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Seafood HACCP Alliance Training Course 12-1

IntroductionWelcome to Module 12. In this module you willlearn about the specific requirements of FDA'sseafood HACCP regulation. You'll review eachsection of the regulation, and see how each of the7 principles of HACCP that you've just learnedabout have been incorporated into it. You will alsolearn what products and processing activities arecovered by the regulation and the specialrequirements included in the regulation for certaintypes of products and processing activities. Thismodule has 30 pages and 6 questions.


BackgroundOn Dec. 18, 1995, FDA published a seafood regulation based on the sevenprinciples of HACCP called "Procedures for the Safe and Sanitary Processing andImporting of Fish and Fishery Products". This regulation is commonly called the"Seafood HACCP Regulation", and in this module we will simply refer to it as "theregulation".

The regulation is part of Title 21 of the Code of Federal Regulations (CFR), Part123, and the requirements of the regulation became mandatory on December 18,1997.

The pages in this Module describe each of the sections in the FDASeafood HACCP Regulation. Turn to page 317 in the third edition of theFDA Hazards Guide to see the exact wording of each section of theregulation.


Regulation Format

Let's take a look at the format of the regulation. When compared to many otherregulations, this one is fairly simple to read and to understand. It is divided intothree Subparts and 13 Sections. An index of each Subpart and Section is shownbelow. The Subparts are numbered A, B, and C. The Sections are preceded by thenumber 123 (for Part 123 of Title 21 of the CFR). For example, the definitionsassociated with the regulation are found in Subpart A, Section 123.3.

Subpart A is considered the "umbrella" portion of the regulation. It is referred toas the "umbrella" portion because it is the part of the regulation that all seafoodprocessors have to comply with. It covers all of the HACCP and sanitationmonitoring requirements.

Subparts B & C cover specific HACCP requirements for two types of seafoodproducts: smoked and smoke-flavored fishery products, and raw molluscanshellfish.

Subpart 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


§ 123.3 DefinitionsLet's take a look at Subpart A first. You'll notice that the first section of subpart A(123.3) includes 20 important terms or definitions. They are:

• Certification number means a unique combination of letters and numbersassigned by a shellfish control authority to a molluscan shellfish processor.

• Critical control point means a point, step or procedure in a food process atwhich control can be applied, and a food-safety hazard can be prevented,eliminated, or reduced to acceptable levels.

• Critical limit means the maximum or minimum value to which a physical,biological or chemical parameter must be controlled at a critical control pointto prevent, eliminate or reduce to an acceptable level the occurrence of theidentified food-safety hazard.

• Fish means fresh or saltwater finfish, crustaceans, other forms of aquaticanimal life (including, but not limited to alligators, frogs, aquatic turtles,jellyfishs, sea cucumbers, sea urchins and roe of such animals) other thanbirds or mammals, and all mollusks, where such animal life is intended forhuman consumption.

• Fishery product means any human food product in which fish is acharacterizing ingredient.

• Food-safety hazard means any biological, chemical or physical propertythat may cause a food to be unsafe for human consumption.

• Importer means either the U.S. owner or consignee at the time of entry intothe United States or the U.S. agent or representative of the foreign owner orconsignee at the time of entry into the United States, who is responsible forensuring that goods being offered for entry into the United States are incompliance with all laws affecting the importation. For the purposes of thisdefinition, ordinarily the importer is not the custom-house broker, the freightforwarder, the carrier or the steamship representative.

• Molluscan shellfish means any edible species of fresh or frozen oysters,clams, mussels, scallops or edible portions of such species, except when theproduct consists entirely of the shucked adductor muscle.

• Preventive measure means physical, chemical or other factors that can beused to control an identified food safety hazard.

• Process-monitoring instrument means an instrument or device used toindicate conditions during processing at a critical control point.

• (1) Processing means, with respect to fish or fishery products: Handling,storing, preparing, heading, eviscerating, shucking, freezing, changinginto different market forms, manufacturing, preserving, packing, labeling,dockside unloading or holding.

(2) The regulations in this part do not apply to:(i) Harvesting or transporting fish or fishery products, without otherwise

engaging in processing.(ii) Practices such as heading, eviscerating or freezing intended solely to

prepare a fish for holding on a harvest vessel.(iii) The operation of a retail establishment.


