meetings, it appears that evolving interna-tional standards will be used as a basis fortrade. There is a committee on sanitary andphytosanitary measures that directs its atten-tion to those areas that protect human, animal,and plant life or health. There are no subcom-mittees or working groups. Joint Canadian-U.S. working groups continue to coordinatewith the NAFTA Sanitary/Phytosanitary Com-mittee.

There is also a committee on standards-re-lated measures to consider quality, nomencla-ture, packaging, and labeling issues.

EUROPEAN COMMUNITY (EC)NMFS is aware that the EC directives re-

garding the inspection and certification re-quirements to be implemented July 1,1993 area matter of concern to exporters of fisheryproducts.

Our meetings with industry across the coun-try during the past several months attemptedto provide the industry with as much advancenotice of the EC’s intentions as possible so thatplans could be made to meet these new re-quirements. It is important to note that the EChas adopted import requirements. Once therequirements are fully implemented, all coun-tries must comply with them if their productsare to be accepted into the EC.

Officials from NMFS, the FDA, and theUSFWS have met with representatives of theEC to discuss the impending directives, ex-plain the various controls and programs in theU.S., and seek clarification on a number ofitems described in the respective directives.These and other efforts have been undertakento assure that there will be minimal disruptionto U.S. export trade in seafood with the EC.

As an official U.S. Government agency re-sponsible for inspecting and certifying fisheryproducts, NMFS cannot ignore the EC importrequirements. It must assure that products itcertifies for export to the EC comply with ap-propriate requirements. In the event that a re-quirement is not being uniformly applied, tothe detriment of the U.S., it will be viewed as anontariff trade barrier and the U.S. Govern-ment will take appropriate trade actions.

Three EC directives have a major impact onfishery products:

1. Council directive 91/493, “laying downthe health conditions for the productionand the placing on the market of fisheryproducts.”

2. Council directive 91/492, “laying downthe health conditions for the production

3.

and the placing on the market of livebivalve molluscs.”Council directive 91/67, “concerning theanimal health conditions governing theplacing on the market of aquacultureanimals and products.”

Council directive 91/493 requires that thirdcountries (for example, the United States) havea system at least equivalent to the system de-scribed in the directive. The general provisionsof the system are delineated under Article 6with additional requirements that would beapplicable in the annex of the directive inchapters 2-7, which covers sanitation of thefacility, handling and storage practices, andproduct requirements.

Article 6 outlines the principles of theHACCP-based system. The value of such a sys-tem has been widely acknowledged by foodcontrol authorities internationally (for ex-ample., Codex Alimentarius) as well as in theUnited States (for example, various reports is-sued by the National Academy of Sciences re-garding meat, poultry, and seafood products).The United States, in particular, has recog-nized the advantages of adopting a HACCPbased inspection system.

EC representatives have acknowledged thattraditional NMFS in-plant inspection tech-niques (such as continuous inspection) wouldalso be considered equivalent to the HACCP-based inspection system. They have acknowl-edged that a lot inspection without knowledgeof the handling and processing conditionswould not be considered adequate.

The forthcoming system under the EC direc-tives contains significant changes from previ-ous experiences:

1.

2.

3.

4.

The establishment must be approved bya competent authority of the thirdcountry for compliance with require-ments equivalent to those laid down indirective 91/493.The establishment must be on a list ofofficially approved establishments thatis submitted to the EC by the competentauthority.The product must bear a mark contain-ing the approval number of the estab-lishment.The shipment must be accompanied bya health certificate.

The United States has identified N M F S theFDA, and the FWS as competent authoritiesfor the inspection and certification of fishery products and has submitted all the required

material pertaining to laws, regulations, proce-dures, and so on, to the EC for evaluation. TheUnited States has been informed that the ECwill perform on-site visits between July 15 andOctober 1993.

Commission decision 93/185/EEC, “layingdown certain transitional measures concerningthe certification of fishery products from thirdcountries in order to facilitate the switchoverto the arrangements laid down in council direc-tive 91/493/EEC,” is to be implemented July 1,1993. We have been informed that these tran-sitional measures for certification have beentaken to provide the EC with sufficient time toconduct site evaluations of the inspection sys-tems of third countries exporting products tothe EC. The decision will apply from July 1,1993 to December 31,1994. NMFS is in theprocess of translating the model certificate intothe nine official languages of the EC. All cer-tificates will be bilingual.

Council directive 91/492, requirements forlive bivalve molluscs, is being discussed by theFDA and the EC.

The major difference between the U.S. andthe EC systems is the method of control. TheEC relies on testing of the meats whereas theU.S. FDA system relies on testing the watersin the growing areas for control purposes. TheUnited States continues to pursue EC approvalfor equivalency of our system.

Council directive 91/67, deals with aquacul-ture animals and products. The USFWS is dis-cussing its programs with the EC to determineequivalency. The measures in this directiveaddress matters pertaining to health and dis-ease control.

The United States will continue to pursueclarification of language and areas in all of theEC directive that are unclear or left to inter-pretation. The industry will be kept informedof the status of the ongoing negotiations.

OTHER ISSUESNMFS has received inquiries from several

countries - Canada, Iceland, Chile, Indonesiaand Ecuador - expressing interest in the devel-opment of memorandums of understanding torecognize each others’ inspection systems forequivalency.

Initial meetings to discuss protocol for thedevelopment of a memorandum of under-standing have taken place with officials fromIceland.

Any development of a memorandum of un-derstanding will be discussed and coordinated

34

with the FDA for mutual agreement before ap-proval.

INTERNATIONAL N M F SThe FAO, Rome, Italy, has requested that

NMFS provide training assistance at work-shops and seminars conducted in South andCentral America over the past 18 months. Therequests have originated from the Food andAgriculture Organization of the United Na-tions, Rome. The training has focused on qual-ity assurance and HACCP inspection systems.All of these seminars and workshops havebeen conducted in Spanish, and U.S. participa-tion has been from the National TrainingBranch of NMFS. The host countries havebeen Chile, Panama, Costa Rica, El Salvador,Honduras, Brazil, and Guatemala.

There were 790 participants in the variousworkshops and seminars, from 40 differentcountries.

NEW NMFS HACCP-BASEDINSPECTION SERVICE

On July 29,1992, NMFS published in theFederal Register the new NMFS inspection ser-vice based on HACCP principles. This inspec-tion service is in addition to the existingtraditional NMFS inspection services availableto industry. As is the case with the traditionalinspection services, participation is voluntary,on a fee-for-service basis, the scope beingsafety, wholesomeness, and economic integrity.The service is available to all interested par-ties.

As of May 14,1992, three firms at four loca-tions have been participating in the NMFSHACCP-based inspection program. NMFS hasreceived twelve HACCP plans for review.There continues to be interest from the retailsector.

NMFS provides HACCP certification by ad-ministering a test. Interested parties can ar-range for a test to be given at a NMFS facility,following an NMFS training workshop, or fol-lowing an industry training workshop. Thiscertification is recognized by the FDA.

REFERENCESFisheries of the United States 1991. U.S.

Department of Commerce, NOAA, NMFSPublication.

Ian DevlinDepartment of Fisheries and Oceans, British Columbia

ODUCTIONDuring the past five years, the Department ofFisheries and Oceans and the Canadian fish-processing industry have worked together todevelop the Quality Management Program(QMP). On February 1,1992 it became manda-tory and is now a condition of federal registra-tion for fish-processing plants.

In this paper I explain the rationale for de-veloping the QMP by providing you with somebackground information on the Canadian fishinspection program and identifying the chal-lenges that we were facing in delivering ourinspection program and that prompted the re-examination of the way industry was beingregulated. I then briefly explain the basic prin-ciples of our new QMP and clarify theGovernment’s and industry’s roles under theQMP.

THE CANADIAN FISH INSPECTIONPROGRAM

The Inspection Services DirectorateMandate

The Inspection Services Branch of the De-partment of Fisheries and Oceans is mandatedthrough federal legislation to inspect all fishand fish products intended for export fromCanada or for interprovincial trade, and allfish and fish products imported into Canada.Through this mandate, we assure that bothdomestic production and imported productsmeet Canadian and foreign standards forgrade, handling, identity, process, quality, andsafety. In simpler terms, the Canadian FishInspection Program ensures that fish productsproduced in Canada or imported and sold inCanada are safe and wholesome and are fairlytraded.

For fish and fish products produced inCanada, we have a dual concern: the healthand safety of Canadian consumers and theoveraIl quality of Canadian fish and fish prod-ucts and their acceptability in internationalmarkets. Eighty-four percent of the fish caughtand processed in Canada is exported. The In-spection Services Branch plays an importantrole in facilitating the trade of these Canadian

fishery products through its product inspectionand certification programs.

To achieve its mandate, the Inspection Ser-vices Branch has developed over the years amultifaceted national fish inspection programthat focuses on the strategic steps of the fish-processing industry to ensure safe and accept-able fish products. This program involves avariety of inspection activities that include theinspection of

domestically produced fish products todetermine the acceptability of theseproducts for sale in Canada or on foreignmarketsdomestic fish-processing establishmentsto determine the degree of compliancewith regulatory requirements forconstruction, equipment, and operationdomestic fishing vessels, unloadingsites, and transport vehicles to deter-mine compliance with the applicableconstruction and operating require-mentsimported product and the offshoreprocessing operations to determine theacceptability of these products for sale inCanada and the monitoring of shellfish-growing waters through the CanadianShellfish Sanitation Program.

Traditionally, many of the decisions madeunder the Fish Inspection Program relied onfinal product analysis and the results of singleindependent inspections of fish-processingplants. Implementing the QMP will expandthe sources of information used in making de-cisions. A new decision-making process basedon interrelated inspection data, gathered overtime by both government inspectors and theprocessor, will be established.

Future ChallengesBefore I focus on the specifics of our new ap-

proach, I would like to comment briefly on thechanging nature of the commercial environ-ment of the 199Os, which is making innovative

.

public media. Because of the increase in con-taminants, pollution, and threats to the envi-ronment, there has been an increase in mediaand public concern regarding the safety of thefood supply in general and fish products in par-ticular. International trends lead us to believethat there will be no letup in media attentionin the next decade. Today’s consumers are bet-ter educated, better informed, and concernedabout the safety of the food they eat. In allprobability the workload of all food inspectionagencies will continue to

The rapid pace of changing technologies pre-sents an additional challenge to industry andfood inspection agencies. As the Canadian fish-processing industry develops new products andprocesses, the Fish Inspection Program mustadapt its inspection methods to continue tomeet its mandate.

Another major challenge for the 1990s willbe responding to trade issues. The movementtowards HACCP in the United States and thedevelopments in the European Community arealready indicating additional demands on theCanadian fish processors and the Fish Inspec-tion Program. These countries and others arerequiring more assurances from the CanadianGovernment that standards are being met.

The factors I have mentioned are all exter-nal factors that will affect both the InspectionServices Branch and the Canadian fish-pro-cessing industry; but there is another key fac-tor internal to government that will have animpact on all of the Canadian food inspectionagencies. That is the question of resources.

The Canadian Government, as well as otherwestern governments, is under constant pres-sure to limit spending and inspection programssuch as the Department of Fisheries andOceans and the Department of Agriculture.Canada cannot expect to have ever increasingresources to meet the challenges of the future.We must find smarter and more cost-effectiveways to carry out our mandate.

The challenges of the 1990s make it neces-sary for government and the food processingindustries to find, develop, and implement in-novative and cost-effective approaches to foodinspection. These new approaches must beflexible and sensitive to the needs of the indus-try and permit industry to adapt and remaincompetitive in the changing markets.

The Department of Fisheries and Oceans’QMP is a key component of our strategy forresponding to the demands of QP fut;ure mar-ketplace and addressing both industry concerns. The QMP has been devel-

oped jointly by the Canadian fish-processingindustry and the Department of Fisheries andOceans. The QMP that the Canadian fish-pro-cessing industry will be required to establishin their plants is based on the HACCP philoso-phy. The QMP is, like HACCP, a system de-signed to prevent instances of public healthsignificance. However, the QMP has been de-signed to also prevent instances of unaccept-able quality and economic fraud.

The development of an individual QMP for afish-processing operation incorporates all ofthe basic steps involved in developing aHACCP system for a specific food product. Ahazard assessment of the process operation isperformed. Critical control points are identi-fied. Defect definitions and tolerances, moni-toring procedures, record-keeping criteria,corrective action systems, and company verifi-cation measures are established for each criti-cal control point.

The QMP is not however purely a HACCPsystem. It could be better described as a regu-latory compliance program as it is closelylinked to the Canadian Fish Inspection Re gu -lations. During the initial stages of the devel-opment of the QMP, the industry-governmentworking group decided that the QMP would bebased on existing regulations, which are de-signed to ensure that fish and fish products aresafe, wholesome, of acceptable quality, andfairly traded.

The QMP is designed for the fish-processingindustry to control their processing operationswithin the compliance boundaries of the regu-lations governing the production of fish prod-ucts. By implementing the QMP, thefish-processing industry will be able to demon-strate that it is operating on a day-to-day basiswith controls that ensure compliance with theregulations.

Let’s look a little closer at our QMP and howit fits into increasing industry’s responsibilityand accountability.

As of February 1, 1992, each fish-processing ingplant is required to have in place and be oper-ating under a QMP specific to its fish-process-ing operations. The department has developedthe QMP Submission Guide sist the in- t --dustry in developing their programs. The guidehelps the processor identify the critical controlpoints in the process and the associated haz-ards and sets out for the fish-processing indus-try the minimum requirements for a plant’sQMP.

The QMP of a fish-processing plant will berequired to address each of the 12 critical con-

36

trol points that are applicable to their opera-tion. Potential hazards should be preventedthrough the monitoring of these 12 points:

1.2.3.4.5.

6.7.8.9.

10.11.12.

incoming fishother ingredientspackaging materiallabelingchemicals (cleaning agents,sanitizers, lubricants, and pesticides)construction and equipmentoperation and sanitationprocess controlstoragefinal productrecall proceduresemployee qualifications

‘Critical control point” is defined as a pointin time or a physical location in the process atwhich failure of preventative measures willexpose the customer to unacceptable risks re-lated to tainted, decomposed, or unwholesomefish or to economic fraud.

At each critical control point the fish plantmust

* identify the standard that is beingapplied to ensure compliance withregulatory requirements

* identify the monitoring procedures andinspection frequencies that will befollowed to ensure that the standard isbeing met during production

. identify the reporting mechanism thatwill be used at each critical control pointto document the results of the inspec-tions. The fish plant will be required todevelop contingency plans or correctiveaction plans that will be followed if andwhen the monitoring procedures iden-tify an instance where the standard isnot being met.

The fish-processing plant will be required tohave available for inspection their documentedQMP that provides a written description of theprogram being implemented in the processingplant. The fish-processing plant will also berequired to retain records of all inspectionsperformed as part of their QMP for threeyears. These records must be made availablewhen requested to inspectors from the Depart-ment of Fisheries and Oceans.

In summary, a fish-processing plant’s re-sponsibilities under QMP will be

l to develop its own in-plant QMP specificto its operation

* to implement the in-plant QMP0 to maintain the QMP records of the

QMP inspectionso to correct all problems identified during

the QMP inspections.

