2541c
FCE
DATAENTRY
FILEUPDATE
FDA FORMS 25412541a2541c
FDA
ON-LINE LACF & AFREGISTRATION & PROCESS FILING
Foreign Inspections
• New LACF processing systems
• Aseptic processing and packaging
• No or little inspection history
0
50
100
150
200
250
'98 '99 '00 '01 '02
LACFOthers
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/
DON'T EVER GIVE UP!