45016 Federal Register /Vol. 62, No. 164/Monday, August 25 ...effective sanitation and HACCP programs. FSIS agrees with the commenter that third-party programs can make a useful contribution

45016 Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Parts 304, 308, 317, 318, 319 and381

[Docket No. 95–032F]

RIN 0583–AB93

Elimination of Prior ApprovalRequirements for EstablishmentDrawings and Specifications,Equipment, and Certain Partial QualityControl Programs

AGENCY: Food Safety and InspectionService, USDA.ACTION: Final rule.

SUMMARY: The Food Safety andInspection Service (FSIS) is amendingthe Federal meat and poultry productsinspection regulations by removing therequirements for prior approval by FSISof establishment drawings,specifications, and equipment used inofficial establishments. Requirementsinvolving the comparison of blueprintsand specifications with actual facilitiesand equipment will end, affordingindustry the flexibility to designfacilities and equipment in the mannerthey deem best to maintain a sanitaryenvironment for food production. FSISwill continue to verify throughinspection that sanitation requirementsare being met. FSIS is also ending itsprior approval of most establishment-operated partial quality controlprograms, which are used byestablishments to control certain kindsof food processing and productcharacteristics. This change will enableestablishments to develop andimplement quality control programswithout first having to receivepermission from FSIS to do so. Thisaction is being taken as part of FSIS’sregulatory reform effort to improveFSIS’s meat and poultry food safetyregulations, better define the roles ofGovernment and the regulated industry,encourage innovations that will improvefood safety, and remove unnecessaryregulatory burdens on inspectedestablishments.DATES: Effective Date: September 24,1997.

Comments: Comments on theguidance material published asAppendices A and B of this documentmust be received by October 24, 1997.ADDRESSES: Submit one original andtwo copies of written comments to: FSISDocket Clerk, DOCKET #95–032F, U.S.Department of Agriculture, Food Safetyand Inspection Service, Room 102, 300

Twelfth Street, S.W., Washington, DC20250–3700.FOR FURTHER INFORMATION CONTACT: Ms.Patricia F. Stolfa, Assistant DeputyAdministrator, Office of Policy, ProgramDevelopment, and Evaluation, FSIS,Room 402 Annex Building, Washington,DC 20250–3700; (202) 205–0699.

SUPPLEMENTARY INFORMATION:

Background

The Federal meat and poultryproducts inspection regulationscurrently require establishmentsapplying for inspection to submit toFSIS multiple sets of drawings andspecifications of the facilities forapproval before inspection can begranted (9 CFR 304.2, 381.19). Theregulations require plans to besubmitted to the Agency for approvalbefore any remodeling of facilities (9CFR 308.2, 381.19(e)). The regulationsalso require approval by FSIS ofequipment and utensils proposed foruse in preparing edible product orproduct ingredients in officialestablishments (9 CFR 308.5, 381.53).Further, the regulations require Agencyapproval of partial quality controlprograms before establishments can usethem for control of food processing orfor other uses (318.4 (d)–(g), 381.145(d)–(g)).

FSIS proposed in the May 2, 1996,Federal Register (61 FR 19578) toamend these regulations to eliminaterequirements for FSIS prior approval.The Agency also proposed a minimumstandard for the design of PQC programsthat is comparable to the standard forprograms the Agency has approved. Forthe reasons given in the preamble to theproposal and in this final rule, FSIS isadopting the proposed amendmentswith some additional changesoccasioned by FSIS’s review of theproposed rule and the comments on thatproposal.

Comments

FSIS received 27 comments duringthe public comment period that endedSeptember 9, 1996. Five were fromindustry consultants, seven fromequipment manufacturers andengineering firms, eight from foodcompanies, four from trade associations,one from a law firm representingpackers and equipment manufacturers,and two from State departments ofagriculture. Twelve commentersexpressed qualified support foreliminating prior approval of equipmentand facility blueprints, thirteen favoredkeeping the present approval system,and two suggested alternatives. All 13comments received on the specific issue

of eliminating PQC prior approvalssupported the proposed change.

In addition to the commentssubmitted on the May 2, 1996, proposal,five comments supporting theelimination of prior approvals weresubmitted in response to the Agency’sDecember 29, 1995, advance notice ofproposed rulemaking ‘‘FSIS Agenda forChange: Regulatory Review.’’ Four ofthe five comments were from personswho also commented on the May 2proposal.

The following summarizes thecomments on the proposal and Agencyresponses by major topic addressed.

Circuit Supervisor and InspectionDecisions

Most commenters, whether favoringor opposing the proposal, expressedconcern that eliminating prior approvalsof facilities and equipment would leaveestablishments without documentedapprovals with which to counteradverse judgments by circuitsupervisors during walkthroughsconducted before the granting ofinspection or by field inspectors duringdaily establishment operations. Thecommenters feared that conflicts arisingover decisions by such Agencypersonnel could delay production andotherwise burden establishments. Tencommenters opposed the proposal forthis reason. Six others, though favoringthe proposal, had the same concern andthought the Agency should take steps toprevent or minimize any disruptionsarising from decisions made by localAgency personnel.

These commenters tended to assumethat FSIS inspection will not change inconjunction with the regulatory reformsnow taking place. FSIS disagrees. FSISinspection roles will changesignificantly under the recentlypromulgated final rule ‘‘PathogenReduction; Hazard Analysis and CriticalControl Point (HACCP) Systems’’ (61 FR38806; July 23, 1996). Under this rule,FSIS personnel will verify theeffectiveness of processes and processcontrols designed to ensure food safety.FSIS is preparing the inspectionworkforce to oversee the safety of meatand poultry products under this newHACCP-oriented inspection. FSISpersonnel will focus on anestablishment’s ongoing compliancewith HACCP-consistent requirements.Inspectors will carry out verificationactivities such as reviewingestablishment monitoring records for aprocess, reviewing records for aproduction lot, directly observingcritical control point controls conductedby establishment employees, collectingsamples for FSIS laboratory analysis,

45017Federal Register / Vol. 62, No. 164 / Monday, August 25, 1997 / Rules and Regulations

and verifying establishment verificationactivities for a process.

Inspection findings that affectfacilities or equipment will be made inthe context of such verificationactivities. Inspectors will retain theauthority to reject facilities orequipment wherever appropriate andwarranted by the circumstances.Establishments will have theresponsibility to take corrective actionwhen they discover process deviationswhile operating their HACCP systems.Proper design and implementation ofsanitation standard operatingprocedures (SOP’s) and the HACCPsystem will minimize any differences ofopinion with Agency personnel thatmay occur.

Provision of Guidance Material,Transition to HACCP

A number of commenters (8) whofavored the proposal thought that theAgency should make guidance materialson facilities and equipment available toinspectors and establishments,especially to small establishments.These commenters stated that theguidance materials, including a revisedAgriculture Handbook 570, U.S.Inspected Meat and Poultry PackingPlants: A Guide to Construction andLayout, and equipment acceptabilitystandards, would help maintainuniformity and consistency ininspection decisions and would also beof use to small establishments. Onecommenter thought there should beperiodic updates to Handbook 570.Some commenters stressed that theAgency should emphasize to inspectorsthat the guidance documents are notrules and regulations, but are intendedto illustrate basic principles to beapplied in a variety of situations.

As explained in the proposal, FSIS ispreserving the final edition ofAgriculture Handbook 570 and thegeneral guidance material in MPI–2,Accepted Meat and Poultry Equipment,for reference. This guidance material isappended to this document asAppendix A. The Agency agrees withthe commenters that this guidancematerial should not be interpreted as aset of regulations, but as a statement ofbasic principles with illustrativeexamples. The specific application ofthese principles will depend, in part, onthe establishment’s implementation ofits sanitation standard operatingprocedures and its HACCP plan. TheAgency also plans to issue a final list ofapproved equipment, reflecting FSISdecisions through November 1996.Appendix A is a final draft on which theAgency will accept comments for 60days. Comments on whether the

material is clear and useful will beespecially helpful in finalizing thematerial.

Effect on Small Companies

A few commenters (3) thought thateliminating prior approvals would beharmful to small companies that areunable to hire experts in foodprocessing facilities or equipment toassist them in complying withregulatory requirements.

As explained above, FSIS hasprepared technical guidance material onfacilities and equipment that should beespecially useful to smallestablishments. The Agency willcontinue to maintain a small staff ofexperts at Washington headquarters tomonitor developments in foodtechnology and disseminate advice andmaterials concerning applications of thetechnology. The Agency also plans tomake the technical guidance material itdevelops available to the public inelectronic format.

Prestige of USDA Acceptance

One commenter thought that, with theending of the FSIS acceptance programfor equipment, U.S. manufacturerswould suffer a disadvantage ininternational markets for foodprocessing equipment. The commenterstated that equipment manufacturerswere previously able to trade on thevalue of USDA acceptance of theirproducts for use in federally inspectedplants.

Although FSIS appreciates the factthat its decisions on meat and poultryslaughtering and processing equipmentare valued, the acceptance program wasnever intended for equipment marketpromotion. Its purpose was to helpensure that meat and poultryestablishments would operate in a safe,sanitary manner, producing andshipping only wholesome,unadulterated meat and poultryproducts.

Limited Value of Prior Approval

One commenter agreed and anotherdisagreed with the Agency’s contentionthat an initial determination that meatand poultry facilities and equipmentmeet Agency requirements is of limitedvalue. Prior approval does not guaranteethat establishments will continuouslyoperate facilities and equipment in asafe and sanitary manner. FSIS’sposition, as previously stated, is thateffective sanitation SOP’s and HACCPsystems will meet the same objectives asprior approvals.

Third-Party Certifications

Several commenters suggested the useof third-party certifications of facilitiesand equipment. One commenterfavoring the proposal suggested thatFSIS consider the voluntary use byestablishments of third-party assessmentand registration programs to ensure thedevelopment and implementation ofeffective sanitation and HACCPprograms.

FSIS agrees with the commenter thatthird-party programs can make a usefulcontribution to the effort of developingand implementing sanitation SOP’s andHACCP plans. The Agency, realizingthat some establishments will be unableto avail themselves of these services andthat many will not need to, is notrequiring the use of such services. Also,the Agency does not intend to formallyrecognize or accredit such services.However, FSIS agrees that third-partycertification services may beadvantageous to many establishmentsand would support an industryinitiative in this area. An example ofsuch a third-party certification service isthe 3–A Sanitary Standards Committee,which conducts a certification programfor equipment used in dairy and eggproducts processing establishments.

Number of Blueprint Submissions andEvaluation

One commenter disputed the numberof blueprint submissions to the Agencyduring fiscal year 1994 (2,100, versusthe Agency’s estimate of 2,900) and theAgency’s attribution of most rejectionsto paperwork errors. The commenterasserted that most rejections wereattributable to deficiencies that couldaffect food safety. The commenter alsosuggested that because the proposal wasbased, in part, on the Agency’s incorrectestimate of the number of blueprints itevaluated and the reasons for returnsand rejections of the blueprints, thebasis for the proposal was faulty, andthat, for this reason, the proposal oughtto be withdrawn.

FSIS’s estimate of the number ofsubmissions at about 2,900 for fiscalyear 1994 was derived from informationin a blueprint evaluation database thatwas intended to show trends inworkflow through the Washingtonreview staff rather than absolutenumbers of submissions. In fiscal year1994, the Agency also maintained aseparate count of returns of blueprintsto their originators. Some blueprint setsgo back and forth between the Agencyand the originating establishmentseveral times before they are approved.The Agency used a sample of blueprintevaluation records from the database,


adjusted for multiple returns, inestimating the number of submissions ithandled.

The commenter’s count may havebeen based, in part, on internal Agencyreports. The data in those reports iscomparable to the data used by theAgency in arriving at its estimate. FSISconsiders the commenter’s count as areasonable lower-bound estimate of thenumber of submissions and is using itfor the purpose of assessing the impactof this rule.

However, FSIS disagrees with thecommenter’s belief that most blueprintrejections were the result of factorsaffecting food safety. During periods ofhigh workload, the Agency’sWashington staff has tended to return ahigher proportion of blueprint sets withadministrative errors to the originatingestablishments and requestresubmission. During periods of lowerworkload, the staff has been able totelephone establishments, offer advicerelating to the compatibility ofblueprints with guidelines, and receivecorrections of administrative errors byfax. The percentage of returns to correctspecifications that have implications forfood safety was somewhat higher inperiods of lower workload than in high-workload periods. Most recently, it hasbeen the policy of the blueprint reviewstaff to focus strictly on regulatorycompliance—that is, on checking forspecifications required by theregulations—rather than oncompatibility with guidelines. As aresult, the percentage of blueprintreturns attributable to paperwork errorshas been higher than in the past.

The estimate of blueprint submissionsand rejections was used to conduct aregulatory impact assessment.Moreover, the Agency’s estimate ofimpact is only a part of the basis for therule. As stated in the preamble to theproposal, there are several otherimportant reasons for the rule. First, itis important to note that the FederalMeat Inspection Act and the PoultryProducts Inspection Act do not requireprior approval of facilities, equipment,and quality control programs. Moreimportantly, prior approvals are limitedin scope because they apply only tocertain aspects of establishmentoperations and in time because they aregiven only once. The establishment isand has always been responsible formaintaining sanitary facilities andequipment every day it operates. Also,prior approval is a feature of thetraditional command-and-controlapproach to regulation that can be anobstacle and deterrent to innovation.Eliminating prior approvals isconsistent with the new regulatory

requirements for establishment-operatedsanitation SOP’s and HACCP systems,under which the establishments willfulfill their responsibility fordetermining and implementing processcontrols that will assure food safety.Under these new requirements, priorapproval is an inappropriate allocationof responsibility between the Agencyand establishments.

Enforcement, Dispute Resolution, andAppeals

A number of commenters (4) askedwhat recourse establishments wouldhave if FSIS took action against orrefused to allow the use of equipment orfacilities that had not previously beenapproved by FSIS. Commenters askedwhether appeal procedures would beprovided or whether another form ofdispute resolution would be available toestablishments if the proposal wereadopted.

FSIS understands the concern and isdeveloping procedures for resolvingissues such as these which may ariseunder the HACCP-based inspectionsystem. The Agency emphasizes,however, that under the new program,inspectors will not be evaluatingequipment and facilities directly.Rather, inspectors will evaluate theoperational effectiveness of facilitiesand equipment in preventing directproduct contamination and otherhazards.

FSIS is currently revising its rules ofpractice and will include procedures fordispute resolution and appeals of FSISdecisions. Until those rules of practicebecome effective, current enforcementand appeal procedures will continue tobe followed.

Partial Quality Control ProgramsAs mentioned above, 13 comments

favored the elimination of priorapproval of establishment-operated PQCprograms, but most were accompaniedby questions and suggestionsconcerning the Agency’s policy on PQCapprovals.

Continued Prior Approval of CertainQuality Control Programs

Three commenters asked why theAgency was eliminating prior approvalfor certain PQC programs, but retainingprior approval requirements for otherPQC programs. One commenter notedthat the proposal did not address priorapproval of Total Quality Controlprograms.

Although eliminating most priorapprovals, FSIS is retaining certainspecific regulatory provisions for priorapproval of PQC programs. Theseinclude programs associated with

certain slaughter inspection systems andwith food irradiation facilities. Also,this final rule does not eliminate priorapproval of TQC programs. The Agencyplans to deal with these issues duringthe next few months in rulemakingsintended to address the remaining priorapproval requirements for PQC andTQC.

Specific Requirements for PQCPrograms

A number of commenters questionedthe requirements that PQC programswould have to continue to meet. Twocommenters wondered why the Agencywas prescribing design criteria for PQCprograms, including the requiredelements and minimal statisticalconfidence, when they were eliminatingprior approval. Another commenterthought that the National Institute ofStandards and Technology (NIST)Handbook 133, concerning net weight,should be amended to eliminate specificreferences to approved PQC programs.

The PQC program design criteria setforth in the regulations are consistentwith those currently observed by theindustry. The Agency proposed therequirements, including the 85-percentstatistical confidence criterion, toprovide the industry with a set ofminimum standards for PQC programs.A sampling plan should be consistentwith the principles of statistical processcontrol and the proposed requirementincluded such a plan. Nevertheless, theAgency agrees that a precise samplingplan does not have to be set out in theregulations. The Agency also agrees thatthe proposed specifications relating tothe minimum confidence level,individual sample means, and sublotmeans are too prescriptive. Accordingly,these specifications are not beingadopted in this final rule.

Further, establishments are notrequired to include all the featurespresented in proposed §§ 318.4(2)(ii)and 381.145(2)(ii) in its individual PQCprograms. The final rule only requiresthat a PQC program include thoseelements that are ‘‘appropriate for theproduct, operation, or part of anoperation which the program concerns.’’The final rule also requires thatgenerally recognized statistical processcontrol procedures be used to determineprocess control. However, the final ruleis worded to accommodate controlprocedures that are not statisticallybased or that do not have measurablecontrol limits, such as the in-plantcontrol procedures for grade-labeledproduct.

As to NIST Handbook 133, FSIS doesnot see a need to amend the Handbookat this time. The Handbook states that


data generated by USDA-approved PQCprograms can be used to substantiate lotcompliance with net weightrequirements. Even without priorapproval by FSIS, a PQC programmeeting the requirements of this finalrule could generate data appropriate fordetermining product compliance withnet weight requirements. Such data willbe recognized and checked by FSISinspection personnel just as datagenerated by prior-approved PQCprograms have been until now.

In order to facilitate establishmentdevelopment of PQC programs that meetthe requirements of this final rule, theAgency has developed guidancematerial which includes the criteria itused to determine whether or not PQC’swere acceptable. The guidance material,which is included as Appendix B, maybe used by establishments at theirdiscretion.

Appendix B, as with Appendix A, isa final draft on which the Agency willaccept comments for 60 days.Comments on whether the material isclear and useful to establishments willbe especially helpful in making finalrevisions to the Appendix.

Upon publication of this final rule,FSIS will revise Agency directives andother documents referring to PQC’s. Thecategory of ‘‘conditional’’ PQC’s in thesedocuments will be eliminated and thecategories ‘‘mandatory’’ and‘‘voluntary’’ will remain. The‘‘mandatory’’ category will be abolishedonce all regulations requiring Agency-approved PQC’s for certain processeshave been amended.

Effect of Mandatory HACCP on PQCPrograms With Public HealthImplications

Two industry commenters wanted toknow what effect the HACCPrequirements would have on existingand future PQC programs, whichinclude measures relating to publichealth or safety protection. Althoughthis final rule eliminates therequirement for prior approval of mostPQC programs, PQC programs remain anoption for controlling certain processes.As HACCP is implemented in anestablishment, safety-related PQCprograms will most likely beincorporated into the establishment’sHACCP plan. As HACCP plans areimplemented throughout the meat andpoultry industry, public health-relatedPQC programs will no longer be needed.Establishments will, of course, continueto be able to develop and use PQCprograms that control ‘‘economic’’factors.

A State government suggested that theAgency continue prior approval of such

PQC programs. FSIS disagrees. TheAgency’s position is that such controlprograms should be implementedvoluntarily, at the establishment’sdiscretion.

Third-Party Certification of PQCPrograms

One commenter suggested that FSISmake use of third-party certificationservices for PQC programs.

