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    CFSAN/Office of Compliance

    June 16, 2006; Revised Octoe! 200"

    #a$a!ds % Cont!ols &uide Fo! 'ai!( Foods #ACC)Guidance for Processors

    Version 1.1 June 16, 2006

    *ale of ContentsI. In tro du ction Page 2

    A. Status

    B. PurposeC. Comparison it! t!e "#A Juice $ACCP %egu&ations

    #. Scope and 'imitations

    II. (er m s and #e f initions Page )

    III. *+ er +ie of t! e CI - S $A CCP P r o g ram Page 6

    A. Vo&untar ature of t!e Program

    B. /e %euirements of t!e CI-S $ACCP Program

    IV. Prer e uisite Progra m s Page

    A. %euired Prereuisite Programs

    B. Accepta&e 'e+e& of Protection Prereuisite ProgramsV. $a3ard Ana&sis Page 10

    A. Preparing for a $a3ard Ana&sis 4 "i+e Pre&iminar Steps

    B. *+er+ie of t!e $a3ard Ana&sis

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    - -nt!oduction

    A Status

    (!is $a3ards and Contro&s Guide represents t!e ationa& Conference on Interstate -i&: S!ipments

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    Reui!ements F'A Juice #ACC) NC-S #ACC)

    Reulation -mplementation'ates3 12202 'arge Business

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    Reui!ements F'A Juice #ACC) NC-S #ACC)

    Reco!d Retention 1 ear after t!e production of t!e

     product

    At &east 1 ear after t!e date t!at

    suc! products ere prepared.

    Reco!d Retention 2 ears for fro3en, preser+ed or 

    s!e&f sta&e, or t!e s!e&f &ife of t!e product, !ic!e+er is greater.

    In t!e case of fro3en, preser+ed or 

    s!e&f sta&e products 2 ears or t!es!e&f &ife of t!e product !ic!e+er 

    is greater, after t!e date t!at t!e

     products ere prepared un&ess

    &onger retention time is reuired

      ot!er regu&ations.

    -ndust!( *!ainin 5#ACC) plan

    develope!s, validato!s and !eco!d

    !evie.e!s o! e1uivalent

    e:pe!ience

    @es

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    -- *e!ms and 'efinitions

    A. A7'-*3 An e+a&uation of t!e entire mi&: p&ant, recei+ing station or transfer station faci&it and CI-S $ACCP Sstem to ensure comp&iance it! t!e CI-S $ACCP Sstem and ot!er CI-S

    regu&ator reuirements.

    B. Cent!ali$ed 'eviation 8o3 A centra&i3ed &og or fi&e identifing data detai&ing an de+iation of critica& &imits and t!e correcti+e actions ta:en as reuired in Appendi; / of t!e Pasteuri3ed -i&: *rdinance #ACC) COR C7RR-C7873 (!e core curricu&um consists ofH

    1. Basic $ACCP training p&us

    2. An orientation to t!e reuirements of t!e CI-S $ACCP Program

    J. 'F-C-NC>3 An e&ement inadeuate or missing from t!e reuirements of t!e $ACCP Sstem

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    %. #A@AR' ANA8>S-S3 (!e process of co&&ecting and e+a&uating information on !a3ards

    associated it! t!e mi&: under consideration, to decide !ic! are reasona&e &i:e& to occur andmust e addressed in t!e $ACCP P&an.

    S. ON-*OR3 (o conduct a p&anned seuence of oser+ations or measurements to assess t!at a CCPis under contro& or to assess t!e conditions and practices of a&& reuired Prereuisite Programs.

    (. NON=CONFOR-*>3 A fai&ure to meet specified reuirements of t!e $ACCP Sstem asdescried in Appendi; / of t!e P-*.

    . )O*N*-A8 #A@AR'3 An !a3ard to e e+a&uated t!e !a3ard ana&sis.