§ 123.3 Definitions (continued)• Processor means any person engaged in commercial, custom or institutional

processing of fish or fishery products either in the United States or in aforeign country. A processor includes any person engaged in the production offoods that are to be used in market or consumer tests.

• Scombroid toxin-forming species means tuna, bluefish, mahi mahi, andother species, whether or not in the family Scombridae, in which significantlevels of histamine may be produced in the fish flesh by decarboxylation offree histidine as a result of exposure of the fish after capture to temperaturesthat permit the growth of mesophilic bacteria.

• Shall is used to state mandatory requirements.

• Shellfish control authority means a federal, state or foreign agency, orsovereign tribal government, legally responsible for the administration of aprogram that includes activities such as classification of molluscan shellfishgrowing areas, enforcement of molluscan shellfish harvesting controls, andcertification of molluscan shellfish processors.

• Shellstock means raw, in-shell molluscan shellfish.

• Should is used to state recommended or advisory procedures or to identifyrecommended equipment.

• Shucked shellfish means molluscan shellfish that have one or both shellsremoved.

• Smoked or smoke-flavored fishery products means the finished foodprepared by:

(1) Treating fish with salt (sodium chloride), and

(2) Subjecting it to the direct action of smoke from burning wood, sawdust orsimilar material and/or imparting to it the flavor of smoke by a meanssuch as immersing it in a solution of wood smoke.

• Tag means a record of harvesting information attached to a container ofshellstock by the harvester or processor.


Products that are Subject to theRegulationAlthough all of the definitions are important to knowand understand, there are a few that need to beemphasized. We'll review these key definitions next.

Together, the terms "fish" and "fishery product"in Section 123.3 define what products aresubject to this regulation. As you can see, thesedefinitions cover just about every seafood oraquatic food product you could think of!

Fish means freshwater or saltwater finfish,crustaceans, other forms of aquatic animal life(including but not limited to alligator, frog, aquaticturtle, jellyfish, sea cucumber, sea urchin and theroe of such animals) other than birds or mammals,and all mollusks, where such animal life is intendedfor human consumption.

Fishery product means any human food productin which fish is a characterizing ingredient. [Note:This definition exempts products from themandatory HACCP requirements that containinconsequential amounts of fish. For example,Worcestershire sauce contains some anchovy pastebut is not characterized by that ingredient.]


Who Must Comply with the RegulationTogether, the terms "importer", "processor", and "processing" define whomust comply with the regulation. Again, you can see that the definitions coverjust about everyone who processes, stores, or handles seafood! Note that thereare three types of operations that are exempt from this regulation that aredescribed at the end of this page.

Importer means either the U.S. owner or consignee or the U.S. agent orrepresentative of the foreign owner or consignee at the time of the product'sentry into the United States. This person is responsible for ensuring that goodsbeing offered for entry into the U.S. are in compliance with all laws affecting theimportation. Ordinarily, the importer is not the custom-house broker, freightforwarder, carrier or steamship representative. [Note: The ownership of animported product can change many times in a short period of time after entry intothe United States. However, the person who is the owner or consignee at the timethat the product is offered for entry is identified as the importer because: 1) thatperson has the ability to decide whether to offer the product for entry, and 2) thatperson is in a position to ensure that the product is processed under appropriatecontrols and to demonstrate this to FDA.]

Processor means any person engaged in commercial, custom or institutionalprocessing of fish or fishery products either in the United States or in a foreigncountry. A processor includes any person engaged in the production of foods thatare used in market or consumer tests.

Processing means handling, storing, preparing, heading, eviscerating, shucking,freezing, changing into different market forms, manufacturing, preserving,packing, labeling, dockside unloading or holding fish or fishery products. [Note:Eviscerating done by an aquaculture grower before delivery to a processing plantwould make it necessary for the grower to comply with the requirements of thisregulation.]

The following operations or activities are not subject to the regulation!

• Fishing vessels if they are only engaged in the harvest and transport offish. This does not exempt factory trawlers and similar vessels that process atsea. [Note: Fishing vessels and carriers may be affected by this regulationindirectly through the controls that processors may impose on them to meetHACCP obligations.]

• Practices such as heading, eviscerating or freezing intended solely toprepare a fish for holding on a harvest vessel. [e.g. gutting fish at sea inorder to maintain the quality of the fish during transport to the processor].

