Written by Barry Nash and David Green of North Carolina State University’s Seafood Laboratoryand the North Carolina Sea Grant College Program.

This work was supported by Grant [NA86RGO 0361 from the National Sea Grant College Program,National Oceanic and Atmospheric Administration, to the North Carolina Sea Grant College Program

and by a North Carolina Fishery Resource Grant to Carl R. Doerter, Project 97ST-2.

Publication UNC-SG-98-05 l North Carolina Sea Grant l Box 8605, NC State University, Raleigh, NC 276953605 l 919/515-2454

Introduction ............................................................................................................................................................ 1

Why Be Your Own Inspector? ............................................................................................................................... 1

Why Be Aware of Your Plant’s Problem Areas? .................................................................................................... 1

Hazards: What Are You up Against? ...................................................................................................................... 2

Writing Your HACCP Plan ..................................................................................................................................... 2

Preliminary Steps ...................................................................................................................................... 2

Conducting the Hazard Analysis.. ............................................................................................................. 3

Setting Critical Control Points .................................................................................................................. 3

Establishing Critical Limits ...................................................................................................................... 3

Monitoring ................................................................................................................................................ 3

Corrective Action ...................................................................................................................................... 4

Verification ................................................................................................................................................ 4

Record Keeping ......................................................................................................................................... 5

Sanitation ................................................................................................................................................................ 5

Appendix ................................................................................................................................................................ 7

Flow Diagram ........................................................................................................................................... 8

Checklists .................................................................................................................................................. 9

Preliminary Steps Checklist ........................................................................................................... 9

Hazard Analysis Checklist ............................................................................................................. 9

Critical Control Points Checklist ................................................................................................. 10

Critical Limits Checklist .............................................................................................................. 10

Monitoring Checklist .................................................................................................................. 11

Corrective Action Checklist.. ....................................................................................................... 11

Record Keeping Checklist ........................................................................................................... 12

Verification Checklist .................................................................................................................. 12

Self-Inspection Sanitation Checklist ............................................................................................ 13

Hazard Analysis Worksheet .................................................................................................................... 14

HACCP Plan Form .................................................................................................................................. 16

References ............................................................................................................................................................ 18

IntroductionHazard Analysis and Critical Control Point, or

HACCP, is a widely accepted monitoring systemused to control the risks that can be associated withfood. To someone who has just started learning aboutHACCP, it can seem complicated and demanding.But once you understand its concepts, you’ll see theprogram as a common-sense tool to control food-safety hazards.

And, considering the United States’ rank as theworld’s second-largest exporter of seafood, theHACCP program will protect your economic well-being in the long run. Complying with a strongHACCP program will result in a continuous supplyof safe seafood for consumers at home and abroad.

The Pillsbury Co. developed the first HACCPprogram in the early 1960s while studying how tosupply packaged food to the U.S. space program.Pillsbury executives thought their quality-controlchecks were not rigorous enough to spot contamina-tion after food was processed. They decided that theonly way to know the food was safe was to preventhazards from reaching the food while being made.

The Food and Drug Administration (FDA) usedPillsbury’s HACCP program as a model for the safeseafood regulation it issued in December 1995. TheFDA took this action to assure the public that seafoodwas safe to eat, and it gave the industry two years tocomply. The regulation also gives processors anddealers a way to document that the seafood theymanufacture and ship is wholesome and safe. Thisregulation went into effect nationwide for all domes-tic and foreign seafood processing firms on Dec. 18,1997.

The FDA defines processing as “handling,storing, preparing, heading, eviscerating, shucking,freezing, changing into different market forms,manufacturing, preserving, packing, labeling anddockside loading or holding.” This definition doesnot pertain to fishing boats, where crews head,

eviscerate or freeze fish solely for holding beforethey come to shore. At this time, the seafood regula-tion does not cover the harvest or transport of fish orthe retail sale of fish and fishery products.

In North Carolina, five kinds of seafood dealersand processors must develop a HACCP program:

l Dealers who sell shrimp that has been dippedin sulfites

l Dealers who sell histamine fish such as bluefish, mackerel, tuna or mahi-mahi

l Blue crab processorsl Smoked fish processorsl Shellfish dealers who ship out of state.