    V. )RR7-S-* )RO&RAS 5))9s3 Procedures, inc&uding Good -anufacturing Practices

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    Industr, State and "edera& regu&ator and &isting personne& s!ou&d e trained toget!er.

    a. $ACCP (raining

    •  Core Curricu&um. (!e #air $ACCP Core curricu&um consists ofH1. Basic $ACCP training p&us

    2. An orientation to t!e reuirements of t!e CI-S $ACCP Program.

    Basic $ACCP training consists of instruction in t!e app&ication of t!e AC-C" Princip&es of$ACCP to "ood Safet. (!is training inc&udes practica& e;ercises in conducting a !a3ard ana&sis

    and e+a&uating potentia& !a3ards in riting a $ACCP P&an, and in t!e +a&idation of t!e p&an. Its!ou&d e taug!t e;perienced instructors.

    (!e orientation component idea&& is coup&ed it! t!e asic $ACCP training, ut can e taug!t

    separate&. (!e content of t!e orientation i&& e conducted under t!e guidance of t!e CI-S. It is

    intended to fami&iari3e industr and regu&ator personne& it! specific dair $ACCP concerns andt!e regu&ator reuirements under t!e CI-S $ACCP Program. It is to e taug!t instructors

    e;perienced in t!e app&ication of $ACCP under t!e CI-S $ACCP Program.

    (!e industr indi+idua&o e;perience ma ua&if an indi+idua& to perform t!ese functions if t!e e;perience !as pro+ided :no&edge at &east eui+a&ent to t!at pro+ided t!roug! t!e standardi3edcurricu&um.

    •  Industr Personne&H *n& industr indi+idua&s !o !a+e met t!e reuirements of Part 1 of Appendi; / Section III of t!e Pasteuri3ed -i&: *rdinance

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    •  (!e ritten $ACCP P&an

    •  %euired $ACCP documents and forms specified in a.1= t!roug! 7= of t!is Section s!a&& e

    dated or identified it! a +ersion numer. ac! page s!a&& e mar:ed it! a ne date or

    +ersion numer !ene+er t!at page is updated.•  A (a&e of Contents and centra&i3ed &ist of t!e $ACCP program records, tit&e,

    documenting t!e ongoing app&ication of t!e $ACCP Sstem s!a&& e maintained and pro+ided for re+ie.

    •  A document c!ange &og s!a&& e :ept.

    •  %ecords documenting t!e ongoing app&ication of t!e $ACCP P&an t!at inc&udeH

    1. -onitoring of Critica& Contro& Points and t!eir Critica& 'imits, inc&uding t!e recording

    of actua& times, temperatures, or ot!er measurements, as prescried in t!e p&antNsrecei+ing stationNs or transfer stationNs $ACCP P&an

    a. Correcti+e actions, inc&uding a&& actions ta:en in response to a de+iation.

     . A centra&i3ed de+iation &og is reuired and

    c. P&an +a&idation dates.

    d. %ecords documenting +erification and +a&idation of t!e $ACCP Sstem, inc&udingt!e $ACCP P&an, !a3ard ana&sis and PPNs.

    2. Genera& %euirementsH %ecords reuired inc&udeHa. (!e identit and &ocation of t!e mi&: p&ant, recei+ing station or transfer station

     . (!e date and time of t!e acti+it t!at t!e record ref&ects

    c. (!e signature or initia&s of t!e person

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    transfer station faci&it for at &east to

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    "reuent&, ot! $ACCP P&an CCPNs and PPNs contro& measures are necessar to contro& a food safet!a3ard.

    $ACCP ma e imp&emented on& in a faci&it t!at is constructed and operated to pro+ide a sanitaren+ironment. -i&: p&ant, recei+ing station or transfer station premises, ui&ding construction, maintenance,

    and !ouse:eeping s!a&& e maintained in a manner sufficient to pro+ide suc! an en+ironment. (!ese factorss!a&& e contro&&ed effecti+e p&ant, recei+ing station or transfer station programs or PPNs, as t!e p&ant,

    recei+ing station or transfer station c!ooses.