M P INSPECTIONThe Department of Fisheries and Oceans

will inspect the fish-processing plant againstthe QMP requirements.

Individual inspectors will perform QMP in-spections that will entail the following:

verification of the written QMP to ensurethat the documented standards, monitor-ing procedures, record-keeping systems,and guidelines for corrective action meetthe minimum requirements as set by theDepartment of Fisheries and Oceansconfirmation that the written QMP isbeing followed in the plant. This willrequire the inspector to observe theprocessor’s QMP activities at eachcritical control point in the plantverification that the processor’s recordsare accurate. This will require theinspector to withdraw and inspectparallel samples of the processor’sproducts and compare the results withthose of the company.

The completion of the QMP inspection willresult in the process operation’s being rated“excellent,” “good,” “satisfactory,” or “fail.”These QMP ratings represent the degree ofconfidence the Department of Fisheries andOceans has in the company’s ability to operatewithin compliance of the regulations and willdetermine the inspection coverage to be di-rected at the operation in subsequent weeks.

Fail-rated plants will be asked to voluntar-ily correct the deficiencies and improve theirrating to at least a “satisfactory.” Refusal todeal with the problems voluntarily will jeopar-dize the federal certificate of registration andtherefore the ability of the processing plant toexport its products. Plants which receive a“satisfactory” rating will be inspected on a fre-quent basis until they gain greater control overtheir process and obtain a higher rating.

Processing operations that are successful inmeeting all but a few of the QMP requirementswill receive an “excellent” or “good” rating.These plants will be qualified to apply for theuse of the “CANADA INSPECTED” logo ontheir product labels. Also the product certifica-tion process will be streamlined and provided

37

without delay, and the company will havemore autonomy in its day-to-day processingoperation.

The Q,MP will provide added assurancesthat problems are identified early in the pro-cess before value is added to the product andbefore the product reaches the market. TheQMP will also allow the department to mea-sure the level of compliance of the industry ina uniform manner and direct its resources tothose areas where problems have beenidentified.

The Quality Management Program-Industry’s Role

The major change for industry under theQMP is that it must accept more responsibilityand accountability in monitoring its perfor-mance. The processing plants will be requiredto perform inspections of the plant and prod-ucts and initiate corrective actions when theyidentify a problem. And records of all theseQ M P activities must be maintained so thatthey are able to demonstrate that they consis-tently operate in compliance with the regula-tions.

The Role of Government in RegulatingUnder QMP

The implementation of the QMP will meana change in the relationship between the fish-processing industry and the department. Un-der the QMP, the Department of Fisheries andOceans’ role will shift from solely an inspectionfunction to include an auditing function.

The inspector will continue to perform ran-dom inspections of the process operation andproducts, but the focus will not be on indi-vidual lots of product or on a day of plant op-eration, as now is the case, but rather on theoverall QMP system. The inspector’s decisionswill be based upon a compilation of interre-lated inspection results gathered over time byboth the inspector and the processor.

CONCLUSION

We feel the QMP will provide the Canadianfish-processing industry and the Departmentof Fisheries and Oceans with an effectivemechanism to ensure the protection and assur-ance needed in today’s demanding markets.The price of this assurance is change.

We will have to change. Industry will haveto change. But this approach should realizemore impact from each inspection. The numberof inspections we do may be somewhat reducedfor some plants, but each inspection will countfor more. We will be able to focus our effort onareas of higher risk and apply our resources ina more cost-effective manner.

In summary, the Department of Fisheriesand Oceans’ new approach to quality manage-ment is a joint industry-government systemthat is aimed at preventing problems beforethey occur. Working together through theQMP, the Canadian fish-processing industryand the Federal Government will be able toprovide Canadian and international customerseven better assurance than in the past so thatthe high standards Canadian fish productshave been known for will be met in the future.

Roger LowellU.S. Food and Drug Administration

Sometimes the impression from the media isthat the Food and Drug Administration (FDA)doesn’t have a mandatory seafood inspectionprogram in this country or that we have noseafood inspection program at all. I take issuewith this position, and in this paper, I’ll showsome statistics for the inspectional work that isdone. I’ll also give some insight into what a dis-trict office looks like and how it works.

The main FDA office for the Pacific region isin Seattle (figure l), which also houses the

as shown in table 1. It can be frustrating todeal with the Washington office because of theinfluence that the east coast industry has onFDA decisions. The west coast, and in particu-lar the Pacific Northwest, accounts for over 50percent of the domestic seafood production andnearly the same amount of exports in thiscountry. Yet, I don’t believe our voice is wellheard. If you look at dollar values of landingson the various ports for the United States, yousee that the west coast dominates the list.

Field Legalsurveillance - action prep.investigations industry

Inspections - EducationFOI

Samplecollectionsresident posts

Processing imports

JohnIIWiskerchenDSB

- Labsupport

- Analyticalservices

Research

seafood products research laboratory for FDA’sfield organization. Seattle has an investiga-tions branch and a compliance branch. Most ofthe people that you see are from the inspectionbranch of the FDA, where Jim Davis is chiefinspector. If you have questions about what isgoing on in your plant and I am not available,Jim Davis is the person to contact. Under thechief inspector, there are eight supervisors,each responsible for various programs. ChrisRezendes is a seafood monitor for the wholePacific region. He is the most knowledgeableperson in the district when it comes to seafoodissues.

The Pacific Northwest should have a greatdeal of power in terms of the seafood industry,

Marleen-1WekellDSPRC

- Seafoodresearch

Methodsdevelopment

KrisThiesA0

Personnel- services

accounting

- Procurement

- Mail/Files

- Data processing

Figure 1.Pacific RegionSeattleDistrict.

When it comes to seafood regulations, our voiceneeds to be heard along with the voices of pub-lic opinion, the bureaucracy, and the law.

State No.Firms

Table 1.Pacificregion

America Samoa 2Alaska 332Arizona 19California 279

seafoodindustry:number offirms ineach state.

Hawaii 20Idaho 46Montana 5Nevada 2Oregon 92Washington 595

The Pacific Region, Seattle district, has1,070 of the 1,392 firms that are registeredwith the FDA The official Establishment In-ventory lists firm names by a central file num-ber. The Seattle district has a great deal to sayabout what happens in seafood in the FDA.

Seafood firms are listed by state, withWashington leading and Alaska and Californiafollowing. We can break down seafood use intoestablishment types as shown in table 2: (1)manufacturers (people who do something withthe seafood); (2) repackers (people who takesomething that someone else has put together,break it into smaller entities, and repack it for

Table 2. Pacificregion seafoodindustryestablishmenttypes.

Establishment N O.Growers 103Manufacturers 830Repackers 583Shell Ship 279Other 44Warehouses 78

retail); (3) shellfish shippers; and (4) growers(who include people in aquaculture). To put thePacific Region Seattle district into nationalperspective, we can talk about the number of

actions that have been made and the per-of the national total accounted for out of

this region. We account for a good share ofwhat happens in seafood out of this region. TheFDA has six regions; we are simply one ofthem. Our region accounts for 27 percent of thenation’s inspections, 26 percent of the hoursspent making those inspections, and 40 per-cent of the samples collected from both importstatus and domestic status. We do wharf ex-ams for imports, which are just short of sam-pling that product. The exam is usually forlabeling, but it could also be for seams on cansor other characteristics that an investigatorcan look at right on the dock without bringinga sample back to our laboratory.

Inspection classifications are assigned tofirms we have inspected (figure 2). NAI means“No Action Indicated,” which doesn’t meanthat you don’t have some problem; it simplymeans that we are not going to take legal ac-tion against your firm. VAI-2 stands for “Vol-untary Action Indicated.” It indicates to usthat there were more serious problems, but weanticipate that you are going to fix them.VAI-3, or “Voluntary Action Indicated,” andOAI, which is “Official Action Indicated,” entailreceiving official written notice from us thatyou have a problem and that we’re going totake action if you don’t remedy the situation.First, we give you a warning letter describingactions you must take and requiring a re-sponse in 10 or 15 days telling us what you’ve

Figure 2. Pacific Region inspection classification

40

FDA@a STATEm REGIONm NATION

done. If we don’t get an adequate response, weare prepared to take FDA legal actions, suchas seizing product, or injunctive action againstmoving your product in interstate commerce,or our last resort, to prosecute. We don’t havemany firms in that last category, but we dohave some.

Sample classifications are listed as classes1, 2, and 3. Classes 1 and 2 are what we con-sider mostly in compliance. Class 3 samplesare considered out of compliance. These are notsurveillance samples: they do not indicate thecondition of the industry. Frequently, the me-dia and other people will pick up on our sampleresults and claim that 20 percent of what theFDA looks at in the seafood industry is con-taminated. Where the misinformation occurs isin not understanding that these samples aretargeted. We do not have enough resources todo a strict surveillance-based sampling pro-gram to show the amount of compliance in theindustry. Our samples, both domestic and im-ported, are focused where we think there areproblems. Therefore, when people look at oursample results, they can get a false image ofwhat seafood looks like in the country.

We have a higher level of samples that weconsider violative in imports. I must empha-size that these are targeted samples. We targetour samples with nationwide alerts. If asample hits New York from a particular coun-try with something wrong, when that sameproduct from the same country hits Seattle, Isample it. That also includes automatic deten-tion, where a country has a reputation of giv-ing us bad products.

Because there is often confusion over whatthe FDA does, I’ll describe the steps of an FDAinspection. First, inspectors show up in yourplant and make an inspection. At the end ofthe inspection, they give you the 483 form,which is a list of observations. The law man-dates that we give you this list before we leave.Next, the inspector writes a report, which isreviewed by a supervisor, so it is not theinspector’s opinion that is going to affect you.There are several further steps before you getin trouble. The report is given to the supervi-sor, and the chief inspector, Jim Davis, takes itto the compliance branch. Our compliance of-ficers review it with national policy to see ifthere is a case. The compliance branch directorreviews it and then I, as district director, re-view any action. Only the OAI violations leaveour district and go to headquarters for the Of-fice of Enforcement review, in Washington,D.C. The general counsel are not Food andDrug employees, but employees of the Depart-

ment of Health and Human Services. The nextstep is to the U.S. Attorney. The FDA does nothave police powers; we can’t lock your doors.The FDA goes through the Justice Departmentto the federal courts before any actions aretaken. There are many steps and reviews be-fore FDA takes action against a firm.

The prohibited acts section of the Food andDrug Law is what applies to your products andthe acts are mandatory. You don’t have achoice in complying with these rules. The lawtalks about the introduction, adulteration, re-ceipt, and interstate commerce of adulteratedproducts. Good manufacturing practices(GMPs) are always going to be here becausethey are a part of the law. The hazard analysisand critical control points program (HACCP) issimply an augment to those GMPs to makethem tighter. I agree that we tend to focus onHACCP, but you can’t forget about GMPs.They are a part of the Food and Drug regula-tions. They are not being replaced by HACCP,they are simply being added.

The seafood complaints that the Seattle dis-trict gets today are the same complaints Iheard 20 years ago. We still see poor employeepractices, especially in moving raw materialthrough finished product areas; that can con-tribute to cross contamination. Employeesmove from one area to another without chang-ing clothes or sanitizing themselves beforeswitching from handling raw product to han-dling finished product. This is especially im-portant when you deal with ready-to-eatproducts where there is potentially Listeria orother pathogens.

Listeria is still a problem, especially in coldsmoked fish. The east coast is enmeshed inListeria from smoked fish. The district directorin New York is preparing many injunctionsagainst firms back there. Dr. Ecklund of theNational Marine Fisheries is on the east coastworking with the east coast industry. Listeriais not going to go away. People keep asking ifwe are going to abolish the zero tolerance level.As Tom Billy said, I do not see our changingthe tolerance on Listeria at all.

Two years ago, we started with the incidentof domoic acid in razor clams. The season wasessentially closed for the entire year. Now ev-eryone is out happily harvesting the largestrazor clams they’ve ever seen, so maybe therewas a good side to that. The next incident wasfinding domoic acid in crab viscera. We neverdid find any crab in interstate commerce fromWashington and Oregon that exceeded the tol-erance of 20 parts per million. We got close andhad some problems especially with exports to

The result of that was a meeting in Sanon domoic acid. This region hired a re-coordinator for domoic acid, actually for

all marine toxins, to try to coordinate what thestates were doing. We awarded state contractsto California, Washington, and Oregon to setup a more intricate monitoring system fordomoic acid, but it didn’t show up this year.Our hope for these systems is that we can closethe season if domoic acid shows up rather thanharvest the resource, or delay the opening o fthe season until the toxic levels go down.Through the work of the states and our seafoodcoordinator, we raised the tolerance for domoicacid in Dungeness crab viscera from 20 to 30parts per million. That same request is beingmade for paralytic shellfish poisoning in crabviscera.

Paralytic shellfish poisoning is the next is-sue. Alaska had a great deal of trouble withparalytic shellfish poisoning in Dungeness crabvicera again this year. We had product thathad to be eviscerated and sold as sectionsrather than as whole crab because of the toxinlevels in the viscera. Alaska has drafted amonitoring program whose goal is to monitorthat area and open and close the crab harvest-ing season to prevent crab with problems fromeven being harvested.

Last, I’d like to discuss the European Com-munity (EC). The FDA intends to issue certifi-cates to firms wishing to export to the EC. Theprotocol is being written and will be reviewedand distributed to industry and others for com-ments. You will apply to us to be placed on alist for exports to the EC. We will then reviewyour firm’s inspection records and, if appli-able, the records of your state agency or of theNational Marine Fisheries Service (NMFS). Ifnecessary, we may have to reinspect your plantto update our information. If you pass thesesteps, other than the VAI-3 or OAI category,we will put you on a list.

When You deal with the EC, you’ve got tohave a firm number, which you have alwayshad from the FDA, called a central file num-ber. We can give that list of numbers to theEC If you are on that list, you can submitfilled-out certificates to us. You are going tohave to give me an English version so that Ican understand what I am signing. After I sign,the certificate is returned to you to accompanythat shipment. I will not inspect those lots. Iwill sign that certificate based on the fact thatyou are on our list as an acceptable firm. Ifyour buyer wants additional quality attributesor you need to have additional inspections, you

are going to have to arrange for them in thesame way you always have, typically, by goingto NMFS and getting their lot certification forthe value added part. If you fail to make ourlist, your choice is probably to go to NMFS,sign up for their program, and pay for the ser-vice. Once you get upgraded, you can alwayscome back to us and ask to be reinstated.

This FDA program has to be resource neu-tral. I have no additional resources to run theprogram. If the inspection of your firm is notroutinely scheduled for six to eight monthsfrom now, then I will not visit your firm until I have it regularly scheduled. If you want to geton to EC, you are going to have to have someother authority come to me and show me thatyour firm is in compliance. That could be theAlaska Department of Environmental Conser-vation, the Oregon State Department of Agri-culture, the Washington State Department ofAgriculture, or NOAA, but if I have to make aninspection to get you on the list, it will be doneonly when I’m on my routine inspection.