• The operation of retail establishments.


Mandatory Requirements orRecommended ProceduresAnd last but not least, we need to review the twoterms that are used in the regulation that definewhether the requirement is mandatory or is onlyrecommended or advised.

Shall is used to state mandatory requirements.

Should is used to state procedures or equipmentthat is recommended or advised.

A couple of additional points that you need to beaware of before we continue include:

* Products that do not move in interstatecommerce are not subject to the regulation.However, products are considered to haveentered into interstate commerce if rawmaterials, ingredients, packaging, etc. haveoriginated outside the state.

* The use of the term "should" in the FDAregulation may differ from its use in Modules 5through 11 of this course. Modules 5 through11 are designed to teach the principles ofHACCP, including certain activities that need tobe carried out to properly implement HACCPplans. Identifying these activities as those that"should" be enacted means they are importantfor the HACCP program to be effective. Manyof these activities may also be mandatoryelements of the regulation.


§ 123.5 Current Good Manufacturing PracticesNow, you may, or may not, be thinking... how does FDA's Current GoodManufacturing Practice Regulation (21CFR Part 110) which has been in existencefor many years and defines the sanitary conditions that shall be applied in a foodprocessing plant, tie into this seafood HACCP regulation? Is this a duplication ofanother regulation that you already have to comply with? Believe it or not, theFDA made every attempt not to duplicate another regulation that you may alreadyhave to comply with. Let's briefly take a look at how this was done.

The Federal Food, Drug, and Cosmetic Act deems food to be adulterated if it isprocessed under insanitary conditions. The Current Good Manufacturing PracticeRegulation (Part 110) describe the conditions and practices that must be followedto avoid producing adulterated food products. 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 safe and whether theproducts have been processed under sanitary conditions. The purpose of theseafood HACCP regulation is to set out additional requirements specific tothe processing of fish and fishery products.


Section 123.6 of the regulation describesrequirements for a processor's hazard analysis andHACCP plan. There are various subsections. Let'stake a look at each of these subsections startingwith 123.6(a) which describes the requirementsrelated to the first HACCP principle—hazardanalysis.

§ 123.6 Hazard AnalysisThe regulation requires that every processorperform a hazard analysis. (Principle 1, module5.) It outlines two major steps in a hazardanalysis:

• Determine whether there are hazards that are"reasonably likely to occur".

AND

• Identify preventive measures to control theidentified hazards


“Reasonably likely to occur?”The regulation says that hazards that are reasonably likely to occur are thosehazards for which a prudent processor would establish controls because there is areasonable possibility that the hazard will occur.

Making your decision of whether or not the hazard is reasonably likely to occurshould be based on things such as experience, illness data, scientific reports andother reference materials such as FDA's Hazards and Controls Guide.

The criteria for including a food-safety hazard in a processor's HACCP plan shouldbe the likelihood that the hazard will occur or develop in that product withoutproper controls (e.g. based on the processing technique, the harvest location, thespecies etc.). For example, take the hazard of histamine. Histamine reaction alsoknown as scombroid poisoning is one of the most frequently reported illnessesfrom fish. The relationship between time and temperature abuse of certainspecies of fish after harvest and the formation of the histamine toxin is wellestablished. Therefore, you would say that the hazard of histamine is "reasonablylikely to occur" in those species of fish that are prone to this hazard if time andtemperature controls are not in place.

Believe it or not...the regulation does not require a written hazard analysis. Thisis because it is the end product of the hazard analysis - the HACCP plan and itsimplementation - that will be judged by the regulator and not the hazard analysisitself. For this reason, the regulation does not require that the hazard analysis beperformed in any particular way or that it be documented in writing for regulatoryreview. However, a written hazard analysis will help the processor remember thethought process used to identify the hazards and develop the HACCP plan. Thiswill be useful when periodic plan reassessments are conducted and when the planis reviewed by regulators.


§ 123.6(b) The HACCP PlanSection 123.6(b) of the regulation states that every processor shall have andimplement a written HACCP plan whenever a hazard analysis reveals one or morefood-safety hazards that are reasonably likely to occur. The HACCP plan must bespecific to:

• Each processing location, meaning that if you process the same product intwo different plant locations, each plant has to have their own HACCP plan,even though the product is the same

AND

• Each species of fish and type of fishery product, with the exception thatsome fish and fishery products may be combined or grouped together in aHACCP plan if all the HACCP components are similar. For example, if youprocess tuna and mackerel, both of which have the same hazards (histamine,parasites), and the same controls (time/temperature), and require the samecritical limits, monitoring, corrective action, records, and verificationprocedures, they can be grouped together and listed in a single HACCP plan.


