Seafood HACCP - Binder

Chap 1 - Introduction to Course and HACCP

Chapter 1: Introduction to Course and HACCP

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Objective:In this module, you will learn the:• Objective of the course,• Format of the course,• Expectations of the participant and• Meaning and importance of HACCP.

Notes:

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Course Objective

Food and Drug Administration Seafood regulations based on the prin-ciples of Hazard Analysis and Critical Control Point (HACCP) becameeffective in the United States in December, 1997. The Food and DrugAdministration (FDA) issued these regulations to ensure safe processingand importing of fish and fishery products. These regulations specify thatcertain critical jobs in seafood processing be performed by someonetrained in HACCP. This person is responsible for developing andmodifying the HACCP plan and reviewing records. This course containsthe information necessary for you or a team to meet the HACCP-trainingrequirements. It is also designed to provide inspectors with the knowledgethey need to evaluate HACCP plans and practices.

Course Format

This seafood HACCP course is divided into three distinct segments:• HACCP fundamentals,• Relationship of HACCP and FDA’s regulation to the seafood industry, and• Work session to develop a seafood HACCP plan.

The first segment defines the seven principles of HACCP. Learning theseprinciples will give a clear understanding of the fundamentals on whichHACCP is based. As each principle is discussed, the class will develop aHACCP plan for cooked shrimp using the fictional ABC Shrimp Co. as amodel. This will help you understand HACCP principles and how theyinterrelate.

The second segment explains the seafood HACCP regulations andguidance materials that are available to help you develop a HACCP plan.The manual also presents information about seafood-specific hazards.

The third segment demonstrates how to develop a seafood HACCP plan.During this part of the course, the class will be divided into teams to writea HACCP plan based on a narrative and flow chart.


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What is Expected of the Participant

HACCP is a common sense technique used to control food-safety hazards.It is an important safety-management system and can be integrated intoany operation. However, HACCP can seem complicated and demandinguntil its concepts are understood. Therefore, you are encouraged to askquestions and to contribute first-hand experiences to discussions. Thismanual includes exercises that require class participation throughout thetraining. Keep in mind that the more you contribute to these exercises, theless complicated the HACCP system will seem and the easier it will be toimplement a HACCP plan later.

How to Use This Manual

This manual is yours. Become familiar with it. Learn where the defini-tions are, where the forms are that will help you develop a HACCP plan,and where to find other basic information. Make as many notes and marksin the text as needed to assist in creating and understanding a HACCPplan. Use the manual as a reference. This manual does not have acopyright. Make as many copies of its forms as necessary or copy thewhole manual to share with others in your company.

Meaning and Importance of HACCP

Many people may not have heard the term “HACCP” until recently.However, it is neither a new term nor a new concept.

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HACCP is merely an acronym that stands for Hazard Analysis andCritical Control Point. But the concept behind this term is important.

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Notes:

HACCP stands for:Hazard Analysis and Critical Control Point

HACCP is:• Preventive, not reactive.• A management tool used to protect the food supply against

biological, chemical and physical hazards.


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HACCP is a preventive system of hazard control rather than a reactiveone. Food processors can use it to ensure safer food products for consum-ers. To ensure safer food, the HACCP system is designed to identifyhazards, establish controls and monitor these controls. Hazards can beharmful microorganisms or chemical and/or physical contaminants.

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The Pillsbury Co. pioneered the application of the HACCP concept tofood production during its efforts to supply food for the U.S. spaceprogram in the early 1960s. Pillsbury decided that their existing quality-control techniques did not provide adequate assurance against contamina-tion during food production. The company found that end-product testingnecessary to provide such assurance would be so extensive that little foodwould be available for space flights.

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The only way to ensure safety, Pillsbury concluded, would be to developa preventive system that kept hazards from occurring during production.Since then, Pillsbury’s system has been recognized worldwide as thestate-of-the-art measure for food-safety control. It is not a zero-risksystem, but it is designed to minimize the risk of food-safety hazards.The FDA first required HACCP controls for food processing in 1973for canned foods to protect against Clostridium botulinum, whichcauses botulism.

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Notes:

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Origins of HACCP:• Pioneered in the 1960s.• First used when foods were developed for the space program.• Adopted by many food processors and the U.S. government.

HACCP is not a zero-risk system.It is designed to minimize the risk of food-safety hazards.

Recommendation:“The HACCP approach be adopted by all regulatory agencies andthat it be mandatory for food processors.”

1985 National Academy of Sciences


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Notes: In an assessment of the effectiveness of food regulation in the UnitedStates, the National Academy of Sciences (NAS) recommended in 1985that the HACCP approach be adopted by all regulatory agencies and thatit be mandatory for food processors.

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This recommendation led to the formation of the National AdvisoryCommittee on Microbiological Criteria for Foods (NACMCF). Thiscommittee standardized the HACCP principles used by industry andregulatory authorities. The committee’s work is the basis of this corecurriculum.

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In 1992, NACMCF adopted the following seven HACCP principles.They are:

In 1997, NACMCF adopted the following seven HACCP principles.They are:1. Conduct hazard analysis.2. Determine the critical control points (CCPs) in the process.3. Establish critical limits.4. Monitor each CCP.5. Establish corrective actions.6. Establish verification procedures.7. Establish record-keeping and documentation procedures.

These principles will be explained in more detail in the followingsessions. The seafood HACCP regulation and other domestic andinternational HACCP control systems are based on these principles.

National Academy of Sciences recommendationled to formation of the National Advisory Committee

on Microbiological Criteria for Foods (NACMCF).

Seven principles of HACCP:1. Conduct hazard analysis.2. Determine the critical control points (CCPs) in the process.3. Establish critical limits.4 Monitor each CCP.5. Establish corrective actions.6. Establish verification procedures.7. Establish record-keeping and documentation procedures.

Instructor’s Note:

NACMCF is continuing torefine the HACCP principlesin an effort to make themmore user friendly andeffective. In August 1997,NACMCF adopted revisedHACCP guidelines. To theextent possible, many of thechanges have been incorpo-rated into this manual. Mostobviously, Principles 6 and 7were switched, therebymaking recordkeepingPrinciple 7. Additionally,“preventative measures” waschanged to “control mea-sures.”

Instructors and studentsshould be aware of thedynamic nature of HACCPand not be surprised orconfused as the principlesare refined.


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HACCP has been endorsed worldwide by organizations such asCodex Alimentarius (a commission of the United Nations) and theEuropean Union and by several countries including Canada, Australia,New Zealand and Japan.

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HACCP is a preventive system for ensuring food safety, but it is not astand-alone system. HACCP must be built upon current food-safetyprograms such as Good Manufacturing Practices (GMPs) (e.g., sanitationand personal hygiene programs) to make it work.

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The HACCP concept is used by regulators during inspections of foodprocessors to focus their attention on the parts of the process that are mostlikely to affect the safety of the product.

The inspection of plants operating under HACCP plans differs fromtraditional inspection methods of food-safety control. Traditional methodsevaluate processing practices on the day or days of inspection. TheHACCP approach allows regulators to look at what happens in the plantthrough time by examining the firm’s monitoring and corrective actionrecords.

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International use:• Codex• European Union• Canada

HACCP is not a stand-alone system.

HACCPGood Manufacturing Practices

Traditional Inspection Methods for Food-Safety Controlversus

The HACCP Approach

• Australia• New Zealand• Japan


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Notes:

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With HACCP, the emphasis is to understand the process system. Thisrequires the regulator and industry to communicate and to work with oneanother. The inspector will be verifying the HACCP plan by determiningthat significant food-safety hazards have been properly identified and thatindustry is consistently controlling these hazards. The inspector willaccomplish this by first surveying the plant and then reviewing theHACCP plan and records. Regulatory inspections will continue to lookfor compliance in areas such as sanitation, economic fraud, foodstandards, etc.

In defining the roles of industry and the regulatory agencies in HACCP,the NACMCF document indicates: “It is the responsibility of the foodindustry to develop and implement HACCP plans and for regulatoryagencies to facilitate this process." Or, in other words, the role of thegovernment is to ensure that industry adheres to their role.

HACCP inpections complement traditional inspection methods.HACCP:• Emphasizes process control.• Concentrates on the points in the process that are critical to the

safety of the product.• Stresses communication between the regulator and industry.


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Notes:

“It is the responsibility of the food industry to develop and implementHACCP plans and for regulatory agencies to facilitate this process.”

NACMCF, June 1993

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As you learn more about HACCP, there will be many new definitions thatyou will need to understand. To assist you, the most common HACCPdefinitions are found in the following two pages. Refer back to thesepages as needed and add other terms as appropriate that will help you indeveloping and implementing your own HACCP plan.

The next sessions will explain the basics of HACCP. We will start by firstdefining the types of hazards.


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Definitions*

• Continuous Monitoring: Uninterrupted collection and recording ofdata such as temperature on a strip chart.

• Control: (a) (verb) To manage the conditions of an operation to maintaincompliance with established criteria.(b) (noun) The state in which correct procedures are being followedand criteria are being met.

• Control Measure: Any action or activity that can be used to prevent,eliminate or reduce a significant hazard (previously known as apreventive measure and is still called a preventive measure in FDA’sHazards and Controls Guide).

• Control Point: Any point, step or procedure at which biological,physical or chemical factors can be controlled.

• Corrective Action: Procedures followed when a deviation occurs.

• Critical Control Point (CCP): A step at which control can be applied and isessential to prevent or eliminate a food-safety hazard or reduce it toan acceptable level.

• CCP Decision Tree: A sequence of questions asked to determinewhether a control point is a CCP.

• Critical Limit: A maximum and/or minimum value to which a biological,chemical or physical parameter must be controlled at a CCP toprevent, eliminate or reduce to an acceptable level the occurrenceof a food-safety hazard.

• Deviation: Failure to meet a critical limit.

• HACCP: A systematic approach to the identification, evaluation andcontrol of food-safety hazards.

• HACCP Plan: The written document that is based upon principles ofHACCP and that delineates the procedures to be followed.

• HACCP System: The result of the implementation of the HACCP plan.

• HACCP Team: The group of people who are responsible for developing,implementing and maintaining the HACCP system.

• Hazard: A biological, chemical or physical agent that is reasonablylikely to cause illness or injury in the absence of its control.

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• Monitor: To conduct a planned sequence of observations ormeasurements to assess whether a CCP is under control and toproduce an accurate record for future use in verification.

• Operating Limits: Criteria that are more stringent than criticallimits and that are used by an operator to reduce the risk ofa deviation.

• Prerequisite Programs: Procedures, including Good ManufacturingPractices (GMPs), that address operational conditions providing thefoundation for the HACCP system.

• Severity: The seriousness of a hazard (if not properly controlled).

• Validation: The element of verification focused on collecting andevaluating scientific and technical information to determine if theHACCP plan, when properly implemented, will effectively controlthe hazards.

• Verification: Those activities that determine the validity of the HACCPplan and that the system is operating according to the plan.

* National Advisory Committee on Microbiological Criteria for Foods,1997. Hazard Analysis and Critical Control Point Principles andApplication Guidelines.

Notes:


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Notes: Acronyms

• CCP: Critical control point

• CL: Critical limit

• FDA: Food and Drug Administration

• GMP: Good Manufacturing Practice

• HACCP: Hazard analysis and critical control point

• MIG: Mercury-in-glass thermometer

• NAS: National Academy of Science

• NACMCF: National Advisory Committee on Microbiological Criteriafor Foods

• PPM: Parts per million

• SCP: Sanitation control procedures

• SOP: Standard operating procedure

• SSOP: Sanitation standard operating procedure

Chapter 1: Introduction

Chapter 1: Introduction1

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Status

This is the third edition of the Food and DrugAdministrations’s (FDA) “Fish and Fishery ProductsHazards and Controls Guidance.” This Guide relatesto FDA’s final regulations (21 CFR 123) that requireprocessors of fish and fishery products to developand implement Hazard Analysis Critical ControlPoint (HACCP) systems for their operations. Thosefinal regulations were published in the FederalRegister on December 18, 1995 and became effectiveon December 18, 1997. The codified portion of theregulations is included in Appendix 8.

FDA intends to revise and reissue this guidance everytwo to three years as the state of knowledge advancesrelative to fish and fishery products hazards andcontrols. The agency will accept public comment onthis third edition of the guidance for consideration indrafting the fourth edition. Comments should besubmitted to:

U.S. Food and Drug AdministrationDockets Management Branch (HFA-305)

Room 1-2312420 Parklawn DriveRockville, MD 20857

Comments should be identified with Docket Number93N-0195.

This guidance is being issued as a companiondocument to “HACCP: Hazard Analysis CriticalControl Point Training Curriculum,” which wasdeveloped by the Seafood HACCP Alliance forTraining and Education. The Alliance is an organiza-tion of federal and state regulators, including FDA,academia, and the seafood industry. FDA encouragesprocessors of fish and fishery products to use the twodocuments together in the development of a HACCPsystem. Copies of the training document may beobtained from:

Florida Sea GrantIFAS - Extension Bookstore

University of FloridaP.O. Box 110011

Gainesville, FL 32611-00111-800-226-1764

Purpose

The primary purpose of this guidance is to assistprocessors of fish and fishery products in the devel-opment of their HACCP plans. Processors of fishand fishery products will find information in thisguidance that will help them identify hazards that areassociated with their products, and help them formu-late control strategies.

Another purpose of this guidance is to help consum-ers and the public generally to understand commer-cial seafood safety in terms of hazards and theircontrols. This guidance does not specifically addresssafe handling practices by consumers or by retailestablishments, although many of the conceptscontained in this guidance are applicable to both.

This guidance is also intended to serve as a tool to beused by federal and State regulatory officials in theevaluation of HACCP plans for fish and fisheryproducts.

Scope & Limitations

The controls and practices provided in this guidanceare recommendations and guidance to the fish andfishery products industry. This guidance providesinformation that would likely result in a HACCP planthat is acceptable to FDA. However, it is not abinding set of requirements. Processors may chooseto use other control measures, as long as they providean equivalent level of assurance of safety for theproduct. However, processors that chose to use othercontrol measures (e.g. critical limits) are responsiblefor scientifically establishing their adequacy.

The information contained in the tables in Chapter 3and in Steps #10 and 11 in Chapters 4-21 provideguidance for determining which hazards are “reason-ably likely to occur” in particular fish and fisheryproducts under ordinary circumstances. The tablesshould not be used separately for this purpose. Thetables list potential hazards for specific species andfinished product types. This information must becombined with the information in the subsequentchapters to determine the likelihood of occurrence.

This guidance is not a substitute for the performanceof a Hazard Analysis by a processor of fish andfishery products, as required by FDA’s regulations.Hazards not covered by this guidance may be rel-evant to certain products under certain circumstances.In particular, processors should be alert to new oremerging problems (e.g., the occurrence of naturaltoxins in fish not previously associated with thattoxin).

This guidance covers safety hazards associated withfish and fishery products only. It does not cover mosthazards associated with non-fishery ingredients (e.g.,Salmonella enteritidis in raw eggs). However, wheresuch hazards are presented by a fishery product thatcontains non-fishery ingredients, control must beincluded in the HACCP plan. Processors may use theprinciples included in this guide for assistance indeveloping appropriate controls for these hazards.For example, the hazard of food allergens and foodintolerance substances that are part of or directlyadded to the food can be controlled using the prin-ciples described in Chapter #19. As a further assis-


tance in this regard, Appendix 6 provides a list of themost common food allergens that can pose a healthrisk to certain sensitive individuals.

This guidance does not cover the hazard associatedwith the formation of Clostridium botulinum toxin inlow acid canned foods (LACF) or shelf-stableacidified foods. Mandatory controls for this hazardare contained in the LACF regulation (21 CFR 113)and the acidified foods regulation (21 CFR 114).Such controls need not be included in HACCP plansfor these products.

This guidance does not cover the sanitation controlsrequired by the Seafood HACCP regulation. How-ever, the maintenance of a sanitation monitoringprogram is an essential prerequisite to the develop-ment of a HACCP program. If necessary sanitationcontrols are not included in a prerequisite sanitationmonitoring program, they must be included in theHACCP plan. It is the agency’s intent to provideguidance on the development of sanitation standardoperating processes and sanitation monitoringprograms in the future.

This guidance does not describe corrective action orverification records, because these records are notrequired to be listed in the HACCP plan. Nonethe-less, such records must be maintained, where appli-cable. Likewise, it does not recount the specificrequirements for the content of records that are setout in § 123.9(a).

This guidance does not cover verification activitiessuch as reassessment of the HACCP plan and/or thehazard analysis and review of consumer complaints,that are mandated by § 123.8.

The guidance also does not provide specific guidanceto importers of fish and fishery products for thedevelopment of required importer verificationprocedures. However, the information contained inthe text, and, in particular, in Appendix 5, shouldprove useful for this purpose. Additionally, it is theagency’s intent to provide more specific guidance forimporters, either in future editions of this guidance,or in a separate guidance document.

ContinuedChapter 1: Introduction

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Changes in this Edition

Following is a summary of the most significantchanges in this edition of the guidance.

The information contained in Table 3-1 (PotentialVertebrate Species Related Hazards) is modified asfollows:• Dace (Rhinichthys spp.) is now listed as having apotential pesticides and environmental contaminantshazard;• Alewife or river herring (Alosa pseudoharengus) isnow listed as having a potential scombrotoxin(histamine) hazard;• Wild-caught freshwater salmon (Oncorhynchusspp., Salmo salar) is no longer listed as having apotential aquaculture drug hazard, an error in theSecond Edition;• Mackerel (Scomber scombrus) is no longer listedas having a potential natural toxin (PSP) hazard.

The information contained in Table 3-3 (PotentialProcess Related Hazards) is modified as follows:• Smoked fish is now listed as having a potential C.botulinum hazard only when it is reduced oxygenpackaged and distributed or stored refrigerated;• A number of products are now listed in Table 3-3as having potential glass inclusion hazards;• Dried fish is now listed as having a potential C.botulinum hazard;• Fully cooked prepared foods are now listed ashaving potential pathogen survival through pasteur-ization and pathogen contamination after pasteuriza-tion hazards.

The recommendations in Chapter 4 for the control ofpathogens from the harvest area are changed asfollows for consistency with 1998 and 1999 InterstateShellfish Sanitation Conference actions:• Raw consumption warnings on tags of molluscanshellfish shellstock containers are now recommendedonly if the shellstock is intended for raw consump-tion and the recommended language has beenmodified;

• Additional information is included about thecontrol of Vibrio parahaemolyticus in shellstockintended for raw consumption, including informationabout water sampling for Vibrio parahaemolyticusperformed by Shellfish Control Authorities undercertain conditions;• Specific controls are now recommended for thecontrol of Vibrio parahaemolyticus in oystershellstock intended for raw consumption if theoysters are harvested in an area which has beenconfirmed as the original source of oysters associatedwith two or more V. parahaemolyticus illnesses in thepast three years. The new control strategy examplerelies on the following critical limits for the timefrom harvest to refrigeration, and is based on theAverage Monthly Maximum Air Temperature(AMMAT):

- For AMMAT of less than 66˚F(less than 19˚C): 36 hours

- For AMMAT of 66˚F to 80˚F(19˚C to 27˚C): 12 hours

- For AMMAT greater than 80˚F(greater than 27˚C): 10 hours;

• For the control of Vibrio vulnificus, the criticallimits recommended for the time from harvest torefrigeration for shellstock intended for raw con-sumption, based on Average Monthly MaximumWater Temperature (AMMWT), are now:

- For AMMWT of less than 65˚F(less than18˚C): 36 hours

- For AMMWT of 65 to 74°F(18 to 23°C): 14 hours;

- For AMMWT of greater than 74 to 84°F(greater than 23 to 28°C): 12 hours;

- For AMMWT of greater than 84°F(greater than 28°C): 10 hours;

• For the control of pathogens other than Vibrioparahaemolyticus and Vibrio vulnificus, the criticallimits recommended for the time from harvest torefrigeration for shellstock intended for raw con-sumption are now:

- For AMMAT of less than 66°F(less than 19°C): 36 hours;

- For AMMAT of 66 to 80°F(19 to 27°C): 24 hours;

- For AMMAT of greater than 80°F(greater than 27°C): 20 hours.


The recommendations in Chapter 4 for the control ofpathogens from the harvest area are additionallychanged as follows:• The information on pathogens in molluscanshellfish is now more clearly divided into twocategories:

- The control of pathogens of human or animalorigin;

- The control of naturally occurring pathogens;• The recommended goal of pasteurization for thecontrol of Vibrio vulnificus is now more clearlydefined as the reduction of the pathogen tonondetectable levels [i.e., less than 3 MPN/gram, asdefined by the National Shellfish Sanitation Program(NSSP)].

The recommendations in Chapter 5 for the control ofparasites are changed as follows:• The results of a survey of U.S. gastroenterologistson U.S. seafood-borne parasitic infections are nowcited;• The recommended freezing times/temperatures arenow:

- Freezing and storing at -4˚F (-20˚C) or belowfor 7 days (total time); or

- Freezing at -31˚F (-35˚C) or below until solidand storing at -31˚F (-35˚C) or below for 15hours; or

- Freezing at -31˚F (-35˚C) or below until solidand storing at -4˚F (-20˚C) or below for 24hours;

• Because of the changes in the recommendedcritical limits, the recommended control strategiesnow refer only to external temperatures duringfreezing and to the length of time that the fish is heldat the appropriate freezer temperature or the length oftime that the fish is held after it is solid frozen,whichever is appropriate;• The parasite hazard is no longer consideredreasonably likely to occur if the finished product isfish eggs that have been removed from the skein andrinsed.

The recommendations in Chapter 6 for the control ofnatural toxins are changed as follows:• PSP in lobster is no longer considered a significanthazard because the levels found in lobster tomale arenot likely to pose a health hazard unless large quantitiesare eaten from a heavily contaminated area.

The recommendations in Chapter 7 for the control ofscombrotoxin formation are changed as follows:• Information is now provided about the salt-tolerantand facultative anaerobic nature of some of thehistamine-forming bacteria, raising concern forscombrotoxin formation in some salted and smokedfishery products and in fishery products packed inreduced oxygen environments (e.g. vacuumpackaging);• The on-board chilling recommendations aresignificantly modified as follows:

- Generally, fish should be placed in ice or inrefrigerated seawater or brine at 40˚F (4.4˚C) orless within 12 hours of death, or placed inrefrigerated seawater or brine at 50˚F (10˚C) orless within 9 hours of death;

- Fish exposed to air or water temperatures above83˚F (28.3˚C), or large tuna (i.e., above 20 lbs.)that are eviscerated before on-board chilling,should be placed in ice (including packing thebelly cavity of large tuna with ice) or inrefrigerated seawater or brine at 40˚F (4.4˚C) orless within 6 hours of death;

- Large tuna (i.e., above 20 lbs.) that are noteviscerated before on-board chilling should bechilled to an internal temperature of 50˚F (10˚C)or less within 6 hours of death;

• It is now recommended that, when refrigeratedbrine or seawater is used for chilling fish on theharvest vessel, the temperature of the cooling mediabe monitored and recorded (harvest vessel controlstrategy only);• It is now recommended that the critical limits atreceiving from the harvest vessel include a require-ment that the chilling of fish on the harvest vessel becontinued to bring the internal temperature of the fishto 40˚F (4.4˚C) or less (harvest vessel control strat-egy only);• It is now recognized that certain data previouslyexpected to be recorded by the harvester on harvestvessel records may, under certain circumstances, bemore efficiently recorded by the primary (first)processor on receiving records (harvest vessel controlstrategy only), such as:

- Method of capture;- Air and water temperature;- Method of onboard cooling;- Estimated date and time of death;


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• It is now recognized that, as an alternative to theprimary processor receiving harvest vessel recordsthat are maintained by the vessel operator, certainharvest operations may lend themselves to monitor-ing and record keeping entirely by the primaryprocessor. This arrangement is suitable only if theprimary processor has direct knowledge about thoseaspects of the harvesting practices that must becontrolled to ensure that the appropriate criticallimits are met. For example, if the harvest vesselleaves from the processor’s facility and returns withthe iced or refrigerated catch to the processor’sfacility within the appropriate time limits for onboard icing or refrigeration of the catch, undercertain circumstances it may be possible for theprocessor to perform all of the monitoring and recordkeeping functions ordinarily performed by theharvester;• It is now recommended that the critical limits atreceiving from the harvest vessel include a require-ment that fish delivered in less than 12 hours afterdeath should exhibit evidence that chilling began onthe harvest vessel (e.g. at receipt the internal tem-perature of the fish is below ambient air and watertemperature);• It is now recommended that the date and time ofoff-loading be recorded on receiving records main-tained by the primary processor;• It is no longer recommended that primary (first)processors check for the adequacy of ice, refrigeratedseawater, refrigerated brine, or other cooling media atreceipt from the harvest vessel;• It is no longer recommended that secondaryprocessors check the internal temperature of fishreceived from other processors. However, it is nowrecommended that the checks for the adequacy of iceor other cooling media at receiving be verifiedperiodically by measuring the internal temperature ofthe fish to ensure that it is at or below 40˚F (4.4˚C);• It is now recommended that the accuracy of time/temperature data loggers or recorder thermometerson vehicles delivering fish to secondary processors bechecked on all new suppliers’ vehicles and at leastquarterly thereafter;• The table of approximate safe shelf-life forscombrotoxin-forming species which was previouslypresent is replaced with more generalized guidancebecause the values contained in the table wereapparently being misused as binding limits;

• The recommended critical limits for storage andprocessing are significantly modified as follows:

- For fish that have not been previously frozen:the fish are not exposed to ambient temperaturesabove 40˚F (4.4˚C) for more than 4 hours,cumulatively, if any portion of that time is attemperatures above 70˚F (21˚C); or the fish arenot exposed to ambient temperatures above 40˚F(4.4˚C) for more than 8 hours, cumulatively, aslong as no portion of that time is at temperaturesabove 70˚F (21˚C);

- For fish that have been previously frozen: thefish are not exposed to ambient temperaturesabove 40˚F (4.4˚C) for more than 12 hours,cumulatively, if any portion of that time is attemperatures above 70˚F (21˚C); or the fish arenot exposed to ambient temperatures above40˚F (4.4˚C) for more than 24 hours,cumulatively, as long as no portion of that time isat temperatures above 70˚F (21˚C);

• There is no longer a minimum length of frozenstorage in the definition of “previously frozen product;”• It is now recommended that ambient air temperaturebe monitored at the processing and packaging criticalcontrol points;• A new concept is introduced to assist in the assess-ment of whether the hazard is significant at receivingby the primary (first) processor: the hazard may not besignificant if the worst case environmental conditions(i.e. air and water temperatures) during the harvestseason in a particular region would not permit theformation of histamine during the time necessary toharvest and transport the fish to the primary processor;• The recommendations previously provided forrefrigerated storage are now also recommended forrefrigerated processing;• For purposes of selecting fish for histamine analysisand sensory examination it is now recommended thatlots be identified that contain only one species;• It is now recommended that the number of fishtested for internal temperature at receipt by theprimary (first) processor be one per ton for lots of 10tons or more, and one per 1000 lbs. for lots of under10 tons, as long as at least 12 fish per lot are examined;• It is now recommended that no less than 18 fish perlot be analyzed for histamine at receipt by the primary(first) processor except where the lot is smaller than 18fish (histamine testing control strategy only). The fish

collected for analysis may be composited for analysisif the critical limit is reduced accordingly;• A sample size of 60 fish and a reject level of anyfish at or above 50 ppm histamine is now recom-mended as one option for corrective action when theprocessing critical limits have been violated;• Another option is now provided for correctiveaction when the sensory critical limit has beenviolated (primary processor):

- Perform histamine analysis on the lot (i.e. fish ofcommon origin) by analyzing 60 fish (or theentire lot for lots smaller than 60 fish) andrejecting the lot if any are found with histaminegreater than or equal to 50 ppm. If found, the lotmay be subdivided and reanalyzed at the samerate, rejecting those portions where a unit greaterthan or equal to 50 ppm is found. The fishcollected for analysis may be composited foranalysis if the critical limit is reduced accordingly;

AND- Perform a sensory examination of all fish in the lot;

• It is now recognized that when refrigerated fish aretransported only short distances (4 hours or less) fromprocessor to processor, a suitable alternative torequiring continuous monitoring during transit maybe for the secondary processor to check the internaltemperature of the fish upon receipt;• It is no longer recommended that maximumindicating thermometers be used to monitor ambientair temperature in storage coolers;• It is now recommended that high temperaturealarms used to monitor ambient air temperature instorage coolers be connected to a 24-hour monitoringservice.

The recommendations in Chapter 11 for the control ofaquaculture drugs are changed as follows:• Additional information is now provided about thelabeling of approved conditions of use on aquaculturedrugs;• Information is now included about the newlyapproved drug, chorionic gonadotropin;• Information is now included about additionalapproved uses for formalin solution;• An additional approved manufacturer of tricainemethansolfonate is now listed;• Thiamine hydrochloride is now listed as a lowregulatory priority drug for treatment of thiaminedeficiency in salmonids;

• Discontinued use of the supplier until correctionsare made is now recommended as a corrective actionfor all control strategy examples in whichaquacultured fish are received from the producer.

The recommendations in Chapter 12 for the control ofpathogen growth and toxin formation (other thanClostridium botulinum) as a result of time/temperatureabuse are changed as follows:• A third set of recommended critical limits is nowprovided for control during processing steps: If theproduct is held at internal temperatures both aboveand below 70˚F (21.1˚C), exposure times above 50˚F(10˚C) should ordinarily be limited to 4 hours, aslong as no more than 2 of those hours are above 70˚F(21.1˚C);• Additional information and guidance is nowprovided to assist in the development of critical limitsduring processing and storage, including:

- Examples of product time/temperature profiles;- A recommendation that most microbiologically

sensitive products be stored at or below 40˚F(4.4˚C), except where control of nonproteolyticC. botulinum by refrigeration is necessary, inwhich case storage at 38˚F (3.3˚C) is usuallyappropriate;

• Additional verification is now recommended, as follows:- The accuracy of recorder thermometers and other

instruments used to monitor temperature intransportation cargo areas should be checked onnew suppliers’ vehicles and at least quarterly foreach supplier thereafter;

- When visual checks of ice or cooling media areused to monitor the adequacy of coolant, theinternal temperatures of the fish should beperiodically checked to ensure that the ice orcooling media is sufficient to maintain producttemperatures at 40˚F (4.4˚C) or less;

• There is now a specific acknowledgement thatfrozen product storage and receipt of frozen rawmaterials are not likely CCPs;• Background information on the pathogens ofconcern now indicates that the infective doses ofListeria monocytogenes and Vibrio parahaemolyticusare unknown;


• The example HACCP plans in Tables 12-1 and 12-2 are modified to correct an error in the Second Edition,in which the cooked crab cooler step was inadvert-ently included as a CCP in the Gulf Coast blue crabprocessing method (Table 12-1), rather than the EastCoast blue crab processing method (Table 12-2).• It is now recognized that when refrigerated fisheryproducts are transported only short distances (4 hoursor less) from processor to processor, a suitablealternative to requiring continuous monitoring duringtransit may be for the secondary processor to checkthe internal temperature of the fish upon receipt;• It is no longer recommended that maximumindicating thermometers be used to monitor ambientair temperature in storage coolers;• It is now recommended that high temperaturealarms used to monitor ambient air temperature instorage coolers be connected to a 24-hour monitoringservice.

The recommendations in Chapter 13 for the control ofC. botulinum toxin formation are changed as follows:• The introductory material is extensively reorga-nized and revised to provide greater clarity;• Information is now provided on a recommendedminimum oxygen transmission rate for oxygen-permeable packages (10,000 cc/m2/24 hrs);• Fishery products packaged in deep containers fromwhich the air is expressed are now identified aspresenting a C. botulinum toxin formation hazard;• Hot smoked product in aerobic packaging is nolonger identified as presenting a C. botulinum toxinformation hazard sufficient to require preventivecontrols in a HACCP plan. However, note that theAssociation of Food and Drug Officials recommendsa minimum water phase salt content of 2.5% inaerobically-packaged smoked fish;• Controls are no longer recommended specificallyfor the control of C. botulinum toxin formation as aresult of time/temperature abuse during the process-ing of unpackaged product. Instead it is now recom-mended that the controls recommended for pathogensother than C. botulinum be applied as appropriate.The chapter also acknowledges that C. botulinumtoxin formation is possible in unpackaged or aerobi-cally packaged product, but that, under those condi-tions, it requires the type of severe temperature abusethat is not reasonably likely to occur in most foodprocessing environments;

• It is now recognized that when refrigerated fisheryproducts are transported only short distances (4 hoursor less) from processor to processor, a suitable alterna-tive to requiring continuous monitoring during transitmay be for the secondary processor to check theinternal temperature of the fish upon receipt;• It now states that 20% salt is the level needed toensure the safety of a shelf stable product relative toall pathogens (based on the maximum salt level forgrowth of S. aureus), rather than providing the appar-ently misleading statement that 10% salt is the levelneeded in a shelf stable product for the control of C.botulinum type A and proteolytic types B and F;• It now provides instruction to consult Chapter 12 forinformation on refrigerated storage temperaturecritical limits suitable for the control of pathogensother than C. botulinum, rather than providing theapparently misleading statement that 50˚F (10˚C) is anappropriate critical limit for the control of C. botuli-num type A and proteolytic types B and F. Refrigera-tion at or below 40˚F (4.4˚C) is recommended for thecontrol of all pathogens;• Specific guidance is now provided for control ofC. botulinum toxin formation in refrigerated, reducedoxygen packaged, pasteurized fishery products,including: 1) those that receive a nonproteolyticC. botulinum pasteurization process in the finalcontainer; and 2) those that receive a nonproteolyticC. botulinum cook and are then hot filled into the finalcontainer;• Specific guidance is now provided for control of C.botulinum toxin formation in refrigerated, reducedoxygen packaged pasteurized surimi-based products,including a recommended control of 2.5% salt incombination with a pasteurization process in thefinished product container of 185˚F (85˚C) (internaltemperature) for at least 15 minutes;• The use of recorder thermometers or digital time/temperature data loggers throughout distribution andretail storage and sales is no longer recommended asan alternative to a second barrier to toxin formation byC. botulinum type E and nonproteolytic types B and F;• It is now acknowledged that, for refrigeratedproducts that are packaged in oxygen-permeablepackaging, an oxygen-impermeable overwrap may beused to extend shelf life while the product is under thecontrol of the processor, as long as the overwrap isremoved before the product leaves the processor’scontrol;


7

• It is now recommended that nitrite analysis accom-pany water phase salt analysis, as appropriate, whensuch analysis is used as the means of monitoring thebrining, dry salting and/or drying steps;• It is now recommended that the accuracy of time/temperature data loggers or recorder thermometerson vehicles delivering fish to secondary processors bechecked on all new suppliers’ vehicles and at leastquarterly thereafter;• It is no longer recommended that maximumindicating thermometers be used to monitor ambientair temperature in storage coolers;• It is now recommended that high temperature alarmsused to monitor ambient air temperature in storagecoolers be connected to a 24-hour monitoring service.

The recommendations in Chapter 14 for the control ofpathogen growth and toxin formation as a result ofinadequate drying are changed as follows:• Controls are now provided for partial drying ofrefrigerated, reduced oxygen packaged foods, wheredrying is targeted for the control of C. botulinum typeE and nonproteolytic types B and F. The controls aredesigned to ensure that the water activity of thefinished product is below 0.97;• The importance of packaging in preventing rehy-dration of dried products is now noted.

The recommendations in Chapter 16 for the control ofpathogen survival through cooking are changed asfollows:• The concept of exceptionally lethal cookingprocesses is eliminated;• Information is now provided about the targetorganism and degree of destruction for cookingprocesses, including recommendations that:

- The target organism should ordinarily beL. monocytogenes;

- The cook should ordinarily provide a 6D process;• Information is now provided about cooking pro-cesses that are designed to eliminate the spores ofClostridium botulinum type E and nonproteolytictypes B and F, such as cooking of soups and saucesthat will be reduced oxygen packaged (e.g. vacuumpackaged) and distributed refrigerated. The informa-tion includes the recommendation that such productsbe hot filled in a continuous filling system to mini-mize the risk of recontamination between cookingand finished product packaging.

The recommendations in Chapter 17 for the control ofpathogen survival through pasteurization are changedas follows:• Information is now provided about the targetorganism and degree of destruction for pasteurizationprocesses, including recommendations that:

- The target organism should ordinarily beClostridium botulinum type E and nonproteolytictypes B and F if the product is reduced oxygenpackaged (e.g. vacuum packaged), does notcontain other barriers that are sufficient toprevent growth and toxin formation by thispathogen, and is stored or distributed refrigerated(not frozen);

- The target organism should ordinarily beL. monocytogenes for other products(e.g. frozen products);

- The pasteurization process should ordinarilyprovide a 6D reduction in the numbers of thetarget pathogen.

The recommendations in Chapter 18 for the control ofpathogen introduction after pasteurization are changedas follows:• Information is now provided on hot filling productssuch as soups and sauces that are cooked to eliminatethe spores of Clostridium botulinum type E andnonproteolytic types B and F, and then reducedoxygen packaged (e.g. vacuum packaged) and thendistributed refrigerated (not frozen). The minimumrecommended hot fill temperature, 185˚F (85˚C), isdesigned to minimize the risk of recontaminationbetween cooking and finished product packaging;• It is now recommended that cooling water flow ratebe controlled when UV treatment is used to treatcontainer cooling water.

The recommendations in Chapter 19 for the control ofallergens, food intolerance substances and prohibitedfood and color additives are changed as follows:• Controls similar to those previously recommendedfor use by primary processors are now recommendedfor use by secondary processors, except that relianceon raw material labeling or documents accompanyingthe raw material shipment (in the case of unlabeledproduct) are included as recommended controlstrategies when the raw material is received fromanother processor;


• Undeclared sulfiting agents are now identified as apotential hazard in cooked octopus;• General information is now provided on the controlof allergenic proteins in foods. Controls similar tothose previously recommended to ensure properlabeling for certain food and color additives are nowrecommended if foods that contain allergenic proteinsare part of or are directly added to a fishery product.Additionally, reference is made to controlling inad-vertent introduction of allergenic proteins, because ofcross-contact, through a rigorous sanitation regime,either as part of a prerequisite program or as part ofHACCP itself.

The recommendations in Chapter 20 for the control ofmetal inclusion are changed as follows:• The reference to the point at which FDA’s HealthHazard Evaluation Board has supported regulatoryaction is corrected to indicate a metal fragment ofbetween 0.3” [7 mm] and 1.0” [25 mm];• The recommended corrective actions to regaincontrol over the operation after metal is detected inthe product now include:

- Locating and correcting the source of the metalfragments; and

- Making adjustments to the materials, equipment,and/or process, as needed, to prevent futureintroduction of metal fragments;

• Injection needles and metal ties are now identifiedas additional sources of metal fragments in theprocessing environment;• It is now recognized that visually inspectingequipment for damage or missing parts may only befeasible with relatively simple equipment, such asband saws, small orbital blenders, and wire-meshbelts.

Chapter 21 has been added to provide guidance onthe control of glass inclusion as a result of the use ofglass containers.

The recommendations in the Appendices are changedas follows:• The maximum water phase salt level for growth ofBacillus cereus is now given as 10 percent;• The maximum water phase salt level for growth ofStaphylococcus aureus is now given as 20 percent;• The minimum temperature for growth of patho-genic strains of Escherichia coli is now given as43.7˚F (6.5˚C);• The maximum temperature for growth of Vibrioparahaemolyticus is now given as 113.5˚F (45.3˚C);• Maximum cumulative exposure times are nowprovided for Bacillus cereus, as follows: 5 days attemperatures between 39.2 and 43˚F (4-6˚C); 17hours at temperatures between 44 and 50˚F (7-10˚C);6 hours at temperatures between 51 and 70˚F (11-21˚C); and 3 hours at temperatures above 70˚F(above 21˚C);• Maximum cumulative exposure times are nowprovided for Clostridium perfringens, as follows:21 days at temperatures between 50 and 54˚F (10-12˚C); 1 day at temperatures between 55 and 57˚F(13-14˚C); 6 hours at temperatures between 58 and70˚F (15-21˚C); and 2 hours at temperatures above70˚F (above 21˚C);• The maximum cumulative exposure times forproteolytic Clostridium botulinum are now given as:11 hours for temperatures between 50 and 70˚F(10-21˚C); and 2 hours for temperatures above 70˚F(above 21˚C);• The maximum cumulative exposure times fornonproteolytic Clostridium botulinum are now givenas: 7 days for temperatures between 37.9 and 41˚F(3.3 - 5˚C); 2 days for temperatures between 42 and50˚F (6-10˚C); 11 hours for temperatures between51 and 70˚F (11-21˚C); and 6 hours for temperaturesabove 70˚F (above 21˚C);• The maximum cumulative exposure times forListeria monocytogenes are now given as: 7 days fortemperatures between 31.3 and 41˚F (-0.4 - 5˚C); and2 days for temperatures between 42 and 50˚F (6-10˚C);• The maximum cumulative exposure time forShigella spp. is now given as 12 hours for tempera-tures between 51 and 70˚F (11-21˚C);



• Tables of lethal rates and process times for 6Dcooks for a range of internal product temperatures arenow provided for Listeria monocytogenes andnonproteolytic Clostridium botulinum type B (TablesA-3 and A-4, respectively).• The FDA guideline for hard or sharp objects, foundin Compliance Policy Guide #555.425, is included inthe listing of FDA and EPA guidance levels – gener-ally 0.3” [7 mm] to 1.0” [25 mm] in length;• A listing of the most common food allergens isincluded (Appendix 6).

Numerous additional references are now included inthe Bibliography, and a number of the original refer-ences are corrected.

In addition to using the above listing to direct you torelevant changes in this guidance, you should care-fully review the chapters that are applicable to yourproduct and process.

Additional Copies

Single copies of this guidance may be obtained as longas supplies last from FDA district offices and from:

U.S. Food and Drug AdministrationOffice of Seafood200 C St., S.W.

Washington, D.C. 20204202-418-3133 (phone)

202-418-3196 (fax)

Multiple copies of this guidance may be obtained from:

Florida Sea GrantIFAS - Extension Bookstore

University of FloridaP.O. Box 110011

Gainesville, FL 32611-00111-800-226-1764

This guidance is also available electronically at:

http://www.fda.gov

Select “foods;” then select “seafood;” then select “HACCP.”

Chapter 2: Steps in Developing Your HACCP Plan

Continued

The HACCP Plan Form

This guidance is designed to walk you through aseries of eighteen steps that will yield a completedHACCP plan. A blank HACCP Plan Form is con-tained in Appendix 1. Note that this is a two pageform, with the second page to be used if your processhas more critical control points than can be listed onone page. The Seafood HACCP Regulation requiresthat you prepare a HACCP plan for fish and fisheryproducts that you process (where significant safetyhazards exist). The regulation does not require thatyou use the form included in Appendix 1. However,using this standardized form will likely help youdevelop an acceptable plan and will expedite regula-tory review.

The Hazard Analysis Worksheet

In order to Complete the HACCP Plan Form you willneed to perform a process called “hazard analysis.”FDA has found that the use of a standardized HazardAnalysis Worksheet assists in this process. A blankHazard Analysis Worksheet is contained in Appendix1. Note that this is also a two page form, with thesecond page to be used if your process has moreprocessing steps than can be listed on one page.While the Seafood HACCP Regulation requires thatprocessors perform a hazard analysis, it does notrequire that it be kept in writing. However, FDAexpects that a written hazard analysis will be veryuseful when you perform mandatory HACCP planreassessments, and when you are asked by regulatorsto justify why certain hazards were or were notincluded in your HACCP plan.

The Steps

Following is a listing of the steps that this guidanceuses in HACCP plan development:

• Preliminary Steps- General information- Describe the food- Describe the method of distribution and storage- Identify the intended use and consumer- Develop a flow diagram

• Hazard Analysis Worksheet- Set up the Hazard Analysis Worksheet- Identify the potential species-related hazards- Identify the potential process-related hazards- Complete the Hazard Analysis Worksheet- Understand the potential hazard- Determine if the potential hazard is significant- Identify the critical control points (CCP)

• HACCP Plan Form- Complete the HACCP Plan Form- Set the critical limits (CL)- Establish monitoring procedures

• What• How• Frequency• Who

- Establish corrective action procedures- Establish a recordkeeping system- Establish verification procedures

Chapter 2: HACCP Plan Steps11

Preliminary Steps

STEP #1: GENERAL INFORMATION.

Record the name and address of your processingfacility in the spaces provided on the first page of theHazard Analysis Worksheet and the HACCP PlanForm (Appendix 1).

STEP #2: DESCRIBE THE FOOD.

Identify the market name or Latin name (species) ofthe fishery component(s) of the product.

Examples:• tuna• shrimp• jack mackerel

Fully describe the finished product food.

Examples:• individually quick frozen, cooked, peeled shrimp• fresh tuna steaks• frozen, surimi-based, imitation king crab legs• fresh, raw drum, in-the-round• raw shrimp, in-shell• raw, shucked soft clams• fresh seafood salad, with shrimp and

blue crab meat• frozen, breaded pollock sticks• frozen lobster cakes

Describe the packaging type.

Examples:• vacuum-packaged plastic bag• aluminum can• bulk, in wax-coated paperboard box• plastic container with snap lid

Record this information in the space provided on thefirst page of the Hazard Analysis Worksheet and theHACCP Plan Form.

STEP #3: DESCRIBE THE METHOD OFDISTRIBUTION AND STORAGE.

Identify how the product is distributed and storedafter distribution (e.g. frozen, refrigerated, on ice, ordry). Identify whether any special shipping methods,such as mail order, are used.

Examples:• stored and distributed frozen• distributed on ice and then stored under

refrigeration or on ice• distributed through mail order with chemical

refrigerant and then stored under refrigeration


STEP #4: IDENTIFY THE INTENDED USEAND CONSUMER.

IDENTIFY HOW THE product will be used by theend user or consumer.

Examples:• to be heated (but not fully cooked) and served• to be eaten with or without further cooking• to be eaten raw or lightly cooked• to be fully cooked before consumption• to be further processed into a heat and serve

product

Identify the intended consumer or user of the prod-uct. The intended consumer may be the generalpublic or a particular segment of the population, suchas infants or the elderly. The intended user may beanother processor, who will further process theproduct.

Examples:• by the general public• by the general public, including some distribution

to hospitals and nursing homes• by another processing facility



STEP #5: DEVELOP A FLOW DIAGRAM.

The purpose of the diagram is to provide a clear,simple description of the steps involved in theprocessing of your fishery product and its associatedingredients as they “flow” from receipt to distribu-tion. The flow diagram should cover all of the stepsin the process which your firm performs. Receivingand storage steps for each of the ingredients, includ-ing non-fishery ingredients, should be included. Theflow diagram should be verified on-site for accuracy.

Figure # A-1 (Appendix 2) is an example of a flowdiagram.

Hazard Analysis Worksheet

STEP #6: SET UP THE HAZARD ANALYSISWORKSHEET.

Record each of the processing steps (from the flowdiagram) in Column 1 of the Hazard AnalysisWorksheet.

STEP #7: IDENTIFY THE POTENTIALSPECIES-RELATED HAZARDS.

Find in Table #3-1 (Chapter 3) or Table #3-2 (Chap-ter 3) the market name (Column 1) or Latin name(Column 2) of the product that you identified in Step#2. Use Table #3-1 for vertebrates (animals withbackbones), such as finfish. Use Table #3-2 forinvertebrates (animals without backbones), such asshrimp, oysters, crab, and lobster. Determine if ithas a potential species related hazard by looking for a“✓ ” mark (or three letter code for a natural toxin) inthe right-hand columns of the table. If so, record thepotential hazard(s) in Column 2 of the HazardAnalysis Worksheet, at each processing step.

Tables #3-1 and 3-2 include the best informationcurrently available to FDA concerning hazards thatare specific to each species of fish. You should useyour own expertise, or that of outside experts, asnecessary, to identify any hazards that may not beincluded in the table (e.g. those that may be new orunique to your region).

You may already have effective controls in place fora number of these hazards as part of your routine ortraditional handling practices. The presence of suchcontrols does not mean that the hazard is not signifi-cant. The likelihood of a hazard should be judged inthe absence of controls. For example, the fact thathistamine development in a particular species of fishhas not been noted, may be the result of: 1) theinability of the fish to produce histamine; or 2) theexistence of controls that are already in place toprevent its development (e.g. harvest vessel tempera-ture controls). In the first case the hazard is notreasonably likely to occur. In the second case thecontrols should be included in the HACCP plan.

FDA plans to update Tables #3-1 and 3-2 as theagency becomes aware of new information.

STEP #8: IDENTIFY THE POTENTIALPROCESS-RELATED HAZARDS.

Find in Table #3-3 (Chapter 3) the finished product,package type, and method of distribution and storagethat most closely matches the information that youdeveloped in Steps #2 and 3. Record the potentialhazard(s) listed in the table for that product intoColumn 2 of the Hazard Analysis Worksheet at eachprocessing step.

You may need to include potential hazards for morethan one finished product food category in Table#3-3. This will happen when your product fits morethan one description. For example if you processshrimp salad using raw shrimp as a raw material, youare processing both a cooked product (i.e. the inter-mediate cooked shrimp) and a salad (i.e. the finishedproduct shrimp salad). Potential hazards from bothfinished product food categories apply to yourproduct and should be listed in Column 2 of theHazard Analysis Worksheet.