Why Be Your Own Inspector?The HACCP regulation requires every seafood

processor to thoroughly review its products andoperations, identify potential hazards and takepreventive measures to control them. No regulatorknows your operation better than you do. So it makessense that you, the owner, should evaluate your plant,determine whether you need a written HACCP planand then, if necessary, write a plan that best suitsyour production and products. And, because youwrite the plan, it makes even more sense for you tohave the right and the responsibility to enforce it foryour company. The seafood regulation gives you thisflexibility because you are the expert on running yourbusiness.

Why Be Aware of Your Plant’s ProblemAreas?

As a business owner, you are responsible forknowing the rules that regulate your business. Ahazard analysis will tell you at the very least how toimprove your sanitation and hygiene practices toensure a safer supply of seafood. Even if you findthat you do not need a written HACCP plan, thesanitation requirements of the regulation will go a

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long way toward improving not only the safety, butalso the quality of your products.

Hazards: What Are You up Against?

HACCP plans must address three kinds ofhazards that may make food unsafe to eat - biologi-cal, chemical and physical.

l Biological hazards include bacteria, viruses andparasites. When ingested, certain bacteria, such assalmonella, can make people ill. They can growrapidly in the intestinal tract and often cause nausea,vomiting, diarrhea, cramping, fever and headache.This is called a food-borne infection because aperson becomes sick only after consuming thebacteria.

A food-borne intoxication is caused by bacteriathat produce a toxin, such as clostridium, which isresponsible for botulism. The toxin, rather than thebacteria, causes the illness. In the case of clostridium,the toxin can even cause death.

Like salmonella, some viruses can cause illnesswhen they are consumed in food. But, unlike bacte-ria, viruses can exist in food without growing, andthey do not cause food to spoil. Viruses cannot begingrowing until they are inside a person’s body. Anexample of a viral food infection is hepatitis, whichpeople can get from eating raw molluscan shellfishfrom polluted harvesting areas.

Parasites are organisms that must live on or in aperson to grow. They are often embedded in the fleshof certain kinds of fish or shellfish such as amberjackor Atlantic cod. A person can be infected by eatingraw fish, such as sashimi, if the meat contains aparasite. A well-known example of a parasite is thetapeworm. It attaches to the walls of the intestine andfeeds on the digested food that passes by it. It cangrow up to 7 feet long, and as it thrives, it will causesevere cramping, gas and diarrhea.

l Chemical hazards can occur naturally, or theycan be intentionally or unintentionally added to foodduring processing. Histamine, found in fish such astuna, mahi-mahi and mackerel, is a naturally occur-ring hazardous chemical that can cause a severeallergic reaction in people who are sensitive to it,such as those suffering from asthma.

Sulfite is a chemical that some harvest boatcrews intentionally add to shrimp to prevent blackspots. It is hazardous to people who are sensitive to

it, and they can develop breathing difficulties soonafter ingesting shrimp containing sulfite.

Unintentionally added chemicals include insecti-cides, lubricants and equipment sanitizers, whichmay contaminate food if they are used or appliedduring food preparation.

l Physical hazards include broken glass or metalfragments in food. These hazards can cause seriouscuts, broken teeth or bleeding that could requireemergency medical treatment. Physical hazards arethe most commonly reported consumer complaintbecause the injury occurs during or soon after eating,making the source of the hazard easy to identify.

Writing Your HACCP Plan

Prel iminary StepsIf possible, a team of at least two people within

the company should analyze the potential hazards ofyour processing operation. These employees shouldbe directly involved with and know the company’sdaily routine. Ideally, at least one team membershould be familiar with food-safety issues. If not,consult an expert such as a university extension orSea Grant specialist, a health official or consultant.

Although a single person can evaluate food-safety risks and write a HACCP plan, businesses mayfind that the team approach is more helpful. Impor-tant points in your firm’s operation can be missed ormisunderstood if only one person looks for possiblehazards. This is especially possible if the companyhires a consultant to write its HACCP plan. Becauseemployees better understand how the operation runs,they will be less likely to overlook key parts of itduring the hazard analysis. Also, the team approachto creating a HACCP program builds employeeownership in the plan. And employee commitment toHACCP is critical for its success in your plant.

The HACCP team’s first job is to write about theproducts the company makes or sells and to tell howproducts are shipped to market, who the customersare (e.g., the general public, infants, the elderly) andhow consumers will use the products (e.g., eaten rawor cooked). The second step is to diagram, in simpleblock or symbol form, each step the business per-forms to manufacture and distribute its products. (Seediagram in the appendix.) The HACCP team thenshould walk through the facility to make sure itrealistically describes the operation on the production

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chart. The team will use this chart as an essentialblueprint for building the HACCP program.

