Regulating the Quality and Regulating the Quality and Safety of FoodsSafety of Foods

Law

Science

Policy

Safety

The ElementsThe Elements of Food of Food SafetySafety

Safety System BasicsSafety System Basics

• Only safe and wholesome foods may be marketed

• Regulatory decision-making is science-based

• Government has enforcement responsibility

• Manufacturers, distributors, importers, and other are expected to comply and face liability for noncompliance

• Regulatory process is transparent and accessible to the public

National Food Safety InitiativeNational Food Safety Initiative

• Food safety from farm to table

• New interagency strategy to prevent food borne disease

• Assesses current system of regulation

• Recommends actions to improve food safety

Food Borne Illness OutbreaksFood Borne Illness Outbreaks

Hudson Foods

• Largest recall of beef in U.S. history

• 25 million pounds

• Escherichia coli 0157:H7

• Supplier to Burger King and Safeway

• Fined $332,000 by OHSA

Scope of Regulatory ResponsibilityScope of Regulatory Responsibility

• 6,100 meat and poultry processing facilites

• 50,000 food establishments

• 537,000 commercial restaurants

• 172,000 institutional food programs

• 190,000 retail stores

• 70,000 separately labeled food products

The ProblemThe Problem

• Resistance and virulence of emerging pathogens

• Patchwork system of food safety regulation

• Lack of an effective, low cost method of ensuring safety of food products

• Lack of regulatory oversight beyond commercial facilities

• Lack of effective consumer education programs

Food Safety RegulationFood Safety Regulation

12 different federal agencies 12 different federal agencies derive their authority over derive their authority over food products from 35 food products from 35 different federal statutesdifferent federal statutes

US spents >$1 billion annually US spents >$1 billion annually on Food Safety Regulationon Food Safety Regulation

Federal Agencies with some Federal Agencies with some jurisdiction over food productsjurisdiction over food products

FDAFDA USDAUSDA FTCFTC(Advertising)(Advertising)

EPAEPA(Pesticides)(Pesticides)

CDCCDC(Foodborne illness)(Foodborne illness)

US CustomsUS Customs(Imports)(Imports)

DOTDOT(Transportation)(Transportation)

NOAANOAA(Seafood HACCP Training)(Seafood HACCP Training)

CVMCVM(Veterinary Medicine)(Veterinary Medicine)

AMSAMS(Shell Eggs surveillance)(Shell Eggs surveillance)

CFSANCFSAN APHISAPHIS(Border quarantines)(Border quarantines)

DOCDOC BATFBATF(Alcohol and Firearms)(Alcohol and Firearms)

FSISFSISERSERS

(food safety (food safety education)education)

Scientific Issues in Food SaScientific Issues in Food Safetyfety

Hazard IdentificationHazard Identification MicrobiologyMicrobiology ChemistryChemistry

ToxicologyToxicology EpidemiologyEpidemiology

Risk AssessmentRisk Assessment HACCP /Quality SystemsHACCP /Quality Systems

Zero toleranceZero tolerance

Lethal Processing StepLethal Processing Step

Regulatory Issues:Regulatory Issues:

• Responsibility Responsibility (liability)(liability)

• Food IrradiationFood Irradiation

• Genetic Genetic ModificationsModifications

• Consumer Consumer protectionprotection

• Food Additive Food Additive RegulationRegulation

• LabelingLabeling

• Novel Food Novel Food ProcessingProcessing

• StandardizationStandardization

Policy IssuesPolicy Issues

• Risk Assessment

• Centralization (Food Czar)

• Strict Liability

• Global Harmonization and Standardization

• GATT / NAFTA (Fortress Europe)

Consumer ExpectationsConsumer Expectations

Consumers expect safe, hazard Consumers expect safe, hazard free foodfree food

Responsibility is shared by:Responsibility is shared by: food producersfood producers processorsprocessors purveyorspurveyors regulatory agenciesregulatory agencies

Safety:Safety:

• Freedom from danger, risk or injury

• Any of the various devices designed to prevent accident such as a gun lock

• A play in which a member of the offensive team is forced to down the football in his own end zone

Good Manufacturing PracticesGood Manufacturing Practices(GMPs)(GMPs)

Regulation vs CooperationRegulation vs Cooperation

FDCA gave authority and FDCA gave authority and responsibility to FDA for ensuring responsibility to FDA for ensuring safety in food supplysafety in food supply

FDCA prohibits poisonous or FDCA prohibits poisonous or deleterious substances in fooddeleterious substances in food

GMPs reference in FDCA states:GMPs reference in FDCA states: food is adulterated if it may have been

rendered injurious to health by conditions under which it was prepared, packed or held...

Food borne illnessFood borne illness

24 million people per year24 million people per year

cost of $7 billioncost of $7 billion

10,000 deaths10,000 deaths

mishandling at retail level is a factormishandling at retail level is a factor 12 million workers in 1 million establishments12 million workers in 1 million establishments

regulatory agencies alone cannot preventregulatory agencies alone cannot prevent

cooperation with industry requiredcooperation with industry required

Adulteration under the FDCAAdulteration under the FDCA

Food Food MAYMAY be adulterated if- be adulterated if- prepared under insanitary prepared under insanitary

conditionsconditions proof of actual adulteration not proof of actual adulteration not

necessarynecessary proof of illness not necessaryproof of illness not necessary

conditions under which food is conditions under which food is prepared, packed, or held is prepared, packed, or held is determinantdeterminant

Good Manufacturing PracticesGood Manufacturing Practices

Procedures developed to ensure Procedures developed to ensure production of safe, wholesome foods and production of safe, wholesome foods and to provide safe working environmentto provide safe working environment

Not "process specific", relate to entire Not "process specific", relate to entire operationoperation

GMPs include facilities/grounds, GMPs include facilities/grounds, equipment pest control, receiving and equipment pest control, receiving and storage, process control, product recall storage, process control, product recall and personnel training. and personnel training.

First proposal for GMPs:First proposal for GMPs:

proposed rule December, 1968proposed rule December, 1968

final rule April, 1969 final rule April, 1969

original GMPs regulation very broadoriginal GMPs regulation very broad

FDA then attempted to develop FDA then attempted to develop specific industry GMPsspecific industry GMPs

FDA concluded it was more effective FDA concluded it was more effective to strengthen “umbrella” GMPsto strengthen “umbrella” GMPs

revisions to GMPs in 1986 revisions to GMPs in 1986

Product specific GMPsProduct specific GMPs

thermally processed low-thermally processed low-acid canned foodsacid canned foods

acidified foodsacidified foods

bottled drinking waterbottled drinking water

GMPs RegulationsGMPs Regulations

21CFR Part 11021CFR Part 110 Subpart A -Subpart A - General ProvisionsGeneral Provisions Subpart B -Subpart B - Building and FacilitiesBuilding and Facilities Subpart C -Subpart C - EquipmentEquipment Subpart D -Subpart D - [Reserved][Reserved] Subpart E -Subpart E - Production and Process Production and Process

ControlsControls Subpart F -Subpart F - [Reserved][Reserved] Subpart G -Subpart G - Defect Action LevelsDefect Action Levels

GMPs RegulationsGMPs Regulations

written as mandatory requirementswritten as mandatory requirements consistent use of “shall” rather than consistent use of “shall” rather than

“should”“should”

GMPs used in inspections of plant GMPs used in inspections of plant and warehousesand warehouses

GMPs - GMPs - General ProvisionsGeneral Provisions

provides definitionsprovides definitions important in understanding implications important in understanding implications

and applicationsand applications

personnelpersonnel management has responsibility for management has responsibility for

performance of personnelperformance of personnel

GMP’s - GMP’s - Buildings and FacilitiesBuildings and Facilities

buildings must be designed buildings must be designed and constructed to facilitate and constructed to facilitate effective maintenance and effective maintenance and sanitationsanitation

results specified rather than results specified rather than method for achievingmethod for achieving

detailed expectations in detailed expectations in sanitation of operationssanitation of operations