Table #3-3 includes the best information currentlyavailable to FDA concerning hazards that are relatedto specific processing techniques. You should useyour own expertise, or that of outside experts asnecessary, to identify any hazards that may not beincluded in the table (e.g. those that are new orunique to your physical plant, equipment, or pro-cess). This is more likely with more complex orinnovative products.

FDA plans to update Table #3-3 as the agencybecomes aware of new information.

STEP #9: COMPLETE THE HAZARDANALYSIS WORKSHEET.

Consult the hazards and controls chapters of thisguidance (Chapters 4 through 21) for each of thepotential hazards that you entered in Column 2 of theHazard Analysis Worksheet. These chapters offerguidance for completing your hazard analysis anddeveloping your HACCP plan.

Complete Steps #10 through 12 in the chaptersrelating to each of the potential hazards. These stepsinvolve: understanding the potential hazard; deter-mining if the potential hazard is significant; andidentifying the critical control points. When youhave finished these steps for all of the potentialhazards that relate to your product, you will havecompleted the Hazard Analysis Worksheet. You maythen proceed to Step #13.

STEP #13: COMPLETE THE HACCP PLANFORM.

Find the processing steps which you have identifiedas CCPs in Column 6 of the Hazard AnalysisWorksheet. Record the names of these processingsteps in Column 1 of the HACCP Plan Form. Enterthe hazard(s) for which these processing steps wereidentified as CCPs in Column 2 of the HACCP PlanForm. This information can be found in Column 2 ofthe Hazard Analysis Worksheet.

Complete the HACCP Plan Form by consulting thehazards and controls chapters of this guidance(Chapters 4 through 21) for each of the significanthazards that you entered in Column 2 of the HACCPPlan Form. Complete Steps #14-18 in the chaptersrelating to each of the significant hazards. Thesesteps involve: setting the critical limits; establishingmonitoring procedures; establishing corrective actionprocedures; establishing a recordkeeping system; andestablishing verification procedures. When you havefinished these steps for all of the significant hazardsthat relate to your product, you will have completedthe HACCP Plan Form.

You should then sign and date the first page of theHACCP Plan Form. The signature must be that ofthe most responsible individual on-site at yourprocessing facility or a higher level official. Itsignifies that the HACCP plan has been accepted forimplementation by your firm.

Chapter 3: Potential Species-Related & Process-Related Hazards

Continued

Purpose

This chapter contains three tables, which provide thefollowing information:

• Table #3-1Potential Vertebrate Species Related Hazardscontains a listing of potential hazards that areassociated with specific species of vertebrate fish(fish with backbones). These hazards are referredto as species-related hazards;

• Table #3-2Potential Invertebrate Species Related Hazardscontains a listing of potential hazards that areassociated with specific species of invertebrate fish(fish without backbones). These hazards are alsoreferred to as species-related hazards;

• Table #3-3Potential Process Related Hazardscontains a listing of potential hazards that areassociated with specific finished fishery products.These hazards are referred to as process-relatedhazards.

It is important to note that the tables provide listingsof potential hazards. You should use the tablestogether with the information provided in chapters 4through 21 in order to determine whether the hazardis significant for your particular product, and, if so,how it should be controlled.

Chapter 3: Hazard Tables15


Table #3-1

Potential Vertebrate Species Related Hazards

Note: ASP = amnesic shellfish poison; CFP = ciguatera fish poison;G = gempylotoxin; PSP = paralytic fish poison; T = tetrodotoxin.

Note: This table does not provide information about methyl mercury, which may be a potentialspecies related hazard in some species of vertebrate fish. FDA policy concerning this matter is under re-evaluation.

See Chapter 10 (Methyl Mercury) for further information.

Market Names Latin Names Hazards

Biological Chemical

Parasites Natural Toxins Histamine Chemical DrugsCHP 5 CHP 6 CHP 7 CHP 9 CHP 11

AHOLEHOLE Kuhlia spp. CFP

ALEWIFE orRIVER HERRING Alosa pseudoharengus 3

ALFONSINO Beryx spp.Trachichthodes spp.

ALLIGATOR Alligatormississippiensis 3

Alligator sienensis 3

ALLIGATORAQUACULTURED Alligator

mississippiensisAlligator sienensis 3 3

AMBERJACK orYELLOWTAIL Seriola spp. CFP 3

ANCHOVY Anchoa spp. ASP6 3Anchoviella spp. ASP6 3Cetengraulis

mysticetus ASP6 3Engraulis spp. ASP6 3Stolephorus spp. ASP6 3

ANGELFISH Holacanthus spp.Pomacanthus spp.

ARGENTINEQUEENFISH Argentina elongata

BARRACUDA Sphyraena spp. CFP 3

6 – This hazard only applies if the product is marketed uneviscerated.

3 3



Biological Chemical


BARRAMUNDI Lates calcarifer ✓

BASS Ambloplites spp. ✓Micropterus spp. ✓Morone spp. ✓Stereolepis gigas ✓Synagrops bellus ✓

BASSAQUACULTURED Morone spp. ✓ ✓

Centropristis spp. ✓ ✓

BASS, SEA Acanthistiusbrasilianus ✓ 4

Centropristis spp. ✓ 4

Dicentrarchus labrax ✓ 4

Lateolabrax japonicus ✓ 4

Paralabrax spp. ✓ 4

Paranthias furcifer ✓ 4

Polyprion americanus ✓ 4

Polyprion oxygeneios ✓ 4

Polyprion yanezi ✓ 4

BIGEYE Priacanthus arenatusPristigenys alta

BLUEFISH Pomatomus saltatrix ✓ ✓

BLUEGILL Lepomis macrochirus ✓

BLUENOSE Hyperoglypheantarctica

BOMBAY DUCK Harpadon nehereus ✓

BONITO Cybiosarda elegans ✓Gymnosarda unicolor ✓Orcynopsis unicolor ✓Sarda spp. ✓

BOWFIN and roe Amia calva ✓

BREAM Abramis bramaArgyrops spp.Sparus auratus

BREAM or BOGUE Boops boops

4 – This hazard does not apply if the product is intended to be cooked by the consumer or end-user.



Biological Chemical


BREAM,THREADFIN Nemipterus japonicus

BUFFALOFISH Ictiobus spp. ✓

BULLHEAD Ameiurus spp. ✓

BURBOT Lota lota ✓

BUTTERFISH Odax pullus ✓Peprilus spp. ✓Stromateus cinereus ✓

CAPELIN and roe Mallotus villosus ✓ 4

CARP Cyprinus carpio ✓Hypophthalmichthys

molitrix ✓

CARPAQUACULTURED Cyprinus carpio ✓ ✓

Hypophthalmichthysmolitrix ✓ ✓

CATFISH Ameiurus catus ✓Brachyplatystoma spp. ✓Ictalurus spp. ✓Pinirampus pirinampu ✓Platynematichthy

notatus ✓Pseudoplatystoma

tigrinum ✓Pylodictis oliveris ✓

CATFISHAQUACULTURED Ictalurus spp. ✓ ✓

CATFISH, SEA Ariopsis felisArius spp.Bagre marinus

CHAR Salvelinus alpinus ✓

CHARAQUACULTURED Salvelinus alpinus ✓ ✓

CHIMAERA Harriota raleighanaHydrolagus spp.




Biological Chemical


CHUB Coregonus kiyi ✓Kyphosus spp. ✓Semotilus

atromaculatus ✓

CISCO or CHUB Coregonus alpenae ✓Coregonus reighardi ✓Coregonus zenithicus ✓

CISCO orTULLIBEE Coregonus artedii ✓

COBIA Rachycentron canadum ✓ 4

COD Arctogadus spp. ✓ 4

Boreogadus saida ✓ 4

Eleginus gracilis ✓ 4

Gadus spp. ✓ 4

COD orALASKA COD Gadus macrocephalus ✓ 4

COD, MORID Lotella rhacina ✓ 4

Mora pacifica ✓ 4

Physiculus barbatus ✓ 4

Pseudophycis spp. ✓ 4

CORVINA Cilus montii ✓ 4

Micropogoniasopercularis ✓ 4

CRAPPIE Pomoxis spp. ✓

CROAKER Argyrosomus spp. ✓Bairdiella spp. ✓Cheilotrema saturnum ✓Genyonemus lineatus ✓Micropogonias spp. ✓Nebris microps ✓Nibea spp. ✓Pachypops spp. ✓Pachyurus spp. ✓Paralonchurus spp. ✓Plagioscion spp. ✓Pseudotolithus spp. ✓Pterotolithus spp. ✓Roncador stearnsi ✓Umbrina roncador ✓Odontoscion dentex ✓




Biological Chemical


CROAKER orCORVINA Cynoscion spp. ✓

CROAKER orSHADEFISH Argyrosomus regius ✓

CROAKER orYELLOWFISH Pseudosciaena

manchurica ✓

CUSK Brosme brosme

CUSK-EEL Lepophidium spp.

CUTLASSFISH Aphanopus carboLepidopus caudatusTrichiurus spp.

DACE Rhinichthys ssp. ✓

DORY Cyttus novaezealandiaeZenopsis spp.Zeus spp.

DRIFTFISH Hyperoglyphe spp.

DRUM Equetus punctatus ✓Larimus spp. ✓Pogonias cromis ✓Stellifer spp. ✓Totoaba macdonaldi ✓Umbrina coroides ✓

DRUM or CUBBYU Equetus umbrosus ✓

DRUM,FRESHWATER Aplodinotus grunniens ✓

DRUM orLION FISH Collichthys spp. ✓

DRUM orMEAGRE Sciaena aquila ✓

DRUM orQUEENFISH Seriphus politus ✓



Biological Chemical


DRUM orREDFISH Sciaenops ocellatus ✓

DRUM or REDFISHAQUACULTURED Sciaenops ocellatus ✓ ✓

EEL Anguilla spp.

EELAQUACULTURED Anguilla anguilla ✓ ✓

Anguilla australis ✓ ✓Anguilla dieffenbachii ✓ ✓Anguilla japonicus ✓ ✓

EEL, CONGER Ariosoma balearicum ✓Conger spp. ✓Gnathophis

catalinensis ✓Hildebrandia spp. ✓Paraconger

caudilimbatus ✓

EEL,FRESHWATER Anguilla rostrata ✓

EEL,FRESHWATERAQUACULTURED Anguilla rostrata ✓ ✓

EEL, MORAY Gymnothorax funebris CFPLycodontis javanicus CFPMuraena retifera CFP

EEL, SPINY Notacanthus chemnitzi

EELPOUT Macrozoarcesamericanus ✓ 4

Zoarces viviparus ✓ 4

ELEPHANT FISH Callorhynchus millii

EMPEROR Lethrinus spp.

ESCOLAR orOILFISH Lepidocybium G ✓

flavobrunneumRuvettus pretiosus G ✓

Note: ASP = amnesic shellfish poison; CFP = ciguatera fish poison; G = gempylotoxin; PSP = paralytic fish poison; T = tetrodotoxin.




Biological Chemical


FLOUNDER Ancylopsetta dilecta ✓ 4 ✓ 1

Arnoglossus scapha ✓ 4 ✓ 1

Atheresthes evermanni ✓ 4 ✓ 1

Bothus spp. ✓ 4 ✓ 1

Chascanopsettacrumenalis ✓ 4 ✓ 1

Cleisthenes pinetorum ✓ 4 ✓ 1

Colistium spp. ✓ 4 ✓ 1

Cyclopsetta chittendeni ✓ 4 ✓ 1

Hippoglossoidesrobustus ✓ 4 ✓ 1

Limanda ferruginea ✓ 4 ✓ 1

Liopsetta glacialis ✓ 4 ✓ 1

Microstomus achne ✓ 4 ✓ 1

Paralichthys albigutta ✓ 4 ✓ 1

Paralichthys oblongus ✓ 4 ✓ 1

Paralichthys olivaceus ✓ 4 ✓ 1

Paralichthyspatagonicus ✓ 4 ✓ 1

Paralichthyssquamilentus ✓ 4 ✓ 1

Pelotretis flavilatus ✓ 4 ✓ 1

Peltorhampusnovaezeelandiae ✓ 4 ✓ 1

Platichthys spp. ✓ 4 ✓ 1

Pseudorhombus spp. ✓ 4 ✓ 1

Rhombosolea spp. ✓ 4 ✓ 1

Samariscus triocellatus ✓ 4 ✓ 1

Scophthalmus spp. ✓ 4 ✓ 1

1 – This hazard does not apply to offshore catch (e.g. areas not subject to shoreside contaminant discharges).4 – This hazard does not apply if the product is intended to be cooked by the consumer or end-user.



Biological Chemical


FLOUNDERAQUACULTURED Ancylopsetta dilecta ✓ 4, 5 ✓ ✓

Arnoglossus scapha ✓ 4, 5 ✓ ✓Atheresthes evermanni ✓ 4, 5 ✓ ✓Bothus spp. ✓ 4, 5 ✓ ✓Chascanopsetta

crumenalis ✓ 4, 5 ✓ ✓Cleisthenes pinetorum ✓ 4, 5 ✓ ✓Colistium spp. ✓ 4, 5 ✓ ✓Cyclopsetta

chittendeni ✓ 4, 5 ✓ ✓Hippoglossoides

robustus ✓ 4, 5 ✓ ✓Limanda ferruginea ✓ 4, 5 ✓ ✓Liopsetta glacialis ✓ 4, 5 ✓ ✓Microstomus achne ✓ 4, 5 ✓ ✓Paralichthys spp. ✓ 4, 5 ✓ ✓Pelotretis flavilatus ✓ 4, 5 ✓ ✓Peltorhampus

novaezeelandiae ✓ 4, 5 ✓ ✓Pseudorhombus spp. ✓ 4, 5 ✓ ✓Rhombosolea spp. ✓ 4, 5 ✓ ✓Samariscus

triocellatus ✓ 4, 5 ✓ ✓Scophthalmus spp. ✓ 4, 5 ✓ ✓

FLOUNDER or DAB Pleuronectes limanda ✓ 4 ✓ 1

Pleuronectesproboscidea ✓ 4 ✓ 1

Pleuronectespunctatissimus ✓ 4 ✓ 1

FLOUNDER orFLUKE Paralichthys dentatus ✓ 4 ✓ 1

Paralichthyslethostigma ✓ 4 ✓ 1

Paralichthys microps ✓ 4 ✓ 1

Platylichthys flesus ✓ 4 ✓ 1

FLOUNDER,ARROWTOOTH Atheresthes stomias ✓ 4

1 – This hazard does not apply to offshore catch (e.g. areas not subject to shoreside contaminant discharges).4 – This hazard does not apply if the product is intended to be cooked by the consumer or end-user.

5 – This hazard only applies if fresh fish or plankton is used as feed.



Biological Chemical


FLYINGFISHand roe Cypselurus spp.

Exocoetus spp.Fodiator acutusHirundichthys spp.Oxyporhamphus

micropterusParexocoetus

brachypterusPrognichthys

gibbifrons

FROG Rana spp. ✓

GAR Lepisosteus spp. ✓

GEMFISH Epinnula magistralisNesiarchus nasutusLepidocybium

flavobrunneum G ✓

GEMFISH orBARRACOUTA Rexea solandri

Thyrsites atun

GEMFISH orCABALLA Thyrsites lepidopoides

GOATFISH Mulloidichthys spp. CFPMullus auratusParupeneus spp.Pseudupeneus spp. CFPUpeneichthys lineatus CFPUpeneus spp.

GRAYLING Thymallus arcticus ✓

GREENBONE Coridodax pullus

GREENLING Hexagrammos spp.

GRENADIER Coryphaenoides spp.Lepidorhynchus

denticulatusMacrourus spp.Nezumia bairdiTrachyrhynchus

murray




Biological Chemical


GROUPER Caprodon schlegelii ✓ 4 CFPCephalopholis spp. ✓ 4 CFPDiplectrum formosum ✓ 4 CFPEpinephelus spp. ✓ 4 CFPMycteroperca spp. ✓ 4 CFP

GROUPER or GAG Mycteropercamicrolepsis ✓ 4 CFP

GROUPER or HIND Epinephelus guttatus ✓ 4 CFP

GROUPER orJEWFISH Epinephelus itajara ✓ 4 CFP

GRUNION Leuresthes tenuis

GRUNT Anisotremusinterruptus

Conodon nobilisHaemulon spp.Orthopristis

chrysopteraPomadasys crocro

GRUNT orCATALINA Anisotremus taeniatus

GRUNT orMARGATE Haemulon album

Haemulonsurinamensis

GRUNT orSWEETLIPS Plectorhynchus spp.

HADDOCK Melanogrammusaeglefinus

HAKE Urophycis spp.

HALIBUT Hippoglossus spp. ✓ 4

HALIBUTAQUACULTURED Hippoglossus spp. ✓ 4, 5 ✓ ✓

HALIBUT orCALIFORNIAHALIBUT Paralichthys

californicus ✓ 4


4 – This hazard does not apply if the product is intended to be cooked by the consumer or end-user.5 – This hazard only applies if fresh fish or plankton is used as feed.



Biological Chemical


HAMLET,MUTTON Epinephelus afer

HERRING Etrumeus teres ✓ 4 ✓ ✓Harengula thrissina ✓ 4 ✓ ✓Ilisha spp. ✓ 4 ✓ ✓Opisthopterus tardoore ✓ 4 ✓ ✓Pellona ditchela ✓ 4 ✓ ✓Alosa spp. ✓ ✓

HERRING orSEA HERRINGor SILD and roe Clupea spp. ✓ 4 ✓

HERRING,THREAD Opisthonema spp. ✓ ✓

HIND Epinephelus guttatus ✓ 4 CFPEpinephelus

adscensionis ✓ 4 CFPEpinephelus

drummondhayi ✓ 4 CFP

HOGFISH Lachnolaimusmaximus ✓ 4 CFP

JACK Caranx spp. ✓ 4 CFP ✓Oligoplites saurus ✓ 4 CFP ✓Selene spp. ✓ 4 CFP ✓Seriola rivoliana ✓ 4 CFP ✓Urapsis secunda ✓ 4 CFP ✓

JACK orBLUE RUNNER Caranx crysos ✓ 4 CFP ✓

JACK orCREVALLE Alectis indica ✓ 4 CFP ✓

JACK orRAINBOW RUNNER Elagatis bipinnulata ✓ 4 CFP ✓

JACK orROOSTERFISH Nematistius pectoralis ✓ 4 CFP ✓

JOBFISH Aphareus spp. ✓ 4 CFP ✓Aprion virescens ✓ 4 CFP ✓Pristipomoides spp. ✓ 4 CFP ✓





Biological Chemical


KAHAWAI Arripis spp. ✓ 4 CFP ✓

KINGFISH Menticirrhus spp.

KINGKLIP Genypterus spp.

LADYFISH Elops spp.

LING Molva spp.

LING,MEDITERRANEAN Molva macrophthalmus

LINGCOD Ophiodon elongatus

LIZARDFISH Synodus spp.

LUMPFISH roe Cyclopterus lumpus

MACKEREL Gasterochismamelampus ✓ 4 ✓

Grammatorcynus spp. ✓ 4 ✓Rastrelliger kanagurta ✓ 4 ✓Scomber scombrus ✓ 4 ✓

MACKEREL, ATKA Pleurogrammusmonopterygius ✓ 4

MACKEREL, CHUB Scomber spp. ✓ 4 ✓

MACKEREL, JACK Trachurus spp. ✓ 4 ✓

MACKEREL,SPANISH Scomberomorus spp. ✓ 4 ✓

Scomberomorus cavalla ✓ 4 CFP ✓

MAHI-MAHI Coryphaena spp. ✓

MAHI-MAHIAQUACULTURED Coryphaena spp. ✓ ✓ ✓

MARLIN Makaira spp. ✓Tetrapturus spp. ✓

MENHADEN Brevoortia spp.Ethmidium maculatum

MILKFISH Chanos chanos ✓




2 – Indicates that the cigutera hazard is only associated with this species in the tropical Pacific Ocean.4 – This hazard does not apply if the product is intended to be cooked by the consumer or end-user.



Biological Chemical


MILKFISHAQUACULTURED Chanos chanos ✓ ✓

MONKFISH Lophius spp. ✓ 4

MORWONG Aplodactylusmeandratus

Cheilodactylus spp.Nemadactylus spp.

MULLET Agonostomusmonticola ✓ 4 ✓

Aldrichetta forsteri ✓ 4 ✓Crenimugil crenilabis ✓ 4 ✓Mugil spp. ✓ 4 ✓Mullus spp. ✓ 4 ✓Neomyxus chaptalii ✓ 4 ✓Xenomugil thoburni ✓ 4 ✓

MUSKELLUNGE Esox masquinongy ✓

OPAH Lampris guttatus

OPALEYE Girella nigricans

OREO DORY Allocyttus nigerPseudocyttus

maculatus

OSCAR Astronotus ocellatus ✓

OSCARAQUACULTURED Astronotus ocellatus ✓ ✓

PACU Myleus pacu

PADDLEFISHand roe Polyodon spp. ✓

PADDLEFISHand roeAQUACULTURED Polyodon spp. ✓ ✓

PARROTFISH Scarus spp. CFP2

PATAGONIANTOOTHFISH orCHILEAN SEA BASS Dissotichus eleginoides ✓ 4



Biological Chemical


PERCH Hermosilla azurea ✓Perca fluviatilis ✓

PERCH, LAKE orYELLOW Perca flavescens ✓

PERCH, NILE Lates niloticus ✓

PERCH, NILEAQUACULTURED Lates niloticus ✓ ✓

PERCH, OCEAN Sebastes spp. ✓ 4

PERCH, PILE Rhacochilus vacca ✓

PERCH, SILVER Bairdiella chrysoura ✓

PERCH, WHITE Morone americana ✓

PICAREL Spicara maena ✓

PICKEREL Esox spp. ✓

PIKE Esox lucius ✓

PILCHARD orSARDINE Sardina pilchardus ✓

Sardinops spp. ✓

PLAICE Hippoglossoidesplatessoides ✓ 4

Pleuronectes platessa ✓ 4

Pleuronectesquadrituberculatus ✓ 4

POLLOCK Pollachius pollachius ✓ 4

Pollachius virens ✓ 4

POLLOCK orALASKA POLLOCK Theragra

chalcogramma ✓ 4

POMFRET Brama spp.Taracetes rubescens

POMPANO Alectis ciliaris CFPParastromateus nigerTrachinotus spp.





Biological Chemical


POMPANO orPERMIT Trachinotus kennedyi

Trachinotus falcatus

POMPANO orPOMPANITO Trachinotus rhodopus

PORGY Calamus spp.Chrysophrys auratusDentex spp.Diplodus spp.Lagodon rhomboidesPagrus spp.Pterogymnus laniarusStenotomus caprinus

PORGY or SCUP Stenotomus chrysops

PUFFER Arothron spp. TFugu spp. TLagocephalus spp.Sphoeroides maculatus

RACEHORSE Congiopodusleucopaecilus

ROCKFISH Helicolenus papillosus ✓ 4

Scorpaena cardinalis ✓ 4

Sebastes spp. ✓ 4

ROCKLING Ciliata spp.Enchelyopus cimbrius

ROSEFISH Helicolenusdactylopterus

ROUGHY Paratrachichthystrailli

ROUGHY, ORANGE Hoplostethus atlanticus

ROUGHY, SILVER Hoplostethusmediterraneus

SABLEFISH Anoplopoma fimbria ✓ 4

SALMON and roe,AQUACULTURED Oncorhynchus spp. ✓ 4, 5 ✓ ✓

Salmo salar ✓ 4, 5 ✓ ✓





Biological Chemical


SALMON and roe(WILD)(FRESHWATER) Oncorhynchus spp. ✓

Salmo salar ✓

SALMON and roe,(WILD) (OCEAN) Oncorhynchus spp. ✓ 4

Salmo salar ✓ 4

SANDDAB Citharichthys sordidus ✓

SANDPERCH Mugiloides chilensisParapercis spp.

SARDINE Harengula spp. ✓Sardinella spp. ✓

SAUGER Stizostedion canadense

SAURY Cololabis saira ✓Scomberesox saurus ✓

SCAD Caranx mate ✓ 4

Decapterus spp. ✓ 4

Selarcrumenophthalmus ✓ 4

Trachurus spp. ✓ 4

SCULPIN Hemitripterusamericanus

Myoxocephaluspolyacanthocephalus

Scorpaenichthysmarmoratus

SEA BREAM Archosargusrhomboidalis

Chrysophrys unicolorPagellus spp.

SEAROBIN Chelidonichthys spp.Peristedion miniatumPrionotus carolinusPterygotrigla picta

SEATROUT Cynoscion spp. ✓ 4

SHAD and roe Alosa spp. ✓ ✓




Biological Chemical


SHAD, GIZZARD Dorosoma spp. ✓ ✓Nematalosa vlaminghi ✓ ✓

SHARK Carcharhinus spp.Cetorhinus maximusGaleocerdo cuviereGaleorhinus spp.Hexanchus griseusLamna ditropisNegaprion brevirostrisNotorynchus

cepedianusPrionace glaucaSphyrna spp.Triaenodon obesusTriakis semifasciata

SHARK orPORBEAGLE Lamna nasus

SHARK orSMOOTHHOUND Mustelus spp.

SHARK, ANGEL Squatina spp.

SHARK, DOGFISHor CAPE SHARK Centrophorus spp.

Mustelus spp.Scyliorhinus spp.Squalus spp.

SHARK, MAKO Isurus spp.

SHARK, THRESHER Alopias spp.

SHEEPHEAD Semicossyphus pulcher ✓Archosargus

probatocephalus ✓

SHINER Notropis spp. ✓

SILVERSIDE Atherinops spp. ✓Basilichthys australis ✓Menidia menidia ✓

SKATE Bathyraja spp. ✓Raja spp. ✓



Biological Chemical


SKILLFISH Erilepis zonifer

SMELT Allosmerus elongatus ✓Argentina spp. ✓Hypomesus spp. ✓Osmerus spp. ✓Plecoglossus altivelis ✓Retropinna retropinna ✓Spirinchus spp. ✓Thaleichthys pacificus ✓

SNAKEHEAD Channa striataOphicephalus

obscurus

SNAPPER Apsilus dentatusEtelis spp. CFPLutjanus spp. CFPMacolor spp.Ocyurus chrysurusPristipomoides spp. ✓ 4 CFP ✓Rhomboplites

aurorubensSymphorichthys

spilurus

SNOOK Centropomus spp. ✓

SOLE or FLOUNDER Aseraggodes spp. ✓ 4

Austroglossus spp. ✓ 4

Buglossidium luteum ✓ 4

Clidodermaasperrimum ✓ 4

Embassichthysbathybius ✓ 4

Eopsetta exilis ✓ 4

Eopsetta jordani ✓ 4

Errex zachirus ✓ 4

Glyptocephalus spp. ✓ 4

Gymnachirus melas ✓ 4

Hippoglossina spp. ✓ 4

Lepidopsetta bilineata ✓ 4

Microchirus spp. ✓ 4

Microstomus kitt ✓ 4

Microstomus pacificus ✓ 4

Pleuronectesamericanus ✓ 4

Pleuronectes vetulus ✓ 4

Psettichthysmelanostictus ✓ 4

Solea vulgaris ✓ 4

Synaptura orientalis ✓ 4

Trinectes spp. ✓ 4

Xystreurys liolepis ✓ 4



SOLE orFLOUNDERAQUACULTURED Aseraggodes spp. ✓ 4, 5 ✓ ✓

Austroglossus spp. ✓ 4, 5 ✓ ✓Buglossidium luteum ✓ 4, 5 ✓ ✓Clidoderma

asperrimum ✓ 4, 5 ✓ ✓Embassichthys

bathybius ✓ 4, 5 ✓ ✓Eopsetta exilis ✓ 4, 5 ✓ ✓Eopsetta jordani ✓ 4, 5 ✓ ✓Errex zachirus ✓ 4, 5 ✓ ✓Glyptocephalus spp. ✓ 4, 5 ✓ ✓Gymnachirus melas ✓ 4, 5 ✓ ✓Hippoglossina spp. ✓ 4, 5 ✓ ✓Lepidopsetta bilineata ✓ 4, 5 ✓ ✓Microchirus spp. ✓ 4, 5 ✓ ✓Pleuronectes

americanus ✓ 4, 5 ✓ ✓Pleuronectes vetulus ✓ 4, 5 ✓ ✓Psettichthys

melanostictus ✓ 4, 5 ✓ ✓Solea vulgaris ✓ 4, 5 ✓ ✓Synaptura orientalis ✓ 4, 5 ✓ ✓Trinectes spp. ✓ 4, 5 ✓ ✓Xystreurys liolepis ✓ 4, 5 ✓ ✓

SPADEFISH Chaetodipterus spp.

SPEARFISH Tetrapturus spp.

SPOT Leiostomus xanthurus ✓

SPRAT orBRISTLING Sprattus spp. ✓ 4 ✓

SQUIRRELFISH Holocentrus spp. CFPMyripristis spp.Sargocentron spp.

STURGEON and roe Acipenser spp. ✓Huso huso ✓Pseudoscaphirhynchus

spp. ✓Scaphirhynchus spp. ✓

STURGEON and roeAQUACULTURED Acipenser spp. ✓ ✓

Huso huso ✓ ✓Pseudoscaphirhynchus

spp. ✓ ✓Scaphirhynchus spp. ✓ ✓



Biological Chemical





3 – Indicates that the cigutera hazard is only associated with this species in the tropical Pacific Ocean.4 – This hazard does not apply if the product is intended to be cooked by the consumer or end-user.



Biological Chemical


SUCKER Carpiodes spp. ✓Catostomus

commersoni ✓Cycleptus elongatus ✓

SUCKER orREDHORSE Moxostoma

macrolepidotum ✓

SUNFISH(not Mola mola) Archoplites interruptus ✓

Lepomis spp. ✓

SURFPERCH Amphistichus spp. ✓Cymatogaster

aggregata ✓Embiotoca spp. ✓Hyperprosopon ✓

argenteumRhacochilus toxotes ✓

SWORDFISH Xiphias gladius

TANG Acanthurus spp. CFP3

Ctenochaetus spp. CFP3

Tenthis spp. CFP3

Zebrasoma spp. CFP3

TARPON Megalops atlanticus ✓

TAUTOG Tautoga onitis ✓

THORNYHEAD Sebastolobus spp. ✓ 4 ✓

THREADFIN Eleutheronematetradactylum

Galeoides decadactylusPolydactylus spp.

TILAPIA Tilapia spp. ✓

TILAPIAAQUACULTURED Tilapia spp. ✓ ✓

TILEFISH Caulolatilus spp.Lopholatilus

chamaeleonticepsMalacanthus plumieriProlatilus jugularis

TOMCOD Microgadus spp. ✓ 4



Biological Chemical


TONGUESOLE Cynoglossus spp. ✓ 4

TREVALLY Caranx sexfasciatus ✓ 4 CFP ✓

TRIGGERFISH Balistes spp. CFPCanthidermis

sufflamen CFPMelichthys niger CFPNavodon spp.

TRIPLETAIL Datnioidesquadrifasciatus

Lobotes spp.

TROUT(AQUACULTURE) Oncorhynchus

aguabonita ✓ ✓Oncorhynchus clarki ✓ ✓Oncorhynchus gilae ✓ ✓Oncorhynchus mykiss ✓ ✓Salmo trutta ✓ ✓Salvelinus fontalis ✓ ✓Salvelinus malma ✓ ✓Salvelinus namaycush ✓ ✓Stenodus leucichthys ✓ ✓

TROUT,RAINBOW orSTEELHEAD Oncorhynchus mykiss ✓ 4

TRUMPETER Latridopis spp. ✓Latris lineata ✓

TUNA (small) Allothunnus fallai ✓ 4 ✓Auxis spp. ✓ 4 ✓Euthynnus spp. ✓ 4 ✓Katsuwonus pelamis ✓ 4 ✓Thunnus tonggol ✓ 4 ✓

TUNA (large) Thunnus alalunga ✓Thunnus albacares ✓Thunnus atlanticus ✓Thunnus maccoyii ✓Thunnus obesus ✓Thunnus thynnus ✓





Biological Chemical


TURBOT Hypsopsetta guttulata ✓ 4

Pleuronichthys spp. ✓ 4

Psettodes spp. ✓ 4

Reinhardtiushippoglossoides ✓ 4

Scophthalmusmaximum ✓ 4

WAHOO Acanthocybiumsolandri ✓

WALLEYE Stizostedion spp. ✓

WAREHOU Seriolella spp.

WEAKFISH Cynoscion spp.Macrodon ancylodon

WHITEFISH Coregonus spp. ✓Prosopium

cylindraceum ✓

WHITING Merluccius gayiMerluccius hubbsiMerluccius merluccius

WHITING, BLUE Micromesistius spp.

WHITING orPACIFIC WHITING Merluccius productus

WHITING,NEW ZEALAND Macruronus

novaezelandiae

WOLFFISH Anarhichas spp. ✓ 4

YELLOWTAIL orAMBERJACK Seriola lalandei CFP ✓

ZANDER Stizostedion lucioperca ✓




Table #3-2

Potential Invertebrate Species Related Hazards


Biological Chemical

Pathogens Parasites Natural Toxins Chemical DrugsCHP 4 CHP 5 CHP 6 CHP 9 CHP 11

ABALONE Haliotis spp. ✓Marinauris roei ✓Notohaliotis ruber ✓Schismotis laevigata ✓

AQUACULTUREDINVERTEBRATES ALL SPECIES ✓ ✓ ✓ ✓

ARKSHELL Anadara subcrenata ✓ ✓ ✓Arca spp. ✓ ✓ ✓

CLAM, BENTNOSE Macoma nasuta ✓ ✓ ✓

CLAM BUTTER Saxidomus spp. ✓ ✓ ✓

CLAM, CALICO Macrocallista maculata ✓ ✓ ✓

CLAM, GEODUCK Panopea abrupta ✓ ✓ ✓Panopea bitruncata ✓ ✓ ✓

CLAM, HARD Arctica islandica ✓ ✓ ✓Meretricinae spp. ✓ ✓ ✓Meretrix spp. ✓ ✓ ✓Venus mortoni ✓ ✓ ✓

CLAM,HARDSHELL orQUAHOG Protothaca thaca ✓ ✓ ✓

Mercenaria spp. ✓ ✓ ✓

CLAM,LITTLENECK Protothaca staminea ✓ ✓ ✓

Protothaca tenerrima ✓ ✓ ✓Tapes aureus ✓ ✓ ✓Tapes decussatus ✓ ✓ ✓Tapes semidecussata ✓ ✓ ✓Tapes variegata ✓ ✓ ✓Tapes virginea ✓ ✓ ✓Venerupis

philippinarum ✓ ✓ ✓

CLAM, MARSH Corbicula japonica ✓ ✓ ✓

CLAM, PISMO Tivela stultorum ✓ ✓ ✓

Hazards

Biological Chemical



Market Names Latin Names

CLAM, RAZOR Ensis spp. ✓ ✓ ✓Siliqua spp. ✓ ✓ ✓Solen spp. ✓ ✓ ✓Tagelus spp. ✓ ✓ ✓

CLAM, SANGUIN Sanguinolaria spp. ✓ ✓ ✓

CLAM, SOFTSHELL Mya arenaria ✓ ✓ ✓

CLAM, SURFSURFCLAM Mactra spp. ✓ ✓ ✓

Mactrellona alata ✓ ✓ ✓Mactromeris spp. ✓ ✓ ✓Mactrotomas spp. ✓ ✓ ✓Simomactra spp. ✓ ✓ ✓Spisula spp. ✓ ✓ ✓Tresus spp. ✓ ✓ ✓

CLAM, SURFAQUACULTURED Mactra schalinensis ✓ ✓ ✓

CLAM, VENUS Chione spp. ✓ ✓ ✓Macrocallista nimbosa ✓ ✓ ✓

CLAM, WEDGE Paphies spp. ✓ ✓ ✓

COCKLE Cardium spp. ✓ ✓ ✓Clinocardium spp. ✓ ✓ ✓Dinocardium robustum ✓ ✓ ✓Serripes groenlandicus ✓ ✓ ✓

CONCH Strombus spp.

COQUINA Donax spp. ✓ ✓ ✓

COQUINA, FALSE Iphigenia brasiliana ✓ ✓ ✓

CRAB, BLUE Callinectes sapidus ✓

CRAB, BROWN Geryon fenneri

CRAB,BROWN KING Lithodes aequispina

CRAB, CENTOLLA Lithodes antarcticusLithodes murrayi

CRAB, DEEPSEA Paralomis granulosa

Hazards

Biological Chemical




CRAB, DUNGENESS Cancer magister ✓ 2 ✓

CRAB, JONAH Cancer borealis ✓ 2

CRAB, KING Paralithodescamtschaticus

Paralithodes platypus

CRAB, KING orHANASAKI Paralithodes brevipes

CRAB, KOREANor KEGANI Erimacrus isenbeckii

CRAB, LITHODES Neolithodes brodiei

CRAB, RED Geryon quinquedens

CRAB, RED ROCK Cancer productus ✓ 2

CRAB, ROCK Cancer irroratusCancer pagurus

CRAB, SNOW Chionoecetes angulatusChionoecetes bairdiChionoecetes opilioChionoecetes tanneri

CRAB, SPIDER Jacquinotia edwardsiiMaja squinado

CRAB, STONE Menippi spp.

CRAB, SWIMMING Callinectes arcuatus ✓Callinectes toxotes ✓Portunus spp. ✓

CRAWFISH orCRAYFISH Cambarus spp. ✓

Cherax spp. ✓Euastacus armatus ✓Pacifastacus spp. ✓Paranephrops spp. ✓Procambarus spp. ✓Astacus spp. ✓

2 – This hazard only applies if the product is marketed uneviscerated.

Hazards

Biological Chemical




CRAWFISH orCRAYFISHAQUACULTURED Cambarus spp. ✓ ✓

Cherax spp. ✓ ✓Euastacus armatus ✓ ✓Pacifastacus spp. ✓ ✓Paranephrops spp. ✓ ✓Procambarus spp. ✓ ✓Astacus spp. ✓ ✓

CUTTLEFISH Sepia spp.

JELLYFISH Rhopilema spp.

KRILL Euphausia spp. ✓Meganyctiphanes

norvegicaThysandoessa inermis

LANGOSTINO Cervimunida johniMunida gregariaPleuroncodes monodon

LIMPET Acmaea testitudinalisCellana denticulataDiodora asperaFissurella maximaLottia giganteaPatella caerulea

LOBSTER Homarus spp. ✓ 7

LOBSTER,NORWAY Nephrops norvegicus

LOBSTER, ROCK Jasus spp.

LOBSTER, ROCKor SPINY Palinurus spp.

Panulirus spp.

LOBSTER,SLIPPER Ibacus ciliatus

Scyllarides spp.Thenus orientalis

LOBSTERETTE Metanephrops spp.Nephropsis aculeata

7 – This hazard only applies if the lobster are held in pounds.

Hazards

Biological Chemical




MUSSEL Modiolus spp. ✓ ✓ ✓Mytilus spp. ✓ ✓ ✓Perna canaliculus ✓ ✓ ✓

OCTOPUS Eledone spp. ✓ 1

Octopus spp. ✓ 1

OYSTER Crassostrea spp. ✓ ✓ ✓Ostrea spp. ✓ ✓ ✓Tiostrea spp. ✓ ✓ ✓

PEN SHELL Atrina pectinata ✓ ✓ ✓

PERIWINKLE Littorina littoreaLunatatia spp.

SCALLOP Aequipecten spp. ✓ 2 ✓ 2 ✓Amusium spp. ✓ 2 ✓ 2 ✓Argopecten nucleus ✓ 2 ✓ 2 ✓Chlamys spp. ✓ 2 ✓ 2 ✓Patinopecten

yessoensis ✓ 2 ✓ 2 ✓Pecten spp. ✓ 2 ✓ 2 ✓Placopectin

magellanicus ✓ 2 ✓ 2 ✓

SCALLOPAQUACULTURED Aequipecten spp. ✓ 2 ✓ 2 ✓

Amusium spp. ✓ 2 ✓ 2 ✓Argopecten nucleus ✓ 2 ✓ 2 ✓Chlamys spp. ✓ 2 ✓ 2 ✓Patinopecten

yessoensis ✓ 2 ✓ 2 ✓Pecten spp. ✓ 2 ✓ 2 ✓Placopectin

magellanicus ✓ 2 ✓ 2 ✓

SCALLOP orBAY SCALLOP Argopecten irradians ✓ 2 ✓ 2 ✓

SCALLOP, CALICO Argopecten gibbus ✓ 2 ✓ 2 ✓

SCALLOP orWEATHERVANE Patinopecten caurinus ✓ 2 ✓ 2 ✓

SEA CUCUMBER Cucumaria spp. ✓Holothuria spp. ✓Parastichopus spp. ✓Stichopus spp. ✓

1 – This hazard only applies if the product is intended to be consumed raw or partially cooked.2 – This hazard only applies if the product is marketed uneviscerated.

Hazards

Biological Chemical




SEA URCHIN roe Echinus esculentus ✓Evechinus chloroticus ✓Heliocidaris spp. ✓Loxechimus spp. ✓Paracentrotus spp. ✓Pseudocentrotus spp. ✓Strongylocentrotus spp. ✓

SEABOB Xiphopenaeus kroyeri

SHRIMP Crangon spp.Metapenaeus affinisPalaemon serratusPalaemonetes vulgarisPandalopsis disparPandalus spp.Penaeus spp.Plesionika martia

SHRIMPAQUACULTURED Crangon spp. ✓ ✓

Exopalaemon styliferus ✓ ✓Macrobrachium spp. ✓ ✓Metapenaeus spp. ✓ ✓Palaemon serratus ✓ ✓Palaemonetes vulgaris ✓ ✓Pandalopsis dispar ✓ ✓Pandalus spp. ✓ ✓Penaeus spp. ✓ ✓Plesionika martia ✓ ✓

SHRIMP,FRESHWATER Macrobrachium spp.

SHRIMP,FRESHWATERAQUACULTURED Macrobrachium spp. ✓ ✓

SHRIMP, ROCK Sicyonia brevirostris

SHRIMP, ROYAL Pleoticus robustus

SHRIMP orPINK SHRIMP Pandalus borealis

Pandalus jordani

Hazards

Biological Chemical




SHRIMP orPRAWN Hymenopenaeus

sibogae

SNAIL orESCARGOT Otala spp. ✓

Helix pomatia ✓Achatina fulica ✓ 1

SQUID Alloteuthis media ✓ 1

Berryteuthis magister ✓ 1

Dosidicus gigas ✓ 1

Illex spp. ✓ 1

Loligo spp. ✓ 1

Lolliguncula spp. ✓ 1

Nototodarus spp. ✓ 1

Ommastrephes spp. ✓ 1

Rossia macrosoma ✓ 1

Sepiola rondeleti ✓ 1

Sepioteuthis spp. ✓ 1

Todarodes sagittatus ✓ 1

TOP SHELL Turbo cornutusNonodonta turbinata

WHELK orSEA SNAIL Buccinum spp.

Busycon spp.Neptunea spp. ✓ 2

1 – This hazard only applies if the product is intended to be consumed raw or partially cooked.2 – This hazard only applies if the product is marketed uneviscerated.


Coo

ked

shrim

p, c

rab,

lobs

ter,

and

othe

r fish

,in

clud

ing

cook

ed m

eat,

sect

ions

, and

who

le fi

sh,

and

incl

udin

g su

rimi-

base

d an

alog

pro

duct

s

Coo

ked

shrim

p, c

rab,

lobs

ter,

and

othe

r fish

,in

clud

ing

cook

ed m

eat,

sect

ions

, and

who

le fi

sh,

and

incl

udin

g su

rimi-

base

d an

alog

pro

duct

s

Coo

ked

shrim

p, c

rab,

lobs

ter,

and

othe

r fish

,in

clud

ing

cook

ed m

eat,

sect

ions

, and

who

le fi

sh,

and

incl

udin

g su

rimi-

base

d an

alog

pro

duct

s

Paste

uriz

ed c

rab,

lobs

ter,

and

othe

r fish

, inc

ludi

ngpa

steur

ized

sur

imi-b

ased

anal

og p

rodu

cts

Not

e: M

AP

= m

odif i

ed a

tmos

pher

e pa

ckag

ing;

CA

P =

cont

rolle

d at

mos

pher

e pa

ckag

ing

Haz

ards

Bio

logi

cal

Che

mic

alPh

ysic

al

Path

ogen

C. b

otul

inum

Toxi

nS.

aur

eus

Path

ogen

Path

ogen

Path

ogen

Alle

rgen

s/M

etal

Gla

ssgr

owth

-gr

owth

form

atio

n-to

xin

batte

rsu

rviv

alsu

rviv

alco

ntam

inat

ion

Add

itive

sin

clus

ion

incl

usio

nte

mpe

ratu

rein

adeq

uate

thro

ugh

thro

ugh

afte

rab

use

dryi

ngco

okin

gpa

steur

izat

ion

paste

uriz

atio

nCH

P 12

CHP

13CH

P 14

CHP

15CH

P 16

CHP

17CH

P 18

CHP

19CH

P 20

CHP

21

Fini

shed

Pro

duct

Foo

dPa

ckag

e Ty

pe

Tabl

e #3

-3

Pote

ntia

l Pro

cess

Rel

ated

Haz

ards

Met

hod

ofD

istr

ibut

ion

and

Stor

age

Froz

en

Oth

er th

anfr

ozen

All

Froz

en

✓✓

✓✓

✓✓

✓✓

✓

✓✓

✓✓

✓✓

✓✓

✓

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Oth

er th

an v

acuu

mpa

ckag

ed, M

AP,

CA

P, h

erm

etic

ally

seal

ed o

r pac

ked

in o

il

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il


Not

e: M

AP

= m

odif i

ed a

tmos

pher

e pa

ckag

ing;

CA

P =

cont

rolle

d at

mos

pher

e pa

ckag

ing

Paste

uriz

ed c

rab,

lobs

ter,

and

othe

r fish

, inc

ludi

ngpa

steur

ized

sur

imi-b

ased

anal

og p

rodu

cts

Paste

uriz

ed c

rab,

lobs

ter,

and

othe

r fish

, inc

ludi

ngpa

steur

ized

sur

imi-b

ased

anal

og p

rodu

cts

Smok

ed fi

sh

Smok

ed fi

sh

Smok

ed fi

sh

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Oth

er th

an v

acuu

mpa

ckag

ed, M

AP,

CA

P, h

erm

etic

ally

seal

ed o

r pac

ked

in o

il

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Oth

er th

an v

acuu

mpa

ckag

ed, M

AP,

CA

P, h

erm

etic

ally

seal

ed o

r pac

ked

inoi

l

Oth

erth

an fr

ozen

All

Froz

en

Oth

er th

anfro

zen

All

✓✓

✓✓

✓✓

✓✓

✓✓

✓

✓✓

✓

✓✓

✓✓

✓✓

✓

Haz

ards

Bio

logi

cal

Che

mic

alPh

ysic

al

Path

ogen

C. b

otul

inum

Toxi

nS.

aur

eus

Path

ogen

Path

ogen

Path

ogen

Alle

rgen

s/M

etal

Gla

ssgr

owth

-gr

owth

form

atio

n-to

xin

batte

rsu

rviv

alsu

rviv

alco

ntam

inat

ion

Add

itive

sin

clus

ion

incl

usio

nte

mpe

ratu

rein

adeq

uate

thro

ugh

thro

ugh

afte

rab

use

dryi

ngco

okin

gpa

steur

izat

ion

paste

uriz

atio

nCH

P 12

CHP

13CH

P 14

CHP

15CH

P 16

CHP

17CH

P 18

CHP

19CH

P 20

CHP

21

Fini

shed

Pro

duct

Foo

dPa

ckag

e Ty

peM

etho

d of

Dis

trib

utio

nan

d St

orag

e


Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Oth

er th

an v

acuu

mpa

ckag

ed, M

AP,

CA

P, h

erm

etic

ally

seal

ed o

r pac

ked

in o

il

All

All

All

Froz

en

Oth

er th

anfr

ozen

All

All

All

All

✓✓

✓✓

✓✓

✓✓

✓

✓✓

✓✓

✓✓

✓

✓✓

✓

✓✓

✓✓

✓

Sala

ds a

nd c

ockt

ails

prep

ared

from

read

y-to

-eat

fish

ery

prod

ucts

Sala

ds a

nd c

ockt

ails

prep

ared

from

read

y-to

-eat

fish

ery

prod

ucts

Sala

ds a

nd c

ockt

ails

prep

ared

from

read

y-to

-eat

fish

ery

prod

ucts

Raw

, bre

aded

shr

imp,

finfis

h, o

yste

rs, c

lam

s,sq

uid,

and

oth

er fi

sh

Stuf

fed

crab

, shr

imp,

finfis

h, a

nd o

ther

fish

Dri

ed fi

sh

Not

e: M

AP

= m

odif i

ed a

tmos

pher

e pa

ckag

ing;

CA

P =

cont

rolle

d at

mos

pher

e pa

ckag

ing

Haz

ards

Bio

logi

cal

Che

mic

alPh

ysic

al

Path

ogen

C. b

otul

inum

Toxi

nS.

aur

eus

Path

ogen

Path

ogen

Path

ogen

Alle

rgen

s/M

etal

Gla

ssgr

owth

-gr

owth

form

atio

n-to

xin

batte

rsu

rviv

alsu

rviv

alco

ntam

inat

ion

Add

itive

sin

clus

ion

incl

usio

nte

mpe

ratu

rein

adeq

uate

thro

ugh

thro

ugh

afte

rab

use

dryi

ngco

okin

gpa

steur

izat

ion

paste

uriz

atio

nCH

P 12

CHP

13CH

P 14

CHP

15CH

P 16

CHP

17CH

P 18

CHP

19CH

P 20

CHP

21

Fini

shed

Pro

duct

Foo

dPa

ckag

e Ty

peM

etho

d of

Dis

trib

utio

nan

d St

orag

e


Not

e: M

AP

= m

odif i

ed a

tmos

pher

e pa

ckag

ing;

CA

P =

cont

rolle

d at

mos

pher

e pa

ckag

ing

Froz

en

Oth

er th

anfr

ozen

All

Froz

en

✓✓

✓✓

✓✓

✓✓

✓

✓✓

✓✓

✓✓

Raw

oys

ters

, cla

ms

and

mus

sels

Raw

oys

ters

, cla

ms

and

mus

sels

Raw

oys

ters

, cla

ms

and

mus

sels

Raw

fish

oth

er th

anoy

ster

s, c

lam

s an

dm

usse

ls (

incl

udes

non-

finfis

h sp

ecie

s)

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

n oi

l

Oth

er th

an v

acuu

mpa

ckag

ed, M

AP,

CA

P, h

erm

etic

ally

seal

ed o

r pac

ked

in o

il

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Haz

ards

Bio

logi

cal

Che

mic

alPh

ysic

al

Path

ogen

C. b

otul

inum

Toxi

nS.

aur

eus

Path

ogen

Path

ogen

Path

ogen

Alle

rgen

s/M

etal

Gla

ssgr

owth

-gr

owth

form

atio

n-to

xin

batte

rsu

rviv

alsu

rviv

alco

ntam

inat

ion

Add

itive

sin

clus

ion

incl

usio

nte

mpe

ratu

rein

adeq

uate

thro

ugh

thro

ugh

afte

rab

use

dryi

ngco

okin

gpa

steur

izat

ion

paste

uriz

atio

nCH

P 12

CHP

13CH

P 14

CHP

15CH

P 16

CHP

17CH

P 18

CHP

19CH

P 20

CHP

21

Fini

shed

Pro

duct

Foo

dPa

ckag

e Ty

peM

etho

d of

Dis

trib

utio

nan

d St

orag

e


Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Oth

er th

an v

acuu

mpa

ckag

ed, M

AP,

CA

P, h

erm

etic

ally

seal

ed o

r pac

ked

in o

il

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Oth

er th

an v

acuu

mpa

ckag

ed, M

AP,

CA

P, h

erm

etic

ally

seal

ed o

r pac

ked

in o

il

Oth

er th

anfr

ozen

All

Froz

en

Oth

er th

anfr

ozen

All

Raw

fish

oth

er th

anoy

ster

s, c

lam

s an

dm

usse

ls (

incl

udes

non

-fin

fish

spec

ies)

Raw

fish

oth

er th

anoy

ster

s, cl

ams

and

mus

sels

(inc

lude

s no

n-fin

fish

spec

ies)

Parti

ally

coo

ked

orun

cook

ed p

repa

red

food

s

Parti

ally

coo

ked

orun

cook

ed p

repa

red

food

s

Parti

ally

coo

ked

orun

cook

ed p

repa

red

food

s

Not

e: M

AP

= m

odif i

ed a

tmos

pher

e pa

ckag

ing;

CA

P =

cont

rolle

d at

mos

pher

e pa

ckag

ing

Haz

ards

Bio

logi

cal

Che

mic

alPh

ysic

al

Path

ogen

C. b

otul

inum

Toxi

nS.

aur

eus

Path

ogen

Path

ogen

Path

ogen

Alle

rgen

s/M

etal

Gla

ssgr

owth

-gr

owth

form

atio

n-to

xin

batte

rsu

rviv

alsu

rviv

alco

ntam

inat

ion

Add

itive

sin

clus

ion

incl

usio

nte

mpe

ratu

rein

adeq

uate

thro

ugh

thro

ugh

afte

rab

use

dryi

ngco

okin

gpa

steur

izat

ion

paste

uriz

atio

nCH

P 12

CHP

13CH

P 14

CHP

15CH

P 16

CHP

17CH

P 18

CHP

19CH

P 20

CHP

21

Fini

shed

Pro

duct

Foo

dPa

ckag

e Ty

peM

etho

d of

Dis

trib

utio

nan

d St

orag

e

✓✓

✓✓

✓✓

✓✓

✓✓

✓✓

✓✓

✓

✓✓

✓✓


Not

e: M

AP

= m

odifi

ed a

tmos

pher

e pa

ckag

ing;

CA

P =

cont

rolle

d at

mos

pher

e pa

ckag

ing

* N

ote:

Con

trol

s fo

r thi

s ha

zard

nee

d no

t be

incl

uded

in H

AC

CP

plan

s fo

r she

lf-s

tabl

e, a

cidi

fied

and

low

aci

d ca

nned

food

s.Se

e 21

CFR

113

and

114

for m

anda

tory

con

trol

s.