    PPs are t!e uni+ersa& procedures used to contro& t!e condition of t!e p&ant en+ironment t!at contriute tot!e o+era&& safet of t!e product. (!e represent t!e sum of programs, practices and procedures t!at must

     e app&ied to produce and distriute safe products in a c&ean, sanitar en+ironment. (!e differ from CCPNsin t!at t!e are asic sanitation programs t!at reduce t!e potentia& occurrence of a food safet !a3ard."reuent&, ot! $ACCP P&an CCPNs and PPNs contro& measures are necessar to contro& a food safet!a3ard. (!e e;act set of PPNs i&& +ar since t!eir app&ication is product and process specific. (!e e;istenceand effecti+eness of PPNs s!ou&d e assessed during t!e design and imp&ementation of eac! $ACCP P&an.PPNs s!ou&d e documented and regu&ar& audited. An audit re+ie consists of +erifing t!at t!e compan!as a program imp&emented t!at indicates !o t!e compan monitors and contro&s eac! of t!e PPNs. PPNsare esta&is!ed and managed separate& from t!e $ACCP P&an.

    ? #a$a!d Anal(sis

    A )!epa!in fo! a #a$a!d Anal(sis = Five )!elimina!( Steps

    A&t!oug! not reuired t!e CI-S $ACCP a&ternati+e, t!e ) pre&iminar steps of $ACCP as out&ined  t!e ationa& Ad+isor Committee of -icroio&ogica& Criteria for "oods

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    of dair product un&ess different tpes of dair products !a+e identica& !a3ards and contro&measures t!at can e comined into one !a3ard ana&sis.

    #o not conduct t!e !a3ard ana&sis unti& t!e prereuisite programs !a+e een de+e&oped,imp&emented and documented. (!is $a3ard and Contro&s Guide ma e used to aid in constructing

    and e+a&uating t!ose prereuisite programs to e considered in t!e !a3ard ana&sis. (!e !a3ard

    ana&sis ma point out t!e need for additiona& prereuisites.

    2. %e&e+ance to $ACCP P&an and Prereuisite Programs

    A&& processors t!at decide to participate in t!e CI-S $ACCP a&ternati+e are reuired to prepare a

    ritten !a3ard ana&sis. If ou determine t!at an !a3ard is ?reasona& &i:e& to occur? in a particu&ar product, ou must contro& t!at !a3ard in t!e product app&ing contro& measures as partof a proper& designed and imp&emented $ACCP p&an, e;cept t!at some !a3ards can e managed

    under our PPNs. If ou determine t!at no !a3ards are ?reasona& &i:e& to occur,? ou are not

    reuired to de+e&op a $ACCP P&an, ut ou must esta&is! and imp&ement PPNs. @our PP

    monitoring and correction records and our !a3ard ana&sis are sti&& su>ect to t!e record :eepingand officia& record re+ie reuirements. nder t!e CI-S $ACCP sstem, pasteuri3ation must

    a&as e managed as a CCP. sefu& e;amp&es of ot! atc! and continuous f&o pasteuri3ation

    can e found in t!e P-*, Appendi; $.

    7. #e+e&oped $ACCP4trained mp&oee or Consu&tant

    @our !a3ard ana&sis must e de+e&oped an appropriate& trained indi+idua&

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    Va&idation of processes reuiring measurement of t!e production of enteroto;in is

    e;pensi+e and difficu&t. $oe+er, during t!e 200) CI-S, t!e CI-S ScientificCommittee re+ieed and accepted some usefu& guide&ines t!at !a+e een actua&&

    incorporated into t!e P-*.

    (!ese guide&ines, e&o, s!ou&d e construed genera&& as ?safe !aror? !enconducting !a3ard ana&ses and +a&idating contro& measuresH

    Ba&ance tan:s or surge tan:s it! an a+erage retention time of one !our or &ess ma

     e safe& operated for up to 29 !ours regard&ess of product temperature in ot!

     pasteuri3ed and unpasteuri3ed dair products.