As stated above, third-partycertification services may be useful andadvantageous to many establishments,and FSIS would support industryinitiatives in this regard. However, theAgency does not plan to require third-party certification or to officiallyrecognize, accredit, or oversee theiroperations.

Export RequirementsOne commenter noted that some

foreign countries require productexported to them from U.S.establishments to have been processedunder approved PQC programs, andrequested that the foreign requirementsbe changed to accord with the new U.S.regulations.

However, FSIS has no direct controlover the requirements of foreigngovernments. Establishments mustabide by the requirements of thecountries to which they export. SinceFSIS is no longer approving PQCprograms, if a foreign governmentrequires a U.S. establishment to processproduct exported to that government’sterritory under an approved PQCprogram, then the establishment shouldobtain approval for the program fromthat government.

The Final RuleFSIS is adopting the provisions in the

proposal in essentially the same form asproposed, but with some technicalchanges. In §§ 318.4(d) and 381.145(d),concerning PQC programs, the phrase‘‘is required to have’’ replaces ‘‘is using’’for greater consistency with the intent toprovide flexibility to establishments andreduce regulatory paperwork burdensassociated with voluntary PQC’s. Asmentioned, some of the PQC programdesign criteria in proposed§§ 318.4(d)(2)(ii) and 381.145(d)(2)(ii)are not being adopted. Also,§§ 318.4(d)(2)(ii) and 381.145(d)(2)(ii)are worded to accommodate proceduresthat do not have measurable limits, aswell as statistically based PQC’s.

Additionally, FSIS is making certaintechnical corrections in this final rule,which are occasioned by FSIS’s reviewof the proposed rule and the commentson that proposal. The wording ofamended §§ 317.21, 318.19(e) and

381.121d is changed somewhat from theproposed wording to clarify that certainrequirements for quality control willcontinue even though the prior approvalrequirements for PQC programs areremoved. The proposal did not includeproposed amendments eliminating theprior-approval requirement forblueprints of import inspectionestablishments or of establishmentsoperating under State meat or poultryinspection programs that are ‘‘at leastequal to’’ the Federal program. Therevised 9 CFR 327.6(d), 331.3 and381.222 eliminate these prior-approvalrequirements. States may continue torequire establishments to submitblueprints for approval as a condition ofreceiving inspection, but because FSISis eliminating its prior approvalprograms, the Agency will no longerconsider prior approval of blueprints tobe a necessary feature of an ‘‘at leastequal’’ inspection program.

Also, FSIS inadvertently omittedchanges, consistent with the intent ofthis rulemaking, to some sections of theregulations that refer to PQC priorapprovals. These sections include 9 CFR319.105, on the processing of cured hamproducts and 9 CFR 318.308 and381.308, on the processing of cannedfoods. The final rule amends thesesections of the regulations to eliminatethe references to PQC prior approvals.

Relationship to Sanitation SOP’s andHACCP

Beginning on the effective date of thisfinal rule, establishments will no longerbe required to submit drawings andspecifications of facilities to FSIS forapproval before beginning inspectedactivities or before remodeling facilities.They will no longer be required to useonly FSIS-approved utensils and modelsof equipment.

Establishment operators must beaware of two things, however. First, incarrying out sanitation SOP’s requiredby the Pathogen Reduction/HACCPregulations, if corrective action isnecessary to maintain or restore sanitaryconditions, an establishment may haveto repair or replace facilities orequipment. FSIS inspectors will beverifying the establishment’s operationof its sanitation SOP’s. If, duringverification activities, inspectors findthat the SOP’s are not being effectivelyimplemented, they will have the fullrange of compliance measures available,including the rejection of equipmentand areas of the establishment. It will bethe responsibility of the establishmentto take action with respect to anyequipment or facilities that may becausing a sanitary hazard.


Second, in conducting the hazardanalyses required to develop its HACCPplan, an establishment must determineall factors that may contribute to theemergence of hazards and the measuresnecessary to prevent or minimize thosehazards. This means that theestablishment’s facilities and equipmentmust be designed to permit the processgoverned by the HACCP plan to becarried out. The facilities andequipment must be capable of meetingthe applicable processing requirementsof a product, must be cleanable, andmust not become a source of hazards tothe product. For example, facilities andequipment should be maintained so thatproduct is not exposed to physicalhazards such as paint chips, rustparticles, or loose machine parts.

Establishments will be responsible forconsulting with equipmentmanufacturers as necessary to completetheir hazard analyses and identifyappropriate critical control points(CCP’s) while developing their HACCPplans. Establishments will be expectedto take appropriate corrective actionswhenever they find deviations fromprocess critical limits while operatingtheir HACCP systems. The actionsnecessary to correct a problem may, attimes, require maintenance, repair, orreplacement of equipment or facilities.

FSIS personnel will verify thatestablishments are effectively operatingtheir HACCP systems. If FSIS finds apattern of recurring hazards to productcaused by facilities and equipment, theAgency has, and will exercise whereappropriate, the authority to take actionon product, equipment, or facilities. Inthose situations where FSIS finds apattern of recurring hazards to product,it will be indicated that the HACCP planis inadequate and the plan may have tobe redesigned and revalidated.Improving the establishment’s facilitiesand equipment could well be among thesteps necessary to redesign andrevalidate the HACCP plan.

FSIS findings will not be directedprimarily at the acceptability offacilities and equipment per se, but atthe functioning of the HACCP plan inoperation. In other words, if hazards toproduct are not being prevented orcritical control points are failing, thefailure may be the result of inadequatefacilities or equipment and theestablishment will be required to correctthe problem.

Equipment and UtensilsFSIS will no longer evaluate

equipment or utensils for acceptance.As mentioned earlier in this document,the final edition of MPI–2, AcceptedMeat and Poultry Equipment, is being

published for reference purposes.Adequate sanitary design of equipmentwill be ensured through establishmentimplementation of SSOP’s and HACCPplans.

Equipment and utensils mustcontinue to meet the general standardthat they are of a material andconstruction that will facilitate thoroughcleaning and cleanliness in preparingedible product and must not interferewith or impede inspection procedures.(9 CFR 308.5(a), 308.15, 381.53(a)(1).)FSIS has authority to prevent the use ofequipment or facilities that pose a threatto public health or interfere withinspection. FSIS must be notified inadvance of any changes to facilities orequipment that may interfere with orforce changes to FSIS’s inspectionoperations.

PQC Programs

With respect to PQC programs, underthis final rule inspectors will verify thatestablishments have written PQCprograms on file, with data andinformation available to the inspectors,and that the process limits prescribed bythe programs are being met. Theestablishments will be responsible fordeveloping PQC programs that meet theregulatory requirements but there is norequirement for the programs to beapproved in advance of their use. Theestablishments may seek advice fromthe Agency concerning requirements forsuch programs. As mentionedpreviously, draft guidance material onPQC programs is provided in AppendixB to this document.

Disposition of FSIS Files onEstablishment Facilities

In concluding its prior approvalactivity for establishment drawings andspecifications, FSIS will archive orotherwise dispose of the files of itsfacilities review staff. Establishmentdrawings and specifications and files,many of which contain proprietaryinformation, will be destroyed withappropriate security under officialsupervision.

Executive Order 12988

This final rule has been reviewedunder Executive Order 12988, CivilJustice Reform. This rule: (1) preemptsall State and local laws and regulationsthat are in conflict with this rule; (2) hasno retroactive effect; and (3) does notrequire administrative proceedingsbefore parties may file suit in courtchallenging this rule.

Executive Order 12866 and Effect onSmall Entities

FSIS is eliminating prior approvalrequirements for establishmentdrawings and specifications, equipment,and certain partial quality controlprograms. Concurrently with this finalrule, FSIS is restructuring inspectionactivities to focus more attention on theability of establishments to maintain asanitary environment. These actions, inaddition to implementation of thesanitation standard operatingprocedures required by the PathogenReduction/HACCP rule, will provide theindustry the flexibility for creating andmaintaining a sanitary workingenvironment without prescriptivecommand-and-control requirements.

Removing these requirements affectsestablishments subject to officialinspection, firms producing and sellingequipment currently subject to priorapproval, firms providing expeditingservices to businesses seeking priorapproval, and consumers. The final rulewill reduce demands on FSIS resourceswhich can be redirected to functionsmore critical to assuring food safety.

FSIS considered a number ofalternatives, including that of making norule changes, before adopting this finalrule. The Agency rejected the alternativeof no rule changes because not changingthe regulations would leave in place aprescriptive regulatory regime forequipment, facilities, and processes thatconflicts in a material way with theobjectives of the Pathogen Reduction/HACCP final rule. Under HACCP,establishments will assumeresponsibility for sanitation and forbuilding science-based, preventiveprocess controls into the foodproduction system to reduce oreliminate food safety hazards. This willinclude taking responsibility forensuring that facilities, equipment, andprocesses conform with soundsanitation principles and food safetyperformance standards. The existingrequirements can also impede theability of establishment management toimplement, on a timely basis, better andmore innovative food safety strategies.

Alternatives to facilities andequipment prior approvals that FSISconsidered included development byFSIS of detailed standards to bepublished in booklets with periodicupdates, recognizing industryorganizations as prior approvalauthorities, and establishing generalperformance standards similar to FDA-recognized good manufacturingpractices. Another alternative whichwould have provided prior approval


services on a voluntary, user-fee basis,was also considered.

FSIS rejected the alternative ofpublishing booklets containing detailedfacility and equipment standardsbecause, although establishments wouldassume responsibility for determiningwhether their facilities and equipmentcomply with the standards,establishments would remain withoutflexibility to implement innovativetechnologies that appear to depart fromthe written standards. It is also likelythat, under this alternative, the Agencywould continue to exercisediscretionary prior approval authorityover the introduction of new food safetytechnologies. Moreover, the Agency’sinspection of facilities and equipmentfor compliance with the publishedstandards would divert resourcesneeded to verify SSOP’s and HACCPsystems. As mentioned above, however,FSIS is publishing draft guidancematerial on facilities and equipment asAppendix A of this document.

FSIS also rejected the alternative ofofficially recognizing industryorganizations as prior-approvalauthorities for facilities and equipment.As mentioned earlier in this document,although such services may bebeneficial to some establishments, manywill not need and some will be unableto use such services. Thus, FSIS doesnot intend to provide officialaccreditation or certification of suchservices. The Agency’s verification ofSSOP and HACCP systems is intendedto be its primary means for determiningthe adequacy of establishment foodsafety protective measures, includingthose measures that depend on welldesigned and maintained facilities andequipment.

FSIS also rejected the alternative ofcontinuing its prior approval of facilitiesand equipment on a user-fee basis. Thisalternative had essentially the samedrawbacks as the alternative of no rulechanges. It would not haveappropriately separated the roles of theestablishment and the Agency. It wouldhave perpetuated adherence toprescriptive design standards ratherthan setting food-safety performancestandards for establishments to achieve.Finally, this alternative would havecontinued to pose the same regulatoryobstacles to innovation as the currentsystem.

FSIS chose the option of eliminatingprior approval requirements forfacilities and equipment, whilemaintaining the general food safetystandards in the existing regulations.This action will remove regulatoryobstacles to innovation and command-and-control requirements inconsistent

with the objectives of the PathogenReduction/HACCP final rule and theAgency’s food safety regulatory strategyand will yield immediate and near-termbenefits. As stated in its December 29,1995, advance notice of proposedrulemaking, the Agency is consideringreplacement of more of its detailedregulatory requirements withperformance standards. Such changeswill be addressed in future documents.

The alternatives to PQC priorapprovals were market sampling offinished products, mandating additionalin-plant controls, sampling finishedproducts for chemical analysis, andgeneral requirements and standards forPQC programs.

FSIS regards market sampling as apotentially useful tool for enforcing thestatutes prohibiting commerce inadulterated and misbranded meat andpoultry products and for checking theeffectiveness of establishment processcontrols. Sampling and testing productsin the marketplace can also help inaddressing food safety hazards arising inpost-processing distribution of meat andpoultry products. However, the Agencydid not see a need for specific regulatoryrequirements concerning such sampling.

The alternative of mandatingadditional in-plant controls in lieu ofPQC prior approvals would result inprescriptive, command-and-controlrequirements and restrict the scope forestablishment food safety innovations,thereby defeating the purpose of thisrulemaking.

In-plant sampling of finishedproducts for chemical analysis also is apotential tool that FSIS has used toverify the effectiveness of in-plantcontrols. The Agency saw no need,however, for a specific regulatorymandate to conduct such sampling andanalysis.

FSIS chose the option of providinggeneral requirements for PQC programsthat establishments would have to meet.This option seemed to provideestablishments with the most flexibilityin implementing PQC programs and astandard applicable to a range ofprocesses.

Benefits of the RuleApproximately 6,200 federally

inspected meat and poultryestablishments will no longer berequired to submit blueprints, drawings,and specifications to FSIS for priorreview and approval. FSIS reviewed anestimated 2,100 to 2,900 submissions inFY 1994. The range of the estimate isattributable to the fact that anindeterminate number of blueprintswere returned to establishments andresubmitted to the Agency, some several

times, before being accepted. The cost ofreceiving FSIS approval for drawingsand specifications and changes theyrepresent includes the administrative,mailing, and labor costs associated withpreparing the required Agency forms.The labor cost is estimated at 30minutes for each submission. Assumingan hourly wage or per-hour salary of$20–$25 for each person submittingblueprints and specifications and theFSIS form, the annual cost to theindustry for making these submissionsis in the range of $21,000 to $40,000.This figure is an estimate of the savingsaccruing to industry by removing therequirement for prior approval.

As many as 1,500 establishments peryear submit for approval PQC programsor amendments to PQC programs. FSISreceives a total of 1,900 submissionseach year. A typical PQC program,prepared according to FSIS guidelines,can be written up in about 4 hours byan individual earning $20 to $25 perhour. Removing the requirement forprior approval of PQC plans is estimatedto save the industry $150,000 to$190,000 per year.

FSIS receives approximately 2,500submissions for approval of equipmenteach year. The cost of these applicationsgenerally falls on equipmentmanufacturers rather than the meat andpoultry firms subject to inspection,although a few meat and poultryestablishments make some of their ownequipment or equipment modifications.FSIS estimates that the costs tomanufacturers of applying forequipment approval are comparable tothe costs to establishments of submittingblueprint and establishmentspecification approvals. Based on 30minutes per submission, a labor cost of$20–$25 per hour, and 2,500submissions annually, the annual costsavings from removing the priorapproval requirement for equipmentwill be in the range of $25,000 to$32,500. In addition, approximately 650applications for approval are contingenton in-plant trials, which involve someadded costs to manufacturers and meatand poultry establishments. The Agencyhas no estimate of these costs to includein this analysis.

The elimination of blueprint priorapprovals will remove a source ofincome for approximately 20 smallfirms, known as ‘‘expediters,’’ thatrepresent official establishments for thepurpose of labeling and blueprintapproval. On the basis of informationsubmitted during the comment period,the Agency understands thatapproximately 35 percent (or about 735to 1,015) of the annual blueprintsubmissions to the Agency are made


using expediters. The estimated annualtotal value of blueprint expediting isabout $300,000 to $400,000 for thecompanies involved. Since the incomelost to the expediters will be transferredto meat and poultry firms, it is not a costof the final rule.

The benefits directly resulting fromthe elimination of prior approvalrequirements in accordance with thisrulemaking are indicated in Table 1.There also will be additional,unquantifiable benefits resulting fromfewer demands on establishmentmanagement, greater incentives to adoptinnovative practices, and the enhancedability to make changes quickly, whichthe prior approval system and itsinherent delays inhibit. Also, the delaysinherent in the prior approval process,which can be translated into lostproduction time, will be eliminated.

Moreover, it is unlikely that anyinspection finding of adulteratedproduct or insanitary conditions underthe amended regulations will result inincreased costs to the industry forrebuilding or remodeling facilities.Establishments planning substantialinvestments in new constructiontypically consult with local authoritiesand experts with up-to-date knowledgeof food establishment constructionbefore beginning major projects.

In addition to the benefits to firmsfrom eliminating these prior approvalrequirements, FSIS expects to benefit byreallocating about $2.3 million to highpriority food safety needs. Currently, theAgency allocates about 15 staff-years($750,000) to reviews of equipment, 20staff-years (about $1 million) to reviewsof drawings and specifications, and 11

staff-years ($550,000) to review andapproval of PQC programs. The truesocial benefits to be expected are theimprovements in food safety that willflow from reallocating these resources tomore important food safety-relatedtasks.

Costs of the Rule

As is currently the practice,establishments will continue to berequired to take corrective action orcease operations if any product has beenadulterated or prepared, packed or heldunder insanitary conditions whereby itmay have been contaminated with filthor may have been rendered injurious tohealth, because of deficient facilitiesand equipment. A finding of productadulteration or insanitary conditionswill entail corrective action which, insome cases, may involve reconstruction,remodeling, or redesign of facilities andequipment. However, it is unlikely thatthis rule will increase the level ofinspection findings that result in suchreconstruction, remodeling, or redesignprimarily because, as mentioned, mostestablishments consult withknowledgeable authorities before majorconstruction or installations. Also,proper operation of sanitation SOP’sand HACCP systems will reduce theoccurrence of adverse inspectionfindings.

Under existing regulatoryrequirements, facility and equipmentplans submitted to FSIS for priorapproval were rejected due either toerrors in paperwork or to deviation fromspecific design criteria developed byFSIS. Under the final rule,establishments will be permitted to

initiate and complete construction orintroduce new equipment withoutsubmitting any paperwork to FSIS. Inaddition, FSIS will eliminate design-related criteria currently utilized toevaluate the acceptability of facilitiesand equipment. Establishments will nothave to incur costs for reconstruction,remodeling, and redesign because thefacility or piece of equipment does notmatch a specified design criterion,blueprint, or equipment specification.

In the absence of prior approval, FSISwill focus inspection on whetherestablishments are maintaining asanitary environment. Under this finalrule and the Pathogen Reduction/HACCP regulations, establishments willassume greater control over theirproduction practices to ensure that asanitary environment is maintained.Currently, many establishments utilizethe services of architects, engineers, andother experts to design facilities andequipment for use in meat and poultryestablishments. Under the regulationsrequiring prior approval, these expertsensured, among other things, that FSISdesign specifications were met. Withoutprior approval, establishments mayrequire these experts to provide moreinformation on the proceduresnecessary for maintaining facilities andequipment in a sanitary condition,which could increase the costs for theseservices. However, this is consistentwith the need for the industry to assumegreater responsibility for its operations.Any cost increases for these serviceswill be commensurate with the transferof responsibility from FSIS to theindustry, and will not be a social costattributable to the rule.

TABLE 1.—BENEFITS TO FIRMS FROM ELIMINATING PRIOR APPROVAL REQUIREMENTS

ActionFirms with more

than 500employees

Firms with fewerthan 500

employeesAll firms

Information collec-tion burden reduc-

tion—all firms(in hours)

Remove blueprint and specification approval .......................... $1,260–2,400 $19,740–37,600 $21,000–40,000 701Remove equipment approval ................................................... 2,500–3,250 22,500–29,250 25,000–32,500 2,990Remove PQC approval ............................................................ 9,000–11,400 141,000–178,600 150,000–190,000 540

Total ............................................................................... 12,760–17,050 183,240–245,450 196,000–262,500 4,321

Regulatory Flexibility Assessment

The Administrator has determinedthat, for the purposes of the RegulatoryFlexibility Act (5 U.S.C. 601–12), thisfinal rule will not have a significanteconomic impact on a substantialnumber of small entities. The entitiesaffected by this final rule are inspectedmeat and poultry establishments,equipment suppliers, and companiesrepresenting official establishments to

the Agency for the purpose of obtainingblueprint approvals. Most of these aresmall entities.