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Vacu

um p

acka

ged

(e.g

. mec

hani

cal

vacu

um, s

team

swee

p, h

ot fi

ll),

MA

P, C

AP,

herm

etic

ally

seal

edor

pac

ked

in o

il

Oth

er th

an v

acuu

mpa

ckag

ed, M

AP,

CA

P, h

erm

etic

ally

seal

ed o

r pac

ked

inoi

l

All

Froz

en

Oth

er th

anfr

ozen

All

All

✓✓

✓✓

✓✓

✓

✓✓

✓✓

✓✓

✓✓

✓✓

✓✓

✓✓

✓

✓✓

*✓

✓✓

Fully

coo

ked

prep

ared

food

s

Fully

coo

ked

prep

ared

food

s

Fully

coo

ked

prep

ared

food

s

Ferm

ente

d, a

cidi

fied,

pick

led,

sal

ted,

and

low

acid

can

ned

food

s

Haz

ards

Bio

logi

cal

Che

mic

alPh

ysic

al

Path

ogen

C. b

otul

inum

Toxi

nS.

aur

eus

Path

ogen

Path

ogen

Path

ogen

Alle

rgen

s/M

etal

Gla

ssgr

owth

-gr

owth

form

atio

n-to

xin

batte

rsu

rviv

alsu

rviv

alco

ntam

inat

ion

Add

itive

sin

clus

ion

incl

usio

nte

mpe

ratu

rein

adeq

uate

thro

ugh

thro

ugh

afte

rab

use

dryi

ngco

okin

gpa

steur

izat

ion

paste

uriz

atio

nCH

P 12

CHP

13CH

P 14

CHP

15CH

P 16

CHP

17CH

P 18

CHP

19CH

P 20

CHP

21

Fini

shed

Pro

duct

Foo

dPa

ckag

e Ty

peM

etho

d of

Dis

trib

utio

nan

d St

orag

e

Chapter 5: Parasites (A Biological Hazard)

Continued


STEP #10: UNDERSTAND THE POTENTIALHAZARD.

Parasites (in the larval stage) consumed in uncooked,or undercooked, unfrozen seafood can present ahuman health hazard. Among parasites, the nema-todes or roundworms (Anisakis spp., Pseudoterranovaspp., Eustrongylides spp. and Gnathostoma spp.),cestodes or tapeworms (Diphyllobothrium spp.)and trematodes or flukes (Chlonorchis sinensis,Opisthorchis spp., Heterophyes spp., Metagonimusspp., Nanophyetes salminicola and Paragonimusspp.) are of most concern in seafood. Some productsthat have been implicated in human infection are:ceviche (fish and spices marinated in lime juice);lomi lomi (salmon marinated in lemon juice, onionand tomato); poisson cru (fish marinated in citrusjuice, onion, tomato and coconut milk); herring roe;sashimi (slices of raw fish); sushi (pieces of raw fishwith rice and other ingredients); green herring(lightly brined herring); drunken crabs (crabs mari-nated in wine and pepper); cold-smoked fish; and,undercooked grilled fish. A recent survey of U.S.gastroenterologists has confirmed that seafood-borneparasitic infections occur in the U.S. with sufficientfrequency to make preventive controls necessaryduring the processing of parasite-containing speciesof fish that are intended for raw consumption.

• Controlling parasites

The process of heating raw fish sufficiently to killbacterial pathogens is also sufficient to kill parasites.Guidance concerning cooking and pasteurizing to killpathogens is provided in Chapters 16 and 17. Regu-latory requirements for retorting (low acid cannedfoods) are contained in 21 CFR 113. This Guidedoes not provide further guidance on retorting.

The effectiveness of freezing to kill parasites dependson several factors, including the temperature of thefreezing process, the length of time needed to freezethe fish tissue, the length of time the fish is heldfrozen, the fat content of the fish, and the type ofparasite present. The temperature of the freezingprocess, the length of time the fish is held frozen, andthe type of parasite appear to be the most importantfactors. For example, tapeworms are more suscep-tible to freezing than are roundworms. Flukes appearto be more resistant than roundworms.

Freezing and storing at -4˚F (-20˚C) or below for 7days (total time), or freezing at -31˚F (-35˚C) orbelow until solid and storing at -31˚F (-35˚C) orbelow for 15 hours, or freezing at -31˚F (-35˚C) orbelow until solid and storing at -4˚F (-20˚C) or belowfor 24 hours is sufficient to kill parasites. FDA’s FoodCode recommends these freezing conditions toretailers who provide fish intended for raw consumption.Note: these conditions may not be suitable for freezingparticularly large fish (e.g. thicker than six inches).

The effectiveness of hydrostatic pressure in theelimination of parasites from fish flesh is beingstudied.

Brining and pickling may reduce the parasite hazardin a fish, but they do not eliminate it, nor do theyminimize it to an acceptable level. Nematodelarvae have been shown to survive 28 days in an80˚ salinometer brine (21% salt by weight).

Fish that contain parasites in their flesh may alsocontain parasites within their egg skeins, but gener-ally not within the eggs themselves. For this reason,eggs that have been removed from the skein andrinsed are not likely to contain parasites.

Trimming away the belly flaps of fish or candling andphysically removing parasites are effective methodsfor reducing the numbers of parasites. However, theydo not completely eliminate the hazard, nor do theyminimize it to an acceptable level.

Chapter 5: Parasites65

STEP #11: DETERMINE IF THE HAZARD ISSIGNIFICANT.

Determine if “parasites” is a significant hazard ateach processing step.

1. Is it reasonably likely that parasites will be intro-duced at the receiving step (e.g. do they come in withthe raw material)?

Tables #3-1 and 3-2 (Chapter 3) list those species forwhich FDA has information that a potential parasitehazard exists. Ordinarily, you should identify thereceiving step for these species as having a significantparasite hazard if you will market the fish for con-sumption without cooking by the end user (e.g. raw).

Species that normally have parasites as a result ofconsuming infected prey, apparently do not have thesame parasite hazard when raised on pelleted food inan aquaculture operation. You need not considersuch aquacultured fish as having a parasite hazard.

On the other hand, aquacultured fish that are fedprocessing waste and by-catch fish may have aparasite hazard, even when wild caught fish of thatspecies do not normally have a parasite hazard.Species of fish other than those identified in Tables#3-1 and 3-2 may have a parasite hazard in certainlocalized areas. You should consider this possibilityin your hazard analysis.

If the finished product is fish eggs that have beenremoved from the skein and rinsed, it is not reason-ably likely that it will contain parasites. You need notconsider such product as having a parasite hazard.However, unrinsed fish eggs or fish eggs that remainin the skein ordinarily will have a parasite hazard ifthe species is identified in Tables #3-1 or 3-2 ashaving a parasite hazard.

It is not reasonably likely that parasites will enter theprocess at other processing steps.

2. Can the parasite hazard be eliminated or reduced toan acceptable level here? (Note: If you are not certainof the answer to this question at this time, you mayanswer “No.” However, you may need to change thisanswer when you assign critical control points inStep #12.)

Parasites should also be considered a significanthazard at any processing step where a preventivemeasure is or can be used to eliminate (or reduce thelikelihood of occurrence to an acceptable level)parasites that are reasonably likely to come in withthe raw material. Preventive measures for parasitescan include:• Retorting (covered in 21 CFR 113);• Cooking (covered in Chapter 16);• Pasteurizing (covered in Chapter 17);• Freezing (covered in this chapter);• Brining or pickling (not a complete control);• Candling and physical removal

(not a complete control);• Trimming away the belly flap

(not a complete control).

List such preventive measures in Column 5 of theHazard Analysis Worksheet, at the appropriateprocessing step(s).

If the answer to either question 1 or 2 is “Yes” thepotential hazard is significant at that step in theprocess and you should answer “Yes” in Column 3 ofthe Hazard Analysis Worksheet. If neither criterionis met you should answer “No.” You should recordthe reason for your “Yes” or “No” answer in Column4. You need not complete Steps #12 through 18 forthis hazard for those processing steps where you haverecorded a “No.”

You should also consider the likelihood that, withoutproper controls, parasites would survive your cook-ing process. Some cooking processes (e.g. retorting)may be exceptionally lethal to parasites, because theprocess is designed to kill more heat-stable bacterialpathogens. In such cases, even significant under-processing would not jeopardize the safety of theproduct relative to parasites, and it may not benecessary to identify “parasites” as a significanthazard.


Continued

It is important to note that identifying this hazard assignificant at a processing step does not mean that itmust be controlled at that processing step. The nextstep will help you determine where the critical controlpoint is located.

• Intended use

In determining whether a hazard is significant, youshould also consider the intended use of the product,which you developed in Step #4. If the fish is in-tended to be cooked by the consumer before con-sumption, then you do not need to consider the hazardsignificant even if the species is listed as having apotential parasite hazard in Table #3-1 or 3-2. Simi-larly, if you have assurance that the fish will beprocessed by a subsequent processor, restauranteur orinstitutional user (e.g. prison, nursing home) in a waythat will kill the parasites, you do not need to identifyparasites as a significant hazard.

Example:A primary processor receives whole salmon from theharvest vessel and re-ices the fish for shipment to asecond processor. The primary processor has assur-ance that the second processor butchers the fish andfreezes it for the sushi market. The primary processorwould not need to identify parasites as a significanthazard.

It is important to note that, at certain levels in certainspecies of fish, parasites constitute filth, and, as aresult, cause the fish to be adulterated. See Compli-ance Policy Guide section 540.590. However, sincethese defect action levels relate to a filth issue,preventive controls to assure that they are not ex-ceeded need not be included in your HACCP plan.

STEP #12: IDENTIFY THE CRITICALCONTROL POINTS (CCP).

For each processing step where “parasites” is identi-fied in Column 3 of the Hazard Analysis Worksheet asa significant hazard, determine whether it is necessaryto exercise control at that step in order to control thehazard. Figure #A-2 (Appendix 3) is a CCP decisiontree that can be used to aid you in your determination.

The following guidance will also assist you in deter-

mining whether a processing step is a CCP for“parasites”:

1. Does the process contain a heating step, such asretorting, cooking, or pasteurizing, that is designed tokill pathogens?

a. If it does, you may identify the heating step asthe CCP.

In this case, you should enter “Yes” in Column6 of the Hazard Analysis Worksheet for theheating step, and enter “No” for the receivingstep. In addition, for the “No” entry, note inColumn 5 that the hazard is controlled by theheating step. (Note: if you have not previouslyidentified “parasites” as a significant hazard atthe heating step in Column 3 of the HazardAnalysis Worksheet, you should change theentry in Column 3 to “Yes”.) See Chapters 16(cooking) and 17 (pasteurizing) for furtherguidance on this control strategy.

Example:A hot-smoked salmon processor could set thecritical control point for parasites at the hot-smoking step, and would not need to identifythe receiving step as a critical control point forthis hazard.

b. If the process does not contain a heating step,you should identify a freezing step as the CCP.

In this case you should enter “Yes” in Column6 of the Hazard Analysis Worksheet for thefreezing step, and enter “No” for the receivingstep. In addition, for the “No” entry, note inColumn 5 that the hazard is controlled by thefreezing step. (Note: if you have not previouslyidentified “parasites” as a significant hazard atthe freezing step in Column 3 of the HazardAnalysis Worksheet, you should change theentry in Column 3 to “Yes”.) This controlapproach will be referred to as “ControlStrategy Example 1” in Steps #14 through 18.


Example:A salmon processor that sells the finishedproduct for raw consumption should identify afreezing step as the CCP for parasites. Theprocessor would not need to identify thereceiving step as a critical control point forthis hazard.

It is important to note that you may select acontrol strategy that is different from thatwhich is suggested above, provided that itassures an equivalent degree of safety of theproduct.

Proceed to Step #13 (Chapter 2) or to Step #10 of thenext potential hazard.

HACCP Plan Form

STEP #14: SET THE CRITICAL LIMITS (CL).

For each processing step where “parasites” is identi-fied as a significant hazard on the HACCP Plan Formidentify the maximum or minimum value to which afeature of the process must be controlled in order tocontrol the hazard.

You should set the CL at the point that if not met thesafety of the product will be questionable. If you seta more restrictive CL you could, as a result, berequired to take corrective action when no safetyconcern actually exists. On the other hand, if you seta CL that is too loose you could, as a result, allowunsafe product to reach the consumer.

As a practical matter it may be advisable to set anoperating limit that is more restrictive than the CL.In this way you can adjust the process when theoperating limit is triggered, but before a triggering ofthe CL would require you to take corrective action.You should set operating limits based on yourexperience with the variability of your operation andwith the closeness of typical operating values to theCL.

Following is guidance on setting critical limits for thecontrol strategy example discussed in Step #12.

• CONTROL STRATEGY EXAMPLE 1 - FREEZING

Critical Limit: Freezing and storing at -4˚F (-20˚C) orbelow for 7 days (total time);

ORFreezing at -31˚F (-35˚C) or below until solidand storing at -31˚F (-35˚C) or below for 15hours;ORFreezing at -31˚F (-35˚C) or below until solidand storing at -4˚F (-20˚C) or below for 24 hours.

Note: these conditions may not be suitable for freezingparticularly large fish (e.g. thicker than six inches).

Enter the critical limit(s) in Column 3 of the HACCPPlan Form.

STEP #15: ESTABLISH MONITORINGPROCEDURES.

For each processing step where “parasites” is identi-fied as a significant hazard on the HACCP PlanForm, describe monitoring procedures that willensure that the critical limits are consistently met.

To fully describe your monitoring program youshould answer four questions: 1) What will bemonitored? 2) How will it be monitored? 3) Howoften will it be monitored (frequency)? 4) Who willperform the monitoring?

It is important for you to keep in mind that thefeature of the process that you monitor and themethod of monitoring should enable you to deter-mine whether the CL is being met. That is, themonitoring process should directly measure thefeature for which you have established a CL.

You should monitor often enough so that the normalvariability in the values you are measuring will bedetected. This is especially true if these values aretypically close to the CL. Additionally, the greaterthe time span between measurements the moreproduct you are putting at risk should a measurementshow that a CL has been violated.


Continued

Following is guidance on establishing monitoringprocedures for the control strategy example discussedin Step #12. Note that the monitoring frequenciesthat are provided are intended to be considered asminimum recommendations, and may not be ad-equate in all cases.

What Will Be Monitored?


What: Freezer temperature;AND

Length of time fish is held at freezer temperatureor held frozen, as appropriate.

How Will Monitoring Be Done?


How: Use a recording thermometer, digitaltime/temperature data logger, or similar device;

ANDVisual check on time and solid frozen condition,as appropriate.

How Often Will Monitoring Be Done(Frequency)?


For temperature:

Frequency: Continuous monitoring, with visualcheck at least once during the cycle, but no lessthan once per day.

For time:

Frequency: Start and end of each freezing cycle;ORTime when fish is solid frozen and end offreezing cycle for each freezing cycle.

Who Will Perform the Monitoring?


Who: Monitoring may be performed by the freezeroperator, a production supervisor, a member ofthe quality control staff, or any other person whohas an understanding of the monitoring deviceand the critical limit.

STEP #16: ESTABLISH CORRECTIVEACTION PROCEDURES.

For each processing step where “parasites” is identi-fied as a significant hazard on the HACCP PlanForm, describe the procedures that you will use whenyour monitoring indicates that the CL has not beenmet.

These procedures should: 1) ensure that unsafeproduct does not reach the consumer; and, 2) correctthe problem that caused the CL deviation. Remem-ber that deviations from operating limits do not needto result in formal corrective actions.

Following is guidance on establishing correctiveaction procedures for the control strategy examplediscussed in Step #12.


Corrective Action: Take one or more of thefollowing actions as necessary to regain controlover the operation after a critical limit deviation:• Make repairs or adjustments to the freezer;OR• Move some or all of the product in the freezer

to another freezer;AND

Refreeze and store the product at -4˚F (-20˚C)or below for 7 days (total time), or refreezeat -31˚F (-35˚C) or below until solid and storeat -31˚F (-35˚C) or below for 15 hours, orrefreeze at -31˚F (-35˚C) or below until solid andstore at -4˚F (-20˚C) or below for 24 hours.

Note: these conditions may not be suitable for freezingparticularly large fish (e.g. thicker than six inches).



STEP #17: ESTABLISH A RECORDKEEPINGSYSTEM.

For each processing step where “parasites” is identi-fied as a significant hazard on the HACCP PlanForm, list the records that will be used to documentthe monitoring procedures discussed in Step #15.The records should clearly demonstrate that themonitoring procedures have been followed, andshould contain the actual values and observationsobtained during monitoring.

Following is guidance on establishing a recordkeeping system for the control strategy examplediscussed in Step #12.


Records: Temperature recorder chart, digital time/temperature data logger printout, with notationsfor start and end of freezing cycle or time whenfish is solid frozen and end of freezing cycle, asappropriate.

STEP #18: ESTABLISH VERIFICATIONPROCEDURES.

For each processing step where “parasites” is identi-fied as a significant hazard on the HACCP PlanForm, establish verification procedures that willensure that the HACCP plan is: 1) adequate toaddress the hazard of “parasites”; and, 2) consistentlybeing followed.

Following is guidance on establishing verificationprocedures for the control strategy example discussedin Step #12.


Verification: When digital time/temperature dataloggers, or recorder thermometers are used formonitoring, check for accuracy against a knownaccurate thermometer (NIST-traceable) at leastonce per day;

ANDReview monitoring, corrective action andverification records within one week ofpreparation.

Enter the verification procedures in Column 10 of theHACCP Plan Form.


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Chap 5 - Principle 1: Hazard Analysis

51

Explanatory Note:

HACCP traditionally dealsonly with food-safety haz-ards. Participants may realizethat issues associated withGMPs — sanitation, eco-nomic fraud and wholesome-ness — are important andmust be properly handled bythe processor. However,unless these issues specificallyaffect food safety, they shouldnot be part of a company’sHACCP program.

Explanatory Note:

Smoked fish offers anexample of consideringfactors beyond the immediatecontrol of the processor.Due to the possibility oftemperature abuse duringdistribution and/or retailsales of smoked fish, thepotential exists for germina-tion, growth and toxinproduction of Clostridiumbotulinum type E. The hazardis controlled by brining fish toachieve salt concentrations atsome specified level (e.g.,3.5 percent water-phase saltin the finished product).Continued

Chapter 5: Principle 1: Hazard Analysis

Overhead 1

The hazard-analysis step is fundamental to the HACCP system. To estab-lish a plan that effectively prevents food-safety hazards, it is crucial that allsignificant safety hazards and the measures to control them be identified.

Overhead 2

As previously stated, a hazard is a biological, chemical or physical agentthat is reasonably likely to cause illness or injury in the absence of itscontrol. The term hazard, when used in the context of HACCP, is limitedto safety.

• Considerations for the HACCP Team

During the hazard analysis, the potential significance of each hazardshould be assessed by considering the likelihood of occurrence and sever-ity. This is usually based upon a combination of experience, epidemiologi-cal data and information in the technical literature. Severity is the serious-ness of a hazard.

During the hazard analysis, factors that may be beyond the immediatecontrol of the processor must be considered. For example, product distribu-tion may be beyond the direct control of your firm, but information on howthe food will be distributed could influence how the food will be processedand/or packaged.

For some processors, the expertise necessary to properly assess the likeli-hood of occurrence and severity of the various hazards is available withinthe company. However, others may need to seek outside assistance toaddress this issue correctly.

Objective:In this module you will learn:• What hazard analysis is.• How to conduct a hazard analysis.• How to identify significant hazards.• What control measures are.• How to identify control measures.

Principle 1:Conduct a hazard analysis.• Likekihood of occurrence• Severity


52

Notes: The HACCP team has the initial responsibility to decide which hazardsare significant and must be addressed by the HACCP plan. Keep in mindthat there may be differences of opinion, even among experts, as to thesignificance of a hazard. The HACCP team may rely on available guid-ance materials and the opinions of experts who assist in the developmentof HACCP plans. During the hazard analysis, safety concerns must bedifferentiated from quality concerns.

Overhead 3

Hazard Analysis

One approach to hazard analysis divides it into two activities— hazardidentification and hazard evaluation. Hazard identification should result ina list of potential hazards at each operational step (use flow diagram) inthe process from the receipt of raw materials to the release of the finishedproduct. During hazard identification, the team need not be confined bythe hazard’s likelihood of occurrence or its potential for causing disease.

All potentially significant hazards must be considered. To assist in this,the following list of hazards will be valuable.

Overhead 4

After hazard identification, the team conducts a hazard evaluation: athree-step process in which the list of potential hazards developed duringthe hazard identification is narrowed to those hazards that are significantto the product and process in question. The steps in hazard evaluation are:

1. Assess severity of health consequences if potential hazard is notproperly controlled;

Explanatory Note:

The list of hazards and FDA’sFish and Fishery ProductsHazards and Controls Guidecan be very useful, especiallyfor firms that do not havestrong technical expertise.These firms may also need toseek technical assistance indeveloping their HACCPprograms.

Hazards List

Biological Hazards:• Pathogenic microorganisms (e.g., bacteria, viruses)• Parasites

Chemical Hazards:• Natural toxins• Chemicals• Pesticides• Drug residues• Unapproved food and color additives• Decomposition (safety only, e.g., histamine)

Physical Hazards:• Metal, glass, etc.

Safety concerns must be differentiatedfrom quality concerns


53

Explanatory Note:

First-time HACCP writersoften identify too manyhazards! This is a problembecause the potential exists todilute a processor’s ability tofocus efforts and control thetruly significant hazards. Thedilemma is deciding what issignificant. A hazard must becontrolled if it is: 1) reason-ably likely to occur AND2) if not properly controlled,it is likely to result as anunacceptable health risk toconsumers. In the case ofhazards for which regulatoryaction levels, tolerances orother limits have beenestablished for safetyconcerns (e.g., pesticides,animal drugs), an unaccept-able health risk is the risk thatthe limit has been exceeded,not the mere presence of thesubstance at a detectablelevel. Therefore, if violation ofan action level in that type offood is reasonably likely tooccur, then the processor’shazard analysis shouldidentify that hazard as one tobe controlled through itsHACCP system.

Explanatory Note:

Verification procedures willbe discussed later, but ABCShrimp Co. may verify theresults of the supplier testingby randomly conducting itsown tests.

Continued

2. Determine the likelihood of occurrence of potential hazard if notproperly controlled; and

3. Determine, using information from steps 1 and 2, if the potentialhazard is to be addressed in the HACCP plan.

HACCP focuses solely on hazards that are reasonably likely to occurand likely to result in an unacceptable health risk to consumers if notcontrolled. Without this focus, it would be tempting to try to control toomuch and thus lose sight of the truly relevant hazards.

Overhead 5

• Hazard-Analysis Worksheet

A hazard-analysis worksheet can be used to organize and document theconsiderations in identifying food-safety hazards. Although there is nospecific or required form, the worksheet should document specificinformation (see HACCP Worksheets, Appendix II). In the cooked-shrimpexample, each step in the process flow diagram should be first listed inColumn 1. The results of the hazards identification are recorded inColumn 2. The results of the hazard evaluation should be recorded inColumn 3, with the justification for accepting or rejecting the listedpotential hazards stated in Column 4.

Control Measures

Control measures are actions and activities that can be used to prevent oreliminate a food-safety hazard or reduce it to an acceptable level. Inpractice, control measures encompass a wide array of activities.

On the hazard-analysis worksheet, please note the hazards that areidentified for IQF cooked shrimp. At the receiving step, bacterial patho-gens and chemicals have been identified as significant hazards for the tworaw material forms (fresh and frozen) used by this company. Bacterialpathogens (e.g., Vibrios) are known to be associated with raw (fresh andfrozen) shrimp, hence they must be identified as significant hazards.Additionally, sulfiting agents used to inhibit the development of blackspotare considered significant hazards.

As ABC Shrimp Co. analyzed its process, it did not identify any controlmeasures that are taken at the receiving step for bacterial pathogens onincoming product. However, it did determine control measures forchemicals. Previously sulfited product will be labeled. For raw productreceived from boats, the company will test for sulfiting agents. For frozen

Hazard AnalysisA hazard must be controlled if it is• reasonably likely to occur, and• likely to result in an unacceptable risk to consumers.


54

Notes: shrimp received from other suppliers, ABC Shrimp Co. will rely onsupplier declarations. ABC Shrimp Co. also has identified sulfites as asignificant hazard at the weigh/pack/label stage because of the need toidentify the presence of any sulfite residual. ABC Shrimp Co. resolvedthis hazard by training weigh/pack/label personnel to identify and use thecorrect label.

Cold storage is identified in the hazard analysis as potentially important interms of food safety. Unless temperatures are properly maintained,bacterial pathogens can increase. Therefore, maintaining refrigeratedstorage conditions is a control measure.

ABC Shrimp Co. also noted a significant hazard at the cooking step. Atthis step, where it is most concerned about the survival of pathogens thatmay contaminate the finished product, ABC Shrimp Co. has determinedthree measures that are important in controlling this hazard. First, anadequate cook time and temperature will be established that ensures thedestruction of bacterial pathogens. Second, cook time and temperatureare monitored to ensure that they meet the requirements of the establishedprocess. Third, cooker personnel will be trained to operate all cookingequipment, including monitoring devices (timers and temperaturerecorders).

Examples of Control Measures

The following are examples of control measures that could be used tocontrol the three types of hazards.

A. Biological Hazards

Bacteria1. Time/temperature control (e.g., proper control of refrigeration

and storage time minimizes the growth of pathogens).2. Heating and cooking processes (e.g., thermal processing).3. Cooling and freezing (e.g., cooling and freezing retard the growth

of pathogenic bacteria).4. Fermentation and/or pH control (e.g., lactic acid-producing

bacteria in yogurt inhibit the growth of some pathogenic bacteriathat do not grow well in acidic conditions).

5. Addition of salt or other preservatives (e.g., salt and otherpreservatives inhibit growth of some pathogenic bacteria).

6. Drying (e.g., the drying process may use enough heat to killpathogenic bacteria, but even when drying is conducted at lowertemperatures, it may remove enough water from the food toprevent some pathogens from growing).

7. Source control (e.g., the presence or amount of pathogens in rawmaterials may be controlled by obtaining them from non-contaminated sources).


55

Continued

Viruses1. Cooking methods (e.g., adequate cooking will destroy viruses).

Parasites1. Dietary control (e.g., preventing the parasite from having access

to the food. For example, infection from Trichinella spiralis inpork has decreased due to better control of pigs’ diets andenvironments. However, this control method is not alwayspractical for all species of animals used for food. The diet andenvironment of wild fish cannot be controlled, for instance).

2. Inactivation/removal (e.g., some parasites are resistant to chemi-cal disinfection but can be inactivated by heating, drying orfreezing. In some foods, visual examination may detect parasites.A procedure called “candling” enables processors to examinefish on a brightly lit table. Over the light, worms, if present, areeasy to see and remove. This procedure cannot ensure 100percent detection. Therefore, it should be combined with othermeans of control, such as freezing.)

B. Chemical Hazards

1. Source control (e.g., vendor certification and raw-materialtesting).

2. Production control (e.g., proper use and application of foodadditives).

3. Labeling control (e.g., finished product properly labeled withingredients and known allergens).

C. Physical Hazards

1. Source control (e.g., vendor certification and raw-materialtesting).

2. Production control (e.g., use of magnets, metal detectors, sifterscreens, destoners, clarifiers, air tumblers, x-ray equipment, andvisual inspection).

NOTE: Control measures for each significant hazard should be recordedin column 5 of the hazard-analysis worksheet.

Notes:


Hazard-Analysis WorksheetABC Shrimp Co.

IQF Cooked Shrimp ProductionExample: For Illustrative Purposes Only*

Note: The ABC Shrimp Co. will serve as our model seafood processing firm. Following thediscussion of each HACCP principle, that principle will be applied to the ABC Shrimp Co. Pleasebecome familiar with the process flow diagram and process narrative associated with the model.

56

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)can be applied to prevent

significant hazards?

(6)Is this stepa criticalcontrolpoint ?(Yes/No)

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Firm Name: Product Description:

Firm Address:

Method of Storage and Distribution:

Signature: Intended Use and Consumer:

Date:

Receiving Fresh Shrimp BIOLOGICAL Yes Raw seafoods can be natural A cook step follows thatBacterial pathogens reservoirs for marine vibrios assumes a high bacterial

and, depending on the quality load.of the harvest, can harborterrestrial pathogens suchas Salmonella.

Note: If this product were marketed raw, the answer in column 3 would be no because the product is highly unlikelyto be used by a consumer without adequate cooking. In this case, this would not be a significant hazard.

CHEMICAL Yes Sulfiting agents may cause Labeling control basedSulfiting agent an allergic-type reaction. on product screening.

Note: If shrimp were aquacultured, hazards could include chemicals such as pesticides, herbicides and heavy metals.Additionally, drugs used to prevent disease, control parasites, and affect growth should be considered.

PHYSICALNone

Cold Storage BIOLOGICAL Yes Without controlled temper- A cook step follows thatBacterial pathogen growth ature, bacterial pathogens assumes a high bacterial

may increase in numbers. load.CHEMICALNone

PHYSICALNone


Receiving Frozen Shrimp BIOLOGICAL Yes Frozen seafoods can be A cook step follows thatBacterial pathogens natural reservoirs for marine assumes a high bacterial

vibrios and, depending on the load.quality of the harvest, canharbor terrestrial pathogenssuch as Salmonella.

CHEMICAL Yes Sulfiting agents may cause Labeling control basedSulfiting agent an allergic-type reaction. on supplier declaration.

PHYSICALNone

Frozen Storage BIOLOGICALNone

CHEMICALNone

PHYSICALNone

Receiving Packaging BIOLOGICAL No Not likely to occurMaterial Bacterial pathogen

contamination

CHEMICAL No • Not likely to occurChemical contaminants • No history of occurrence

PHYSICALNone

Dry Storage BIOLOGICALNone

CHEMICALNone

PHYSICALNone

Thawing BIOLOGICAL Yes If not properly controlled, A cook step follows that• Bacterial pathogen growth bacterial pathogens can assumes a high bacterial

grow during thawing. load.

• Bacterial pathogen No Controlled by SSOPcontamination

CHEMICALNone

PHYSICALNone

57

IQF Cooked Shrimp


(2)Identify potential hazardsintroduced, controlled, or

enhanced at this step?

(3)Are anypotential

food-safetyhazards



column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazard?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)


Size Grading BIOLOGICAL No Not likely to occur because• Bacterial pathogen growth of the continuous process.

• Bacterial pathogen No Controlled by SSOP contamination

CHEMICAL No Controlled by SSOPSanitizer residues

PHYSICALNone

Peeling BIOLOGICAL No Not likely to occur• Bacterial pathogen growth (See size grading)

• Bacterial pathogen No (See size grading) contamination


PHYSICALNone

Razor Slide BIOLOGICAL No Not likely to occur• Bacterial pathogen growth (See size grading)

• Bacterial pathogen No (See size grading) contamination


PHYSICAL No Subsequent processingMetal fragments removes any fragments.

No historical problem.

Tumbler/Deveiner BIOLOGICAL No Not likely to occur• Bacterial pathogen growth (See size grading)

• Bacterial pathogen No (See size grading)contamination


PHYSICALNone

Cull Table BIOLOGICAL No Not likely to occur• Bacterial pathogen growth (See size grading)

• Bacterial pathogen No (See size grading)contamination


PHYSICALNone

IQF Cooked Shrimp




(3)Are anypotential

food-safetyhazards



column 3.




(Yes/No)

58


IQF Cooked Shrimp



enhanced at this step.

(3)Are anypotential

food-safetyhazards


(4)Justify your decision in

column 3.


can be applied to prevent thesignificant hazards?


(Yes/No)

59

Cold Storage BIOLOGICAL Yes Without controlled A cook step follows thatBacterial pathogen growth temperatures, bacterial assumes a high bacterial

pathogens may increase load.in numbers.


PHYSICALNone

Cooker BIOLOGICAL Yes Without proper processing Adequate cooking timeBacterial pathogen survival time and temperature, and temperature

bacterial pathogens such asListeria monocytogenes,Salmonella spp. andVibrio spp. may survive.


PHYSICALNone

Shuffler BIOLOGICAL No Controlled by SSOP• Recontamination with bacterial pathogens

Note: Companies that DO NOT have SSOPs in place would need to control post-processing contamination with appropriate HACCP sanitation CCPs.

• Bacterial pathogen growth No Not likely to occur becauseof the continuous process

Note: Under different conditions where time and temperature abuse may occur, controls must be sufficient to minimize the growthof bacterial pathogens in the product. Remember, this product does not have to be heated by the consumer.


PHYSICALNone

Cull BIOLOGICAL No Controlled by SSOP• Recontamination with

bacterial pathogens

• Bacterial pathogen growth No (See remarks for shuffler)


PHYSICALNone identified

Spiral Freezer BIOLOGICAL No Not likely to occur due toBacterial pathogen growth rapid freezing rate

CHEMICALSanitizer residues No Controlled by SSOP



Glaze Station BIOLOGICAL No Use potable water and• Recontamination with equipment cleaned bacterial pathogens per SSOP.

• Bacterial pathogen growth No (See shuffler)


PHYSICALNone

Weigh/Pack/Label BIOLOGICAL No (See shuffler)• Recontamination with bacterial pathogens

• Bacterial pathogen growth No (See shuffler)

CHEMICAL Yes Potential allergic-type Accurate label declarationSulfiting agent reaction (accurate label

declaration)

Sanitizer residues No Controlled by SSOP


Mastercase/Palletize BIOLOGICAL No Not likely to occur becauseBacterial pathogen growth frozen

CHEMICALNone

PHYSICALNone

Freezer Storage BIOLOGICAL No Not likely to occur becauseBacterial pathogen growth frozen

CHEMICALNone

PHYSICALNone

IQF Cooked Shrimp


(2)Identify potential hazardsintroduced, controlled or


(3)Are anypotential

food-safetyhazards



column 3.




(Yes/No)

60

Chapter 6: Natural Toxins (A Chemical Hazard)

Continued



Contamination of fish with natural toxins from theharvest area can cause consumer illness. Most ofthese toxins are produced by species of naturallyoccurring marine algae (phytoplankton). Theyaccumulate in fish when they feed on the algae oron other fish that have fed on the algae. There arealso a few natural toxins which are naturally occur-ring in certain species of fish.

There are five recognized fish poisoning syndromesin the United States: paralytic shellfish poisoning(PSP), neurotoxic shellfish poisoning (NSP),diarrhetic shellfish poisoning (DSP), amnesic shell-fish poisoning (ASP), and ciguatera fish poisoning(CFP). Scombrotoxin formation, the subject ofChapter 7, is not considered a natural toxin.

• Species involved

This section will provide information about speciesand geographic areas which have been linked to oneof the five fish poisoning syndromes by historicaloccurrence of the syndrome. However, it is impor-tant to note that historical occurrence may be aninadequate guide to future occurrence in the case ofnatural toxins, since the source algae vary in theirdistribution. Processors need to be alert to thepotential for emerging problems.

Paralytic shellfish poisoning in the U.S. is generallyassociated with the consumption of molluscanshellfish from the northeast and northwest coastalregions of the U.S. PSP in other parts of the worldhas been associated with molluscan shellfish fromenvironments ranging from tropical to temperatewaters. In addition, in the U.S., PSP toxin hasrecently been reported from the viscera of mackerel,lobster, Dungeness crabs, tanner crabs, and red rockcrabs. While the viscera of mackerel are not normally

eaten, the viscera of lobster and crabs are. However, thelevels of PSP toxin that are found in lobster tomale arenot likely to pose a health hazard unless large quantitiesare eaten from a heavily contaminated area.

Neurotoxic shellfish poisoning in the U.S. is gener-ally associated with the consumption of molluscanshellfish harvested along the coast of the Gulf ofMexico, and, sporadically, along the southern Atlan-tic coast. There has been a significant occurrence oftoxins similar to NSP in New Zealand, and somesuggestions of occurrence elsewhere.

Diarrhetic shellfish poisoning is generally associatedwith the consumption of molluscan shellfish. Therehas been no documented occurrence to date in theU.S. However, instances have been documented inJapan, southeast Asia, Scandinavia, western Europe,Chile, New Zealand, and eastern Canada.

Amnesic shellfish poisoning is generally associatedwith the consumption of molluscan shellfish from thenortheast and northwest coasts of North America. Ithas not yet been a problem in the Gulf of Mexico,although the algae that produces the toxin has beenfound there. ASP toxin has recently been identifiedas a problem in the viscera of Dungeness crab, tannercrab, red rock crab, and anchovies along the westcoast of the United States. The viscera of anchoviesare also eaten.

Marine toxins are not ordinarily a problem in scal-lops if only the adductor muscle is consumed.However, products such as roe-on scallops and wholescallops do present a potential hazard for naturaltoxins.

Ciguatera toxin is carried to humans by contaminatedfin fish from the extreme southeastern U.S., Hawaii,and subtropical and tropical areas worldwide. In thesouth Florida, Bahamian, and Caribbean regions,barracuda, amberjack, horse-eye jack, black jack,other large species of jack, king mackerel, largegroupers, and snappers are particularly likely tocontain ciguatoxin. These species are not generally

Chapter 6: Natural Toxins73

associated with ciguatera in the northern Gulf ofMexico. Many other species of large fish-eatingfishes may be suspect. In Hawaii and throughout thecentral Pacific, barracuda, amberjack, and snapperare frequently ciguatoxic, and many other speciesboth large and small are suspect. Mackerel andbarracuda are frequently ciguatoxic from mid tonortheastern Australian waters.

• Natural toxin detection

FDA has established action levels for all of thenatural toxins except CFP.• PSP- 0.8 ppm (80ug/100g) saxitoxin equivalent;• NSP- 0.8 ppm (20 mouse units/100g) brevetoxin-2

equivalent;• DSP- 0.2 ppm okadaic acid plus 35-methyl okadaic

acid (DXT 1);• ASP- 20 ppm domoic acid, except in the viscera of

Dungeness crab, where 30 ppm is permitted.

There are no validated, rapid methods that aresuitable for shipboard, dockside, or commercialtesting of lots of fish for any of these toxins.

• Natural toxin control

Natural toxins cannot be reliably eliminated by heat.However, severe heating processes, such as retorting,may be effective at reducing the levels of somenatural toxins.

To minimize the risk of molluscan shellfish contain-ing natural toxins from the harvest area, State andforeign government agencies, called ShellfishControl Authorities, classify waters in which mollus-can shellfish are found, based, in part, on the pres-ence of natural toxins. As a result of these classifica-tions, molluscan shellfish harvesting is allowed fromsome waters, not from others, and only at certaintimes, or under certain conditions, from others.Shellfish Control Authorities then exercise controlover the molluscan shellfish harvesters to ensure thatharvesting takes place only when and where it hasbeen permitted. Molluscan shellfish include oysters,clams, mussels, and scallops, except where thescallop product contains the shucked adductormuscle only.

Significant elements of Shellfish Control Authorities’efforts to control the harvesting of molluscan shell-fish include: 1) a requirement that containers of in-shell molluscan shellfish (shellstock) bear a tag thatidentifies the type and quantity of shellfish, harvester,harvest location, and date of harvest; 2) a requirementthat molluscan shellfish harvesters be licensed; 3) arequirement that processors that shuck molluscanshellfish or ship, reship, or repack the shucked productbe certified; and, 4) a requirement that containers ofshucked molluscan shellfish bear a label with theprocessor’s name, address, and certification number.

An established water classification system similar tothe molluscan shellfish system is not in place forcontrolling CFP in fin fish. However, some statesissue advisories regarding reefs that are known to betoxic. In areas where there is no such advisorysystem, fishermen and processors must depend onfirst-hand knowledge about the safety of the reefsfrom which they obtain fish.

Where PSP or ASP have become a problem in fin fishor crustaceans, states generally have closed or restrictedthe appropriate fisheries. In addition, removal anddestruction of the viscera will eliminate the hazard.

• Escolar, puffer fish, and whelk

There are naturally occurring toxins in some speciesthat do not involve marine algae. Escolar or oilfish(i.e. Lepidocybium flavobrunneum, Ruvettus pretiosus)contains a strong purgative oil, called gempylotoxin,that may cause diarrhea when consumed. FDAadvises against importation and interstate marketingof these fish.

Puffer fish, or fugu, may contain tetrodotoxin.Poisonings from tetrodotoxin have usually beenassociated with the consumption of puffer fish fromwaters of the Indo-Pacific ocean regions. However,several reported cases of poisonings, includingfatalities, involved puffer fish from the AtlanticOcean, Gulf of Mexico, and Gulf of California.There have been no confirmed cases of poisoningsfrom Spheroides maculatus but there is still reasonfor concern.


Tetramine is a toxin that is found in the salivaryglands of Neptunia spp., a type of whelk. The hazardcan be controlled by removing the glands.

FDA makes no recommendations in this Guide andhas no specific expectations with regard to controlsfor tetrodotoxin or tetramine in processors’ HACCPplans.

STEP #11: DETERMINE IF THEPOTENTIAL HAZARD IS SIGNIFICANT.

At each processing step, determine whether “naturaltoxins” is a significant hazard. The criteria are:

1. Is it reasonably likely that unsafe levels ofnatural toxins will be introduced here (e.g. does itcome in on the raw material at an unsafe level)?

Tables #3-1 and 3-2 (Chapter 3) identify the speciesof fish for which natural toxins is known to be apotential hazard. Under ordinary circumstances, itwould be reasonably likely to expect that, withoutproper controls, natural toxins from the harvest areacould enter the process at unsafe levels at the receiv-ing step from those species. There may be circum-stances in your geographic area that would allow youto conclude that it is not reasonably likely for aparticular natural toxin to occur at unsafe levels infish from your area. You should be guided by thehistorical occurrence of the toxin, at levels above theestablished guidance levels, in your geographic area.However, you should remain alert to the potential foremerging problems.

If you are receiving fish, other than molluscanshellfish, from another processor you should not needto identify “natural toxins” as a significant hazard.This hazard should have been fully controlled by theprimary (first) processor.

2. Can natural toxins which were introduced at unsafelevels at an earlier step be eliminated or reduced to anacceptable level here? (Note: If you are not certain ofthe answer to this question at this time, you mayanswer “No.” However, you may need to change thisanswer when you assign critical control points inStep #12).

“Natural toxins” should also be considered a signifi-cant hazard at any processing step where a preventivemeasure is or can be used to eliminate (or is adequateto reduce the likelihood of occurrence to an accept-able level) unsafe levels of natural toxins that arereasonably likely to come in with the raw material.Preventive measures for “natural toxins” can include:• Making sure that incoming fish have not been

caught in an area that has been closed because of anatural toxin problem;

• Making sure that incoming fin fish have not beencaught in an area for which there is a CFP advisoryor for which you have knowledge there is a CFPproblem;

• Checking incoming molluscan shellfish to ensurethat they are properly tagged or labeled;

• Making sure that incoming molluscan shellfish aresupplied by a licensed harvester (where licensing isrequired by law) or by a certified dealer.

List such preventive measures in Column 5 of theHazard Analysis Worksheet at the appropriateprocessing step(s).

If the answer to either question 1 or 2 is “Yes” thepotential hazard is significant at the receiving stepand you should answer “Yes” in Column 3 of theHazard Analysis Worksheet. If neither criterion ismet you should answer “No.” You should record thereason for your “Yes” or “No” answer in Column 4.You need not complete Steps #12 through 18 for thishazard for those processing steps where you haverecorded a “No.”

It is important to note that identifying this hazard assignificant at a processing step does not mean that itmust be controlled at that processing step. The nextstep will help you determine where in the process thecritical control point is located.

ContinuedChapter 6: Natural Toxins

75

• Intended use

In determining whether a hazard is significant youshould also consider the intended use of the product,which you developed in Step #4. However, in mostcases, it is not likely that the significance of thishazard will be affected by the intended use of theproduct. One exception is with products in whichonly the muscle tissue will be consumed. For ex-ample, where the finished product is only the shuckedadductor muscle of the scallop, or the muscle tissueof a crab or finfish, it is reasonable to assume that theproduct as consumed will not contain natural toxins.Similarly, in species, such as mackerel, in which theviscera is not normally consumed, it is reasonable toassume that the product as consumed will not containnatural toxins. In either case you should then enter“No” in Column 3 of the Hazard Analysis Worksheetfor each of the processing steps. For each “No” entrybriefly explain in Column 4 that the product isconsumed without the viscera. In this case, you neednot complete Steps #12 through 18 for this hazard.