    Pasteuri3ed mi&: and mi&: products to e condensed andor dried, can e maintainedat a temperature of 10C

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    +ad +u +ooE 

    .S. "ood D #rug Administration Center for "ood Safet D App&ied  ,utrition

    Foodou!ne )atoenic ic!oo!anisms

    and Natu!al *o:ins #andooE 

    Facto!s Affectin te &!o.t of Some Foodou!ne )atoens

    &!o.t *empe!atu!e

    5C6

    &!o.t p# &!o.t a.O!0anism

    6.) 4 95 9.) 4 O 0.)

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    1. (!is section of t!e "#A N s Co m p&iance Po&ic Guide #ea&s it! "ood A&&ergens

    2. "#A A&&erg Inspection Guide

    7. "ood A&&ergen 'ae&ing and Consu m er Protection Act of 2009

    9. I#"A, I#"ANs #air $ACCP P&ant -anua&

    ). #eie&, /., (. (rautman, (. #eBoom, F. $. S+eum, G. #unaif, V. . Scott, D #.(. Bernard. 15. A Compre!ensi+e Approac! to %educing t!e %is: of A&&ergens in"ood. ournal o/ 0ood Protection. Vo&. 60, o. 9H 9764991.

    4ile not . itin te sc o pe of te NC- S 'ai!( p!odu c t sa f et( #ACC) s(ste m , it

    is necessa ! ( fo! milE pl a nts tat m a nufactu!e Guice o! ote! food p ! odu c ts us in

    common e uipment fo! ot milE o! milE p!oducts and t es e ote! fo od s to t a Eep!ecautions to p!event c ontamination of tese foods . it milE alle!ens 

     . A&&ergens and sustances t!at cause food sensiti+ities added to dair products as

    ingredients.

    A&&ergens are not present in a&& products. Sc!edu&ing product c!angeo+ers and runmatrices, &ae&ing, and sanitation practices are suggested prereuisite programs used to

    manage products containing a&&ergens. Some products uice= can contain ingredients suc! as

    so protein or preser+ati+es, suc! as su&fites, t!at can cause a&&ergic or food into&erancereactions in sensiti+e indi+idua&s. (!e presence of an ingredient must e dec&ared on

    t!e &ae& in accordance it! t!e food &ae&ing regu&ations in 21 C"% Part 101. Programs

    to ensure t!at t!e proper &ae&s are used s!ou&d e part of t!e PP it!in t!e $ACCP

    Program. Ingredient contro&s s!ou&d e imp&emented for t!e ig eig!t a&&ergens andingredients !ic! cause food sensiti+ities.

    c. C&eaning and Saniti3ing C!emica& %esidues

    C&eaning c!emica& and saniti3ers are used ide& in dair p&ants (!e proper use of

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    t!e .S. !as demonstrated t!at domestica&& gron fruits and +egeta&es !a+e a !ig!

    &e+e& of comp&iance it! .S. pesticide to&erance regu&ations and t!at t!e occurrence of un&afu& pesticide residues in food is &i:e& to e infreuent and un&i:e& to !a+e a

    se+ere pu&ic !ea&t! impact. Based on current regu&ator programs and "#A mar:et as:et sur+es, pesticide residues do not present food !a3ard &i:e& to occur in dair

     products and do not need to e addressed in t!e !a3ard ana&sis.

    Anima& drug residues are present at &o &e+e&s in a +er &o percentage of ra mi&:recei+ed at mi&: p&ants in t!e .S. (!ese residues are regu&ated under P-* Appendi;

    for ot! t!e traditiona& and t!e $ACCP a&ternati+e sstems.