You need to provide specific information.You should be able to describe the HACCP pro-gram for your firm. You must be site specific. Ifyou’re a company that has five firms, I have tohave a letter for each one of your sites becausethat is the way your firms appear in our filesright now. You also have to be product specific.You must provide a contact person for eachprogram. If you have five different plants, youcan give me one contact person, but that con-tact person should be knowledgeable aboutthose five sites. I also need to know what othergovernment agencies are inspecting you, likeyour state’s Department of Agriculture orNOAA, and when those inspections are madeand who is doing that in your plant. I don’tneed to know about the Occupational Safetyand Health Administration or the EPA. I sim-ply need to know about those that would begermane to shipping to the EC. I need permis-sion to look at those other records. This espe-cially applies to NMFS. When NMFS does aninspection in your plant, that is a contract be-tween you and them. Those records are be-tween you and them. They are not available tome unless you tell NMFS that I can look atthem.

Canned salmon has had the “canned salmoncontrol plan” for over 70 years. This is anagreement between industry, the FDA, theAlaska Department of Environmental Conser-vat ion and the National Food Processors Asso-ciation with their lab in Seattle. Everythingthat has been done under that plan is a

42

HACCP program, and we will sign certificates long as you’re in good standing under thatfor shipments of firms in good standing under plan, your canned salmon will get a certificatethat plan right now. That includes the past from the FDA.year’s production and current production. As

43

Christian FelterConsulting Agricultural Engineer, Nice, France

In this paper I discuss the current status ofquality certification in the French and Euro-pean markets. I focus on the organization ofFrench markets, using examples from the sea-food industry.

BACKGROUND

The French Market in EuropeThe French market has a dominant position

in Europe for all food products, whether des-tined for at-home or away-from-home con-sumption, for three main reasons:

1. French cuisine sets the internationalstandard for food preparation andpresentation.

2. France has developed a high level oftechnical knowledge of both innovationand tradition in human nutrition, ofwhich the invention of vacuum cookingby a student of the famous chefTroisgros is the best illustration.

3. The German market strongly prefers“French quality,” and Germany, in allmatters concerning the organization ofEuropean markets for food products, isvery receptive to French proposals.

Treaties, Directives, and RegulationsThe European Common Market is organized

around three levels of agreements with verydistinct functions:

1. The Treaty of Rome. This provides theconstitution. All regulations must be in strictconformity with the Rome Treaty. As withother constitutions, the treaty text is unknownto most of those in the business world. Its realsignificance is revealed in the legal decisions ofthe European Law Court, which constantly re-fer to it.

2. Directives. Directives are the directions orpositions established by the European Com-mission. These directions are not optional;each member state must set its national legis-lation in conformity with them. But in practice,national laws demonstrate a strong passiveresistance to these directives. In addition, it is

very often the jurisprudence of the EuropeanLaw Court which must determine preciselywhich modifications will be required. For in-stance, a member state is not permitted to ad-vertise the national origin of its products; thus,France is not allowed to build an advertisingcampaign with and about “qualité France.”The passive resistance of national law, every-day practice, and the threats and sanctions ofthe EC Commission combine to provide thecontext within which the directives becomeregulations.

3. Regulations. These are laws. Memberstates are given only the time period set by theregulation itself in which to make their ownlaws conform to these regulations. For this rea-son regulations encounter much less passiveresistance from national law and practice thando directives.

The Use of StandardsThe primary function of a standard is to pro-

vide security to transactions made over a dis-tance. It is the industrial world that hascontributed the most to the definition andpropagation of the standards that support andguarantee contractual relationships betweenfirms placing orders and those that carry themout, or their subcontractors. Inherent in astandard is reference to a sale contract, that is,the given commercial practice at a given timeconcerning the exchange of merchandise. Themerchandise itself functions as a support forthe system which allows the individuals con-cerned with the exchange to make the neces-sary profits.

In regard to human nutrition, the develop-ment of standards is much more recent, for twomain reasons. First, the definition of what con-stitutes human food is complex, with a strongcultural component. The constant change thatcharacterizes technology and culture presentsan ongoing challenge to this definition. Second,tradition is efficient, which is to say thatexpectations of “fair and customary use” pro-vide the main guarantee, at the national level,of the success of food products sales.

47

I should emphasize that the safety of a food(the first priority of every regulation) is onlythe first step toward consumer satisfaction,which is the real driving force behind every ex-change involving food products. Safety is animplicit expectation of consumers. But con-sumer expectations are evolving and vary fromone country to another, as do the methods ofsatisfying them. Since each market can refer,in good faith, to its own tradition of “fair andcustomary use,” a preoccupation with legalprotections has arisen in the competition be-tween EC members. In the hope of improvingcredibility and protection, economic partnerswill demand more and more sophisticatedproof of facts that support the fairness of alle-gations and the safety of common food uses.

Fundamental to understanding the currentevolution of the EC regulations concerningquality certification are the specific require-ments of human nutrition. It is equally impor-tant to keep in mind the essential function of astandard, whatever this standard might be: toprovide security to an economic transactionfrom a distance.

The "New Approach" and the Cassis deDijon Case

The requirement of free circulation of goodsbetween member states of the EC affects everyproduct. When the unifying act was signed, itwas technically impossible to define a full setof regulations guaranteeing free trade within ashort period. This is why the “New Approach”directives were adopted. These directives arelimited to the essentials, leaving the workingout of technical details to the standardizationprocess (or, as we shall discuss further, the“professional approach”). The object of havingthese directives come into force simultaneouslyin each national legal system is to set up an“automatic” harmonization process amongthese systems. The application schedule ofthese New Approach directives is determinedby the goods’ complexity, to allow time for con-cerned firms to gather correct information andto adapt their production processes to EC stan-dards.

The directive of 22 July 1991 (see appendix),fixing the sanitation regulations for productionand trade of seafood products, is typical of the"New Approach.” To make it easier for readersto understand the following discussion, I ad-vise them to take a break for a careful readingof this directive, integrating the informationprovided above before going on. (This advice isin fact a directive, since the contents of the

July 22 1991 directive will be referred to belowwithout further citation than the article num-ber).

At the same time as the New Approach wasdefining a method of harmonizing varioustypes of “fair and customary uses,” the outcomeof the Cassis de Dijon case nipped in the budthe protectionist tendencies embodied withinvarious national legal interpretations of "fairand customary use.” This case merits furtherexamination in order to elucidate the essentialcommon rights it established.

In the 1970s a German importer was re-fused authorization to import Cassis de Dijoninto Germany. The reason: the alcoholic con-tent of Cassis de Dijon is 18%, and only alco-holic beverages with a minimum alcoholiccontent of 32% are allowed to be called "Cassis"for sale in Germany. This national law con-formed to what was considered “fair and cus-tomary use” in the German market. Germanauthorities took the position commonly held byall member states at that time in cases not cov-ered by EEC regulations: a national law thatforbids the trade of a product, whether pro-cessed locally or imported, concerns EC prod-ucts too, as there should be no discriminationbetween the treatment of domestic and com-munity goods. The European Law Court re-futed this position by affirming that anyproduct legally processed and traded in one ofthe member states, must, in principle, be al-lowed in trade in every other member state.

This case set a precedent confirming one ofthe fundamental principles of the RomeTreaty: free circulation of goods. It further in-troduced an equivalence between the “fair andcustomary uses” of different member states. Inso doing it established an initial practice thatis the basis of the lowest common denominatorof the food trade: the less demanding “usage”must be allowed in as far as the relevant au-thority allows it.

The New Approach and the Cassis de Dijoncase established also, as a corollary, a clear re-sponsibility on the part of the processor as aprerequisite to any transaction. It is the estab-lishment of the processor’s credibility which isthe goal of the development of quality certifica-tion systems.

Defining Concepts: Competent AuthorityThe dictionary offers two different meanings

for the term quality:

1. what it is that makes a thing what it is(with reference to final uses)

2. the excellence inherent in something(with reference to ethical consider-ations)

Food consumers’ expectations can be basedon one or both of these concepts. Food technolo-gists and industry concern themselves prima-rily with the first concept; consumers andtraders with the second. The fact that the EC’s“competent authority” should be composed ofveterinary technicians (article 2 directive 91/493) provides a clear indication of the kind ofcertification expected from a firm: it consistsessentially of its capacity to organize and guar-antee the processes within the competentauthority’s charge (article 6 directive 91/493).

We now turn to the general context of firmcertification, or a firm’s quality assurance sys-tems, as an implicit element of the New Ap-proach to the approval of firms (article 7directive 91/493). As I will discuss later, theoversight of this implicit trend of EuropeanCommunity regulation is managed in Francethrough applications initiated by AFAQ (Asso-ciation Française pour l'Assurance Qualité).However, as a preamble, I must emphasizethat this is a trend and not a legal obligation.

We have already mentioned the effect of theinertia of national laws on EC directives. Thisis even more important in cases of quality as-surance applications, In such cases, the inertiais strengthened by the perverse effects of theCassis de Dijon case, which concerns de factothe former French colonies in Africa (throughthe Lomé convention), thus allowing very low-quality goods into the EC. Some French pro-cessors actually seek trade in such goods or usethem as inputs in their production processes todiversify their sources of profit. Several ex-amples of such behavior are famous on thecanned fish market, including sardines in oil,anchovy fillets, and canned tuna A good part ofthe turnover of this sector comes from low-quality product imported by small French pro-cessors and sold under their own brand names.

At the opposite end of the scale, large pro-cessors such as SAUPIQUET anticipated theevolution of the regulations and have alreadycertified their own quality assurance systemsto ISO 9000 standards. In fact, there is cur-rently a clear split between two categories ofoperators in France:

l firms that anticipated regulatoryevolution and are involved in certifica-tion of their quality assurance processes

l firms that are unaware of this evolutionor wish to profit from current regulatory

distortions of free competition and freecirculation of goods

Limits of the Current System: an Exampleof Regulatory Distortion

It is generally accepted that it is the largefirms that will be most concerned with certify-ing their quality assurance systems. The fol-lowing example concerns a large distributionfirm with a quality assurance program thattrades seafood products under its own brandname, imported from Denmark as fresh prod-ucts with a nine-month shelf life. There is cur-rently a strong demand in France for allseafood sold fresh, especially in the saurisserie,or smoked foods, department: smoked fish,taramas, snack products, fish fritters, andso on.

For products or meals prepared in advanceand sold as fresh, French regulations allowFrench processors to indicate, following preciseprocedures, a shelf life date of 21 days forvacuum cooked products and 42 days for pas-teurized products. Processors are not allowedto claim a shelf life of over 42 days for fresh orprocessed seafood (article 2 directive 91/493),except for “semiconserves.” For these products,the minimum shelf life is over two weeks, dueto the use of conservation techniques indicatedon the label. Danish products imported andtraded under this distributor’s brand name areeffectively sold in the fresh department as“semiconserves,” with instructions to keepthem at 8 degrees Celsius. Last year they weresold as canned.

This example and others are very wellknown among French processors, and some ofthem are actually trying to define new lines of“fresh canned products” for sale under the cur-rent regulatory loophole.

TOTAL QUALITY MANAGEMENT

IS0 9000 StandardsCertification of quality assurance systems

originated mainly within thecustomer-supplier relationship. A customer,having certain specifications for a product,would seek out suppliers who could meet thesespecifications and purchase only from thosesuppliers. Certificates attesting to the suppli-ers’ ability to meet specifications could begranted either by an independent organization(third-party certification) or directly by thebuyer or distributor (second-party certifica-tion). Various terms of reference can be used in

49

these two cases. In the case of third-party cer-tification, ISO 9000 standards are usuallyused, for easier recognition both of the certify-ing body specializing in these standards andfor the certified firm’s use in communicatinginternationally known references.

The definition of quality assurance in ISO9000 standards is as follows, roughly trans-lated into English: “the combination of prees-tablished and systematic actions necessary togive appropriate confidence that a product orservice will satisfy requirements related toquality,” these requirements being “the combi-nation of properties and characteristics of aservice or product which confer upon it theability to satisfy expressed or implicit needs.”

It must be noted that the notion of quality isdefined here in its wider sense, including allthe expectations of the concerned public, with-out specifying a particular level of quality. Itmust be emphasized as well that it is the firmitself which selects the set of preestablishedprocesses that are to be verified, processes thatwill be established through its own technicalexpertise in quality management. Also, it canonly be a voluntary effort, indicative of boththe firm’s management expertise and of thequality of production due to this management.The voluntary nature of this approach pre-sumes a clarity of objectives within the firmnecessary to mobilize the staff to realize theseobjectives.

Third-party certification of quality assur-ance systems under ISO 9000 thus functionsas a management tool attesting to a highly ef-fective level of management. It is this tool andthis level that give the processor credibility,even from a distance. The function of ISO 9000standards, like that of every set of standards,is effectively to give security to a transactionfrom a distance.

The Relationship Between Distributorsand Processors: Competent Authority andCurrent Developments in France

At the moment, most distributors who wantto distribute goods under their own brandname accord limited importance to third-partycertification of their quality assurance sys-tems, preferring their own controls to those ofan independent organization. The current levelof development of trade standards embodied indirective 91/493 allows distributors to imposecommercial pressure in the guise of second-party certification “standards,” at very low costto themselves. However, the inevitable trend is

toward independently imposed standards origi-nating with an international certification bodythat will ensure the independence of themanufacturer from the distributor of themanufacturer’s product. French processorsknow very well that without third-party ISO-9000 certification, they risk being submitted toarbitrary audits on the part of their foreigncustomers, which in some cases could be an ill-disguised effort to create barriers to free trade.

The best ally of the French processor, andthose in the EC or other countries, is the com-petent authority in France that deals withcommunity regulations: the state veterinaryservices. The veterinary services in charge ofhygiene and food safety in France are powerfuland efficient. Their actions are founded, ac-cording to “fair and customary use,” on allow-ing processors to be progressively moreresponsible for setting up and verifying qual-ity-control processes. This means that overall,French authorities have responded positivelyto the increasing complexity of productiontechniques (for example, “4th range” andvacuum cooking) and the rising level of qualityassurance requirements. From the beginning,the French have accepted the challenge of com-bining voluntary efforts and the legal obliga-tions put upon them by France and the EC.

Indeed, everyone - firms, administrators,and experts-knows that at the beginning, theprocess of firm certification will be long anddifficult, but that quality certification, thoughit is not a miracle drug, is the single best wayto meet the managerial needs inextricablylinked to the long-term satisfaction of consum-ers in developed nations.

The French Quality AssuranceAssociation (AFAQ) and the NationalTesting Network (RNE

Many industrial applications of quality as-surance certification led to the creation, in1988, of AFAQ, constituted by three “collèges”:

collège A: AFNOR and professional salesorganizations

collège B: buyerscollège C: technical controllersAFAQ certification, like every standardiza-

tion process, requires an interdisciplinary pro-fessional approach. AFAQ certification is basedon international standard practices:

l standard 45012 for a firm’s own manage-ment

l IS0 9000 standards applied to firms

. ISO 10011 standards for selection ofexperts

The final objective of this professional ortho-doxy is to facilitate agreements between andpartnerships with firms certified by otheranalogous certification centers, to improve therelationship between customers and suppliers.This kind of partnership already exists be-tween German, Canadian, and Swiss bodies.Although AFAQ has no ambition to take con-trol of international certification, it is clearthat all significant firm certification programscurrently being tested in France are aimed to-ward achieving AFAQ certification.