§ 123.6(c) The contents of the HACCP PlanSection 123.6(c) of the regulation describes what must be included in your HACCPplan. Specifically each of the 7 principles of HACCP are required as follows:

• Principle 1: List the food-safety hazards that are reasonably likely tooccur. This includes natural toxins, microbiological contamination, chemicalcontamination, pesticides, drug residues, decomposition that is related tosafety (e.g., scombroid toxin-forming species), parasites that are related tosafety (e.g., fish used for raw consumption), unapproved food and coloradditives, and physical hazards. They can be hazards that are introducedinside the processing plant or hazards that occur before, during, or afterharvest. This is not an all inclusive list. Other hazards, such as allergens, mayalso be relevant to your product or process.

• Principle 2: List the critical control points

• Principle 3: List the critical limits

• Principle 4: List the monitoring procedures.

• Principle 5: List predetermined corrective actions*

• Principle 6: List the verification measures

• Principle 7: Provide for a system of monitoring records

* Note that processors are not required to pre-determine corrective actions—this will be discussed in section §123.7 Corrective Action.

HACCP plans are required to address each of the 7 HACCP principles. Your planwill be evaluated by FDA at your processing site in order to determine if it iscomplete, adequate, and is being implemented properly. FDA does not pre-approve your plan and therefore plans should not be submitted to the agency forreview.


§ 123.6(d) Signing and Dating theHACCP Plan

Along with the mandatory contents of yourHACCP plan, the regulation also makes it

mandatory that:

"The HACCP plan be signed and datedeither by the most responsible individual

on-site at the processing facility or by ahigher level official of the processor. Thissignature shall signify that the HACCP planhas been accepted for implementation by thefirm."

The frequency of signing and dating your planis also mandatory and is:

• Upon initial acceptance.

• *Upon any modification.

• At least annually*

*This is part of a verification requirement that willbe discussed in §123.8.


§ 123.6(e) Product subject to other regulations(Specifically Low Acid Canned Foods and Acidified Foods)

Processors of low-acid canned foods and acidified foods must comply with therequirements of two existing regulations: 21 CFR Part 113 and 114. Thoseregulations specifically address the hazard of Clostridium botulinum in low acidfoods. In an attempt not to duplicate requirements, the seafood HACCP regulationstates that those processors who must comply with the requirements of Part 113or 114 (acidified and low-acid canned foods regulations) of the CFR do not needto address the hazard of Clostridium botulinum in their HACCP plans. However,other hazards may be reasonably likely to occur in an acidified or low-acid cannedfishery product (e.g. histamine in canned tuna), and these hazards must beaddressed in the HACCP plan as appropriate.

§ 123.6(f) Sanitation controls and the HACCP PlanFDA recognizes that sanitation controls may be difficult to manage in the contextof a HACCP plan. This is because it is often difficult to determine appropriatecritical limits and corrective actions for sanitation controls, particularly thoserelating to employee practices or personnel hygiene (e.g., hand washing). Forexample, if the identified hazard was bacterial cross contamination and the CCPwas packaging, you would need to identify the critical limits, corrective actionsand so forth at that CCP. If we were to think through this example, we mightassign a critical limit of something like, no employees allowed to touch finishedproduct without washing their hands. Then, if during monitoring you noticed anemployee touch a dirty surface and then return to the process line and continueto package the finished product, what would the corrective action be? Hold all ofthe product since the last monitoring interval and have it evaluated—and then firethe employee to correct the process?

As you can see from this example, sanitation controls can be difficult to managein a HACCP system. For this reason, the regulation does not require thatsanitation controls be included in the HACCP plan. However, sanitation controlsthat are not in the plan must be monitored according to the sanitation provisionsof the regulation which is discussed in section 123.11.


