Physical HazardsPhysical HazardsDennis BursonDennis Burson

University of NebraskaUniversity of Nebraska

Hazard AnalysisHazard Analysis

•• Assure that your are dealing with safety Assure that your are dealing with safety issues.issues.

•• Physical Hazard = A physical property Physical Hazard = A physical property that may cause a food to be unsafe for that may cause a food to be unsafe for consumption.consumption.

•• Quality and economic issues (not Quality and economic issues (not involving safety) must be excluded.involving safety) must be excluded.

What Parts of the Human Anatomy What Parts of the Human Anatomy are at Risk from Physical Hazards?are at Risk from Physical Hazards?

•• Digestive TractDigestive Tract•• Respiratory TractRespiratory Tract•• Mouth and TeethMouth and Teeth•• Extremities (Hands)Extremities (Hands)

Hazards to the Digestive TractHazards to the Digestive Tract

•• Esophageal lacerationEsophageal laceration•• Esophageal perforationEsophageal perforation•• Fistula formationFistula formation•• Laceration or perforation of other portions of the Laceration or perforation of other portions of the

digestive tract digestive tract •• PharynxPharynx•• StomachStomach•• IntestineIntestine

Hazards to the Respiratory Hazards to the Respiratory TractTract

•• ChokingChoking----occlusion of occlusion of the airwaythe airway•• Children under age 3 Children under age 3

at greatest riskat greatest risk•• Common hazards are Common hazards are

foreign objects (coins foreign objects (coins or toys) or food, or toys) or food, though not foreign though not foreign objects in foodobjects in food

•• Objects may become Objects may become lodged in the upper lodged in the upper esophagus and cause esophagus and cause choking/asphyxiation choking/asphyxiation by compression of the by compression of the tracheatrachea

Hazards to the Respiratory Hazards to the Respiratory TractTract

•• AspirationAspiration----inhalation of foreign matter into the inhalation of foreign matter into the bronchial treebronchial tree----may result in:may result in:•• partial lung collapsepartial lung collapse•• secondary infectionsecondary infection•• destruction of lung tissue from retained materialdestruction of lung tissue from retained material

Hazards to the Mouth and Hazards to the Mouth and TeethTeeth

•• Lacerations of the mouthLacerations of the mouth•• Lacerations of the tongueLacerations of the tongue•• Chipped teethChipped teeth•• Broken fillingsBroken fillings•• Damage to prostheticsDamage to prosthetics

Other HazardsOther Hazards

•• Lacerations on the hands occurring Lacerations on the hands occurring during food preparationduring food preparation

•• Illness complaintsIllness complaints•• Nausea and vomitingNausea and vomiting•• DiarrheaDiarrhea•• Headache, fever and dizzinessHeadache, fever and dizziness•• Chest painChest pain

Characteristics of Foreign Characteristics of Foreign Materials that May be HazardousMaterials that May be Hazardous

Size of the ObjectSize of the Object•• Consumer Product Safety Commission Consumer Product Safety Commission

(1995): spherical objects < 1.75 inches (1995): spherical objects < 1.75 inches in diameter are dangerous to children in diameter are dangerous to children under 3 years (choking, ingestion or under 3 years (choking, ingestion or aspiration)aspiration)

•• CPSC uses a Small Parts Test Fixture (a CPSC uses a Small Parts Test Fixture (a cylinder) to judge other noncylinder) to judge other non--spherical spherical objects for choking hazardobjects for choking hazard

Characteristics of Foreign Characteristics of Foreign Materials that May be HazardousMaterials that May be Hazardous

Size of the ObjectSize of the Object•• FDA Health Hazard Evaluation Board FDA Health Hazard Evaluation Board

conclusions in cases of foreign materials conclusions in cases of foreign materials (1972(1972--1997) found that 56% of objects 11997) found that 56% of objects 1--6 6 mm might pose a limited acute hazardmm might pose a limited acute hazard

•• For objects > 6 mm, only 2.9% were For objects > 6 mm, only 2.9% were judged to present no hazardjudged to present no hazard

Clinical Observations about Clinical Observations about Foreign Body IngestionForeign Body Ingestion

•• About 80% of foreign body (FB) About 80% of foreign body (FB) ingestions occur in the pediatric age ingestions occur in the pediatric age groupgroup

•• 8080--90% of 90% of FBsFBs ingested will pass ingested will pass spontaneously over 4spontaneously over 4--7 days7 days

•• Estimated that 1Estimated that 1--5% of 5% of FBsFBs ingested will ingested will result in injuryresult in injury

Clinical Observations about Clinical Observations about Foreign Body IngestionForeign Body Ingestion

•• Sharp objects account for about 10% of FB Sharp objects account for about 10% of FB ingestions, but a disproportionate number of ingestions, but a disproportionate number of injuriesinjuries