Created in 1979, th Rèse a u Nationald’Essais (National Testing Network) managesaccreditation of laboratories to the EN 45001standard according to detailed requirementsfor accredited laboratories and candidates foraccreditation. Accreditation of a laboratory isthe formal recognition of its ability to under-take specified tests and to ensure the quality ofthese tests. The political purpose of the RNE isto set up a network of similar organizations inother countries to establish more consistentstandards between competent authorities.

Food SecurityIt is not by chance that the food security

theme accompanied the complete set of com-mon agricultural policy reforms. The entirepolicy was systematically linked to the estab-lishment of professional strategies in qualitycertification, in all sectors. It is not possible tolimit the free circulation of goods and services,but the increasing concern with health andsafety by consumers in developed countriesgoes hand in hand with the increasing chal-lenge to firms in developed countries to main-tain their market positions. Certification ofquality assurance systems is clearly the key tofuture access to EC markets for firms in devel-oped countries.

TOTAL QUALITY PRODUCT

Specialty FoodsCertification systems for quality assurance

mainly concern large industrial firms of theagro-food sector, producing goods for massconsumption. But many French producersfamous for the quality of their product are verysmall firms, often "artisan" sized. This isparticularly true for such products as wines,cheeses, poultry, red meat, pork specialties,

and regional specialties such as Cassoulet deCastelnaudary.

At the national level, these specialty proprod-ucts are subject to a double set of consumer- recognized certifications:

g a certificate of higher quality indicated bythe authorization to stamp the productLabel Rouge (Label Rouge is a nationalcollective brand name for higher qualityfoods; in French the word label connotesquality and not information requirements)

o a certificate of regional specialty attestedto by the indication Appellation d'OrigineContr ô lée (specified origin label or AOC).

Usually, certification by one of these meth-ods precludes certification by the other, andthus products given the Appellation d'OrigineContrôlée would not also be certified with theLabel Rouge. The Appellation d'OrigineContrôlée is reserved for products or processesgiving proof of a strong historic tradition andprecedence in setting a special or high-qualitystandard. The Appellation d'Origine Contrôléeconcerns mainly wines and cheeses. Qualityhere refers essentially to bioclimatic conditionsor traditional, often secret, technicalknowledge.

Label Rouge concerns any superior-qualityproduct. In order to be granted this label, aproducer must adhere to precise terms of refer-ence, explaining what differentiates it from ge-neric products and justifying its higher price.Proof must be offered that this product of su-perior quality is produced in significant quan-tity (this was the main issue of contention inproviding Scottish salmon with the LabelRouge).

The terms of reference for foods certifiedwith the Label Rouge are public. The registra-tion of these terms of reference is done by anindependent certification organization usingthe 45011 standard. So, for products certified“Label Rouge,” our general definition of qualityis met: the following of preestablished proce-dures, with verification.

As this was not necessarily the case for Ap-pellation d'Origineorigine Contrôlée there has for along time been a kind of philosophical opposi-tion between the approaches followed by theInstitut National des Appellations d'Origineorigine(which focuses on tradition and French art devivre) and the Commission Nationale des La-bels (which focuses on consumer expectations).Each of these organizations has been lobbyingBrussels for at least five years to publish

directives or rules allowing it to determine theprofessional methods for certifying the qualityof foods at the EEC level.

The Rule of 14 July 1992 on Agro-FoodSpecialties and the Rule of 14 July 1992on Protection of Geographic Indicationsand Origin Appellations of Food Products

Rather than choose between the methodsproposed by the two organizations, the EECCommission permitted both, with these twoclosely related rules. The rule about food spe-cialties is no more than the elevation to the EClevel of the French Label Rouge. However “spe-cialty,” in the rule, is not limited to superiorquality for this type of product. Further, theharmonizing of the EEC register of recognizedspecialties between member states and pro-ducer groups has been difficult and complex,although the register has been adapted tochanges in the terms of reference on whichspecialties are based. And, in order to main-tain superior-quality levels, these changes arestrictly necessary.

The rule about protected geographic indica-tions mentions terms of reference as well (ar-title 4 of the rule), explicitly the “description ofthe method of obtaining the agricultural orfood product, and where relevant the fair andcustomary practices.”

These two rules have two points in common:l the professional character of each

method, managed by concerned profes-sional groups

l the obligation of every member of theprofessional group to submit to thecontrol of an independent certificationbody using the 45011 standard, valid to1998 at the latest

Standard EN 45011 specifies criteria thatmust be met by a certification organization be-fore the certification of products, in order to berecognized at the EC level as competent andreliable to set up such a certification system,whatever the concerned sector might be. The1998 limit date on anything concerning the45011 standard of certifying organizations forfood specialties and origin appellations is con-nected with article 17 of directive 91/493

The Redeployment of ProfessionalOrganizations

These two rules will come into force nextJuly and will certainly allow a new deployment

of the largest French professional organiza-tions, which have been crippled for a long timebecause of the illegal origin of their income(national obligatory parafiscal taxes). Indeed,there are strong similarities between the objec-tives of professional organizations and those ofcertification organizations.

In France, the goals of agro-food trade orga-nizations are those which the individual firmcannot assume alone, including

0 collective research and development0 collective promotion and advertisinge procedures and controls

These are also the goals of certification orga-nizations dealing with producers who have al-ready achieved the 45011 standards as well asthose who have attained the “Label Rouge.”

The Challenge for “Peripheral”Agriculture

A few years ago, there was a clear distinc-tion between the “agro-industrial,” or profit-making agricultural sector (milk, corn, and soon), and agricultural products from the periph-eral regions, especially from the Mediterra-nean zone. At that time food security strategiesconcerned production only in these peripheralzones, while other producers had to compete ininternational markets around the world.

Recent developments show that this as-sumption was mistaken and that food securitystrategies concern the entire Europeanagro-industrial sector. In this context it wasimperative to immediately develop effectivetools (rules) which would allow differentialmarketing for products from peripheral zones.Putting these rules into practice will be just asimportant as putting into place the new regu-lations tied to the common agricultural policy.

Perspectives for Other CountriesIt is likely that the application of these two

rules will be extended to agro-food products ofnon-EC states that are able to guarantee qual-ity assurance practices equivalent to those inthe EC and in which the competent certifyingauthority meets 45011 standards. These regu-lations could provide an excellent and usefultool for third-country professional groups tomeet quality challenges, by furthering theirunderstanding of the current evolution of ECfood product quality management practices.

COUNCIL DIRETTIVE

of 22 July 1991

laying down the health conditions for the production and the placingon the market of fishery products

(91/493/EEC)

THE COUNCIL OF THE EUROPEAN COM-MUNITIES,

Having regard to the Treaty establishing theEuropean Economic Community, and inparticular Article 43 thereof,

Having regard to the proposals from theCommission (1),

Having regard to the opinions of the EuropeanParliament (2),

Having regard to the opinions of the Economicand Social Committee (3),

Whereas, with a view to achieving the internalmarket and more especially to ensuring thesmooth operation of the common organizationof the market in fishery products establishedby Regulation (EEC) No 3796/81 (4), as lastamended by Regulation (EEC) No 2886/89 (5),it is essential that the marketing of fish andfish products should no longer be hindered bydisparities existing in the Member States inrespect of health requirements; whereas thiswill enable production and placing on themarket to be better harmonized and bringabout competition on equal terms, whilstensuring quality products for the consumer;

Reprinted with permission of the EuropeanCommunities from the Official Journal of theEuropean Communities, L 268,24.9.91, p 15.

OJ No C 66 , 11.3. 1988, p. 2;OJ No C 282,8.11.1989 p. 7 and OJ No C 84,2.4. 1990, p. 56.OJ No C 96,17.4.1989, p. 29 and OJ No C183,15. 7. 1991.OJ No C 134,24.5.1988, p. 31 and OJ No C332,31. 12. 1990, p. 59.OJ No L 379, 31. 12. 1981, p. 1.OJ No L 282,2. 10. 1989, p. 1.

Whereas the European Parliament in itslegislative resolution of 17 March 1989 (6)requested the Commission to come forwardwith comprehensive proposals on the hygienicproduction and placing on the market offishery products, including solutions for theproblem of nematodes;

Whereas fishery products freshly caught are inprinciple free of contamination with micro-organisms; whereas however contaminationand subsequent decomposition may occurwhen handled and treated unhygienically;

Whereas therefore the essential requirementsshould be laid down for the correct hygienichandling of fresh and processed fishery prod-ucts at all stages of production and duringstorage and transport;

Whereas it is appropriate to apply by analogycertain marketing standards which are laiddown pursuant to Article 2 of Regulation(EEC) No 3796/81, in order to fix the healthquality of these products;

Whereas it is the responsibility primarily ofthe fisheries industry to ensure that fisheryproducts meet the health requirements laiddown in this Directive;

Whereas the competent authorities of theMember States must, by carrying out checksand inspections, ensure that producers andmanufacturers comply with the said require-ments;

Whereas Community control measures shouldbe introduced to guarantee the uniform

~__(6) OJ No C 96, 17.4. 1989, p. 199.

53

application in all Member States of the stan-dards laid down in this Directive;

Whereas, in order to ensure the smoothoperation of the internal market, the measuresshould apply in an identical manner to tradewithin the Member States and to trade be-tween the Member States;

Whereas in the context of intra-Communitytrade, the rules laid down in Council Directive89/662/EEC of 11 December 1989 concerningveterinary checks in intra-Community tradewith a view to the completion of the internalmarket (7) as amended by Directive 90/675/EEC (8) apply to fishery products;

Whereas fishery products from third countriesintended to be placed on the market of theCommunity must not qualify for morefavourable arrangements than those applied inthe Community; whereas provision shouldtherefore be made for a Community procedurefor the inspection in third countries of theconditions of production and placing on themarket in order to permit the application of acommon import system based on conditions ofequivalence;

Whereas the products in question are subjectto the rules concerning checks and to safe-guard measures covered by Council Directive90/675/EEC of 10 December 1990 laying downthe principles governing the organization ofveterinary checks on products entering theCommunity from third countries;

Whereas, so that account may be taken ofparticular circumstances, derogations shouldbe granted to some establishments alreadyoperating before 1 January 1993 so as to allowthem to adapt to all the requirements laiddown in this Directive;

Whereas the Commission should be entrustedwith the task of adopting certain measures forimplementing this Directive; whereas, to thatend, procedures should be laid down introduc-ing close and effective cooperation between theCommission and the Member States withinthe Standing Veterinary Committee;

(7) OJ No L395,30.12.1989,p.13.(8) OJ No L 373,31.12.1990,p.1.

Whereas the essential requirements laid downin this Directive may need further specifica-tion,

HAS ADOPTED THIS DIRECTIVE

CHAPTER 1

General provisions

Article 1

This Directive lays down the health conditionsfor the production and the placing on themarket of fishery products for human con-sumption.

Article 2

For the purposes of this Directive, the follow-ing definitions shall apply:

1.

2.

3.

4.

'fishery products’ means all seawater orfreshwater animals or parts thereof,including their roes, excluding aquaticmammals, frogs and aquatic animalscovered by other Community acts;

‘aquaculture products’ means all fisheryproducts born and raised in controlledconditions until placed on the market as afoodstuff However seawater or freshwa-ter fish or crustaceans caught in theirnatural environment when juvenile andkept until they reach the desired commer-cial size for human consumption are alsoconsidered to be aquaculture products.Fish and crustaceans of commercial sizecaught in their natural environment andkept alive to be sold at a later date are notconsidered to be aquaculture products ifthey are merely kept alive without anyattempt being made to increase their sizeor weight;

‘chilling’ means the process of coolingfishery products to a temperature ap-proaching that of melting ice;

“fresh products’ means any fishery productwhether whole or prepared, includingproducts packaged under vacuum or in amodified atmosphere, which have notundergone any treatment to ensurepreservation other than chilling;

5.

6.

7.

8.

9.

10.

11.

12.

13.

‘prepared products’ means any fisheryproduct which has undergone an opera-tion affecting its anatomical wholeness,such as gutting, heading, slicing, filleting,chopping, etc.;

‘processed products’ means any fisheryproduct which has undergone a chemicalor physical process such as the heating,smoking, salting, dehydration or marinat-ing, etc., of chilled or frozen products,whether or not associated with otherfoodstuffs, or a combination of thesevarious processes;

'preserve' means the process wherebyproducts are packaged in hermeticallysealed containers and subjected to heattreatment to the extent that any micro-organisms that might proliferate aredestroyed or inactivated, irrespective ofthe temperature at which the product isto be stored;

'frozen products’ means any fisheryproduct which has undergone a freezingprocess to reach a core temperature of -18°C or lower after temperature stabiliza-tion;

‘packaging’ means the procedure ofprotecting fishery products by a wrapper,a container or any other suitable device;

‘batch’ means the quantity of fisheryproducts obtained under practicallyidentical circumstances;

‘consignment’ means the quantity offishery products bound for one or morecustomers in the country of destinationand conveyed by one means of transportonly;

‘means of transport’ means those parts setaside for goods in automobile vehicles, railvehicles and aircraft, the holds of vessels,and containers for transport by land, seaor air;

‘competent authority’ means the centralauthority of a Member State competent tocarry out veterinary checks or any author-ity to which it has delegated that compe-tence;

14.

15.

16.

17.

18.

1.

‘establishment’ means any premiseswhere fishery products are prepared,processed, chilled, frozen, packaged orstored. Auction and wholesale markets inwhich only display and sale by wholesaletakes place are not deemed to be estab-lishments;

‘placing on the market’ means the holdingor displaying for sale, offering for sale,selling, delivering or any other form ofplacing on the market in the Community,excluding retail sales and direct transferson local markets of small quantities byfishermen to retailers or consumers,which must be subject to the healthchecks laid down by national rules forchecking the retail trade;

‘importation’ means the introduction intothe territory of the Community of fisheryproducts from third countries;

‘clean seawater’ means seawater or brinywater which is free from microbiologicalcontamination, harmful substances and/ortoxic marine plankton in such quantitiesas may affect the health quality of fisheryproducts and which is used under theconditions laid down in this Directive;

‘factory vessel’ means any vessel on whichfishery products undergo one or more ofthe following operations followed bypackaging: filleting, slicing, skinning,mincing, freezing or processing.

The following are not deemed to befactory vessels’:

- fishing vessels in which only shrimpsand molluscs are cooled on board,

- fishing vessels on board which onlyfreezing is carried out.

Article 3

The placing on the market of fisheryproducts caught in their natural environ-ment shall be subject to the followingconditions:

(a) they must have:

55

(i) been caught and whereappropriate handled forbleeding, heading, gutting andthe removal of fins, chilled orfrozen, on board vessels inaccordance with hygiene rulesto be established by theCouncil acting by a qualifiedmajority on a proposal fromthe Commission. The Commis-sion shall submit proposals tothat effect before 1 October1992;

(ii) where appropriate, beenhandled in factory vesselsapproved in accordance withArticle 7, and in accordancewith the requirements ofChapter I of the Annex.