For each processing step where “natural toxins” isidentified in Column 3 of the Hazard AnalysisWorksheet as a significant hazard, determine whetherit is necessary to exercise control at that step in orderto control the hazard. Figure #A-2 (Appendix 3) is aCCP decision tree that can be used to aid you in yourdetermination.

The following guidance will also assist you indetermining whether a processing step is a CCP for“natural toxins”:

1. Where preventive measures, such as those describedin Step #11 are available to you, the hazard of“natural toxins” can best be controlled at the receivingstep.

In these cases, you should enter “Yes” in Column 6of the Hazard Analysis Worksheet for the receivingstep. This control approach will be referred to as“Control Strategy Example 1” in Steps #14 through

18. Note that this control strategy is identical toControl Strategy Example 1 for “pathogens from theharvest area” (Chapter 4) and Control StrategyExample 6 for “environmental chemical contaminantsand pesticides” (Chapter 9). If you choose an identi-cal control strategy for two or more of these hazards,you may combine the hazards in the HACCP PlanForm.

It is important to note that you may select a controlstrategy that is different from that which is suggestedabove, provided that it assures an equivalent degree ofsafety of the product.


HACCP Plan Form


For each processing step where “natural toxins” isidentified as a significant hazard on the HACCP PlanForm identify the maximum or minimum value towhich a feature of the process must be controlled inorder to control the hazard.

You should set the CL at the point that if not met thesafety of the product will be questionable. If you set amore restrictive CL you could, as a result, be requiredto take corrective action when no safety concernactually exists. On the other hand, if you set a CL thatis too loose you could, as a result, allow unsafeproduct to reach the consumer.

As a practical matter it may be advisable to set anoperating limit that is more restrictive than the CL. Inthis way you can adjust the process when the operat-ing limit is triggered, but before a triggering of the CLwould require you to take corrective action. Youshould set operating limits based on your experiencewith the variability of your operation and with thecloseness of typical operating values to the CL.

Following is guidance on setting critical limits for thecontrol strategy example discussed in Step #12.


• CONTROL STRATEGY EXAMPLE 1 -SOURCE CONTROL

Critical Limit: No fish may be harvested from:• An area that is closed to fishing by foreign,

federal, state, or local authorities;OR• An area that is the subject of a CFP advisory;OR• An area for which you have knowledge that

there is a CFP problem;AND

All shellstock (in-shell molluscan shellfish) mustbear a tag that discloses the date and place theywere harvested (by State and site), type andquantity of shellfish, and by whom they wereharvested (i.e., the identification numberassigned to the harvester by the shellfish controlauthority, where applicable or, if suchidentification numbers are not assigned, the nameof the harvester or the name or registrationnumber of the harvester’s vessel). For bulkshipments of shellstock (loose shellstock), theshellstock must be accompanied by a bill oflading or other similar shipping document thatcontains the same information.

ANDAll molluscan shellfish must have been harvestedfrom waters authorized for harvesting by ashellfish control authority. For U.S. Federalwaters, no molluscan shellfish may be harvestedfrom waters that are closed to harvesting by anagency of the federal government.

ANDAll containers of shucked molluscan shellfishmust bear a label that identifies the name,address, and certification number of the packeror repacker of the product.

ANDAll molluscan shellfish must be from a harvesterthat is licensed as required (note that licensingmay not be required in all jurisdictions) or from aprocessor that is certified by a shellfish controlauthority.

(Note: only the primary processor [the processorthat takes possession of the molluscan shellfishfrom the harvester] need apply controls relativeto the identification of the harvester, theharvester’s license, or the approval status of theharvest waters.)



For each processing step where “natural toxins” isidentified as a significant hazard on the HACCP PlanForm, describe monitoring procedures that willensure that the critical limits are consistently met.




Following is guidance on establishing monitoringprocedures for the control strategy example dis-cussed in Step #12. Note that the monitoring fre-quencies that are provided are intended to be consid-ered as minimum recommendations, and may not beadequate in all cases.

ContinuedChapter 6: Natural Toxins

77



For molluscan shellfish:

What:• The tags on containers of shellstock. The Bill

of Lading or other similar shipping documentaccompanying bulk shipments of shellstock;

AND• The harvest site listed on the tag or on the Bill

of Lading or other similar shipping document;AND

• The labels on containers of shucked molluscanshellfish;

AND• The license of fishermen, where applicable;

AND• The certification number of suppliers (other

than fishermen) of shellstock or shuckedmolluscan shellfish;

For other fish:

What: The harvest area location.




How: Make visual checks;

For other fish:

How: Ask the harvester for the harvest site at the timeof receipt, or obtain the information from theharvester’s catch record, where applicable.



For Molluscan Shellfish:

Frequency:• For checking tags: every container;

AND• For checking harvest site: every lot;

AND• For checking labels: at least three containers

randomly selected from throughout every lot;AND

• For checking licenses: every delivery;AND

• For checking certification numbers: everydelivery.

For other fish:

Frequency: Every lot of fish received.



Who: Monitoring may be performed by a receivingor production employee or supervisor, a memberof the quality control staff, or any other personwho has an understanding of the nature of thecontrols.

(Note: only the primary processor [the processorthat takes possession of the molluscan shellfishfrom the harvester] need apply controls relativeto the identification of the harvester, theharvester’s license, or the approval status of theharvest waters.)

Enter the “What,” “How,” “Frequency,” and “Who”monitoring information in Columns 4, 5, 6, and 7,respectively, of the HACCP Plan Form.



For each processing step where “natural toxins” isidentified as a significant hazard on the HACCP PlanForm, describe the procedures that you will use whenyour monitoring indicates that the CL has not been met.


Following is guidance on establishing correctiveaction procedures for the control strategy examplediscussed in Step #12.



Corrective Action:• Reject shellstock that is not properly tagged or

is not accompanied by a proper shippingdocument;

AND• Reject shucked molluscan shellfish that is not

properly labeled;AND

• Reject molluscan shellfish that has beenharvested from unapproved waters;

AND• Reject molluscan shellfish that is not from a

licensed harvester or certified processor;AND

• Discontinue use of supplier until evidence isobtained that harvesting, tagging, and/orlabeling practices have changed.

Note: If an incoming lot that fails to meet a receivingcritical limit is mistakenly accepted, and the error islater detected, the following actions should be taken:1) the lot and any products processed from that lotshould be destroyed, diverted to a nonfood use or to ause in which the critical limit is not applicable, orplaced on hold until a food safety evaluation can becompleted; and 2) any products processed from thatlot that have already been distributed should berecalled and subjected to the actions described above.

(Note: only the primary processor [the processorthat takes possession of the molluscan shellfish fromthe harvester] need apply controls relative to the

identification of the harvester, the harvester’s license,or the approval status of the harvest waters.)

For other fish that fail to meet the CL:

Corrective Action: Reject the lot;AND

• Discontinue use of supplier until evidence isobtained that harvesting practices havechanged.

Enter the corrective action procedures in Column 8 ofthe HACCP Plan Form.


For each processing step where “natural toxins” isidentified as a significant hazard on the HACCP PlanForm, list the records that will be used to documentthe accomplishment of the monitoring proceduresdiscussed in Step #15. The records should clearlydemonstrate that the monitoring procedures havebeen followed, and should contain the actual valuesand observations obtained during monitoring.

Following is guidance on establishing arecordkeeping system for the control strategy ex-ample discussed in Step #12.


• CONTROL STRATEGY EXAMPLE 1 -SOURCE CONTROLS

For molluscan shellfish shellstock:

Records: A receiving record that documents:• Date of harvest;

AND• Location of harvest by State and site;

AND• Quantity and type of shellfish;

AND• Name of the harvester, name or registration

number of the harvester’s vessel, or anidentification number issued to the harvesterby the shellfish control authority;

AND• Number and date of expiration of the

harvester’s license, where applicable;AND

• Certification number of the shipper, whereapplicable.

(Note: only the primary processor [the processorthat takes possession of the molluscan shellfish fromthe harvester] need apply controls relative to the

identification of the harvester, the harvester’s license,or the approval status of the harvest waters.)

For shucked molluscan shellfish:

Records: Receiving record that documents:• Date of receipt;

AND• Quantity and type of shellfish;

AND• Name and certification number of the packer or

repacker.

For other fish:

Records: Receiving record that documents the harvestarea.

Enter the names of the HACCP records in Column 9of the HACCP Plan Form.



For each processing step where “natural toxins” areidentified as a significant hazard on the HACCP PlanForm, establish verification procedures that willensure that the HACCP plan is: 1) adequate toaddress the hazard of “natural toxins”; and, 2)consistently being followed.

Following is guidance on establishing verificationprocedures for the control strategy example discussedin Step #12.


Verification: Review monitoring and correctiveaction records within one week of preparation.



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roce

ssor

in H

awai

i tha

t rec

eive

s lo

cally

har

vest

ed b

arra

cuda

, usi

ng C

ontro

l Stra

tegy

Exa

mpl

e 1

- Sou

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It is

pro

vide

d fo

r illu

stra

tive

purp

oses

onl

y. N

atur

al to

xins

may

be

only

one

of s

ever

al s

igni

fican

t haz

ards

for t

his

prod

uct.

Ref

er to

Tab

les

3-1,

3-2

, and

3-3

(Cha

pter

3) f

or o

ther

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entia

l haz

ards

(e.g

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ants

).Ta

ble

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r mol

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Notes:

Chap 7 - Principle 3: Establish Critical Limits

73

Continued

Chapter 7: Principle 3: Establish Critical Limits

Overhead 1

Critical limits must be established for each CCP identified in the hazardanalysis.

Overhead 2

Overhead 3

A critical limit represents the boundaries that are used to ensure that anoperation produces safe products. Each CCP must have one or morecritical limits for each food-safety hazard. When the process deviatesfrom the critical limit, a corrective action must be taken to ensure foodsafety. Examples of critical limits are listed in Table 1.

Establishing Critical Limits

In many cases, the appropriate critical limit may not be readily apparentor available. Tests may need to be conducted or information gatheredfrom sources such as scientific publications, regulatory guidelines, expertsor experimental studies (Table 2).

Objective:In this module, you will learn:• How to define critical limits.• How to set critical limits for a CCP.• How to find sources of critical limit information.• How to determine the relationship between critical limits

and operating limits.

Principle 3:Establish critical limits.

Definition:Critical Limit: A maximum and/or minimum value to which abiological, chemical or physical parameter must be controlled at aCCP to prevent, eliminate or reduce to an acceptable level theoccurrence of a food-safety hazard.

Notes:


74

Overhead 4

Overhead 5

If the information needed to define the critical limit is not available,a conservative value should be selected. The rationale and referencematerial used to establish a critical limit should become part of thesupport documentation for the HACCP plan.

Often a variety of options exist for controlling a particular hazard. Thecontrol options usually necessitate the establishment of different critical

Table 1. Examples of Critical Limits

Hazard CCP Critical Limit

bacterial pathogens pasteurizer ≥ 161 F for ≥ 15 seconds for elimination of pathogens from milk(biological)

bacterial pathogens drying oven Drying schedule — oven temperature: ≥ 200 F, drying time:(biological) ≥ 120 min., air flow rate: ≥ 2 cuft/min, product thickness: ≤ 0.5

inches (to achieve aw ≤ to 0.85 to control pathogens in dried foods)

bacterial pathogens acidification Batch schedule — product weight: ≤ 100 lbs., soak time: ≥ 8 hrs.,(biological) acetic acid concentration: ≥ 3.5 percent, volume ≤ 50 gal. (to achieve

maximum pH of 4.6 to control Clostridium botulinum in pickled foods)

Explanatory Note:

These critical limits are forillustrative purposes only. Theydo not relate to any specificproduct but demonstrate howcritical limits could apply atCCPs utilizing different controlparameters for bacterialpathogens. In actual practice,critical limits must be scientifi-cally based.

Table 2. Sources of Information on Critical Limits

General Source Examples

scientific publications journal articles, food science texts,microbiology texts

regulatory guidelines state and local guidelines, tolerances andaction levels; USDA guidelines, tolerances andaction levels; FDA guidelines, tolerances andaction levels

FDA FDA Fish and Fisheries Products Hazards andControls Guidance Manual (referenced inChapter 13)

experts NACMCF (National Advisory Committee onMicrobiological Criteria for Foods), thermalprocess authorities; consultants, foodscientists/microbiologists, equipmentmanufacturers, sanitarians, universityextension, trade associations

experimental studies in-house experiments; contract labs


75

Notes:

Continued

limits. The selection of the best control option and the best critical limitis often driven by practicality and experience. The following examplessuggest control options and critical limits that could be applied at thefryer step to control bacterial pathogens in fried fish patties.

Overhead 6

Setting a microbial limit as a critical limit for an in-process CCP is rarelypractical. Microbiological limits are difficult to monitor, and testing todetermine critical limit deviations may require several days. Therefore,microbiological limits cannot be monitored on a timely basis. Microbio-logical contamination is often sporadic, and samples may need to be largeto be meaningful. In this example, sampling and microbiological tests ofthe fish patties are unlikely to be sensitive enough or practical.

Overhead 7

Setting a microbial critical limit is not necessary in this example as longas an appropriate critical limit can be set that is based on the conditionsneeded to inactivate the microorganisms of concern. Pathogens of concernin fish patties are destroyed by cooking the patties to an internal tempera-ture of 150 F for one minute. In this option, the product temperature at theend of frying is used as a critical limit. This option is typically morepractical and sensitive than finished-product pathogen testing.

Option No. 1Monitoring for Pathogens

Hazard — presence of pathogens (microbiological)CCP — fryer

Critical limit — no pathogens detected

(Not typically the best option)

Option No. 2Controlling Internal Temperature

Hazard — presence of pathogens (microbiological)CCP — fryer

Critical limit — minimum internal temperature of 150 F for one minute


76

Notes: Overhead 8

In many cases, it is not practical to continually monitor the internaltemperature of the food product to ensure conformance with a criticallimit. As an alternative, critical limits may be set that establish conditionsnecessary to ensure that the cooking process achieves the necessaryminimum product temperature. In this option, the oil temperature, the fishpatty thickness and the time that the patty stays in the hot oil are allfactors that affect the final patty temperature. Tests must be performed toensure that controlling these factors within the critical limits will alwaysresult in an internal product temperature that will inactivate the microor-ganisms of concern. Typically, this option is easier to control and tomonitor than the previous two. In addition, the cooker temperature andcooking time can be monitored continually, which gives greater confi-dence that every item has been adequately cooked.

The process should be capable of operating within the bounds set by thecritical limit. The parameters for the fryer — minimum fryer-oil tempera-ture, maximum patty thickness and minimum cook time — become thecritical limits for the CCP. The critical limits should not be confused withthe operating parameters of the equipment.

Establishing Operating Limits

Overhead 9

If monitoring shows a trend toward lack of control at a CCP, operatorsshould take action to bring the CCP under control before the critical limitis exceeded. The point where operators take such an action is called theoperating limit. Operating limits should not be confused with criticallimits. Operating limits are established at a level that would be reachedbefore the critical limit is violated.

Definition:Operating Limits: Criteria that are more stringent than critical limitsand that are used by an operator to reduce the risk of a deviation.

Option No. 3Controlling Factors that Affect Internal TemperatureHazard — presence of pathogens (microbiological)

CCP — fryerCritical limit — minimum fryer oil temperature of 350 FCritical limit — maximum patty thickness of 1/4 inch

Critical limit — minimum cook time in the oil of one minute


77

Notes:

Definition:Process Adjustment: An action taken by the firm to bring the processback within operating limits.

Overhead 10

The process should be adjusted when the operating limit is reached toavoid violating critical limits. These actions are called process adjust-ments. A processor may use these adjustments to avoid loss of control andthe need to take corrective action. Spotting a trend toward loss of controlearly and acting on it can save product rework, or worse yet, productdestruction. Corrective action is only required when the critical limit isexceeded.

Operating limits may be selected for various reasons:• For quality reasons (e.g., higher cooking temperatures for flavor

development or to control organisms that can cause spoilage).• To avoid exceeding a critical limit (e.g., a cooking temperature higher

than the critical limit could be used as an alarm point to warn theoperator that the temperature is approaching the critical limit andneeds adjusting).

• To account for normal variability (e.g., a fryer with a 5 F variabilityshould be set at least 5 F above the critical limit to avoid violating it).

Figures 1 and 2 are graphical representations of several important points:1) operating limits and process adjustments, 2) critical limits andcorrective actions, and 3) implications of lot size. In this example of ageneralized cooking process, an operating limit is established at 200 Fand a critical limit at 190 F. Somewhere in the 10 F range between thesetwo points, wise processors will make a process adjustment to bring thecook temperature back above 200 F. Because an adjustment is madebefore the temperature drops below the critical limit of 190 F, no HACCPrecord is required. However, if an adjustment is not taken until after thetemperature drops below the critical limit, as shown in Figures 1 and 2,appropriate corrective actions must be taken and a corrective action reportmust be placed in the HACCP records file (corrective actions and recordswill be discussed in subsequent chapters).

When a corrective action is necessary, processors must be able to identifyand segregate the affected lots. If lot sizes are big, large quantities ofproduct may require segregation and corrective action despite the fact thatonly a small amount of product was produced when critical limits wereexceeded. Coding production into smaller lots means far less product maybe involved when violation of a critical limit occurs. Therefore, wiseprocessors should change codes often during the production day andmatch monitoring frequency with code changes.


78

Notes:

Degr

ees F

205

200

195

190

185

180

Time

LOT 1

OperatingLimit

CriticalLimit

Cooker Temperature

Corrective ActionRequired

▼

▼

▼

▼

▼

ProcessAdjustment

Needed

Degr

ees F

205

200

195

190

185

180

OperatingLimit

CriticalLimit

Cooker Temperature

▼

▼

▼

Figure 1

Figure 2

Overhead 11

▼

▼

ProcessAdjustment

Needed

Corrective ActionRequired

Time

LOT 1 LOT 5LOT 3 LOT 4LOT 2


79

Table 4. Establishment of Critical LimitsCritical Control Point Critical Limit

CCP — Cooker Cook at ≥212 F for three minutes(to achieve minimum internal temp-erature of 145 F for 15 sec.)

CCP — Weigh/Pack/Label All product containing sulfiting agentmust declare presence

Critical Limits for ABC Shrimp Co.

The hazard-analysis worksheet for the IQF cooked-shrimp exampleidentifies two CCPs: cooker and weigh-pack-label. The following tablelists examples of critical limits for these CCPs.

Overhead 12

Overhead 13

The CCP, hazards and critical limits should be recorded in columns 1, 2 and 3on the HACCP plan form.

HACCP Plan Form

Critical Limits:

1. 2. 3. 4. 5. 6. 7. 8. 9. 10.

CCP Hazard Critical Monitoring Corrective Verification RecordsLimits What How Frequency Who Action(s)

Notes:

Explanatory Note:

For the purpose of thisexample, we have assumedthat a study was performed todetermine the worst case(e.g., largest shrimp, lowestinitial temperature). Theshrimp would be heated to aninternal temperature of 145 Ffor 15 seconds by cookingfor at least three minutes at212 F or greater. In practice,processors may choose tovary process times dependingon shrimp size. Therefore,shrimp size grading wouldlikely become a CCP.

Explanatory Note:

Since residuals of sulfitingagents may trigger allergic-type reactions, labeling isrequired on product withdetectable residues. Detectionlevels range above 10ppm.


80

Firm

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ABC

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Chap 9 - Principle 5: Corrective Actions

91

Explanatory Note:

Corrective actions areimplemented whenmonitoring results indicatea deviation from criticallimits. Effective correctiveactions depend heavily onan adequate monitoringprogram.

Continued

Chapter 9: Principle 5: Corrective Actions

Overhead 1

Overhead 2

Corrective actions must be taken when critical limits at a CCP have beencompromised. When possible, these actions should be predeterminedwhen developing the HACCP plan.

Overhead 3

When critical limits are violated at a CCP, the predetermined, documentedcorrective actions should be instituted. These corrective actions shouldstate procedures to restore process control and determine the safedisposition of the affected product. It may be possible, and is alwaysdesirable, to correct the problem on the spot.

Corrective action options include:• isolating and holding product for safety evaluation.• diverting the affected product or ingredients to another line where

deviation would not be considered critical.• reprocessing.• destroying product.

Objective:In this module, you will learn:• The definition of corrective actions,• Procedures for corrective action and• Record-keeping requirements for corrective actions.

Principle 5:Establish corrective actions.

Definition:Corrective Action: Procedures to be followed when a deviation occurs.


92

Notes: The primary objective is to establish a HACCP program that permits rapididentification of deviations from a critical limit. The sooner the deviationis identified, the more easily corrective actions can be taken and thegreater the potential for minimizing the amount of noncompliant product.An individual who has a thorough understanding of the process, productand HACCP plan and who has the authority to make decisions needs to beassigned the responsibility of making corrective actions.

Effective corrective action plans must:• Correct and eliminate the cause of the noncompliance to assure that the

CCP is brought back under control.• Segregate, assess and determine the disposition of the noncompliant

product.

All corrective actions taken must be documented. Documentation willassist the firm in identifying recurring problems so that the HACCP plancan be modified. Additionally, corrective action records provide proof ofproduct disposition.

Components of Corrective Actions

There are two components of corrective actions: 1) to correct andeliminate the cause of the deviation and restore process control and2) to identify the product that was produced during the process deviationand determine its disposition.

Overhead 4

• Correct and Eliminate the Cause of the Deviation and RestoreProcess Control

Corrective actions must bring the CCP back under control. A correctiveaction should take care of the immediate (short-term) problem as well asprovide long-term solutions. The objective is to implement a short-termfix so that control can be re-established and the process started again assoon as possible without further process deviation.

Corrective Action Components:• To correct and eliminate the cause of the deviation and restore

process control.• To identify the product that was produced during the process

deviation and determine its disposition.


93

Continued

It may be necessary to determine the cause of the deviation to preventfuture recurrence. A critical limit failure that was not anticipated orreoccurs should result in an adjustment to the product or process or are-evaluation of the HACCP plan.

One outcome of the re-evaluation may be a decision to modify theHACCP plan. A permanent solution to eliminating or minimizing theinitial cause or causes for the process deviation should be implemented ifnecessary. Specific instructions for corrective actions must be available toplant workers and should be part of the documented HACCP plan.

• Identify the Product that was Produced During the Process Deviationand Determine the Disposition

When a deviation occurs, identify nonconforming product. There are foursteps that may be used for determining product disposition and develop-ing a corrective action plan.

Overhead 5

Explanatory Note:

If a product is to be testedand released, the samplingmethod is highly important.The use of a faulty samplingprotocol can result inaccepting, rather thanrejecting, an undesirableproduct. The limits ofsampling plans must beunderstood. It may beprudent to consult an expert.

Explanatory Note:

It is important to ensure thatany reworking does not resultin the creation of a newhazard. Of primary concernare toxic materials, includingheat-stable biological toxins.It must be realized thatreworked product is stillsubject to regulatory scrutinyand that reworking mustresult in a safe product.

Four Steps:A. Step One: Determine if the product presents a safety hazard:

a. Based on expert evaluation.b. Based on physical, chemical or microbiological testing.

B. Step Two: If no hazard exists based on the evaluations inStep 1, the product may be released.

C. Step Three: If a potential hazard exists (based on theevaluations in Step 1), determine if the product can be:a. Reworked/reprocessed.b. Diverted for a safe use.

D. Step Four: If potentially hazardous product cannot be handledas described in Step 3, the product must be destroyed. This isusually the most expensive option and is usually regarded asthe last resort.

Notes:


94

Notes: Corrective Action Format Examples

Corrective actions are usually written in an “if/then” format. The “if”part of the corrective action describes the condition and the “then” partdescribes the action taken. For example:

Overhead 6

Overhead 7

Overhead 8

IF deviation: Temperature of milk at pasteurizerdrops below critical limit.

THEN corrective action: Milk flow is diverted until temperaturerecovers. Diverted product isrepasteurized. Check the operation ofthe heating/cooling units to determinethe reason for the temperaturedeviation that caused the flowdiversion. Repair if necessary,re-establish control and resumeproduction.

IF deviation: Product (e.g., hot smoked fish)does not reach required internaltemperature for the required time.

THEN corrective action: Recook or destroy product.

IF deviation: Mahi-mahi held at elevatedtemperature for excess time period(temperature limit exceeded, possibleelevated histamine level).

THEN corrective action: Bury product in ice, place on holdand conduct sensory analysis andhistamine test. Determine the reasonfor the process delay. Prevent futureoccurrences.

Explanatory Note:

During the process, it ispossible to extend the cooktime until the desired internaltemperature is reached forthe required time. However,this would be a “processadjustment” rather than acorrective action.


95

Corrective Action Records

Predetermined corrective actions are written into the HACCP plan. Whencritical limits are exceeded and a corrective action occurs, it is recorded.A corrective-action report form is helpful.

The corrective-action report should contain the following:a. Product identification (e.g., product description, amount of product

on hold).b. Description of the deviation.c. Corrective action taken including final disposition of the affected

product.d. Name of the individual responsible for taking the corrective action.e. Results of the evaluation when necessary.

HACCP plan records could contain a separate file in which all deviationsand corresponding corrective actions are maintained in an organizedfashion. Corrective actions are recorded in column 8 of the HACCPplan form. Following is the corrective actions for the IQF cooked-shrimpexample.

Overhead 9

Continued

HACCP Plan Form

Corrective Actions:

1. 2. 3. 4. 5. 6. 7. 8. 9. 10.


Specify the corrective-action procedures for each CCP.

Explanatory Note:

The corrective actionrecording should be closelylinked with the correspondingmonitoring that recorded adeviation. Recommendedapproaches include recordingthe monitoring and correctiveactions on the same form,piece of paper, or electronicrecord.


96

Firm

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ABC

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97

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98

Notes:

Chapter 10: Methyl Mercury (A Chemical Hazard)

The draft Fish and Fishery Products Hazards andControls Guide (February 16, 1994) listed methylmercury as a potential safety hazard for bonito,halibut, Spanish mackerel, king mackerel, marlin,shark, swordfish, and bluefin tuna. The selection ofthese species was based on historical data on levelsof methyl mercury found in fish consumed in theU.S. The selection was also based on an FDA actionlevel of 1.0 ppm in the edible portion of fish.

While FDA has not changed the 1.0 ppm action level,the agency is re-evaluating it in light of significantnew data on the health effects of methyl mercuryfrom consumption of fish. These data have becomeavailable since the action level was developed.

When the action level re-evaluation is completed,FDA will, among other things, update this Guide byincluding advice on how to assess the significance ofa potential methyl mercury hazard in fish, and whatcontrols, if any, are necessary to ensure the safety offish in this regard.

Chapter 10: Mercury125

Notes:

Chapter 10: Mercury126

Chap 10 - Principle 6: Verification Procedures

99

Explanatory Note:

Routine monitoring activitiesfor critical limits should notbe confused with verificationmethods, procedures oractivities. This could be apoint of confusion, and theinstructor should keep this inmind while addressing thischapter.

Continued

Chapter 10: Principle 6: Verification Procedures

Overhead 1

Overhead 2

Overhead 3

Verification

One of the more complex HACCP principles is verification. Although it iscomplex, the proper development and implementation of the verificationprinciple is fundamental to the successful execution of the HACCP plan.HACCP has spawned the use of a new adage — “trust what you verify,”which speaks to the heart of the verification principle. The purpose of theHACCP plan is to prevent food-safety hazards, and the purpose ofverification is to provide a level of confidence that the plan is based onsolid scientific principles, is adequate to control the hazards associatedwith the product and process, and is being followed.

Objective:In this module, you will learn:• How to define verification.• What functions are part of HACCP plan verification.• What functions are part of validation.

Principle 6:Establish verification procedures.

Definition:Verification: Those activities, other than monitoring, that determinethe validity of the HACCP plan and that verify the system isoperating according to the plan.


100

Notes: Overhead 4

Perhaps one of the reasons verification has been difficult to understand isbecause there are several elements associated with this principle, includ-ing validation and reviews. Confusion also arises because the HACCPplan must include verification procedures for individual CCPs and for theoverall plan. To facilitate understanding, each of these elements will bediscussed.

Overhead 5

• Validation

Overhead 6

Validation is an essential component of verification and requires substan-tiation that the HACCP plan, if implemented effectively, is sufficient tocontrol the food-safety hazards that are likely to occur. Validation of theplan occurs before the plan is actually implemented. The purpose of

“Trust What You Verify”Verification provides a level of confidence that the HACCP plan isbased on solid scientific principles, is adequate to control thehazards associated with the product and process, and is beingfollowed.

Elements of Verification:• Validation• CCP verification activities

– Calibration of monitoring devices– Calibration record review– Targeted sampling and testing– CCP record review

• HACCP system verification– Observations and reviews– Microbiological end-product testing

• Regulatory agencies

Definition:Validation: The element of verification focused on collecting andevaluating scientific and technical information to determine if theHACCP plan, when properly implemented, will effectively control thehazards.


101

Continued

validation is to provide objective evidence that all essential elements ofthe plan have a scientific basis and represent a “valid” approach tocontrolling the food-safety hazards associated with the specific productand process. There are several approaches to validating the HACCP plan,among them are: incorporation of fundamental scientific principles, use ofscientific data, reliance on expert opinion or conducting in-plant observa-tions or tests.

Overhead 7

Validation can be performed by the HACCP team or by an individualqualified by training or experience. Validation activities may be similar inscope and time commitment to the original HACCP plan development. Anin-plant validation should be performed initially before actual reliance onthe HACCP plan and when factors warrant. These factors could include:changes to the raw materials, product or process; adverse review findings;recurring deviations; new scientific information about potential hazards orcontrol measures; on-line observations; or new distribution or consumer-handling practices. Validation involves a scientific and technical review ofthe rationale behind each part of the HACCP plan from hazard analysisthrough each CCP verification strategy.

Overhead 8

Validation of the HACCP plan, who does it?• HACCP team• Individual qualified by training or experience

What does validation involve?• A scientific and technical review of the rationale behind each part

of the HACCP plan from hazard analysis through each CCPverification strategy.

Validation Frequency:• Initially• When factors warrant. The following may warrant validation of

the plan:– changes in raw materials,– changes in product or process,– adverse review findings,– recurring deviations,– new information on hazards or control measures,– on-line observations, and– new distribution or consumer handling practices.

Notes:


102

Notes: Examples of Validation Activities:

1. One approach to controlling vegetative pathogens as a hazard incooked hamburgers is to ensure that the hamburgers are cooked toan internal temperature that destroys pathogens. In the HACCPplan, parameters for maximum patty thickness, maximum beltspeed and minimum oven temperature could be the critical limits toensure that an adequate temperature is reached at the cook step.These criteria would be established after collecting enough data on-line to ensure that controlling those points would also control theminimum internal temperature of every hamburger patty as it iscooked.

2. An internal temperature of 145 F was determined as critical todestroy pathogens in cooked shrimp. The firm uses a process of212 F for three minutes to provide an internal temperature of atleast 145 F. The ability of the process time and temperature toachieve the internal temperature of the cooked shrimp should bevalidated by measuring the center temperature of a representativenumber of cooked shrimp. The cooking equipment should also bevalidated using temperature distribution tests to determine thatadequate temperatures are delivered throughout the cooker duringprocessing.

• Verification of CCPs

Overhead 9

Verification activities developed for CCPs are essential to ensure that thecontrol procedures used are properly functioning and that they are operat-ing and calibrated within appropriate ranges for food-safety control.Additionally, CCP verification includes supervisory review of CCPcalibration, monitoring and corrective action records to confirm compli-ance with the HACCP plan. CCP verification may also include targetedsampling and testing.

• Calibration

Verification activities at CCPs include calibration of monitoring devicesto assure the accuracy of the measurements taken. Calibration is con-ducted to verify that monitoring results are accurate.

CCP Verification Activities:• Calibration• Calibration record review• Targeted sampling and testing• CCP record review


103

Continued

Calibration of CCP monitoring equipment is fundamental to the success-ful implementation and operation of the HACCP plan. If the equipment isout of calibration, then monitoring results will be unreliable. If thishappens, the CCP should be considered out of control since the lastdocumented acceptable calibration. This situation should be given ampleconsideration when establishing the frequency of calibration. Frequencyof calibration should also be influenced by equipment sensitivity.

Overhead 10

Examples of calibration activities:

1. A thermometer used to monitor temperature at a cook CCPmay be checked for accuracy by comparing it against a certifiedthermometer in a hot-water bath.

2. The continuous temperature chart recorder on a pasteurizer maybe compared during each batch against a certified accuratethermometer.

3. A pH meter is calibrated against pH buffer standards of 7.0 and 4.0when it is used to test products with a final pH of 3.8 to 4.2.

• Calibration Record Review

Reviewing the equipment calibration records involves checking the datesand methods of calibration and the test results (e.g., equipment passing orfailing). Calibration records are kept and reviewed. This review may beconducted as part of an audit (audits are discussed later in this chapter).

Example of calibration record review:

1. A review of the thermometer records indicates that thethermometer was checked for accuracy against a certifiedthermometer at a frequency specified in the HACCP plan. Therecords also indicate that the thermometer performed withinestablished limits and did not need adjustment. This reviewdisclosed no problems in the MIG calibrations.

• Targeted Sampling and Testing

Verification may also include targeted sampling, testing and other peri-odic activities. Vendor compliance may be checked by targeted samplingwhen receipt of material is a CCP and purchase specifications are relied

Calibrations are performed:• On equipment and instruments used in monitoring or verification.• At a frequency to ensure accuracy of measurements.• By checking accuracy against a recognized standard at or near

the condition that the instrument or equipment will be used.


104

Notes: on as critical limits. Typically, when a monitoring procedure is not asstringent as desired, it should be coupled with a strong verificationstrategy.

Examples of targeted sampling and testing:

1. In the cooked-shrimp example, the firm may purchase frozenshrimp under a supplier’s guarantee for a sulfite-free product. Aquarterly sample is collected for laboratory analysis to verify thatthe product being tested is sulfite-free.

2. In the cooked-shrimp example, verification of sulfite residualcontrol at receiving of fresh shrimp may involve quarterly analysisof samples to ensure that the results obtained through the originalmonitoring procedure are accurate. Records should indicate anydeviations.

3. Egg white is used as an ingredient in meringue-pie topping.Historically, egg whites have been associated with a risk ofSalmonella. Since the meringue is not cooked or otherwise treatedto kill Salmonella, the preventive measure could be to ensure thatall egg whites received are Salmonella-free. The CCP would beegg-white receiving, and the critical limit would be “every lot has aguarantee ensuring it is pasteurized and Salmonella-free.” Theadequacy of the supplier’s certificate could be periodically verifiedby collecting samples from a lot and testing for Salmonella.

When critical limits are set for equipment operation, product samples maybe taken to ensure that the equipment settings are appropriate for productsafety. For example, the firm processing cooked shrimp may collect in-line samples of selected product after cooking to measure internal tem-perature.

• CCP Record Review

At least two types of records are generated at each CCP: monitoring andcorrective action. These records are valuable management tools, provid-ing documentation that CCPs are operating within established safetyparameters and that deviations are handled in a safe and appropriatemanner. However, records alone are meaningless unless someone in asupervisory capacity reviews them on a periodic basis to “verify” that theHACCP plan is being followed. Current seafood HACCP regulationsmandate a second review of monitoring records within one week after theinitial records were taken.

HACCP System Verification

In addition to the verification activities for CCPs, strategies should bedeveloped for scheduled verification of the complete HACCP system. Thefrequency of the system-wide verification should be yearly (at a mini-


105

mum) or whenever there is a system failure or a significant change in theproduct or process. The HACCP team is responsible for ensuring that thisverification function is performed. Often, the HACCP team will contractan independent third party to conduct the system-wide verificationactivities.

Overhead 11

• System Verification Activities

Systematic verification activities include on-site observations and recordreviews. Reviews are usually performed by an unbiased person who is notresponsible for performing the monitoring activities.

System verification should occur at a frequency that ensures the HACCPplan is being followed continuously. This frequency depends on a numberof conditions, such as the variability of the process and product.

Overhead 12

Overhead 13

HACCP System Verification Frequency:• Annually• Occurrence of a system failure or significant change in product

or process

Verification Activities of the HACCP System:• Check the accuracy of the product description and flow chart.• Check that CCPs are monitored as required by the HACCP plan.• Check that processes are operating within established critical limits.• Check that records are completed accurately and at the time

intervals required.

Explanatory Note:

The frequency of verificationactivities will likely changeover time. A history of reviewfindings that indicate that theprocesses are consistently incontrol may justify safelyreducing the frequency. Onthe other hand, adversefindings, such as inconsistentmonitoring activities, incon-sistent record keeping andimproper corrective actionswarrant correcting theproblems and more frequentverification reviews. Adversefindings may indicate a needfor subsequent validation ofthe HACCP plan. FDA’sseafood HACCP regulationrequires “reassessment” ofthe HACCP plan on anannual basis. This is aprocess that includes atechnical review of thehazard analysis and eachelement of the HACCP planas well as on-site review ofall flow diagrams andappropriate records from theoperation of the plan. Thepurpose of the reassessmentis to ensure that the HACCPplan accurately identifies andcontrols relevant hazards.

Record Review:• Monitoring activities have been performed at the locations

specified in the HACCP plan.• Monitoring activities have been performed at the frequencies

specified in the HACCP plan.• Corrective actions have been performed whenever monitoring

indicated deviation from critical limits.• Equipment has been calibrated at the frequencies specified in the

HACCP plan.

Continued


• End-Product Microbiological Testing in HACCP Verification

As explained in Chapter 2, microbiological testing is ineffective forroutine monitoring but can be used as a verification tool. Microbiologicaltesting can be used to determine (e.g., during verification audits or onperiodic basis that the overall operation is under control.

Example of microbiological testing:

1. Several years ago, NACMCF recommended a microbiologicalcriteria for Staphylococcus aureus in cooked, ready-to-eatcrabmeat. The recommended criteria for plants operating under aHACCP plan and following GMPs are as follows: for every fivesample units (n=5), no more than two units (c = 2) can exceed 100organisms per gram (m = 100/g), and no unit can exceed 1,000organisms per gram (M = 1,000/g). Obviously, analysis for thisorganism would not be useful for routine CCP monitoring.However, it may be useful for periodically verifying theeffectiveness of the HACCP system.

• Company Verification Schedule

Table 1 is an example of company-established HACCP verificationschedule.

Table 1 and Overhead 14

106

Notes:

Example of a Company-EstablishedHACCP Verification Schedule

Activity Frequency

Initial validation of HACCP plan Prior to and during initialimplementation of plan

Subsequent validation When critical limits changed,of HACCP plan significant changes in process

occurred, equipment failed,system failed, etc.

Verification of CCP monitoring According to HACCP planas described in the plan (e.g., daily record review)(e.g., monitoring of shrimpcook time and temperature)

Review of monitoring and Weeklycorrective action records toshow compliance with the plan

Reassessment of HACCP plan Yearly


107

Notes:The Role of Regulatory Agenciesin HACCP Plan Verification

The major role of regulatory agencies in a HACCP system is to verify thatHACCP plans are effective and are being followed. Verification normallywill occur at the inspected facility; however, some aspects of verificationmay be conducted at other appropriate locations.

HACCP plans are unique documents prepared by a processor to ensurethe control of a specific process or procedure. The plans may containproprietary information and must be appropriately protected by theregulatory agency. Agency personnel must have access to records thatpertain to CCPs, deviations, corrective actions and other informationpertinent to the HACCP plan that may be required for verification.

Overhead 15

Verification procedures by an agency include:• Review of the HACCP plan and any modification.• Review of CCP monitoring records.• Review of corrective action records.• Review of the verification records.• Visual inspections of operations to determine if the HACCP plan

is followed and records are properly maintained.• Random sample collection and analysis.


108

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110

Notes:

Chapter 11: Aquaculture Drugs (A Chemical Hazard)

Continued



Unregulated/unapproved drugs administered toaquacultured fish pose a potential human healthhazard. These substances may be carcinogenic,allergenic, and/or may cause antibiotic resistance inman. To control this hazard in food animals, alldrugs, whether for direct medication or for additionto feed, must be approved by FDA. Under certainconditions authorized by FDA, unapproved newanimal drugs may be used in conformance with theterms of an Investigational New Animal Drug(INAD) application.

Incentives for the use of animal drugs in aquaticanimal species include the need to: 1) treat andprevent disease; 2) control parasites; 3) affect repro-duction and growth; and, 4) tranquilization (e.g.during transit). Relatively few drugs have beenapproved for aquaculture. As a result, aquaculturegrowers may use unapproved drugs, general purposechemicals that are not labeled for drug use, andapproved drugs in a manner that deviates from thelabeled instructions.

When a drug is approved by FDA’s Center forVeterinary Medicine, the conditions of the approvalare listed on its label. These conditions include: thespecies for which the drug is approved; the approveddosage; the approved route of administration; theapproved frequency of use; and the approved indica-tions for use. Only a licensed veterinarian maylegally prescribe or use a drug under conditions thatare not listed on the label. This restriction is morefully explained in 21 CFR 530.

Labels of approved drugs list mandatory withdrawaltimes, where applicable. These withdrawal timesmust be observed to ensure that the edible tissue issafe when it is offered for sale. Tissue residuetolerances have been established for some drugs.

STEP #11: DETERMINE IF THISPOTENTIAL HAZARD IS SIGNIFICANT.

At each processing step, determine whether “aquac-ulture drugs” is a significant hazard. The criteria are:

1. Is it reasonably likely that unsafe levels of aquacul-ture drugs will be introduced at this processing step(e.g. do raw materials come in with unsafe levels ofaquaculture drugs, or are they used at this step)?

Under ordinary circumstances, it would be reason-ably likely to expect that unsafe levels of aquaculturedrugs could enter the process during the receiving ofany type of aquacultured fish, including:• Fin fish;• Crustaceans;• Aquatic animals, such as alligator.

Under ordinary circumstances it would also bereasonably likely to expect that unsafe levels ofaquaculture drugs could enter the process during theholding of live lobster (e.g. lobster pounds).

Under ordinary circumstances it would not bereasonably likely to expect that aquaculture drugscould enter the process during the receiving of wild-caught fish. Currently, FDA is not aware of drug usein the grow-out of molluscan shellfish. If the agencybecomes aware of such use, this Guide, and, inparticular, Table #3-2 (Chapter 3) will be updatedaccordingly. On a regional basis, it may be reason-able for you to conclude that aquaculture drug use isnot a significant hazard for other species, becausethey are not used by producers in your region.

2. Can the presence of unsafe levels of aquaculturedrugs, which are reasonably likely to occur, be elimi-nated or reduced to an acceptable level here? (Note:If you are not certain of the answer to this question atthis time, you may answer “No.” However, you mayneed to change this answer when you assign criticalcontrol points in Step #12)

Chapter 11: Drugs127

“Aquaculture drugs” should also be considered asignificant hazard at any processing step where apreventive measure is, or can be, used to eliminatethe hazard (or reduce the likelihood of its occurrenceto an acceptable level), if it reasonably likely to occur.

Preventive measures for the control of aquaculturedrugs used in aquaculture operations can include:• On-farm visits to review drug usage (other than

INADs) before receipt of the product, coupledwith a supplier’s lot-by-lot certificate that anyINADs used were used in conformance with theapplication requirements;

• Receipt of supplier’s lot-by-lot certification ofproper drug usage, coupled with appropriateverification (See Step #18 - Verification);

• Review of drug usage records (other than INADs)at receipt of the product, coupled with a supplier’slot-by-lot certificate that any INADs used wereused in conformance with the applicationrequirements;

• Drug residue testing;• Receipt of evidence (e.g. third party certificate)

that the producer operates under a third party-audited Quality Assurance Program for aquaculturedrug use.

(Note: The use of Investigational New Animal Drugs(INAD) is confidential unless an exception is madeby the sponsor of the drug research. Thus, review ofINAD drug usage records by the processor may notbe practical in certain situations. Written certifica-tion from the grower to the processor stating that anyINAD drug usage is in accordance with authoriza-tions from FDA/Center for Veterinary Medicine, willbe acceptable on a lot-by-lot basis.)

Preventive measures for the control of aquaculturedrugs used during the holding of live fish (e.g. lobsterpounds) can include controlled application of animaldrugs in a manner consistent with:• The established withdrawal times;• The labeled instructions for use;• Extralabel use of FDA-approved drugs, under a

veterinarian’s supervision in accordance with FDAregulations and guidelines;

• The conditions specified in the FDA “lowregulatory priority aquaculture drug” list;

• The conditions of an INAD application.


List such preventive measures in Column 5 of theHazard Analysis Worksheet at the appropriateprocessing step(s). Ordinarily this will be either thereceiving step or the preharvest step. However, in thecase of an integrated operation, where fish processingand grow-out, and, perhaps feed manufacture, areperformed by the same firm, it may be possible anddesirable to exercise preventive measures early in theprocess (ideally at feed manufacture), rather than atreceipt of the fish at the processing plant. Suchpreventive measures will not be covered in thischapter. For the holding of live fish (e.g. lobsterpounds) the preventive measure will usually beapplied at the holding step.

If the answer to either question 1 or 2 is “Yes,” thepotential hazard is significant at that step in theprocess and you should answer “Yes” in Column 3 ofthe Hazard Analysis Worksheet. Except in the caseof an integrated aquaculture operation, this willusually be the receiving step. If none of the criteriaare met you should answer “No.” You should recordthe reason for your “Yes” or “No” answer in Column4. You need not complete Steps #12 through 18 forthis hazard for those processing steps where you haverecorded a “No.”


• Intended use

In determining whether a hazard is significant youshould also consider the intended use of the product,which you developed in Step #4. However, foraquaculture drugs, it is unlikely that the intended usewill affect the significance of the hazard.

In this case, you should enter “Yes” in Column 6 ofthe Hazard Analysis Worksheet for the pre-harveststep. This control approach will be referred to as“Control Strategy Example 1” in Steps #14 through18. (Note: if you have not previously identified“aquaculture drugs” as a significant hazard at the pre-harvest step in Column 3 of the Hazard AnalysisWorksheet, you should change the entry in Column 3to “Yes.”)

b. If you have no such relationship with the grower,then you may identify the receiving step as the CCPfor “aquaculture drugs.” At the receiving step youmay exercise one of the following preventivemeasures:

• Supplier’s lot-by-lot certification of proper drugusage, coupled with appropriate verification(See Step #18 - Verification).

Example:A processor of aquacultured shrimp thatpurchases raw material shrimp through variousbrokers could receive lot-by-lot certificates fromthe growers. The certificates would state that alldrugs were used in conformance with applicableregulations and labeled instructions. Theprocessor combines this monitoring procedurewith quarterly raw material testing for verification.

In this case, you should enter “Yes” in Column 6 ofthe Hazard Analysis Worksheet for the receiving step.This control approach will be referred to as “ControlStrategy Example 2” in Steps #14 through 18.

• Review of drug usage records (other than INADs)at receipt of the product, coupled with a supplier’slot-by-lot certificate that any INADs used wereused in conformance with the applicationrequirements.

Example:A processor of aquacultured shrimp thatpurchases raw material shrimp through variousbrokers could receive records of drug use (otherthan INADs) from the growers when the productis delivered. Additionally, the processor couldreceive a lot-by-lot certificate that would statethat any INADs were used in conformance withthe application requirements.

Continued


For each processing step where “aquaculture drugs”is identified in Column 3 of the Hazard AnalysisWorksheet as a significant hazard, determine whetherit is necessary to exercise control at that step in orderto control the hazard. Figure #A-2 (Appendix 3) is aCCP decision tree that can be used to aid you in yourdetermination.

The following guidance will also assist you indetermining whether a processing step is a CCP for“aquaculture drugs”:

Is the hazard the result of the use of aquaculturedrugs during the raising of fish (i.e. aquaculture) orduring the holding of live fish (e.g. lobster pounds)?

1. If it is the result of aquaculture, is your relationshipwith the grower one that enables you to visit the farmbefore receipt of the fish?

a.If you have such a relationship with the grower,then you may identify a pre-harvest step as theCCP for “aquaculture drugs.” The preventivemeasure for this type of control is on-farm visits toreview drug usage, coupled with a supplier’s lot-by-lot certificate that any INADs used were used inconformance with the application requirements.

Example:A processor of aquacultured catfish thatregularly purchases from the same growerswould visit the grower before the fish areharvested and review the grower’s drug usagepractices and records. The processor could alsoreceive a guarantee that any INADs used wereused in conformance with the applicationrequirements. The processor could then set thecritical control point for aquaculture drugs at thepre-harvest step.



• Drug screening on all lots at receipt. Thisscreening can be performed by rapid analyticalmethods which may indicate the presence of afamily of drugs, rather than any specific drug. Ifthe rapid screening test indicates that a family ofdrugs is present, further testing and/or follow-upwith the supplier would be necessary.

Note: A limited number of drug screening tests foraquaculture are available. Tests are not available toassay for all drugs that might be used in allaquacultured species. Processors should be cau-tioned that tests that have not been validated may beunreliable. These tests may fail to detect a residue ormay give a false positive. FDA has not validated anyof the aquaculture screening tests; nor has theAssociation of Official Analytical Chemists (AOAC).Processors should assure themselves that the teststhat they intend to use have otherwise been validatedand are appropriate for the species and tissue to betested.