The final rule is expected to have abeneficial effect on small and largeentities, on both those regulated underthe FMIA and PPIA and some that arenot regulated under the inspection lawsbut which are affected by the Agency’sreview of their products, e.g., suppliers

of equipment used in inspected meatand poultry establishments.

There are about 5,800 federallyinspected small establishments. In thisanalysis, FSIS is using the SmallBusiness Administration (SBA) businesssize standards (13 CFR 121.201) thatapply to meat packing establishments,establishments that produce sausagesand other prepared meats, and poultryslaughtering and processing


establishments. A small establishmentin any of these categories is consideredto be one with 500 or fewer employees.Under current regulations, allestablishments are required, as acondition of receiving inspection, tosubmit blueprints, drawings, andspecifications of new or remodeledfacilities to FSIS for review andapproval. Under this final rule,establishments will continue to incurthe cost of preparing blueprints andspecifications for construction andmajor installations. However, they willno longer bear the cost of submittingthese drawings and specifications to theAgency for review because therequirement to do so is beingeliminated.

The savings to be obtained byeliminating FSIS approval for drawingsand specifications and the changes theyrepresent includes the administrativeand mailing costs and the time(resources) required to fill out therequired Agency form (‘‘Submission andApproval of Plans and Specifications,’’FSIS–5200–S), which is estimated at 30minutes each submission. As mentionedabove, the annual savings to the meatand poultry products industry fromeliminating the requirement of makingthe submissions will be in theneighborhood of $21,000–40,000. FSISdoes not consider this savings to besignificant. In addition to these directsavings, the largest potential savings tothe industry from this final rule will bethose savings associated witheliminating delays—of up to severalweeks per submission—in obtainingapproval. This estimated delay includesthe time needed to resolvedisagreements over plans andspecifications, should suchdisagreements arise between the Agencyand the establishment. This savingscould be significant for some smallentities, but there is no information toindicate that it will be significant for asubstantial number of them.

The savings will not be significant forat least two reasons. First,establishments engaged in constructionprojects plan for the eventuality of anFSIS review, or at least are advised byknowledgeable food establishmentarchitects and engineers to build FSISreview time into their project timelines.Costs are minimized because delays thatdo occur are anticipated. Second, underthe current prior review and approvalsystem, the Agency is able to exercisediscretion expediting reviews ofblueprints and facilities in specific casesto prevent economic hardship fromoccurring.

Eliminating the cost of blueprint priorapprovals to small establishments

producing meat and poultry productswill necessarily remove a source ofincome for about 20 small expeditingfirms that represent officialestablishments for the purpose oflabeling and blueprint approvals. Theseexpediters are frequently able to shortenthe time for these approvals and reducethe rejection rate on submissionsbecause of their knowledge of Agencyrequirements and proximity to Agencyoffices. As mentioned above, theestimated annual total value ofblueprint expediting is about $300,000to $400,000 for the companies involved.This is a small part of the expediters’total business, which is mainly that ofexpediting label approvals andconsulting work. These firms may,however, experience an increaseddemand for their consulting servicesfrom inspected establishments whodepended upon the Government’s priorapproval to assure they were incompliance with the regulations, whonow need help from a third party toassure they are in compliance with theregulations. These 20 entities, in anyevent, do not constitute a substantialnumber of small entities.

The equipment acceptance procedureprincipally affects manufacturers orother vendors of equipment. Theequipment manufacturers range in sizefrom small to large concerns and, underthe current regulations, depend on FSISprior approval to be able to sell theirproducts to inspected establishments. Itis estimated that up to 90 percent of theequipment manufacturers and otherapplicants for FSIS equipmentacceptance are small entities. Accordingto the SBA small business sizestandards (13 CFR 121.201), a smallfood products machinery manufactureris one that employs 500 or fewer people.A substantial number of these smallentities, several hundred, will beaffected by this rule. As shown in Table1, equipment manufacturers andvendors that are classified as smallentities will save in the aggregatebetween $22,500 and $29,250 fromelimination of the cost of applying toFSIS for acceptance of equipment. Asindicated previously, equipmentmanufacturers and vendors will saveabout $10 to $12.50 per year on eachnew equipment model or utensil fromnot applying to FSIS for acceptance.FSIS does not consider this effect of therule to be significant, even if some firmshave submitted several applications peryear.

Also favorably affected by theapproval process are inspectedestablishments that may want to installnewly developed equipment or applynew technologies to improve their

operations. The savings from avoiding adelay before installation and operationof a newly developed piece ofequipment, although it could besignificant for a few entities, large orsmall, will not be significant for mostestablishments.

Finally, FSIS has determined that theelimination of prior approval of mostPQC programs will not have asignificant economic impact on asubstantial number of small entities.Although prior approval will beeliminated, both large and smallestablishments subject to FSISinspection will be permitted to continueto develop and implement PQCprograms for their products andprocesses. Accordingly, theadministrative delay for review thatoccurs under the present system will beeliminated.

It takes a minimum of 2 weeks for theAgency to review a typical PQCprogram, and as many as 1,500establishments per year submit suchprograms or amendments to programs—a total of nearly 1,900 submissions peryear—and about 90 percent of theseestablishments could be regarded assmall entities. Therefore, roughly 1,100establishments will avoid the costsassociated with having to wait aminimum of 2 weeks for PQC approval,but it is not possible to identify whatcosts would be saved under thesecircumstances.

For these reasons, the Administratorhas determined that this final rule willnot have a significant economic impacton a substantial number of smallentities. The economic impact on suchentities will, in most cases, involve theelimination of certain costs—somequantifiable, some not quantifiable—associated with doing business subjectto Federal regulation, and hence will bebeneficial to those entities. Though non-quantifiable, increasing the benefits thatcome from reducing an establishment’sdependence on Government decisions isan important objective of the final rule.

Paperwork RequirementsFSIS has reviewed the paperwork and

recordkeeping requirements in this finalrule in accordance with the PaperworkReduction Act. This final rule willsubstantially reduce ‘‘reporting’’requirements for official establishmentsand other entities. FSIS estimates thetotal reduction in reporting to be 4,231burden hours. The reductions will occurin the following information collectionreports:

♦ 0583–0082, ‘‘Meat and PoultryInspection; Application for Inspection,Sanitation, and EquipmentRequirements and Exemptions’’:


Establishments subject to inspectionwill no longer have to submit blueprintsand specifications along with FormFSIS–5200–5. The response time isestimated to be 30 minutes, and thereare 701 total burden hours approved bythe Office of Management and Budget(OMB) for this activity. Therefore, FSISwill request OMB to remove the 701approved burden hours.

♦ 0583–0082, ‘‘Meat and PoultryInspection; Application for Inspection,Sanitation, and EquipmentRequirements and Exemptions’’: FSISprior approval will no longer berequired for the products of equipmentcompanies that are used in officialestablishments. The response time isestimated to be 30 minutes for the priorapproval of equipment. There are 2,990total burden hours approved by OMBfor this activity. Therefore, FSIS willrequest OMB to remove the 2,990approved burden hours.

♦ 0583–0089, ‘‘ProcessingProcedures and Quality ControlSystems’’: Establishments can continueto develop and implement PQCprograms according to Agencyguidelines. These establishments, withthe exception of poultry irradiationfacilities, are no longer required tosubmit a letter requesting approval of aproposed PQC program and a copy ofthe program to the Agency for approvalprior to implementation. The responsetime is estimated to be 30 minutes forwriting the request letter and sendingthe PQC program to FSIS. There are 600total burden hours approved by OMBfor this activity. In consideration ofpoultry irradiation facilities, 60 hours ofburden will remain. FSIS does notforesee more than two irradiationfacilities requesting FSIS approval ofPQC programs. Therefore, FSIS willrequest OMB to remove 540 approvedburden hours. The burden hours forPQC program development andreporting remain the same.

List of Subjects

9 CFR Part 304

Drawings, Information to befurnished, Grant or refusal ofinspection, Meat inspection.

9 CFR Part 308

Meat inspection, Sanitation.

9 CFR Part 317

Meat inspection, Reporting andrecordkeeping requirements.

9 CFR Part 318

Meat inspection, Establishment-operated quality control.

9 CFR Part 319

Food grades and standards, foodlabeling

9 CFR Part 327

Imports, meat inspection

9 CFR Part 381

Poultry and poultry productsFor the reasons set forth in the

preamble, FSIS is amending 9 CFR Parts304, 308, 317, 319, 327, and 381 of theFederal meat and poultry inspectionregulations, as follows:

PART 304—APPLICATION FORINSPECTION; GRANT OR REFUSALOF INSPECTION

1. The authority citation for Part 304continues to read as follows:

Authority: 21 U.S.C. 601–695; 7 CFR 2.18,2.53.

2. Section 304.2 is amended byrevising the heading; removingparagraph (b); redesignating paragraphs(c) through (f) as paragraphs (b) through(e), respectively; and revising paragraph(a), to read as follows:

§ 304.2 Information to be furnished; grantor refusal of inspection.

(a) FSIS shall give notice in writing toeach applicant granted inspection andshall specify in the notice theestablishment, including the limits ofthe establishment’s premises, to whichthe grant pertains.* * * * *

PART 308—SANITATION

3. The authority citation for part 308continues to read as follows:


§ 308.2 [Removed and reserved]

4. Section 308.2 is removed andreserved.

5. Section 308.5 is amended byremoving ‘‘, in the judgment of theAdministrator,’’ from the first and thirdsentences of paragraph (a); removingparagraphs (b) through (f); redesignatingparagraph (g) as (b); and revising thesection heading to read as follows:

§ 308.5 Equipment and utensils to beeasily cleaned; those for inedible productsto be so marked; PCB-containingequipment.

* * * * *

PART 317—LABELING, MARKINGDEVICES, AND CONTAINERS



§ 317.21 [Amended]7. Paragraph (b) of § 317.21 is

amended by removing the words ‘‘anFSIS approved’’ and adding, in theirplace, the word ‘‘a’’.

PART 318—ENTRY INTO OFFICIALESTABLISHMENTS; REINSPECTIONAND PREPARATION OF PRODUCTS

8. The authority citation for part 318is revised to read as follows:

Authority: 7 U.S.C. 138f; 7 U.S.C. 450,1901–1906; 21 U.S.C. 601–695; 7 CFR 2.18,2.53.

9. Section 318.4 is amended to read asfollows:

a. Paragraph (d) is revised;b. The words ‘‘or Partial Quality

Control’’ are removed from the headingof paragraph (e);

c. Paragraph (e)(1) is amended byremoving the words ‘‘or (d)’’ from thefirst sentence and both occurrences ofthe words ‘‘or partial quality controlprogram’’ in the second sentence;

d. Paragraph (e)(2) is amended byremoving the words ‘‘or program’’ fromthe first and second sentences;

e. Paragraph (e)(3) is amended byremoving the words ‘‘or partial qualitycontrol program’’ from the firstsentence;

f. The words ‘‘or Partial QualityControl’’ are removed from the headingof paragraph (g);

g. Paragraph (g)(1) is amended byremoving the words ‘‘or a partial qualitycontrol program’’ and paragraph (g)(2) isamended by removing the words ‘‘orpartial quality control program’’; and

h. Paragraph (g)(3) is revised.The amendments and revisions read

as follows:

§ 318.4 Preparation of products to beofficially supervised; responsibilities ofofficial establishments; establishment-operated quality control.

* * * * *(d) Partial Quality Control Programs.

(1) Any owner or operator of an officialestablishment preparing meat foodproducts who is required to have aquality control program for a product,operation, or part of an operation shallmake the written program and data andinformation generated by the programavailable to Program employees.

(2)(i) This quality control programshall include, as appropriate for theproduct, operation, or part of anoperation which the program concerns,detailed information on: raw materialcontrol, the critical check or controlpoints, the nature and frequency of teststo be made, the charts and records that


will be used, the length of time suchcharts and records will be maintained inthe custody of the official establishment,the limits which will be used and thepoints at which corrective action will betaken to prevent recurrence of a loss ofcontrol, and the nature of the correctiveaction—ranging from the least to themost severe.

(ii) This quality control program shallensure that the product, operation, orpart of an operation which it concernsis in control and that applicable productor label limits are being met. Processcontrol is to be determined by generallyrecognized statistical process controlprocedures.

(e) Evaluation and Approval of TotalPlant Quality Control. (1) TheAdministrator shall evaluate thematerial presented in accordance withthe provisions of paragraph (c) of thissection. If it is determined by theAdministrator, on the basis of anevaluation, that the total quality controlsystem will result in finished productscontrolled in this manner being in fullcompliance with the requirements of theAct and regulations thereunder, the totalquality control system will be aprovedand plans will be made forimplementation under departmentalsupervision.

(2) In any situation where the systemis found by the Administrator to beunacceptable, formal notification shallbe given to the applicant of the basis forthe denial. The applicant will beafforded an opportunity to modify thesystem in accordance with thenotification.* * * * *

(3) The establishment owner oroperator shall be responsible for theeffective operation of the approved totalplant quality control system to assurecompliance with the Act andregulations thereunder. The Secretaryshall continue to provide the Federalinspection necessary to carry out hisresponsibilities under the Act.

(f) * * *(g) Termination of Total

Establishment Quality Control.(1) The approval of a total plant

quality control system may beterminated at any time by the owner oroperator of the official establishmentupon written notice to theAdministrator.

(2) The approval of a total plantquality control system may beterminated upon the establishment’sreceipt of a written notice from theAdministrator under the followingconditions:

(i) * * *(ii) * * *(3) If approval of the total

establishment quality control systemhas been terminated in accordance withthe provisions of this section, anapplication and request for approval ofthe same or a modified totalestablishment quality control systemwill not be evaluated by theAdministrator for at least 6 months fromthe termination date.* * * * *

10.–11. Section 318.7 is amended toread as follows:

a. Paragraphs (b)(3)(i) and (b)(3)(ii) of§ 318.7 are revised; and

b. In the table in § 318.7(c)(4) underthe Class of substance ‘‘Miscellaneous,’’the entry under the Substance ‘‘AscorbicAcid, erythorbic acid, citric acid,sodium ascorbate, and sodium citrate’’is revised.

The revisions read as follows:

§ 318.7 Approval of substances for use inthe preparation of products.

* * * * *(b) * * *(3) * * *(i) 100 ppm ingoing (potassium nitrite

at 123 ppm ingoing); and 500 ppmsodium ascorbate or sodium erythorbate(isoascorbate) shall be used; providedthat the establishment has a partialquality control program as provided in§ 318.4(d) that results in compliancewith this provision, or

(ii) A predetermined level between 40and 80 ppm (potassium nitrite at a levelbetween 49 and 99 ppm); 550 ppmsodium ascorbate or sodium erythorbate(isoascorbate); and additional sucrose orother similar fermentable carbohydrateat a minimum of 0.7 percent and aninoculum of lactic acid producingbacteria such as Pediococcus acetolactiior other bacteria demonstrated to beequally effective in preventing thegrowth of botulinum toxin at a levelsufficient for the purpose of preventingthe growth of botulinum toxin; providedthat the establishment has a partialquality control program as provided in§ 318.4(d) that results in compliancewith this provision.* * * * *

(c) * * *(4) * * *

Class of substance Substance Purpose Product Amount

* * * * * * *Miscellaneous ........ Ascorbic acid,

erythorbic acid,citric acid, so-dium ascorbateand sodium cit-rate, singly or incombinationunder qualitycontrol.

To delay discolora-tion.

Fresh beef cuts,fresh lamb cuts,and fresh porkcuts.

Not to exceed, singly or in combination, 500 ppm or 1.8mg/sq inch of product surface of ascorbic acid (in ac-cordance with 21 CFR 182.3013), erythorbic acid (inaccordance with 21 CFR 182.3041), or sodiumascorbate (in accordance with 21 CFR 182.3731); and/or not to exceed, singly or in combination, 250 ppm or0.9 mg/sq inch of product surface of citric acid (in ac-cordance with 21 CFR 182.6033), or sodium citrate (inaccordance with 21 CFR 182.6751).

* * * * * * *

* * * * *

§ 318.19 [Amended]

12. Paragraph (e) of § 318.19 isamended in the first sentence byremoving the words ‘‘total’’ and ‘‘partialquality control’’.

§ 318.308 [Amended]

13. Paragraph (b) of § 318.308 isamended by removing the words ‘‘an

approved’’ and ‘‘program’’ andparagraph (c) is amended by removing‘‘and submitted to the Administrator forapproval’’.

14. Paragraph (a) of § 318.309 isamended by removing the words ‘‘anapproved’’ and ‘‘program’’ andparagraphs (b) and (c) of § 318.309 isamended by removing ‘‘and submittedto the Administrator for approval’’.

PART 319—DEFINITIONS ANDSTANDARDS OF IDENTITY ORCOMPOSITION


Authority: 7 U.S.C. 450, 1901–1906; 21U.S.C. 601–695; 7 CFR 2.18, 2.53.

16. Section 319.5 is amended byrevising the first two sentences ofparagraph (e)(2) to read as follows:


§ 319.5 Mechanically Separated (Species).

* * * * *(e) * * *(2) A prerequisite for label approval

for products consisting of or containing‘‘Mechanically Separated (Species)’’ isthat such ‘‘Mechanically Separated(Species)’’ shall have been produced byan establishment under anestablishment quality control system.* * * * *

§ 319.104 [Amended]

17. The last sentence in footnote 3 tothe chart in § 319.104 is amended byremoving the words ‘‘approved by theAdministrator under § 318.4 of thissubchapter.’’

§ 319.105 [Amended]

18. The last sentence in footnote 2 tothe chart in § 319.105(a) is amended byremoving the words ‘‘approved by theAdministrator under § 318.4 of thissubchapter.’’

PART 327—IMPORTED PRODUCTS



20. Paragraph (d) of § 327.6 is revisedto read as follows:

§ 327.6 Products for importation; programinspection, time and place; application forapproval of facilities as official importinspection establishment; refusal orwithdrawal of approval; official numbers.

* * * * *(d) Approval for Federal import

inspection shall be in accordance withpart 304 of this subchapter.* * * * *

PART 331—SPECIAL PROVISIONSFOR DESIGNATED STATES ANDTERRITORIES; AND FORDESIGNATION OF ESTABLISHMENTSWHICH ENDANGER PUBLIC HEALTHAND FOR SUCH DESIGNATEDESTABLISHMENTS



22. Paragraph (a) of § 331.3 is revisedto read as follows:

§ 331.3 States designated under paragraph301(c) of the Act; application of regulations.

* * * * *(a) Each establishment located in such

a designated State, shall be grantedinspection required under § 302.1(a)(2)of this subchapter only if it is found,upon a combined evaluation of its

premises, facilities, and operatingprocedures, to be capable of producingproducts that are not adulterated ormisbranded.* * * * *

PART 381—POULTRY PRODUCTSINSPECTION REGULATIONS


Authority: 7 U.S.C. 138f; 7 U.S.C. 450,1901–1906; 21 U.S.C. 451–470; 7 CFR 2.18,2.53.