The cooking of shrimps andmolluscs on board mustcomply with the provisions ofChapter III, section I(5), orChapter IV, section IV(7), ofthe Annex. Such vessels shallbe specifically registered bythe competent authorities;

(b) during and after landing they must (b) they must, in addition, comply withhave been handled in accordance the requirements laid down under 1with Chapter II of the Annex; (c) to (g).

(c) they must have been handled and,where appropriate, packaged,prepared, processed, frozen, de-frosted or stored hygienically inestablishments approved in accor-dance with Article 7, in compliancewith the requirements of ChaptersIII and IV of the Annex.

The competent authority may,notwithstanding Chapter II, section2 of the Annex, authorize the trans-fer of fishery products ex quay intocontainers for immediate delivery toan approved establishment orregistered auction or wholesalemarket to be checked there;

(d) they must have undergone a healthcheck in accordance with Chapter Vof the Annex;

56

(e)

(f)

(g)

they must have been appropriatelypackaged in accordance with Chap-ter VI of the Annex;

they must have been given anidentification mark in accordancewith Chapter VII of the Annex;

they must have been stored andtransported under satisfactoryconditions of hygiene, in accordancewith Chapter VIII of the Annex.

2. Where gutting is possible from a technicaland commercial viewpoint, it must becarried out as quickly as possible after theproducts have been caught or landed.

3. The placing on the market of aquacultureproducts shall be subject to the followingconditions:

(a) they must have been slaughteredunder appropriate conditions ofhygiene. They must not be soiledwith earth, slime of faeces. If notprocessed immediately after havingbeen slaughtered, they must be keptchilled;

4. (a) The placing on the market of livebivalve molluscs shall be subject to therequirements laid down in CouncilDirective 91/492/EEC of 15 July 1991laying down the health conditions for theproduction and the placing on the marketof live bivalve molluscs (1).

(b) When processed, bivalve molluscsmust, in addition to the requirements inpoint (a), satisfy those of paragraph 1 (c)to (g).

Article 4

Fishery products to be placed on the marketalive shall at all times be kept under the mostsuitable survival conditions.

(1) See page 1 of this Official Journal.

Article 5

The placing on the market of the followingproducts shall be forbidden:

- poisonous fish of the following families:Tetraodontidae, Molidae, Diodontidae,Canthigasteridae,

- fishery products containing biotoxins suchas ciguatera toxins or muscle-paralysingtoxins.

Detailed requirements concerning the speciescovered by this Article and concerning methodsof analysis shall be laid down in accordancewith the procedure prescribed in Article 15.

Article 6

1. Member States shall ensure that personsresponsible for establishment take all neces-sary measures, so that, at all stages of theproduction of fishery products, the specifica-tions of this Directive are complied with.

To that end, the said persons responsible mustcarry out their own checks based on thefollowing principles:

- identification of critical points in theirestablishment on the basis of the manufac-turing processes used;

- establishment and implementation ofmethods for monitoring and checking suchcritical points;

- taking samples for analysis in an approvedlaboratory by the competent authority forthe purpose of checking cleaning anddisinfection methods and for the purpose ofchecking compliance with the standardsestablished by this Directive;

- keeping a written record or a recordregistered in an indelible fashion of thepreceding points with a view to submittingthem to the competent authority. Theresults of the different checks and testswill in particular be kept for a period of atleast two years.

2. If the results of own checks or any infor-mation at the disposal of the persons respon-

sible referred to in paragraph 1 reveal the riskof a health risk or suggest one might exist andwithout prejudice to the measures laid down inthe fourth subparagraph of Article 3 (1) ofDirective 89/662/EEC, the appropriate mea-sures shall be taken, under official supervision.

3. Rules for the application of the secondsubparagraph of paragraph 1 shall be estab-lished in accordance with the procedure laiddown in Article 15.

Article 7

1. The competent authorities shall approveestablishments once they have verified thatthese establishments meet the requirements ofthis Directive, with regard to the nature of theactivities they carry out. The approval must berenewed if an establishment decides to carryout activities other than those for which it hasreceived approval.

The competent authorities shall take thenecessary measures if the requirements ceaseto be met. To this end, they shall take particu-lar account of the conclusions of any checkcarried out in accordance with Article 8.

The competent authority shall register thoseauction and wholesale markets which are notsubject to approval after verifying that suchinstallations comply with the provisions of thisDirective.

2. However, subject to the express conditionthat products coming from factory-vessels andestablishments, auction and wholesale mar-kets meet the hygiene standards set by thisDirective, Member States may, for the require-ments relating to equipment and structureslaid down in Chapters I to IV to the Annex,grant to factory-vessels and establishments,auction and wholesale markets a furtherperiod expiring on 31 December 1995 withinwhich to comply with the conditions of ap-proval set out in Chapter IX. Such derogationsmay be granted only to factory-vessels andestablishments, auction and wholesale mar-kets, already operating on 31 December 1991,which have, before 1 July 1992, submitted aduly justified application for derogation to thecompetent national authority. This applicationmust be accompanied by a work plan andprogramme indicating the period within which

57

it would be possible for them to comply withthe requirements in question. Where financialassistance is requested from the Community,only requests in respect of projects complyingwith the requirements of this Directive can beaccepted.

3. The competent authorities shall draw up alist of their approved establishments, each ofwhich shall have an official number.

Each Member State shall notify the Commis-sion of its list of approved establishments andof any subsequent amendment thereof. TheCommission shall forward this information tothe other Member States.

4. The inspection and monitoring of estab-lishments shall be carried out regularly underthe responsibility of the competent authority,which shall at all times have free access to allparts of establishments, in order to ensurecompliance with the requirements of thisDirective.

If such inspections and monitoring reveal thatthe requirements of this Directive are notbeing met, the competent authority shall takeappropriate action.

5. Paragraphs 1,3 and 4 shall also apply inrespect of factory vessels.

6. paragraphs 3 and 4 shall also apply towholesale and auction markets.

Article 8

1. Experts from the Commission may, incooperation with the competent authorities ofthe Member States, make on-the-spot checksinsofar as this is necessary to ensure theuniform application of this Directive. Theymay in particular verify whether establish-ments are in effect complying with the require-ments of this Directive. A Member State inwhose territory a check is being carried outshall give all necessary assistance to theexperts in carrying out their duties. Thecommission shall inform the Member States ofthe results of the investigations.

2. The arrangements for implementingparagraph 1 shall be adopted in accordancewith the procedure laid down in Article 15.

Article 9

1. The rules laid down in Directive 89/662/EEC, as regards fishery products intended forhuman consumption, shall apply, in particularas regard the organization of and the action tobe taken following the inspections to be carriedout by the Member States of destination, andthe protective measures to be implemented.

2. Directive 89/662/EEC shall be amended asfollows:

(a) in Annex A the following indent shallbe added:

'- Council Directive 91/493/EEC of22 July 1991 laying down thehealth conditions for the produc-tion and placing on the marketof fishery products (OJ No L 268,24.9. 1991, p. 15);

(b) in Annex B the following indent shallbe deleted:

'- fishery products intended forhuman consumption’.

CHAPTER II

Imports from third countries

Article 10

Provisions applied to imports of fishery prod-ucts from third countries shall be at leastequivalent to those governing the productionand placing on the market of Communityproducts.

Fishery products caught in their naturalenvironment by a fishing vessel flying the flagof a third country must undergo the checkslaid down in Article 18 (3) of Directive 90/675/EEC.

Article 11

1. For each third country or group of thirdcountries, fishery products must fulfil thespecific import conditions fixed in accordancewith the procedure laid down in Article 15,depending on the health situation in the thirdcountry concerned.

2. In order to allow the import conditions tobe fixed, and in order to verify the conditions ofproduction, storage and dispatch of fisheryproducts for consignment to the Community,inspections may be carried out on the spot byexperts from the Commission and the MemberStates.

The experts of the Member States who are tobe entrusted with these inspections shall beappointed by the Commission acting on aproposal from the Member States.

These inspections shall be made on behalf ofthe Community, which shall bear any expendi-ture incurred.

The frequency of and procedure for theseinspections shall be determined in accordancewith the procedure laid down in Article 15.

3. When fixing the import conditions offishery products referred to in paragraph 1,particular account shall be taken of:

(a) the legislation of the third country;

(b) the organization of the competent author-ity of the third country and of its inspectionservices, the powers of such services and thesupervision to which they are subject, as wellas their facilities for effectively verifying theimplementation of their legislation in force;

(c) the actual health conditions during theproduction, storage and dispatch of fisheryproducts intended for the Community;

(d) the assurances which a third country cangive on the compliance with the standards laiddown in Chapter V of the Annex.

4. The import conditions referred to inparagraph 1 shall include:

(a) the procedure for obtaining a healthcertificate which must accompany consign-ments when forwarded to the Community;

(b) the placing of a mark identifying thefishery products, in particular with the ap-proval number of the establishment of origin,except in the case of frozen fishery products,landed immediately for canning and bearingthe certificate provided for under (a);

(c) drawing up a list of approved establish-ments and auction or wholesale marketsregistered and approved by the Commission inaccordance with the procedure laid down inArticle 15;

For that purpose, one or more lists of suchestablishments shall draw up on the basis of acommunication from the competent authoritiesof the third country to the Commission. Anestablishment may not appear on a list unlessit is officially approved by the competentauthority of the third country exporting to theCommunity. Such approval shall be subject toobservance of the following requirements:

- compliance with requirements equivalentto those laid down in this Directive,

- monitoring by an official inspectionservice of the third country.

5. The conditions referred to in paragraph 4(a) and (b) may be modified in accordance withthe procedure laid down in Article 15.

The list referred to in paragraph 4 (c) may beamended by the Commission, in accordancewith the rules established by CommissionDecision 90/13/EEC (1).

6. To deal with specific situations and inaccordance with the procedure laid down inArticle 15, imports may be authorized directfrom an establishment or factory vessel of athird country where the latter is unable toprovide the guarantees laid down in paragraph3, provided that the establishment or factoryvessel in question has received special ap-proval following an inspection carried out inaccordance with paragraph (2). The authoriza-tion decision shall fix the specific importconditions to be followed for products comingfrom that establishment or factory vessel.

7. Pending the fixing of the import conditionsreferred to in paragraph 1, the Member Statesshall ensure that the conditions applied toimports of fishery products from third coun-tries shall be at least equivalent to thosegoverning the production and placing on themarket of Community products.

-_I(l) OJ No L 8,11. 1. 1990, p. 70.

59

Article 12

1. The rules and principles laid down byDirective 90/675/EEC shall apply, notably asregards the organization of and follow up tothe inspections to be carried out by the Mem-ber States.

2. Without prejudice to compliance with therules and principles referred to in paragraph 1of this Article and pending implementation ofthe decisions provided for in Article 8 (3) andArticle 30 of Directive 90/675/EEC, and inArticle 11 of this Directive the relevant na-tional rules for applying Article 8 (1) and (2) ofthe said Directive shall continue to apply.

CHAPTER III

Final Provisions

Article 13

The Annexes shall be amended by the Council,acting by a qualified majority on a proposalfrom the Commission.

Article 14

The Commission, after consulting the MemberStates, shall by 1 July 1992 submit a report tothe Council concerning the minimum struc-tural and equipment requirements to be metby small establishments which distribute onthe local market and are situated in regionssubject to particular supply constraints,together with any proposals, on which theCouncil, acting under the voting procedure laiddown in Article 43 of the Treaty, shall actbefore 31 December 1992.

Article 15

1. Where the procedure laid down in thisArticle is to be followed, the Chairman shallrefer the matter to the Standing VeterinaryCommittee set up by Decision 68/361/EEC (2)hereafter referred to as the Committee, eitheron his own initiative or at the request of aMember State.

2. The representative of the Commissionshall submit to the committee a draft of the

(2) OJ No L 255, 18. 10. 1968, p. 23.

measures to be taken. The committee shalldeliver its opinion on the draft within a timelimit which the chairman may lay downaccording to the urgency of the matter. Theopinion shall be delivered by the majority laiddown in Article 148 (2) of the Treaty in thecase of decisions which the Council is requiredto adopt on a proposal from the Commission.The votes of the representatives of the MemberStates within the committee shall be weightedin the manner set out in that Article. Thechairman shall not vote.

3. (a)

(b)

The Commission shall adopt themeasures envisaged if they are inaccordance with the opinion of thecommittee.

If the measures envisaged are not inaccordance with the opinion of thecommittee, or if no opinion is delivered, the Commission shall, withoutdelay, submit to the Council a proposal relating to the measures to betaken. The Council shall act by aqualified majority.

If, on the expiry of a period of threemonths from the date of referral tothe Council, the Council has notacted, the proposed measures shall beadopted by the Commission, savewhere the Council has decidedagainst the said measures by a simplemajority.

Article 16

In order to take into account the possiblefailure to take a decision on the detailed rulesfor applying this Directive by 1 January 1993,necessary transitional measures may beadopted in accordance with the procedure laiddown in Article 15 for a period of two years.

Article 17

The provisions of this Directive shall be re-examined before 1 January 1998 by theCouncil, acting on proposals from the Commis-sion, on the basis of experience gained.

Article 18

The Member States shall bring into force thelaws, regulations and administrative provi-sions necessary to comply with this Directivebefore 1 January 1993. They shall notify the

Commission thereof.

When Member States adopt these measures,they shall contain a reference to this Direc-tive or shall be accompanied by such refer-ence on the occasion of their official publica-tion. The methods of making such a referenceshall be laid down by the Member States.

Article 19

This Directive is addressed to the Memberstates.

Done at Brussels, 22 July 1991.

For the CouncilThe PresidentP. DANKERT

Robert JosephRed Lobster, Orlando, Florida

General Mills Restaurants Inc. is a division ofGeneral Mills. General Mills is the “Companyof Champions." Each division operates underthe company goal statement, "To be thenation’s best food company in terms of productquality and shareholder value.”

Consumer Foods makes up 67 percent ofcompany sales and earnings. Most of the majorbrands are common household items that youand your family use all the time.

The restaurant group makes up the other 33percent of sales and earnings. The Red Lobstername is General Mills’ largest brand.

With sales of over $1.5 billion this year, RedLobster will serve over 150 million guests. RedLobster is the largest dinnerhouse chain in theworld. The second largest is Olive Garden,with sales of over $900 million. The newestconcept is China Coast Restaurant, with fiveunits and ambitious goals to be as large as itssister companies. Asian food is the fastestgrowing segment of dining occasions in theU.S. By the year 2000, three out of the twenty-one meals you eat each week will be Asian.

Projected growth for all three chains is forover 50 units per concept in the next few years.General Mills believes that restaurants will bea critical part of its projected growth plans. Bythe year 2000, the goal is to have over 2000restaurants worldwide.

The restaurant industry is very competitive.Currently, there is over 55 percentovercapacity in seating. The hardest hit seg-ment is fine dining, but all segments are hav-ing trouble maintaining their market shareand traffic.