Example:A processor of aquacultured shrimp thatpurchases raw material shrimp through variousbrokers could screen all incoming lots of shrimpwith a bank of validated rapid tests that targetthe families of drugs likely to be used duringgrow-out.


• Receipt of evidence (e.g. continuing or lot-by-lotthird party certificate) that the producer operatesunder a third party-audited Quality Assuranceprogram for aquaculture drug use.

Example:A processor of aquacultured trout that regularlypurchases raw material trout from the samegrower could obtain a third party certificate,valid for one year, that attests that the groweroperates under a Quality Assurance Program

which covers aquaculture drug usage.


2. If the hazard is the result of live fish holding (e.g.lobster pounds), then you may identify the holding stepas the CCP for “aquaculture drugs.” The preventivemeasure for this type of control is the controlledapplication of animal drugs (e.g. oxytetracycline) in amanner consistent with: the established withdrawaltimes; the labeled instructions for use; extralabel use ofan FDA-approved drug, under a veterinarian’s supervi-sion in accordance with FDA regulations and guide-lines; the conditions specified in the FDA “low regula-tory priority aquaculture drug” list; and, the conditionsof an INAD application.

Example:A processor that uses oxytetracycline in theholding of live lobster in a lobster pound woulduse the drug in accordance with the establishedwithdrawal time and any other labeledinstructions.

In this case, you should enter “Yes” in Column 6 ofthe Hazard Analysis Worksheet for the holding step.This control approach will be referred to as “ControlStrategy Example 6” in Steps #14 through 18.

It is important to note that you may select a controlstrategy that is different from those which aresuggested above, provided that it assures an equiva-lent degree of safety of the product.



OR• Listed on the FDA “low regulatory priority

aquaculture drug” list;OR• Permitted by FDA for use in food fish under

the conditions of an INAD (as evidenced by alot-by-lot written certificate from the grower).

• CONTROL STRATEGY EXAMPLE 2 -SUPPLIER’S CERTIFICATION

Critical Limit: Certificate indicating proper drugusage accompanying each lot of incomingaquacultured fish.

• CONTROL STRATEGY EXAMPLE 3 -RECORDS OF DRUG USE

Critical Limit: Animal drugs used on fish only if thedrugs have been:• Approved by FDA and used in accordance with

proper withdrawal times and other labeledconditions;

OR• Approved by FDA and used in an extra-label

manner under a veterinarian’s supervision inaccordance with FDA regulations and guidelines. The regulations and guidelines areavailable from the FDA Center for VeterinaryMedicine, HFV-230, 7500 Standish Place,Rockville, MD 20855;

OR• Listed on the “low regulatory priority


the conditions of an INAD (as evidenced by alot-by-lot written certificate from the grower).

• CONTROL STRATEGY EXAMPLE 4 -RESIDUE DRUG TESTING

Critical Limit: No fish will be accepted that containsunapproved drug residues (other than those usedwithin the provisions of an INAD application orused in accordance with the criteria specified inthe “low regulatory priority aquaculturedrug” list).

Continued

HACCP Plan Form


For each processing step where “aquaculture drugs”is identified as a significant hazard on the HACCPPlan Form, identify the maximum or minimum valueto which a feature of the process must be controlledin order to control the hazard.

You should set the critical limit at the point that if notmet the safety of the product may be questionable. Ifyou set a more restrictive critical limit you could, as aresult, be required to take corrective action when nosafety concern actually exists. On the other hand, ifyou set a critical limit that is too loose you could, asa result, allow unsafe product to reach the consumer.

As a practical matter it may be advisable to set anoperating limit that is more restrictive than thecritical limit. In this way you can adjust the processwhen the operating limit is triggered, but before atriggering of the critical limit would require you totake corrective action. You should set operatinglimits based on your experience with the variabilityof your operation and with the closeness of typicaloperating values to the critical limit.

Following is guidance on setting critical limits for thecontrol strategy examples discussed in Step #12.

• CONTROL STRATEGY EXAMPLE 1 -ON-FARM VISITS

Critical Limit: Animal drugs are used on fish only ifthe drugs have been:• Approved by FDA and used in accordance with



manner under a veterinarian’s supervision inaccordance with FDA regulations and guidelines. The regulations and guidelines areavailable from the FDA Center for VeterinaryMedicine, HFV-230, 7500 Standish Place,Rockville, MD 20855;



• CONTROL STRATEGY EXAMPLE 5 - QA PROGRAM

Critical Limit: Third party certificate indicating thatthe producer operates under a third party-auditedQuality Assurance program for aquaculture druguse, either for each lot of incoming aquaculturedfish or for each producer of incomingaquacultured fish.

• CONTROL STRATEGY EXAMPLE 6 -CONTROL DURING HOLDING

Critical Limit: Animal drugs are used on fish only ifthe drugs have been:• Approved by FDA and used in accordance with



manner under a veterinarian’s supervision inaccordance with FDA regulations andguidelines. The regulations and guidelines areavailable from the FDA Center for VeterinaryMedicine, HFV-230, 7500 Standish Place,Rockville, MD 20855;

OR• Listed on the FDA “low regulatory priority


the conditions of an INAD.

• FDA-approved aquaculture drugs

FDA approved aquaculture drugs with their approvedsources, species and withdrawal times are listedbelow. Additional details on conditions of use (e.g.disease conditions and dosage levels) can be obtainedfrom: the Code of Federal Regulations as citedbelow; the labeling for the drug; the FDA Center forVeterinary Medicine (www.fda.gov/cvm/index/aquaculture); or “Guide to Drug, Vaccine, andPesticide Use in Aquaculture,” Texas AgriculturalExtension Service, Publication B-5085.• Chorionic Gonadotropin

Supplied by Intervet, Inc., Millsboro, DE, may beused as an aid in improving spawning function inmale and female brood finfish, (21 CFR 522.1081);

• Formalin solutionSupplied by Natchez Animal Supply Co., Natchez,MS or Argent Laboratories, Redmond, WA, mayonly be used in salmon, trout, catfish, largemouthbass, and bluegill for the control of protozoa andmonogenetic tremetodes, and on the eggs ofsalmon, trout and pike (esocids) for control offungi of the family Saprolegniacea,(21 CFR 529.1030);

• Formalin solutionSupplied by Western Chemical, Inc., Ferndale, WA,may be used to control: external protozoa andmonogenetic tremetodes on all fin fish species;external protozoan parasites on shrimp; and fungiof the family Saprolegniaceae on the eggs of all finfish species, (21 CFR 529.1030);

• Tricaine methanesulfonate (MS-222)Supplied by Argent Laboratories, Redmond, WA,and Western Chemical, Inc., Ferndale, WA, mayonly be used in the families Ictaluridae (catfish),Salmonidae (salmon and trout), Esocidae (pike),and Percidae (perch) when the fish is intended tobe used for food. It may not be used within 21 daysof harvesting fish for food. In other fish and incold-blooded animals, the drug should be limited tohatchery or laboratory use, (21 CFR 529.2503);

• OxytetracyclineFor feed use, supplied by Pfizer, Inc., may only beused in salmonids, catfish, and lobster. Withdrawaltimes are: marking in pacific salmon, 7 days;disease control in salmonids, 21 days; catfish,21 days; lobster, 30 days (21 CFR 558.450).Oxytetracycline tolerance in the flesh is 2.0 ppm,(21 CFR 556.500).

• SulfamerazineSupplied by Roche Vitamins, Inc., may only beused in trout. It may not be used within 21 days ofharvest (21 CFR 558.582). Sulfamerazine tolerancein the flesh is zero, (21 CFR 556.660). Note: thisproduct is currently not marketed.

• Sulfadimethoxine/ormetoprim combinationSupplied by Roche Vitamins, Inc., may only beused in salmonids and catfish. Withdrawal timesare: salmonids, 42 days; catfish, 3 days (21 CFR558.575). Sulfadimethoxine/ormetoprimcombination tolerance in the flesh is 0.1 ppm forboth drugs, (21 CFR 556.640).


Continued

• FDA low regulatory priority aquaculture drugs

FDA’s Center for Veterinary Medicine has identified anumber of “low regulatory priority aquaculture drugs.”The following list identifies these compounds andprovides their indicated use and usage levels. Thesecompounds have undergone review by the Food andDrug Administration and have been determined to benew animal drugs of low regulatory priority. Additionalinformation on this subject can be obtained from: theFDA Center for Veterinary Medicine (www.fda.gov/cvm/index/aquaculture); or “Guide to Drug, Vaccine,and Pesticide Use in Aquaculture,” Texas AgriculturalExtension Service, Publication B-5085.• Acetic Acid

Used in a 1000 to 2000 ppm dip for 1 to 10minutes as a parasitide for fish.

• Calcium ChlorideUsed to increase water calcium concentration toinsure proper egg hardening. Dosages used wouldbe those necessary to raise calcium concentrationto 1-20 ppm CaCO3. Used up to 150 ppmindefinitely to increase the hardness of water forholding and transporting fish in order to enable fishto maintain osmotic balance.

• Calcium OxideUsed as an external protozoacide for fingerlings toadult fish at a concentration of 2000 mg/L for 5seconds.

• Carbon Dioxide GasUsed for anesthetic purposes in cold, cool, andwarm water fish.

• Fuller’s EarthUsed to reduce the adhesiveness of fish eggs toimprove hatchability.

• Garlic (whole form)Used for control of helminth and sea liceinfestations of marine salmonids at all life stages.

• Hydrogen PeroxideUsed at 250-500 mg/L to control fungi on allspecies and life states of fish, including eggs.

• IceUsed to reduce metabolic rate of fish during transport.

• Magnesium SulfateUsed to treat external monogenic trematodeinfestations and external crustacean infestations infish at all life stages. Used in all freshwaterspecies. Fish are immersed in a 30,000 mgMgSO4/L and 7000 mg NaCl/L solutions for 5 to10 minutes.

• Onion (whole form)Used to treat external crustacean parasites, and todeter sea lice from infesting external surface ofsalmonids at all life stages.

• PapainUsed in a 0.2% solution to remove the gelatinousmatrix of fish egg masses in order to improvehatchability and decrease the incidence of disease.

• Potassium ChlorideUsed as an aid in osmoregulation; relieves stressand prevents shock. Dosages used would be thosenecessary to increase chloride ion concentration to10-2000 mg/L.

• Povidone IodineUsed in a 100 ppm solution for 10 minutes as anegg surface disinfectant during and after waterhardening.

• Sodium BicarbonateUsed at 142 to 642 ppm for 5 minutes as a meansof introducing carbon dioxide into the water toanesthetize fish.

• Sodium ChlorideUsed in a 0.5% to 1.0% solution for an indefiniteperiod as an osmoregulatory aid for the relief ofstress and prevention of shock; and 3% solution for10 to 30 minutes as a parasitide.

• Sodium SulfiteUsed in a 15% solution for 5 to 8 minutes to treateggs in order to improve their hatchability.

• Thiamine HydrochlorideUsed to prevent or treat thiamine deficiency insalmonids. Eggs are immersed in an aqueoussolution of up to 100 ppm for up to four hoursduring water hardening. Sac fry are immersed inan aqueous solution of up to 1,000 ppm for up toone hour.

• Urea & Tannic AcidUsed to denature the adhesive component of fisheggs at concentrations of 15g urea and 20g NaCl/5liters of water for approximately 6 minutes, followedby a separate solution of 0.75 g tannic acid/5 litersof water for an additional 6 minutes. Theseamounts will treat approximately 400,000 eggs.

The Agency is unlikely to object to the use of lowregulatory priority substances if the followingconditions are met: 1) the substances are used for thestated indications; 2) the substances are used at theprescribed levels; 3) the substances are used accord-ing to good management practices; 4) the product isof an appropriate grade for use in food animals; and,5) there is not likely to be an adverse effect on theenvironment.

The Agency’s enforcement position on the use ofthese substances should not be considered an ap-proval, nor an affirmation of their safety and effec-tiveness. The Agency reserves the right to take adifferent position on the use of any or all of thesesubstances at some time in the future.

Classification of these substances as new animaldrugs of low regulatory priority does not exemptfacilities from complying with other Federal, State,and local environmental requirements. For, example,facilities using these substances would still berequired to comply with National Pollutant DischargeElimination System (NPDES) requirements.



For each processing step where “aquaculture drugs”is identified as a significant hazard on the HACCPPlan Form, describe monitoring procedures that willensure that the critical limits are consistently met.


It is important for you to keep in mind that thefeature of the process that you monitor and themethod of monitoring should enable you to deter-mine whether the critical limit is being met. That is,the monitoring process should directly measure thefeature for which you have established a criticallimit.

You should monitor often enough so that the normalvariability in the values you are measuring will bedetected. This is especially true if these values aretypically close to the critical limit. Additionally, thegreater the time span between measurements themore product you are putting at risk should a mea-surement show that a critical limit has been violated.

Following is guidance on establishing monitoringprocedures for the control strategy examples dis-cussed in Step #12. Note that the monitoring fre-quencies that are provided are intended to be consid-ered as minimum recommendations, and may not beadequate in all cases.



What: On-farm drug usage procedures;AND

Producer certificate indicating proper INADusage.


What: Producer certificate indicating proper drugusage.


What: On farm drug usage procedures;AND

Producer certificate indicating proper INADusage.


What: Fish flesh for drug residues.


What: Third party certificate indicating operationunder third-party audited QA program.



What: Type of aquaculture drug used;AND

Date and quantity of drug use;AND

Any other conditions of drug use that arerelevant to: the established withdrawal times; thelabeled instructions for use; the extralabel use ofan FDA-approved drug used under aveterinarians’s supervision in accordance withFDA regulations and guidelines; the conditionsspecified in the FDA “low regulatory priorityaquaculture drug” list; or, the conditions of theINAD application;

ANDDate of distribution of the finished product.



How: Survey farm husbandry procedures, askquestions, and review drug usage records;

ANDVisual for presence of INAD certificate.


How: Visual for presence of lot-by-lot certificate.


How: Review drug records;AND

Visual for presence of INAD certificate.


How: Obtain samples and analyze for drugs, usingrapid screening methods.


Note: A limited number of drug screening tests foraquaculture are available, and these have not beenvalidated by FDA or AOAC. This topic is furtherdiscussed in Step #12.


How: Visual for presence of third party certificate.


How: Visually observe drug use and distribution.



Frequency: At least once per year for eachaquaculture site.


Frequency: Each lot received.






Frequency: Each lot received checked for presenceof certificates. Certificates may be issued on alot-by-lot or continuing basis, but at leastannually.

Continued



Frequency: Every time aquaculture drugs are usedduring holding;

ANDEvery time the product is distributed.



Who: Field agent (employee or contractor) or anyother person who has an understanding of animaldrug usage and limits.


Who: Receiving employee or supervisor, productionsupervisor, member of the quality control staff,or any other person who has an understanding ofthe control procedure.


Who: Production supervisor, member of thequality control staff, or any other personnel whohas an understanding of animal drug usage andlimits.


Who: Member of the quality control staff or contractlaboratory.


Who: Receiving employee or supervisor, productionsupervisor, a member of the quality control staff,or any other person who has an understanding ofthe control procedure.


Who: Production employee or supervisor, memberof the quality control staff, or any otherpersonnel who has an understanding of drugusage and limits.



For each processing step where “aquaculture drugs”is identified as a significant hazard on the HACCPPlan Form, describe the procedures that you will usewhen your monitoring indicates that the critical limithas not been met.

These procedures should: 1) ensure that unsafeproduct does not reach the consumer; and, 2) correctthe problem that caused the critical limit deviation.Remember that deviations from operating limits donot need to result in formal corrective actions.

Following is guidance on establishing correctiveaction procedures for the control strategy examplesdiscussed in Step #12.


Corrective Action: Reject product, if the CL isnot met;

ANDDiscontinue use of supplier until evidence isobtained that drug treatment practices havechanged.


Corrective Action: Reject lot, if the CL is not met;AND

Discontinue use of supplier until a commitment isobtained that a certificate will accompany each lot.




Discontinue use of supplier until evidence isobtained that drug treatment practices havechanged.


Corrective Action: Reject lot, if the CL is not met; AND

Discontinue use of supplier until evidence isobtained that drug treatment practices havechanged.



Discontinue use of supplier until a certificate isprovided.


Corrective Action: Hold the product until the drugresidue is at or below tolerance. This may beaccomplished by collecting and analyzing arepresentative sample of the product, using anapproved method;ORDestroy the product;ORDivert the product to non-food use.

ANDModify drug use practices

Note: If an incoming lot that fails to meet a receivingcritical limit is mistakenly accepted, and the error islater detected, the following actions should be taken:1) the lot and any products processed from that lotshould be destroyed, diverted to a nonfood use or to ause in which the critical limit is not applicable, orplaced on hold until a food safety evaluation can be

completed; and 2) any products processed from thatlot that have already been distributed should berecalled and subjected to the actions described above.



For each processing step where “aquaculture drugs”is identified as a significant hazard on the HACCPPlan Form, list the records that will be used todocument the accomplishment of the monitoringprocedures discussed in Step #15. The records shouldclearly demonstrate that the monitoring procedureshave been followed, and should contain the actualvalues and observations obtained during monitoring.

Following is guidance on establishing arecordkeeping system for the control strategy ex-amples discussed in Step #12.


Records: On-site audit report;AND

INAD certificate.


Records: Certificate;AND

Receiving record showing lots received andpresence/absence of certificate.


Records: Grower’s drug records;AND

INAD certificate;AND


Continued


Records: Analytical results.


RECORDS: Third party certificate;AND



Records: Drug use records;AND

Records indicating date of distribution of drug-treated product.



For each processing step where “aquaculture drugs”is identified as a significant hazard on the HACCPPlan Form, establish verification procedures that willensure that the HACCP plan is: 1) adequate toaddress the hazard of “aquaculture drugs”; and, 2)consistently being followed.

Following is guidance on establishing verificationprocedures for the control strategy examples dis-cussed in Step #12.




Verification: Visit all new aquacultured fishsuppliers within the year and all existing fishsuppliers at a predetermined frequency to reviewthe grower’s drug usage procedures;ORCollect a representative sample of the rawmaterial, in-process product, or finished productat least quarterly and analyze for drug residues.

ANDReview monitoring, corrective action andverification records within one week of preparation.












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e 2

- Sup

plie

r’s c

ertif

icat

ion.

It i

s pr

ovid

ed fo

r illu

stra

tive

purp

oses

onl

y.A

quac

ultu

re d

rugs

may

be

only

one

of s

ever

al s

igni

fican

t haz

ards

in th

is p

rodu

ct. R

efer

to T

able

s 3-

1, 3

-2, a

nd 3

-3(C

hapt

er 3

) for

oth

er p

oten

tial h

azar

ds (e

.g. c

hem

ical

con

tam

inan

ts, f

ood

and

colo

r add

itive

s, a

nd m

etal

frag

men

ts).

Aqua

cultu

re D

rugs

•Re

ject l

ot

AND

•Di

scon

tinue

use

until

supp

lier

agre

es to

pro

vide

certi

ficate

for

each

lot

•Gr

ower

’s dr

ugus

age

certi

ficate

•Re

ceivi

ng re

cord

Rece

ivin

g(1)

Cri

tical

Con

trol

Poin

t (C

CP)

Pres

ence

of a

certi

ficate

indi

catin

g pr

oper

drug

usa

ge

Certi

ficate

indi

catin

gpr

oper

dru

g us

age

acco

mpa

nyin

g all

lots

ofin

com

ing

pond

-raise

dsh

rimp

Each

lot r

eceiv

edVi

sual

Rece

iving

doc

kem

ploy

ee

(10)

Veri

ficat

ion

•V i

sit al

l new

pond

-raise

dsh

rimp

supp

liers

with

inth

e yea

r and

all ex

istin

gsu

pplie

rs at

25%

per

yea

r on

a rot

ating

bas

isto

revi

ew th

egr

ower

’s dr

ugus

age

proc

edur

es

•Re

view

mon

itorin

g,co

rrecti

veac

tion,

and

verif

icatio

nre

cord

s with

inon

e wee

k of

prep

arati

on


Exam

ple

Onl

y

See

Text

for

Ful

l Rec

omm

enda

tion

s

Anim

al dr

ugs u

sed

on fi

shon

ly if

the d

rugs

hav

ebe

en: a

) app

rove

d by

FDA

and

used

in ac

cord

ance

with

pro

per w

ithdr

awal

times

and

othe

r lab

eled

cond

ition

s; b)

appr

oved

by F

DA an

d us

ed in

anex

tra-la

bel m

anne

run

der a

vete

rinar

ian’s

supe

rvisi

on in

acco

rdan

cewi

th F

DA re

gulat

ions

and

guid

eline

s; c)

liste

d on

the

“low

regul

atory

prio

rity

aqua

cultu

re d

rug”

list;

or

d) p

erm

itted

by

FDA

for

use i

n fo

od fi

sh u

nder

the

cond

ition

s of a

n IN

AD(a

s evi

denc

e by

a lot

-by-

lot w

ritten

certi

ficate

)

•On

-farm

dru

gus

age

proc

edur

es

•Ce

rtific

atein

dica

ting

prop

er IN

ADus

age

(2)

Sign

ifica

ntH

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch P

reve

ntiv

eM

easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Rec

ords

Wha

tH

owFr

e que

ncy

Who

(10)

Veri

ficat

ion

TABL

E #1

1-3

Cont

rol S

trat

egy

Exam

ple

3 -

Reco

rds

of d

rug

use

This

tabl

e is

an

exam

ple

of a

por

tion

of a

HA

CC

P pl

an re

latin

g to

the

cont

rol o

f aqu

acul

ture

dru

gs in

pon

d-ra

ised

shr

imp,

usin

g C

ontro

l Stra

tegy

Exa

mpl

e 3

- Rec

ords

of d

rug

use.

It i

s pr

ovid

ed fo

r illu

stra

tive

purp

oses

onl

y.A

quac

ultu

re d

rugs

may

be

only

one

of s

ever

al s

igni

fican

t haz

ards

in th

is p

rodu

ct. R

efer

to T

able

s 3-

1, 3

-2, a

nd 3

-3(C

hapt

er 3

) for

oth

er p

oten

tial h

azar

ds (e

.g. c

hem

ical

con

tam

inan

ts, f

ood

and

colo

r add

itive

s, a

nd m

etal

frag

men

ts).

Aqua

cultu

re D

rugs

•R e

view

dru

gre

cord

s at

rece

ipt

•V i

sual

•Gr

ower

’s dr

ugus

age r

ecor

ds

•Re

ceivi

ng re

cord

•Ce

rtific

ate o

fIN

AD u

sage

•Ea

ch lo

tre

ceive

d

•Sa

me

•Re

ject l

ot

AND

•Di

scon

tinue

use

of su

pplie

r unt

ilev

iden

ce is

obtai

ned

that

drug

trea

tmen

tpr

actic

es h

ave

chan

ged

•Sa

me

•Pr

oduc

tion

supe

rviso

r

•Sa

me

•Re

view

mon

itorin

gan

d co

rrecti

veac

tion

reco

rds

with

in o

ne w

eek

of p

repa

ratio

n

Rece

iving(1

)C

ritic

al C

ontr

olPo

int (

CC

P)


Exam

ple

Onl

y

See

Text

for

Ful

l Rec

omm

enda

tion

s

(2)

Sign

ifica

ntH

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch P

reve

ntiv

eM

easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

Wha

tH

owFr

eque

ncy

Who

TABL

E #1

1-4

Cont

rol S

trat

egy

Exam

ple

4 -

Resi

due

drug

test

ing

This

tabl

e is

an

exam

ple

of a

por

tion

of a

HA

CC

P pl

an re

latin

g to

the

cont

rol o

f aqu

acul

ture

dru

gs in

farm

-rai

sed

catfi

sh,

usin

g C

ontro

l Stra

tegy

Exa

mpl

e 4

- Res

idue

dru

g te

stin

g. I

t is

prov

ided

for i

llust

rativ

e pu

rpos

es o

nly.

Aqu

acul

ture

dru

gs m

ay b

e on

ly o

ne o

f sev

eral

sig

nific

ant h

azar

ds in

this

pro

duct

. Ref

er to

Tab

les

3-1,

3-2

, and

3-3

(Cha

pter

3) f

or o

ther

pot

entia

l haz

ards

(e.g

. che

mic

al c

onta

min

ants

and

met

al fr

agm

ents

).

Aqua

cultu

re D

rugs

No fi

sh w

ill b

e acc

epted

that

cont

ains u

napp

rove

ddr

ug re

sidue

s (ot

her t

han

thos

e use

d un

der a

n IN

ADap

plica

tion

or in

clude

d on

the “

low re

gulat

ory

prio

rity

aqua

cultu

re d

rug”

list)

Fish

fles

h fo

r dru

gre

sidue

sOb

tain

sam

ples

and

analy

ze fo

rdr

ugs u

sing

rapi

dsc

reen

ing

meth

ods

Note:

A li

mite

dnu

mbe

r of d

rug

scre

enin

g tes

ts fo

raq

uacu

lture

are

avail

able,

and

thes

eha

ve n

ot b

een

valid

ated

by F

DAor

AOA

C. T

his

topi

c is f

urth

erdi

scus

sed

in S

tep#1

2.

Each

lot r

eceiv

edQu

ality

ass

uran

cepe

rsonn

el•

Rejec

t lot

AND

•Di

scon

tinue

use

of su

pplie

r unt

ilev

iden

ce is

obtai

ned

that

drug

trea

tmen

tpr

actic

es h

ave

chan

ged

Rece

ivin

g(1)

Cri

tical

Con

trol

Poin

t (C

CP)

(9)

Rec

ords

•An

alytic

alre

sults

(10)

Veri

ficat

ion

Revi

ewm

onito

ring

and

corre

ctive

acti

onre

cord

s with

inon

e wee

k of

prep

arati

on


Exam

ple

Onl

y

See

Text

for

Ful

l Rec

omm

enda

tion

s

(2)

Sign

ifica

ntH

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch P

reve

ntiv

eM

easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

Wha

tH

owFr

e que

ncy

Who

TABL

E #1

1-5

Cont

rol S

trat

egy

Exam

ple

5 -

QA

pro

gram

This

tabl

e is

an

exam

ple

of a

por

tion

of a

HA

CC

P pl

an re

latin

g to

the

cont

rol o

f aqu

acul

ture

dru

gs fo

r an

aqua

cultu

red

trout

proc

esso

r, us

ing

Con

trol S

trate

gy E

xam

ple

5 - Q

A p

rogr

am.

It is

pro

vide

d fo

r illu

stra

tive

purp

oses

onl

y.A

quac

ultu

re d

rugs

may

be

only

one

of s

ever

al s

igni

fican

t haz

ards

for t

his

prod

uct.

Ref

er to

Tab

les

3-1,

3-2

, and

3-3

(Cha

pter

3) f

or o

ther

pot

entia

l haz

ards

(e.g

. che

mic

al c

onta

min

ants

and

met

al fr

agm

ents

).

Aqua

cultu

re D

rugs

Third

par

ty ce

rtific

atein

dica

ting

that

the

prod

ucer

ope

rates

und

era t

hird

par

ty au

dited

Quali

ty A

ssur

ance

Prog

ram

that

cove

rsaq

uacu

lture

dru

g us

age

Pres

ence

of t

hird

party

cer

tifica

teVi

sual,

for

pres

ence

of

certi

ficate

Each

lot c

heck

ed to

see i

f cov

ered

by

certi

ficate

, whi

chis

rene

wed

annu

ally

Rece

iving

doc

kem

ploy

ee•

Rejec

t lot

AND

•Di

scon

tinue

use

until

a ce

rtific

ateis

obtai

ned

(9)

Rec

ords

•Th

ird p

arty

certi

ficate

of

oper

ation

•Re

ceivi

ng re

cord

(10)

Veri

ficat

ion

Revi

ewm

onito

ring

and

corre

ctive

acti

onre

cord

s with

inon

e wee

k of

prep

arati

on

Rece

iving(1

)C

ritic

al C

ontr

olPo

int (

CC

P)


Exam

ple

Onl

y

See

Text

for

Ful

l Rec

omm

enda

tion

s

(2)

Sign

ifica

ntH

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch P

reve

ntiv

eM

easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

Wha

tH

owFr

eque

ncy

Who

TABL

E #1

1-6

Cont

rol S

trat

egy

Exam

ple

6 -

Cont

rol d

urin

g ho

ldin

g

This

tabl

e is

an

exam

ple

of a

por

tion

of a

HA

CC

P pl

an re

latin

g to

the

cont

rol o

f aqu

acul

ture

dru

gs fo

r a p

roce

ssor

that

hol

ds li

velo

bste

r in

a lo

bste

r pou

nd, u

sing

Con

trol S

trate

gy E

xam

ple

6 - C

ontro

l dur

ing

hold

ing.

It i

s pr

ovid

ed fo

r illu

stra

tive

purp

oses

onl

y.A

quac

ultu

re d

rugs

may

be

only

one

of s

ever

al s

igni

fican

t haz

ards

for t

his

prod

uct.

Ref

er to

Tab

les

3-1,

3-2

, and

3-3

(Cha

pter

3) f

or o

ther

pot

entia

l haz

ards

(e.g

. nat

ural

toxi

ns a

nd fo

od a

nd c

olor

add

itive

s).

Aqua

cultu

re D

rugs

•Lo

bster

will

be w

ithhe

ldfro

m d

istrib

utio

n fo

r 30

days

after

trea

tmen

twi

th o

xytet

racy

cline

inac

cord

ance

with

the

labele

d di

recti

ons f

orus

e

•No

oth

er aq

uacu

lture

drug

s will

be u

sed

•Ty

pe o

faq

uacu

lture

dru

gus

ed

•Da

te an

d qu

antit

yof

dru

g us

e

•Da

te of

fini

shed

prod

uct

distr

ibut

ion

•V i

sual

obse

rvati

on o

fdr

ug u

se

•V i

sual

obse

rvati

on o

fdr

ug u

se

•V i

sual

obse

rvati

on o

fdr

ug u

se

•Ev

ery

time

aqua

cultu

redr

ugs a

re u

sed

•Ev

ery

time

aqua

cultu

redr

ugs a

re u

sed

•Ev

ery

time

aqua

cultu

redr

ugs a

re u

sed

•Pr

oduc

tion

empl

oyee

•Pr

oduc

tion

empl

oyee

•Sh

ippi

ngsu

perv

isor

•Ho

ld th

e pro

duct

AND

•Co

llect

a sam

ple

of th

e fin

ished

prod

uct a

nd h

ave

analy

zed

for

oxyt

etrac

yclin

ere

sidue

by

cont

act

labor

atory.

If 2

.0pp

m o

r les

s,re

lease

. If h

ighe

rth

an 2

.0 pp

m,

hold

pro

duct

anad

ditio

nal 5

day

san

d th

en re

test

AND

•De

stroy

the l

otwh

enun

appr

oved

drug

s are

use

d

AND

•m

odify

dru

g us

epr

actic

es

Hold

ing(1

)C

ritic

al C

ontr

olPo

int (

CC

P)

(9)

Rec

ords

•Dr

ug u

se re

cord

•Dr

ug u

se re

cord

•Sh

ippi

ng re

cord

(10)

Veri

ficat

ion

Revi

ewm

onito

ring

and

corre

ctive

acti

onre

cord

s with

inon

e wee

k of

prep

arati

on

Chap 11 - Principle 7: Record-Keeping Procedures

111

Notes:

Continued

Chapter 11: Principle 7: Record-Keeping Procedures

Overhead 1

Accurate record keeping is an essential part of a successful HACCPprogram. Records provide documentation that the critical limits have beenmet or that appropriate corrective actions were taken when the limits wereexceeded. Likewise, they provide a means of monitoring so that processadjustments can be made to prevent a loss of control.

Overhead 2

Types of Records Needed

Overhead 3

Objective:In this module, you will learn:• What kinds of records are needed in a HACCP system.• When to record monitoring information.• How computerized records can be used.• How to conduct a record review.

Principle 7:Establish record-keeping and documentation procedures.

Four kinds of categories are kept as part of the HACCPsystem.1. HACCP plan and support documentation used in developing

the plan2. Records of CCP monitoring3. Records of corrective action4. Records of verification activities


112

• 1. HACCP-Plan Support Documents

HACCP-support documents include the information and data used todevelop the HACCP plan. This includes the written hazard-analysisworksheet (Chapter 5) and records of any information used in performingthe hazard analysis and establishing the critical limits.

Support documents may include: sufficient data used to establish theadequacy of any barriers to bacterial pathogen growth, to establish thesafe shelf life of the product (if age of the product can affect safety), andto establish the adequacy of a heating process in destroying bacterialpathogens. In addition to data, support documents may also includecorrespondence with consultants or other experts.

Support documents should also include:• A list of the HACCP team and their responsibilities.• A summary of the preliminary steps taken in the development of the

HACCP plan.• Prerequisite programs.

• 2. Monitoring Records

HACCP monitoring records are primarily kept to demonstrate control atCCPs. HACCP records provide a useful way to determine if critical limitshave been violated. Timely record review by a management representativeensures that the CCPs are being controlled in accordance with theHACCP plan. This was discussed in Chapter 10. Monitoring records alsoprovide a means by which regulators can determine whether a firm is incompliance with its HACCP plan.

By tracking the values recorded on monitoring records, an operator ormanager can determine if a process is approaching its critical limit.Trends can be identified through record review to make necessary processadjustments. If timely adjustments are made before the critical limit isviolated, processors can reduce or eliminate the labor and material costsassociated with corrective actions.

Explanatory Note:

Although not required by theseafood HACCP regulation,it is advisable to maintainHACCP-plan supportdocumentation describedin this chapter.


113

Continued

Overhead 4

Examples of CCP monitoring records may include:• Storage temperature records for temperature-sensitive ingredients,

in-process materials and finished products where temperature control isnecesssary to ensure product safety.

• Container-seal examination records where the hermetic seal affectsproduct safety.

• Salometer-measurement records where salt brine is used to establish abarrier to bacterial pathogen growth in the finished product

• 3. Corrective Action Records

Corrective action records were discussed in Chapter 9.

• 4. Verification Records

Verification records (Chapter 10) should include:• Modifications to the HACCP plan (e.g., changes in ingredients,

formulations, processing, packaging and distribution);• Processor audit records verifying supplier compliance with guarantees

or certifications;• Verification of the accuracy and calibration of all monitoring

equipment;• Results of microbiological challenge tests, environmental

microbiological tests, and periodic in-line and finished-productmicrobiological, chemical and physical tests if applicable;

• Results of in-house, on-site inspections; and• Results of equipment-evaluation tests.

Examples of verification records include:• Temperature distribution studies for thermal processes.• Metal detector challenges.

All HACCP monitoring records should be on formsthat contain the following information:• Form title,• Firm name and location,• Time and date,• Product identification (including product type, package size,

processing line and product code, where applicable),• Actual observation or measurement,• Critical limits,• Operator’s signature or initials,• Reviewer’s signature or initials, and• Date of review.


114

Record-Monitoring Information

Monitoring information should be recorded at the time the observation ismade. False or inaccurate records filled out before the operation takesplace or ones that are completed later are inappropriate for a HACCPsystem.

Computerized Records

Computerized records are an option to manual record keeping. Whenusing computerized records, include controls to ensure that records areauthentic, accurate and protected from unauthorized changes.

Record Review

Monitoring records for CCPs and critical-limit deviations must bereviewed in a timely manner by a representative of plant management.All records should be signed or initialed and dated by the reviewer.This subject is discussed more in Chapter 10.

ABC Shrimp Company IQF Cooked-Shrimp Example

• Monitoring Records

Sample records are included for each of the monitoring activitiesidentified in columns 4 to 7 of the HACCP plan for IQF cooked shrimp.The names of these forms should be entered in column 10 of the HACCPplan form. These records include:

Figure 1. Raw material evaluation sheet.This form records the presence or absence of sulfiting agents detected inincoming raw shrimp at the receiving-raw-shrimp step. It is alsoused to record the vendor’s name and the presence or absence of asupplier’s certificate for incoming frozen shrimp at the receiving-frozen-shrimp step.

Figure 2. Supplier’s guarantee.This document indicates that the shrimp from this vendor does not containsulfiting agents.

Figure 3. Shrimp cooker log.This form is used to record the time and temperature of cooking at thecooker step.

Figure 4. Pack-room inspection record.The form is used to note that shrimp treated with sulfiting agents areappropriately labeled.

Notes:


115

Continued

• Additional Records

Figure 5. Laboratory results - sulfite residuals.This document indicates the results of a laboratory analysis for sulfiteresidual, which is used as a quarterly verification of the supplier’scertification.

Figure 6. Cooking process validation letter.This document confirms that the cooking critical limits are scientificallysound.

Figure 7. Cooking equipment validation letter.This document confirms that the temperature throughout the cookingequipment is at or above the critical limit when the equipment is properlyoperated.

Figure 8. Equipment calibration log.This form records the results of the quarterly calibration of the MIGthermometers used on the cookers.

Figure 9. Laboratory report - product microbiology.This document indicates the results of finished product laboratoryanalyses for total plate count (TPC), coliform bacteria, Escherichia coli,Staphylococcus aureus and Salmonella.

Figure 10. Sample corrective action record.This record relates to the cooking process records that have beenpreviously discussed. This form is used to document the action takenwhen a critical limit is exceeded.

Figure 11. Employee Training Record.This document indicates the training courses completed by eachemployee.

Overhead 5

Notes:

HACCP Plan Form

Records:

1. 2. 3. 4. 5. 6. 7. 8. 9. 10.


Specify the record-keeping procedures for each CCP.


Figure 1 and Overhead 6

Raw-Material Evaluation SheetABC Shrimp Co., Smithville, GA

Date: Time of Examination:Lot Number: Declared Wt:

Actual Wt:Brand: Country of Origin:Packer: Shrimp Type:Vendor: Process Type:

Sample No. 1 2 3 4 5 6Actual Color

Frozen Wt.Drained Wt.

No./Pkg.

Ct./Lb.% Peel

% Pieces

% Shell SpotsForeign Mat.

% Meat Spots

Dehydrated% Swimmerets

% Missing Tail

SulfitesVeins

Phosphate

% SpinesBleaching

% Discolored

SaltBilge Odor

Stale

Certificate for Sulfite Use (Yes/No):

Operator:

Reviewed By: Date:

(Items in bold are part of HACCP record.)

116

Explanatory Note:

Figure 1 also includesinformation for a variety ofnonsafety attributes inaddition to the sulfiting agentinformation. It exemplifies theuse of existing forms forHACCP purposes. Some firmsmay choose to separate theirHACCP records fromnonsafety control records.Note the critical limits at thebottom of the form.


117

Notes:


Supplier’s GuaranteeEast Bay Fishing Co., Yourtown, LA

December 25, 1995

ABC Shrimp Co.P.O. Box 54Smithville, GA 43898

Dear Mr. Smith,This certifies that, in accordance with your purchasing

specification, this shipment of frozen shrimp has not been treated withany sulfite compounds — East Bay Lot Number 12345.

Yours truly,Ira M. HonestQC Director, East Bay Fishing Co.

Explanatory Note:

Figure 3: Continuoustemperature monitoring isperformed by a recordingthermometer. Manual time andtemperature checks areperformed every hour, and theoperator confirms that thecritical limit was continuallymet since the last reading.Time checks are performed bydetermining how long it takesa block to move through thesteam tunnel using a stop-watch. A comparison betweenthe standard thermometer andthe recording thermometer ismade daily. A deviationoccurred at 4:28 p.m.,triggering a corrective actionthat is documented in Figure10. Note that during the 5:01p.m. temperature check, therecording thermometer wasreading lower than thestandard thermometer. Thiscondition is acceptable as longas the two instruments are asclose as reasonably possible.However, it would not beacceptable for the recordingthermometer to read higherthan the standard thermom-eter.

LineNumber

LotNumber

Timeof Day

SteamTemp.

(F)

Temp.from

Recorder(F)

CookTime

(Min.)

CriticalLimits

Met

Comments

1 034 2:34 p.m. 214 3.2 Yes

1 043 3:30 p.m. 214 3.2 Yes

See correc-1 053 4:28 p.m. 210 3.1 No tive actions

1 053 4:29 p.m. 212 Yes Steam valveadjusted

1 053 5:01 p.m. 213 212 3.1 Yes


Shrimp Cooker LogABC Shrimp Co., Smithville, GA

Date: 3/4/96 Critical Limits: ≥ 212 F for ≥ 3 minutes

Line: Number 1 Product: IQF cooked shrimp

Operator: Jamie Good

Temperature/time to be checked hourly during operation.

Reviewer: Date:

If critical limits are exceeded, notify the shift supervisor,and separate and identify the batch involved.



Pack-Room Inspection RecordABC Shrimp Co., Smithville, GA

Date: 3/4/95

Line: Number 1 Product: IQF cooked shrimp

Label Room Supervisor: Betty Smith

Reviewer: Date of Review:

Critical Limits: All shrimp treated with sulfiting agents must beaccurately labeled.

118

Notes:


A-One Laboratory Report for:ABC Shrimp Co., Smithville, GA

Date: 3/5/95 Sample Number: ABC Shrimp lot# 002

Vendor: East Bay Sulfites, ppm: < 10 ppm

Examined by: Sheila Good

Remarks:The above sample was analyzed for the presence of

sulfites using official AOAC recognized methods.

Irvine R. WrightLaboratory DirectorA-One LaboratoriesJonestown, PA 25418

Label Type& Comments

Sulfite Statementon LabelYes/No

043 3:45 p.m. Yes Yes ABC 8 oz.

044 4:45 p.m. Yes Yes Smith Brothers12 oz.

LotNumber

Timeof Day

Presence ofSulfiting Agents

Yes/No


119

Notes:


Cooking-Process Validation LetterSeafood Processing Research and Extension Unit

Your State University

January 5, 1996


Dear Mr. Smith:Various published studies document that a process which

provides an internal temperature of 145 F in shrimp is adequatefor pasteurization. This supports our studies revealing thatpathogenic organisms are destroyed by processing the shrimp at212 F for three minutes. This process provides an internaltemperature above 145 F for a minimum of 15 seconds.

Sincerely,I.M. HelpfulSeafood Processing Research and Extension UnitYour State University


120

Explanatory Note:

Figure 7: Emphasize that allthermal-processing equip-ment should be tested toverify that it will perform therequired process.


Cooking-Equipment Validation LetterSeafood Processing Research and Extension Unit

Your State University

January 5, 1996


Dear Mr. Smith:

On Dec. 20, 1995, during a visit to your firm, temperaturedistribution tests were performed in your shrimp steam cooker on linenumber one using a portable data logger and 12 thermocouple leads.Test results from three production runs indicated that the temperaturedistribution in your steam cooker, when operated at a mercury-in-glassreading of 212 F, ranges from 212 F to 214 F. These studies indicatethat your steam cooker continues to operate as designed.

On this same date, the internal temperature of six shrimp fromindividual lots of large (3.5 to 5.0 shrimp per oz.), medium (5.0 to 9.0shrimp per oz.) and small (9.0 to 17.0 shrimp per oz.) shrimp weremeasured in the cooker during production runs at 212 F for threeminutes. The internal temperature of the large shrimp exceeded 150 F;the medium shrimp, 160 F; and the small shrimp, 165 F. The internaltemperatures noted during these tests exceed your firm’s HACCPcritical limits of an internal temperature of 145 F for 15 seconds.

Sincerely,I.M. HelpfulSeafood Processing Research and Extension UnitYour State University


121

Explanatory Note:

Figure 8: Emphasize that allmonitoring equipment such asthermometers and scalesshould be checked against astandard. In some cases, thisstandard may be a boiling-water bath, an ice slush or aknown weight, dependingupon the instrument and theaccuracy requirements for thecritical limit being monitored.Note that on the 6/12/89calibration, the thermometerwas 1 F above the standard.This could have an impact onthe previously producedproduct and could haveresulted in critical limitdeviations. These should beevaluated, and appropriatecorrective action should betaken and recorded.


Equipment-Calibration LogTemperature Measurement

Instrument/EquipmentABC Shrimp Co., Smithville, GA

Instrument/Equipment: Standard thermometer

Location in Plant: Shrimp Cooker Line Number One

Serial Number: B546

Model Number: Always Right 140 F to 260 F

Date Received in Plant: 3/2/95

DateCalibrated

CalibrationResults

EmployeeMethodof Calibration

3/15/95 Thermometer Tested in steam Sam Smith Becky Allenwas in calibration. flow 215 F using 3/18/95

certified thermo-meter S.N. 07569

6/12/95 Thermometer scale Tested in steam Stan Jones Becky Allenadjusted 1 F down flow 215 F using 6/15/95to match standard certified thermo-thermometer. meter S.N. 07569

9/10/95 Thermometer was Tested in steam Sam Smith Joe Noblein calibration. flow 215 F using 9/15/95

certified thermo-meter S.N. 56432

12/2/95 Thermometer was Tested in steam Sam Smith Becky Allenreading 5 F below flow 215 F using 12/6/95the standard thermo- certified thermo-meter scale. meter S.N. 56432Adjusted.

2/29/96 Thermometer was Tested in oil bath Jean Jones Joe Noblein calibration. 215 F by laboratory 3/3/96

using certifiedthermometer S.N.56432

ReviewerDate



A-One Laboratory ReportABC Shrimp Co., Smithville, GA

Date: 4/5/96 Sample No.: ABC Shrimp Lot # 0112

Vendor: East Bay Analyst: Sheila Good

The results of the analyses of sample 0112 consisting of 6/8 oz.samples of shrimp identified as batch 1 to 6 are as follows:

Remarks:

The above sample was analyzed using methods found in the FDABacteriological Analytic Manual, 7th Edition.

Irvine R. WrightLaboratory DirectorA-One LaboratoriesJonestown, PA 25418

122

Explanatory Note:

There are situations when theresults of a verificationactivity would necessitate acorrective action. For ex-ample, with the positiveSalmonella result in Batch 1,it would be appropriate forthe processor to hold any ofthe affected lot still in storageand recall any of the productthat was no longer under theprocessor’s control. Then theprocessor could recook ordestroy the lot. It would alsobe appropriate to re-evaluatethe HACCP plan and itsimplementation to determinehow the defect could haveoccurred.

Explanatory Note:

Figure 9: Finished productanalyses may often beincluded as part of a firm’speriodic verification efforts.Firms should establishspecifications for the micro-biological tests that areperformed as part ofverification.

1 40 0 0 Negative Positive

2 48 0 0 Negative Negative





Batch T.P.C./g

E. Coli/10g

Coliforms/10g

Salmonella/sample

Staph/g



Corrective-Action ReportABC Shrimp Co., Smithville, GA

Date: 3/4/96 Lot I.D.: 053

Description of Problem:

At 4:28 p.m., the temperature dropped to 210 F for 30 seconds

according to the recorder.

Action Taken:

Temperature drop was noted immediately. Steam valve was

adjusted and the product exiting the cooker for the next five

minutes was destroyed.

Date Problem Solved: 3/4/96

Current Status:

Remainder of lot is acceptable.

Supervisor: Ollie K. Fellows

Reviewer: Seymour Samples Date: 3/4/96

123

Explanatary Note:

See Figure 3 for correspond-ing monitoring recordshowing process deviation.

Explanatory Note:

Figure 10: The critical limitfailure in the first correctiveaction report would not likelyhave been noted without thecontinuous monitoringprovided by the recordingthermometer. In a continuouscooker, when a temperaturedrop occurs, the product inthe cooker at the time of thedeviation must be held andevaluated, recooked,destroyed or shifted to someother acceptable use unlessthe line can be stopped togive a still cook.


Sanitation in the processing plant, July 6, 19944-hour course, state inspection service.

Computer operation of the pasteurizer, Feb. 2-5, 1995Best Yet Pasteurizer Co.,John Jones, customer representative.three days on-the-job training.

Sanitation in the processing plant, Aug. 3, 19954-hour course, state inspection service, update.

124

Notes:


Employee-Training RecordABC Shrimp Co.

Employee: Richard J. Smith

Training Course Date of Course


125

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126

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Chap 12 - The Seafood HACCP Regulation

127

Continued

Chapter 12: The Seafood HACCP Regulation

Overhead 1

In December 1997, the FDA initiated a seafood regulation based on theseven principles of HACCP called “Procedures for the Safe and SanitaryProcessing and Importing of Fish and Fishery Products.” This regulationhas become known as “the seafood HACCP regulation.” It will bereferred to in this chapter as “the regulation.” A copy of the regulationis provided in Appendix I.

• Regulation Format

The regulation is part of Title 21 of the Code of Federal Regulations(CFR), Part 123, and is subdivided into three subparts and 13 sections.

Overhead 2

Objective:In this module, you will learn:• What are the requirements of the seafood HACCP regulation.• How to reference the specific requirements.

Regulation FormatSubpart A — General provisions

• 123.3 Definitions• 123.5 Current GMPs• 123.6 HACCP plan• 123.7 Corrective actions• 123.8 Verification• 123.9 Records• 123.10 Training• 123.11 Sanitation control procedures• 123.12 Special requirements for imported products

Subpart B — Smoked and smoke-flavored fishery products• 123.15 General• 123.16 Process controls

Subpart C — Raw molluscan shellfish• 123.20 General• 123.28 Source controls

Notes:


128

• Definitions 123.3

Twenty important terms are used throughout the regulation. They are:

Overhead 3

Of the terms listed above, a few definitions need to be emphasized.

