Lecture 4 Hard or Sharp Foreign Objects in Food

Student Learning Outcomes Understand hazards associated with hard or sharp foreign objects in foods and methods to control the hazards Understand the sizes of hard or sharp objects that cause injury or trauma Be able to list potential sources of hard or sharp objects in a flour mill, feed mill, or a bakery Assessment by instructor: Answers to questions in the first lecture exam

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

Naturally Occurring Hard Objects Bones in seafood -Consumer’s awareness eliminates hazard Exception: when the food label claims that naturally occurring hard objects have been removed Consumer’s 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

Main Materials of Concern as Physical Hazards and Common Sources (Hyman et al. 1991) 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 Pens/pencils, buttons, careless employee practices. Metal 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

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

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 choking hazard Sources Raw materials From machinery/equipment Glass fixtures

FDA Compliance Policy Guide http://www. fda FDA Compliance Policy Guide http://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)

If there is a hazard, product is deemed adulterated (342 (a) (1)) 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 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))

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

Chocolate and Cocoa Products Eight Most Common Food Categories Implicated In Reported Foreign Object Complaintsa Food Category Number of Complaints Percentb Bakery 227 8.3 Soft Drinks 228 8.4 Vegetables 226 Infant Food 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.

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))

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; plastic materials) Effective pest management programs Preventive equipment maintenance programs

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

Questions Physical hazards are regulated under what sections of Food, Drug, and Cosmetic Act? What length(s) of hard or sharp object is considered hazardous in the US? Give examples of two physical hazards and explain how a food plant ensures that the product is free of such hazards Give methods to prevent or reduce hazards from hard or sharp foreign objects What can a company do if it finds out that a product with a physical hazard may be in the marketplace?