General Mills restaurants will use over 85million pounds of frozen seafood this year.Forty-two percent will be shrimp products, 18percent crab products, 17 percent fish fillets,10 percent lobster, and 13 percent other shell-fish and seafood products. We will also serveover 5 million pounds of fresh fish and 1.5 mil-lion pounds of live lobster. By the year 2000,our seafood needs will double to over 170 mil-lion pounds.

Not only are our seafood needs growing, butso are the needs of most dining segments.There has been a 4 percent increase in thenumber of restaurants serving seafood. This

shows that America still prefers to eat seafoodaway from home. But even as U.S. consump-tion has turned down, so has consumption atrestaurants. However, restaurants are usingseafood to offer healthy alternatives to theirguests. The American pallet has changed inrecent years. Variety sells, and people aremore wilIing to experiment with different typesof foods when dining out.

The history of the departments of Purchas-ing and Quality Control started at the sametime. The founders of the company realizedback in the early 1970s that the limiting factorto growing Red Lobster into a national chainthe size it is today would be the supply of high-quality, value-priced seafood. The founders be-lieved that these two traits, plus great servicein a clean, efficient restaurant, would be thekey to success.

In the early seventies we were buyingthrough brokers and distributors. The qualityof the products varied greatly. Supply was in-consistent and prices were unpredictable. Sothe decision was made to create a purchasingdepartment. Today the purchasing departmenttravels to over 40 countries a year. Our buyersspend over 50 percent of their time at the pro-ducing areas and production facilities whereour products are harvested and packaged. Buy-ers spend time training in their products sothat they can travel anywhere in the world andteach fishers, production workers, and plantquality control personnel how to produce RedLobster quality. Over 70 percent of our seafoodcomes from overseas. One hundred percent ofour shrimp now comes from aquaculture. Nomatter where the resource is, our buyers arewilling to go and learn about what this area ofthe world can offer our guests. We continue touse some brokers and importers who under-stand our needs and philosophy of quality,value, and service.

Marketing supplies Purchasing with chang-ing trends in dining patterns and guest expec-tations. Purchasing plays a large role indeveloping new products and species and intro-ducing value added products to save on back ofthe house labor. Today every item is made ateach restaurant daily to ensure that our food isfresh and that our guests receive only the

highest quality seafood they can buy. It is aconstantly changing environment, and whatwas good enough yesterday will not meet theneeds or standards of today. By having an in-ternal purchasing and quality control function,it has been easier to communicate neededchanges to industry so that we can maintainour competitive edge.

By having the buying team visit the world’sseafood-producing areas, we have been able toanticipate shortages, embargoes, and foreigncompetition that can drive price. Our menuand promotions are flexible, so we can worktogether with marketing to smooth out supplyor price problems. Years ago when McDonaldsput Pandalus shrimp on the menu and pricesreached over $5.00 a pound, we were forced toreduce our usage from 3 million pounds toabout 100,000 pounds. Now that the price hasreturned to a more stable level, our usage hasincreased to about 750,000 pounds. But itnever gained its place completely back becausethe product we substituted continues to occupythat space and popularity. This year we substi-tuted Dungeness crab for Opilio when supplyand price became issues. On every trip we lookfor new ideas, products, or items. People forgetthat it was Red Lobster that introducedAmerica to snow crab, popcorn shrimp, andorange roughy. This conference is an exampleof taking the opportunity to talk to industryabout our company and to explore with thisindustry mutual areas of interest and potentialbusiness.

All our specifications are developed by ourPurchasing Department with advice from in-dustry. Before they are written up, RestaurantOperations and Test Kitchen approve them tomake sure that our restaurants are receivingthe correct product, properly packaged, andwith maximum ease of use.

Once a specification is developed, productsare shipped to one of our primary freezer loca-tions (Atlanta, Los Angeles; Indianapolis;Trenton, Ontario). At each of these facilities,we have built quality control labs to inspectevery shipment of seafood and other products.These labs are set up to evaluate packagingand physical characteristics and to checkmicrolevels. No product ever is sent to one ofour restaurants before it is inspected. Countsand weights are checked to ensure we pay forwhat we ordered and they meet our specifica-tions.

Specifications address chemical additives,acceptable species, receiving temperatures,and other defects that could be seen with eachindividual product. Most of our specificationsare stricter and more detailed than currentgovernment standards. They have been devel-oped with industry so that what we inspect foris what industry can produce and package. Weown our own shrimp processing plant, whichenables us to understand that side of the busi-ness and teaches us what we should expectfrom other processing facilities. Our specifica-tions are available for anyone to use.

During the late 1980s there were a numberof seafood scares and bad publicity. To head offthe issue that seafood was not government in-spected, we worked with the U.S. Departmentof Commerce to have our inspection programcertified. Our Integrated Lot Inspection Pro-gram has been very successful in that it is onemore step to ensure that our guests receiveonly the best seafood. Red Lobster was one ofthe first companies to institute this programon a national level.

Training and continuing education pro-grams are a key step to ensuring that the qual-ity message is understood through all levels ofthe organization. Publications such as LobsterTales and Expert’s Guide To Seafood are usedto train our employees and keep them currenton all changes. Brochures in our restaurants’lobbies educate our guests to our quality pro-grams, the health advantages of seafood, andnutritional levels of all our products.

All these programs together ensure that wedeliver our goal: to provide a continuous supplyof top quality seafood for our guests.

This translates into a pleasurable, safe, andconfident dining experience for our guests ev-ery time they dine with us. If we do a poor jobone percent of the time, over 1.5 million guestswill have a bad experience. That is why wehave always joined forces with industry andgovernment to work together to create the bestseafood dining experience for our guests.

It takes a complete understanding of allthese areas to produce the quality story. forwithout a commitment to quality by all seg-ments of our industry, consumers will findother ways to spend their food dollars.

THE NEED FOR DEVELOPINGSTANDARDSJae Park and Michael T. MorrisseyOregon State University Seafood Laboratory

INTRODUCTIONSurimi is washed, minced, fish flesh to whichcryoprotectants have been added to maintainthe functional properties of the proteins duringfrozen storage. More than any other seafood, itis relatively homogeneous in composition andphysical attributes. Although there are a num-ber of processing techniques, the end product(if made from the same species) will have simi-lar characteristics whether it is made aboard afactory trawler or a shore-based surimi plant.

Japan has been the recognized leader in theglobal surimi industry. Surimi processing grewfrom a small traditional fisheries in Japan tolarge-scale operations during the 1950s. Theinitial phases of the industry depended onshore-based operations (Okada 1992). In 1965,the use of cryoprotectants allowed the produc-tion of surimi at sea, which greatly expandedthe resource base for Japan (Zenkama 1987).The Americanization of the Alaska pollockfishery that began in the 1980s and was fol-lowed by the Pacific whiting fishery in the1990s forced Japan to be more dependent onforeign harvests for their surimi Nonetheless,Japan has dominated the world’s surimi pro-cessing technology for on-shore and at-sea op-erations. The total production of surimi in theworld has fluctuated between 390,000 to530,000 metric tons over the last five years(Kano 1992).

More than 100 types of surimi-based sea-food products currently are produced in Japan.In the United States the majority of the surimiis processed into shellfish analogs, primarilyimitation crab. The nature of the final productis such that gel strength and color are the mostimportant attributes of surimi. Although anumber of analog products are made in Japanand other Asian countries, gel strength andcolor continue to be critical characteristics ofsurimi sold overseas.

Surimi is one of the few seafood commodi-ties that will receive a price differential basedon a grading system. Understanding and ma-nipulating the production to take advantage ofthis grading system is crucial in the marketingof surimi. For example, if company X makes

three different grades of surimi - A, B, and C-for which there is a 10 percent price differen-tial, it may be to the company’s advantage toproduce the higher-grade surimi, depending onthe market conditions. However, if the cost ofmaking the higher-grade surimi (lower yields,added production costs) are such that the pricedifferential is negated, it may be more eco-nomically beneficial to make grade B surimi.In either case, knowing how the grading sys-tem operates and how different factors can af-fect grading of surimi samples can meansubstantial increases to profit margins.

Factors Affecting the Grading SystemThe grading system for surimi is based on a

number of its characteristics, some more im-portant than others. These include

Gel strengthColorMoisture contentImpuritiesMicrobiological count

Other properties of surimi that can influ-ence the final grade are pH, protein content,fat content, cryoprotectants, and otheringredients such as protease inhibitors, gelenhancers, and whiteners. A number of factorswill have an effect on these surimi charac-teristics and are taken into account duringsurimi production.

Gel strength depends on the functionality ofthe myofibrillar protein and its ability to formheat-set gels (Matsumoto 1979). The gelstrength is affected by the species of fish, sea-sonality, and time and temperature factorsduring handling onboard the vessel as well asduring the processing steps. Compositional fac-tors will also affect the gel strength readings.Lower moisture content will improve gelstrength as well as starches and gel enhancers(Hamann and MacDonald 1992; Lee 1986).

Color largely depends on the species of fishthat are used for surimi products. The typicallow-fat white fish species such as Alaska pol-lock and whiting will give a color that isslightly off-white but will turn a creamy white

during analog processing. Pelagic species suchas sardine or mackerel will have a more gray-ish hue, while other species will take on theinherent color of the flesh. The degree of wash-ing will greatly affect the final color as well.The washing away of pigments or impuritieswill generally lighten the color of the surimi.

As mentioned previously, the moisture con-tent will affect gel strength: the lower themoisture, the higher the gel strength. How-ever, a lower moisture content in surimi re-sults in lower yields and decreased profitmargins. Since analog manufacturers add wa-ter to their formulations, they prefer the mois-ture to be lower than 75 percent. This is withinthe manufacturing tolerances of present surimiproducers.

Impurities are normal bits of skin or viscerathat have not been washed out during process-ing. They have little affect on the gel strengthof the surimi but do affect consumer accep-tance of the product, especially, if the finalproduct is a creamy white analog. Some spe-cies have a certain percentage of “black spot-ting” in the flesh. If these fish are not culled,they can cause a defect that appears like “pep-per on snow” and will cause a reduction in thegrade (Morrissey et al. 1992).

Microbiological levels of surimi are impor-tant for quality control and health standards.Standards may include total plate count andcoliform count as well as specific pathogenssuch as Listeria. The initial bacterial load onthe fish is the most important factor for finalbacterial count of the surimi (Lee 1992). Re-searchers have found that the washing stepsdid not appreciably reduce the microbial count(Himelbloom et al. 1991). With the increasinguse of HACCP in the surimi industry, therewill be increasing reliance on good microbio-logical controls in the plant.

The pH of the final surimi can greatly affectits gel strength and should be monitored dur-ing processing (Chung et al. 1993). Other addi-tives, such as calcium compounds, can affectgel strength while glycerides and hydroge-nated vegetable oil will have an effect on coloror the sheen of the final block. Protease inhibi-tors, such as beef plasma protein, used in Pa-cific whiting surimi, markedly improve gelstrength but may cause an increase in yellowcolor if used in too great. a concentration.

Surimi Characteristics: Measurementsand Additives

Uniform surimi standards require a uniformmethodology for testing surimi characteristics.

Unfortunately, at present, this is not the casefor surimi. There are a number of different in-struments as well as methods for evaluatingcharacteristics such as gel strength, color, andmoisture. While the principles for measuringthese characteristics may be similar among theinstruments, there are a number of differencesas well.

The measurement of gel strength is one ofthe more problematic. The traditional surimimethod is the fold test by which a 3-mm-thickslice of surimi is folded several times and in-spected for cracks resulting from the folding(Lee 1984). This procedure, although simple touse, can have a wide variation and is not verydiscriminatory among surimi samples with ahigh gel strength. Because of the subjectivenature of the evaluation, it is difficult to stan-dardize this type of test.

The punch test is currently the method ofchoice among surimi producers to measure gelstrength. Recently, an electronic rheometer(Rheo Tex) has been commonly used to deter-mine gel strength (NFI 1991). In this method,a plunger is driven at a constant speed into asurimi gel, and values are reported by mea-surements of force (force needed to penetratethe gel) and depth (the distance the plungertravels inside the gel). Gel strength (jellystrength) is expressed as the force (g) x depth(cm). While this method is more objective thanthe fold test, it still can give highly variableresults that could lead to discrepancies be-tween buyer and seller. Furthermore, there isno method to calibrate the instrument afterextended use. Nonetheless, even with theseshortcomings, the punch test is preferredbecause of its ease of use during at-seaprocessing.

A more accurate test of overall gel strengthis the torsion test developed at North CarolinaState University (Hamann and Lanier 1987).This procedure requires a standardizedmethod of preparing the gel for testing such asbringing the moisture content of samples to 78percent. The torsion test involves the twistingof an hourglass-shaped gel to failure. The re-sistance to the twisting is related to gelstrength and is reported as stress while thedegree of twisting that occurs before breakingis related to the elasticity of the gel and is re-ported as strain. The disadvantages of the in-strument are that the accuracy of the resultscan depend on the technical expertise of thelab technician and that the instrument wouldbe impractical on an at-sea factory trawler roll-ing in the Bering Sea.

65

Other researchers have used the compres-sion test (most commonly performed with theInstron) as well as other instruments for ana-lyzing texture. While these are good researchtools, they are usually impractical for the typi-cal surimi producer. The making of the cookedsurimi gel to be measured is as much an art asa science. There are a number of factors, suchas the type of sausage stuffer, and the use of avacuum chopper, that will influence the resultsof the gel test (Babbitt and Reppond 1988).

The surimi paste is often prepared for test-ing by various methods that can lead to differ-ences in the results. The surimi industry hasbeen using three different formulas to preparethe surimi paste. One method uses 97 percentsurimi and 3 percent salt, while anothermethod uses 100 parts of surimi and 3 parts ofsalt. A third method uses 94 percent surimi, 3percent salt, and 3 percent potato starch.There are only minor differences in the firsttwo methods, but by adding starch to measuresurimi gel strength (third method), we arelikely to observe increased gel-strength valuesdue to starch gelatinization. Park (1993) foundthat the addition of starch up to a 6 percentlevel raised the gel strength by 15 to 45 per-cent, depending on its kind and modification.An addition of 3 percent potato starch in thesurimi gel will upgrade the gel-strength of thesurimi.

The surimi industry currently uses threedifferent cooking methods for testing surimigels. They are (a) a 90 C cook for 30-40 min-utes, (b) 24-40 C preincubation for 2-6 hoursfollowed by a 90 C cook for 30-40 minutes, and(c) a 5 C preincubation for 18-24 hours followedby a 90 C for 30-40 minutes. Preincubation iscalled suwari in Japanese. This technique isused in the industry to facilitate molding andforming products for kamaboko or crab ana-logs. The effects of preincubation have beenstudied by a number of investigators(Numakura et al. 1985; Kim 1987; Kamath1990; Park et al. 1993). There is a minimumeffect on gel elasticity, but preincubation canaffect the gel stress (strength) by 15-60 per-cent, depending on the method and fish spe-cies. Because of these effects on gel strength,there is some confusion between buyers andsellers in surimi evaluation.

