low acid canned foods dennis m. dignan, ph.d. center for food safety and applied nutrition november...
TRANSCRIPT
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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
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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
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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
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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
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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
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ACTIVE REGISTRATIONS
DOMESTIC
FOREIGN
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7000 FY 2003
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SCHEDULED PROCESS FILING
RECEIPTS
RETURNS
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14000 FY 2002
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Low-Acid Canned Food
• pH > 4.6
• Water Activity > 0.85
• Thermally Processed
• Hermetically Sealed Container
• Non-refrigerated
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• 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
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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
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Avoiding LACF/AF Delays at Import
• Knowledge of product
• Register
• File scheduled processes in advance
• container types and sizes
• product name
• pH
• water activity
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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?
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BATCH ORIENTED LACF/AF FIRM REGISTRATION,
PROCESS FILING & EVALUATION SYSTEM
RECEIVEBATCHTRACK
TECHNICAL EDIT
PROCESSEVALUATION
FDA FORMS 2541a2541c
FCE
DATAENTRY
FILEUPDATE
FDA FORMS 25412541a2541c
FDA
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ON-LINE LACF & AFREGISTRATION & PROCESS FILING
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Foreign Inspections
• New LACF processing systems
• Aseptic processing and packaging
• No or little inspection history
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'98 '99 '00 '01 '02
LACFOthers
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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/
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DON'T EVER GIVE UP!