Fish means freshwater or saltwater finfish, crustaceans, aquatic animal life(including alligators, frogs, aquatic turtles, jellyfish, sea cucumbers,sea urchins and roe) other than birds or mammals, and all mollusks,where such animal life is intended for human consumption.

Fishery product means any human food product where fish is a character-izing ingredient. [Note: This definition exempts products from themandatory HACCP requirements that contain inconsequentialamounts of fish. For example, Worcestershire sauce contains someanchovy paste but is not characterized by that ingredient.]

Overhead 4

Definitions 123.3• certification number • processing• critical control point • processor• critical limit • scombroid toxin-forming species• fish • shall• fishery product • shellfish-control authority• hazard • shellstock• importer • should• molluscan shellfish • shucked shellfish• preventive measure • smoked or smoke-flavored• process-monitoring instrument fishery products

• tag

Explanatory Note:

The terms "fish" and "fisheryproduct" together define theproducts that are subject tothis regulation.

Who must comply?ImporterProcessor — domestic and foreign


129

Continued

Importer means either the U.S. owner/consignee or the U.S. agent/representative of the foreign owner/consignee at the time of theproduct’s entry into the United States. This person is responsible forensuring that goods being offered for entry are in compliance with alllaws affecting the importation. Ordinarily, the importer is not thecustom-house broker, freight forwarder, carrier or steamshiprepresentative. [Note: The ownership of an imported product canchange many times in a short period of time after entry into theUnited States. However, the person who is the owner or consignee atthe time that the product is offered for entry is identified as theimporter because: 1) that person has the ability to decide whether tooffer the product for entry, and 2) that person is in a position to ensurethat the product is processed under appropriate controls and todemonstrate this to FDA.]

Processor means any person engaged in commercial, custom or institu-tional processing of fish or fishery products either in the United Statesor in a foreign country.

Processing means handling, storing, preparing, heading, eviscerating,shucking, freezing, changing into different market forms, manufactur-ing, preserving, packing, labeling, dockside unloading or holding fishor fishery products. [Note: Eviscerating done by an aquaculturegrower before delivery to a processing plant would make it necessaryfor the grower to comply with the requirements of this regulation.Fishing vessels and carriers may be affected by this regulationindirectly through the controls that processors may impose on them tomeet HACCP obligations. However, vessels are not directly affectedby the regulation, except for factory trawlers and similar vessels.Retail establishments must follow state and local governmentregulations. The Food Code (FDA’s model food ordinance that manystate and local regulatory authorities use in developing their food lawsand regulations) requires that raw materials for retail establishmentscome from approved sources.]

Overhead 5

Shall is used to state mandatory requirements.

Should is used to state recommended or advisory procedures or to identifyrecommended equipment.

Explanatory Note:

The terms importer, processorand processing togetherdefine who is subject to thisregulation.

Explanatory Note:

Products that do not move ininterstate commerce are notsubject to the regulation.However, products areconsidered to have enteredinto interstate commerce ifraw materials, ingredients,packaging, etc. have origi-nated outside the state.

Explanatory Note:

The use of the term “should”in the FDA regulation maydiffer from its use in Chapters5 through 11 of this manual.Chapters 5 through 11 aredesigned to teach the prin-ciples of HACCP, includingcertain activities that need tobe carried out to properlyimplement HACCP plans.Identifying these activitiesas those that “should” beenacted means they areimportant for the HACCPprogram to be effective.Many of these activitiesmay be mandatory elementsof the regulation.

This regulation does not apply to:• The harvest or transport of fish or fishery products.• Practices such as heading, eviscerating or freezing intended

solely to prepare a fish for holding on a harvest vessel.• The operation of a retail establishment.


130

Notes: • Current Good Manufacturing Practices (CGMPs) 123.5

Overhead 6

The Food Drug and Cosmetic Act deems food to be adulterated ifprocessed under insanitary conditions. The Current Good ManufacturingPractices describe the conditions and practices that must be followed toavoid producing adulterated food product. Part 110 applies to theprocessing of all FDA-regulated food products including fish and fisheryproducts because it is the basis for determining whether the facilities,methods, practices and controls used to process these products are safeand whether the products have been processed under sanitary conditions.The purpose of the seafood HACCP regulation is to set out requirementsspecific to the processing of fish and fishery products.

• Hazard Analysis 123.6(a)

Overhead 7

The regulation requires that every processor perform a hazard analysis. Itoutlines two major steps in a hazard analysis:• Determine whether there are hazards that are reasonably likely to occur.• Identify preventive measures to control the identified hazards.

Overhead 8

This means a prudent processor would establish controls because there isa reasonable possibility that a hazard will occur. To make this decision,examine:

Current Good Manufacturing Practices 123.5

• Regulations found in Title 21, Part 110 of the Code of FederalRegulations

• Proper practices for the safe and sanitary handling of all foods

Hazard Analysis 123.6(a)

Every processor shall conduct or have conducted a hazard analysis.

Hazards that are "reasonably likely to occur:"

Those "for which a prudent processor would establish controls"


131

Notes:

Continued

• Experience,• Illness data,• Scientific reports and• Other information

(e.g., FDA’s Fish and Fishery Products Hazards and Control Guide).

The criteria for including a food-safety hazard in a processor’s HACCPplan should be the likelihood that the hazard will occur or develop in thatproduct without proper controls (e.g., based on the processing technique,the harvest location, the species).

An example of a hazard that is reasonably likely to occur is histamine incertain fish species. Histamine reaction is one of the most frequentlyreported illnesses from seafood. The relationship between time andtemperature abuse after harvest and the formation of the toxin is well-established.

It is the end product of the hazard analysis — the HACCP plan and itsimplementation — that will be judged by the regulator and not the hazardanalysis itself. For this reason, the regulation does not require that thehazard analysis be performed in any particular way or that it be docu-mented in writing for regulatory review. However, a written hazardanalysis will help the processor remember the thought process used toidentify the hazards and develop the HACCP plan. This will be usefulwhen periodic plan reassessments are conducted and when the plan isreviewed by regulators.

• HACCP Plan 123.6(b)

Overhead 9

Overhead 10

When HACCP plan components are similar, some fish and fisheryproducts may be grouped under a single HACCP plan.

HACCP Plan 123.6(b)

Every processor shall have and implement a written HACCP planwhenever a hazard analysis reveals one or more food-safetyhazards that are reasonably likely to occur.

A HACCP plan shall be specific to:

• Each processing location.• Each species of fish and type of fishery product.


• HACCP Plan Contents 123.6(c)

Overhead 11

Food-safety hazards can include: natural toxins, microbiological contami-nation, chemical contamination, pesticides, drug residues, decompositionthat is related to safety (e.g., scombroid toxin-forming species), parasitesthat are related to safety (e.g., fish used for raw consumption), unap-proved food and color additives, and physical hazards. They can behazards that are introduced inside the processing plant or hazards thatoccur before, during or after harvest.

The frequencies of the monitoring and verification procedures must beincluded in the HACCP plan. Monitoring records must provide the actualvalues or observations noted during monitoring.

• Signing and Dating the HACCP Plan 123.6(d)

Overhead 12

The HACCP plan shall:

• List the food-safety hazards that are reasonably likely to occur.• List the CCPs.• List the critical limits.• List the monitoring procedures.• List predetermined corrective-action plans.*• List the verification measures.• Provide for a system of monitoring records.

* Processors are not required to predetermine corrective actions.

The HACCP plan shall be signed and dated by:

The most responsible individual at the processing facilityor a higher level official of the processor.

This signature shall signify that the HACCP plan has been acceptedfor implementation by the firm.

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Notes:


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• Low Acid Canned Foods and Acidified Foods 123.6(e)

Processors who must comply with the requirements of part 113 or 114(acidified and low-acid canned foods) of the CFR do not need to addressthe hazard of Clostridium botulinum in their HACCP plans. Their HACCPplans do not need to include controls to prevent that hazard, but they mustcontinue to comply with 113 or 114. Other hazards may be reasonablylikely to occur in an acidified or low-acid canned fishery product (e.g.,histamine in canned tuna), and these must be addressed in the HACCPplan as appropriate.

• Sanitation Controls and the HACCP Plan 123.6(f)

FDA recognizes that sanitation controls may be troublesome to manage ina HACCP plan. It is often difficult to determine appropriate critical limitsand corrective actions for sanitation controls, particularly those relating topersonnel hygiene (e.g., hand washing). For this reason, the regulationdoes not require that sanitation controls be included in the HACCP plan.However, sanitation controls that are not in the plan must be monitoredaccording to the sanitation provisions of the regulation. Sanitation isdiscussed in section 123.11.

• Legal Basis 123.6(g)

FDA’s application of HACCP is primarily based on the Federal FoodDrug and Cosmetic Act. This section of the act makes it unlawful toprocess food under conditions that may render it injurious to health. Anyfish or fishery products processed or imported in violation of thisregulation can be considered adulterated and subject to regulatory action.

The HACCP plan shall be signed and dated:

• Upon initial acceptance.• Upon any modification.*• At least annually.*

* This is a verification requirement.

Explanatory Note:

HACCP plans will not bepreapproved by FDA beforethey are implemented by theprocessor. They should not besubmitted to the agency forreview. FDA reached thisdecision because:• HACCP plans should beevaluated on-site, a processbest accomplished duringinspections of processingfacilities.• FDA does not have suffi-cient resources to reviewHACCP plans from alldomestic and foreign seafoodprocessors in advance ofHACCP implementation byprocessors.

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Notes:

Continued


• Corrective Action 123.7

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The regulation requires that a corrective action take place whenever acritical limit is not met at a CCP.

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Processors have a choice of developing a predetermined corrective-actionplan in advance as part of their HACCP plans or of following the alternateprocedure for corrective actions provided in the regulation. When aprocessor develops a plan in advance, he/she follows the plan that isappropriate when the deviation occurs. These corrective-action plansbecome part of their HACCP plans as previously described in section123.6(c).

A predetermined corrective-action plan provides a processor with benefitssuch as faster action when a deviation occurs and less need to justify tomanagement the appropriateness of the corrective action after it has beentaken. But unusual situations may arise that may not be addressed inpredetermined corrective-action plans. Processors may choose not topredetermine their corrective actions. In these cases, the alternatecorrective-action procedure must be followed.

A proper corrective-action plan describes the steps that are to be taken andassigns responsibility for taking those steps. It is designed to ensure that:

• No product enters commerce that is either injurious to health or isotherwise adulterated as a result of the deviation.

• The cause of the deviation is corrected.

Corrective Actions — Two Choices• Predetermined• Alternate Procedure

• Segregate and hold product.• Determine product acceptability.• Apply corrective action to product and process.• Reassess the HACCP plan.

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Notes:

Corrective Action 123.7

Whenever a deviation from a critical limit occurs, a processor shalltake corrective action.


The alternate corrective-action procedure involves:• Segregating and holding the affected product until the next two

requirements are met.• Determining whether the product is safe for distribution. This

decision must be made by someone who has suitable trainingor experience. This training or experience must be in the field(s) ofscience that is necessary for the person to understand the publichealth consequences of the critical-limit deviation.

• Take corrective action, as necessary, to ensure no unsafe productenters commerce.

• Take corrective action, as necessary, to fix the problem that causedthe deviation.

• Determine whether the HACCP plan needs to be modified to reducethe risk that the deviation will happen again and modify the HACCPplan as necessary. This decision must be made by someone who hasmet the training requirements covered in section 123.10.

All corrective actions must be fully documented in records.

• Verification 123.8

Overhead 16

Every processor must verify that the HACCP plan is adequate to controlfood safety hazards that are reasonably likely to occur, and that the plan isbeing effectively implemented. Verification must include, at a minimum,reassessment of the HACCP plan, ongoing verification activities, andrecord reviews.

The HACCP plan must be reassessed at least once per year and wheneverany changes occur that could affect the hazard analysis or the HACCPplan in any way. This could include changes in:• Raw materials or source of raw materials.• Product formulation.• Processing methods or systems.• Finished product distribution systems.• The intended use or consumers of the finished product.

The purpose of the reassessment is to ensure that the HACCP plan isadequate to control the food-safety hazards which are reasonably likely tooccur. It must be performed by an individual who meets the trainingrequirements described in section 123.10. If a processor has no HACCPplan because no significant hazards were identified, then the hazardanalysis must be reassessed whenever any changes occur that could affectthe hazard analysis.

Every processor shall verify:

• That the HACCP plan is adequate to control the food-safetyhazards that are reasonably likely to occur.

• That the HACCP plan is implemented effectively.

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Continued


The regulation requires ongoing verification activities in addition toperiodic reassessment. These ongoing activities are in keeping with theHACCP principle that verification must ensure that the HACCP plan isbeing implemented on a day-to-day basis. These ongoing verificationprocedures must be listed in the HACCP plan.

Overhead 17

Records must be kept of the calibration procedures and end-product or in-process testing that is performed as part of a processor’s HACCPactivities.

Consumer complaints must be reviewed by the processor to determinewhether they relate to problems at a CCP. The regulation does not giveregulators access to consumer complaints but does give them access tocorrective action records that relate to problems identified by consumercomplaints.

Overhead 18

The regulation requires that processors review certain records as part ofverification. The purpose of these reviews is to ensure that the recordsare complete and that the activities occurred in accordance with theprocessor’s written procedures. The records must be reviewed bysomeone who meets the training requirements described in section123.10.

Monitoring and corrective-action records must be reviewed within oneweek of when the record was made. Calibration and in-process or end-product testing records must be reviewed in a timely manner.

Sometimes the review of a consumer complaint or the performance ofverification procedure will indicate a potential public-health problem.When this happens, the processor must follow the corrective-actionprocedures described in section 123.7.

Ongoing verification:• Consumer complaint review.• Calibration of process-monitoring instruments.• Periodic end-product and in-process testing (processor’s option).

Review of records:• CCP monitoring records.• Corrective-action records.• Calibration records.• In-process and end-product testing records.

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Notes:

Explanatory Note:

Importer and sanitationrecords are not required tobe reviewed.


• Records 123.9

Overhead 19

The records required by the regulation must:• Contain certain information.• Be completed at the time of the activity.• Be signed or initialed by the operator or observer.• Be retained for specified periods of time.• Be available for review and copying by regulatory authorities.

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Overhead 21

If permanent storage at the processing facility is not practical (e.g.,a remote processing site or a processing vessel), the records may betransferred to some other facility at the end of the season. But therecords must be able to be promptly returned when requested by aregulatory agency.

Records required by the regulation:• Monitoring records.• Corrective-action records.• Verification records.• Sanitation-control records.• Importer-verification records.

Required information on each record:• Name and location of the processor or importer.• Date and time of the activity being recorded.• Signature or initials of the person making the record.• Identity of the product and the production code where appropriate.

Record retention:• One year for refrigerated products.• Two years for frozen or preserved products.

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Continued


A key feature of the HACCP verification process is access by governmentinspectors to the the HACCP plan, monitoring records and corrective-action records. Examination of HACCP records enables an inspector tosee how the processing facility operates over time rather than just on theday of the inspection. Additionally, it enables the inspector to review theadequacy of the processor’s preventive-control system.

FDA has concluded that records and plans should be protected to theextent possible to promote the implementation of HACCP across theseafood industry. The regulation generally states that HACCP plans andrecords which come into FDA’s possession will be treated as either tradesecrets or commercial confidential materials.

• Training 123.10

The regulation requires that certain activities and functions be performedby an individual trained in HACCP.

Overhead 22

Processors can use a trained employee or a trained third party to performthese functions. The jobs may be done by one person or by several as longas they have been properly trained. The regulation defines a “HACCP-trained individual” as one “who has successfully completed training in theapplication of HACCP principles to fish and fishery product processingthat is at least equivalent to that received under a standardized curriculumrecognized as adequate by the U.S. Food and Drug Administration or whois otherwise qualified through job experience to perform these functions.Job experience will qualify if it has provided knowledge at least equiva-lent to that provided through the standardized curriculum.” This coursematerial, developed by the National Seafood HACCP Alliance, is thestandardized curriculum that has been recognized by FDA.

• Sanitation Control Procedures (SCP) 123.11

Sanitation is a prerequisite program that is necessary for the effectiveimplementation of HACCP. In writing the seafood HACCP regulation,FDA concluded that the GMP regulations (21 CFR 110) had not provenfully effective in encouraging seafood processors to take full responsibil-ity for ensuring that sanitation in their plants consistently met minimumstandards. For these reasons, the regulation requires that processors takecertain actions to control sanitation conditions and practices.

The HACCP-trained individual shall:• Develop the HACCP plan.• Reassess and modify the HACCP plan and hazard analysis.• Review HACCP records.

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Notes:


These actions must be taken even if a processor determines there is noneed for a HACCP plan. The sanitation requirements of the regulationmay be made part of the processor’s HACCP plan or may be managedseparately. Some processors may choose to use a combination of theseapproaches.

Overhead 23

The SCP regulation encourages, but does not require, that each processordevelops a Sanitation Standard Operating Procedures (SSOP). The SSOPshould describe how the processor will ensure that certain key sanitationconditions and practices will be met. It should also describe how the plantoperations will be monitored to ensure that the conditions and practiceswill be met.

Whether or not a processor chooses to write an SSOP, the key sanitationconditions and practices that are relevant to the plant must be monitored.

Overhead 24

The purpose of the monitoring is to ensure that the requirements of thecurrent GMP regulations are met. Monitoring frequencies are notspecified but must be sufficient to ensure that the current GMP require-ments are met.

General Requirement• Current GMP regulations are the standard for proper sanitation

conditions and practices.• Eight key sanitation conditions and practices.• Mandatory sanitation monitoring with record keeping.• Mandatory corrections with record keeping.• Recommended SSOP.

Eight key sanitation conditions and practices:• Safety of water.• Condition and cleanliness of food-contact surfaces.• Prevention of cross-contamination.• Maintenance of hand-washing, hand-sanitizing and toilet facilities.• Protection from adulterants.• Labeling, storage and use of toxic compounds.• Employee health conditions.• Exclusion of pests.

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Notes:

Continued


When the conditions and practices contained in the current GMPregulations are not met, they must be corrected in a timely manner.Records must be kept of the monitoring and the corrections. Theserecords are subject to the same requirements as the HACCP records,except plant-verification review.

• Imported Products 123.12

It has always been the importer’s responsibility to offer for entry into thiscountry products that are not adulterated under U.S. law. FDA’s surveil-lance system for imports has traditionally consisted of: reviews ofcustoms entry forms for fish and fishery products being offered for entryinto the United States, sensory analyses (wharf examinations) and samplecollections for laboratory anlysis of products awaiting entry, and auto-matic detention of products with a history of problems. As with traditionalprocessing-plant inspections, this method is a “snapshot” approach that isnot preventive.

Under the seafood HACCP regulation, HACCP controls are required forimported fish and fishery products as well as for domestic products. Thedefinition of processor explicitly includes those who process seafood inforeign countries. Additionally, the regulation requires that importers takecertain steps to verify that their foreign suppliers meet the requirements ofthe regulation.

Overhead 25

Importers may meet their obligation in one of two ways. They mayimport fish and fishery products that are covered by memorandums ofunderstanding between the United States and a foreign country. In thiscase, they do not need to take any other action to meet the requirementsof the regulation.

Otherwise, the importer must have and implement written verificationprocedures for ensuring that the fish and fishery products offered forimport into the United States were processed in accordance with therequirements of the regulation.

Importer Verification:• Import from countries with a memorandum of understanding (MOU)

or• Implement verification procedures.

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Notes:


Importer Verification Procedures:• Product specifications and• Affirmative steps.

Importer Verification ProceduresAffirmative steps may include any of the following:• Obtain foreign processor’s HACCP and sanitation monitoring

records for the lot being entered.• Obtain continuing or lot-by-lot certificate from competent

third party.• Regularly inspect foreign processor.• Obtain foreign processor’s HACCP plan and written guarantee

that regulation is being met.• Test the product and obtain written guarantee that regulation

is being met.• Perform other verification procedures that provide equivalent

level of assurance.

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Continued

Overhead 26

Product specifications should cover those characteristics of the productthat would be useful in providing assurance that the product is notadulterated under section 402 of the Federal Food, Drug and CosmeticAct. This section relates to contaminants that may render the foodinjurious to health and to insanitary processing conditions. It may beappropriate for a specification for frozen tuna steaks to include amaximum limit for histamine of 50 ppm.

Overhead 27

An importer may hire a competent third party to perform verificationactivities. However, the importer remains responsible for demonstratingto FDA that the requirements have been met.

The importer must keep records in English that document that theaffirmative steps have been performed. The records must describe theresults of the steps. These records are subject to the records requirementsdescribed in section 123.9. Importers that also process fish or fisheryproducts must also meet the HACCP and sanitation requirements of theregulation for their processing operations.


• Smoked and Smoke-Flavored Fishery Products 123.15 and 123.16

Overhead 28

Smoked fish has been linked to a few cases of botulism. Clostridiumbotulinum, the bacteria that causes botulism, is prevented from growing inproperly smoked fish by a combination of barriers, including salt, smoke,nitrite and, in the case of hot-smoked fish, heat. Careful control of theseparameters is necessary to ensure the safety of the finished product. Suchcontrols must be included in the HACCP plans of these products, unlessthe product is preserved by the addition of acid or heat under the controlsrequired by the acidified or low-acid canned food regulations (21 CFR113 and 114).

It is important to note that if there are other significant hazards, they mustbe included in the HACCP plan.

• Raw Molluscan Shellfish 123.20 and 123.28and Control of Communicable Diseases 1240.60

Overhead 29

The largest number of reported illnesses from consumption of seafood iscaused by raw molluscan shellfish (oysters, clams and mussels). Thesehazards are primarily introduced before the molluscan shellfish areharvested. The risk of occurrence of these hazards is reduced by ensuringthat the molluscan shellfish come from sanitary growing waters. In mostcases, the sanitary quality of molluscan-shellfish growing waters isdetermined by a state or national agency called a shellfish-controlauthority.

Raw Molluscan Shellfish 123.20• HACCP plans must include a means for controlling the origin of

the raw molluscan shellfish.• Where processing includes a treatment that ensures the destruction

of vegetative cells of microorganisms of public health concern,the HACCP plan need not include controls on sources of origin.

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Notes:

Smoked and Smoke-Flavored Fishery Products• HACCP plan must include controls for Clostridium botulinum

toxin formation for the shelf life of the product under normal andmoderate abuse conditions.

• Where product is subject to 21 CFR 113 or 114, the HACCPplan need not include such controls.


Raw Molluscan Shellfish 123.28Processors shall only process molluscan shellfish from:• Growing waters approved by a shellfish-control authority.• Federal growing waters not closed by an agency of the federal

government.

Raw Molluscan Shellfish 123.28Shellstock Receiving• If source is a harvester, harvester must be in compliance with any

license requirement.• If source is another processor, processor must be certified by a

shellfish-control authority.• Containers of shellstock must be properly tagged.

Raw Molluscan Shellfish 1240.60Required information on tag:• Date and place shellfish were harvested (state and site).• Type and quantity of shellfish.• Harvester identification number, name of harvester or name or

registration number of harvester’s vessel.

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Notes:The regulation provides very specific requirements for controlling thesource of origin for raw molluscan shellfish. It is important to note,however, that other hazards may also be reasonably likely to occur inthese products, and they must be identified in the HACCP plan.

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Continued


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Notes:

Raw Molluscan Shellfish 123.28Records for shucked product must document:• Date of receipt.• Quantity and type of shellfish.• Name and certification number of the packer or repacker.

Raw Molluscan Shellfish 123.28Records for shellstock receiving must document:• Date of harvest.• Location of harvest by state and site.• Quantity and type of shellfish.• Date of receipt by the processor.• Name of harvester, name or registration number of the

harvester’s vessel or harvester’s identification number.

Raw Molluscan Shellfish 123.28Shucked molluscan shellfish containers must bear a label thatcontains:• Name of packer or repacker.• Address of packer or repacker.• Certification number of packer or repacker.

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Chapter 14: Pathogen Growth & Toxin Formationas a Result of Inadequate Drying (A Biological Hazard)

Continued



Pathogen growth in the finished product as a result ofinadequate drying of fishery products can causeconsumer illness. Examples of dried fish productsare: salmon jerky; octopus chips; dried shrimp; and,stock fish.

• Control of drying

Dried products are usually considered shelf stableand are, therefore, often stored and distributedunrefrigerated. The characteristic of dried foods thatmakes them shelf stable is their low water activity(Aw). Water activity is the measure of the amount ofwater in a food that is available for the growth ofmicroorganisms, including pathogens. A wateractivity of 0.85 or below will prevent the growth andtoxin production of all pathogens, including Staphy-lococcus aureus and Clostridium botulinum, and isnecessary for a shelf-stable dried product. S. aureusgrows at a lower water activity than other pathogens,and should, therefore, be considered the targetpathogen for drying for shelf-stable products.

Some dried products that are reduced oxygen pack-aged (e.g. vacuum packaged, modified atmospherepackaged) are dried only enough to control growthand toxin production by C. botulinum type E andnonproteolytic types B and F, and are then refriger-ated to control growth and toxin formation byC. botulinum type A and proteolytic types B and F,and other pathogens that may be present in theproduct, including S. aureus. A water activity ofbelow 0.97 will prevent the growth of C. botulinumtype E and nonproteolytic types B and F, and isnecessary for these refrigerated, partially driedproducts. More information on C. botulinum andreduced oxygen packaging is contained in Chapter 13.

This chapter covers the control of the drying processto prevent the growth and toxin production of patho-gens, including S. aureus and C. botulinum in thefinished product. Such control is critical to productsafety.

This chapter does not cover the growth of pathogens,including S. aureus, that may occur as a result oftime/temperature abuse during processing, includingbefore or during the drying process. That hazard iscovered in Chapter 12. It also does not cover thecontrol of C. botulinum type A and proteolytic typesB and F, and other pathogens that may be present,including S. aureus, during refrigerated storage ofreduced oxygen packaged, partially dried products.That hazard is covered in Chapters 12 and 13.

Controlling pathogen growth and toxin formation bydrying is best accomplished by:

• Scientifically establishing a drying process thatreduces the water activity to 0.85 or below, if theproduct will be stored and distributed unrefrigerated(shelf-stable);

• Scientifically establishing a drying process thatreduces the water activity to below 0.97, if theproduct will be stored refrigerated (not frozen) inreduced oxygen packaging;

• Designing and operating the drying equipment sothat every unit of product receives at least the estab-lished minimum process;

• Packaging the finished product in a container thatwill prevent rehydration.

You should select a packaging material that willprevent rehydration of the product under the expectedconditions of storage and distribution. Additionally,finished product package closures should be free ofgross defects that could expose the product tomoisture during storage and distribution.

Chapter 14: Drying191

Pathogen growth is not a concern in dried productsthat are stored, distributed, displayed and sold frozen,and are so labeled. These products need not meet thecontrol measures outlined in this chapter since dryingin this case is not critical to product safety. Similarly,drying may not be critical to the safety of driedproducts that are stored refrigerated, unless they arereduced oxygen packaged, since refrigeration may besufficient to prevent pathogen growth in aerobicallypackaged products.

The drying operation used in the production ofsmoked or smoke-flavored fish is not designed toresult in a finished product water activity of 0.85 orbelow. Drying controls for these products are de-scribed in Chapter 13.

Because spores of Clostridium botulinum are knownto be present in the viscera of fish, any product thatwill be preserved by salting, drying, pickling, orfermentation must be eviscerated prior to processing(see Compliance Policy Guide sec. 540.650). With-out evisceration, toxin formation is possible duringthe process even with strict control of temperature.Evisceration must be thorough and performed tominimize contamination of the fish flesh. If even aportion of the viscera or its contents is left behind, therisk of toxin formation by C. botulinum remains.Small fish, less than 5 inches in length, that areprocessed in a manner that prevents toxin formation,and that reach a water phase salt content of 10 percentin refrigerated products, or a water activity of below0.85 (Note: this value is based on the minimum wateractivity for growth of S. aureus) or a pH of 4.6 or lessin shelf-stable products, are exempt from the eviscera-tion requirement.

• Strategies for controlling pathogen growth

Pathogens can enter the process on raw materials.They can also be introduced into foods during pro-cessing from the air, unclean hands, insanitaryutensils and equipment, unsafe water, and sewage.There are a number of strategies for the control ofpathogens in fish and fishery products. They include:

• Controlling the amount of moisture that is availablefor pathogen growth, water activity, in the product bydrying (covered in this chapter);

• Controlling the amount of moisture that is availablefor pathogen growth, water activity, in the product byformulation (covered in Chapter 13);

• Controlling the amount of salt or preservatives,such as sodium nitrite, in the product (covered inChapter 13);

• Controlling the level of acidity, pH, in the product(covered by the acidified foods regulations, 21 CFR114 for shelf-stable acidified products; and forrefrigerated acidified products in Chapter 13);

• Managing the amount of time that food is exposedto temperatures that are favorable for pathogengrowth and toxin production (covered in Chapter 12;for C. botulinum, in Chapter 13; and for S. aureus inhydrated batter mixes, in Chapter 15);

• Killing pathogens by cooking (covered in Chapter16), pasteurizing (covered in Chapter 17), or retorting(covered by the low acid canned foods regulations,21 CFR 113).


At each processing step, determine whether “patho-gen growth and toxin formation as a result of inad-equate drying” is a significant hazard. The criteria are:

1. For shelf-stable products, is it reasonably likely thatS. aureus will grow and form toxin in the finishedproduct if the product is inadequately dried?

Table #A-1 (Appendix 4) provides information on theconditions under which S. aureus will grow. If yourfood meets these conditions before drying, thendrying will usually be important to the safety of theproduct, because it provides the barrier to S. aureusgrowth. Under ordinary circumstances, it would bereasonably likely that S. aureus will grow and formtoxin in such products during finished productstorage and distribution, if drying is not properlyperformed. However, see also the informationcontained in “Intended use and method of distribu-tion and storage,” below.


2. For shelf-stable products, can S. aureus toxinformation, which is reasonably likely to occur, beeliminated or reduced to an acceptable level at thisprocessing step? (Note: If you are not certain of theanswer to this question at this time, you may answer“No.” However, you may need to change this answerwhen you assign critical control points in Step #12.)

“Pathogen growth and toxin formation as a result ofinadequate drying” should also be considered asignificant hazard at any processing step where apreventive measure is, or can be, used to eliminate(or reduce the likelihood of occurrence to an accept-able level) the hazard, if it is reasonably likely to occur.

3. For refrigerated (not frozen), reduced oxygenpackaged products, is it reasonably likely thatC. botulinum type E and nonproteolytic types B and Fwill grow and form toxin in the finished product if theproduct is inadequately dried?

Table #A-1 (Appendix 4) provides information on theconditions under which C. botulinum type E andnonproteolytic types B and F will grow. If yourrefrigerated (not frozen), reduced oxygen packagedfood meets these conditions before drying, thendrying will usually be important to the safety of theproduct, because it provides the barrier to growthand toxin formation by C. botulinum type E andnonproteolytic types B and F. Under ordinarycircumstances, it would be reasonably likely thatC. botulinum type E and nonproteolytic types B andF will grow and form toxin in such products duringfinished product storage and distribution, if dryingis not properly performed. However, see also theinformation contained in “intended use and methodof distribution and storage,” below.

4. For refrigerated (not frozen), reduced oxygenpackaged products, can C. botulinum type E andnonproteolytic types B and F toxin formation, which isreasonably likely to occur, be eliminated or reduced toan acceptable level at this processing step? (Note: Ifyou are not certain of the answer to this question atthis time, you may answer “no.” However, you mayneed to change this answer when you assign criticalcontrol points in Step #12.)

“Pathogen growth and toxin formation as a result ofinadequate drying” should be considered a significanthazard at any processing step where a preventivemeasure is, or can be, used to eliminate (or reduce tothe likelihood of occurrence to an acceptable level)the hazard, if it is reasonably likely to occur.

Step #10 discusses a number of pathogen controlstrategies. This chapter covers control of pathogensby drying. Delivering a properly designed dryingprocess can be an effective preventive measure forthe control of pathogens. If this preventive measureis applied list it in Column 5 of the Hazard AnalysisWorksheet at the drying step.

If the answer to question 1, 2, 3 or 4 is “Yes” thepotential hazard is significant at the drying step in theprocess and you should answer “Yes” in Column 3 ofthe Hazard Analysis Worksheet. If neither criterionis met you should answer “No.” You should recordthe reason for your “Yes” or “No” answer in Column4. You need not complete Steps #12 through 18 forthis hazard for those processing steps where you haverecorded a “No.”


• Intended use and method of distribution and storage

In determining whether a hazard is significant youshould also consider the intended use and method ofdistribution and storage of the product, which youdeveloped in Steps #4 and 3, respectively. Becauseof the highly stable nature of S. aureus toxin and theextremely toxic nature of C. botulinum toxin, it isunlikely that the intended use will affect the signifi-cance of the hazard.

However, the hazard may not be significant if: 1) theproduct is immediately frozen after processing,maintained frozen throughout distribution, andlabeled to be held frozen and to be thawed underrefrigeration immediately before use (e.g. “Impor-tant, keep frozen until used, thaw under refrigerationimmediatley before use”); or 2) the product is

ContinuedChapter 14: Drying

193

unpackaged or aerobically packaged, and is distrib-uted refrigerated throughout the chain of commerce,and is labeled to be kept refrigerated. In both ofthese cases, the hazard of pathogen growth is con-trolled by the control of temperature, rather than bythe drying of the product. In these cases, you mayenter “No” in Column 3 of the Hazard AnalysisWorksheet for each of the processing steps. Inaddition, for each “No” entry briefly explain inColumn 4 that the hazard is controlled by freezing orrefrigeration. In this case, you need not completeSteps #12 through 18 for this hazard. However, referto Chapter 12 for the control of pathogen growth byrefrigeration.


For each processing step where “pathogen growthand toxin formation as a result of inadequate drying”is identified in Column 3 of the Hazard AnalysisWorksheet as a significant hazard, determine whetherit is necessary to exercise control at that step in orderto control the hazard. Figure #A-2 (Appendix 3) is aCCP decision tree that can be used to aid you in yourdetermination.

You should identify the drying step as the criticalcontrol point for this hazard. Therefore, you shouldanswer “Yes” in Column 6 of the Hazard AnalysisWorksheet at the drying step and “No” in that columnfor the other processing steps for which the hazardwas identified as a significant hazard. In addition,for each “No” entry make sure that Column 5 indi-cates that the hazard is controlled at the drying step.(Note: if you have not previously identified “patho-gen growth and toxin formation as a result of inad-equate drying” as a significant hazard at the dryingstep in Column 3 of the Hazard Analysis Worksheet,you should change the entry in Column 3 to “Yes”.)

This control approach is referred to as “ControlStrategy Example 1” in Steps #14-18. It is importantto note that you may select a control strategy that isdifferent from that which is suggested above, pro-vided that it assures an equivalent degree of safety ofthe product.

Example:

A salmon jerky processor could set the criticalcontrol point for controlling the hazard of “pathogengrowth and toxin formation as a result of inadequatedrying” at the drying step. The processor would notneed to identify the processing steps prior to dryingas critical control points for that hazard. However,these steps may be CCPs for the control of otherhazards, such as the growth of pathogens as a resultof time/temperature abuse during processing, coveredby Chapter 12.


HACCP Plan Form


For the drying step, identify the maximum or mini-mum value to which a feature of the process must becontrolled in order to control the hazard.

You should set the CL at the point that if not met thesafety of the product is questionable. If you set amore restrictive CL you could, as a result, be re-quired to take corrective action when no safetyconcern actually exists. On the other hand, if you seta CL that is too loose you could, as a result, allowunsafe product to reach the consumer.

As a practical matter it may be advisable to set anoperating limit that is more restrictive than the CL.In this way you can adjust the process when theoperating limit is triggered, but before a triggering ofthe CL would require you to take corrective action.You should set operating limits based on yourexperience with the variability of your operation andwith the closeness of typical operating values to the CL.

Following is guidance on setting critical limits for thedrying step.


It is important for you to keep in mind that the featureof the process that you monitor and the method ofmonitoring should enable you to determine whetherthe CL is being met. That is, the monitoring processshould directly measure the feature for which youhave established a CL.


Following is guidance on establishing monitoringprocedures for the drying step. Note that the moni-toring frequencies that are provided are intended tobe considered as minimum recommendations, andmay not be adequate in all cases.


• CONTROL STRATEGY EXAMPLE 1 -CONTROL OF DRYING

What: Critical factors of the established dryingprocess that affect the ability of the process toensure the desired finished product water activity(i.e. 0.85 or below for shelf stable products, lessthan 0.97 for refrigerated [not frozen], reducedoxygen packaged products). These may includedrying time, air temperature, humidity, andvelocity, and flesh thickness;ORPercent weight loss;ORWater activity.

Continued


Critical Limit: The minimum or maximum values forthe critical factors established by a scientificstudy (i.e. for shelf-stable products, those whichmust be met in order to ensure that the finishedproduct has a water activity of 0.85 or less; forrefrigerated [not frozen], reduced oxygenpackaged products, those which must be met inorder to ensure that the finished product has awater activity of less than 0.97). These willlikely include drying time, input/output airtemperature, humidity, and velocity, and fleshthickness. Other critical factors that affect therate of drying of the product may also beestablished by the study;ORThe minimum percent weight loss established bya scientific study (i.e. for shelf-stable products,those which must be met in order to ensure thatthe finished product has a water activity of 0.85or less; for refrigerated [not frozen], reducedoxygen packaged products, those which must bemet in order to ensure that the finished producthas a water activity of less than 0.97);ORFor shelf-stable products: Maximum finishedproduct water activity of 0.85 or less;ORFor refrigerated (not frozen), reduced oxygenpackaged products: Maximum finished productwater activity of less than 0.97.



For the drying step, describe monitoring proceduresthat will ensure that the critical limits are consistentlymet.





For batch drying equipment:

How: Monitor the drying time and the input/outputair temperature (as specified by the study) with atemperature recording device or digital time/temperature data logger. The device should beinstalled where it can be easily read and thesensor for the device should be installed toensure that it accurately measures the air input/output temperature;ANDMonitor all other critical factors specified by thestudy with equipment appropriate for themeasurement;ORUsing all or a portion of the batch, determinethe percent weight loss by weighing the productbefore and after drying;ORCollect a representative sample of finishedproduct and conduct water activity analysis.

For continuous drying equipment:

How: Monitor the input/output air temperature (asspecified by the study) with a temperaturerecording device or digital time/temperature datalogger. The device should be installed where itcan be easily read and the sensor for the deviceshould be installed to ensure that it accuratelymeasures the air input/output temperature;ANDMonitor the time by measuring either:• The RPM of the belt drive wheel, using a stop

watch or tachometer;OR

• The time necessary for a test unit or beltmarking to pass through the equipment, using astop watch;

ANDMonitor all other critical factors specified by thestudy with equipment appropriate for themeasurement;

ORUsing all or a portion of the lot, determinethe percent weight loss by weighing the productbefore and after drying;ORCollect a representative sample of finishedproduct and conduct water activity analysis.




Frequency: Temperature requirements of the dryingprocess should be monitored continuously by theinstrument itself, with visual check of themonitoring instrument at least once per batch;ANDTime requirements of the drying process shouldbe monitored for each batch;ANDMonitor all other critical factors specified by thestudy as often as necessary to maintain control;

ORPercent weight loss should be determined foreach batch of finished product;

ORWater activity should be determined for eachbatch of finished product.


Frequency: Temperature requirements of the dryingprocess should be monitored continuously by theinstrument itself, with visual check of themonitoring instrument at least once per day;ANDTime requirements of the drying process shouldbe monitored at least once per day, and wheneverany changes in belt speed are made;ANDMonitoring of all other critical factors specifiedby the study as often as necessary to maintaincontrol;


Continued

ORPercent weight loss should be determined foreach lot of finished product;

ORWater activity should be determined for each lotof finished product.




Who: Time and temperature monitoring isperformed by the equipment itself. However, avisual check should be made of the recorded dataat least once at the end of each cycle in order toensure that the critical limits have consistentlybeen met. These checks, as well as the monitoringof the other critical factors in the drying process,the percent weight loss, or the water activity maybe performed by the equipment operator, aproduction supervisor, a member of the qualitycontrol staff, a member of the maintenance orengineering staff, or any other person who has anunderstanding of the operation of the equipmentand the critical limit. In assigning responsibilityfor monitoring you should consider the complexityof the monitoring equipment. For example,accurately performing water activity analyses

requires considerable training.


Who: Temperature monitoring is performed by theequipment itself. However, a visual checkshould be made of the recorded data at least dailyin order to ensure that the critical limits haveconsistently been met. These checks, as well asthe monitoring of the drying time and the othercritical factors in the drying process, the percentweight loss, or the water activity may beperformed by the equipment operator, aproduction supervisor, a member of the qualitycontrol staff, a member of the maintenance orengineering staff, or any other person who has

an understanding of the operation of theequipment and the critical limit. In assigningresponsibility for monitoring you shouldconsider the complexity of the monitoringequipment. For example, accurately performingwater activity analyses requires considerabletraining.



For the drying step, describe the procedures that youwill use when your monitoring indicates that the CLhas not been met. These procedures should: 1)ensure that unsafe product does not reach the con-sumer; and, 2) correct the problem that caused theCL deviation. Remember that deviations fromoperating limits do not need to result in formal correc-tive actions.

Following is guidance on establishing correctiveaction procedures for the drying step.


Corrective Action: Take one or more of thefollowing actions as necessary to regain controlover the operation after a CL deviation:• Adjust the air temperature or velocity;OR• Adjust the length of the drying cycle to

compensate for a temperature or velocity drop,humidity increase, or inadequate percentweight loss;

OR• Adjust the belt speed to increase the length of

the drying cycle;AND

When there has been a failure to maintainspecified critical factors of the drying process, orwhen the prescribed minimum percent weightloss is not met, take one of the following actionsto the product involved in the deviation:• Destroy the product;


OR• Redry the product (provided that redrying does

not present an unacceptable opportunity forpathogen growth);

OR• Segregate and hold the product (under

refrigerated conditions) for an evaluation ofthe adequacy of the drying process. Theevaluation may involve water activity determination on a representative sample of the finishedproduct. If the evaluation shows that theproduct has not received an adequate dryingprocess the product should be destroyed,diverted to a non-food use, or redried;

OR• Divert the product to a use in which the critical

limit is not applicable because pathogen growthin the finished product will be controlled bymeans other than drying (e.g. divert inadequatelydried fish to a frozen fish operation);

OR• Divert the product to a non-food use.

ANDWhen finished product testing shows that thewater activity is above 0.85, take one of thefollowing actions to the product involved in thedeviation:• Destroy the product;OR• Re-dry the product (where re-drying does not

create a hazard for pathogen growth);OR• Divert the product to a use in which the critical

limit is not applicable because pathogengrowth in the finished product will becontrolled by means other than drying (e.g.divert inadequately dried fish to a frozen fishoperation);

OR• Divert the product to a non-food use.



For the drying step, list the records that will be usedto document the accomplishment of the monitoringprocedures discussed in Step #15. The recordsshould clearly demonstrate that the monitoringprocedures have been followed, and should containthe actual values and observations obtained duringmonitoring. Following is guidance on establishing arecordkeeping system for the drying step.



Records: Temperature recorder charts or digitaltime/temperature data logger printout;ANDRecords that are appropriate for the other criticalfactors (e.g. drying log that indicates input/outputair humidity and/or velocity);

ORRecords of weight before and after drying;

ORRecords of water activity analysis for each lotof product.


Records: Temperature recorder charts or digitaltime/temperature data logger printout;ANDDrying log that indicates the RPM of the beltdrive wheel or the time necessary for a test unitor belt marking to pass through the drier;ANDRecords that are appropriate for the other criticalfactors (e.g. drying log that indicates input/outputair humidity and/or velocity);

ORRecords of weight before and after drying;

ORRecords of water activity analysis for each lotof product.




For the drying step, establish verification proceduresthat will ensure that the HACCP plan is: 1) adequateto address the hazard of “pathogen growth and toxinformation as a result of inadequate drying; and, 2)consistently being followed. Following is guidanceon establishing verification procedures for the dryingstep.


Verification: Process establishment (except wherefinished product water activity analysis is themonitoring procedure): The adequacy of thedrying process should be established by ascientific study. For shelf-stable products, itshould be designed to ensure the production of ashelf stable product with a water activity of 0.85.For refrigerated (not frozen), reduced oxygenpackaged products, it should be designed toensure a finished water activity of less than 0.97.Expert knowledge of drying process calculationsand the dynamics of mass transfer in processingequipment is required to establish such a dryingprocess. Such knowledge can be obtained byeducation or experience or both. Establishmentof drying processes requires access to adequatefacilities and the application of recognizedmethods. The drying equipment must be


designed, operated and maintained to deliver theestablished drying process to every unit ofproduct. In some instances, drying studies willbe required to establish the minimum process.In other instances, existing literature whichestablish minimum processes or adequacy ofequipment, are available. Characteristics of theprocess, product and/or equipment that affect theability of the established minimum dryingprocess should be taken into consideration in theprocess establishment. A record of the processestablishment should be maintained;

ANDFinished product sampling and analysis todetermine water activity at least once every threemonths (except where such testing is performedas part of monitoring);

ANDCheck the accuracy of the temperature recordingdevice or digital time/temperature data loggersagainst a known accurate thermometer(NIST-traceable) at least once per day;

ANDCalibrate other instruments as necessary toensure their accuracy;

ANDReview monitoring, corrective action, andverification records within one week ofpreparation.



Exam

ple

Onl

y

See

Text

for

Ful

l Rec

omm

enda

tion

s

•M

axim

um p

rodu

ctth

ickne

ss 1

/4"

•M

inim

um d

ryin

g tim

e5

hour

s

•M

inim

um o

ven

tempe

ratu

re 1

40o F

To ac

hiev

e a fi

nal w

ater

activ

ity o

f 0.8

5 or

less

•Pr

oduc

tth

ickn

e ss

•Dr

ying

tim

e

•Ov

en a

ir in

put

tem

pera

ture

(2)

Sign

ifica

ntH

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch P

reve

ntiv

eM

easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Rec

ords

Wha

tH

owFr

eque

ncy

Who

(10)

Veri

ficat

ion

TABL

E #1

4-1

Cont

rol S

trat

egy

Exam

ple

1 -

Cont

rol o

f dr

ying

This

tabl

e is

an

exam

ple

of a

por

tion

of a

HA

CC

P pl

an re

latin

g to

the

cont

rol o

f pat

hoge

n gr

owth

and

toxi

n fo

rmat

ion

as a

resu

lt of

inad

equa

te d

ryin

g fo

r a p

roce

ssor

of s

helf-

stab

le s

alm

on je

rky,

usi

ng C

ontro

l Stra

tegy

Exa

mpl

e 1

- Con

trol o

f dry

ing.

It is

pro

vide

d fo

r illu

stra

tive

purp

oses

onl

y. P

atho

gen

grow

th a

nd to

xin

form

atio

n as

a re

sult

of in

adeq

uate

dry

ing

may

be

only

one

of s

ever

al s

igni

fican

t haz

ards

for t

his

prod

uct.

Ref

er to

Tab

les

3-1,

3-2

, and

3-3

(Cha

pter

3)

for o

ther

pot

entia

l haz

ards

(e.g

. aqu

acul

ture

dru

gs, c

hem

ical

con

tam

inan

ts, p

aras

ites,

and

met

al fr

agm

ents

).

Path

ogen

gro

wth

and

toxi

n fo

rmati

on•

Pres

et sli

cer t

oju

st les

s tha

n1/

4"

•Di

gital

tim

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mpe

ratu

reda

ta lo

gger

•Di

gital

tim

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mpe

ratu

reda

ta lo

gger

•Pr

oces

sing

log

•Da

ta lo

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prin

tout

•Da

ta lo

gger

prin

tout

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ce p

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aybe

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ope r

a tio

ns

•Co

ntin

uous

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isual

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ntin

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tch

•Re

adju

st sli

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•Ex

tend

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ngpr

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s

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uct a

nd h

old

for e

valu

ation

.Ev

aluate

by

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gwa

ter a

ctivi

tyan

alysis

on

finish

ed p

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ct.Re

-dry

if m

ore

than

0.8

5

•Sl

icer o

pera

tor

•Ov

en o

pera

tor

•Ov

en o

pera

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•Do

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of d

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gpr

oce s

se s

tabl

ishm

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rifica

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and

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with

in o

newe

ek o

fpr

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n

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eck

the

accu

racy

of t

heda

ta lo

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daily

.

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a lyz

efin

ished

pro

duct

sam

ple

once

ever

y 3

mon

ths

for w

ater

a ctiv

ity

Dryi

ng (f

orce

dco

nvec

tion

oven

)

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

Not

e: T

he c

ritic

al li

mits

in th

is e

xam

ple

are

for i

llust

rati v

e pu

rpos

es o

nly,

and

are

not

rela

ted

to a

ny re

com

men

ded

proc

ess.

Chapter 15: Staphylococcus aureus Toxin Formationin Hydrated Batter Mixes (A Biological Hazard)

Continued



Staphylococcus aureus toxin formation in hydratedbatter mixes can cause consumer illness. This toxinin particular is a concern because the toxin cannot bedestroyed by heating steps that may be performed bythe processor or the consumer. Pathogens other thanS. aureus, such as those described in Chapter 12, are,in many cases, less likely to grow in hydrated battermixes, and are likely to be killed by the heating stepsthat follow.