Surimi additives used in commercial pro-cessing are another important issue that weneed to look at for the standardization ofsurimi. Cryoprotectants have been used in theprocessing of surimi since Japanese scientistsfound the combination of sugar and phos-phates can extend the shelf life by inhibiting

freeze-induced protein denaturation (Okada1992). Different levels of sugar (4-5 percent),sorbitol(4-8 percent), phosphates (0.25-0.3 per-cent), and more recently glyceride (0.1-0.2 per-cent) for whiting surimi have been used bymanufacturers. Manufacturers believe theirrecipe is specially blended with a patentablepropriety.

With the processing of Pacific whiting forthe last three years on the Pacific coast, theuse of enzyme inhibitors is necessary to makequality surimi. In 1991-1992, several enzymeinhibitors such as beef plasma protein, eggwhite, and potato flour were evaluated bymanufacturers and research institutes. In1993, all manufacturers of Pacific whitingsurimi used beef plasma protein (1.0-1.5 per-cent) as an enzyme inhibitor. With continuingefforts to make whiting surimi comparable topollock surimi, calcium carriers (such as cal-cium lactate, calcium sulfate, and calcium ca-seinate), sodium bicarbonate, and canola oilhave been used as a gel enhancer or a color-improving agent. Again, all manufacturers usedifferent levels as well as different combina-tions in the name of proprietary blending.

There are some problems with the gradesand specifications of surimi from the viewpoint of consumers and analog manufacturers.First, each manufacturing company has itsown specification of grades and additives. Sec-ond, there are no uniform grades among com-panies. Third, there is no uniformity incompositional properties, because of the addi-tion of different levels and kinds of additives.Fourth, there is not a universally acceptedtesting methodology. In 1991, the TechnicalCommittee of Surimi and Surimi Seafoodsthrough the National Fisheries Institute estab-lished the U.S. standard of surimi measure-ments (NFI 1991). However, none of the surimimanufacturers have shown their willingness toadopt it.

Current Practices in Surimi IndustryTechnical systems for surimi processing

have been developed by the five most impor-tant fisheries in Japan (Taiyo, Nisui, Hoko,Nichiro, and Kyokuyo) based upon their owninterest and business involvement. These tech-nical systems have been further modified byKorea and the United States, again because oftheir own interests.

To demonstrate the different grades, wehave selected 11 major surimi manufacturersof Pacific whiting surimi (table 1). The gradingsystems vary from company to company, and

66

there are even differences between two factorytrawlers within the same company (I-l and I-2). The eleven companies use very similargrades and specifications for Alaska pollock.The only grade they all agree on is the SAgrade for their best surimi. Most of the compa-nies use the FA terminology for their secondbest grades. Four different grades are avail-able for their third best category. Five differentgrade names are offered for the low-gradesurimi. Interestingly, company K offers onlytwo grades, SA and FA.

<2 mm, while other companies give 1 point forlengths >2 mm, l/2 point for l-2 mm, and 0points for <l mm. There are two systems usedin the industry for determining the impurity ofsurimi. The most common method is to use de-fect counts, while the other method uses a 1 to10 scale purity point such as company B. Thenumbers shown in table 2 are extremely differ-ent among companies because of the samplesize and the counting method.

As previously mentioned, gel strength is oneof the most important factors in surimi quality

H SA FA A KA BI-1 SA A KA B KBI-2 SA FA A KA K BJ SA FA AA A RA

Specifications of each quality parameterhave been used as guidelines for grading. Fivemajor companies were selected to compare thedifferences in their specifications. The mois-ture level in surimi is important and is relatedto whether or not the surimi-based seafoodmanufacturers are buying water or fish pro-tein. There is about a 1 percent differenceamong companies for the top two grades. Mostof the companies set the same specifications forall grades; company A and company D are ex-ceptions. Four different heating elements maybe used to determine moisture. They are infra-red, microwave heat/auto scale, electric heat/auto scale, and oven methods. The first threecan give relatively good results within 10 to 15minutes, whereas the oven method needs 16 to20 hours. However, the oven method gives themost accurate results.

For the measurement of skin bits or defects,all manufacturers follow the guidelines of theJapanese Surimi Association with various de-grees of modification. Sample size may vary,being either 10 or 40 grams. The countingscale may also vary when counting skin bits ordefects. Some companies assign 1 point tolengths >2 mm and 1/3 of a point for lengths

Table 1. Grades ofcommercial Pacificwhiting surimi.

measurements. However, there is a large dif-ference among the companies. Gel strength(gm-cm) is calculated based on the force (gm)required to break or tear the gel and ondeformation (cm), which indicates the degree ofthe gel’s resistance to a penetration probe.Most of the companies use the gel strength asa force value multiplied by deformation, whilecompany H uses a force value only. The rangeamong the companies is between 850 and 1000for the SA grade and between 900 and 750 forFA grade. These differences may be due to thetype of gel preparation and whether starch isused when making the sample gels. Preincu-bating of the surimi will also affect the final gelstrength measurements (Kamath 1990). Thegreatest difference between the differentcompanies is in the lower grade surimi (AAand KA), where there is a 200-unit difference.

Color specifications for surimi are extremelydifferent among the companies, as shown intable 2. The surimi industry has been usingthree different brands of colorimeters: Minolta,HunterLab, and Nippon Denshoku Kogyo.Even though the principle of color measure-ment is identical, there is still a small but sig-nificant difference between the machines.

67

1 Moisture (± 0.3%) 3, Gel Strength(gram.cm) d*Force(Gram)Onlyl- r

Table 2. Specifications of commercial Pacific whiting surimi. Companies A, B, D, and H are selected from table 1.

A

SA

FA

KA

RA

RB

D G H

74.3 SA 74.5

74.3 FA 74.5

74.3 A 74.5

74.3 KA 74.5

B 74.5

B

74.5

74.5

74.5

74.5

77

77

SA

FA

A

B

SA 73.5

FA 73.5

P 74

K 74.5

B 75

SA 74.1

FA 74.1

A 74.1

KA 74.1

SA

FA

KA

RB

1000

900

800

700

300

<30C

SA

FA

A

KA

750

600

450

SA

FA

P

K

B

SA

FA

A

B

750

600

450

SA

FA

2,Skin and Defect Counts *PurityScore T-

4,Color (L*/b*) l- -rB* D GA

SA 15

FA 20

AA 20

KA 20

RA 15

RB 30

SA 8

FA 14

A 14

B 23

15

20

25

80

80

SA 47 SA 7614.5 SA 74/12 SA 75/4.5 SA 46

FA 46 FA 75/5.0 F A 73/14 FA 75/5.0 FA

AA 45 A 74/5.5 P 72/15 A 74/5..5 A

KA 72/8.5 K B 74/8.5 K A

B

71/l 5

70/17 B

RB

SA

FA

A

KA

B

SA 10

FA 10

P 10

K 25

B 35

SA 9

FA 8

A 7

KA 7

Companies A and H use a whiteness indexbased on an equation using X, Y, Z values; theother three use L* (lightness) and b* (yellow-ness). When L* and b* values are comparedbetween companies (B, D) using the sameequipment, a significant difference is observed,as shown on table 2.

Reasons for Establishing SurimiStandards

The setting of surimi grades has been a pro-cess that has evolved with each company overthe years. In the past, when surimi was asmall land-based industry concentrated in Ja-pan, the traditional fold test was adequate todetermine the gelling characteristics of theproduct made from the landed catch. As theindustry has become more global and the pro-duction has grown to approximately 1 billionpounds per year of product being producedfrom at-sea factory trawlers and shore-basedplants, these traditional methods are inad-equate to define the product. There are, nodoubt, advantages to individual companies inhaving their own grading system. If they arelarge producers, they can have a tighter con-trol of their product and thus their markets.Ideally, they could have a complete under-standing of their own surimi measurementsand know how these measurements relate toharvest variables, yield, and protein content.They can lock in customers using their gradingsystem and make it difficult for a customer tochange to other brands.

However, the setting of different gradingsystems and values within the industry leadsto high information costs. It becomes more dif-ficult for a surimi-based seafood producer tochange suppliers and fully know the character-istics of the surimi. How does a different grad-ing system affect his formulation and finalproduct quality? If there are differences, howdoes this affect consumer satisfaction? Does anFA grade of 900 gel strength from company Atranslate to the same protein quality of an FAgrade of 750 gel strength for company B, ifcompany A is using starch in its gel measure-ments?

These differences in measurements andgrading can cause confusion in the marketingof surimi. Larkin (1993) states that different“firm-specific grades are not an efficientmechanism for conveying the key surimi char-acteristics for the following reasons:

1) Surimi is not an homogeneous productdespite its appearance, i.e., laboratory

2)

3)

tests are needed to determine levels ofkey characteristics;External processors face unnecessarilyhigh costs of gathering informationabout alternative supplier grades, i.e.,search costs exist;External processors may develop adependency on a past supplier, i.e.,buyer loyalty exists that may ensureproduct consistency while allowingsuppliers to restrict substitutionpossibilities and monitor their potentialrivals in the final surimi-based seafoodmarket.”

Standards for any raw material help to de-fine that commodity and promote fair tradepractices. It is as important for buyers to knowexactly what they are receiving as it is for sell-ers to receive a fair price for their product.Standards are beneficial to the industry as awhole and will encourage growth and promotestable markets. At present, the United Statesis the largest producer of surimi and Japan isthe largest user. Any development of a surimistandard requires agreement between thesetwo countries. A unilateral agreement by ei-ther one of the countries could cause greaterconfusion and mistrust in the surimi industryand uncertainty in world markets. Both coun-tries need to fully agree on the standards andgrading system.

A standard grading system requires thestandardization of methodology and instru-mentation. Preparation of samples, reagents,and calibration of instruments need to be accu-rately defined and followed. A start in the rightdirection has been the publication of themanual for measuring surimi quality by theNational Fisheries Institute (NFI 1991). Al-though the manual does not establish a systemof grades, it explains which compositionalproperties are important for measuring surimiquality and describes the methodology for mea-suring these properties. These standardizedmethods are suggested for in-house measure-ments to ensure quality control and accurateproduct formulation. Accurate measurementsfor surimi depends, in part, on whether asimple methodology can be followed by techni-cians at shore-based plants, on factory ships atsea, and in various counties. Cooking times,sample size, and ingredients for forming thetest sample are important considerations. Thesalt concentration and moisture percentage areimportant variables that need to be held con-stant for a standardized testing regime. Asnoted previously, several companies add

69

starch. Since starch is an added variable in the Reduced costs related to information gatheringtesting and can exhibit its own gel-forming could be translated to decreased costs in finalproperties, it should be eliminated from the product form and to the consumer. This willtesting methods. These are some of the issues allow surimi to be cost competitive againstthat should be decided by a standardization other seafood and nonseafood items and ex-committee. pand its marketing opportunities.

The standardization of testing equipment isalso a necessary component of determiningstandards for surimi. The most commonly usedmethods for measuring gel strength are thepunch test and the torsion method. There arelimitations in correlating the punch test withthe torsion test in surimi (NFI 1991). Thesecorrelations are weak for measuring the elas-ticity of the gels or for lower grade surimi. Thiscould be especially true for some of the newspecies of fish that are being introduced intothe surimi marketplace. It will be beneficial tothe industry as a whole if only one type of in-strument is used and the methodology is welldescribed. This would require an accurate wayto calibrate the instruments so that they wouldmeasure the same functions throughout theseason. This should be true for the color mea-surement as well. The establishing of a colorstandard (or hitching tile) is necessary to accu-rately calibrate the instruments before takingcolor measurements.

REFERENCESBabbitt, J., and Reppond, K.D. 1988. Factors

affecting the gel properties of surimi. J.Food Sci. 53: 965-966.

Chung, Y.C., Richardson, L., and Morrissey,M.T. 1993. Effects of pH and NaCl on gelstrength in Pacific whiting surimi. Acceptedfor publication in J. Aquatic Food ProductTech.

Hamann, D.D. and Lanier, T.C. 1987. Instru-mental methods for predicting seafoodsensory texture quality. In Seafood QualityDetermination, D.E Kramer and J. Liston(Eds.), p. 123-136. Elsevier, New York.

Hamann, D.D. and MacDonald, G.A. 1992.Rheology and texture properties of surimiand surimi-based foods. Ch. 17 in SurimiTechnology, T.C. Lanier and C.M. Lee (Ed.),429-495. Marcel Dekker, New York.

Himelbloom, B.H., Brown, E.K., and Lee, J.S.1991. Microbiological evaluation of Alaskashore-based surimi production. J. Food Sci.56: 291-293,314.

The surimi industry has evolved rapidlyover the last half century. It has changed froma small, traditional, shore-based industry inJapan to a billion dollar industry involving anumber of countries and increasingly a num-ber of species of fish. The grading system hasevolved as well from a subjective analysis oftexture and color to a more sophisticated objec-tive system of analysis of gel strength, L value,moisture, and so on. Although there are sev-eral discrepancies in how these quality param-eters are currently measured, there is acommon goal for most companies to have a sys-tematic way to evaluate surimi blocks. Thereare differences, at present, in the grading ofthe surimi. However, there are also a numberof similarities, and the numbers almost beg fora committee to establish a standard gradingsystem for measuring surimi. Any committeeformed to establish standards and gradesneeds to include representatives from theJapanese and the U.S. surimi industry. Thesurimi industry should support the establish-ment of grading standards to help stabilize theindustry, A uniform grading system would im-prove the efficiency of the industry and in-crease competitiveness across all sectors.

Kamath, G.G. 1990. Investigation of physico-chemical basis for the unique “setting”phenomenon of Alaska pollack and Atlanticcroaker surimi, Ph.D. dissertation, NorthCarolina State University, Raleigh, NC.

Kano, I. 1992. The situation of global surimi,with special emphasis on the Japanesemarket. In Pacific Whiting: Harvesting,Processing Marketing and Quality Assur-ance, G. Sylvia and M.T. Morrissey (Eds.), p.73-79. Oregon Sea Grant, Corvallis, Oregon.

Kim, B.B. 1987. Rheological investigation ofgel structure formation by fish proteinsduring setting and heat processing. Ph.D.dissertation, North Carolina State Univer-sity, Raleigh, NC.

Larkin, S. 1993. Personal communication.Lee, C. 1984. Surimi process technology. Food

Technol. 38( 11): 69-80.Lee, C. 1986. Surimi manufacturing and

fabrication of surimi-based products. FoodTechnol. 40(3): 115-124.

Lee, J, 1992. Microbiological considerations insurimi manufacturing. In Surimi Technol-ogy, T.C. Lanier and C. Lee (Eds.), 113-121.Marcel Dekker, New York.

Matsumoto, J.J. 1979. Denaturation of muscleproteins during frozen storage. In Proteinsat Low Temperature, 0. Fenema (ed.) p.205-224. ACS Symposium Series 180, Amer.Chem. Soc., Washington, D.C.