24. Section 381.19 is revised to readas follows:

§ 381.19 Application for inspection;irradiation facilities.

All applicants for inspection whoseoperations include irradiation and otherprocessing shall submit, to theAdministrator, a proposed qualitycontrol system as provided in § 381.149of this part.

25. Section 381.20 is revised asfollows:

§ 381.20 Survey and grant of inspection.(a) Before inspection is granted, FSIS

shall survey the establishment todetermine if the construction andfacilities of the establishment are inaccordance with the regulations. FSISwill grant inspection, subject to§ 381.21, when these requirements aremet.

(b) FSIS shall give notice in writing toeach applicant granted inspection andshall specify in the notice theestablishment, including the limits ofthe establishment’s premises, to whichthe grant pertains.

26. Section 381.53 is amended byremoving paragraphs (a)(2) through(a)(5) and paragraph (b); redesignatingparagraphs (c) through (m) asparagraphs (b) through (l), respectively;and redesignating paragraph (a)(1) asparagraph (a) and revising it to read asfollows:

§ 381.53 Equipment and utensils.(a) Equipment and utensils used for

processing or otherwise handling anyedible poultry product or componentingredient shall comply with applicableprovisions of paragraphs (b) through (l)of this section and otherwise shall be ofsuch material and construction as willfacilitate their thorough cleaning, ensurecleanliness in the preparation andhandling of all edible poultry products,and avoid adulteration and misbrandingof such products. In addition to theserequirements, equipment and utensilsshall not in any way interfere with orimpede inspection procedures.Receptacles used for handling inedible

products shall be of such material andconstruction that their use will notresult in adulteration of any edibleproduct or in unsanitary conditions atthe establishment, and they shall bearconspicuous and distinctive marking toidentify them as only for such use andshall not be used for handling anyedible poultry products.* * * * *

§ 381.121d [Amended]27. Paragraph (b) of § 381.121d is

amended by removing the words ‘‘anFSIS approval’’ and adding, in theirplace, the word ‘‘a’’.

28. Section 381.145 is amended toread as follows:

a. Paragraph (d) of § 381.145 isrevised;

b. The words ‘‘Programs or’’ areremoved from the heading of paragraph(e);

c. Paragraph (e)(1) is amended byremoving the words ‘‘or (d)’’ from thefirst sentence and both occurrences of ‘‘,partial quality control program,’’ fromthe second sentence;

d. Paragraph (e)(2) is amended byremoving the words ‘‘or program’’ fromthe first and second sentences;

e. Paragraph (e)(3) is amended byremoving ‘‘, partial quality controlprogram,’’ from the first sentence;

f. The words ‘‘Programs or’’ areremoved from the heading of paragraph(g);

g. Paragraph (g)(1) is amended byremoving the words ‘‘or a partial qualitycontrol program’’;

h. Paragraph (g)(2) introductory text isamended by removing ‘‘, partial qualitycontrol program,’’ and paragraph(g)(2)(ii) is amended by removing thewords ‘‘or program’’ from the firstsentence; and

i. Paragraph (g)(3) is revised.The amendments and revisions read

as follows:

§ 381.145 Preparation of products to beofficially supervised; responsibilities ofofficial establishments; establishmentoperated quality control.

* * * * *(d) Partial Quality Control Programs.

(1) Any owner or operator of an officialestablishment preparing poultryproducts who is required to have aquality control program for a product,operation, or part of an operation shallmake the written program and data andinformation generated by the programavailable to Program employees.

(2)(i) This quality control programshall include, as appropriate for theproduct, operation, or part of anoperation which the program concerns,detailed information on: raw material


control, the critical check or controlpoints, the nature and frequency of teststo be made, the charts and records thatwill be used, the length of time suchcharts and records will be maintained inthe custody of the official establishment,the limits which will be used and thepoints at which corrective action will betaken to prevent recurrence of a loss ofcontrol, and the nature of the correctiveaction—ranging from the least to themost severe.

(ii) This quality control program shallensure that the product, operation, orpart of an operation which it concernsis in control and that applicable productor label limits are being met. Processcontrol is to be determined by generallyrecognized statistical process controlprocedures.

(e) Evaluation and Approval ofQuality Control Systems.

(1) The Administrator shall evaluatethe material presented in accordancewith the provisions of paragraph (c) ofthis section. If it is determined by theAdministrator on the basis of anevaluation, that the total quality controlsystem will result in finished productscontrolled in this manner being in fullcompliance with the requirements of theAct and regulations thereunder, the totalquality control system will be approvedand plans will be made forimplementation under departmentalsupervision.

(2) In any situation where the systemis found by the Administrator to beunacceptable, formal notification shallbe given to the applicant of the basis forthe denial. The applicant will beafforded an opportunity to modify thesystem in accordance with thenotification.* * * * *

(3) The establishment owner oroperator shall be responsible for theeffective operation of the approved totalplant quality control system or qualitycontrol system for irradiation facilitiesto assure compliance with therequirements of the Act and regulationsthereunder.* * * * *

(f) * * *(g) Termination of Total

Establishment Quality Control.(1) The approval of a total plant

quality control system may beterminated at any time by the owner oroperator of the official establishmentupon written notice to theAdministrator.

(2) The approval of a total plantquality control system or quality controlsystem for irradiation facilities may beterminated upon the establishment’sreceipt of a written notice from the

Administrator under the followingconditions:

(i) * * *(ii) If the establishment fails to

comply with the quality control systemto which it has agreed after beingnotified by letter from the Administratoror his designee.* * * * *

(3) If approval of the totalestablishment quality control systemhas been terminated in accordance withthe provisions of this section, anapplication and request for approval ofthe same or a modified totalestablishment quality control systemwill not be evaluated by theAdministrator for at least 6 months fromthe termination date.* * * * *

29. Paragraph (a) of § 381.222 isrevised to read as follows:

§ 381.222 States designated underparagraph 5(c) of the Act; application ofregulations.

* * * * *(a) Each establishment located in such

a designated State, shall be grantedinspection required under § 381.6(b)only if it is found, upon a combinedevaluation of its premises, facilities, andoperating procedures, to be capable ofproducing products that are notadulterated or misbranded.

§ 381.308 [Amended]30. Paragraph (b) in section 381.308 is

amended by removing ‘‘an approved’’and ‘‘program’’ and paragraph (c) isamended by removing ‘‘and submittedto the Administrator for approval’’.

§ 381.309 [Amended]31. Paragraph (a) of § 381.309 is

amended by removing the words ‘‘anapproved’’ and ‘‘program’’ andparagraphs (b) and (c) of § 381.309 isamended by removing ‘‘and submittedto the Administrator for approval’’.Done, at Washington, DC, August 11, 1997.Thomas J. Billy,Administrator.

Note: The following appendices will notappear in the Code of Federal Regulations.

Appendix A—Guidance onEstablishment Facilities and Equipment

OVERVIEW

This Guidebook is intended for use bymeat and poultry establishments inconsidering decisions about design andconstruction of their facilities, as well asthe selection of equipment to be used intheir operations. The material that formsthe basis for this Guidebook is drawnprincipally from technical knowledgeand experiences used by the Food

Safety and Inspection Service in makingits prior approval decisions about theacceptability of facilities andequipment.

The Agency is no longer making theseprior approval decisions for inspectedestablishments; however, the technicalconsiderations on which those decisionswere based may be of interest toestablishments in the future. That is thematerial which is reflected in thisGuidebook.

Chapter 1

LOCATION

Selecting the location for yourestablishment is an important factor inproviding a sanitary environment forproducing meat and poultry products.When selecting a location, you willneed to consider the physicalenvironment of the site, accessibility,separation of your premises from otherbusinesses, common areas shared byyou and other establishments, andwhether or not you will conductuninspected businesses such as retailstores or custom slaughter on or nearyour premises. This chapter providesguidelines you may wish to considerwhen the select a location for yourestablishment.

1. Site

The size of the site should allow forall buildings, parking lots, access roads,and future expansion. The site shouldbe large enough to accommodate apotable water supply for yourprocessing needs, and a sewage systemthat can efficiently handle liquid wasteand process water created by yourestablishment. In addition, potentialbuilding locations should be evaluatedfor sanitation hazards. In determiningthat possibility, consider the followingguidelines:

* To the extent possible,establishments should be located inareas free of industries that attractvermin such as sanitary landfills andjunk yards.

* To the extent possible,establishments should be located inareas free of odors and airborneparticulate matter that may be producedby neighboring industries or otheroutside sources, such as oil refineries,trash dumps, chemical plants, sewagedisposal plants, dyeworks, and paperpulpmills.

* The prevailing winds are animportant factor in site determinationbecause substances emanating frommore distant sources may be a problemif the winds carry them to theestablishment site.


2. Separation of Official and Non-Official Establishments

Sometimes an establishment islocated next to or in the same buildingas other businesses which are not underFSIS inspection. In those circumstancesyou should take great care to keepproduct from becoming contaminatedfrom the operation of the adjoiningbusiness.

Chapter 2

LAYOUT

One of the most important decisionsyou make in building or modifying anestablishment is how you plan thelayout of your building, including theplacement of rooms and equipment,product flow and people traffic patterns.Not only does a poorly designedestablishment affect your productivity,but it may result in congestedoperations that can lead to unsanitaryconditions. This chapter providesguidelines that you may wish toconsider in planning any modificationsto your existing establishment or inbuilding a new one.

1. Flow of Operations

The direction in and means by whichproduct moves or flows within a plantis an important but often neglectedconsideration that can have enormousinfluence on sanitation and the safety offinished products. From a product flowstandpoint, all raw meat and poultryproducts ought to be considered aspotentially microbiologicallycontaminated and handled accordingly.Product being processed should flowprogressively from highest potentialexposure to contamination to the leastpotential exposure to contamination,with intervening processes designed toremove or otherwise reduce thecontaminants whenever possible. Theflow of air and people should be just theopposite, moving from the cleanestareas progressively toward less cleanareas.

When designing product flow,consider the following:

* Moving product from raw to finalcooked product areas to systematicallyreduce the risks of contamination alongthe way.

* Locating trash dumpsters andreceptacles so that they do not create arisk of product contamination.

* Selecting rooms large enough topermit the installation of all necessaryequipment with space for establishmentoperations and inspection.

* Locating people passageways toprovide maximum clearance toproducts, work areas, and productionequipment.

* Keeping truckways unobstructed.

2. People Traffic Flow

Inadequate control of the flow ofpeople through product operationalareas is one of the most serious risks forproduction contamination. People canact as carriers and bring from theoutside contaminants such as dirt,debris, and vermin which are idealvectors for microbiological growth andwhich can both directly and indirectlycontaminate product. Ways in whichyou can reduce and control the flow ofpeople include the following:

* Establishment design should notrequire personnel not routinely assignedto specific work areas to be routedthrough those work areas. For example,personnel working in the live animalareas should not be required to travelthrough cooked product areas to usewelfare rooms.

* Welfare rooms, such as toiletrooms, dressing (locker) rooms, andcafeterias, should be designed tominimize contamination because of thetraffic patterns of the people.

3. Separation of Raw and Ready-to-EatProduct

Cross contamination of ready-to-eatproduct by raw products may occur ifthe layout does not provide forseparation of these products. To preventcross contamination in the preparationof products, the following are guidelinesfor you to consider:

* Exposed cooked product areasshould be physically separated fromother areas of the establishment. Non-pedestrian passage openings may bepresent for the transfer of product orsupplies.

* A ventilation system should beused to direct air flow away fromexposed cooked product areas.

* Environmental control equipmentsuch as fans and evaporatorcondensation pans should not belocated above the product.

* Welfare rooms, dry storage,maintenance, box/carton make up,packaging, and palletizing areas shouldbe separate, but adjacent to, the exposedcooked product rooms.

* Cooked product should be coveredin rigid containers to protect it fromcontamination while in storage.

* Separate coolers and/or freezersshould be available to use for exposedcooked product.

* All cooking apparatuses forexposed products should have separateentry and exit portals.

* No cooked product wash orreconditioning sinks should be used.

4. Perishable Product Rooms

Special care should be taken inperishable product rooms to inhibitgrowth of microorganisms in operationswhich could contaminate product. Inaddition, care should be taken toprevent contamination from otheroperations such as where rawingredients are prepared. Non-meat ornon-poultry ingredients should beprepared in a room or rooms separatefrom meat or poultry processing rooms.For example, preparation of rawvegetables for use in product should beperformed in a room separate from meator poultry processing rooms.

5. Edible and Inedible Products Roomsand Areas

Edible product can be easilycontaminated by contact with inedibleproducts, grease or sewage frominedible product areas. In order toprevent this contamination fromoccurring, consider the following in theplacement of these rooms:

* The flow of inedible andcondemned product should be designedso that it does not come into contactwith edible product.

* An inedible products departmentshould be separate and distinct from theareas used for edible products. Inedibleproduct rooms, grease interceptors, andsewage treatment equipment must belocated away from edible productrooms.

* Hooded, closed chutes that leaddirectly from the slaughter room to theinedible handling room are designed toprevent objectionable odors frominedible and condemned products fromentering edible products rooms.

* If rendering facilities are notavailable at the establishment watertightstorage facilities should be provided tohold these products before their removalto rendering plant. These storagefacilities should be separate and apartfrom edible products rooms, andconstructed to prevent unsanitaryconditions including attraction orharborage for vermin.

* Areas for inedible trucks should bepaved and enclosed for ease of cleaningand to control odors and vermin.

* Where necessary, the boiler roomshould be a separate room to preventdirt and objectionable odors enteringfrom it into rooms where meat productsare processed or handled.

6. Byproducts for Use in Animal, Pet, orFish Food

Establishments that processbyproducts into animal, pet, or fish foodshould provide rooms fordecharacterizing, chilling, packaging, or


otherwise preparing the byproducts.Consider the following guidelines whendesigning and constructing these rooms:

* Byproducts to be used as animal,pet, or fish food should be storedseparately to prevent crosscontamination and commingling withedible products.

7. Coolers and Freezers

Coolers and freezers need to haveenough space to refrigerate and storeproduct. Product should be stored in amanner that will preclude conditionswhich may lead to contamination ofproduct. The following guidelines willassist you in preventing conditionswhich could lead to contamination ofyour product:

* Coolers and freezers, includingdoors, should be constructed ofmaterials that can be readily andthoroughly cleaned, and durable, rigid,impervious to moisture, non-toxic, andnon-corrosive. Freezer doors should beconstructed and installed to preventaccumulation of frost.

* Coolers and freezers should beequipped with floor racks, pallets orother means to ensure protection ofproduct from contamination from thefloor.

8. Dry Storage

Packaging materials and ingredientsshould be stored to preclude conditionswhich may lead to contamination ofproduct. The following are guidelineswhich may assist you in the planning ofyour dry storage area:

* Dry storage materials should bestored in a room dedicated to drystorage only.

* The dry storage area should beconstructed so that racks can be spacedaway from the walls and passagewaysmaintained between rows. Thisfacilitates cleaning of the area. Inaddition, the construction should allowfor all meat or poultry ingredients and/or packaging materials to be stored inclosed containers on racks or pallets.

9. Incubation Room for CannedProducts

A room or incubator for incubatingsamples of fully-processed canned meator poultry must be provided in allestablishments conducting regularcanning operations. Consider thefollowing guidelines when building thisroom:

* An accurate time/temperaturerecorder must be provided. To preventtemperature variations, a means for aircirculation should be provided.

* Shelves should be provided to holdcanned product. The shelves should bemade of expanded metal or heavy gauge

wire mesh and be removable forcleaning.

* The floor in the room should bepitched to a floor drain equipped witha removable screw-plug.

* The door of the room should beequipped for sealing by the inspector, ifnecessary.

10. Vehicular Areas Outside theBuilding

Special care should be given in thedesign of vehicular areas outside yourbuilding, not only to provide room fortrucks and other vehicles to operatewithout damaging your building, but toprevent unsanitary conditions whichmight contaminate product in yourestablishment. You should consider thefollowing in designing your vehicularareas:

* Areas outside the building wherevehicles are loaded or unloaded shouldbe paved with concrete or a similar hardsurface. Hard surface areas allow theseareas to be kept clean and eliminate thepotential for water puddles or dust.

* Areas outside the building wherevehicles are loaded or unloaded shouldbe drained. Drainage from the loadingdocks should be confined to theimmediate area of the dock.

* The vehicular areas should be largeenough to accommodate the turningradius of the largest trucks or shippingvehicles used by the establishment.

* The vehicular areas adjacent to theestablishment should have hoseconnections for cleaning.

Chapter 3

WELFARE FACILITIES FORESTABLISHMENT EMPLOYEES

One source of potential contaminationof product is cross contamination fromemployee welfare facilities. In designingand locating employee facilities, greatcare should be given to preventingovercrowding and congestion and toproviding enough handwash sinks andtoilets for your employees. This chapterprovides additional guidelines that youmay wish to consider in making anymodifications to or building any welfarefacilities for your employees.

1. Dressing (Locker) Rooms

Dressing rooms must be provided foremployees. In addition to privacyconsiderations, these dressing roomsshould be located where they will notbe a potential source of crosscontamination of product. Consider thefollowing guidelines for these dressingrooms:

* Dressing rooms should be separatefrom rooms or compartments whereproduct is prepared, stored, or handled.

* Dressing rooms should be separatedfrom the toilet area.

* Separate dressing rooms should beprovided for each sex if both sexes areemployed by the establishment.

* Dressing rooms should haveabundant, well-distributed light of goodquality.

* Separate dressing rooms for rawproduct and other product departmentemployees will help prevent crosscontamination of product.

* Receptacles for soiled clothingshould be provided adjacent toemployees’ dressing rooms.

2. LockersLockers should be provided for

employees clothing and personal items.To prevent insanitary conditions,consider the following guidelines whenchoosing the type of lockers and thearrangement and locations for them:

* To prevent the potential for crosscontamination, the location of lockersshould be separate from rooms orcompartments where product isprepared, stored, or handled.

* Lockers should be large enough tostore a change of clothing and otherpersonal items.

* For ease of cleaning, lockers shouldbe constructed of materials that arerigid, durable, non-corrosive, easilycleaned and inspected, impervious tomoisture, a light, solid color, with asmooth or easily cleaned texture, andhave sloping tops.

* Lockers should either be installedso that there is enough room under themthat they can be easily cleaned andinspected, or they should be sealed tothe floor.

3. Drinking FountainsSanitary drinking water fountains

should be provided. Consider thefollowing guidelines when installingdrinking water fountains:

* Drinking water fountains should beprovided at convenient locationsthroughout the establishment tominimize the distance that employeesneed to travel to reach a fountain. Thisis especially important in preventingcross-contamination from employeesworking in raw or inedible areas andtraveling to processing or ready-to-eatareas to use a fountain. Consider thefollowing locations for placing drinkingfountains:

** welfare areas including cafeterias,dressing (locker) rooms, and toiletrooms

** inspectors’ offices** edible product areas including kill

floor, deboning, and cut-up areas** inedible product areas** immediately outside freezers and

coolers


** storage areas* Drinking water fountains should be

connected to the potable water supplyand either directly connected to theunderfloor drainage system or shoulddischarge through an air gap to a hubdrain.