• Control of Staphylococcus aureus in batter mixes

S. aureus can enter the process on raw materials. Itcan also be introduced into foods during processingfrom unclean hands and insanitary utensils andequipment.

The hazard develops when a batter mix is exposed totemperatures favorable for S. aureus growth forsufficient time to permit toxin development. S. aureustoxin does not normally reach levels that will causefood poisoning until the numbers of the pathogenreach 100,000 to 1,000,000/gram. S. aureus willgrow at temperatures as low as 41-43˚F (5.0-6.1˚C)and at a water activity as low as .85 (additionalinformation on conditions favorable toS. aureus growth are provided in Table #A-1 (Appen-dix 4). However, toxin formation is not likely attemperatures lower than 50˚F (10˚C). For thisreason, toxin formation can be controlled by mini-mizing exposure of hydrated batter mixes to tempera-tures above 50˚F (10˚C). Exposure times greaterthan 12 hours for temperatures between 50˚F (10˚C)and 70˚F (21.1˚C) could result in toxin formation.Exposure times greater than 3 hours for temperaturesabove 70˚F (21.1˚C) could also result in toxinformation.


There are a number of strategies for the control ofpathogens in fish and fishery products. They include:

• Managing the amount of time that food is exposedto temperatures that are favorable for pathogengrowth and toxin production (covered in this chapterfor S. aureus in hydrated batter mix; Chapter 13 forC. botulinum; and Chapter 12 for other pathogensand conditions);

• Killing pathogens by cooking (covered in Chapter16), pasteurizing (covered in Chapter 17), or retorting(covered by the low acid canned foods regulations,21 CFR 113);

• Controlling the amount of moisture that is availablefor pathogen growth, water activity, in the product bydrying (covered in Chapter 14);

• Controlling the amount of moisture that is availablefor pathogen growth, water activity, in the product byformulation (covered in Chapter 13);


• Controlling the level of acidity, pH, in the product(covered by the acidified foods regulations, 21 CFR114 for shelf-stable acidified products; and forrefrigerated acidified products in Chapter 13).

Chapter 15: Batter201


At each processing step, determine whether“S. aureus toxin formation in hydrated batter mixes”is a significant hazard. The criteria are:

1. Is it reasonably likely that S. aureus will grow andform toxin in the hydrated batter mix at the hydratedbatter mix storage/recirculation step?

Remember that you should consider the potential fortime/temperature abuse in the absence of controls.You may already have controls at the hydrated battermix storage/recirculation step that minimize thepotential for time/temperature abuse that could resultin S. aureus growth and toxin formation. This andthe following steps will help you determine whetherthose or other controls should be included in yourHACCP plan.

Step #10 provides information to help you decide ifthe time/temperature conditions of your hydratedbatter mix storage/recirculation step are significantfor this hazard.

2.Can S. aureus growth and toxin formation, which isreasonably likely to occur, be eliminated or reduced toan acceptable level at this processing step?(Note: If you are not certain of the answer to thisquestion at this time, you may answer “No.” How-ever, you may need to change this answer when youassign critical control points in Step #12.)

“S. aureus toxin formation in hydrated batter mixes”should also be considered a significant hazard at anyprocessing step where a preventive measure is, or canbe, used to eliminate (or reduce the likelihood ofoccurrence to an acceptable level) the hazard, if it isreasonably likely to occur.

Step #10 discusses a number of pathogen controlstrategies. This chapter covers control of S. aureustoxin formation that occurs as a result of time/temperature abuse at the hydrated batter mix storage/recirculation step. A preventive measure for toxinformation can include controlling the amount of timethat batter mixes are exposed to temperatures above50˚F (10˚C).

List this preventive measure in Column 5 of theHazard Analysis Worksheet at the batter mix storage/recirculation step.

If the answer to either question 1 or 2 is “Yes” thepotential hazard is significant at that step in theprocess and you should answer “Yes” in Column 3 ofthe Hazard Analysis Worksheet. If none of thecriteria is met you should answer “No.” You shouldrecord the reason for your “Yes” or “No” answer inColumn 4. You need not complete Steps #12 through18 for this hazard for those processing steps whereyou have recorded a “No.”

It is important to note that identifying this hazard assignificant at a processing step does not mean that itmust be controlled at that processing step. The nextstep will help you determine where the criticalcontrol point is located.

• Intended use

In determining whether a hazard is significant youshould also consider the intended use of the product,which you developed in Step #4. However, becauseof the highly stable nature of S. aureus toxin, it isunlikely that the intended use will affect the signifi-cance of the hazard.


STEP #12: IDENTIFY CRITICAL CONTROLPOINTS (CCP).

For each processing step where “S. aureus growthand toxin formation in hydrated batter mixes” isidentified in Column 3 of the Hazard AnalysisWorksheet as a significant hazard, determine whetherit is necessary to exercise control at that step in orderto control the hazard. Figure #A-2 (Appendix 3) is aCCP decision tree that can be used to aid you in yourdetermination.

You should identify the hydrated batter mix storage/recirculation step as the critical control point for thishazard. For hand battering operations, where hy-drated batter mix is stored at each hand batteringstation, each station should be identified as a CCP.

This control approach will be referred to as “ControlStrategy Example 1” in Steps #14-18. It is importantto note that you may select a control strategy that isdifferent from that which is suggested above, pro-vided that it assures an equivalent degree of safety ofthe product.

You should answer “Yes” in Column 6 of the HazardAnalysis Worksheet at the hydrated batter mixstorage/recirculation step and “No” in that columnfor the other processing steps for which the hazardwas identified as a significant hazard. In addition,for each “No” entry make sure that Column 5 indi-cates that the hazard is controlled at the hydratedbatter mix storage/recirculation step. (Note: if youhave not previously identified “S. aureus growth andtoxin formation in hydrated batter mixes” as asignificant hazard at the hydrated batter mix storage/recirculation step in Column 3 of the Hazard Analy-sis Worksheet, you should change the entry inColumn 3 to “Yes”.)

Example:A breaded fish processor could set the critical controlpoint for controlling the hazard of “S. aureus growthand toxin formation in hydrated batter mixes” at thehydrated batter mix storage/recirculation step. Theprocessor would not need to identify other processingsteps as critical control points for that hazard.


HACCP Plan Form


For the hydrated batter mix storage/recirculation step,identify the maximum or minimum value to which afeature of the process must be controlled in order tocontrol the hazard.

You should set the CL at the point that if not met thesafety of the product may be questionable. If you seta more restrictive CL you could, as a result, berequired to take corrective action when no safetyconcern actually exists. On the other hand, if you seta CL that is too loose you could, as a result, allowunsafe product to reach the consumer.


Following is guidance on setting critical limits for thehydrated batter mix storage/recirculation step.

• CONTROL STRATEGY EXAMPLE 1 -HYDRATED BATTER MIX CONTROL

Critical Limit: Hydrated batter mix temperaturesshould not exceed 50˚F (10˚C) for more thantwelve hours, cumulatively;

ANDHydrated batter mix temperatures should notexceed 70˚F (21.1˚C) for more than three hours,cumulatively.


ContinuedChapter 15: Batter

203



How: Use a digital time/temperature data logger;ORUse a recorder thermometer;ORUse a maximum indicating thermometer;ORUse a high temperature alarm;ORUse an indicating thermometer.



Frequency: Continuous monitoring, with visualcheck at least once per day;ORFor indicating thermometers: at least every twohours.



Who: With recorder thermometers, high temperaturealarms, maximum indicating thermometers, anddigital data loggers, monitoring is performed bythe equipment itself. However, when suchinstruments are used, a visual check should bemade at least once per day in order to ensure thatthe critical limits have consistently been met.These checks, as well as indicating thermometerchecks, may be performed by a productionemployee, a production supervisor, a member ofthe quality control staff, or any other person whohas an understanding of the process and themonitoring procedure.



For the hydrated batter mix storage/recirculation step,describe monitoring procedures that will ensure thatthe critical limits are consistently met.




Following is guidance on establishing monitoringprocedures for the hydrated batter mix storage/recirculation step. Note that the monitoring frequen-cies that are provided are intended to be consideredas minimum recommendations, and may not beadequate in all cases.



What: The temperature of the hydrated batter mix.



For the hydrated batter mix storage/recirculation step,list the records that will be used to document theaccomplishment of the monitoring proceduresdiscussed in Step #15. The records should clearlydemonstrate that the monitoring procedures havebeen followed, and should contain the actual valuesand observations obtained during monitoring.

Following is guidance on establishing arecordkeeping system for the hydrated batter mixstorage/recirculation step.


Records: Printout from digital time/temperaturedata logger;ORRecorder thermometer chart;ORRecord showing the results of the maximumindicating thermometer checks;ORRecord showing the results of the hightemperature alarm checks;ORRecord showing the results of the indicatingthermometer checks.


Continued



For the hydrated batter mix storage/recirculation step,describe the procedures that you will use when yourmonitoring indicates that the CL has not been met.These procedures should: 1) ensure that unsafeproduct does not reach the consumer; and, 2) correctthe problem that caused the CL deviation. Remem-ber that deviations from operating limits do not needto result in formal corrective actions.

Following is guidance on establishing correctiveaction procedures for the hydrated batter mix storage/recirculation step.


Corrective Action: Take one or more of thefollowing actions to regain control over theoperation after a CL deviation:• Add ice to the hydrated batter mix storage/

recirculation tank;OR• Make repairs or adjustments to the hydrated

batter mix refrigeration equipment;AND

Take one of the following actions to productinvolved in the critical limit deviation:• Destroy the product and the remaining

hydrated batter mix;OR• Divert the product and the remaining hydrated

batter mix to a non-food use;OR• Hold the product and hydrated batter until it

can be evaluated based on its total time/temperature exposure;

OR• Hold the product and hydrated batter

mix until the hydrated batter mix can besampled and analyzed for the presence ofstaphylococcal enterotoxin.



For the hydrated batter mix storage/recirculation step,establish verification procedures that will ensure thatthe HACCP plan is: 1) adequate to address the hazardof “S. aureus growth and toxin formation in hydratedbatter mixes”; and, 2) consistently being followed.

Following is guidance on establishing verificationprocedures for the hydrated batter mix storage/recirculation step.

• CONTROL STRATEGY EXAMPLE 1 -

HYDRATED BATTER MIX CONTROL

Verification: Review monitoring, corrective action,and verification records within one week ofpreparation;

ANDWhen digital time/temperature data loggers,recorder thermometers, or high temperaturealarms are used, check for accuracy against aknown accurate thermometer (NIST-traceable) atleast once per day;

ANDWhen indicating thermometers or maximumindicating thermometers are used, check foraccuracy against a known accurate thermometer(NIST-traceable) when first used and at leastonce per year thereafter. (Note: optimalcalibration frequency is dependent upon thetype, condition, and past performance of themonitoring instrument.)



Exam

ple

Onl

y

See

Text

for

Ful

l Rec

omm

enda

tion

s

Hydr

ated

batte

r mix

tempe

ratu

re n

ot to

exce

ed 5

0o F fo

r mor

eth

an 1

2 hr

s, no

r 70o F

for

mor

e tha

n 3

hrs,

c um

ula t

ive

Hydr

ated

batte

rm

ix te

mpe

ratu

re

(2)

Sign

ifica

ntH

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch P

reve

ntiv

eM

easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Rec

ords

Wha

tH

owFr

e que

ncy

Who

(10)

Veri

ficat

ion

TABL

E #1

5-1

Cont

rol S

trat

egy

Exam

ple

1 -

Hyd

rate

d ba

tter

mix

con

trol

This

tabl

e is

an

exam

ple

of a

por

tion

of a

HA

CC

P pl

an re

latin

g to

the

cont

rol o

f S. a

ureu

s to

xin

form

atio

n in

hyd

rate

d ba

tter

mix

es fo

r a b

read

ed fi

sh p

roce

ssor

, usi

ng C

ontro

l Stra

tegy

Exa

mpl

e 1

- Hyd

rate

d ba

tter m

ix c

ontro

l. It

is p

rovi

ded

for i

llust

rativ

epu

rpos

es o

nly.

S. a

ureu

s to

xin

form

atio

n in

the

hydr

ated

bat

ter m

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in th

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are

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are

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Batte

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rec i

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Cri

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Con

trol

Poin

t (C

CP)


Notes:

Continued



The introduction of pathogens after pasteurization andcertain cooking processes can cause consumer illness.

Pasteurization is a mild or moderate heat treatment,usually performed on fishery products after theproduct is placed in the hermetically sealed finishedproduct container. The purpose of pasteurization is toeither: 1) make the product safe for an extendedrefrigerated shelf-life, which, in most cases, involveseliminating the spores of Clostridium botulinum typeE and nonproteolytic B and F (the types of C. botuli-num most commonly found in fish); or 2) eliminate orreduce the numbers of other target pathogens (e.g.Listeria monocytogenes, Vibrio vulnificus, Vibrioparahaemolyticus).

In addition to eliminating pathogens, the pasteuriza-tion process also greatly reduces the number ofspoilage bacteria present in the fishery product.These bacteria normally restrict the growth of patho-gens through competition. Rapid growth of patho-gens that may be introduced after pasteurization is,therefore, a concern. This chapter covers control ofrecontamination after pasteurization.

For some products that are marketed refrigerated,cooking is performed immediately before reducedoxygen packaging (e.g. vacuum packaging, modifiedatmosphere packaging). For these products, thecooking process is targeted to eliminate the spores ofClostridium botulinum type E and nonproteolytictypes B and F, particularly when the product does notcontain other barriers that are sufficient to preventgrowth and toxin formation by this pathogen (e.g.many refrigerated, vacuum packaged hot-filled soupsand sauces). These cooking processes, which arediscussed in Chapter 16, have much in common with

pasteurization processes, which are discussed inChapter 17. For example, control of recontaminationafter they are placed in the finished product containeris critical to the safety of these products. Addition-ally, because these products are cooked before theyare packaged, they are at risk for recontaminationbetween cooking and packaging. The risk of thisrecontamination is minimized by filling the containerin a continuous filling operation while the product isstill hot (i.e. hot filling), another critical step for thesafety of these products. This control strategy issuitable for products that are filled directly from thecooking kettle, where the risk of recontamination isminimized. It is not ordinarily suitable for productssuch as crabmeat, lobster meat, or crayfish meat, orother products that are handled between cooking andfilling. Hot filling is covered in this chapter.

• Control of pathogen introduction after pasteurizationand after cooking that is performed immediately beforereduced oxygen packaging

There are three primary causes of recontaminationafter pasteurization and after cooking that is per-formed immediately before reduced oxygen packag-ing. They are:

• Defective container closures;• Contaminated container cooling water;• Recontamination between cooking and reduced

oxygen packaging.

Poorly formed or defective container closures canincrease the risk of pathogens entering the container,especially during container cooling performed in awater bath. Contaminated cooling water can enterthrough the container closure, especially when theclosure is defective. Container closure can becontrolled by adherence to seal guidelines that areprovided by the container or sealing machine manu-facturer. Control is accomplished through periodicseal inspection.

Chapter 18: Post-pasteurization227

Chapter 18: Introduction of Pathogens After Pasteurizationand Specialized Cooking Processes (A Biological Hazard)

Contamination of cooling water can be controlled byensuring that a measurable residual of chlorine, orother approved water treatment chemical, is presentin the cooling water, or by ensuring that ultraviolet(UV) treatment systems are operating properly.

Recontamination between cooking and reducedoxygen packaging in continuous filling systemswhere the product is packaged directly from thekettle can be controlled by hot filling at temperaturesat or above 185˚F (85˚C). FDA is interested ininformation on the value of adding a time component(e.g. 3 minutes) to this hot filling temperaturerecommendation, to provide limited lethality for anynonproteolytic C. botulinum spores present on thepackaging material.

It may also be prudent to use packaging that has beenmanufactured or treated to inactivate spores of C.botulinum type E and nonproteolytic types B and F(e.g. gamma irradiation, hot extrusion). FDA isinterested in comment on the utility of such mea-sures.


There are a number of strategies for the control ofpathogens in fish and fishery products. They include:

• Controlling the introduction of pathogens after thepasteurization process and after cooking processperformed immediately before reduced oxygenpackaging (covered in this chapter);

• Killing pathogens by cooking (covered in Chapter16), pasteurizing (covered in Chapter 17), or retorting(covered by the low acid canned foods regulations,21 CFR 113);

• Controlling the level of acidity, pH, in the product(covered by the acidified foods regulations, 21 CFR114 for shelf-stable acidified products; and forrefrigerated acidified products in Chapter 13);

• Controlling the amount of moisture that is availablefor pathogen growth, water activity, in the product bydrying (covered in Chapter 14);

• Controlling the amount of moisture that is avail-able for pathogen growth, water activity, in theproduct by formulation (covered in Chapter 13);


• Managing the amount of time that food is exposedto temperatures that are favorable for pathogengrowth and toxin production (covered in Chapter 12;for C. botulinum, in Chapter 13; and for S. aureus inbatter mix, in Chapter 15).


At each processing step determine whether “intro-duction of pathogens after pasteurization” is asignificant hazard. The criteria are:

1. Is it reasonably likely that pathogens will be intro-duced at this processing step (consider post-pasteur-ization processing steps, only)?

It is reasonable to assume that, in the absence ofcontrols, pathogens of various types may enter thefinished product container during a water bathcooling process or between cooking and reducedoxygen packaging.

2. Can the introduction of pathogens after pasteuriza-tion be eliminated or reduced to an acceptable levelhere? (Note: If you are not certain of the answer tothis question at this time, you may answer “No.”However, you may need to change this answer whenyou assign critical control points in Step #12)

“Introduction of pathogens after pasteurization”should also be considered a significant hazard at anyprocessing step where a preventive measure is, orcan be, used to eliminate (or reduce the likelihood ofoccurrence to an acceptable level) the hazard, if it isreasonably likely to occur.


However, if your product is immediately frozen afterprocessing, maintained frozen throughout distribu-tion, and labeled to be held frozen and to be thawedunder refrigeration immediately before use (e.g.“Important, keep frozen until used, thaw underrefrigeration immediately before use”), then forma-tion of C. botulinum toxin may not be a significanthazard.


For each processing step where “introduction ofpathogens after pasteurization” is identified inColumn 3 of the Hazard Analysis Worksheet as asignificant hazard, determine whether it is necessaryto exercise control at that step in order to control thehazard. Figure #A-2 (Appendix 3) is a CCP decisiontree that can be used to aid you in your determina-tion.

You should identify the container sealing step, thewater bath container cooling step, and the hot fillingstep (where applicable) as the critical control pointsfor this hazard. Therefore, you should answer “Yes”in Column 6 of the Hazard Analysis Worksheet forthe container sealing, water bath container cooling,and hot filling steps. (Note: if you have not previ-ously identified “pathogen introduction after pasteur-ization” as a significant hazard at the containersealing, water bath container cooling, and hot fillingsteps in Column 3 of the Hazard Analysis Worksheet,you should change the entries in Column 3 to “Yes”).

This control approach is referred to as “ControlStrategy Example 1” in Steps #14-18. It is importantto note that you may select a control strategy that isdifferent from that which is suggested above, pro-vided that it assures an equivalent degree of safety ofthe product.


Continued

Step #10 discusses a number of pathogen controlstrategies. This section covers control of pathogenintroduction that can occur after the pasteurizationprocess and between cooking and reduced oxygenpackaging. Preventive measures for the introductionof pathogens at these times can include:

• Controlling container sealing;• Controlling the residual of chlorine, or other

approved water treatment chemical, in containercooling water;

• Controlling UV light intensity of bulbs used fortreating container cooling water and the flow rateof the cooling water moving through the UVtreatment system;

• Hot filling the product into the final container in acontinuous filling system.




• Intended use and method of storage and distribution

In determining whether a hazard is significant youshould also consider the intended use of the product,which you developed in Step #4. However, for thosefishery products which are currently pasteurized, it isunlikely that the intended use will affect the signifi-cance of the hazard.


HACCP Plan Form


At each processing step where “introduction ofpathogens after pasteurization” is identified as asignificant hazard on the HACCP Plan Form (e.g.container sealing, water bath container cooling andhot filling) identify the maximum or minimum valueto which a feature of the process must be controlledin order to control the hazard.


As a practical matter it may be advisable to set anoperating limit that is more restrictive than the CL.In this way you can adjust the process when theoperating limit is triggered, but before a triggering ofthe CL would require you to take corrective action.You should set operating limits based on yourexperience with the variability of your operation andwith the closeness of typical operating values to theCL.

Following is guidance on setting critical limits for thecontrol strategy example identified in Step #12.

• CONTROL STRATEGY EXAMPLE 1 -CONTROL OF RECONTAMINATION

For container sealing:

Critical Limit: Container or sealing machinemanufacturer’s seal guidelines.

For container cooling:

Critical Limit: Measurable residual of chlorine, orother approved water treatment chemical, at thedischarge point of the container cooling tank;OREquipment manufacturer’s UV light intensity andflow rate guidelines.

For hot filling:

Critical Limit: Product temperature of 185˚F (85˚C) orhigher as the product enters the final container.



For each processing step where “introduction ofpathogens after pasteurization” is identified as asignificant hazard on the HACCP Plan Form (e.g.container sealing, container cooling tank and hotfilling), describe monitoring procedures that willensure that the critical limits are consistently met.




Following is guidance on establishing monitoringprocedures for the control option discussed in Step#12. Note that the monitoring frequencies that areprovided are intended to be considered as minimumrecommendations, and may not be adequate in allcases.


OR- For pouches: Visual examination should be

sufficient to detect gross closure defects,including: cuts, fractures, non-bonding,malformation, puncture, abrasion, blister,contaminated seal, delamination, seal creep,wrinkle, flex cracks, crushed package or otherobvious defects;

OR- For glass containers, visual examination

should be sufficient to detect gross closureand glass defects, including: cap tilt, cockedcap, crushed lug, stripped cap, cut through,and chipped and cracked glass finish;

ANDDetailed examination of containers (destructive):• Recommendations for seal evaluation

measurements that ensure a reliable hermeticseal should be obtained from the container orsealing machine manufacturer. They shouldinclude:- For double seamed metal and plastic cans:

The examination should include a teardownexamination of the can. If the micrometermethod is used, three (3) measurements,approximately 120˚ apart around the doubleseam, should be made. Measurements shouldinclude: cover hook, body hook, width,tightness, and thickness. If the opticalmethod (seamscope or projector) is used, cutsshould be made at at least two (2) differentlocations, excluding the side seam juncture.Measurements should include body hook,overlap, tightness, and thickness;

OR- For pouches: The examination should

include: burst testing or vacuum or bubbletesting. It may also include: drop testing, peeltesting (tensile strength), residual gas testing,electroconductivity testing, and dye testing;

OR- For glass containers: The examination should

include cold water vacuum testing.Additional examinations can include: securityvalues (lug-tension) for lug-type caps; and,pull-up (lug position) for lug-type, twist caps.

Continued




What: Container integrity


What: Residual chlorine, or other approved watertreatment chemical, in the cooling water;

ORIntensity of UV light;ANDCooling water flow rate.

For hot filling:

What: Product temperature as the product enters thefinal container.




How: Visual examination of containers(non-destructive):• Recommendations for visual examinations that

ensure a reliable hermetic seal should beobtained from the container or sealing machinemanufacturer. They should include:- For double seamed metal and plastic cans:

The external features of the double seamshould be examined for gross closure defects,including: cutovers, seam sharpness, falseseams, deadheading, droop, damage to thecountersink wall indicating a broken chuck,cable cuts, and product overlapping theflange. In addition, visual examinationshould include examination of the entirecontainer for product leakage or otherobvious defects;



How: Measure residual of chlorine, or otherapproved water treatment chemical, at thedischarge point of the container cooling tank;

ORUse a UV light meter;ANDUse a flow rate meter.

For hot filling:

How: Use a digital time/temperature data logger;ORUse a recorder thermometer.




Frequency: Visual examination of containers: Atleast one container from each sealing head at leastevery 30 minutes of sealing machine operation.At a minimum this should include visualexaminations made at the beginning ofproduction, and immediately following a jam inthe sealing machine, or machine adjustment,repair, or prolonged shut down;

ANDDetailed examination of containers: At least onecontainer from each sealing head at least everyfour hours of sealing machine operation. At aminimum this should include examinations madeat the beginning of production and immediatelyfollowing a jam in the sealing machine, ormachine adjustment, repair, or prolonged shutdown.


Frequency: For residual water treatment chemical:Sufficient frequency to assure control, but no lessfrequently than once every four hours of use;

ORFor UV light meter and flow rate meter:at least daily.

For hot filling:

Frequency: Continuous monitoring by the instrumentitself, with visual check of the instrument at leastonce per batch of cooked product.




Who: Monitoring may be performed by the sealingmachine operator, a production supervisor, amember of the quality control staff, or anyperson who is trained and qualified to conductcontainer examinations.


Who: Monitoring may be performed by theequipment operator, a production supervisor, amember of the quality control staff or any otherperson who has an understanding of the testingprocedure and the critical limits.

For hot filling:

Who: With recorder thermometers and digital dataloggers, monitoring is performed by theequipment itself. However, when suchinstruments are used a visual check should beperformed at least once per batch of cookedproduct in order to ensure that the critical limitshave consistently been met. These checks maybe performed by a production employee, aproduction supervisor, a member of the qualitycontrol staff, or any other person who has anunderstanding of the process and the monitoringprocedure.


Continued



At each processing step in which “introduction ofpathogens after pasteurization” is identified as asignificant hazard in the HACCP Plan Form (e.g.container sealing, water bath container cooling andhot filling), describe the procedures that you will usewhen your monitoring indicates that the CL has notbeen met.


Following is guidance on establishing correctiveaction procedures for the control option discussed inStep #12.



Corrective Action: Identify and correct the sourceof the defect after a CL deviation;

ANDEvaluate the seriousness of the defects, and, ifnecessary, identify, segregate, and hold theaffected product for appropriate follow-upaction. That may include, but is not limited to,100% visual inspection of all affected containersto remove the defective containers;ORRepack the affected product.


Corrective Action: If no measurable residualchlorine, or other approved water treatmentchemical, is detected, add chlorine or adjust thechlorine metering system and recheck forchlorine residual;

ORIf UV intensity is inadequate, replace or clean thebulbs or shields;ANDIf flow exceeds the critical limit, adjust orreplace the pump.

For hot filling:

Corrective Action: Take one or more of the followingactions to regain control over the operation after a CLdeviation:

• Adjust the cooking equipment to increase theprocessing temperature;

OR• Adjust the post-cook process to minimize time

delays;AND

Take one of the following actions to the productinvolved in the critical limit deviation:• Destroy the product;OR• Recook the product;OR• Segregate and hold the product for a safety

evaluation. If the product is found to beunsafe, it should be destroyed, diverted to a

non-food use, or recooked to eliminatepotential pathogens of public health concern;

OR• Divert the product to a use in which the critical

limit is not applicable (e.g. divert to a canningoperation);

OR• Divert to a non-food use.




At each processing step in which “introduction ofpathogens after pasteurization” is identified as asignificant hazard and critical control point in theHACCP Plan Form (e.g. container sealing, water bathcontainer cooling and hot filling), list the records thatwill be used to document the accomplishment of themonitoring procedures discussed in Step #15. Therecords should clearly demonstrate that the monitor-ing procedures have been followed, and shouldcontain the actual values and observations obtainedduring monitoring.

Following is guidance on establishing arecordkeeping system for the control option dis-cussed in Step #12.



Records: Record of visual examination ofcontainers;

ANDRecord of detailed examination of containers.


Records: Record of residual chlorine, or otherapproved water treatment chemical, levels;

ORRecord of UV intensity testing;ANDRecord of flow rate testing.

For hot filling:

Records: Printout from digital time/temperature datalogger;ORRecorder thermometer chart.



At each processing step in which “introduction ofpathogens after pasteurization” is identified as asignificant hazard in the HACCP Plan Form (con-tainer sealing, water bath container cooling and hotfilling), establish verification procedures that willensure that the HACCP plan is: 1) adequate toaddress the hazard of “introduction of pathogensafter pasteurization”; and, 2) consistently beingfollowed.

Following is guidance on establishing verificationprocedures for the control option discussed in Step#12.



Verification: Obtain container seal guidelines fromcontainer or sealing machine manufacturer;

ANDReview monitoring and corrective action recordswithin one week of preparation.



For hot filling:

Verification: Review monitoring and corrective actionrecords within one week of preparation.




Exam

ple

Onl

y

See

Text

for

Ful

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s

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ody

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(2)

Sign

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Cri

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(4)

(5)

(6)

(7)

Mon

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)C

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Rec

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Wha

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Who

TABL

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Exam

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1 -

Cont

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f re

cont

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atio

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This

tabl

e is

an

exam

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of a

por

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of a

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CC

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the

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Tab

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(1)

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Wate

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(10)

Veri

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Notes:


Chapter 19: Allergens, Food Intolerance Substances andProhibited Food & Color Additives (A Chemical Hazard)

Continued



Certain food and color additives can cause anallergic-type reaction (food intolerance) in consum-ers. Examples of such food and color additives thatare used on fish and fishery products include:sulfiting agents and FD&C Yellow #5. Sulfitingagents are mostly used during on-board handling ofshrimp and lobster to prevent the formation of“black spot.” They are sometimes used by cookedoctopus processors as an antioxidant, to retain thered color of the octopus skin. FD&C Yellow #5 isused during in-plant processing. These food andcolor additives are permitted for use in foods, withcertain restrictions, but their presence must bedeclared on the label. This label declaration isparticularly important to sensitive individuals.

Certain other food and color additives are prohibitedfrom use in food because of a determination by FDAthat they present a potential risk to the public health.Examples of such food and color additives include:safrole and FD&C Red #4.

Additionally, a number of foods contain allergenicproteins that can pose a health risk to certain sensi-tive individuals. Appendix 6 contains a list of suchfoods that account for most of all food allergies.While the controls in this chapter are not directlyapplicable to the hazard of allergenic proteins, ifthese foods are part of or are directly added to yourfishery product, you may use the principles con-tained in this chapter to ensure that the product isproperly labeled. However, these controls are notdesigned to prevent the unintentional introduction ofallergenic proteins from such foods into your fisheryproduct because of cross-contact (e.g. use of com-mon equipment, improper production scheduling, orimproper use of rework material). Unintentional

introduction of allergenic proteins must be controlledthrough a rigorous sanitation regime, either as part ofa prerequisite program or as part of HACCP itself.The Seafood HACCP Regulation requires such aregime.

STEP #11: DETERMINE IF THISPOTENTIAL HAZARD IS SIGNIFICANT

At each processing step, determine whether “allergens/additives” is a significant hazard. The criteria are:

1. Is it reasonably likely that a food or color additivethat can cause an allergic-type reaction (e.g. sulfitingagents or FD&C yellow #5) or a prohibited substance(e.g. safrole and FD&C Red #4) will be introduced at alevel that can cause an allergic-type reaction at thisprocessing step (e.g. does it come in with the rawmaterial or will the process introduce it)?

For example, under ordinary circumstances, it wouldbe reasonably likely to expect that food or coloradditives that can cause an allergic-type reactioncould enter the process under the following circum-stances:

• Sulfiting agents may be used on shrimp and lobsterbetween capture and delivery to the processor.However, in some regions even with these products(e.g. some aquacultured shrimp) this practice maynot be reasonably likely.

• Sulfiting agents may also be used in the processingof cooked octopus.

Sulfiting agents added directly to a finished foodmust be declared on a product’s labeling regardlessof the concentration of the sulfiting agent. When notdirectly added to the finished food, sulfiting agentsmust be declared on a product’s labeling when thelevel is at or above 10 ppm.

Chapter 19: Allergens/Additives237

• FD&C Yellow #5 may be used in the processing offormulated fishery products or in the production ofsmoked fish.

2. Can the hazard be eliminated or reduced to anacceptable level here? (Note: If you are not certain ofthe answer to this question at this time, you mayanswer “No.” However, you may need to change thisanswer when you assign critical control points inStep #12)

“Allergens/additives” should also be considered asignificant hazard at a processing step if a preventivemeasure is or can be used to prevent or eliminate thehazard or is adequate to reduce the likelihood ofoccurrence of the hazard to an acceptable level, if itis reasonably likely to occur. Preventive measuresfor allergic-type reactions that can result from thepresence of certain food and color additives (e.g.sulfiting agents and FD&C yellow #5) could include:

• Declaring the presence of food and color additivesthat can cause an allergic-type reaction on finishedproduct labeling;

• Testing incoming shrimp or lobster for residues ofsulfiting agents at or above 10 ppm;

• Receiving a supplier’s certification of the lack ofsulfiting agent use on incoming lots of shrimp orlobster (with appropriate verification – see Step

#18);• Reviewing the labeling (or accompanying

documents, in the case of unlabeled product) onshipments of shrimp or lobster received fromanother processor for the presence of a sulfitingagent declaration

A preventive measure for the presence of prohibitedfood and color additives could include:

• Testing incoming lots of fish for the presence ofprohibited food and color additives which there isreason to believe may be present.

• Receiving a supplier’s certification that prohibitedfood and color additives were not used on the incom-ing lot of fish (with appropriate verification – seeStep #18).




• Intended use

In determining whether a hazard is significant youshould also consider the intended use of the product,which you developed in Step #4. However, in thecase of allergens/additives, it is not likely that thesignificance of the hazard will be affected by theintended use of the product.


For each processing step where “allergens/additives”is identified in Column 3 of the Hazard AnalysisWorksheet as a significant hazard, determine whetherit is necessary to exercise control at that step in orderto control the hazard. Figure #A-2 (Appendix 3) is aCCP decision tree that can be used to aid you in yourdetermination.

The following guidance will also assist you indetermining whether a processing step is a CCP for“allergens/additives”:

1. In the case of shrimp or lobster for which you haveidentified sulfiting agents as a significant hazard, willthe finished product label declare the presence ofsulfiting agents?


a.If it will, you may identify the finished productlabeling step as the CCP. Alternately, you mayidentify the receipt of product labels as the CCP(where you can check labels for the presence of asulfiting agent declaration). The raw materialreceiving step would then not require control andwould not need to be identified as a CCP for thehazard of improper use of allergens/additives.

In this case enter “Yes” in Column 6 of theHazard Analysis Worksheet for the finishedproduct labeling step or receipt of product labelsstep, and enter “No” for the raw materialreceiving step. In addition, for the raw materialreceiving step enter in Column 5 that the hazardis controlled by the finished product labeling stepor the receipt of product labels step. (Note: ifyou have not previously identified “allergens/additives” as a significant hazard at the finishedproduct labeling step or receipt of product labelsstep in Column 3 of the Hazard AnalysisWorksheet, you should change the entry inColumn 3 to “Yes”.) This control approach willbe referred to as “Control Strategy Example 1”in Steps #14 through 18.

Example:A frozen shrimp processor that labels allfinished product with a sulfiting agentdeclaration could set the critical control pointfor sulfiting agents (allergens/additives) atthe finished product labeling step. The processorwould not need to have a critical control pointfor this hazard at the shrimp receiving step.

b.If the finished product labeling will not declarethe presence of sulfiting agents, you may identifythe raw material receiving step as the CCP.

In this case enter “Yes” in Column 6 of theHazard Analysis Worksheet for the raw materialreceiving step. This control approach will bereferred to as “Control Strategy Example 2” inSteps #14 through 18.

Example:A frozen shrimp processor that receives shrimpdirectly from the harvest vessel and does notlabel finished product with a sulfiting agentdeclaration could set the critical control pointfor sulfiting agents (allegens/additives) at the

raw material receiving step and test incominglots of shrimp for the presence of sulfiting agents.

The processor would not need to have a criticalcontrol point for this hazard at finished productlabeling.

Example:A frozen shrimp processor that receives shrimpfrom another processor and does not labelfinished product with a sulfiting agent declarationcould set the critical control point for sulfitingagents (allegens/additives) at the raw materialreceiving step and reject incoming lots that areidentified as having been treated with a sulfitingagent (e.g. identified on the labeling or, in thecase of unlabeled product, on documentsaccompanying the shipment). The processorwould not need to have a critical control pointfor this hazard at finished product labeling.

c. If the finished product labeling will only declarethe presence of sulfiting agents when it is presentin the raw material, you may identify the finishedproduct labeling step or the receipt of productlabels step (where you can check labels for thepresence of a sulfiting agent declaration) as theCCP. Testing or certification at the raw materialreceiving step will be necessary to ensure controlat the CCP. However, the raw material receivingstep would not need to be identified as a CCP forthe hazard of “allergens/additives.”

In this case enter “Yes” in Column 6 of theHazard Analysis Worksheet for the finishedproduct labeling step or the receipt of productlabels step, and enter “No” for the raw materialreceiving step. In addition, for the raw materialreceiving step enter in Column 5 that the hazardis controlled by the finished product labeling stepor the receipt of product labels step. (Note: ifyou have not previously identified “allergens/additives” as a significant hazard at the finished

ContinuedChapter 19: Allergens/Additives

239

product labeling step or receipt of product labelsstep in Column 3 of the Hazard AnalysisWorksheet, you should change the entry inColumn 3 to “Yes”.) This control approach willbe referred to as “Control Strategy Example 3” inSteps #14 through 18.

Example:A frozen shrimp processor that receives shrimpdirectly from the harvest vessel and labelsfinished product with a sulfiting agent declarationonly if testing at receipt identifies a residue of asulfiting agent could set the critical control pointfor sulfiting agents (allergens/additives) at thefinished product labeling step or the receipt ofproduct labels step. The processor would not

need to have a critical control point for thishazard at the raw material receiving step.

Example:A frozen shrimp processor that receives shrimpfrom another processor and labels finishedproduct with a sulfiting agent declaration only ifthe incoming lot was identified as having beentreated with a sulfiting agent (e.g. identified onthe labeling or, in the case of unlabeled product,on documents accompanying the shipment),could set the critical control point for sulfitingagents (allergens/additives) at the finishedproduct labeling step or the receipt of productlabels step. The processor would not need tohave a critical control point for this hazard at theraw material receiving step.

2. In the case of cooked octopus for which you haveidentified sulfiting agents as a significant hazard, andin the case of products for which you have identifiedFD&C Yellow #5 as a significant hazard because youuse one of these food and color additives in the productformulation, you should identify the finished productlabeling step or receipt of product labels step (whereyou can check labels for the presence of a sulfitingagent or FD&C Yellow #5 declaration, as appropriate)as the CCP. The processing step at which you add asulfiting agent or FD&C Yellow #5 would then notrequire control and would not need to be identified asa CCP for the hazard of “allergens/additives.”

In this case enter “Yes” in Column 6 of the HazardAnalysis Worksheet for the finished product labelingstep or receipt of product labels step, and enter “No”for the treatment step. In addition, for the treatmentstep enter in Column 5 that the hazard is controlledby the finished product labeling step or receipt ofproduct labels step. (Note: if you have not previouslyidentified “allergens/additives” as a significanthazard at the finished product labeling step or receiptof product labels step in Column 3 of the HazardAnalysis Worksheet, you should change the entry inColumn 3 to “Yes”.) This control approach will alsobe referred to as “Control Strategy Example 1” inSteps #14 through 18.

Example:A smoked sablefish processor that treats the fishwith FD&C Yellow #5 before smoking could setthe critical control point for FD&C Yellow #5(allergens/additives) at the finished productlabeling step or receipt of product labels step.The processor would not need to have a criticalcontrol point for this hazard at the treatmentstep.

Example:A cooked octopus processor that treats the fishwith a sulfiting agent could set the criticalcontrol point for sulfiting agents (allergens/additives) at the finished product labeling step orreceipt of product labels step. The processorwould not need to have a critical control pointfor this hazard at the treatment step.

3. In the case of products for which you have identifiedprohibited food and color additives (e.g. safrole andFD&C Red #4) as a significant hazard in incoming rawmaterials you should identify the raw material receivingstep as the CCP.

In this case enter “Yes” in Column 6 of the HazardAnalysis Worksheet for the raw material receivingstep. This control approach will be referred to as“Control Strategy Example 2” in Steps #14 through 18.



ORThe labeling or shipping documents for incominglots of shrimp or lobster received from anotherprocessor must not contain a sulfiting agentdeclaration;ORIncoming lots of raw materials must not containa detectable level of prohibited food and coloradditives;ORIncoming lots of raw materials must beaccompanied by a supplier’s lot-by-lot certificatethat prohibited food and color additives were notused.

• CONTROL STRATEGY EXAMPLE 3 -LABELING CONTROLS WITH RAW MATERIALSCREENING

Critical Limit: Finished product labels for productprocessed from raw materials that contain adetectable level of sulfite must contain asulfiting agent declaration.



For each processing step where “allergens/additives”is identified as a significant hazard on the HACCPPlan Form, describe monitoring procedures that willensure that the critical limits are consistently met.



Continued


HACCP Plan Form


For each processing step where “allergens/additives”is identified as a significant hazard on the HACCPPlan Form identify the maximum or minimum valueto which a feature of the process must be controlledin order to control the hazard.




• CONTROL STRATEGY EXAMPLE 1 -LABELING CONTROLS

Critical Limit: All finished product labels mustcontain a sulfiting agent or FD&C Yellow #5declaration, as appropriate.

• CONTROL STRATEGY EXAMPLE 2 -RAW MATERIAL SCREENING

Critical Limit: Incoming lots of shrimp or lobstermust not contain a detectable level of sulfite;ORIncoming lots of shrimp or lobster must beaccompanied by a supplier’s lot-by-lot certificatethat sulfiting agents were not used;







What: Finished product labels for presence ofsulfiting agent or FD&C Yellow #5 declaration,as appropriate.


What:Representative sample of each lot at receiptfor sulfiting agent residual analysis, or prohibited

food and color additive residual analysis, asappropriate;ORSupplier’s lot-by-lot certificate that no sulfitingagent, or prohibited food and color additive,as appropriate, was used on the lot (withappropriate verification – see Step #18);ORLabeling or accompanying documents for eachlot received from another processor, for thepresence of a sulfiting agent declaration.


What:Finished product labels for presence ofsulfiting agent declaration;

ANDOne of the following:• Representative sample of each lot for sulfiting

agent residual analysis;OR• Supplier’s lot-by-lot certificate that no sulfiting

agent was used on the lot (with appropriateverification – see Step #18);

ORLabeling or accompanying documents for eachlot received from another processor, for thepresence of a sulfiting agent declaration.



How: Visual examination.


How: Screening test for sulfiting agents or prohibitedfood and color additives, as appropriate;ORVisual examination of certificates;ORVisual examination of the labeling oraccompanying documents, for lots received fromanother processor.


How: Visual examination of labels;AND

One of the following:• Screening test for sulfiting agents;OR• Visual examination of certificates;ORVisual examination of the labeling oraccompanying documents, for lots received fromanother processor.



Frequency: At least one label from every case oflabels or one label from each pallet of pre-labeled

packaging material delivered to the packagingarea;ORAt least one label from every case of labels orone label from each pallet of pre-labeledpackaging material received at the firm.OROnce per day for on-site computer generatedlabels.


Frequency: Each incoming lot.


Frequency: At least one label from every case oflabels or one label from each pallet of pre-labeled

packaging material delivered to the packagingarea;OR

At least one label from every case of labels orone label from each pallet of pre-labeledpackaging material received at the firm.OROnce per day for on-site computer generatedlabels.

ANDEach lot of incoming shrimp or lobster.



Who: Monitoring may be performed by the labelingequipment operator, the receiving employee, aproduction supervisor, a member of the qualitycontrol staff, or any other person who has anunderstanding of the proper content of the label.


Who: Monitoring may be performed by the receivingemployee, a production supervisor, a member ofthe quality control staff, or any other person whothat has an understanding of the proper screeningprocedure. Assignment of responsibility fortesting procedures should be based, in part, onthe degree of difficulty of the analysis.


Who: Monitoring may be performed by the labelingequipment operator, the receiving employee, aproduction supervisor, a member of the qualitycontrol staff, or any other person that has anunderstanding of proper content of the label orthe screening procedure, as appropriate.Assignment of responsibility for testingprocedures should be based, in part, on thedegree of difficulty of the analysis.


ContinuedChapter 19: Allergens/Additives

243


For each processing step where “allergens/additives”is identified as a significant hazard on the HACCPPlan Form, describe the procedures that you will usewhen your monitoring indicates that the CL has notbeen met.




Corrective Action: Segregate and relabel anyimproperly labeled product;

ANDSegregate and return or destroy any label stockor pre-labeled packaging stock that does notcontain the proper declaration.


Corrective Action: Reject any incoming lot inwhich sulfiting agent or prohibited food andcolor additive, as appropriate, is detected ordeclared or which is not accompanied by asupplier’s certificate.

Note: If an incoming lot that fails to meet a receivingcritical limit is mistakenly accepted, and the error islater detected, the following actions should be taken:1) the lot and any products processed from that lotshould be destroyed, diverted to a nonfood use or to ause in which the critical limit is not applicable, orplaced on hold until a food safety evaluation can becompleted; and 2) any products processed from thatlot that have already been distributed should berecalled and subjected to the actions described above.


Corrective Action: Segregate and relabel anyimproperly labeled product;

ANDSegregate and return or destroy any label stockor pre-labeled packaging stock that does notcontain the proper declaration.



For each processing step where “allergens/additives”is identified as a significant hazard on the HACCPPlan Form, list the records that will be used todocument the accomplishment of the monitoringprocedures discussed in Step #15. The recordsshould clearly demonstrate that the monitoringprocedures have been followed, and should containthe actual values and observations obtained duringmonitoring.

Following is guidance on establishing a record-keeping system for the control strategy examplesdiscussed in Step #12.


Records: Record of labeling checks.


Records: Test results for sulfiting agent or prohib-ited food and color additives, as appropriate;

ORSupplier’s lot-by-lot certificates;ORRecord of raw material labeling oraccompanying document checks.



Records: Record of labeling checks;AND

One of the following:• Sulfiting agent test results;OR• Supplier’s lot-by-lot certificates;ORRecord of raw material labeling oraccompanying document checks.



For each processing step where “allergens/additives”is identified as a significant hazard on the HACCPPlan Form, establish verification procedures that willensure that the HACCP plan is: 1) adequate toaddress the hazard of improper use of food and coloradditives; and, 2) consistently being followed.





Verification: Review monitoring, corrective action,and, where applicable, verification records withinone week of preparation;

ANDWhen supplier’s certificates are used formonitoring, collect at least one representative

sample per quarter, randomly selected fromamong your suppliers, and analyze for sulfitingagents or prohibited food and color additives, asappropriate. Additionally, collect at least onerepresentative sample for each new supplier, andanalyze for sulfiting agents or prohibited foodand color additives, as appropriate.


Verification: Review monitoring, corrective action,and, where applicable, verification records withinone week of preparation;

ANDWhen supplier’s certificates are used formonitoring, collect at least one representative

sample per quarter, randomly selected fromamong your suppliers, and analyze for sulfitingagents. Additionally, collect at least onerepresentative sample for each new supplier, andanalyze for sulfiting agents.




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CC

P)

Chapter 20: Metal Inclusion (A Physical Hazard)

Continued



Metal fragments can cause injury to the consumer.

Metal-to-metal contact, especially in mechanicalcutting or blending operations, other equipment withmetal parts that can break loose, such as moving wiremesh belts, injection needles, screens, portion controlequipment, metal ties and can openers are likelysources of metal that may enter food during processing.

FDA’s Health Hazard Evaluation Board has sup-ported regulatory action against product with metalfragments of 0.3” (7 mm) to 1.0” (25mm) in length.See FDA Compliance Policy Guide #555.425.


At each processing step, determine whether “metalinclusion” is a significant hazard. The criteria are:

1. Is it reasonably likely that metal fragments will beintroduced at this processing step (e.g. does it come inwith the raw material or will the process introduce it)?

For example, under ordinary circumstances, it wouldbe reasonably likely to expect that metal fragmentscould enter the process from the following sources asa result of worn, damaged or broken equipment parts:

• Mechanical crabmeat pickers;• Wire-mesh belts used to convey product in a batter/

breading operation;• Teeth from saw blades used to cut portions or

steaks;• Wire from mechanical mixer blades;• Blades from mechanical chopping or blending

equipment;• Rings, washers, nuts, or bolts from sauce cooling,

liquid dispensing, and portioning equipment;

• Blades from automatic filleting equipment;• Injection needles;• Metal ties used on raw material, in-process, orfinished product containers or equipment.

Under ordinary circumstances it would not bereasonably likely to expect that metal fragmentscould enter the food from the following sources:

• Manual cutting, shucking, gutting, or boningknives;

• Metal processing tables or storage tanks;• Wire mesh baskets or utensils.

2. Can metal fragments, which were introduced at anearlier step, be eliminated or reduced to an acceptablelevel at this processing step? (Note: If you are notcertain of the answer to this question at this time, youmay answer “No.” However, you may need tochange this answer when you assign critical controlpoints in Step #12.)

“Metal inclusion” should also be considered asignificant hazard at any processing step where apreventive measure is or can be used to prevent oreliminate the inclusion of metal fragments, that havebeen introduced to the product at a previous step, oris adequate to reduce the likelihood of occurrence ofthe hazard to an acceptable level. Preventive mea-sures for “metal inclusion” can include:

• Periodically checking cutting or blending equipmentor wire-mesh belts for damage or missing parts;

• Passing the product through metal detection orseparation equipment.