§ 123.6(g) Legal basisThis section of the regulation describes the legal basisused by the FDA for this regulation. FDA's applicationof HACCP is primarily based on the Federal Food,Drug, and Cosmetic Act. This section of the act makesit unlawful to process food under conditions that mayrender it injurious to health. Any fish or fisheryproduct processed or imported in violation of theseafood HACCP regulation can be consideredadulterated and subject to regulatory action.


§ 123.7 Corrective ActionsThe regulation states that whenever a deviation from a critical limit occurs, aprocessor shall take corrective action. As we discussed in module 9, correctiveactions have two components: they must address both the product and theprocess.

The regulation also gives processors a choice of whether or not they want toinclude "predetermined" corrective actions in their written HACCP plans. A properpredetermined 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 is otherwiseadulterated as a result of the deviation.

• The cause of the deviation is corrected.

If you decide not to include a "predetermined" corrective action in your HACCPplan, the regulation outlines an alternative procedure.

The alternate corrective-action procedure in the regulation requires thatyou:

• Segregate and hold the affected product until the next two requirements aremet.

• Determine whether the product is safe for distribution. This decision must bemade by someone who has suitable training or experience. This training orexperience must be in the field(s) of science that is necessary for the personto understand the public health consequences of the critical-limit deviation.

• Take corrective action, as necessary, to ensure no unsafe product enterscommerce.

• Take corrective action, as necessary, to fix the problem that caused thedeviation.

• Determine whether the HACCP plan needs to be modified to reduce the riskthat the deviation will happen again and modify the HACCP plan as necessary.This decision must be made by someone who has met the trainingrequirements covered in section 123.10.

Note that while the alternative procedure addresses corrections in the productand the process, it has an additional requirement that your HACCP plan bereassessed by a trained individual.

A predetermined corrective action plan may provide 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 been taken.But unusual situations may arise that may not be addressed in predeterminedcorrective action plans. Processors may choose not to predetermine theircorrective actions. In these cases, the alternate corrective-action procedure mustbe followed.

Remember!!!! All corrective actions must be fully documented in records.


§ 123.8 VerificationThe regulation breaks verification activities into 3 components:

• overall verification

• ongoing verification, and

• record review.

All of these verification activities are mandatory to ensure that the HACCP plan isadequate to control food safety hazards that are reasonably likely to occur andthat the HACCP plan is being implemented effectively. Let's look at therequirements of each of these verification activities.

Overall VerificationThe HACCP plan must be reassessed at least once per year and whenever anychanges occur that could affect the hazard analysis or the HACCP plan 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 this reassessment is to ensure that the HACCP plan is adequate tocontrol the food-safety hazards that are reasonably likely to occur. It must beperformed by an individual who meets the training requirements described insection 123.10. If a processor has no HACCP plan because no significant hazardswere identified, then the hazard analysis must be reassessed whenever anychanges occur that could affect the results of the hazard analysis.


§ 123.8 Verification (continued)

Ongoing verificationThese verification activities are required to ensure thatthe HACCP plan is being implemented on a day-to-daybasis and is being followed.

Ongoing verification procedures must be listed in theHACCP plan and include:

• Consumer complaint review to determinewhether a complaint may relate to a problem at aCCP. The regulation does not give inspectors accessto consumer complaints but does give them accessto corrective action records that relate to problemsidentified by consumer complaints.

• Calibration of process monitoringinstruments. Records must be kept of thecalibration procedures.

• Periodic end-product and in-process testing.Testing is optional, but if you included in your plan,records must be kept of end-product or in-processtesting.

Review of RecordsThe regulation requires that processors review certainrecords as part of their verification procedure. Thepurpose of these reviews is to ensure that the recordsare complete and that the activities occurred inaccordance with the processor's written procedures. Therecords must be reviewed by someone who meets thetraining requirements described in section 123.10.

Records that require review are:

• CCP monitoring records shall be reviewedwithin one week of when the record is made.

• Corrective action records shall be reviewedwithin one week of when the record is made.

• Calibration records must be reviewed in atimely manner.

• In-process and end-product testing recordsmust be reviewed in a timely manner.

Note: The FDA regulation does not require thatSanitation records be reviewed.

Sometimes the review of a consumer complaint or theperformance of a verification procedure will indicate thatthere is a potential public-health problem. When thishappens, the processor must follow the corrective-action procedures described in section 123.7.


§ 123.9 RecordsThe regulation requires that certain records must be kept AND that there arecertain record keeping procedures that must be followed AND that there is atleast some minimum information on the records. The following summarizes therecord keeping requirements in the regulation.