See the appendix for a sample HACCP PlanForm and for checklists to help guide you throughthe process. The appendix also includes a list ofadditional reading material.

C o n d u c t i n g t h e H a z a r d A n a l y s i sThe HACCP plan should focus solely on hazards

that are reasonably likely to occur and would causeillness or injury to the consumer. The HACCP teammembers must decide which hazards are significantto their business and how to control them in theiroperation. (See Hazard Analysis Worksheet in theappendix.)

To determine how critical a hazard is, the teamcan rely on a combination of personal experience,scientific literature, guidance materials such as theFDA’s Fish and Fisheries Products Hazards andControls Guide and the expertise of state regulatoryagencies. Do not confuse quality issues with safetyconcerns during the hazard analysis. While spoilage,insects and hair are undesirable in food, they do notpose a significant health hazard to consumers. Agood sanitation program, rather than a HACCP plan,will address these issues.

S e t t i n g C r i t i c a l C o n t r o l P o i n t sEvery hazard you identify during the analysis

must have one or more critical controlpoints (CCPs)to manage the hazard. A critical control point is anystep in the production process where a biological,physical or chemical hazard can be controlled so thatfood-safety risks are prevented, eliminated or re-duced to acceptable levels. If the step does notcontrol the hazard, it cannot be a CCP.

For example, you can prevent disease-causingbacteria (pathogens) from growing on finfish byrefrigerating the fish. You can eliminate these samebacteria from crabmeat through pasteurization. Andyou can reduce the bacteria to an acceptable level inshellfish by harvesting oysters, clams and musselsonly from approved waters.

Sometimes a CCP can be used to control morethan one hazard. For example, refrigeration cancontrol the growth of pathogens on the surface oftuna as well as slow the formation of histamine in themeat.

E s t a b l i s h i n g C r i t i c a l l i m i t sCritical limits are the boundaries set around a

CCP to ensure that seafood is produced safely. EachCCP must have critical limits. When a process straysoutside these limits, you must take corrective actionto return the process to compliance. As in the hazardanalysis, the HACCP team may draw on personalexperience, regulatory guidelines or expert opinion toset the critical limits.

Here’s an example of this concept. Cooking isthe CCP for killing potential pathogens in ready-to-eat shrimp. The critical limit for this CCP would beheating the shrimp to 212 F for three minutes so thatthe internal temperature reaches at least 145 F forthree seconds.

A deviation occurs the moment an operationstrays outside the critical limits. To prevent a devia-tion, set your operating limits within a CCP’s criticallimits. For example, keep tuna, mahi-mahi andbluefish iced and refrigerated at 35 to 40 F to mini-mize histamine formation in the meat. That way, themeat’s temperature never comes close to the 50 Fupper limit for the first receiver set by the FDA.

M o n i t o r i n gIt is essential that you know your critical limits

are met consistently. If they are ever out of line, acorrective action must follow quickly. Workersmaintain control at a CCP by following a plannedsequence of observations or measurements. Youshould keep a diary of events for each day’s produc-tion as a record that all of your firm’s products areproduced in compliance with its HACCP plan.

Monitoring procedures must encompass thefollowing issues:

l What will you monitor? This may meanmeasuring something on the production line (such asrefrigeration temperatures) or on the product (such asthe presence of sulfite on shrimp). It also mayinclude observing that a preventive measure at a CCPis being performed (such as verifying that shellfishare harvested from approved waters).

l How will you measure the critical limits? Themonitoring system must generate results rapidly sothat deviations can be corrected as soon as they aredetected. Physical and chemical measurements arerecommended because they can be taken quickly.Examples of monitoring equipment include ther-mometers, clocks, scales, pH meters and chemical

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analytical devices. No matter what method is chosen,it must deliver accurate results.

l How frequently will you monitor a critical limit?Monitoring can be continuous or intermittent, butyou should use continuous monitoring whereverpossible. For example, you should constantly recordthe time and temperature of crabmeat pasteurizationon a temperature-recording chart.

