§318.300

(Hi)Brain or trigeminal ganglia. Skulth t enter the AMR system have ti -sue of brain or trigeminal ganglia.

(i Spinal cord. Vertebral colubone that enter the AMRsystem h vetissue of spinal cord. or the pro uctthat e its the AMR system con ainsspinal rd.

(v) D . The product that exiAMRsys em contains DRG.

(2)If pr duct that may not beor used a "meat" under thismeets the equirements of §319. of thissubchapter it may bear e name"Mechanic ly Separated pecies)"except as fo ows:

(i) If sk Is or vertebr columnbones of catt younger tha 30monthsof age that en r the AMR ystem havetissues of brai trigemin ganglia. orspinal cord. the roduct at exits theAMRsystem sh not be used as an in-gredient of a mea food oduct.

(ii) If product at xits the AMRsystem contains s in cord or DRGfrom bones of catt ounger than 30months of age. it s not be used asan ingredient of a me food product.

(iii) If product d rived from anybones of cattle of y age does notcomply with (c)(l)(i) (ii}, it may beara common or usual ame that is notfalse or misleadin. xcept that theproduct may not b ar the name .'Me-chanically Separat d ( eef)."

(3) Spent skulls~r ve tebral columnbone materials f om ttle youngerthan 30 months f age that exit the

rounded to the n~a est ioou, a d expressed asa percentage of t total wei t of the sam-ple. In lieu of dat demonstrat ng otherwise.the values of IP to be used in he above for-mula are as follows: For beef roducts thevalue of IPR is kqual to 0.104. ex ept for anycombination ~ bones that Inclu e any beefneckbone pro uct, for which th value of0.138 is to be sed; for pork product. the IPRvalue is 0.052 Other IPR values c be usedprovided th the operator of an e tabJish-ment has v ified and documented t e ratioof iron co tent to protein content in theskeletal uscle tissue attached to bonesprior to ,Tir entering the AMR s stem.based on .alyses of hand-deboned spies.and the ~cumented value is to b sub-stituted for the IPR value (as appltca e) inthe above formula with respect to pi uctthat the establishment mechanically sepa-rates from those bones.

9 CFR Ch. III (l-1-05 Edition)

AMRsystem al not be used as an in-gredient of a me food product.

[69 FR 1884. Jan. 2. 200

Subparts B-F [Reserved]

Subpart G-Canning and CannedProducts

SOURCE: 51 FR 45619, Dec. 19. 1986, unlessotherwise noted.

§318.300 Definitions.(a) Abnormal container. A container

with any sign of swelling or productleakage or any evidence that the con-tents of the unopened container may bespoiled.

(b) Acidified low acid product. Acanned product which has been formu-lated or treated so that every compo-nent of the finished product has a pH of4.6 or lower within 24 hours after thecompletion of the thermal process un-less data are available from the estab-lishment's processing authority dem-onstrating that a longer time period issafe.

(c)Bleeders. Small orifices on a retortthrough which steam. other gasses, andcondensate are emitted from the retortthroughout the entire thermal process.

(d) Canned product. A meat food prod-uct with a water activity above 0.85which receives a thermal process eitherbefore or after being packed in a her-metically sealed container. Unless oth-erwise specified, the term "product" asused in this subpart G shall mean"canned product."

(e) Closure technician. The indi-vidual(s) identified by the establish-ment as being trained to perform spe-cific container integrity examinationsas required by this subpart and des-ignated by the establishment to per-form such examinations.

(f) Code lot. All production of a par-ticular product in a specific size con-tainer marked with a specific con-tainer code.

(g) Come-up time. The elapsed time,including venting time (if applicable),between the introduction of the heat-ing medium into a closed retort andthe start of process timing.

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(h) Critical factor. Any characteristic,condition or aspect of a product, con-tainer, or procedure that affects theadequacy of the process schedule. Crit-ical factors are established by proc-essing authorities.

(I) Headspace. That portion of a con-tainer not occupied by the product.

(1) Gross headspace. The vertical dis-tance between the level of the product(generally the liquid surface) in an up-right rigid container and the top edgeof the container (i.e., the flange of anunsealed can, the top of the doubleseam on a sealed can, or the top edge ofan unsealed jar).

(2) Net headspace. The vertical dis-tance between the level of the product(generally the liquid surface) in an up-right rigid container and the insidesurface of the lid.

(j) Hermetically sealed containers. Air-tight containers which are designedand intended to protect the contentsagainst the entry of microorganismsduring and after thermal processing.

(1) Rigid container. A container, theshape or contour of which, when filledand sealed, is neither affected by theenclosed product nor deformed by ex-ternal mechanical pressure of up to 10pounds per square inch gauge (0.7 kg!ems) (t.e., normal firm finger pressure).

(2) Semirigid container. A container,the shape or contour of which, whenfilled and sealed, is not significantlyaffected by the enclosed product undernormal atmospheric temperature andpressure, but can be deformed by exter-nal mechanical pressure of less than 10pounds per square inch gauge (0.7 kg!crn-) (i.e., normal firm finger pressure).