Required records include:

• Monitoring records.

• Corrective action records.

• Verification records.

• Sanitation control monitoring records.

• Importer verification records.

Records must:

• 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.

Required information on each record includes:

• 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.

Records need to be kept for:

• One year for refrigerated products.

• Two years for frozen or preserved products.

If permanent storage of records at the processing facility is not practical (e.g. aremote processing site or a processing vessel), the records may be transferred tosome other facility at the end of the season. But the records must be able to bepromptly returned when requested by a regulatory agency.

Official review of records:

All records required in this regulation and all plans and procedures required bythis regulation shall be made available for official review and copying atreasonable times.

A key feature of the HACCP regulation provides government inspectors access tothe HACCP plan, monitoring records and corrective action records. Examination ofHACCP records enables an inspector to see how the processing facility operatesover time rather than just on the day of the inspection. Additionally, it enables theinspector to review the adequacy of the processor's control system.


§ 123.10 TrainingThe regulation requires that certain activities andfunctions be performed by an individual trained inHACCP. So what are those activities and just whatdoes "trained in HACCP" mean?

The following are the activities and functions thatneed to be performed by a HACCP-trainedindividual:

• Develop the HACCP plan

• Reassess and modify the HACCP plan andhazard analysis

• Review HACCP records.

The regulation defines a "HACCP-trained individual"as one "who has successfully completed training inthe application of HACCP principles to fish and

fishery product processing at least equivalent to that received under astandardized curriculum recognized as adequate by the U.S. Food and DrugAdministration or who is otherwise qualified through job experience to performthese functions. Job experience will qualify an individual to perfom thesefunctions if it has provided knowledge at least equivalent to that provided throughthe standardized curriculum."

And the good news is: The course material that you are now using, developed bythe National Seafood HACCP Alliance, is the standardized curriculum that hasbeen recognized by FDA. So you are well on your way to becoming a "HACCP-trained individual". You can meet this training requirement by completing a "live"three day standardized training program, or by completing this Segment OneInternet training course and a one-day Segment Two training session. To reviewthe description of these training courses in the Introduction section of this course,go here:

http://distance-ed.arme.cornell.edu/seafood/module12/IntroRepro.html

Note: The regulation does say that processors can use a trained employee or atrained third party to perform these functions. These jobs may be done by oneperson or by several as long as they have met the training requirement.


§ 123.11 Sanitation Control ProceduresSanitation is a prerequisite program that is necessary for the effectiveimplementation of HACCP (prerequisite programs were reviewed in Module 3). Inwriting the seafood HACCP regulation, FDA concluded that the GoodManufacturing Practice regulations (21 CFR Part 110) had not proven fullyeffective in encouraging seafood processors to take full responsibility for ensuringthat sanitation in their plants consistently met minimum standards. In otherwords, most seafood processors were not doing a very good job in the sanitationdepartment. For these reasons, the regulation requires that processors takecertain actions to control sanitation conditions and practices.

The sanitation requirements of the regulation are mandatory for all processors -whether or not they have a HACCP plan. Remember that when we discussed thecontents of the HACCP plan in section §123.6, that the regulation gave you theoption of including the sanitation requirements as part of your HACCP plan ormanaging some of them outside of the plan. Some processors may choose to usea combination of these approaches.

The regulation outlines the following general requirements for sanitation controlprocedures:

• Written Sanitation Standard Operating Procedures (SSOP) should bedeveloped. The regulation encourages but does not require, that eachprocessor develop a written SSOP. The SSOP should describe how theprocessor will ensure that certain key sanitation conditions and practices willbe met. It should also describe how the plant operations will be monitored toensure that the conditions and practices will be met.

• The regulation does require that each processor shall monitor thesanitary conditions and practices during processing, and makecorrections to deficient practices. The regulation also outlines 8 key areas ofsanitation, that at minimum, need to be monitored.


§ 123.11 Sanitation Control Procedures (continued)The 8 key sanitation conditions or practices that must be monitored are:

1.Safety of water.

2.Condition and cleanliness of food-contact surfaces

3.Prevention of cross-contamination.

4.Maintenance of hand washing, hand sanitizing and toilet facilities.

5.Protection from adulterants.