If continuous monitoring is impossible, keep themonitoring interval short. The frequency of noncon-tinuous monitoring will depend on the variability ofthe process being monitored or the amount of aproduct you are willing to risk destroying if a criticallimit is violated. For example, record the temperatureof your holding cooler twice a day.

l Who will monitor? Monitors can include lineworkers, supervisors or quality-control workers.They should fully understand the importance of CCPmonitoring and be trained to run the CCP monitoringequipment. Also, monitors should report their resultsaccurately, and they must report any deviationsimmediately so corrective action can be taken andrecorded.

Correct ive Act ionWhen a critical limit has been violated, you must

follow procedures to bring the process under control.Isolate the product made during the deviation anddetermine how to handle it. It is very important tocorrect the process as soon as possible to preventmore of the product from being produced under theseunacceptable conditions.

An example of a deviation would be when onlypart of a batch of crabmeat reaches its requiredpasteurization temperature for its required cook time.The corrective action would be to recook or destroythe entire batch of crabmeat.

When a product has been produced out ofcompliance, follow four steps to decide how tohandle it:

1. Determine whether the product could be asafety hazard. This decision can be based on physi-cal, chemical or bacterial tests or by consulting anexpert, such as a health official, university extensionor Sea Grant specialist, or a consultant.

2. If there is no hazard, the product can bereleased.

3. If there is a hazard, decide whether the productcan be reprocessed.

4. If a potentially hazardous product cannot besafely reprocessed or reworked, it must be destroyed.

All corrective actions must be documented. Awritten report should include four components:

l The kind of product.l A description of the problem in the process.l The steps taken to correct the problem and the

action taken with the product made when the prob-lem occurred.

l The name of the person responsible for takingthe corrective action. This should be someone whounderstands the process, the product and thecompany’s HACCP plan and who has the authority tomake decisions.

V e r i f i c a t i o nThe role of verification is to show that a

company’s HACCP system can control food-safetyhazards and that all personnel follow it. Verificationinvolves the following:

l Validating that the HACCP plan will work.Before you implement the plan, thoroughly reviewall of the information used during the hazard analysisto ensure the plan is based on sound scientificprinciples. The HACCP team or a consultant can dothis. If you find your critical limits are frequentlybeing violated after your plan is in force, you need torevalidate your plan. You also should revalidate yourHACCP plan any time you have to alter it, such aswhen you change your products or the way youprocess and distribute them. Finally, amend theHACCP plan when new information becomesavailable about potential hazards and the means tocontrol them. Remember that as your company’sbusiness changes over time, your HACCP plan willtoo. The effort to improve food safety never stops,and processors have to adapt to new regulations aswell.

l Calibrating the monitoring equipment. Youneed to calibrate the equipment to make sure moni-toring results are always accurate.

l Reviewing the calibration records to make surethe monitoring equipment performs as it should overtime. Record the dates and methods of calibration, aswell as the test results (i.e., whether it passed orfailed).

l Performing physical, chemical or bacterialtests on products to confirm that they comply withthe HACCP plan. For example, a dealer might test a

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sample of raw shrimp for sulfites to ensure that theboat captains who guarantee that they do not usesulfites are in fact not using them.

l Reviewing monitoring and corrective actionrecords to make sure employees follow the HACCPplan.

l Having regulatory personnel review yourHACCP plan to verify that it can control the hazardsyou identify and to review your records to make surethey are accurate.

R e c o r d K e e p i n gMaintaining records is an important part of your

HACCP system. You can store these records on acomputer, but it is best to keep a paper copy too, asinsurance against a system failure. Keep four kindsof records:

1. The HACCP plan and all of the informationyou used to create it. This includes the hazardanalysis and documentation used to do the analysisand to establish critical control points and criticallimits. This file also should include notes or corre-spondence from experts who helped with your hazardanalysis.

2. Monitoring records. Keep monitoring recordsto show the HACCP team and regulators that CCPsare under control and that the company is complyingwith its HACCP plan. Monitoring records also canhelp identify trends in production where adjustmentsmay be needed to improve product safety.

3. Records of corrective actions. These recordsdocument how a company brought a deviation undercontrol and how it handled the product made duringthe deviation.

4. Verification records. These records includeany changes the team makes to the HACCP plan. Youalso should add the results of accuracy tests per-formed on the monitoring equipment and the resultsof plant inspections or equipment evaluation tests.