GMPs - GMPs - EquipmentEquipment

equipment and utensilsequipment and utensils designed and constructed to be easily designed and constructed to be easily

and properly cleanedand properly cleaned

temperature measuring and temperature measuring and recording on refrigerators and recording on refrigerators and freezersfreezers

measurement of critical parametersmeasurement of critical parameters

GMP’s: GMP’s: Production and Process ControlsProduction and Process Controls

end results emphasizedend results emphasized ensuring that no adulterated food enters ensuring that no adulterated food enters

marketplacemarketplace terms used subject to variation in terms used subject to variation in

interpretation interpretation

raw materials and ingredients properlyraw materials and ingredients properly inspected, analyzedinspected, analyzed segregated, storedsegregated, stored handledhandled

Production and Process Controls:Production and Process Controls:

manufacturing operations must manufacturing operations must be monitoredbe monitored pH, water activity, temperaturespH, water activity, temperatures elimination of metal from productelimination of metal from product

personnel should be trained and personnel should be trained and aware of GMP requirementsaware of GMP requirements

GMP’sGMP’s - - Defect Action LevelsDefect Action Levels

natural or unavoidable defects may natural or unavoidable defects may be in food be in food not harmful at levels presentnot harmful at levels present present even with GMPspresent even with GMPs

FDA establishes DALs when FDA establishes DALs when necessary and possiblenecessary and possible

defect level may not be reduced by defect level may not be reduced by blendingblending

Summary of General GMPsSummary of General GMPs

Intended to Intended to preventprevent adulteration adulteration

Opportunity for considerable Opportunity for considerable judgment in defining and judgment in defining and interpreting regulationsinterpreting regulations

““spirit” of GMPs is to do what is spirit” of GMPs is to do what is reasonable and necessary to reasonable and necessary to ensure safe and unadulterated ensure safe and unadulterated food supplyfood supply

Specific GMPs:Specific GMPs:LLow acid canned foodsow acid canned foods

Life threatening risk if improperly Life threatening risk if improperly processedprocessed

Requires supervision of personnel Requires supervision of personnel who have been trainedwho have been trained

Regulations quite detailed for Regulations quite detailed for equipment design and operationequipment design and operation

Extensive record keeping Extensive record keeping requirementsrequirements

Acidified foods:Acidified foods:

Defined as a low acid food with Defined as a low acid food with AAw w greater than 0.85greater than 0.85 acid added to lower pH to 4.6 or loweracid added to lower pH to 4.6 or lower

Product examplesProduct examples includes beans, cucumbers, cabbageincludes beans, cucumbers, cabbage excludes carbonated beveragesexcludes carbonated beverages

Personnel trained under approved Personnel trained under approved programprogram

Bottled Drinking Water:Bottled Drinking Water:

All water sealed in bottles, All water sealed in bottles, packages for human consumptionpackages for human consumption

Regulations are general and similar Regulations are general and similar to umbrella GMPsto umbrella GMPs

Source of water must be approvedSource of water must be approved

Sanitation, equipment designed, Sanitation, equipment designed, personnel emphasizedpersonnel emphasized

Extensive record keepingExtensive record keeping

The History of HACCPThe History of HACCP

HACCP initiated in early 1960s as HACCP initiated in early 1960s as cooperative effortcooperative effort PillsburyPillsbury NASANASA Natik labs of U.S. ArmyNatik labs of U.S. Army U.S. Air Force Space LaboratoryU.S. Air Force Space Laboratory

Purpose was to produce zero defect Purpose was to produce zero defect food for astronautsfood for astronauts

HACCP History:HACCP History:

NASA asked Pillsbury to design NASA asked Pillsbury to design products for use in outer spaceproducts for use in outer space