6.Labeling, storage and use of toxic compounds.

7.Employee health conditions.

8.Exclusion of pests.

The regulation also requires that processors shall maintain sanitation controlrecords, that at minimum, document the monitoring and corrections todeficient items of the eight key areas of sanitation. These records aresubject to the same requirements as the HACCP records, except plant verificationreview.

The purpose of the monitoring is to ensure that the requirements of the currentGMP regulations are met.

Additional information on these sanitation requirements is available in otherSeafood HACCP Alliance training courses. Monitoring frequencies for each of these8 areas of sanitation are recommended in the Seafood HACCP Alliance "Encore"course. For a more in depth view of FDA's recommendations for sanitationmonitoring, frequencies of monitoring and record keeping from the SeafoodHACCP Alliance "Encore" course, visit this site: http://distance-ed.arme.cornell.edu/seafood/module12/UCDavisSanit.html

The Seafood HACCP Alliance has also developed a one day Sanitation ControlProcedures (SCP) course that covers each of these 8 areas of sanitation in detail.Visit this web site (http://seafood.ucdavis.edu/haccp/training/reg-cal.htm) todetermine what SCP courses are currently scheduled.


§ 123.12 Special Requirements forImported ProductsIt has always been the importer's responsibility to offer forentry into this country products that are not adulteratedunder U.S. law. FDA's surveillance system for imports hastraditionally consisted of: reviews of customs entry formsfor fish and fishery products being offered for entry into theUnited States, sensory analyses (wharf examinations) andsample collections for laboratory analysis of productsawaiting entry, and automatic detention of products with ahistory of problems. As with traditional processing-plantinspections, this method is a "snapshot" approach that isnot preventive.

Under the seafood HACCP regulation, HACCP controls are required for importedfish and fishery products as well as for domestic products. The definition ofprocessor explicitly includes those who process seafood in foreign countries.Additionally, the regulation requires that importers take certain steps to verifythat their foreign suppliers meet the requirements of the regulation.

Importers can meet the requirements of the regulation in one of two ways:

• Import fish and fishery products from countries with a memorandum ofunderstanding (MOU) between the United States (FDA) and a foreign country.In this case, importers of products from a country with an MOU do not needto take any other action to meet the requirements of the regulation.

OR

• Have and implement written verification procedures for ensuring that the fishand fishery products offered for import into the United States were processedin accordance with the requirements of the regulation. Importers of productsfrom most countries will need to comply with this option that requires writtenverification procedures to document that the imported product meets therequirements of the regulation.


§ 123.12 Special Requirements for Imported ProductsSo what are written verification procedures? To simplify the language in the regulation it isbest to deal with these importer verification procedures by outlining the three requireddocuments/procedures for imported fish and fishery products:

1. Product SpecificationsThe importer must develop product specifications that cover those characteristics of theproduct that would be useful in providing assurance that the product is not adulteratedunder section 402 of the Federal Food, Drug and Cosmetic Act. This section relates tocontaminants that may render the food injurious to health and to unsanitary processingconditions. For example, the product specifications for frozen tuna steaks would include amaximum limit for histamine of 50 ppm.

2. Affirmative StepsImporters need to perform, at minimum, one of the following affirmative steps:

• Obtain the foreign processor's HACCP and sanitation monitoring records for the lotbeing entered. In this case it will be necessary for the importer to evaluate the firm'sHACCP plan to ensure that food safety hazards and controls have been adequatelyevaluated.

• Obtain a continuing or lot-by-lot certificate from a competent third party certifyingthat the product was processed in accordance with the FDA HACCP regulation.

• Regularly inspect the foreign processor. In this case it is necessary that the inspectionand result of the inspection is documented.

• Obtain foreign processor's HACCP plan and written guarantee that regulation is beingmet. In this case it will be necessary for the importer to evaluate the firm's HACCPplan to ensure that food safety hazards and controls have been adequately evaluated.

• Test the product and obtain written guarantee that regulation is being met.

• Perform other verification procedures that provide equivalent level of assurance.

3. Written Verification ProceduresThe third requirement requires the importer to have and implement written verificationprocedures. This requirement can be met by simply documenting the name of the exporterand the product description along with the review and documentation that both theproduct specifications and one affirmative step were accomplished.