Sanitation

After completing a hazard analysis, you may findthat your business does not need a HACCP plan. Butthe regulation does require you to maintain recordsshowing that you comply with eight key sanitationpoints. (See the appendix for a checklist.)

l Document that the water you use to clean orprocess your seafood and to make ice is drawn from

a sanitary source or is treated to make it sanitary. Forexample, you may ask the city that supplies yourwater to write a letter verifying that the water issanitary.

l In handling and processing seafood, use onlyutensils and equipment that are made of nontoxicmaterials and that can be cleaned with food-cleaningchemicals and sanitizers. This provision covers allstorage rooms for raw and processed products as wellas ice machines. Stainless steel is the best surface forequipment that touches food.

l Don’t allow cross-contamination from unsani-tary objects to food, food packages or anything thatfood comes in contact with, such as utensils, gloves,aprons and table surfaces. In addition, you musthandle raw and cooked seafood separately in differ-ent parts of your plant so the raw product can’tcontaminate the cooked product.

l Locate hand-washing and hand-sanitizingstations in all processing areas, where good hygienepractices require employees to wash and sanitizetheir hands. You must maintain toilets that properlydispose of sewage in sanitary condition for allemployees and require employees to wash theirhands after using the toilet.

l Prevent contamination of food, food-contactsurfaces and food packaging by lubricants, fuel,pesticides, sanitizers, metal fragments or otherphysical and chemical food hazards.

l Label any toxic chemicals that you store inyour plant. Use and store them far enough away fromfood and food-contact surfaces so that contaminationdoes not occur.

l Do not allow an employee with an illness,infected wound, open sore or any other problem thatmight contaminate food, food-contact surfaces orfood packaging to work in your plant until thecondition has healed or been treated by a physician.

l Do not allow insects or animals to enter anypart of your food plant.

F l o w D i a g r a m

C h e c k l i s t s

H a z a r d A n a l y s i s W o r k s h e e t

HACCP Plan Form

F l o w D i a g r a m F o r a S m a l l S e a f o o d D e a l e r

CRAB FISH SHRIMP PACKAGING

8

9

10

12

13

Firm Name:

Firm Address:

(21

Identify potential hazardsintroduced, controlled or

enhanced at thii step

Biological

Chemical

Physical

Biological

Chemical

Physical

Biological

Chemical

Physical

Biological

Chemical

Physical

Product Description:

Method of Storage and Distribution:

Intended Use and Consumer:

(3)

Are anypotentialood-safetyhazards

ignificant?(Yes/No)

(4 (5) (6)

Justify your decisionsfor column 3.

Lit measure(s) to preventthe significant hazards

s this stepa criticalcontrolpoint?

(YESIYO)

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Identify potential hazardsintroduced, controlled orenhanced at this step(l)

Biological

Chemical

Physical

Biological

Chemical

Physical

Biological

Chemical

Physical

Biological

Chemical

Physical

Biological

Chemical

AIT anvpotential

‘ood-safe0hazards

ignificant:(Y&O)

Justify your decisionsfor column 3.

List measure(s) to preventthe significant hazards

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SignificantHazard(s)

Critical Limitsfor each Preventive

Measure

(4) (5) (6) (7)

What How Frequency Who

(8)

CorrectiveAction(s)

Records

These additional materials can help you develop andimplement your HACCP plan and sanitation program:

l HACCP: Hazard Analysis and Critical Control PointTraining Curriculum; Second Edition 1997. NationalSeafood HACCP Alliance, North Carolina Sea Grant,Raleigh, NC. UNC-SG-96-02.

l Fish and Fisheries Products Hazards and ControlsGuide; Second Edition, U.S. Department of Healthand Human Services, Public Health Service, Food andDrug Administration, Center for Food Safety andApplied Nutrition, Office of Seafood. January 1998.

l Do Your Own Plant Inspection -A Guide forSelf-Inspection for the Shellfish Shipper orProcessor. U.S. Department of Health and HumanServices, Public Health Service, Food and DrugAdministration, Bureau of Foods, HHS PublicationNo. (FDA) 91-2248, 1991.

l HACCP Program Assistance for Small SeafoodProcessors and Dealers. North Carolina FisheryResource Grant Program. North Carolina Sea Grant,Raleigh, NC. Project No. 97ST-2, March 1998.

9 Federal Register, Vol. 60, No. 242, Monday, Dec. 18,1995, Rules and Regulations, pages 65197-65202.

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