Visually inspecting equipment for damage or missingparts may only be feasible with relatively simpleequipment, such as band saws, small orbital blenders,and wire-mesh belts. Other, more complex, equip-ment may contain to many parts, some of which maynot be readily visible, to make such visual inspectionreliable in a reasonable time period.

Chapter 20: Metal249




• Intended use

In determining whether a hazard is significant youshould also consider the intended use of the product,which you developed in Step #4. In most cases youshould assume that the product will be consumed in away that would not eliminate any metal fragmentsthat may be introduced during the process. In thiscase, you would need to identify the hazard assignificant if the above criteria are met.

However, in some cases, if you have assurance thatthe product will be run through a metal detector, fordetection of metal fragments, or through screens or amagnet, for separation of metal fragments, by asubsequent processor you may not need to identifymetal fragment inclusion as a significant hazard.

Example:A primary processor produces frozen fish blocks bymechanically heading, eviscerating, and filleting fishin-the-round. The primary processor sells exclusivelyto breaded fish stick processors and has been givenassurance by these processors that the finished,breaded product will be subjected to a metal detector.The primary processor would not need to identify“metal inclusion” as a significant hazard.

In this case, you should enter “No” in Column 3 ofthe Hazard Analysis Worksheet for each of theprocessing steps. In addition, for each “No” entrybriefly explain in column 4 that the hazard is con-trolled by a subsequent processor. In this case, youneed not complete Steps #12 through 18 for thishazard.


For each processing step where “metal inclusion” isidentified in Column 3 of the Hazard AnalysisWorksheet as a significant hazard, determine whetherit is necessary to exercise control at that step in orderto control the hazard. Figure #A-2 (Appendix 3) is aCCP decision tree that can be used to aid you in yourdetermination.

The following guidance will also assist you indetermining whether a processing step is a CCP for“metal inclusion”:

Will the product be run through a metal detector, orthrough a screen, magnet, flotation tank, or otherequipment for separation of metal fragments, on orafter the last step where metal inclusion is identifiedas a significant hazard?

1. If it will be, you may identify final metal detection orseparation as the CCP. Processing steps prior to metaldetection will then not require control and will not needto be identified as CCPs for the hazard of metalfragments.

In this case enter “Yes” in Column 6 of the HazardAnalysis Worksheet for the metal detection orseparation step, and enter “No” for the other process-ing steps where “metal inclusion” was identified as asignificant hazard. In addition, for each “No” entry,note in Column 5 that the hazard is controlled by thefinal metal detection or separation step. (Note: if youhave not previously identified “metal inclusion” as asignificant hazard at the metal detection or separationstep in Column 3 of the Hazard Analysis Worksheet,you should change the entry in Column 3 to “Yes”.)This control approach will be referred to as “ControlStrategy Example 1” in Steps #14 through 18.


Example:A breaded fish processor could set the critical controlpoint for “metal inclusion” at the packaged productmetal detection step, and would not need to havecritical control points for this hazard at each of thesteps at which there was a reasonably likelihood thatmetal fragments could be introduced.

You should recognize that by setting the criticalcontrol point at or near the end of the process, ratherthan at the point of potential metal fragment entryinto the process, you are likely to have more laborand materials invested in the product before theproblem is detected or prevented.

2. If the product will not be run through such a device,you should have procedures to periodically check theprocessing equipment for damage or lost parts at eachprocessing step where “metal inclusion” is identified asa significant hazard. In this case you should identifythose processing steps as CCPs. It would not ordinarilybe necessary to identify these steps as CCPs in additionto identifying a final metal detection or separation stepas a CCP.

Visually inspecting equipment for damage or missingparts may only be feasible with relatively simpleequipment, such as band saws, small orbital blenders,and wire-mesh belts. Other, more complex, equip-ment may contain to many parts, some of which maynot be readily visible, to make such visual inspectionreliable in a reasonable time period.

In this case, You should enter “Yes” in column 6 ofthe Hazard Analysis Worksheet for each of thoseprocessing steps. This control approach will bereferred to as “Control Strategy Example 2” in Steps#14 through 18.

Example:A processor that cuts tuna steaks from whole fish hasidentified the band saw cutting step as the only stepthat is reasonably likely to introduce metal fragmentsto the process. The processor does not have a finalmetal detection or separation step. The processorchecks the condition of the band saw blade every fourhours to ensure that it has not been damaged. Theprocessor identifies the band saw cutting step as theCCP for this hazard.



HACCP Plan Form


For each processing step where “metal inclusion” isidentified as a significant hazard on the HACCP PlanForm identify the maximum or minimum value towhich a feature of the process must be controlled inorder to control the hazard.




• CONTROL STRATEGY EXAMPLE 1 -METAL DETECTION OR SEPARATION

Critical Limit: No metal fragments in finishedproduct. (Note: FDA’s Health Hazard EvaluationBoard has supported regulatory action againstproduct with metal fragments of 0.3" [7 mm] to1.0" [25mm] in length. See also FDA CompliancePolicy Guide #555.425.)

ContinuedChapter 20: Metal

251


• CONTROL STRATEGY EXAMPLE 2 -EQUIPMENT CHECKS

Critical Limit: No broken or missing metal partsfrom equipment at the CCPs for “metal inclusion”



For each processing step where “metal inclusion” isidentified as a significant hazard on the HACCP PlanForm, describe monitoring procedures that willensure that the critical limits are consistently met.







What: The presence of metal fragments in productpassing the CCP.

• CONTROL STRATEGY EXAMPLE 2 -METAL INCLUSION PREVENTION PROCEDURES

What: The presence of broken or missing metal partsfrom equipment at the CCPs.



How: Use a metal detection device;ORUse a magnet for separating metal fragmentsfrom a product stream, where feasible (e.g. dryingredients);ORUse screens for separating metal fragments froma product stream, where feasible (e.g. dry orliquid ingredients).


How: Visually check the equipment for broken ormissing parts.

Examples:• Check saws for missing teeth;• Check that all parts are secure on blending

equipment;• Check for missing links in metal belts.


Who: Monitoring may be performed by theequipment operator, a production supervisor, amember of the quality control staff, a member ofthe maintenance or engineering staff, or any otherperson who has a thorough understanding of theproper condition of the equipment.



For each processing step where “metal inclusion” isidentified as a significant hazard on the HACCP PlanForm, describe the procedures that you will use whenyour monitoring indicates that the CL has not been met.

These procedures should: 1) ensure that unsafeproduct does not reach the consumer; and, 2) correctthe problem that caused the CL deviation. Rememberthat deviations from operating limits do not need toresult in formal corrective actions.



Corrective Action: Take the following correctiveaction to regain control over the operation after aCL deviation:• Attempt to locate and correct the source of the

fragments found in product by the metaldetector or separated from the product streamby the magnets, screens, or other devices;

Continued



Frequency: Subject all product to the control.Check that device is operating or is in place atstart of each production day.


Frequency: Check before starting operationseach day;

ANDCheck every four hours during operation;

ANDCheck at the end of operations each day;

ANDCheck whenever there is an equipmentmalfunction that could increase the likelihoodthat metal could be introduced into the food.



Who: Monitoring is performed by the equipmentitself. A check should be made at least once perday to ensure that the device is operating or is inplace. This may be performed by the equipmentoperator, a production supervisor, a member ofthe quality control staff, a member of themaintenance or engineering staff, or any otherperson who has an understanding of the operationof the equipment.


ANDMake adjustments to the materials, equipment,and/or process, as needed, to prevent futureintroduction of metal fragments;

ANDTake the following action to product involved ina CL deviation:• Destroy;OR• Divert to non-food use;OR• Rework to eliminate metal fragments;OR• Hold and evaluate any product in which the metal

detector has detected metal fragments;AND

Take one of the following actions to the productwhen product is processed without a properlyfunctioning metal detector or separation device:• Destroy the product;

OR• Hold all product produced since controls were

last confirmed as functioning properly until itcan be run through a metal detector;OR

• Hold all product produced since controls werelast confirmed as functioning properly until aninspection of the processing equipment thatcould contribute metal fragments can becompleted to determine whether there are anybroken or missing parts;OR

• Divert all product produced since controls werelast confirmed as functioning properly to a usein which it will be run through a metal detector(e.g. divert fish fillets to a breading operationthat is equipped with a metal detector);OR

• Divert all product produced since controlswere last confirmed as functioning properlyto a non-food use;

AND• Repair or replace the metal detector or

separation device


Corrective Action: Take one of the followingcorrective actions to regain control over theoperation after a CL deviation:• Stop production;

AND• If necessary, adjust or modify the equipment to

reduce the risk of recurrence;AND

Take one of the following actions to productinvolved in a CL deviation:• Destroy all product produced since the previous

satisfactory equipment check;OR• Run all product produced since the previous

satisfactory equipment check through a metaldetector;

OR• Divert all product produced since the previous

satisfactory equipment check to a use in whichit will be run through a metal detector (e.g.divert fish fillets to a breading operation that isequipped with a metal detector);


satisfactory equipment check to a non-food use.




For each processing step where “metal inclusion” isidentified as a significant hazard on the HACCP PlanForm, list the records that will be used to documentthe accomplishment of the monitoring proceduresdiscussed in Step #15. The records should clearlydemonstrate that the monitoring procedures havebeen followed, and should contain the actual valuesand observations obtained during monitoring.

Following is guidance on establishing arecordkeeping system for the control strategy ex-amples discussed in Step #12.


Records: Record documenting that the metaldetection or separation device is operating or is

in place, as appropriate.


Records: Record of equipment inspections.



For each processing step where “metal inclusion” isidentified as a significant hazard on the HACCP PlanForm, establish verification procedures that willensure that the HACCP plan is: 1) adequate toaddress the hazard of metal inclusion; and, 2) consis-tently being followed.



Verification: Test the effectiveness of the metaldetection device, or check the condition of themagnet, screen, or other metal separation deviceat least once per day, before start of operations;

ANDReview monitoring, corrective action andverification records within one week ofpreparation.



Enter the verification procedures in column 10 of theHACCP Plan Form.



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Notes:

Chapter 21: Glass Inclusion (A Physical Hazard)

DRAFT

Continued

This chapter is provided as draft guidance at thistime. FDA requests that interested parties withinformation on the hazard of glass inclusion and itscontrol provide comments on the content of thechapter.



Glass fragments can cause injury to the consumer.FDA’s Health Hazard Evaluation Board has sup-ported regulatory action against products with glassfragments of 0.3” (7 mm) to 1.0” (25 mm) in length.See FDA Compliance Policy Guide #555.425.

Glass inclusion can occur whenever processinginvolves the use of glass containers. Normal handlingand packaging methods, especially mechanizedmethods, can result in breakage. Most productspacked in glass containers are intended as a ready-to-eat commodity.

The purpose of this chapter is to address only thehazard of glass fragments that results from the use ofglass containers. Glass fragments originating fromother sources must be addressed where applicable ina prerequisite sanitation program. The SeafoodHACCP Regulation requires such a program.


At each processing step, determine whether “glassinclusion” is a significant hazard. The criteria are:

1. Is it reasonably likely that glass fragments from glasscontainers will be introduced at this processing step(e.g. does it come in with the raw material or will theprocess introduce it)?

Under ordinary circumstances, it would be reason-ably likely to expect that glass fragments could enterthe process during processing of any product that ispacked in a glass container. Likely areas of concernfor glass container breakage are:

• Receiving;• Storage, when cases are moved mechanically;• Mechanized Cleaning;• Conveyor Lines;• Mechanized Filling;• Hot-filling;• Mechanized Capping;• Pasteurizing.

2. Can glass fragments from glass containers, whichwere introduced at an earlier step, be eliminated orreduced to an acceptable level at this processing step?(Note: If you are not certain of the answer to thisquestion at this time, you may answer “No.” How-ever, you may need to change this answer when youassign critical control points in Step 12.)

“Glass inclusion” should also be considered asignificant hazard at any processing step where apreventive measure is or can be used to prevent oreliminate the inclusion of glass fragments from glasscontainers, that have been introduced at a previousstep, or is adequate to reduce the likelihood ofoccurrence of the hazard to an acceptable level.Preventive measures for “glass inclusion” caninclude:

• Visual examination of empty glass containers;• Cleaning (water or compressed air) and inverting

empty glass containers;• Periodically monitoring processing lines for

evidence of glass breakage;• Proper adjustment of capping equipment

(not a complete control);• Visual examination of glass containers containing

transparent liquid fishery products;• Passing the product through x-ray equipment or

other defect rejection system.

Chapter 21: Glass259


If the answer to either question 1 or 2 is “Yes” thepotential hazard is significant at that step in theprocess and you should answer “Yes” in Column 3 ofthe Hazard Analysis Worksheet. If neither criterion ismet you should answer “No.” You should record thereason for your “Yes” or “No” answer in Column 4.You need not complete Steps 12 through 18 for thishazard for those processing steps where you haverecorded a “No.”


• Intended use

In determining whether a hazard is significant youshould also consider the intended use of the product,which you developed in Step 4. In most cases youshould assume that the product will be consumed in away that would not eliminate any glass fragmentsthat may be introduced during the process. In thiscase, you would need to identify the hazard assignificant if the above criteria are met.


For each processing step where “glass inclusion” isidentified in Column 3 of the Hazard AnalysisWorksheet as a significant hazard, determine whetherit is necessary to exercise control at that step in orderto control the hazard. Figure A-2 (Appendix 3) is aCCP decision tree that can be used to aid you in yourdetermination.

The following guidance will also assist you indetermining whether a processing step is a CCP for“glass inclusion”:

Will the containers be run through x-ray equipmentor other defect rejection system, undergo visualinspection for detection of glass fragments, or becleaned (water or compressed air) and inverted on orafter the last step where glass inclusion is identifiedas a significant hazard?

1. If it will be, you may identify final glass detection orseparation as the CCP. Processing steps prior to glassdetection or separation will then not require controland will not need to be identified as CCPs for thehazard of glass inclusion.

In this case enter “Yes” in Column 6 of the HazardAnalysis Worksheet for the glass detection or separa-tion step, and enter “No” for the other processingsteps where “glass inclusion” was identified as asignificant hazard. In addition, for each “No” entry,note in Column 5 that the hazard is controlled by theglass detection or separation step. (Note: if you havenot previously identified “glass inclusion” as asignificant hazard at the glass detection or separationstep in Column 3 of the Hazard Analysis Worksheet,you should change the entry in Column 3 to “Yes”.)This control approach will be referred to as “ControlStrategy Example 1” in Steps 14 through 18.

Example:A pickled herring processor that mechanically packsthe product into glass jars could set the criticalcontrol point for “glass inclusion” at the packagedproduct x-ray examination step, and would not needto have critical control points for this hazard at eachof the steps at which there was a reasonable likeli-hood that glass fragments could be introduced.

Example:A processor that manually packs caviar into glassjars has identified the glass container receiving andstorage steps as the only steps that are reasonablylikely to introduce glass fragments into the process.The processor does not have finished product x-rayequipment. The processor manually inspects eachcontainer during the filling process. The processoridentifies the container inspection step as the CCPfor this hazard.


Example:Another processor that manually packs caviar intoglass jars has identified the glass container receivingand storage steps as the only steps that are reason-ably likely to introduce glass fragments into theprocess. The processor does not have finishedproduct x-ray equipment. Just before filling, theempty glass jars are inverted and cleaned, usingfiltered, compressed air. The processor identifies thecontainer cleaning and inverting step as the CCP forthis hazard.

You should recognize that by setting the criticalcontrol point at or near the end of the process, ratherthan at the point of potential glass fragment entryinto the process, you are likely to have more laborand materials invested in the product before theproblem is detected or prevented.

2. If the containers will not be run through detectionequipment, visually inspected, or cleaned and invertedon or after the last step where “glass inclusion” isidentified as a significant hazard, you should haveprocedures to periodically check the processing areasand equipment for glass breakage at each processingstep where “glass inclusion” is identified as a significanthazard. In this case you should identify those process-ing steps as CCPs. It would not ordinarily be necessaryto identify these steps as CCPs in addition to identifyinga final glass detection or separation step as a CCP.

In this case, you should enter “Yes” in column 6 ofthe Hazard Analysis Worksheet for each of thoseprocessing steps. This control approach will bereferred to as “Control Strategy Example 2”in Steps 14 through 18.

Example:A processor bottles clam juice and has identifiedreceiving, storage, mechanical conveying, mechani-cal filling, and mechanical capping, as processingsteps reasonably likely to introduce glass fragmentsinto the process. The processor does not have on-linex-ray equipment. The processor visually inspects allprocessing areas for broken glass at start-up andonce every four hours. If broken glass is observed,the line is stopped, the glass is removed and the

product that has moved through that area since thelast inspection is placed on hold to be run throughoff-line x-ray equipment. The processor identifiesreceiving, storage, mechanical conveying, mechani-cal filling, and mechanical capping as the CCP’s forthis hazard.


Proceed to Step 13 (Chapter 2) or to Step 10 of thenext potential hazard.

HACCP Plan Form


For each processing step where “glass inclusion” isidentified as a significant hazard on the HACCP PlanForm identify the maximum or minimum value towhich a feature of the process must be controlled inorder to control the hazard.


As a practical matter it may be advisable to set anoperating limit that is more restrictive than the CL. Inthis way you can adjust the process when the operat-ing limit is triggered, but before a triggering of theCL would require you to take corrective action. Youshould set operating limits based on your experiencewith the variability of your operation and with thecloseness of typical operating values to the CL.

Following is guidance on setting critical limits for thecontrol strategy examples discussed in Step 12.

ContinuedChapter 21: Glass

261


• CONTROL STRATEGY EXAMPLE 1 -GLASS DETECTION OR SEPARATION

Critical Limit: No glass fragments in finished product.(Note: FDA’s Health Hazard Evaluation Boardhas supported regulatory action against productswith glass fragments of 0.3” [7 mm] to 1.0”[25 mm] in length. See also FDA CompliancePolicy Guide #555.425.)


Critical Limit: No broken glass at the CCPs for“glass inclusion”.



For each processing step where “glass inclusion” isidentified as a significant hazard on the HACCP PlanForm, describe monitoring procedures that willensure that the critical limits are consistently met.


It is important for you to keep in mind that thefeature of the process that you monitor and themethod of monitoring should enable you to deter-mine whether the CL is being met. That is, themonitoring process should directly measure thefeature for which you have established a CL.You should monitor often enough so that the normalvariability in the values you are measuring will bedetected. This is especially true if these values aretypically close to the CL. Additionally, the greater thetime span between measurements the more productyou are putting at risk should a measurement showthat a CL has been violated.

Following is guidance on establishing monitoringprocedures for the control strategy examples dis-cussed in Step 12. Note that the monitoring frequen-cies that are provided are intended to be consideredas minimum recommendations, and may not beadequate in all cases.



What: The presence of glass fragments in glasscontainers passing the CCP.


What: The presence of broken glass on or nearequipment at the CCP’s.



How: Use of x-ray equipment or other defect rejectionsystem;ORVisual examination of empty glass containers;ORVisual examination of glass containerscontaining transparent liquid fishery products;ORCleaning (water or compressed air) and invertingof empty glass containers.



Who: For x-ray detection, other defect rejection systems,glass separation equipment and visual examination,monitoring is performed by the equipment itselfor by properly trained and qualified inspectionpersonnel. A check should be made at least onceper day to ensure that the device is operating orthat the appropriate personnel are on hand. Thischeck may be performed by the equipmentoperator, a production supervisor, a member ofthe quality control staff, a member of themaintenance or engineering staff, or any otherperson who has an understanding of the operationof the equipment or the staffing needs.


Who: Monitoring may be performed by theequipment operator, a production supervisor, amember of the quality control staff, a member ofthe maintenance or engineering staff, productionpersonnel, or any other person who has athorough understanding of the proper condition

of the equipment and surrounding area. Inassigning responsibility forthis monitoring function youshould consider the complexity of the equipment

and the level of understanding necessary toevaluate its condition.



For each processing step where “glass inclusion” isidentified as a significant hazard on the HACCP PlanForm, describe the procedures that you will use whenyour monitoring indicates that the CL has not been met.

Continued


How: Visually check the glass handling areas forbroken glass.

Examples:• Check pallets and cases of empty jars for damage,

broken jars, and glass fragments;• Check mechanical glass cleaning equipment and

surrounding floors for broken glass;• Check floors around conveyors for broken glass;• Check filling and capping equipment and

surrounding floors for broken glass;• Check hot-filling and pasteurizing equipment and

surrounding floors for broken glass.



Frequency: Continuous. Each container is subjectedto detection or separation. For x-ray equipment,other defect rejection systems and glass separationequipment, check that the device is operating atleast at the start of each production day. Forvisual inspection, check that appropriatepersonnel are assigned to the processing step atthe start of each production day.


Frequency: Check before starting operations each day;AND

Check at least every four hours during operation;AND

Check at the end of operations each day;AND

Check whenever there is an equipment or othermalfunction that could increase the likelihoodthat glass containers could be damaged.


These procedures should: 1) ensure that unsafeproduct does not reach the consumer; and, 2) correctthe problem that caused the CL deviation. Rememberthat deviations from operating limits do not need toresult in formal corrective actions.

Following is guidance on establishing correctiveaction procedures for the control strategy examplesdiscussed in Step 12.


Corrective Action: Take the following correctiveactions to regain control over the operation aftera CL deviation:• Stop operations and attempt to locate and

correct the source of the glass fragments;AND• Make adjustments to the materials, equipment,

and/or process, as needed, to prevent futureintroduction of glass fragments;

ANDTake one of the following corrective actions toproduct in which glass fragments weredetected:

• Destroy the product;OR• Rework the product to eliminate the glass

fragments;OR• Divert the product to non-food use;OR• Hold and evaluate the product;

ANDTake one of the following corrective actionswhen product is processed without properlyfunctioning glass detection or separation equipmentor without proper visual inspection:• Destroy all product produced since controls

were last confirmed as functioning properly;OR

• Hold all product produced since controls werelast confirmed as functioning properly until itcan be examined by x-ray equipment or otherdefect rejection system, or visual inspection,where appropriate;

OR• Divert all product produced since controls

were last confirmed as functioning properly toa non-food use;

AND• Repair or replace the glass detection or

separation equipment.


Corrective Action: Take one of the followingcorrective actions to regain control over theoperation after a CL deviation:• Stop production;AND• If necessary, adjust or modify the materials,

equipment and/or processes to reduce the riskof recurrence;

AND• Remove all broken glass from the equipment

and surrounding area;AND

Take one of the following actions to the productinvolved in the critical limit deviation:• Destroy all product produced since the

previous satisfactory equipment check;OR• Hold all product produced since the previous

satisfactory equipment check until it can beexamined by x-ray equipment or other defectrejection system, or visual inspection ifappropriate;


satisfactory equipment check to a non-food use.




For each processing step where “glass inclusion” isidentified as a significant hazard on the HACCP PlanForm, list the records that will be used to documentthe accomplishment of the monitoring proceduresdiscussed in Step 15. The records should clearlydemonstrate that the monitoring procedures havebeen followed, and should contain the actual valuesand observations obtained during monitoring.

Following is guidance on establishing arecordkeeping system for the control strategy ex-amples discussed in Step 12.


Records: Records documenting that the glass detectionor separation device is operating, or that glassinspection personnel are assigned to theprocessing step, as appropriate.


Records: Records of equipment and processing areainspection results.




For each processing step where “glass inclusion” isidentified as a significant hazard on the HACCP PlanForm, establish verification procedures that willensure that the HACCP plan is: 1) adequate toaddress the hazard of glass inclusion; and, 2) consis-tently being followed.

Following is guidance on establishing verificationprocedures for the control strategy examples dis-cussed in Step 12.


Verification: Test the effectiveness of the x-rayequipment, other defect reject system or glassseparation equipment at least once per day,before start of operations;

ANDReview monitoring, corrective action andverification records within one week of preparation.


Verification: Review monitoring and corrective actionrecords within one week of preparation.

Enter the verification procedures in column 10 of theHACCP Plan Form.


Exam

ple

Onl

y

See

Text

for

Ful

l Rec

omm

enda

tion

s

No d

etecta

ble

glas

sfra

gmen

ts in

fini

shed

prod

uct

Pres

ence

of

detec

table

glas

sfra

gmen

ts in

finish

ed p

rodu

cts

(2)

Sign

ifica

ntH

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch P

reve

ntiv

eM

easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Rec

ords

Wha

tH

owFr

eque

ncy

Who

TABL

E #2

1-1

Cont

rol S

trat

egy

Exam

ple

1 -

Gla

ss D

etec

tion

or S

epar

atio

n

This

tabl

e is

an

exam

ple

of a

por

tion

of a

HA

CC

P pl

an re

latin

g to

the

cont

rol o

f gla

ss in

clus

ion

for a

pro

cess

or o

f pic

kled

her

ring

in g

lass

jars

, usi

ng C

ontro

l Stra

tegy

Exa

mpl

e 1

- Gla

ss D

etec

tion

or S

epar

atio

n. It

is p

rovi

ded

for i

llust

rativ

e pu

rpos

es o

nly.

Gla

ss in

clus

ion

may

be

only

one

of s

ever

al s

igni

fican

t haz

ards

for t

his

prod

uct.

Ref

er to

Tab

les

3-1,

3-2

, 3-3

(Cha

pter

3)

for o

ther

pot

entia

l haz

ards

(e.g

., pa

rasi

tes,

his

tam

ine,

che

mic

al c

onta

min

ants

, una

ppro

ved

food

& c

olor

add

itive

s,m

etal

frag

men

ts, C

lost

ridi

um b

otul

inum

toxi

n fo

rmat

ion,

and

pat

hoge

n gr

owth

as

a re

sult

of te

mpe

ratu

re a

buse

).

Glas

s inc

lusio

nX-

ray

devi

ceX-

ray

oper

ation

log

Ever

y fin

ished

prod

uct p

acka

ge,

with

ope

ratio

nch

eck

befo

resta

rtup

•De

stroy

any

prod

uct r

ejecte

dby

x-ra

ye q

uipm

ent

AND

•St

op o

pera

tions

and

iden

tify

sour

ce o

f glas

sfo

und

in p

rodu

ctan

d fix

dam

aged

equi

pmen

t

AND

•If

prod

uct i

spr

oce s

sed

with

out x

-ray

equi

pmen

t, ho

ldfo

r dete

ction

by

off-l

ine

x-ra

ye q

uipm

ent

Prod

uctio

nem

ploy

e eX-

ray

equi

pmen

t

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

(10)

Veri

ficat

ion

•Te

st x-

ray

devi

ce b

efor

epr

oduc

tion

each

day,

and

reca

libra

te if

nee d

e d

•Re

vie w

mon

itorin

g,c o

rrec t

ive

actio

n an

dve

rific

a tio

nre

cord

s with

inon

e wee

k of

pre p

a ra t

ion.


Exam

ple

Onl

y

See

Text

for

Ful

l Rec

omm

enda

tion

s

No b

roke

n gl

ass o

npa

llets

of e

mpt

y jar

s

No b

roke

n gl

ass a

t the

filler

/capp

er s

tatio

n

Pres

ence

of

brok

en g

lass o

rph

ysica

l dam

age

to c

ases

Brok

en g

lass o

n&

aro

und

filler

/ca

pper

stati

on

(2)

Sign

ifica

ntH

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch P

reve

ntiv

eM

easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Rec

ords

Wha

tH

owFr

e que

ncy

Who

TABL

E #2

1-2

Cont

rol S

trat

egy

Exam

ple

2 -

Equi

pmen

t Che

cks

This

tabl

e is

an

exam

ple

of a

por

tion

of a

HA

CC

P pl

an re

latin

g to

the

cont

rol o

f gla

ss in

clus

ion

for a

pro

cess

or o

f cla

m ju

ice

ingl

ass

jars

, usi

ng C

ontro

l Stra

tegy

Exa

mpl

e 2

– Eq

uipm

ent c

heck

s. It

is p

rovi

ded

for i

llust

rativ

e pu

rpos

es o

nly.

Gla

ss in

clus

ion

may

be o

nly

one

of s

ever

al s

igni

fican

t haz

ards

for t

his

prod

uct.

Ref

er to

Tab

les

3-1,

3-2

, and

3-3

(Cha

pter

3) f

or o

ther

pot

entia

l haz

ards

(e.g

., p

atho

gens

from

the

harv

est a

rea,

che

mic

al c

onta

min

ants

, nat

ural

toxi

ns,

unap

prov

ed fo

od &

col

or a

dditi

ves,

and

met

al fr

agm

ents

)

Glas

s inc

lusio

n

Glas

s Inc

lusio

n

Visu

a l

Visu

a l

Rece

ivin

g re

port

Equi

pmen

tm

ainten

ance

log

Each

pall

et of

jars

Befo

re st

art-u

p,ev

ery

4 ho

urs

durin

g op

erati

on,

after

bre

aks,

and

after

equ

ipm

ent

jam

s.

•Re

ject p

allets

with

mor

e tha

n 3

dam

aged

case

s or

with

bro

ken

jars.

•Iso

late

palle

tswi

th 1

to 3

dam

aged

case

san

d op

en an

din

spec

t all

case

s.•

Rejec

t cas

es th

atco

ntain

bro

ken

glas

s.

•St

op p

rodu

ction

AND

•Ad

just

capp

ing

equi

pmen

tAN

D•

Isolat

e an

d ho

ldpr

oduc

t sin

celas

t sati

sfacto

rych

eck

until

itca

n be

run

thro

ugh

off-l

ine

x-ra

y an

dde

stroy

rejec

tsAN

D•

Rem

ove

brok

engl

ass f

rom

are

a.

Rec e

ivin

gpe

rson

nel

Capp

er o

pera

tor

Rec e

ivin

g

Me c

hani

c al

fillin

g an

dc a

ppin

g(1)

Cri

tical

Con

trol

Poin

t (C

CP)

(10)

Veri

ficat

ion

Revi

e wm

onito

ring

and

corre

ctive

acti

onre

cord

s with

inon

e wee

k of

pre p

a ra t

ion.

Revi

e wm

onito

ring

and

corre

ctive

acti

onre

cord

s with

inon

e wee

k of

pre p

a ra t

ion

Note:

Sto

rage

and

con

veyi

ng o

f em

pty

jars a

re n

ot id

entif

ied a

s CCP

s bec

ause

cas

es o

f em

pty

jars a

re h

andl

ed m

anua

lly, w

ithou

t for

klift

s or m

echa

nize

d co

n vey

ors


Notes:

18

FNA/ANA 21, 1998

T rade in food can be of great benefit to countries. Foodimport increases the choice of products, allowing

improvements in the nutritional and health status of thepopulation. Food export stimulates the development of localindustry and helps to upgrade food production facilities,standards and practices, which can lead to improvements inthe standard of living. Under these conditions, trade makes apositive contribution to food security.

It is assumed that substantial economic losses result fromunsafe food entering the international market, although theyhave not been systematically quantified worldwide. Suchlosses involve the costs of food spoilage and damage fromcontamination; the direct and indirect costs of illnessescaused by unsafe food, including health care treatment andlosses in productivity resulting from morbidity, disabilityand mortality; and the costs to the industry entailed in recallof products, court actions and recovery of productcredibility.

Despite substantial progress in basic and applied sciencerelating to food safety, contaminated food (including water)remains a major public health problem. Foodborne diseasesare very common in every country. They constitute one of themost important types of health problem. Furthermore, theyare an important cause of reduced economic productivity(WHO, 1984, 1995). In the United States alone, it has beenreported that as many as 9 000 deaths and 6.5 million to33 million illnesses occurring each year are food related(Foegeding et al., 1994). For only seven specific pathogens,costs for lost productivity have been estimated to rangebetween US$6 000 million and $9 000 million. The cost ofsalmonellosis alone in the United States was estimated to beabout US$1 000 million in 1987 (Roberts, 1988).

The observation of hygienic practices in food processing,transport and storage has gained more importance as thedistance between producer and consumer has increased andconsumers have become more dependent on processed andsemi-prepared foods. A worldwide initiative on food safetyis therefore becoming indispensable. While the publiccommonly shows concern about the safety of additives infood, the scientific evidence indicates that unhygienic

Codex Alimentarius Commission:protecting food today and in the future

A.W. Randell, K. Miyagishima and J. MaskeliunasAlan Randell is Senior Officer and Jeronimas Maskeliunas is Food Standards Officer, Joint FAO/WHO Food Standards Programme.

Kazuaki Miyagishima is Associate Professor, Department of Public Health, Faculty of Medicine, Kyoto University.

practices represent more significant risks to human health(WHO, 1992).

THE CODEX ALIMENTARIUS INITIATIVEFood laws and regulations existed in some form in mostancient cultures, as in modern societies, to addressconsumers’ concerns. Historically speaking, regulationsdealing with food production, manufacture and trade werechiefly related to the criterion of honesty in commerce.During the first half of the twentieth century it wasscientifically validated that some substances in food candamage consumers’ health. Contaminated or adulteratedfood moving into the international market can impair healthin remote countries.

Consumer safety became a subject of international concernin the late 1950s and early 1960s. FAO and the World HealthOrganization (WHO) were requested to address thisemerging issue in food trade. The Codex AlimentariusCommission (CAC) was established in 1962 as an executiveorgan of the Joint FAO/WHO Food Standards Programme,with the chief objective of protecting the health of consumersand ensuring fair practices in food trade. CAC is the onlyinternational forum that is able to bring together scientists,technical experts, government regulators and internationalconsumer and industry organizations.

With over 200 Codex standards, more than 2 500maximum limits for pesticide residues, 41 codes of practiceand 25 guideline levels for contaminants adopted to date,CAC has proved to be one of the most successfulprogrammes of the specialized agencies of the UnitedNations, contributing to international harmonization in theimportant area of food quality and safety (Randell, 1995).The final Codex texts are used by governments as part oftheir national food safety requirements. They are also usedby commercial partners in specifying the grade and qualityof consignments moving in international trade.

During its more than 30 years of existence, CAC has neverbeen indifferent to the changing demands of consumers andthe needs of those who use international standards. Afteradoption, Codex standards and other texts have been

FNA/ANA 21, 1998

19

revisited when the necessity has arisen; in fact, many of themhave been revised to take account of new scientific evidenceor current food manufacturing techniques. CAC has adaptedto emerging global challenges so that the internationalstandards elaborated by the commission will remainpertinent and will always meet their purpose in theinternational trade of foods.

NEW DEMANDS FOR CODEXRecent changes in the international environment arising fromthe conclusion of the Uruguay Round of multilateral tradenegotiations have nearly redefined the role of Codexstandards. These changes include the creation of the WorldTrade Organization (WTO) and the Agreement on theApplication of Sanitary and Phytosanitary Measures (SPSAgreement) which all members of WTO are expected toobserve. Under the SPS Agreement, which entered into forcein January 1995, Codex standards, guidelines andrecommendations have been granted the status of a referencepoint for international harmonization. They also serve as thebasic texts to guide the resolution of trade disputes.

In 1991 the FAO/WHO Conference on Food Standards,Chemicals in Food and Food Trade adopted a number ofrecommendations which set new directions for CAC (FAO/WHO/GATT, 1991). These have helped prepare thecommission for its new role. Among the recommendationswere:

•the use of a horizontal approach regarding foodadditives and possibly other areas;

•the strengthening of the work of general subjectcommittees;

•assurance of a sound scientific basis for standards;•the use of explicit risk assessment methods by

committees;•review of Codex elaboration and acceptance procedures;•the establishment of a Codex committee to deal with

import and export control problems.Among the actions taken by CAC following these

recommendations was the establishment of the CodexCommittee on Food Import and Export Inspection andCertification Systems.

CODEX COMMITTEE ON FOOD HYGIENEThe principal work of developing standards is undertaken bythe CAC’s subsidiary bodies. The Codex Committee on FoodHygiene is one of the most long-standing and active of thegeneral subject committees. The recent work of the committeeprovides a good example of how CAC keeps its foodstandards and other texts relevant to current needs throughthe establishment of appropriate working principles. Hosted

by the Government of the United States, the CodexCommittee on Food Hygiene had convened 30 sessions by1997.

Food hygiene means all conditions and measures necessaryto ensure the safety and suitability of food at all stages ofthe food chain. The main task of the Codex Committee onFood Hygiene is to draft provisions on food hygiene that arerelevant to all foods as well as provisions that are applied tospecific food items or food groups. The basic texts on foodhygiene developed by the committee are meant for use inpreventing the spread of foodborne pathogens and diseases.Considering both the health and economic consequences ofunsafe food, governments should give greater attention to theprevention and control of food contamination at the nationallevel.

A look at the more than 30-year history of the CodexCommittee on Food Hygiene indicates that countries arepaying increased attention to its work. Participation in itssessions has increased (see Figure). The thirtieth session, heldin October 1997, saw a record attendance of 266 delegatesrepresenting 56 countries and 14 international scientific,technical, industry and consumer organizations.

Recent work of the committeeThe Recommended International Code of Practice – GeneralPrinciples of Food Hygiene is one of the most widely usedCodex texts. It has been revised three times since its firstadoption. The 1997 revised version (FAO/WHO, 1997a) hasa new format and provisions based on the concept of riskassessment. The revised text sets out the objectives to be metthroughout the food chain, from primary production to thefinal consumer, in order to ensure safety and suitability offood by applying a risk-based approach.

One of the methods referred to in the text is the HazardAnalysis and Critical Control Point (HACCP) system.Guidelines for the application of HACCP (FAO/WHO,1997a) were initially adopted by CAC in 1993. The widestpossible use of the basic text in all areas of foodmanufacturing implies the furthering of a horizontalapproach and is expected to facilitate the efficient use ofresources in key food safety and food control activities.

Another notable output of the Codex Committee on FoodHygiene is the Principles for the Establishment andApplication of Microbiological Criteria for Foods (CAC/GL21 – 1997), adopted by the twenty-second session of theCodex Alimentarius Commission (FAO/WHO, 1997a). Whileadherence to good hygienic practices in conjunction with theuse of the HACCP system is considered to be the bestpreventive system to ensure food safety, microbiologicalcriteria may be used to examine foods of uncertain origin or

20

FNA/ANA 21, 1998

when other means of verifying the efficiency of the HACCPsystem or good hygienic practices are not available. They canalso be useful for determining whether processes areconsistent with the General Principles of Food Hygiene. Toavoid the possibility of microbiological criteria being appliedin an arbitrary and non-scientific manner, this new text fullyincorporates the idea of risk assessment and describes theprinciples to be applied in establishing microbiologicalcriteria.

Ongoing workNow that the text of the revised General Principles of FoodHygiene has been adopted by CAC, the Codex Committee onFood Hygiene will begin the work of revising the existingcommodity-specific codes of practice to reflect the newphilosophy in these texts: a preventive and risk-basedapproach.

In parallel, the HACCP system is being promoted in manyareas. The Codex Committee on Food Hygiene, incooperation with other Codex committees such as the CodexCommittee on Food Inspection and Certification Systems, isalso looking into the modality whereby countries shouldpromote the use of HACCP or related systems nationally.The future work should take account of:

•the limited resources available in small businesses andthe opportunity of recommending alternative approachesto the HACCP system;

•the status of the HACCP system as a possiblecomponent of more comprehensive quality controlsystems operated by companies.

Both issues are closely related to how government agenciesshould apply regulatory requirements to ensure compliancewith food hygiene standards.

Another field of food hygiene of increasing importanceregards fresh produce such as fruits and vegetables. Asconsumers’ interest in foods perceived as healthy grows, sodoes the need to ensure the safety of fresh produce, which isoften consumed raw or with minimal cooking.

The Codex Committee on Food Hygiene is also continuingits work on the general methodology of risk assessment formicrobiological hazards. It has started elaborating thePrinciples and Guidelines for the Conduct of MicrobiologicalRisk Assessment, which would provide guidance to CACitself as well as to governments conducting microbiologicalrisk assessment on their own. The principles are significant inthat they attempt to identify the basic concepts of riskanalysis, such as transparency, and to describe componentsand steps of microbiological risk assessment (FAO/WHO,1997b).

As shown above, the Codex Committee on Food Hygienewill incorporate further risk-based principles in the Codextexts addressing microbiological hazards for foods bybuilding on the available scientific knowledge and data. Thisprocess will be pursued in close liaison with other bodies ofCAC. To consolidate the scientific basis for itsrecommendations, the Codex Committee on Food Hygienehas requested that FAO and WHO consider theestablishment of an expert group to conduct riskassessments on microbiological hazards. Thisrecommendation has been endorsed by CAC. If approved by

Participation in sessions of the Codex Committee on Food Hygiene

1964 1966 1969 1971 1973 1975 1977 1979 1982 1984 1986 1989 1993 1995 19970

10

20

30

40

50

60Number participating

Member countries

International non-governmental organizations

Developing countries

FNA/ANA 21, 1998

21

FAO and WHO, such a body will play a crucial part in thefuture work of the Codex Committee on Food Hygiene. Withthe increasing input from scientific risk assessment , thecommittee is expected to offer further contributions toachieving CAC’s objectives of protecting human health andfacilitating food trade. ◆

REFERENCES

FAO/World Health Organization (WHO). 1997a. Codex

Alimentarius, Suppl. to Vol. 1B, General requirements

(food hygiene). Rome. 2nd ed.

FAO/WHO. 1997b. Report of the 30th session of the Codex

Committee on Food Hygiene, Appendix IV. ALINORM

99/13. Rome.

FAO/WHO/General Agreement on Tariffs and Trade (GATT).

1991. FAO/WHO Conference on Food Standards,

Chemicals in Food and Food Trade, Vol. 1, Report. Rome,

18-27 March 1991. Rome.

Foegeding, P.M., Roberts, T., Bennet, J., Bryan, F.L., Cliver,

D.O., Doyle, M.P., Eden, R.F., Flowers, R.S., Forman,

C.T. & Lorber, B. 1994. Foodborne pathogens: risk and

consequences. Council for Agricultural Science and

Technology Task Force Report No. 122. Ames, Iowa,

USA, Council for Agricultural Science and Technology.

Randell, A. 1995. Codex Alimentarius: How it all began. Food

Nutr. Agric., 13/14: 35-40.

Roberts, T. 1988. Salmonellosis control, estimated economic

costs. Poultry Sci., 67(6): 936-943.

WHO. 1984. The role of food safety in health and development.

Report of a Joint FAO/WHO Expert Committee on Food

Safety. WHO Technical Report Series No. 705. Geneva,

Switzerland.

WHO. 1992. Our planet, our health. Report of the WHO

Commission on Health and Environment. Geneva,

Switzerland.

WHO. 1995. Food technologies and public health: food safety

issues. Geneva, Switzerland.◆

22

Summary/Résumé/Resumen

FNA/ANA 21, 1998

Despite scientific progress, contaminated food (including water) remains a major public health problemand foodborne diseases are common in every country. When unsafe food enters the international market,there are substantial losses from food spoilage and damage; illnesses; and court actions, recall ofproducts and recovery of product credibility. Hygienic practices in food handling, processing, transportand storage have gained importance as consumers depend more on processed and semi-prepared foods.A worldwide initiative on food safety is becoming indispensable.

The Codex Alimentarius Commission, established in 1962, aims to protect the health of consumers andensure fair practices in the food trade. This international forum brings together scientists, technicalexperts, government regulators and international consumer and industry organizations. It contributes tointernational harmonization in the area of food quality and safety. Codex texts are used by governmentsas part of their national food safety requirements and by commercial partners in specifying the grade andquality of consignments. The creation of the World Trade Organization and the Agreement on theApplication of Sanitary and Phytosanitary Measures which arose from the Uruguay Round of multilateraltrade negotiations have nearly redefined the role of Codex standards. Codex standards, guidelines andrecommendations have become a reference point for international harmonization and serve as the basictexts to guide the resolution of trade disputes.

The work of the Codex Committee on Food Hygiene illustrates how the Codex AlimentariusCommission keeps its food standards and other texts relevant to current needs through the establishmentof appropriate working principles. This committee drafts provisions on food hygiene which are relevant toall foods. It is working on risk assessment methodologies for microbiological hazards. The committee hasstarted elaborating principles and guidelines for the conduct of microbiological risk assessment. TheCodex Alimentarius Commission publishes texts on food hygiene to assist in preventing the spread offoodborne pathogens and diseases.

Malgré les progrès scientifiques, la contamination des aliments (y compris de l’eau) demeure unimportant problème de santé publique et les maladies transmises par les aliments sont courantes danstous les pays. L’entrée d’aliments malsains sur le marché international est lourde de conséquences:aliments qui se gâtent ou sont endommagés; maladies; poursuites judiciaires suivies du retrait desproduits et nécessité de restaurer la crédibilité du produit. Les usages en matière d’hygiène lors dutraitement, de la transformation, du transport et de l’entreposage des aliments ont pris de l’importancecar les consommateurs dépendent davantage de produits alimentaires importés ou préconditionnés. Uneinitiative mondiale sur l’innocuité des aliments est désormais indispensable.

La Commission du Codex Alimentarius, établie en 1962, vise à protéger la santé des consommateurs età assurer des pratiques commerciales équitables dans le domaine alimentaire. Cette instance internationalerassemble des scientifiques, des experts techniques, des responsables gouvernementaux de laréglementation et des organisations internationales de consommateurs et d’industriels. Elle contribue àune harmonisation internationale des normes de qualité et de sécurité des aliments. Les gouvernements seréfèrent aux textes du Codex pour établir certaines de leurs dispositions nationales en matière de sécuritédes aliments, de même que les partenaires commerciaux pour spécifier la catégorie et la qualité de leursexpéditions. La création de l’Organisation mondiale du commerce et l’Accord sur l’application desmesures sanitaires et phytosanitaires issu des négociations commerciales multilatérales du Cycled’Uruguay ont déjà redéfini le rôle des normes Codex. Les normes, les directives et les recommandationsdu Codex sont devenues un point de référence pour l’harmonisation internationale et servent de guidepour la résolution des différends commerciaux.

Le travail du Comité du Codex sur l’hygiène alimentaire montre comment, grâce à l’établissement deprincipes de travail appropriés, les normes alimentaires et les autres textes de la Commission du CodexAlimentarius restent adaptés aux besoins actuels. Ce Comité prépare des dispositions concernantl’hygiène alimentaire pour tous les types de produits. Actuellement, ses travaux portent sur lesméthodologies d’évaluation des risques microbiologiques. Le Comité a commencé à élaborer des principes

CodexAlimentariusCommission –protecting foodtoday and in thefuture

Commission duCodexAlimentarius –protéger lesalimentsaujourd’hui etdemain

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et des directives régissant la conduite de l’évaluation des risques microbiologiques. La Commission duCodex Alimentarius publie des textes sur l’hygiène alimentaire afin d’aider à prévenir la propagationd’agents pathogènes et de maladies transmises par les aliments.

A pesar de los progresos científicos, la contaminación de los alimentos (incluida el agua) sigue siendo unimportante problema de salud pública y las enfermedades de origen alimentario son frecuentes en todoslos países. Cuando un alimento insalubre llega al mercado internacional, se producen cuantiosos daños ypérdidas como consecuencia del deterioro de los alimentos, enfermedades, acciones judiciales, retirada deproductos y merma de la credibilidad de éstos. Las prácticas de higiene en la elaboración, el transporte yel almacenamiento de alimentos han adquirido importancia al hacer un mayor uso los consumidores dealimentos importados y precocinados. Se está haciendo indispensable una iniciativa a nivel mundial enrelación con la inocuidad de los alimentos.

La Comisión del Codex Alimentarius, creada en 1962, tiene como finalidad proteger la salud de losconsumidores y asegurar prácticas leales en el comercio de alimentos. Este foro internacional reúne acientíficos, expertos técnicos, funcionarios gubernamentales encargados de la reglamentación yorganizaciones internacionales de consumidores y de la industria y contribuye a la armonizacióninternacional en el ámbito de la calidad e inocuidad de los alimentos. Los textos del Codex son utilizadospor los gobiernos, que los incorporan a sus requisitos nacionales en materia de inocuidad de losalimentos, y por los interlocutores comerciales para especificar la categoría y la calidad de los envíos. LaRonda Uruguay de Negociaciones Comerciales Multilaterales y el Acuerdo de la Organización Mundialdel Comercio sobre la Aplicación de Medidas Sanitarias y Fitosanitarias han realzado la función de lasnormas del Codex. Las normas, directrices y recomendaciones del Codex han pasado a ser un punto dereferencia para la armonización internacional y son los textos fundamentales por los que se rige lasolución de las diferencias comerciales.

El Comité del Codex sobre Higiene de los Alimentos es un ejemplo de cómo la Comisión del CodexAlimentarius adapta sus normas alimentarias y otros textos a las necesidades existentes mediante elestablecimiento de principios adecuados. Este Comité prepara proyectos de disposiciones en materia dehigiene que son aplicables a todos los alimentos. En la actualidad está elaborando métodos de evaluaciónde riesgos para determinar los peligros microbiológicos y ha iniciado la preparación de principios ydirectrices para llevar a cabo evaluaciones de riesgos microbiológicos. La Comisión del CodexAlimentarius publica textos sobre higiene de los alimentos con la finalidad de ayudar a prevenir lapropagación de patógenos y enfermedades transmitidos por los alimentos. ◆

Comisión delCodexAlimentarius:La protecciónde los alimentoshoy y en elfuturo

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