* Drinking water fountains should beother than hand operated, and if placedas part of handwash sink, should belocated high enough to avoid splashfrom the sink.

4. Toilet Rooms

Toilet rooms can easily become asource of potential contamination ofproduct. Care should be taken in thedesign of these rooms from theirlocation in the establishment’s layout tothe number of toilets provided. Considerthe following guidelines:

* Toilet rooms need to be separatedfrom the rooms and compartments inwhich products are prepared, stored, orhandled.

* Toilet rooms that open directly intorooms where meat products are exposedshould have self-closing doors andshould be ventilated to the outside ofthe building.

* Toilet rooms should be arranged sothey are entered through an interveningdressing room or vestibule and notdirectly from a production or storageroom.

5. Eating Rooms and Areas

To prevent employees fromcontaminating products orcontaminating their food withmicroorganisms from the raw productsor from their working environmentconsider the following:

* Separate eating rooms or areasshould be provided for employees.

6. Handwash Sinks

One of the most important steps youcan take to prevent cross contaminationof product by your employees is toprovide conveniently located handwashsinks. Handwash sinks are needed intoilet rooms, dressing (locker) rooms,and production rooms. Consider thefollowing guidelines when makingdecisions as to where you need ahandwash sink:

* Handwash sinks are needed neartoilet rooms and dressing (locker)rooms. They should be other than handoperated. There should be hot and coldrunning water, soap, and towels. Singleuse towels should be used.

* Handwash sinks in welfare roomsand areas should have a combinationmixing faucet delivering both hot andcold water with an high enough abovethe rim of the bowl to enable thewashing of arms as well as hands.

7. Ventilation

In designing your welfare rooms, suchas toilet and dressing rooms, careshould be taken to make sure that theyare ventilated to prevent odors fromentering production areas. Consider thefollowing guidelines:

* Welfare rooms that are not airconditioned should be mechanicallyventilated through an exhaust fan takingair to the outside. Airflow from welfarerooms should be released outside theestablishment.

* Toilet and dressing rooms that arelocated where no natural ventilation isavailable should be equipped with anexhaust fan (activated by a commonswitch with the lighting in the area) anda duct leading to the outside. Doors todressing and toilet rooms ventilated inthis manner should have a louveredsection about 12 inches by 12 inchesminimum in the lower panel to facilitateairflow.

8. Employees Working in InedibleProduct Areas

Association of employees working ininedible product areas with otheremployees through common welfarerooms increases the risk of cross-contamination of product. To minimizethis risk to product, consider thefollowing guidelines:

* Separate welfare rooms foremployees working in areas such ashide cellars, condemned or inedibleproduct rooms, or live animal holdingareas, from welfare rooms of otheremployees working with raw or heatprocessed, exposed, edible product.

Chapter 4

CONSTRUCTION

A frequently overlooked area ofconstruction design is the selection ofappropriate construction materials forthe establishment. This chapterprovides guidelines for construction andthe selection of construction materialsthat you may wish to consider whenmaking modifications to your currentestablishment or building a new one.

1. Building Construction Materials forRooms (Finished Surfaces)

Production and storage areas need tobe constructed with materials that arereadily and thoroughly cleaned. Productin production and storage areas is at riskfor contamination from indirect contactwith materials used for construction ofthe building. In order to be readily andthoroughly cleaned, buildingconstruction materials in productionand storage areas must be:

* Rigid and durable.* Non-toxic and non-corrosive.

* Impervious to moisture.* A light, solid color such as white.* Smooth or textured with an easily

cleaned, open pattern, for example, apattern where the veins and depressedareas are continuous or have an outletand are not enclosed.

In addition, consider the followingguidelines for selecting constructionmaterials:

* In non-production and non-storageareas, building construction materialsshould be easy to clean thoroughly.

* Special consideration should begiven before using wood as aconstruction material.

** Wood is absorbent and can absorbnot only water but other substancesincluding chemicals that create a riskfor contamination of meat or poultryproducts.

** Wood is easily damaged and maycreate wood particles (splinters) thatcontaminate meat or poultry products.

** If wood is used as a constructionmaterial in exposed product areas of theofficial establishment, it isrecommended that the wood be milledsmooth and completely sealed with acoating to prevent the wood fromadulterating meat or poultry product.The coating should be able to be readilyand thoroughly cleaned durable, rigid,impervious to moisture, non-toxic, andnon-corrosive.

** The use of hot linseed oil to treator coat wood in exposed product areasis not recommended because itpromotes the growth of molds andfungi.

2. Floors

In addition to any obvious debris ona floor, product can becomecontaminated by the flooring ormicroorganisms living in debris in tinycrevices in the floor. In order to avoidthese sources of contamination,consider the following guidelines whenselecting and installing flooring in yourestablishment:

* Floors in areas where product ishandled or stored should be constructedof durable, easily cleanable materials,and be impervious to moisture.Commonly used materials are concrete,quarry tile, brick, and syntheticmaterial.

* Floors should be installed andmaintained to reduce the likelihood ofcracks, depressions, or other low areasthat would accumulate moisture.

* Floors where operations areconducted should have a slip-resistantsurface. Good results are obtained byusing brick or concrete floors withabrasive particles embedded in thesurface. Concrete floors should have arough finish.


* Floors should be sloped to avoidpuddles or depressions within the slopewhere water will stand.

3. Coving/Curbs

Coving is used at the wall-floorjuncture, column (post)—floor juncture,and equipment support-floor juncture toprovide a smooth transition for ease ofcleaning and inspection. Consider thefollowing guidelines when using covingor curbs:

* Coving in production and storageareas should include the followingcriteria:

** All seams should be tight-fittingand sealed to eliminate all cracks andcrevices which may shelter insects,vermin, and microorganisms.

** The coving should eliminate anysharp angles that allow theaccumulation of materials.

* Curbs should be provided to protectwalls and wall finishes. Curbs should behigh enough to protect the walls frompallets, trucks, or containers used in theestablishment. Coving should beprovided at the base of the curb.

4. Stairs

In selecting stairs consider thefollowing:

* Stairs should have solid treads andclosed risers and should have side curbsof similar material.

5. Catwalks and Access Platforms

When installing catwalks and accessplatforms consider the followingguidelines:

* Catwalks and access platforms inedible product handling departmentsshould be constructed of materials thatmeet the same guidelines as flooring.

* Open grating should not be used forthe flooring of catwalks and accessplatforms inside the establishment,particularly in production areas. Dirtand other debris from shoe soles can bescraped off by the grating andcontaminate product, packagingmaterial, and equipment.

* Catwalks and access platformsshould not be installed over productionlines and processing equipment.

6. Interior Walls Including Posts andPartitions

To prevent product from becomingcontaminated by contact with interiorwalls, care needs to be taken inselection of materials for the finishedsurface of walls. Consider the followingwhen selecting a finish:

* Interior walls, in areas whereproduct is stored or handled, should befinished with materials that will makethem susceptible to being readily andthoroughly cleaned and impervious to

moisture. Examples of such materialsare glazed brick, glazed tile, smoothconcrete, and fiberglass reinforcedplastic (FRP).

* Walls should have a smoothtexture, not one that is rough or uneven.

* Fasteners for wall covering materialshould be solid, smooth headed, and nothave recesses which allows thecollection of foreign material.

7. Ceilings

Ceilings, in areas where product isstored or handled, should beconstructed to prevent the collection ofdirt or dust that might sift through fromthe areas above or fall from overheadcollecting surfaces onto equipment orexposed products. Therefore, it isrecommended that ceilings andoverhead structures be maintained freeof sealing paint or plaster, dust,condensate, leaks, and other materialsor defects. In addition, ceilings in areaswhere product is stored or handledshould be constructed and finished withmaterials that can be thoroughly cleanedand are moisture resistant. Examples ofsuch materials are smooth concrete andfiberglass reinforced plastic.

8. Windows and Skylights

Windows (and skylights) can be apotential source of contamination ofproduct by dirt, water, debris, or brokenglass. Consider the following whenselecting and installing windows:

* All outside windows, except forthose in receiving and feed rooms,should have protection to excludeinsects, birds, and other vermin.

* Window ledges should be slopedabout 45 degrees to prevent theaccumulation of dirt, water, or debris.

* To avoid damage to window glassfrom impact of hand trucks and similarequipment, the sills should be at least3 feet above the floor.

* Windows that are installed in wallsin exposed product rooms should havepanes of acrylic or polycarbonate plasticor other shatter-proof material.

9. Doorways and Doors (General)

Doors are barriers that allow themovement of product and people, butalso present a barrier to contaminationsuch as dirt, insects, and other verminas well as the microbiological hazardsthat they carry. The door type,construction material, and room inwhich the door is located are allimportant considerations when doorsare installed in the establishment. Doorsare important in maintaining sanitaryconditions especially in production andstorage areas. In production and storageconsider the following guidelines fordoors:

The most effective doors have thefollowing characteristics:

* They are impervious to moisture.* They are tight fitting to minimize

air exchange and to prevent the entry ofinsects and vermin into theestablishments.

* They are self-closing and usedthroughout the establishment, especiallyin areas where toilet rooms opendirectly into rooms where meat andpoultry are exposed, to preventcontamination of products with odorsand their associated contaminants.

* They are high and wide enough toallow the movement of exposed productthrough the doorways without it cominginto contact with the door or jamb.

* They are rigid and durable, and thejunctions at jambs, walls, and floors aresealed to eliminate all cracks andcrevices for debris, insects, and dirt tocollect.

* Doors that open directly to theoutside of the building from productionrooms should have an interveningclosed space, such as a vestibule orenclosed lock, to prevent the directaccess of contaminants and microbialorganisms to areas inside theestablishment.

10. Types of Doors

In selecting a type of door for yourestablishment you need to consider thelocation of the door and whether or notproduct will be traveling through it. Thefollowing guidelines for different typesof doors may be useful to you whenselecting a door:

* The horizontal double-swinging,impact door is a bi-parting, inflexiblepanel door with plastic windows (visionpanels) that swings only in thehorizontal plane. If you select this door,consider the following:

** This door may be useful in roomswith dimensions that would not permitthe use of a roll-up, vertical sliding orhorizontal sliding door.

** Because this door must bemanually opened, the door can bedamaged creating sanitation andmaintenance problems.

* The horizontal sliding door(manual and automatic) is a single or bi-parting, inflexible door that moves onlyin the horizontal plane. If you select thisdoor, consider the following:

** This door may be useful in roomswith dimensions that would not permitthe use of a roll-up or vertical slidingdoor.

** The automatic opening option isrecommended not only for sanitationreasons, but it also prevents damage.

* The vertical sliding door (manualor automatic) is a single, inflexiblepanel door that moves only in the


vertical plane. If you select this door,consider the following:

** This door may be useful in roomswith dimensions that would not permitthe use of a roll-up or horizontal slidingdoor.

** The automatic opening option isrecommended not only for sanitationreasons, but it also prevents damage.

* The overhead garage-type door(manual or automatic) is a hinged,multi-paneled door that moves from thevertical to the horizontal plane. If youselect this door, consider the following:

** This door may be an excellentchoice for sheds or buildings used tostore equipment, such as a lawn mower,that is used for the outside maintenanceof the establishment’s property.

** It is recommended that these typesof doors not be used in exposed productareas or areas subject to wet clean-upbecause these doors have spacesbetween the panels that allow thecollection of product, such as meat andfat, as well as contaminants.

* The roll-up door (manual orautomatic) is a single flexible panel doorthat moves only in the vertical planeand when open, coils tightly onto adrum assembly. If you select this door,consider the following:

** This door can be an excellentalternative especially where space foropening a door is limited.

** Several additional features shouldbe installed on this type of door to makeit an effective barrier againstcontamination.

* The air curtain or air door is a doorthat uses a layer of air generated bymechanical fans to separate two roomsor areas. If you select this door, considerthe following:

** This door needs to be carefullyselected, installed, and maintained to beeffective.

** If an air imbalance (pressureimbalance) develops at the dooropening, the separation effect may bediminished or eliminated. Airimbalance can occur from air flowchanges from any other openings in therooms especially other doors.

** The movement of the air can stirup contaminants, such as dirt and dust,if the area around the door is not keptclean.

Chapter 5

LIGHTING, VENTILATION,REFRIGERATION, AND EQUIPMENT

Controlling the manufacturingenvironment is important inmaintaining a sanitary environment inmeat and poultry operations. Thischapter provides guidelines concerninglighting, ventilation, refrigeration, and

equipment for meat and poultryestablishments that you should considerin building or modifying anestablishment.

1. LightingWell-distributed, good-quality

artificial lighting is needed at all placeswhere natural light is unavailable orinsufficient. Lighting is critical tomaintaining a sanitary environment forslaughter and processing operations.Without adequate lighting, insanitaryconditions are often difficult to see andcorrect. When selecting and installinglighting systems, consider the followingrequirements:

* Light fixtures in rooms whereexposed meat or poultry is handledshould ensure maximum safety, topreclude contamination of productswith broken glass and prevent thecollection of dirt, product, and debris onlamp surfaces, including fixture surfacesnot easily cleaned or inspected.

* Lighting must be intense enough toallow both the establishment andinspection personnel to see insanitaryconditions and product contamination.The intensity of lighting is measured infoot candles. The following chartsprovide recommendations for minimumfoot candles for artificial lighting:

TABLE 1.—GUIDELINES FOR MINIMUMLIGHTING INTENSITY IN MEAT ESTAB-LISHMENTS

Area 30 ft.candles

50 ft.candles

General lighting (inareas where animalsare killed, eviscerated,and products areprocessed orpackaged) .................. X

Offal cooler .................... XCarcass coolers ............ XFreezers ........................ XDry storage ................... XAnte-mortem inspection XSuspect pen inspection

area ........................... .............. XInspection stations ........ .............. XEstablishment quality

control inspectionareas .......................... .............. X

Reconditioning and rein-spection areas ........... .............. X

All other areas ............... X

TABLE 2.—GUIDELINES FOR MINIMUMLIGHTING INTENSITY IN POULTRY ES-TABLISHMENTS

Area 30 ft.candles

50 ft.candles

200 ft.candles

Ante-mortem in-spection ........ X

TABLE 2.—GUIDELINES FOR MINIMUMLIGHTING INTENSITY IN POULTRY ES-TABLISHMENTS—Continued

Area 30 ft.candles

50 ft.candles

200 ft.candles

Inspection sta-tion (tradi-tional) ........... .............. X

Inspection sta-tion (NELS/SIS/NTI) ....... .............. .............. X

Pre and postchill inspec-tion areas ..... .............. .............. X

Reconditioningand reinspec-tion areas ..... .............. .............. X

Establishmentquality controlinspectionareas ............ .............. .............. X

All other areas X

2. Ventilation

There should be enough ventilationfor all areas of the establishmentincluding workrooms, processing,packaging, and welfare rooms to ensuresanitary conditions. A good ventilationsystem is important to the production ofwholesome meat and poultry products.Without controlling the quality of theair coming into the establishment,products may become contaminatedwith dust, insects, odors, orcondensation. When designing yourventilation systems, you shouldconsider the following guidelines:

* The ventilation system should bedesigned so that turbulence is avoided.The longer the distance the air has toflow, the greater the resistance the airencounters not only from static air, butfrom solid objects such as walls,equipment, people, and product.

* The ventilation system should bedesigned with the size of theestablishment in mind. The larger thefacility, the greater the volume of airthat must be moved.

* The ventilation system should bedesigned to compensate for changes inoutside temperature and humidity thatcause condensation problems within theestablishment.

* Screens and filters should be usedwhere needed to screen out dust, odors,and insects brought in from the outsideto prevent product contamination.

* Mechanical ventilation should beused to bring in fresh air to areas wherenatural ventilation is inadequate.

* Ventilation should prevent vaporformation, such as steam or fog, thatwould affect sanitation or interfere withthe inspector’s ability to performinspection.


* When exhaust fans are installed,provision should be made to provideenough outside make up air to preventair from being drawn into and throughdocks, coolers, and production areas tothe area served by the exhaust fan.

3. Equipment (General Design andConstruction)

Equipment materials should complywith 21 CFR, Parts 170–190 of the Foodand Drug Administration (FDA)regulations for direct food contact.

Equipment and utensils used forhandling as preparing edible product oringredient in any official establishmentshould be easily cleaned and not be asource of contamination. Consider thefollowing guidelines when selectingequipment.

* All direct product contact surfacesshould be smooth; maintained free ofpits, cracks, crevices and scale;corrosion and abrasion resistant; non-absorbent; shatterproof; nontoxic; andnot capable of migrating into foodproducts.

* Equipment should not be paintedon areas in or above the direct productcontact area.

* Construction materials that aresources of contamination includecadmium, antimony or lead as plating orthe plated base material, lead exceeding5 percent in an alloy and enamelwareand porcelain used for handling andprocessing product.

* Equipment should be designed andinstalled in such a way that foreignmaterials, such as lubricants, heatexchanger media, condensate, cleaningsolutions, sanitizers and other nonfoodmaterials, do not contaminate foodproducts.

* Equipment is self-draining ordesigned to be evacuated of water.

* All product contact surfaces allowcontact with cleaning solutions andrinse water.

* Clean-in-place (CIP) systems shouldhave sanitation procedures that are ascomplete and effective as those forcleaning and sanitizing disassembledequipment. To remove all organic andinorganic residues, CIP systems shouldmeet the following criteria:

** Cleaning and sanitizing solutionsand rinse water should contact allinterior surfaces of the system.

** The system should be self-draining, with no low or sagging areas.

** The pipe interiors should behighly polished (120–180 grit) stainlesssteel for easy inspection.

** Easily removable elbows withquick-disconnect mechanisms should beinstalled at each change of direction.Elbows should be short enough to

permit verification that the interior hasbeen cleaned.

Chapter 6

WATER SUPPLYThe water supply should be ample,

clean, and potable with adequatepressure and facilities for itsdistribution in the establishment and itsprotection against contamination andpollution.

1. Potable WaterAn adequate supply of fresh clean

water is of primary importance in plantoperations. The first requirement is thatthe water supply to the plant be potableor safe for human consumption or foodprocessing. The plant water supplymust meet the potability standards inthe National Primary Drinking WaterRegulations issued by theEnvironmental Protection Agency(EPA).

2. BackflowPublic health officials have long been

concerned about cross-connections thatmay permit backflow in potable watersupply distribution systems. Cross-connections may appear in many formsand in unsuspected places. Reversal ofpressure and flow in the water systemmay be unpredictable. Plumbing cross-connections between a potable andnonpotable water supply may constitutea serious public health hazard. Thereare numerous cases where cross-connections have been responsible forcontamination of potable water andhave resulted in the spread of disease.These concerns, as they relate to meatand poultry plants, deserve specialattention. The problem is continual aspotable water and piping systems areinstalled, repaired, replaced, orextended.

Two basic types of hazard may becreated in piping systems: the solid pipewith valved connections and thesubmerged inlet. The solid pipeconnection is often installed to supplyan auxiliary piping system from thepotable source. It is a direct connectionof one pipe to another pipe orreceptacle. Solid pipe connections maybe made accidentally to waste disposallines when it is incorrectly assumed thatthe flow will always be in one direction.An example would be connecting a linecarrying used, nonpotable cooking waterfrom a water jacket or condenserdirectly to a waste line without an airgap (see below). ‘‘Backflow’’ will occurwith a submerged inlet if the pressuredifferential is reversed without an airgap. Submerged inlets are created whenthe outflow end of a potable water lineis covered with water or other liquid.