Morrissey, M.T., Peters, G. and Sylvia, G.1992. Quality issues in the Pacific whitingfisheries. In Pacific Whiting: Harvesting,Processing, Marketing and Quality Assur-ance, G. Sylvia and M.T. Morrissey (Eds.), p.9-16. Oregon Sea Grant, Corvallis, Oregon.

NFI. 1991. A Manual of Standard Methods forMeasuring and Specifying the Properties ofSurimi. T. C. Lanier, K. Hart, and R.E.Martin (Ed.). National Fisheries Institute,Washington, D.C.

Numakura, T., Seki, N., Kimura, I., Toyota, K.,Fujita, T., and Arai, K. 1985. Crosslinkingreaction of myosin in fish paste duringsetting (suwari), Nippon Suisan Gakkaishi51:1559.

Park, J. W., Yongsawatigul, J., and Lin, T.M.1993. Rheological behavior and potentialbindings of Pacific whiting surimi gel asaffected by settings and chemicals. Unpub-lished manuscript.

Park, J.W. 1993. Starches and protein addi-tives. Presented at the 1st Annual OSUSurimi Technology School, Astoria, Oregon.March 29-3 1.

Okada, M. 1992. History of surimi technologyin Japan. In Surimi Technology, T.C. Lanierand C. Lee (Eds.), p. 3-21. Marcel Dekker,New York.

Zenkama. 1987. Outline of All JapanKamaboko Makers Association (Zenkama)and All Japan Surimi Users Committee. AllJapan Kamaboko Makers Association.Tokyo, Japan.

IMPLEMENTING AN ISEUROPEAN SEAFOOD

INTERNATIONALLY

Sigurdur BogasonIcelandic Freezing Plant Corporation

INTRODUCTIONIn this paper I will discuss the various aspectsof systematic quality management as pre-sented in the ISO standards. Where appropri-ate, I will try to refer to my personalexperience working with an ISO 9001-certifiedquality system. The focus of my discussion willbe the following points.

l What is meant by the terms qualityand quality assurance?

l What are the typical components of anISO 9000 quality system?

l Why should a seafood company chooseto work with a structured qualitysystem?

l What are the benefits?l How long does it take to integrate this

kind of a system into an organizationand how much might it cost?

I will discuss the general principles involvedand use some practical examples that relate tothe seafood industry.

The international business world seems tobe deeply concerned about quality. This con-cern may be only a new fad or the hope of sal-vation for every businessman and industry. Mypersonal experience is that nobody with anysincerity can afford to look at this only as afashionable idea. To compete successfully onthe global food market, an industry like theseafood industry needs to take quality manage-ment very seriously. This recent interest inquality seems to arise mainly from the factthat the Western world has come to under-stand that the basis of Japan’s industrial suc-cess in the last few decades is quality. Now weare all extremely busy trying to come to termswith this. Everybody wants to be saved byquality or at least use it somehow to achieve acompetitive edge in the future.

The next logical question becomes, what isquality? The term has many meanings, de-pending on culture and type of industry. It isimportant to define quality before going anyfurther. Many have said (Juran 1989; Surakand McAnelly 1992) that quality is the eco-nomical production of consistent products andservices that meet or exceed customer require-ments. We can add to this statement, and con-formance to regulations. Furthermore, it isobvious that customer requirements are morethan just meeting specifications.

To meet customer requirements, we needinformation from market research that lets usunderstand customers’ needs and problems.Then we need to develop a process for produc-ing goods and services that meet or exceedcustomer’s needs or desires. Finally, we needto sell the products or services at appropriateprices. When any of these criteria can’t be met,it is obvious that the product or services havenot met the definition for quality. For example,rework, waste, or loss during production or dis-tribution of seafood product means there is adecrease in quality. This is because the cus-tomer eventually will have to pay more for theproduct or the owners of the company will re-ceive less return from their investment. To il-lustrate further the true meaning of quality,we can compare two automobiles. A Rolls-Royce, which meets the specifications for aRolls-Royce, is a quality car. But it is equallytrue that a Russian-built Lada, which meetsthe specifications for a Lada, is a quality car.Quality is meeting the requirements.

Another term one comes across frequently(Surak and McAnelly 1992) is quality assur-ance, which is the planned and systematic ac-tions necessary to provide adequate confidencethat processes, products, and services satisfythe requirements of quality. This definitionbrings us back to the IS0 9000 standards sincethey are probably the best tool available to anyindustry for setting up a system to managequality and maintain quality assurance.

The following standards (published in 1987)are used as guidelines for quality managementsystems:

* IS0 9000 - quality management andquality assurance standards-guide-lines for selection and use

* IS0 9001-model for quality assurancein design/development, production,installation, and servicing

0 IS0 9002-model for quality assurancein production and installation

* IS0 9003-model for quality assurancein final inspection and testing

l IS0 9004-quality management andquality system elements-guidelines

For practical purposes most quality systemsthat I know about are based on either ISO9001 or 9002. Figure 1 shows the elementaldifference between the models. IS0 9001 is themost comprehensive one, and IS0 9003 is the

simplest, as it deals only with final inspectionand testing. To add to the confusion, the stan-dards have different reference names in Brit-ain and in the EEC. In the UK, 575O:part 1 isthe same as EN 29001 in the EEC; both areidentical to what internationally is called IS09001 (BSI Quality Insurance publication).Gudmundsson (1992) points out some of thekey reasons for using the IS0 standards: toprovide direction, generate ideas for change,design or redesign systems, implementchanges, measure results, and manage changethrough audits and reviews.

The IFPC Quality Assurance Manual de-scribes a typical ISO 9001 quality system. Fig-ure 2 lists the contents of the manual. Each ofthe 20 chapters in the manual deals with spe-cific activities.

Many people think of quality in the limitedsense of product quality and quality control.However, the standards address all the usualactivities taking place in an organization. Inthe food industry one can easily visualize many

IS0 9001EN 29001BS 575O:l

Source: Pira International

Relevant Quality System Standard

Statement of Quality Policy

Issue Log

CONTENTS

1

2

3

4

5

6

7

8

9

10

11

12

13

14

15

16

17

18

19

20

Management Responsibility

Quality System

Contract Review

Design Control

Document Control

Purchasing

Customer Supplied Product

Product identification and

Process Control

Inspection and Testing

Inspection, Measuring and Test Equipment

Inspection and Test Status

Control of Nonconforming Product

Corrective Action

Handling, Storage, Packaging and Delivery

Quality Records

Internal Quality Audits

Training

Servicing

Statistical TechniquesAppendices:

::List of Quality Plan and Quality Procedures - ReykjavikList of Quality Plan and Quality Procedures - Hamburg

Section: Contents Page: 1 Issue: 3

Figure 2. Contents page of IFPC’s Quality Assurance Manual.

of these activities also being addressed with aHACCP-based system. The main differencebetween the two systems is that HACCP con-centrates on process control and is one of thebest tools available for this. ISO 9000 systems,on the other hand, ensure the overall manage-ment of quality in all quality-sensitive aspectsof the organization.

The company I work for, Icelandic FreezingPlants Corporation, has a long history of usingthe term quality as a key part of its market ap-proach. The corporation celebrated its 50th an-niversary last year, and in March 1992 becamecertified towards ISO 9001. Commitment tothis work was made in the spring of 1991, andI was given the task of compiling the qualityassurance manual and quality procedures incooperation with other IFPC staff and consult-ants from a British company with extensiveexperience in this field. It took us at IFPCabout eight months to have the system writ-ten, implement it, do a number of internal au-dits, amend procedures, introduce somechanges to work routines, and finally pass theassessment of BSI quality assurance (Bogason1992).

The reason this was possible in such a shorttime was that there was total commitment andleadership from the top management of thecompany. Also almost all the personnel partici-pated in some aspect of the work.

There is no mystique involved in this pro-cess. Basically what you need is to start orga-nizing and documenting in a formal mannerthe actual work being carried out within thecompany. The only new aspect in the process isusing the ISO 9000 standard to guide you insetting up the controls required by the indi-vidual ISO standard you choose as the modelfor your quality system. The result is a for-mally written quality assurance manual andquality procedures that describe yourcompany’s tradition for doing the daily taskswhile adding the security of controls in spe-

the quality policy. In the next layers are thequality assurance manual, quality procedures,and work instructions. The foundation of thedocumentation is the records that prove we dowhat we say we will do. The description of thework routines is increasingly detailed towardthe base of the pyramid.

Examples of new tasks that most companieswould have to deal with are controlling the for-mal documents, assessing the supplier, andconducting internal quality audits. Figure 4shows a form that was introduced at IFPC todeal in part with the requirement of the ISO9001 standard: “Part 4.6.2 Assessment of sub-contractors - The supplier (company) shall se-lect sub-contractors on the basis of their abilityto meet sub-contract requirements, includingquality requirements. The supplier (company)shall maintain records of acceptable sub-con-tractors." Figure 5 shows a sample outline ofthe quality procedure that corresponds to thispart of the standard. Also, we maintain a list ofapproved suppliers for IFPC, and in manycases we visit the suppliers to perform qualityassessments. The reason for taking this as anexample from the standard is to point out theobvious. Certified companies will establish cri-teria for assessing their suppliers, and themain criterion will soon become that the sup-plier company also be certified. This will re-duce the amount of inspection required forgoods or services being purchased. Credibilityand confidence will be greater for certified sup-pliers. Al l competent companies will gradually

QUALITY POLICY

cific areas of work, many of which may benew to the company. The individualchapters in the typical quality assur-ance manual specify how the com-pany operates and ensures that therequirements of the ISO 9000standard are met. The qualityprocedures describe in moredetail how they are met.

The IFPC quality manage-

QUALITY PROCEDURES

WORK INSTRUCTIONS

QUALITY RECORDS

ment system documentationcould be viewed as a pyramid(figure 3). At the top we place Figure 3. Structure of the IFPC quality management system.

75

SÖLUMIDSTÖD HRADFAYSTIHÚSANNAICELANDIC FREEZING PLANTS CORP.

VENDOR ASSESSMENT QUESTIONNA!RE

Figure 4. Vendor assessment questionnaire.

76

ASSESSMENT OF SUPPLIERS

ObjectiveTo ensure that suppliers Of goods and services used within thequality system areselected on the basis of their ability and thattheir performance is monitored.

Procedure

1. Quality ManagerSuppliers of goods and services are assessed and theirperformance is monitored in consultation with the Purchasing,Quality Control, Shipping, xxxxx xxxxx xxxxxx xxxxx xxxxxxxxxxxxxx xxxxxxxxxxxxxxxxx.

2. Functional ManagersInformation about suppliers performance and complaintsresulting from their services or goods are relayed to theQuality Manager. Complaint xxx xxxx xxxxxxxxxxxxx xxxxxxxxxxxxxxx xxxxxx xxxxxxxx xxxxxxxxxx xx xxxx xxxxxxxxxxxxxxxxxxxxx xxx xxx xxxxxx xxx xxx xx . A. Manual.

3. Quality ManagerWherever possible suppliers registered as firms of assessedcapability to ISO 9000 or similar are selected. Othersuppliers are selected using one or more of the followingcriteria:-

- Supplier questionnaire form- Evaluation of sample products- On site assessment- Past history of performance.

xxxxxxxxx xxxxxx xxxxxxx xxx xxxxxxxxxxxx xxxxxxx xxxx xxxxxxxxxxxxx "Approved".

4. Quality Managerxxxxx xxxx xx x xxxxxxxx xxxxx xxxxx xxxxxxx xxxxxxxxx xxxxxxxx xxxxx xx x x xxxxxx xxxxxx xxxxxxx xxxxx xxxxxx xxxx xxxxxxx xxxxx xxxx xxxxxxxx xxxx xxxxx xxxxxx xxxxx xxx arerecorded and filed.

Figure 5. Sample outline of a quality procedure.

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be pulled on this bandwagon, willing or not.Those who refuse to put their effort into qual-ity issues will lose market shares, just as thosewho pull their weight with enthusiasm willgain the competitive edge. Remember that atsome stage everybody is both a supplier and acustomer. The same thing is true within a com-pany as each department needs to be sure whoits customers are and what their requirementsare.

We found forms to be very useful in effi-ciently introducing the controls and record-keeping required. In many cases the staff com-plained about the forms, but that was beforethey realized that using forms didn’t take anylonger to relay information than scribbling theinformation or request on some piece of paper.Also everybody quickly saw that the securitygained was immensely important as informa-tion was not being lost and actions becamemore accurate. The number of failures to actupon an internal request was reduced and thestaff became more responsible for their actions.Doing it right the first time is extremely im-portant in all organizations because it reducesthe cost of redoing the work (Bogason 1992).

At IFPC a new computer system has beenset up. In designing its routines, we made aneffort to automatically log in as much as pos-sible of the record-keeping information re-quired by the quality system. Consequently,many of the forms introduced when the systemwas being implemented have now become su-perfluous. Always remember the kind of moti-vation needed for the people who have to carryout the routine tasks like working according toprocedures and using forms. You have to showthe staff why a routine is required and helpthem see for themselves the benefits comingfrom this approach. Training is a key elementin the effort, and the standard stipulates gen-eral requirements for training. Each companyhas to specify how its training needs willbe met.

WHAT ARE THE BENEFITS?There are four reasons the ISO standards

can be useful to a company. First, the stan-dards are internationally recognized. Second,they help organize the internal operations inan organization; in other words they can makeall work flow more easily and prevent mistakesfrom happening. The quality system shouldreduce the effort needed for internal inspectionand double checking within the company.

Third, a company receives public benefits fromISO standards. A company that has a certifiedquality system can tell its customers it hasbeen certified to the ISO standards. As custom-ers are informed about the third-party assess-ment involved, the company and the quality itstands for gain credibility for the customers.European firms are under increasing pressureto become certified, and more frequently it isbecoming a requirement for doing business.The fourth reason ISO standards can be usefulis that the standards help establish proof ofdue diligence on part of the organization inmaintaining the safety of processes, products,and services and in meeting legal require-ments. Due diligence is the term used when acompany has taken all possible steps and pre-ventive measures to ensure the safety of itsproduct.

APPROACH FOR SEAFOOD COMPANIESHow can a quality management system be

beneficial specifically to seafood companies?There are no simple answers. Let’s put it thisway: if a company chooses not to manage qual-ity in any formal manner, will it be competitiveor be able to maintain the necessary credibilityfor customers, consumers, and regulatory bod-ies? My approach is as follows (Bogason 1992).By setting up a quality management systemaccording to the ISO 9000 standards, any orga-nization has then invested time, effort, andmoney to develop an immensely powerful toolfor managing that organization. A carefullydesigned quality system is a general manage-ment tool for almost all operational activities.The finance department is usually excludedfrom the ISO 9000-based system. Although thestandards do not require the financial depart-ment to be a part of the quality managementsystem offered for certification, it can be orga-nized and controlled by the same methods andphilosophy.

How long will it take to become registered?If the company has a formal quality system-e.g., a HACCP system-in place, it could takeonly six months. However, this would be theexception; a company starting without a formalquality system should allow a year or two tobecome ready for assessment.

The ISO 9000 standards do not by them-selves specify or demand any specific level ofquality or service. Each company has to estab-lish its own standards of excellence or its ser-vice level. The standards basically require only