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Hard or Sharp Foreign Objects in Food

Hard or Sharp Foreign Objects in Food. Bhadriraju Subramanyam, PhD Professor Department of Grain Science and Industry Kansas State University Manhattan, KS 66504 E-mail: sbhadrir@ksu.edu Website: www.oznet.ksu.edu/grsc_subi. Foreign Objects as Physical Hazards.

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Hard or Sharp Foreign Objects in Food

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  1. Hard or Sharp Foreign Objects in Food Bhadriraju Subramanyam, PhD Professor Department of Grain Science and Industry Kansas State University Manhattan, KS 66504 E-mail: sbhadrir@ksu.edu Website: www.oznet.ksu.edu/grsc_subi

  2. Foreign Objects as Physical Hazards • Potentially hazardous: Hard and sharp foreign objects • Glass, metal fragments • Cause traumatic injury (laceration and perforation) • Non-Hazardous: • Tiny metal shavings while opening canned food • Insects, mites, rodent filth

  3. Naturally Occurring Hard Objects • Bones in seafood • Consumers awareness eliminates hazard • Exception: when the food label claims that naturally occurring hard objects have been removed • Consumers awareness is lacking • Examples: Pit fragments in pitted olives (DALs) • Average of 1.3% or more by count of olives with whole pits and/or pit fragments 2 mm or longer measured in the longest dimension

  4. FDA Definition of Foreign Objects that Pose a Physical Hazard • There is clinical evidence of physical trauma or injury from ingestion • Medical authorities recognize the type of object as a potential ingestion hazard • Subsequent processing or intended use of the product does not eliminate or neutralize the hazard

  5. Hard or Sharp Foreign Objects • Trauma • FDA: 7 mm or larger; 2 mm could be a risk to elderly or infants • USDA: Over 7 mm is hazardous; 2-7 mm is non-hazardous • Health Canada: 2 mm or greater • Does not apply to naturally occurring hard or sharp objects • Choking hazards • The Consumer Product Safety Commission: 25 mm or larger is NOT a chocking hazard • Sources • Raw materials • From machinery/equipment • Glass fixtures

  6. FDA Compliance Policy Guidehttp://www.fda.gov/ora/compliance_ref/cpg/cpgfod/cpg555-425.htm(March 23, 1999) • 1972-1997 FDA Health Hazard Evaluation Board • Evaluated 190 cases (injury and non-injury cases) • Objects <7 mm rarely cause injury or trauma, except in elderly, infants, and surgery patients • Regulatory action: Seizure (Div. Compliance Mgmt. & Operations) • Product contains object 7-25 mm long • Product is ready to eat • Minimal preparation does not neutralize the hazard • Product is considered adulterated, within the meaning of 342 (a) (1)

  7. Regulatory action: Legal action pending review (CFSAN Office of Field Programs, Div. Enforcement Programs) • Product contains object 7-25 mm long and will be subjected to further preparation or processing or • Product contains object <7 mm long and is intended for consumption by the sensitive groups or • Product contains object over 25 mm long • If there is a hazard, product is deemed adulterated (342 (a) (1)) • If there is no hazard for the first two product categories, product may be deemed adulterated and unfit for consumption (342 (a) (3))

  8. FDA Complaints • October 1988-September 1989: 10,923 complaints registered with FDA • 25% involved foreign objects in food or drink • 14% resulted in illness or injury from foreign objects • Examples: glass, slime/scum, metal, plastic, stones/rock, crystals/capsules, shells/pits, wood, and paper • Most (82%) were reported by consumers and not health professionals

  9. aAdapted from Hyman et al.(1991). Does not include meat and poultry categories or suspected or confirmed tampering complaints.bPercent of total (2726) reported foreign object complaints received by the FDA Complaint Reporting System from 10/1/88 through 9/30/89.

  10. Addition of Foreign Objects • Intentional addition is a criminal act • Can be prosecuted under Federal Anti-Tampering Act (FBI) if intent is fraud or sabotage • Cannot imbed foreign objects in confectionary products (342 (a) (1))

  11. Methods to Control Hard or Sharp Foreign Objects • Raw material specification and inspection • Vendor certification and letters of guarantee • Metal detectors • X-ray technology (bone fragments) • Effective pest management programs • Preventive equipment maintenance programs • Some hard objects are regulated under a different category—Defect Action Levels

  12. Flow Chart for Evaluating Significance of Hazards in Foods Is a contaminant found? No action is indicated Yes No Is the contaminant a hazard or an indication of a potential hazard? No Yes Is there an effective control to eliminate or neutralize the hazard? Immediate correction action is required Yes No Is a contaminant an indication of unsanitary conditions? The contaminant may be an aesthetic defect Yes No SSOP or other corrective action is required

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