The other liquid may not be potable.Submerged inlets could be created by ahose lying in a pool or puddle of wateron the floor.

Once a cross-connection exists, anysituation that causes a pressuredifferential with the potable line havingthe lower pressure can result incontamination of the entire waterdistribution system and potable watersupply. This is called backflow and canbe produced under a variety ofcircumstances as illustrated below:

* Backsiphonage is one form ofbackflow. It is caused by negativepressure in the delivery pipes of apotable water supply and results influid flow in the reverse direction. Itmay also be caused by atmosphericpressure exerted on a pollutant liquidsource that forces the pollutant into apotable water supply system that isunder vacuum. The action in this caseis the common siphon phenomenon.The negative pressure differential thatwill begin the siphoning action is apotential occurrence in any supply line.

* Differential pressure backflowrefers to a reversed flow because ofbackpressure other than siphonic action.Any interconnected fluid systems inwhich the pressure in one exceeds thepressure of the other may cause flowfrom one to the other because of thedifferential. This type of backflow is ofconcern in buildings where two or morepiping systems are maintained. Thepotable water supply is usually underpressure from the city water main.Occasionally, a booster pump is used.The auxiliary system often ispressurized by a centrifugal pump,although backpressure may be causedby gas or steam pressure from a boiler.A reversal in differential pressure mayoccur when pressure in the potablesystem drops below that in the systemto which the potable water is connected.The best method of preventing this typeof backflow is the complete separationof the two systems and/or an air gap.Other safety methods involve theinstallation of mechanical backflowprevention devices. All methods requireregular scheduled inspection andmaintenance to ensure ongoingeffectiveness of installed devices.

Some areas that you should considerproviding some form of protection frombackflow and back siphonage includethe following:

* Water supply to pens for washdown or livestock watering.

* Water supply to compressor coolingsystems, cooling towers, and boilerrooms.

* Water supply to cleanup systems,clean in place (CIP) systems, etc.

* Water supply to hose connections.


Various mechanical antibackflowdevices are available to preventbackflow into a potable water supplysystem. Generally, the selection of thetype and number of fail-safe devicesshould be based upon the degree ofhazard from contamination. Additionalconsiderations include piping size,location, and the need to testperiodically the backflow devices toensure proper operation.

There are six basic types of devicesthat can be used to correct cross-connections:

* Air gap* Barometric loops* Vacuum breakers—both

atmospheric and pressure type* Double check valves with

intermediate atmosphere vent* Double check valve assemblies* Reduced pressure principal

backflow preventers* Specific requirements concerning

backflow can be found in local buildingand board of health codes.

Chapter 7

GENERAL PLUMBING FACILITIES

One of the most important factors toconsider in the design and modificationof establishments is the plumbingsystem. If the plumbing system is notproperly installed, contamination ofproducts can occur from flooding, backsiphonage, stoppages and cross-connections with the potable watersystem. This chapter providesguidelines concerning the plumbingfacilities, in meat and poultryestablishments. For additionalinformation on the design andmodification of plumbing facilities,consult the National Plumbing Code.

1. Hose Connections and Hoses

There should be enough convenientlylocated hose connections with steamand water mixing valves or hot waterconnections provided throughout theestablishment for cleaning purposes.Hose connections are important inpromoting routine cleaning of theestablishment. Consider the followingguidelines when determining how manyhose connections, location of hoseconnections, and storage of hoses:

* The number of hose connectionsdepends on the number of drains.

* If a shut-off nozzle is provided onthe hose after the hot and cold watermixing valve, the vacuum breaker at thehose connection to the mixing valvewill not work. Vacuum breakers shouldbe installed on the hot and cold watersupplies prior to the mixing valve toprevent such problems.

* Hose connections should beprovided with vacuum breakers toprevent back siphonage.

2. Establishment Drainage System

There need to be efficient drainageand plumbing systems for the promptremoval of liquid and suspended solidwastes from the processingenvironment. Consider the followingguidelines when designing or modifyingyour drainage system:

* All plumbing should be sized,installed and maintained in accordancewith applicable state and localplumbing codes, ordinances, andregulations.

* Drainage lines should be located sothat if leakage occurs, it will not affectproduct or equipment.

3. Floor Drains

All parts of floors where operationsare conducted should be well drained.There are two basic types of drains:point drains and trench drains. Pointdrains, the most commonly used drainin most areas, are located in strategicpoints in the room with the floor slopedtoward the drain. The waste water flowsover the surface of the floor until itreaches and is carried away by thedrain. Trench drains involve a trough ortrench that collects the waste from alarger area and directs the flow to adrain opening. The flooring is slopedtoward the trench.

In a typical plant, one four-inch(10.16 cm) drainage inlet is provided foreach 400 square feet (37.16 squaremeters) of floor space. A slope of aboutone-quarter inch per foot (2.08 cm permeter) to drainage inlets is generallyadequate to ensure proper flow with nopuddling. In dry production areas,where only a limited amount of water isdischarged on to the floor, an adequateslope may be about one-eighth inch perfoot (1.04 cm per meter). It is importantthat floors slope uniformly to drainswith no low spots to collect liquid.

* The location of floor drainsdepends upon many factors such as thetype of task conducted in the space, thegeometric shape of the area drained,truck traffic patterns, and equipmentlocations.

* There are special drainageconsiderations in areas where there is ahigh volume of water usage. The waterin trench drains should flow in theopposite direction of the product flow,for example, from the poultryevisceration to the picking areas.

* All parts of floors where wetoperations or where floors are to befrequently hosed down should bepitched to floor or trench drains.

* Floor drains should not be locatedunder equipment because it makes theminaccessible cleaning.

* Rooms without floor drains such asdry storage, large finished productcoolers, and distribution warehousesmay prefer to use mechanical cleaningmachines instead of installing drains.Examples of such cleaning devices arefloor scrubbers and dry/wet vacuummachines.

4. Trap SealsEach floor drain should be equipped

with a deep seal trap and ventedproperly to the outside. The purpose ofsuch traps is to seal off the drainagesystem so that foul odors (sewer gases)cannot enter the plant. Effectiveness ofthe trap depends upon enough waterremaining to constitute a seal. As waterflows through the trap and down thedrainpipe, suction is created that willpull the water out of the trap and breakthe seal unless the suction is broken byventing the drainpipe on the effluentside of the trap to the outside air. Theseal can also be broken by evaporationof trapped water. This is not a problemin frequently used drains, but doesoccur where drains are seldom used.

5. Drainage LinesAll drainage lines must comply with

local code requirements. They should beinstalled and maintained to beleakproof. To prevent drainage linesfrom becoming entrances into the plantfor pests, including rats and mice, alllines must be equipped with effectiverodent screens. Secure drain covers, inaddition to keeping out pests, also serveto prevent blockage of the traps anddrainage lines with product scraps orother material too large to flow freely.

6. CleanoutsCleanouts should be installed in the

drainage system to prevent sewerblockages. Consider the followingguidelines when installing cleanouts:

* Cleanouts should be located so theyare readily accessible, and can be usedwithout constituting a threat ofcontamination to edible products.

* To help avoid water puddling,cleanouts should be located on the‘‘high lines’’ of floor slopes and awayfrom traffic patterns.

Chapter 8

ESTABLISHMENT SEWAGETREATMENT

The design and construction ofsewage treatment facilities must complywith local code requirements. Animproperly designed sewage system cancontaminate the ground and watersupply. This chapter provides


guidelines concerning sewage treatmentat meat and poultry establishments thatyou may wish to consider in theinstallation of a sewage treatmentfacility.

1. Establishment Sewage Treatment

Sewage, one the most dangeroussources of human pathogens, shouldnever be allowed to come into contactwith products, equipment, utensils, orany food contact surfaces. Wheninstalling an establishment sewagetreatment facility, consider thefollowing guidelines:

* The system should be large enoughto handle the amount of sewage that theestablishment produces andaccommodate future increases.

* If a private septic tank, pre-treatment, or treatment system is used,it should be designed and operated toprevent contamination of products.

* The sewage facility should belocated away from product operationsand ingredient and packaging storageareas.

* An area for cleaning solid wastecontainers with hot water, drains, andcurbing should be located near any solidwaste disposal facility.

2. Grease Catch Basins or Interceptors

Grease catch basins can be a source ofcontamination of products if notproperly designed and located. Considerthe following guidelines whenconstructing a grease catch basin:

* Catch basins or interceptors forrecovering grease should not be locatedin or near edible product departments orareas where edible products are shippedor received.

* When a catch basin is locatedinside an establishment, it should besealed with a gastite cover and locatedin a ventilated room.

* Grease catch basins should beconstructed so they can be completelyemptied of their contents for cleaning.

* The area surrounding an outsidecatch basin should be paved withimpervious material, such as concrete,and drained.

Chapter 9

MEAT SLAUGHTERESTABLISHMENTS

Although the flesh of healthylivestock is practically sterile, when theanimal is killed many factors cancontribute to contamination of thecarcass including improperly designedand constructed slaughter facilities.This chapter provides guidelines formeat slaughter facilities to consider inbuilding or modifying slaughterfacilities.

Because different species of livestockneed different slaughter facilities, thischapter is organized in the followingway:

* Sections 1 through 8 describegeneral guidelines for facilities thatslaughter cattle, calves, sheep, goats,hogs, and equines.

* Sections 9 through 37 describeadditional guidelines for slaughterfacilities as follows:

* Sections 9 through 19 containadditional guidelines for cattle slaughteroperations;

* Section 20 contains additionalguidelines for calf, sheep, and goatslaughter operations;

* Sections 21 through 26 containadditional guidelines for hog slaughteroperations; and

* Section 27 contains additionalguidelines for equine slaughteroperations.

Note: The guidelines in this chapter are inaddition to Chapters 1 through 8 whichcontain general guidelines which apply to allofficial meat and poultry establishments.

Meat Slaughter—General FacilitiesGuidelines

The following guidelines apply to allestablishments that slaughter cattle,calves, sheep, goats, hogs and equines.If you are building or modifying anestablishment that slaughters thesespecies, consider these facilitiesguidelines to prevent contamination ofcarcasses during slaughter operations.

1. Livestock Pens

In addition to preventingcontamination of the slaughterdepartment and minimizingcontaminates on the hides of theanimals, proper design and constructionof livestock pens prevent injury to theanimals. Consider the followingfacilities guidelines when designing andconstructing livestock pens:

* Livestock pens should be locatedoutside the slaughter department toprevent contamination of products fromdust, odors, and other contaminates. Ifpossible, the livestock pens should beseparated from the department by full-height partitions of impervious material.

* Livestock pens, driveways, andramps should be free from sharp orprotruding objects which could causeinjury or pain to the animals.

* Floors of the pens, ramps,unloading chutes, and runways shouldbe constructed to provide good footingfor livestock. Waffled floor surfaces andcleated ramps are effective constructiondesigns.

* Floors of the pens, ramps,unloading chutes, and runways shouldbe sloped for drainage and cleaning.

* Pen enclosures (except gateways)should be high and sturdy enough toprevent livestock from escaping.

* Gates, fences, and chutes shouldhave smooth surfaces that are easilycleaned.

* Man gates or, if the walls areconcrete, toe holds formed in the wallsshould be present to allow people toescape from pen enclosures in anemergency.

* To help prevent livestock fromslipping and falling on floors coveredwith excess water, thereby furthercontaminating their hides, water troughsshould be provided with overflowslocated above or adjacent to pen floordrains.

* Hose connections should beprovided for cleanups.

* Covered pens should be providedto protect crippled or downer animalsfrom adverse climatic conditions. If heldovernight, the pens should be largeenough to allow the animals to lie downand have facilities for feed and water.Pens and driveways should be arrangedso that sharp corners and directionreversals of driven animals areminimized.

* A ‘‘U.S. suspect’’ or ‘‘U.S.condemned’’ pen should be available atall times and designed to allow forcomplete separation, including thedrainage system, from other livestock.

2. Ante-mortem Inspection Areas

Ante-mortem inspection areas shouldbe designed and constructed to facilitateinspection and to prevent animals frombeing injured. Consider the followingguidelines in designing andconstructing these areas:

* To avoid delays in slaughteroperations, pens for ante-morteminspection should have the capacity forholding the maximum number ofanimals of the various species that willbe slaughtered in a single day.

* To facilitate the ante-morteminspection of animals, a separatesuspect pen with a squeeze chuteshould be provided, where thetemperature of the animals may betaken.

* At least 50 percent of the livestockpen, including the area where thesuspect pen and squeeze chute arelocated, should be under a weather tightroof to provide an area for proper ante-mortem inspection in inclementweather.

* Special consideration should begiven to designing ante-morteminspection facilities to allow for humanetransporting of crippled or downeranimals into the slaughteringdepartment. Because crippled anddowner animals have difficulty moving,


special doorways and hoists to transportthem to the stunning area should beprovided.

3. Slaughter Area

The slaughter area is one of the mostdifficult areas to keep sanitary becauseof the nature of slaughter operations.Consider the following guidelines indesigning and constructing slaughterareas to minimize contamination ofcarcasses:

* The slaughter area should beseparated from the outside by a full-height partition or wall made ofimpervious material.

* Any doors to the outside of theslaughter area should be self closing tominimize the risk of contamination,including contamination by vermin.

* Slaughter areas should have floorspace arranged to facilitate the sanitaryconduct of operations and efficientinspection. For example, to preventcontamination of carcasses, truckwaysthrough which products are conveyedfrom the slaughter area to rooms such asthe offal cooler, should be located sothat the material is not trucked beneathrails from which dressed carcasses andproducts are suspended. For the samereason, personnel traffic should notmove through lines of carcasses.

4. Stunning Areas Including Chutes andAlleys

Stunning areas, chutes and alleys,should be designed to preventcongestion, injury to animals, andminimize contamination of hides whichcan lead to contamination of thecarcasses. Consider the followingguidelines when designing thesefacilities:

* All pathways, chutes, and alleysleading to stunning areas, and thestunning areas, should be large enoughfor the species being slaughtered.

* All pathways, chutes, and alleysleading to stunning areas, and thestunning areas, should be free frompain-producing restraining devices,sharp projections such as loose boards,exposed bolt ends, splintered or brokenplanking, protruding metal, andexposed wheels or gears.

* All pathways, chutes, and alleysleading to stunning areas, and thestunning areas, should be free ofunnecessary holes and openings wherethe animals’ feet or legs may be injured.

* Overhead gates should be coveredat the bottom edge to prevent, injury tothe animals.

* Flooring should be constructed ofroughened or cleated cement to reducefalls.

* Stunning areas should be providedfor confining animals for stunningbefore bleeding.

* If ritualistic slaughter operationsare conducted in the stunning area,shackles to confine the animals alsoshould be provided.

* When captive bolt stunners areused, the stunning areas should bedesigned and constructed to limit thefree movements of animals so that theoperator can locate the stunning blowwith a high degree of accuracy.

* When electrical stunning is used,the stunning area should be constructedso that any power activated gates willnot cause injury to the animals.

5. Rail Arrangement and Truckways

To prevent contamination ofcarcasses, rails should be arranged toprovide enough room for carcasses tomove without touching equipment,walls, columns, other fixed parts of thebuilding, and other carcasses. Considerthe following guidelines when arrangingrails in your establishment:

* Consideration should be given tothe type of rail and the rail speed whendetermining how rails are to bearranged.

* Trim rails should be arranged sothat carcasses pass the final carcassinspection position after the final trim.

* To prevent the carcass frombecoming contaminated by debris on thefloor and from splashes duringcleanups, the cooler rails shouldprovide for clearance from the lowestpart of the carcass to the highest pointof the floor.

* A room or area for washinggambrels, hooks, and trolleys should beprovided. The room or area should havean exhaust fan in an outside wall todispense steam.

6. Viscera Separation and EdibleByproducts Refrigeration

Because edible organs and parts (offal)are handled at temperatures conduciveto bacterial growth, care must be takenin providing facilities for separation ofviscera and for refrigeration of ediblebyproducts to prevent them frombecoming contaminated. Consider thefollowing guidelines for holding edibleby products:

* Facilities, such as viscera trucks orpans, should be provided for separatingand handling viscera of the variousspecies of animals to preventcommingling.

* To prevent cross contamination, aseparate cooler or a separately drainedpart of a carcass cooler should beprovided for holding edible organs andparts (offal) under refrigeration.

* To convey the edible byproducts toa cooler, a truck with removable metaldrip pans should be provided.

* To prevent cross contamination,establishment and inspection personnelfrom the slaughter department shouldbe able to access the edible byproductcooler without passing through a line ofcarcasses or through a congested carcasscooler.

7. Carcass Washing

Special facilities for washinginspected carcasses are needed toremove bone dust and other accidentalcontamination from the carcass.Consider the following guidelines whendesigning and constructing this area:

* A separately drained area or an areathat is sloped to a floor drain should beprovided where inspected carcasses arewashed.

* If the carcasses are washedmanually by establishment personnel, aplatform should be provided to allowestablishment personnel to be able toreach all parts of the carcass.

8. Retain Room/Compartment

* A retain room, cage, compartment,or receptacle may be required byinspection. Depending on the needs ofinspection, consider the followingguidelines for designing andconstructing this room:

* The retain room or compartmentmust be equipped for locking or sealing.

* The room or compartment needs tobe marked conspicuously ‘‘U.S.Retained.’’

* If the retain compartment is locatedin the cooler, the compartment shouldbe separated from the remainder of thecooler to prevent cross-contamination ofinspected and passed carcasses. Theseparation can be accomplished bycreating a compartment constructed ofpartitions of corrosion resistant wirescreen or flat expanded metal.

Cattle—Additional Facilities Guidelines

In addition to the guidelines (sections1 through 8) for all establishments thatslaughter livestock, the guidelines in thefollowing sections 9 through 19 apply toestablishments that slaughter cattle.

9. Cattle Dressing Layout

There are a number of different cattledressing layouts that can be used in acattle slaughtering operation. Dependingon the number of animals slaughtered,rate of inspection, and number ofinspectors, you should carefullyconsider your options for a layout forslaughter operations.


10. Rail Heights, Distances, and otherSlaughter Area Dimensions

To assist you in planning the layoutof your slaughter area, the following isa chart for recommended distancesincluding rail heights, rail distances,and other cattle slaughter areadimensions:

TABLE 3.—GUIDELINES FOR DIS-TANCES IN CATTLE SLAUGHTERINGESTABLISHMENTS

Item Verticaldistance

Horizontaldistance

Bleeding rail (dis-tance from rail topoint of applica-tion of shackle toshackle foot—4feet (1.2 m)).

16 feet(4.9 m)

Dressing rails (trol-ley length—1foot 3 inches.(.4 m)) ................

12 feet 3inches(3.7 m)

Beef cooler rails(trolley length—1foot 3 inches.(.4 m)) ................

11 feet(3.4 m)

Moving equip-ment—heights ofconveyor rails,platforms, top ofviscera inspec-tion table.

Dry landing area infront of stunningpen.

7 by 8 feet(2.1 by2.5 m)

Curb of bleedingarea to pitchplates (no head-er rails).

5 feet(1.5 m)

Between headerrail and carcasswashing rail, ifparallel.

6 feet(1.8 m)

Between header orwashing rails andwall of slaughter-ing room.