(3) Flexible container. A container, theshape or contour of which, when filledand sealed, is significantly affected bythe enclosed product.

(k) Incubation tests. Tests in whichthe thermally processed product iskept at a specific temperature for aspecified period of time in order to de-termine if outgrowth of microorga-nisms occurs.

(1) Initial temperature. The tempera-ture, determined at the initiation of athermal process cycle, of the contentsof the coldest container to be proc-essed.

§318.300

(m) Low add product. A canned prod-uct in which any component has a pHvalue above 4.6.

(n) Process schedule. The thermalprocess and any specified critical fac-tors for a given canned product re-quired to achieve shelf stability.

(0) Process temperature. The minimumtemperature(s) of the heating mediumto be maintained as specified in theprocess schedule.

(p) Process time. The intended time(s)a container is to be exposed to theheating medium while the heating me-dium is at or above the process tern-perature(s) .

(q) Processing authority. The person(s)or organization(s) having expert knowl-edge of thermal processing require-ments for foods in hermetically sealedcontainers, having access to facilitiesfor making such determinations, anddesignated by the establishment to per-form certain functions as indicated inthis subpart.

(r) Program employee. Any inspectoror other individual employed by theDepartment or any cooperating agencywho is authorized by the Secretary todo any work or perform any duty inconnection with the Program (see§301.2(f).

(s) Retort. A pressure vessel designedfor thermal processing of productpacked in hermetically sealed con-tainers.

(t) Seals. Those parts of a semirigidcontainer and lid or of a flexible con-tainer that are fused together in orderto hermetically close the container.

(u) Shelf stability. The conditionachieved by application of heat, suffi-cient, alone or in combination withother ingredients and/or treatments, torender the product free of microorga-nisms capable of growing in the prod-uct at nonrefrigerated conditions (over50 OF or 10°C) at which the product isintended to be held during distributionand storage. Shelf stability and shelfstable are synonymous with commer-cial sterility and commercially sterile,respectively.

(v) Thermal process. The heat treat-ment necessary to achieve shelf sta-bility as determined by the establish-ment's processing authority. It isquantified in terms of:

(1)Time(s) and temperature(s); or

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§318.301

(2)Minimum product temperature.(w) Venting. The removal of air from

a retort before the start of process tim-ing.

(x) Water activity. The ratio of thewater vapor pressure of the product tothe vapor pressure of pure water at thesame temperature.

§318.301 Containers and closures.(a) Examination and cleaning of empty

containers. (1) Empty containers, clo-sures, and flexible pouch roll stockshall be evaluated by the establish-ment to ensure that they are clean andfree of structural defects and damagethat may affect product or containerintegrity. Such an examination shouldbe based upon a statistical samplingplan.

(2) All empty containers, closures,and flexible pouch roll stock shall bestored, handled, and conveyed in such amanner that will prevent soiling anddamage that could affect the hermeticcondition of the sealed container.

(3) Just before filling, rigid con-tainers shall be cleaned to prevent in-corporation of foreign matter into thefinished product. Closures, semirigidcontainers, preformed flexible pouches,and flexible pouch roll stock containedin original wrappings do not need to becleaned before use.

(b) Closure examinations for rigid con-tainers (cans)-(l) Visual examinations. Aclosure technician shall visually exam-ine the double seams formed by eachclosing machine head. When seam de-fects (e.g., cutovers, sharpness,knocked down flanges, false seams,droops) are observed, necessary correc-tive actions, such as adjusting or re-pairing the closing machine, shall betaken. In addition to the double seams,the entire container shall be examinedfor product leakage or obvious defects.A visual examination shall be per-formed on at least one container fromeach closing machine head, and the ob-servations, along with any correctiveactions, shall be recorded. Visual ex-aminations shall be conducted withsufficient frequency to ensure properclosure and should be conducted atleast every 30 minutes of continuousclosing machine operation. Additionalvisual examinations shall be made bythe closure technician at the beginning

9 CFRCh. III (1-1-05 Edition)

of production, immediately followingevery jam in the closing machine andafter closing machine adjustment (in-cluding adjustment for changes in con-tainer size).

(2) Teerdown examinations. Teardownexaminations of double seams formedby each closing machine head shall beperformed by a closure technician at afrequency sufficient to ensure properclosure. These examinations should bemade at intervals of not more than 4hours of continuous closing machineoperation. At least one container fromeach closing head shall be examined onthe packer's end during each regularexamination period. Examination re-sults along with any necessary correc-tive actions, such as adjusting or re-pairing the closing machine, shall bepromptly recorded by the closure tech-nician. The establishment shall havecontainer specification guidelines fordouble seam integrity on file and avail-able for review by Program employees.A teardown examination of the canmaker's end shall be performed on atleast one container selected from eachclosing machine during each examina-tion period except when teardown ex-aminations are made on incomingempty containers or when, in the caseof self-manufactured containers, thecontainers are made in the vicinity ofthe establishment and the containerplant records are made available toProgram employees. Additional tear-down examinations on the packer's endshould be made at the beginning of pro-duction, immediately following everyjam in a closing machine and afterclosing machine adjustment (includingadjustment for a change in containersize). The following procedures shall beused in teardown examinations of dou-ble seams:

(i) One of the following two methodsshall be employed for dimensionalmeasurements of the double seam.