•• In a review of FDA consumer complaints of In a review of FDA consumer complaints of foreign materials in food, the most frequently foreign materials in food, the most frequently reported injury was mouth or throat lacerationreported injury was mouth or throat laceration

•• In the FDA review glass was the foreign In the FDA review glass was the foreign material most frequently reported as causing material most frequently reported as causing illness or injuryillness or injury

Characteristics of Foreign that Characteristics of Foreign that May be Hazardous MaterialsMay be Hazardous Materials

Size of the ObjectSize of the Object•• FSIS in its 1995 Public Health Hazard FSIS in its 1995 Public Health Hazard

Analysis Board on bone particles Analysis Board on bone particles concluded:concluded:•• bone particles < 1 cm not a safety hazard;bone particles < 1 cm not a safety hazard;•• particles 1particles 1--2 cm are a low risk;2 cm are a low risk;•• particles > 2 cm have the potential to be a particles > 2 cm have the potential to be a

safety hazard and may cause injurysafety hazard and may cause injury

Characteristics of Foreign Characteristics of Foreign Materials that May be HazardousMaterials that May be Hazardous

Size of the ObjectSize of the Object•• FSIS (1995): The presence of foreign FSIS (1995): The presence of foreign

material other than bone may pose a material other than bone may pose a potential hazard, and each instance potential hazard, and each instance should be considered on a caseshould be considered on a case--byby--case case basis, irrespective of size basis, irrespective of size

Characteristics of Foreign Characteristics of Foreign Materials that May be HazardousMaterials that May be Hazardous

Size of the ObjectSize of the Object•• FDA/ORA Compliance Policy GuideFDA/ORA Compliance Policy Guide

•• Criteria for direct reference seizure: Hard or Criteria for direct reference seizure: Hard or sharp objects 7sharp objects 7--25 mm and RTE 25 mm and RTE

•• Criteria for recommending legal action :Criteria for recommending legal action :•• 77--25 mm and requires additional preparation25 mm and requires additional preparation•• < 7 mm and intended for special< 7 mm and intended for special--risk grouprisk group•• > 25 mm in length> 25 mm in length

Reference for Physical HazardsReference for Physical Hazards

•• Olsen, A.R. 1998. Regulatory action Olsen, A.R. 1998. Regulatory action criteria for filth and other extraneous criteria for filth and other extraneous materials. I. Review of hard or sharp materials. I. Review of hard or sharp foreign objects as physical hazards in foreign objects as physical hazards in food. Reg. food. Reg. ToxTox. . PharmPharm. 28:181. 28:181

•• Concluded that any sharp pointed object Concluded that any sharp pointed object equal to or greater than 7 mm would be equal to or greater than 7 mm would be considered a health hazard.considered a health hazard.

Analysis of Physical HazardsAnalysis of Physical Hazards

•• The decision to include a physical The decision to include a physical hazard control in a HACCP plan may hazard control in a HACCP plan may depend ondepend on•• Past complaints from consumersPast complaints from consumers•• Assessment of the plant Assessment of the plant GMP’sGMP’s•• The extent of HACCP Prerequisite records The extent of HACCP Prerequisite records

and monitoring.and monitoring.

Consumer Complaint Monitoring System (CCMS) by FSIS

• CCMS is a passive surveillance system designed to document and track all consumer complaints that are reported to the Food Safety and Inspection Service.

•• A consumer complaint is any complaint A consumer complaint is any complaint reported to FSIS that is initiated by a reported to FSIS that is initiated by a consumer, or on behalf of a consumer, that is consumer, or on behalf of a consumer, that is related to an FSISrelated to an FSIS-- inspected productinspected product

What has CCMS found ?What has CCMS found ?

•• N= 1309 from 01/01/02 to 09/13/02N= 1309 from 01/01/02 to 09/13/02•• Foreign material (FM) complaints = 331Foreign material (FM) complaints = 331

•• 25% of all CCMS complaints25% of all CCMS complaints•• injury n = 20 or 6%injury n = 20 or 6%•• illness n = 24 or 7% illness n = 24 or 7%

•• 5% of foreign material in food 5% of foreign material in food results in minor to serious injury results in minor to serious injury Hamilton and Hamilton and PolterPolter 19891989Hyman 1993Hyman 1993

Breakdown of foreign Breakdown of foreign materials materials (n = 331)(n = 331)

0

20

40

60

80

100

120

140

160

othermetalplasticglasschemicals

Glass n = 32Glass n = 32

•• 10% of foreign material complaints10% of foreign material complaints•• Allegedly resulted in 4 injuries (12%) and 2 Allegedly resulted in 4 injuries (12%) and 2

illnesses (6%)illnesses (6%)