3 feet(.9 m)

Between centerlines of dressingbeds.

8 feet(2.5 m)

Between movingtop table anddressing rail atinspector’s plat-form.


Area for sterilizingviscera inspec-tion truck.

7 by 8 feet(2.1 by2.5 m)

Note.—When rails are involved in horizontaldistance measurements, the distance is meas-ured from the center of the rail. When rails areinvolved in vertical distance measurements,the distance is measured from the top of therail to the highest part of the floor.

11. Dry Landing Area

A dry landing area large enough toaccommodate stunned animals removedfrom the stunning pen should be

provided adjacent to the stunning pen.Consider the following guidelines indesigning and constructing this area:

* The area should allow enough roomfor the livestock.

* The dry landing area should belocated and drained separately from thebleeding area.

* The dry landing area should beenclosed by a fence high enough andsturdy enough to prevent escape ofinadequately stunned animals.

12. Bleeding Area

To contain blood and prevent it fromcontaminating carcasses, a curbedbleeding area should be provided.Consider the following guidelines indesigning and constructing this area:

* The bleeding area should be locatedso that blood will not be splashed onstunned animals lying in the drylanding area or on carcasses beingskinned on the cradle beds, if they areused.

* The curb around the bleeding areashould be located far enough from thedressing bed or cradle to allow room forthe carcasses to be maneuvered into thebed or cradle.

13. Facilities for Head Removal

To avoid contamination of thecarcasses from rumen contents, facilitiesfor head removal need to be carefullydesigned:

* Space should be provided fordehorning, flushing, washing, andinspecting heads; for storing heads onracks or trucks after removal fromcarcasses; and for head workup.

* When a down hide puller is used,the head drop and head removal areashould be curbed and drained.

* A head wash cabinet should beprovided.

14. Facilities for Hide Removal

To limit contamination by hides, ahide chute should be provided near thepoint where hides are removed fromcarcasses. Consider the followingguidelines when designing andconstructing these facilities:

* The chute should have a hood ofsturdy rust-resistant metal with a push-in door closely fitting a metal frameinclined so as to be self-closing. In orderto evacuate airborne contaminants fromhides such as scurf, dirt, spores, odors,and hairs, a vent pipe should extendfrom the hood vertically to a pointabove the roof.

* Space needs to be providedbetween hide pulling and carcassevisceration to permit cervicalinspection prior to viscera inspection.

15. Facilities for Feet and Udders

Because of the high risk ofcontamination of carcasses from feetand udders which have been removedfrom carcasses, special facilities, such asa chute or slide, should be used fortransferring these parts to containers.Consider the following guidelines forthese facilities:

* A chute or slide should be used toavoid splashing of milk or othercontaminants onto the carcasses, floor,equipment, and personnel.

16. Foot Platforms

Foot platforms installed forestablishment employees performingvarious carcass dressing operations needto be carefully designed and installed toprevent contamination of carcasses.Consider the following guidelines:

* If elevated foot platforms are used,they should be located so they do nottouch skinned portions of the carcass.

* If stationary platforms are used,they should be set far enough away fromthe dressing rail to prevent contact withthe forelegs of cattle.

* To provide space for operations andto prevent cross contamination bycarcasses, push fingers or rail stops onpowered conveyor or gravity flow railsshould be spaced far enough apart toprevent contact between carcasses.

17. Viscera Trucks

In establishments with a limited rateof slaughter, viscera are usually placedin a specially designed handtruck forinspection. Consider the followingguidelines for use of viscera trucks:

* For ease of cleaning, viscera trucksshould be constructed of stainless orgalvanized steel.

* Viscera trucks should have aninspection pan and a lower visceracompartment.

* When viscera trucks are used, aseparately drained area should beavailable for washing and sterilizingsuch equipment.

* To prevent contamination ofproducts, the washing facilities shouldbe located at or near the point wherecondemned products are dischargedfrom the trucks. When placed wheresplash might contaminate edibleproducts, the truck washing area shouldhave walls high enough to contain anysplash.

18. Moving-Top Inspection Tables

In some establishments, viscera areplaced on a moving-top table forinspection. These tables have specialconsiderations as follows:

* The table should be of a length thatprovides for evisceration, inspection,and viscera removal.


* A continuous cleaning andsanitizing system should be available forthe table.

* To prevent contamination ofproducts and the surrounding area, theviscera inspection table should have adrain under the table to prevent waterfrom draining across the floor to otherareas of the room.

* To prevent contamination ofcarcasses, the foot platform, handwashsinks, hand tool disinfection unit(sterilizer), boot washing cabinet, andboot storage locker should be locatedalongside the loading end of the table.

19. USDA Post-mortem InspectionStation and Retain Rail

Special facilities are needed for USDApost-mortem inspection for cattle.

Consider the following provisions thatmust be met when designing thesestations:

* An inspection station consisting of5 feet (1.5 m) of unobstructed line spacefor each head or carcass inspector.

* When viscera tables are used, theremust be 8 feet (2.5 m) for each viscerainspector on the inspector’s side of thetable needs to be provided.

* A minimum of 50 foot candles ofshadow-free lighting at the inspectionsurfaces of the head, viscera, andcarcass.

* A handwash sink (other than onewhich is hand operated), furnished withsoap, towels, and hot and cold water,and located adjacent to the inspector’swork area.

* For each head and viscera inspectoron cattle slaughter lines a sterilizer

located adjacent to the inspector’s workarea.

* For mechanized operations, a linecontrol switch adjacent to eachinspection station.

* Facilities to position tally sheets orother recording devices, such as digitalcounters and facilities to contain USDAcondemned brands.

* Rail(s) for holding retainedcarcasses for final disposition alongwith platforms and handwash sinks. Toprevent possible cross contamination,the retain rail must be long enough toprevent carcasses from touching.

20. Calves, Sheep, and Goats—Chart ofGuidelines for Distances for Rails andOther Facilities

TABLE 4.—GUIDELINES FOR DISTANCES IN CALF, SHEEP, AND GOAT SLAUGHTERING ESTABLISHMENTS

Item Vertical distance Horizontal distance

Bleeding rail for calves (distance from top of rail to pointof application of shackle to shackled foot—2 feet 6inches (.8 m)).

11 feet (3.3 m) ..........................................

Bleeding rails if only sheep or goats are slaughtered ..... 9 feet–11 feet (2.7 m–3.4 m) ....................Dressing rail (trolley length—1 foot (.3 m)) ..................... 8 feet 6 inches (2.6 m) ..............................Cooler rails, calf carcasses (trolley length—1 foot (.3

m)).8 feet 6 inches (2.6 m) ..............................

Cooler rails, sheep or goat carcasses (trolley length—1foot (.3 m)).

7 feet 6 inches–8 feet 6 inches (2.3 m–2.6 m).

Moving equipment ............................................................ ....................................................................Vertical of rail to edge of viscera inspection stand .......... .................................................................... 2 feet (.6 m)Length of rail from point of evisceration to point where

carcass inspection is completed..................................................................... 6 feet (1.8 m)

Note.—When rails are involved in horizontal distance measurements, the distance is measured from the center of the rail. When rails are in-volved in vertical distance measurements, the distance is measured from the top of the rail to the highest part of the floor.

Hogs—Additional Facilities Guidelines

In addition to the general guidelinesin sections 1 through 8, the followingguidelines apply to those establishmentsthat slaughter hogs. Consider theseadditional guidelines when building ormodifying an establishment thatslaughters hogs.

21. Livestock Pens

* To prevent hogs from overheating,pens for hogs should have either a rooffor shelter or a shower system to keepthe animals cool in weather withtemperatures greater than 70 °F (21 °C).

22. Location of Certain Operations

* To prevent contamination, thefollowing equipment and operationsshould be located in an area or areasseparate from the carcass dressing area,except for the openings for access andpassage of carcasses:

** Hoisting, sticking, and bleeding.** Scalding vat.

** Dehairing machine located withina curbed area having noncloggingdrainage outlet.

** Gambrelling table.** Singeing operations.

23. Rail Arrangements for Hogs

The following chart gives guidance forrecommended distances for rails andother facilities for hog slaughteroperations.

TABLE 5.—GUIDELINES FOR DIS-TANCES IN HOG SLAUGHTERING ES-TABLISHMENTS

Item Vertical dis-tance

Bleeding rail to sticker’s plat-form.

10 feet 6inches (3.2m).

Extension of bleeding rail totop of scalding vat.

9 feet (2.7m).

Dressing rails 1 ....................... 11 feet (3.3m).

Gambrels (suspending car-casses to floor (1 foot (.3m)).

10 feet (3 m).

TABLE 5.—GUIDELINES FOR DIS-TANCES IN HOG SLAUGHTERING ES-TABLISHMENTS—Continued

Item Vertical dis-tance

Distances from rail to bottomof inspection pans and var-ious foot platforms.

Rails in coolers for hog car-casses with heads removed(1 foot (.3 m)).

9 feet (2.7m).

Rails to coolers for carcasseswith heads attached (1 foot(3 m)).

10 feet (3 m).

Vertical of dressing rail to var-ious foot platforms andwidths of platforms.

1 Heads dropped but still attached.Note.—When rails are involved in vertical

distance measurements, the distance is meas-ured from the top of the rail to the highest partof the floor.

24. Scalding

To avoid contamination of thecarcass, a scalding tank is used toremove hair and other contaminants.


Consider the following when installinga scalding tank:

* A mechanical exhaust fan above thescalding tank will disperse steam.

25. Shaving, Singeing, and CarcassWashing

* A shaving rail (throw-out rail)should be provided prior to the headdropping operation, so that uncleanhogs can be removed from the dressingline for cleaning.

* If a singer is used to remove hair,it should have an automatic cut off andstarter switch to prevent the carcassfrom burning when the chain stops.

* If a polisher is used, water spraysto clean the carcass of hair should beprovided.

* To remove hair from the hidewhich was missed by the scalder anddehairing process, a carcass washershould be located at a point aftercompletion of shaving operations andbefore the head dropper’s station.

26. Inspection Facilities

Special facilities are needed for USDApost-mortem inspection for swine.Consider the following guidelines whendesigning these stations:

* An inspection station consisting of5 feet (1.5 m) of unobstructed line spacefor each head or carcass inspector mustbe provided.

* When viscera tables are used, theremust be 8 feet (2.5 m) for each viscerainspector on the inspector’s side of thetable needs to be provided.

* A minimum of 50 foot candles ofshadow-free lighting at the inspectionsurfaces of the head, viscera, andcarcass must be provided.

* A handwash sink (other than onewhich is hand operated), furnished withsoap, towels, and hot and cold water,must be provided adjacent to theinspector’s work area.

* For each head inspector on swineslaughter lines, a sterilizer must belocated adjacent to the inspector’s workarea.

* For mechanized operations, a linecontrol switch must be providedadjacent to each inspection station.

* For swine slaughter lines requiringthree or more inspectors, and for thoseone-and two-inspector configurationswhere the establishment installs amirror, special facilities are needed. Atthe carcass inspection station one glassor plastic, distortion-free mirror, at leastfive by 5 feet (1.5 by 1.5 m), must bemounted at the carcass inspectionstation. The mirror should be mountedfar enough away from the vertical axisof the moving line to allow the carcassto be turned, but not over 3 feet (90 cm)away, to allow any inspector standing at

the carcass inspection station to readilyview the back of the carcass.

* Facilities to position tally sheets orother recording devices, such as digitalcounters and facilities to contain USDAcondemned brands must be provided.

Equines—Additional FacilitiesIn addition to the general guidelines

in sections 1 through 8, and theguidelines for cattle in sections 9–19, ifyou plan to slaughter equines, such ashorses, mules, donkeys, and ponies, thefollowing are additional guidelineswhen building or modifying equineslaughter facilities.

27. Equine Slaughter Facilities* The facilities for equine slaughter

establishments are essentially the sameas those for slaughtering cattle.Exceptions include the following railheights and clearances.

TABLE 6.—GUIDELINES FOR DIS-TANCES IN EQUINE SLAUGHTERINGESTABLISHMENTS

Items Verticaldistance

Horizontaldistance

Bleeding rail .......... 18 feet(5.5 m)

Dressing rails (trol-ley length—1foot 3 inches (.4m)).


Cooler rails (trolleylength—1 foot 3inches (.4 m)).


Cooler rails for car-casses in quar-ters.


Line of drop-offs toline of half hoists.

17 feet(5.2 m)

Clearance betweenwalls, posts, etc.and adjoiningrails in slaughterrooms and cool-ers.

3 feet(.9 m)

Curb of bleedingarea to pritchplates.

6 feet (1.8m)

Dry landing area(minimum).

7 by 8 feet(2.1 by2.5 m)

Note.—When rails are involved in horizontaldistance measurements, the distance is meas-ured from the center of the rail. When rails areinvolved in vertical distance measurements,the distance is measured from the top of therail to the highest part of the floor.

Chapter 10

POULTRY SLAUGHTERESTABLISHMENTS

Although the flesh of healthy livingpoultry is practically sterile, when thebird is killed many factors cancontribute to contamination of thecarcass including improperly designed

and constructed slaughter facilities.This chapter provides guidelines forfacilities for poultry slaughterestablishments for you to consider inbuilding or modifying your slaughterfacilities. If you slaughter small animalssuch as rabbits or migratory fowl undervoluntary inspection, use this chapterfor guidance. See Chapters 1 through 8for general information which applies toall official meat and poultryestablishments.

1. Holding Sheds or Coops

When building holding sheds orcoops for poultry, consider thefollowing guidelines:

* A minimum of 30 foot candles oflighting must be provided to facilitateante-mortem inspection.

* The holding sheds should beweather tight.

2. Docks for Receiving and Hanging LivePoultry

Consider the following guidelines toprevent dust, feathers, and otherobnoxious substances from enteringareas where edible products are beingprepared, handled, or stored:

* The live hanging dock needs to bephysically separated from these areas.The separation should be accomplishedby full height impervious walls withself-closing impervious doors, andopenings limited to that necessary forpoultry conveyor systems.

3. Slaughter Area

Consider the following guidelines forthe slaughter area to minimize risk ofcontamination to products:

* The slaughter area (includingstunning, bleeding, picking, scalding,and eviscerating operations) should beseparated from those areas of theestablishment where edible products areprepared or stored to minimize the riskof contamination.

* The blood in the slaughtering area,especially the stunning and bleedingarea, should be contained in as small anarea as possible.

4. USDA Post-Mortem InspectionStation

There are four systems of post-morteminspection: Traditional Inspection, theStreamlined Inspection System, theNew Line Speed Inspection System, andthe New Turkey Inspection System.Each of the systems has mandatoryrequirements to minimize the risk ofcontamination to products and topromote efficient inspection. However,with the exception of the lightingrequirements, there are no facilitiesguidelines for these post-mortemsystems.


5. Facility Guidelines for PoultryInspection Stations

Note: There are no facility guidelinesfor Traditional Inspection Systemfacilities except for lighting.

TABLE 7.—FACILITY GUIDELINES FOR POULTRY INSPECTION STATIONS

Facility SIS NELS NTI

The conveyor line should be level for the entire length of the inspection station ................................... X X XThe vertical distance from the bottom of the shackles to the top of the adjustable inspection platform,

when it is set in its lowest position, should be a minimum of 60 inches (150 cm) ............................. X X XThere should be a minimum of 8 feet (2.5 m) of space along the conveyor line for one inspection

station and 16 feet (4.9 m) for two inspection stations ........................................................................ X XThere should be a minimum of 42 feet (12.8 m) of space along the conveyor line for three inspection

stations .................................................................................................................................................. XThere should be a minimum of 6 feet (1.8 m) of space along the conveyor line for the establishment

employee presenting the birds ............................................................................................................. XThere should be a minimum of 4 feet (1.2 m) of space for inspector and a minimum of 4 feet (1.2 m)

of space for the establishment helper along the conveyor line ........................................................... X X XThere should be selectors or ‘‘kick-outs’’ with birds on shackles with 12 inch (30 cm) centers (two in-

spection stations on line) ...................................................................................................................... XThere should to be selectors or ‘‘kick-outs’’ with birds on shackles with 18 inch (45 cm) centers

(three inspection stations on line) ........................................................................................................ XA distortion-free mirror should be located at each inspection station which is: at least 3 feet (.9 m)

wide and 2 feet (.6 m) high; adjustable between 5 inches (12.5 cm) and 15 inches (38 cm) behindthe shackles; positioned in relation to the inspection platform so that the inspector is positioned op-posite it 8 to 12 inches (20.3 cm to 30.5 cm) from the downstream edge; installed so that guidebars do not extend in front of the inspection mirror; and illuminated by a light which is positionedabove and slightly in front of the mirror to facilitate the illumination of the bird and mirror surface ... X

There should be a slip-resistant inspection platform with a 42 inch (105 cm) high rail on the backside and with 1⁄2 inch (4 cm) foot bumpers on both sides and front ................................................... X X X

There should be an inspection platform with a minimum length of 4 feet (1.2 m) and minimum widthof 2 feet (.6 m) ...................................................................................................................................... X X X

There should be an adjustable inspection platform that easily and rapidly adjusts a minimum of 14inches (35 cm) vertically while standing ............................................................................................... X X X

A trough or other facilities extending beneath the conveyor where processing operations are con-ducted from carcass opening to trimming should be provided which is wide enough to prevent trim-mings, drippings, and other debris from accumulation on the floor or platform; and has enoughclearance between suspended carcasses and the trough to prevent contamination of carcasses bysplash .................................................................................................................................................... X X X

A conveyor line stop/start switch should be provided at each inspection station within easy reach ofthe inspector ......................................................................................................................................... X X X

A minimum of 200-foot candles of shadow-free lighting with minimum CRI value of 85, which can bemet by deluxe cool fluorescent lighting, must be provided .................................................................. X X X

Online hand rinsing facilities with continuous flow water withineasy reach should be provided foreach inspector and establishment helper ............................................................................................. X X X

Online hand rinsing facilities with continuous flow water within easy reach must be provided for eachestablishment presenter ....................................................................................................................... X

Receptacles for condemned carcasses and parts should be provided at each inspection station ........ X X XHang-back racks should be provided and located within easy reach for establishment helpers ........... X X X

6. Facility Guidelines for PoultryReinspection Stations

Note: There are no guidelines forTraditional Inspection System facilitiesexcept for lighting.