An importer may hire a competent third party to perform verification activities. However,the importer remains responsible for demonstrating to FDA that the requirements havebeen met.

The importer must keep records in English that document that the affirmative steps havebeen performed. The records must describe the results of the steps. These records aresubject to the records requirements described in §123.9. Importers that also process fishor fishery products must also meet the HACCP and sanitation requirements of theregulation for their processing operation.


Subpart B—Smoked and Smoke Flavored Fishery Products

§ 123.5 GeneralSmoked and smoke flavored fishery products are considered "high risk" productsdue to the risk of Clostridium botulinum. Because of this, the regulation sets forthspecific requirements for processors of those products.

§ 123.6 Process ControlsThe specific requirements for processors of smoked and smoke flavored fisheryproducts are:

• HACCP plans shall include controls for Clostridium botulinum toxin formationfor the shelf life of the product under normal and moderate abuse conditions.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.

• However, if the product is a low-acid canned food or an acidified food that issubject to 21 CFR 113 or 114, the HACCP plan need not include such controls.


Subpart C—Raw Molluscan Shellfish

§ 123.20 GeneralThe largest number of reported illnesses from consumption of seafood is causedby raw molluscan shellfish (oysters, clams and mussels). These hazards areprimarily introduced before the molluscan shellfish are harvested. The risk ofoccurrence of these hazards is reduced by ensuring that the molluscan shellfishcome from sanitary growing waters. In most cases, the sanitary quality ofmolluscan shellfish growing waters is determined by a state or national agencycalled a shellfish control authority.

Because the hazard is primarily attributed to the harvest area, the regulationprovides very specific requirements for controlling the source of origin for rawmolluscan shellfish. The only exception to source controls is where processingincludes a treatment that ensures the destruction of vegetative cells ofmicroorganisms of public health concern. If that is the case, the source controlsdo not need to be included in the HACCP plan. It is important to note, however,that other hazards may also be reasonably likely to occur in these products, andthey must be identified in the HACCP plan.


§ 123.28 Source Controls—raw molluscan shellfish (continued)The regulation outlines the specific requirements of source controls for rawmolluscan shellfish. They are:

Processors 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.

Processors who receive shellstock shall only accept shellstock from:

• a harvester that is in compliance with any license requirement, OR

• a processor that is certified by a shellfish-control authority.

Containers of shellstock must be tagged with the following information:

• Date and place shellfish were harvested (state and site).

• Type and quantity of shellfish.

• Harvester identification number, name of harvester, or name or registrationnumber of harvester's vessel.

Records 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 orharvester's identification number

Shucked molluscan shellfish containers must bear a label that contains:

• Name of packer or repacker.

• Address or packer or repacker.

• Certification number of packer or repacker.

Records for shucked product must document:

• Date of receipt

• Quantity and type of shellfish.

• Name and certification number of the packer or repacker.


Whew! We've reviewed the important parts of the FDA Seafood HACCP regulation.You can see that all of the elements of a complete HACCP system that we coveredin this training course are incorporated into the regulation—HACCP principles,sanitation and pre-requisite programs. In addition, there are other specificrequirements for importers and processors of smoked fish and molluscanshellfish.

If you would like to review all or any of the specific parts of the FDA seafoodHACCP regulation, read the Appendix of the FDA Hazards and Controls Guide orthe Appendix of the blue Seafood HACCP training curriculum manual.

This is the last module in the Seafood HACCP Alliance Internet training course.After you have completed the Check Your Knowledge section of this Module andsubmitted your answers, you will receive a notice from the Cornell Food IndustryManagement Distance Education Program stating that you have completedSegment One—Internet Seafood HACCP training course of the Seafood HACCPAlliance Training program. If you want or need to meet the training requirementof the FDA regulation you will need to complete a one-day Segment Two trainingsession. Completion of this one day "live" session and the Internet course willmake you eligible to receive a "Certificate of Course Completion" from theAssociation of Food and Drug Officials (AFDO) that is equivalent to the certificatereceived upon completion of a "live" three day AFDO certified course. To see a listof scheduled training courses and certified trainers in each state, visit this website: http://seafood.ucdavis.edu/haccp/training/reg-cal.htm.


Check Your Knowledge

Now you need to return to Module 12 via the Internet.

Click through the text pages until you get to the Check YourKnowledge page (page 12-29).

Good Luck!

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