Metal n = 100Metal n = 100

•• Represents 30% of foreign material Represents 30% of foreign material consumer complaintsconsumer complaints

•• 5% allegedly resulting in injury5% allegedly resulting in injury•• Lacerations to tissues of mouth, gums, Lacerations to tissues of mouth, gums,

and throatand throat•• Multiple broken teethMultiple broken teeth

Plastic n = 32Plastic n = 32

•• Represents 15% of foreign material Represents 15% of foreign material complaintscomplaints

•• 4% allegedly resulted in illness, one case 4% allegedly resulted in illness, one case requiring surgical interventionrequiring surgical intervention

•• 10% allegedly resulted in injury/choking10% allegedly resulted in injury/choking•• Special concern is for young childrenSpecial concern is for young children

Chemicals n = 3Chemicals n = 3

•• To date, these complaints in CCMS To date, these complaints in CCMS resulted in no injury or illnessresulted in no injury or illness

•• Complainants identified through smell, Complainants identified through smell, taste, and sighttaste, and sight

Other n = 147Other n = 147

•• Consists primarily of wood, fingernails, Consists primarily of wood, fingernails, and stonesand stones

•• Represents 44% of foreign material Represents 44% of foreign material complaintscomplaints

•• 4% allegedly resulted in injury 4% allegedly resulted in injury (wood=lacerations, stones=dental)(wood=lacerations, stones=dental)

•• 12% allegedly resulted in illness (most 12% allegedly resulted in illness (most not lab confirmed)not lab confirmed)

Hazard AnalysisHazard Analysis

•• The HACCP Team must identify and list The HACCP Team must identify and list all physical hazards.all physical hazards.

•• Finished productFinished product•• IngredientsIngredients•• Handling proceduresHandling procedures•• Manufacturing operationsManufacturing operations•• StorageStorage•• DistributionDistribution

Physical HazardsPhysical Hazards

•• What are some physical hazards you What are some physical hazards you have found in meat or food?have found in meat or food?

•• Section 7 of your book (Table 3 page Section 7 of your book (Table 3 page 38906 Federal Register Vol. 61, No. 144)38906 Federal Register Vol. 61, No. 144)

•• Chapter 7 of your FPI bookChapter 7 of your FPI book

•• What is the most unusual physical What is the most unusual physical material you have found?material you have found?

Arrow in a Beef CarcassArrow in a Beef Carcass

Physical HazardsPhysical Hazards•• GlassGlass•• MetalMetal•• WoodWood•• StonesStones•• PlasticsPlastics•• BoneBone•• Bullet/BB Shot/NeedlesBullet/BB Shot/Needles•• Jewelry (tongue studs)Jewelry (tongue studs)

Physical HazardsPhysical Hazards

•• InsectsInsects•• HairHair•• Rodent droppingsRodent droppings•• GumGum•• Paint flakesPaint flakes•• BandBand--aidaid•• Writing pensWriting pens•• Carcass ID tagsCarcass ID tags

•• FeathersFeathers•• Gasket materialsGasket materials•• ArrowsArrows•• Wire clipsWire clips•• StringString•• Plastic Straps or bagsPlastic Straps or bags•• KnivesKnives•• Meat hooksMeat hooks

Eight Most Common Foods in Eight Most Common Foods in Foreign Object ComplaintsForeign Object Complaints

•• BakeryBakery 10.2%10.2%•• Soft drinksSoft drinks 8.4%8.4%•• VegetablesVegetables 8.3%8.3%•• Infant FoodsInfant Foods 6.9%6.9%•• FruitsFruits 6.7%6.7%•• CerealsCereals 6.6%6.6%•• FisheryFishery 5.3%5.3%•• ChocolateChocolate 4.8%4.8%•• MeatMeat ??????

When Conducting the Hazard When Conducting the Hazard Analysis Consider the Sources of Analysis Consider the Sources of

Physical HazardsPhysical Hazards•• Raw MaterialsRaw Materials•• FacilityFacility•• Processing EquipmentProcessing Equipment•• Employee PracticesEmployee Practices

Controls for Physical Hazards / Controls for Physical Hazards / Foreign MaterialForeign Material

•• Plant Plant GMP’sGMP’s•• Employee programs (training)Employee programs (training)•• Ingredient specificationsIngredient specifications

•• Prerequisite programs for HACCPPrerequisite programs for HACCP•• Letters of guaranteeLetters of guarantee•• Practices to identify and record sources of physical Practices to identify and record sources of physical

hazardshazards•• Monitoring and documenting controlsMonitoring and documenting controls

•• CCP’sCCP’s in the HACCP planin the HACCP plan•• Last steps in the processingLast steps in the processing