Pillsbury presented HACCP plan at Pillsbury presented HACCP plan at 1971 Conference on Food Protection1971 Conference on Food Protection

FSIS asked NAS to evaluate inspection FSIS asked NAS to evaluate inspection process and recommend process and recommend modernizationmodernization

HACCP recommended by NAS to FSIS HACCP recommended by NAS to FSIS in 1985in 1985

HACCPHACCP

Sec. 342 of FDCA is basis for Sec. 342 of FDCA is basis for HACCP (Adulteration provisions)HACCP (Adulteration provisions)

By adopting HACCP, companies By adopting HACCP, companies share in responsibility for safetyshare in responsibility for safety

GMPs and HACCP are increasingly GMPs and HACCP are increasingly important as more and more food important as more and more food is produced, processed, and is produced, processed, and handled by othershandled by others

HACCP Basics:HACCP Basics:

Defects always possible with less Defects always possible with less than 100% testingthan 100% testing

Detection of hazards by end product Detection of hazards by end product testing is only as good as statistics testing is only as good as statistics behind sampling and testing behind sampling and testing protocolsprotocols

HACCP prevents rather than detectsHACCP prevents rather than detects

HACCP BasicsHACCP Basics

Seven elementsSeven elements Science based system of food safetyScience based system of food safety Made mandatory in EUMade mandatory in EU Mandatory for seafood first (1995)Mandatory for seafood first (1995) Meats Meats (beef, pork, poultry)(beef, pork, poultry) in 1996 in 1996 Voluntary for other productsVoluntary for other products

Seven Steps of HACCP:Seven Steps of HACCP:

Assess Potential Assess Potential HazardsHazards Determine Determine Critical Control PointsCritical Control Points Establish Establish requirementsrequirements for each CCP for each CCP Establish procedure to Establish procedure to monitormonitor each CCP each CCP Establish Establish corrective actioncorrective action if deviation if deviation Establish Establish record keepingrecord keeping procedures procedures Establish procedure to Establish procedure to monitor monitor

effectivenesseffectiveness

Step #1Step #1: : Determine Potential HazardsDetermine Potential Hazards

First step in developing programFirst step in developing program what hazards might existwhat hazards might exist

What is a hazardWhat is a hazard poisonous or deleterious substancepoisonous or deleterious substance

(P/D)(P/D) microbiologicalmicrobiological chemicalchemical physicalphysical

Hazard more specific than adulterant Hazard more specific than adulterant b/c product may be adulterated b/c product may be adulterated without being hazardouswithout being hazardous

Sources of hazardsSources of hazards

Review of operation to determine Review of operation to determine where hazard might occurwhere hazard might occur ingredients and other raw materialsingredients and other raw materials breakdown in some part of processbreakdown in some part of process

Knowledgeable person must review:Knowledgeable person must review: ingredientsingredients formulaformula processprocess storage conditionsstorage conditions

Step #2Step #2: : Identify Critical Control Points (CCPs)Identify Critical Control Points (CCPs)

CCP is a point at which a hazard CCP is a point at which a hazard might developmight develop if hazard results from loss of control, if hazard results from loss of control,

point is criticalpoint is critical

QCP is point where quality might be QCP is point where quality might be affectedaffected if reduction in quality occurs, point is a if reduction in quality occurs, point is a

quality control pointquality control point

Step #3Step #3: : Establishing Control LimitsEstablishing Control Limits

Hazard may develop if CCP out Hazard may develop if CCP out of controlof control

Determine how much out of Determine how much out of control results in a hazardcontrol results in a hazard

Limits must be set for each CCPLimits must be set for each CCP

Knowledge of both hazards and Knowledge of both hazards and the process is importantthe process is important

Step #4Step #4:: Establish System to Monitor CCPsEstablish System to Monitor CCPs

Monitoring system to determine when Monitoring system to determine when process exceeds limitsprocess exceeds limits

Continuous monitoring preferred with Continuous monitoring preferred with immediate correctionimmediate correction