(a) Micrometer measurement. For cylin-drical containers, measure the fol-lowing dimensions (Figure 1) at threepoints approximately 120degrees aparton the double seam excluding and atleast one-half inch from the side seamjuncture:

(1)Double seam length-W;(~ Double seam thickness-S;(3) Body hook length-BH; and

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Food Safety and Inspection Service, USDA

(4)Cover hook length-CH.

§318.301

Maximum and rrummum values foreach dimensional measurement shallbe recorded by the closure technician.

w1BH1

I-.Oil--- S--- ••...1

tot

CH

+

Body~

(b) Seamscope or seam projector. Re-quired measurements of the seam in-clude thickness. body hook. and over-lap. Seam thickness shall be obtainedby micrometer. For cylindrical con-tainers. at least two locations. exclud-ing the side seam juncture. shall be

used to obtain the required measure-ments.

(it) Seam tightness. Regardless of thedimensional measurement method usedto measure seam dimensions. at a min-imum. the seam(s) examined shall be

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§318.301

stripped to assess the degree of wrin-kling.

(iii) Side seamjuncture rating. Regard-less of the dimensional measurementmethod used to measure seam dimen-sions, the cover hook shall be strippedto examine the cover hook droop at thejuncture for containers having sideseams.

(rv) Examination of noncylindrical con-tainers. Examination of noncylindricalcontainers (e.g., square, rectangular,"D"-shaped, and irregularly-shaped)shall be conducted as described in para-graphs (b)(2) (i), (ii), and (iii) of thissection except that the required dimen-sional measurements shall be made onthe double seam at the points listed inthe establishment's container speci-fication guidelines.

(c) Closure examinations for glass con-tainers-(l) Visual examinations. A clo-sure technician shall visually assessthe adequacy of the closures formed byeach closing machine. When closure de-fects, such as loose or cocked caps,fractured or cracked containers andlow vacuum jars, are observed, nec-essary corrective actions, such as ad-justing or repairing the closing ma-chine shall be taken and recorded. Inaddition to the closures, the entirecontainer shall be examined for de-fects. Visual examinations shall bemade with sufficient frequency to en-sure proper closure and should be con-ducted at least every 30 minutes of con-tinuous closing machine operation. Ad-ditional visual examinations shall bemade by the closure technician and theobservations recorded at the beginningof production, immediately followingevery jam in the closing machine, andafter closing machine adjustment (in-cluding adjustment for a change incontainer size).

(2) Closure examinations and tests. De-pending upon the container and clo-sure, tests shall be performed by a clo-sure technician at a frequency suffi-cient to ensure proper closure. Theseexaminations should be made eitherbefore or after thermal processing andat intervals of not more than 4 hours ofcontinuous closing machine operation.At least one container from each clos-ing machine shall be examined duringeach regular examination period. Ex-amination results along with any nee-

9 CFR Ch. III (1-1-Q5 Edition)

essary corrective actions, such as ad-justing or repairing the closing ma-chine, shall be promptly recorded bythe closure technician. The establish-ment shall have specification guide-lines for closure integrity on file andavailable for review by Program em-ployees. Additional closure examina-tions should be made at the beginningof production, immediately followingevery jam in the closing machine, andafter closing machine adjustment (in-cluding adjustment for a change incontainer size).

(d) Closure examinations for semirigidand flexible containers-(l) Heat seals-(I) Visual examinations. A closure tech-nician shall visually examine the sealsformed by each sealing machine. Whensealing defects are observed, necessarycorrective actions, such as adjusting orrepairing the sealing machine, shall betaken and recorded. In addition to ex-amining the heat seals, the entire con-tainer shall be examined for productleakage or obvious defects. Visual ex-aminations shall be performed beforeand after the thermal processing oper-ation and with sufficient frequency toensure proper closure. These examina-tions should be conducted at least inaccordance with a statistical samplingplan. All defects noted and correctiveactions taken shall be promptly re-corded.

(ii) Physical tests. Tests determinedby the establishment as necessary toassess container integrity shall be con-ducted by the closure technician at afrequency sufficient to ensure properclosure. These tests shall be performedafter the thermal processing operationand should be made at least every 2hours of continuous production. Theestablishment's acceptance guidelinesfor each test procedure shall be on fileand available for review by Programemployees. Test results along with anynecessary corrective actions, such asadjusting or repairing the sealing ma-chine, shall be recorded.

(2) Double seams on semirigid orflexible containers shall be examinedand the results recorded as provided inparagraph (b) of this section. Anyaddi-tional measurements specified by thecontainer manufacturer shall also bemade and recorded.

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