Hard or Sharp Foreign Objects in Food

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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_at_ksu.edu Website www.oznet.ksu.edu/grsc_s
ubi
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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

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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

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Main Materials of Concern as Physical Hazards and Common Sources (Hyman et al. 1991) Main Materials of Concern as Physical Hazards and Common Sources (Hyman et al. 1991) Main Materials of Concern as Physical Hazards and Common Sources (Hyman et al. 1991)
Material Injury Potential Sources
Glass Cuts, bleeding may require surgery to find or remove Bottles, jars, light fixtures, utensils, gauge covers
Wood Cuts, infection, choking may require surgery to remove Fields, pallets, boxes, buildings
Stones Choking, broken teeth Fields, buildings
Bullet/BB Shot/Needles Cuts, infection may require surgery to remove Animals shot in field, hypodermic needles used for infections.
Jewelry Cuts, infection may require surgery to remove Pens/pencils, buttons, careless employee practices.
Metal Cuts, infection may require surgery to remove Machinery, fields, wire, employees
Insects and other filth Illness, trauma, choking Fields, plant post-process entry
Insulation Choking long-term if asbestos Building materials
Bone Choking, trauma Fields, improper plant processing
Plastic Choking, cuts, infection may require surgery to remove Fields, plant packaging materials, pallets, employees
Personal effects Choking, cuts, broken teeth may require surgery to remove Employees
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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

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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

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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 lt7 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)

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• 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 lt7 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))

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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

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Eight Most Common Food Categories Implicated In Reported Foreign Object Complaintsa Eight Most Common Food Categories Implicated In Reported Foreign Object Complaintsa Eight Most Common Food Categories Implicated In Reported Foreign Object Complaintsa
Food Category Number of Complaints Percentb
Bakery 227 10.2
Soft Drinks 228 8.4
Vegetables 226 8.3
Infants Foods 187 6.9
Fruits 183 6.7
Cereal 180 6.6
Fishery 145 5.3
Chocolate and Cocoa Products 132 4.8
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.
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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))

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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
  categoryDefect Action Levels

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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