Periodic sampling and testing may be only Periodic sampling and testing may be only reasonable alternativereasonable alternative

Continuous or frequent monitoring used to Continuous or frequent monitoring used to establish trends establish trends

Step #5:Step #5:Corrective actionCorrective action

May be as simple as rejecting May be as simple as rejecting a shipment or ingredienta shipment or ingredient

May require adjusting May require adjusting calibration of measuring calibration of measuring devicedevice

May necessitate shutting down May necessitate shutting down an operationan operation

Step #6:Step #6: Record KeepingRecord Keeping

Must have effective record Must have effective record keeping system to:keeping system to: demonstrate establishment of demonstrate establishment of

systemsystem document its utilizationdocument its utilization verify efficacyverify efficacy

Step #7:Step #7:Verification of Program - HACCP PlanVerification of Program - HACCP Plan

WrittenWritten plan to describe system plan to describe system

May be shown to FDA as evidence May be shown to FDA as evidence that plan has been developedthat plan has been developed

Monitoring data and records of Monitoring data and records of actions may be reviewed by:actions may be reviewed by: company managementcompany management regulatory officialsregulatory officials

HACCP PlanHACCP Plan

Section 123.6 requires that every Section 123.6 requires that every processor shall have implemented a processor shall have implemented a writtenwritten HACCP plan HACCP plan specific to the specific to the process and the productprocess and the product

FSIS has developed "FSIS has developed "Generic HACCP Generic HACCP Models"Models" for major process categories for major process categories

Must be signed by "responsible Must be signed by "responsible establishment individual"establishment individual"

HACCP training big businessHACCP training big business

Flow ChartsFlow Charts

Step by step path traveled by food Step by step path traveled by food during processingduring processing

Shows CCPsShows CCPs Shows where to take corrective Shows where to take corrective

actionaction Can use to monitor CCPsCan use to monitor CCPs Helps verify effectivenessHelps verify effectiveness

HACCP Issues:HACCP Issues:

Should HACCP be voluntary or Should HACCP be voluntary or mandatory?mandatory?

Should small businesses be exempt?Should small businesses be exempt?

Should foreign exporters be exempt?Should foreign exporters be exempt?

What records should be available?What records should be available?

What training should be required?What training should be required?

GMPs and HACCPGMPs and HACCP

Prior to the development of HACCP plan, Prior to the development of HACCP plan, establishment should verify that all establishment should verify that all GMPs are in place and effectiveGMPs are in place and effective

Effective GMP programs ensure that Effective GMP programs ensure that HACCP plans focus specifically on the HACCP plans focus specifically on the critical control points necessary to critical control points necessary to ensure product safetyensure product safety

GMPs and HACCPGMPs and HACCP

GMPs establish guidelines, GMPs establish guidelines, requirements, and expectation for requirements, and expectation for reducing adulterationreducing adulteration

GMPs along cannot guarantee safetyGMPs along cannot guarantee safety

HACCP represents joint effortHACCP represents joint effort

Policies, procedures, regulations are Policies, procedures, regulations are evolvingevolving

ISO - 9000ISO - 9000 International International Food QualityFood Quality Standards Standards Non-prescriptiveNon-prescriptive

StandardizationStandardization

GATT and NAFTAGATT and NAFTA HarmonizationHarmonization of trade restrictions of trade restrictions Fortress Europe ConceptFortress Europe Concept

Single Europe ActSingle Europe Act Free movement of goods and servicesFree movement of goods and services

History of StandardizationHistory of Standardization Eli WhitneyEli Whitney

ISO-9000ISO-9000

Non-prescriptive standard that Non-prescriptive standard that does not specify how a company's does not specify how a company's quality assurance must occur, but quality assurance must occur, but mandates that a company define mandates that a company define appropriate quality standards, appropriate quality standards, document its processes, and prove document its processes, and prove that it consistently adheres to that it consistently adheres to both.both.