TABLE 8.—FACILITY GUIDELINES FOR POULTRY REINSPECTION STATIONS

Facility

Prechill andpostchill re-inspectionstations

Reinspection stations

SIS

NELS NTI

There should be a minimum of 6 feet (1.8 m) of space along the conveyor line for the establishmentpresenter ............................................................................................................................................... X

There should be a minimum of 3 feet (.9 m) of space along each conveyor line and for SIS aftereach chiller ............................................................................................................................................ X X


TABLE 8.—FACILITY GUIDELINES FOR POULTRY REINSPECTION STATIONS—Continued

Facility

Prechill andpostchill re-inspectionstations

Reinspection stations

SIS

NELS NTI

A table for reinspecting sample birds should be provided which is at least 2 feet (.6 m) wide, 2 feet(.6 m) deep, and 3 feet (.9 m) high; readily cleanable; and drainable ................................................ X

A table for reinspecting sample birds should be provided which is at least 3 feet (.9 m) wide and 2feet (.6 m) deep; readily cleanable; and drainable .............................................................................. X X

A space which is level and protected from all traffic and overhead obstructions should be provided ... X X XThe vertical distance from the bottom of the shackles to floor needs to be a minimum of 48 inches

(120 cm) should be provided ................................................................................................................ X X XA minimum of 200-foot candles of shadow-free lighting with a minimum CRI of 85 at the table sur-

face, which can be met by deluxe cool white fluorescent lighting, must be provided ......................... X X XA separate clipboard holder for holding the recording sheets should be provided ................................. X X XHandwash sinks within easy access of all persons working at the station should be provided ............. X X XHang-back racks should be provided which are within easy reach of all persons working at the sta-

tion, and designed to hold 10 carcasses ............................................................................................. X X X

7. Evisceration and Reprocessing Areas

The evisceration area should bearranged to facilitate efficient sanitaryoperations and inspection. Consider thefollowing guidelines when designingthese areas:

* Production lines should have drip pansinstalled beneath them, when these lines arelocated above areas such as walkways,truckways, work stations, and equipment, toprevent water, poultry products, or any othermaterial from falling on the production areasbelow.

* An area should be provided for areprocessing station for the reconditioning ofretained products including removal ofcontamination.

8. Inedible Offal

In poultry establishments, the facilities forhandling inedible offal should be designed toaccommodate the size of the poultry beinghandled and to prevent the contamination ofedible products. Consider the followingguidelines when designing these areas:

* The facilities, whether troughs orotherwise, should be large enough to allowclean and orderly removal of inedible offalduring processing, without a pile up andwithout cross contamination of edibleproducts.

* The water rail for semi-dry poultry offalsystems for young chickens should rangefrom 34 to 36 inches (86 to 90 cm) in heightabove the standing surface and be positioned7 to 10 inches (18 to 26 cm) horizontally fromthe vertical line of the shackle.

* The water rail for semi-dry poultry offalsystems for turkeys should range from 34 to36 inches (86 to 90 cm) in height above thestanding surface and be positioned 13 to 15inches (33 to 38 cm) horizontally from thevertical line of the shackle.

* The floor gutter should be distinct, withvertical sides inside the post supporting thewater rail (a minimum of 6 inches or 15 cmis suggested to prevent workers feet frombeing in the gutter). Gutters should also bewide enough to catch all material droppingfrom the carcass.

* Splash protectors should be installed atall points along the evisceration line wheresplashing of employees might occur.

* Pipes for conveying offal should beconstructed to permit daily cleaning andpositioned so that sanitation will not be aproblem, i.e., no pipes lying on the floor orbottom of a gutter.

* Side walls of hoppers should be pitchedto assure that material deposited in thehopper will slide to the point where the offalis being mechanically conveyed.

Chapter 11

PLANT WASTE DISPOSAL

Control and disposal of plant wastesare major concerns. Optimum use andreduction of waste are essential goals ofeconomic production in all plants. Froma plant sanitation standpoint, there aretwo vital concerns with waste disposal:(1) Plant waste contains most of thecontaminants and disease-producingand product-spoiling microorganismsfrom the plant production processes; (2)plant wastes attract pests such as insectsand rodents.

1. Organic Waste Disposal

When disposing of organic wastes such asfeathers, viscera, blood, and manure, thefollowing guidelines should be considered:

* Waste materials should not be allowedto accumulate on or near the premises.

* Waste should be disposed of withoutcreating insanitary or objectionableconditions.

* Waste should be removed daily.* Holding bins should be cleaned before

reuse and protected from insect and rodentharborage and infestations.

2. Rubbish Removal

Rubbish, such as paper towels, cartons,office waste, and labeling materials, canbecome a sanitation problem. The followingguidelines should be followed whenremoving rubbish:

* Suitable containers should beconveniently located throughout the plantand emptied frequently.

* The accumulation of rubbish before itsremoval should not cause a nuisance.

* Plant refuse should be removed daily, ormore often if necessary, to prevent anuisance.

Appendix B—Guidelines forDeveloping Partial Quality ControlPrograms (PQC’s)

Guidelines for Developing PartialQuality Control Programs Overview

Quality control programs are essentialto the proper functioning of any meat orpoultry processing establishment.Processors have found quality control isgood business because it can reducecosts, control product uniformity, andensure that proper standards are beingmaintained throughout the productioncycle. By increasing controls over rawingredients, processes, and othervariables, effective quality controlsystems can ensure compliance withcompany specifications and with theguidelines and requirements of theDepartment of Agriculture. Although in-plant inspectors have a role in theoversight of these programs, qualitycontrol is a management function andplant management should develop andimplement effective quality controlplans specific to their process andproducts.

There are many approaches plants cantake to ensure quality control. Someplants do not take any special measuresduring production, and changes aremade only on finished product. Someplants incorporate preventive measures,such as product testing, duringprocessing, and others undertake aseries of specific actions to preventmistakes and to ensure that productsmeet consumer expectations. Whether


limited or comprehensive, a qualitycontrol system should be in the writtenrecord of the plant. As experience isgained, the record keeping system maybe improved by focusing on ‘‘hot spots’’which are responsible for the majorproblems, revising specifications, orupgrading them to include sensitivetesting devices, for example.

Proper documentation of plantactivities will become increasinglyimportant in a HACCP inspectionenvironment. Proper documentation ofany in-plant process can save time andmoney and result in fewer mistakes bythe establishment. The degree andcomplexity of the records depend on thescope of the processing operation;completeness of the records is also areflection of management commitmentto quality control.

Plant or corporate managementsupport is the key to a successful qualitycontrol program. Plant personnel willsense a lack of commitment to qualityif management support is not apparent.

Good quality control managers do notnecessarily have to use complex,expensive methods to ensure control.Experience has shown that successfulestablishments function smoothly bypaying close attention to the basics,documenting the process when it isrunning smoothly and when problemsoccur, and making necessary correctionsas quickly as possible.

Chapter 1. Introduction

Title 9 of the Code of FederalRegulations at Parts 318.4(d) and381.145(d) require Federal meat andpoultry processing plants to establishand maintain written records for eachcritical check or critical control pointand make the records available to FSISinspection personnel upon request.

* Although the regulatoryrequirement for FSIS to review andapprove PQC programs has beenrescinded, the new regulatoryrequirements in 318.4(d) and 381.145(d)provide information to plants about thenecessary steps they must take to meetthe new record keeping requirements ina Pathogen Reduction and HACCPinspection environment.

* FSIS will continue to provideguidance to establishments to ensurethat their Partial Quality Control (PQC)programs for specific products andprocesses are adequate to ensureproduct compliance with regulatoryrequirements. The information in thisdocument is intended to be used asguidance material and is based on FSIS’experience and historical perspectivereviewing and approving PQC programs.

A few model PQC programs,representative of many products andprocesses, are presented below.

Chapter 2. Components of PQCPrograms

PQC programs should address fourareas: (1) raw materials control; (2)process control; (3) records control; and(4) corrective/preventive action.

1. Raw Materials Control

Raw materials control involves thereceiving and stocking of only thosematerials that conform to establishedspecifications. To ensure successfulcontrol of raw materials, establishmentsshould consider the following:

* To begin the development of a rawmaterials control procedure, plantsshould list each of the materials used toproduce the product.

* Once the list has been created,establishments should develop areceiving inspection procedure.

* The procedure may address rawmaterials specifications, propermaterials handling, proper storage, anddisposal of nonconforming materials.

* Materials should be routinelymonitored to ensure they are meetingthe established procedures.

2. Process Control

Process control programs ensurecontinuous control of particularprocesses so that product standards willbe met. Process control programs shouldmeet the following criteria:

* They should identify the productsor processes to be controlled.

* They should identify the controlfeatures necessary for productcompliance.

* They should establish controllimits.

* They should establish proceduresfor meeting the established limits.

* They should provide monitoringprocedures for ensuring that proceduresare followed.

An important aspect of processcontrol is effective data collection andanalysis. Process control programsshould include sampling plans thatpermit reliable collection and analysisof data. After sampling plans have beendeveloped, process limits can beestablished.

* The limits established should beappropriate to ensure that qualitystandards will be met.

* The limits established should beappropriate to ensure that meetregulatory or label limits for the productor process will be met.

* Variation in materials, methods,processes, and products requires thesetting of a tolerance for each quality

standard. A tolerance limit is the totalallowable deviation from an establishedstandard. The limit allows for thenormal variability which is inherent inany process.

* Tolerance limits may need to becontinuously adjusted to preventproblems.

* Limits for certain processes havebeen established and used historicallyby industry; these limits are reflected inPQC programs previously approved byFSIS. The tolerances meet the intent ofthe requirements in 318.4(d) and318.145(d)(2)(ii) and may continue to beused.

* Establishments may elect to usethese previously established tolerancesor develop their own by following therequirements outlined in the regulation.

3. Records

An important aspect of quality controlis process documentation. Adequaterecords are essential to the system’scapacity to provide the necessarycontrols. The records provide a historyof the process and document when theprocess is working and when problemsare occurring. The use of standardsheets, check-off forms, and othersimple records is generally moresuccessful than a complicated system.Charts and graphs already in use may beall that is necessary to document thesystem. The degree of record keepingand the complexity of the recordsdepend, in large part, on the scope ofthe processing operation. In reviewingrecords, plant management should:

* Look at those aspects of productionmost likely to cause problems. Thisprocedure also can be useful indetermining what critical checks needto be incorporated into a quality controlprogram.

* Correct problems as they occur.Proper documentation of the processcan save time and money because itprovides an establishment anopportunity to correct a problem beforethe finished product has beencompleted.

4. Corrective/Preventive Action

Corrective action plans address theaction to be taken when problemsdevelop in a production process.Corrective action plans are essentialcomponents and important indicators ofthe strength of quality control programs.The primary emphasis of the plansshould be on correction/prevention ofproblems in the production process. Thetype of plan used in a particular qualitycontrol program will be determined bythe establishment and the processesconducted at the plant. Generally,


corrective action plans should includethe following features:

* They should provide for theidentification of problems or deviationsin processes.

* They should provide for theidentification of the causes of problems.

* They should specify the correctivesteps to be initiated and the criteria fordetermining how noncompliantproducts should be handled.

* The plans should provide thatcorrective/preventive measures beimplemented after a determination thatno safety hazards exist.

* The plans should provide fordocumentation of the corrective andpreventive measures taken.

ModelsThe following models are intended to

be used as general guidelines todevelopers of quality control programs.They are not intended to be completeQC programs or a complete listing of allrotational QC programs but offer aframework and one approach to QCprogram development. In actual QCprograms, details regarding tests, actioncriteria, corrective actions, andresponsible personnel would reflect thespecific process and establishmentcircumstances. Any specifications orlimits cited are only examples and donot establish or imply Agencystandards.

Model 1—Preparation of a PQC Programfor the Addition of 10-Percent Solutionto Poultry

Raw Material Control

* Poultry—Chicken breasts will bereceived frozen, examined for condition,and immediately placed in the receivingdock freezer. (Specifications to be set byestablishment.)

* Dry ingredients—Upon receipt, thedry ingredients will be visuallyinspected for acceptance andimmediately placed in the dry storagewarehouse. (Specifications to be set byestablishment.)

* Corrective action—If either thepoultry or the dry ingredients is foundto be unacceptable, it will be taggedimmediately and Quality Control will benotified. QC will evaluate and initiateappropriate product disposition.

* Documentation—All critical checksand corrective actions will be recordedon the receiving log.

Process Control

* Formulation control.** Formulation control—A pumping

solution will be formulated according tothe label formulation. One ingredient ofthe solution will be weighed by aquality control technician for each

batch. If an ingredient is found to bem0ore than 0.5 percent above or belowthe weight stated on the formula, thefollowing will result: (1) the problemwill be evaluated and the appropriatecorrective action taken; (2) eachingredient of every batch will bechecked until five consecutive batchesare found to be in compliance.

** Documentation—All formulationcheck results and corrective actions, ifneeded, will be recorded on theformulation log.

** Scale accuracy control.*** Scale checks—All scales

associated with the pumping operationwill be verified for accuracy beforeoperations begin. Scale accuracy will bechecked against a known weight. If ascale is found to be inaccurate, it willnot be used until it has been calibrated.

*** Documentation—All scale checkresults and corrective actions, ifrequired, will be recorded on the scalemaintenance record.

Lotting

* A lot will be defined as one shift’sproduction; a sublot as approximately500 pounds of product.

Added Solutions

* Green weight determination—Eachsublot will be identified with a uniquecode representing date and time of daythe sublot is being produced.

** The sublot will be weighed beforepumping.

** The identifying code and weightwill be written on a tag, which will beattached to the combo bin containingthe sublot.

* Pumping—Every 30 minutes, 10turkey breasts will be selected from asublot before it is pumped. The 10turkey breasts will be weighed, thenpassed through the pumping machine.The turkey breasts will be allowed todrain for 5 minutes, then weighed again.

** Tolerances—Each pump checkwill not be more than 0.5 percent overthe target pump of 10 percent. If a pumpcheck is found to exceed the tolerance,all product back the last pump checkwill be retained and allowed to drainuntil it reaches the target pump. Inaddition, the pumping operations willbe stopped, evaluated by a QCtechnician, and not allowed to startuntil the problem has been corrected.

** Documentation—All pump checksand corrective actions, if needed, will bedocumented in the pumping log book.

* Finished weight determination—After a sublot has been pumped, a finalweight will be obtained and recorded onthe pumping tag.

** Tolerances—No sublot will bemore than 1.2 percent above the target

pump of 10 percent. The average of allsublots will meet the target pump. If anysublot or the average of the sublotsexceeds tolerances, all product will beretained and allowed to drain until thetarget pump has been reached.

** Documentation—All greenweights, finished product weights, andcorrective actions, if needed, will berecorded in the finished product logbook.

Note: Model also can be used indeveloping the following PQC programs:

Percent Labeling ControlWater-misted/Ice-glazed Meat and

Poultry ProductsAddition of Solution to Raw/Cooked

Meat and Poultry Products (Injection,Massaging, Tumbling, Basting,Marination, and Tenderization)

Fat and/or added water for Raw Product

Model 2.. Preparation of a PQC Programfor Fat-Content-per-Serving Labeling forMeat and Non-Meat Products

Scales/Meters

* Establish verification procedures toensure that all scales/meters used in theformulation and analytical testing of theproduct are accurate. The procedureshould include checks against astandard weight or measurement.

Lotting

* Define lot and sublot.* Establish a standardized procedure

for identifying the lot throughout theprocess.

Formulation

* Establish a procedure to verify theformulation of each lot/sublot incompliance with the approved labelformulation.

* Establish tolerances for non-restricted ingredients.

* No ingredient in the formulationshould be substituted for another.Fat content of the meat portion (ground

beef, ground pork, or products with adeclared fat limit on the label)* Establish a statistically sound

sampling procedure for each lot/sublotof the meat portion.

* Identify the analytical methodused, such as an AOAC method. WeightControl (serving and component).

* Establish a statistically soundsampling procedure to ensure that eachportion and component of the productwithin a lot/sublot is checked againstthe label transmitted.

* Raw weights—The weight ischecked on all portions and componentson finished raw and cooked products.

* Cooked weights—Cooked weightsare checked and compared with theportion size stated on the transmittal


and on the Child Nutrition (CN) label.Weights also are checked for precookedcomponents of products againstinformation on the label transmittal.

* The sampling plans and tolerancesshould be based on generally recognizedstatistical process control methods andshould ensure that the process is incontrol and that applicable product orlabel limits are being met.

* Each CN product should have itsown lot average.

Batter and Breading (if applicable)* Establish a procedure to verify that

the batter/breading application does notexceed regulatory limits, labeldeclarations, or product standards. Themonitoring procedure should identifythe following:

** pre-batter/breading applicationweight

** sample size** sample frequency** post-batter/breading application

weight* Post-batter/breading weight should

be determined at the end of theapplication procedure and beforefurther processing. Note: Model also canbe used in developing the followingPQC programs:

Batter and BreadingFES Labeling Content for Meat and

Non-Meat ProductsPrecooked Breakfast Sausage Yield

Control

Model 3. Low Temperature Renderingfor the Production of Partially DefattedChopped (P.C.) Beef/Pork, Fat-ReducedSpecies, and Partially Defatted Beef/Pork Fatty Tissue

Raw Materials Control* Define a lot and sublot* If producing P.C. beef/pork or fat-

reduced species, establish a statisticallybased sampling procedure to ensure thelot is in compliance with raw materialrequirements (12 percent lean).

Heat Processing* Identify processing temperature

(minimum and maximum).

* Identify the target processing time,which is the time the product issubjected to the target.

* Establish procedures for monitoringprocessing temperatures and times.

Cooling and Freezing Controls* Identify the cooling and freezing

temperatures for the finished product.* Identify the amount of time the

cooling and freezing process will take toreach established temperatures.

Microbiological* If the cooling/freezing process

(starting from the time heat is applieduntil the product is 40 degrees F forless) exceeds 30 minutes, amicrobiological sampling procedureshould be developed. The followingsampling procedures and limits havebeen used in PQC programs in the past,and current regulations permit theircontinued use.

** Using a statistically basedsampling plan, select two samples perlot from the raw material and finishedproducts.

** Test samples for total plate count,coliforms, E. coli, and C. Perfringens.

** Demonstrate that the process doesnot increase the product’s microbialload by 1 log or more.

** Sampling can be reduced to oneper lot when control has beendemonstrated in three consecutive lots.

Finished Product Controls* If producing finely textured lean or

finely textured extra lean, productshould be tested for fat, protein, andprotein efficiency ratio (PER) oressential amino acid (EAA).

* Incorporate the sampling procedurefor fat and protein.

** Individual—Obtain a one-poundsample from each lot. After 10consecutive analyses are in compliancewith single sample limits, sampling maybe reduced to one randomly sampled lotout of every three lots.

** Process Average—A process(moving) average of 10 lots should bemaintained.

Sampling Procedures for PER/EAA

* Initially, each lot should be heldand tested until compliance has beenestablished. Once compliance has beenestablished in three consecutive lots,sampling may be reduced. Samplingfrequency should begin with at least onesample per month until compliance hasbeen established. When threeconsecutive samples are in compliance,the frequency may be reduced to onesample every three months.

* Analytical Standard Limits

Finely Textured Lean Product

Individual;Fat—Maximum 30%Protein—Minimum 13%

Process Average:Fat—Maximum 30%Protein—Minimum 14%PER 2.5 orEAA 33%

Finely Textured Extra Lean SimilarProducts

Individual:Fat—Maximum 11%Protein—Minimum 13%

Process Average:Fat—Maximum 10%Protein—Minimum 14%PER 2.5 orEAA 33%

Corrective and Preventive Actions

* Develop corrective and preventiveactions for each critical check pointestablished.

Note: Model also can be used indeveloping the following PQC programs:Low Temperature Rendering for Control of

Partially Defatted Chopped Beef/PorkFat-Reduced Species and Partially Defatted

Beef/Pork Fatty Tissue

[FR Doc. 97–21882 Filed 8–22–97; 8:45 am]BILLING CODE 3410–DM–P

Documents

45016 Federal Register /Vol. 62, No. 164/Monday, August 25 ...effective sanitation and HACCP programs. FSIS agrees with the commenter that third-party programs can make a useful contribution