    Information in recent ationa& -i&: #rug %esidue #ataase %eports s!oed t!at &esst!an one4tent! of 1 percent of mi&: samp&es from u&: mi&: pic:4up tan:ers

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    ?- *e #ACC) #a$a!d 'ecision )!ocess

    a valuate All )otential #a$a!ds

    +a&uate eac! of t!e potentia& !a3ards

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    f  Cont!ols fo! )otential #a$a!ds A!isin f!om Food Contact Su!faces

    $a3ards can occur in mi&: due to unsanitar food contact surfaces t!at can contaminate mi&: it!

     pat!ogens or it! residua& a&&ergens from product processed on t!e euipment in prior runs t!at can causea&&ergic reactions in sensiti+e indi+idua&s. $a3ards t!at arise from unsanitar food contact surfaces !a+e t!e

     potentia& to affect t!e safet of a mi&: product ecause t!e arise from points it!in t!e process and not

    from genera& conditions it!in t!e faci&it. Contro& of t!ese !a3ards ma e accomp&is!ed t!e use of

    Prereuisite Programs. "or e;amp&e, an appropriate PP cou&d e to esta&is! a procedure for c&eaningeuipment it! a c&eaning so&ution, e.g., a pre4rinse fo&&oed a caustic as! fo&&oed a rinse. (!e

     procedure cou&d inc&ude maintaining a &og of !ic! foods, e.g., >uice, eggnog, so drin:s, ere processedon t!e euipment, t!e seuence in !ic! t!e foods ere processed, and !o!en t!e euipment as

    c&eaned. (!e operator cou&d c!ec: t!at &og prior to starting an production run for mi&:. (!e procedurecou&d pro+ide t!at t!e euipment ou&d not e used for mi&: unti& t!e prescried c&eaning procedure as

    carried out, recorded in t!e &og, and t!e euipment as +isua&& c!ec:ed for c&ean&iness.

      -dentif( Cont!ol easu!es and CC)s

      #ACC) Cont!ol easu!es

    nder t!e +o&untar $ACCP a&ternati+e, ou are reuired to imp&ement $ACCP contro& measures if oudetermine in our !a3ard ana&sis t!at a food !a3ard is reasona& &i:e& to occur in our dair product.

    ;amp&es of $ACCP contro& measures used in t!e processing of dair products inc&ude measures carried

    out at CCPs specified in a $ACCP p&an suc! as pasteuri3ation of dair products for t!e e&imination or

    reduce to an accepta&e &e+e& of micoio&ogica& pat!ogens

    1. Contro& -easures for Bio&ogica& $a3ards

    (!e pasteuri3ation of mi&: is t!e most effecti+e sing&e contro& measure for protecting consumersfrom pat!ogenic microorganisms. (!erefore, t!e pasteuri3ation process is a reuired contro&

    measure for pat!ogens.

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    anima& drug residue present in t!e ra mi&:. (!e monitoring record for t!is CCP i&& e t!eanima& drug residue testing record maintained t!e on4site industr &aorator.

    c. "ood4grade +itamins 4 (!is c!emica& !a3ard, if deemed ?reasona& &i:e& to occur? i&& e

    contro&&ed a CCP at t!e point of in>ection or addition into t!e mi&: stream. (!e critica& &imiti&& e t!e "#A4esta&is!ed &e+e&s of +itamin A and # for f&uid drin:ing mi&: and possi&e t!eactua& measurement of t!e +itamin addition +ia pump speed or +o&ume per atc!. -onitoring

    i&& e ased on manua& &ogs capturing t!e actua& measurements of +itamin addition

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     AC-C" CCP #ecision (ree 1

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     AC-C" CCP #ecision (ree 2

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     AC-C" CCP #ecision (ree 4 I#"A -odification

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    ?--- Cont!ol easu!es

    A #ACC) Cont!ol easu!es

    nder t!e +o&untar $ACCP a&ternati+e, ou are not reuired to imp&ement contro& measures if oudetermine in our !a3ard ana&sis t!at a food !a3ard is not reasona& &i:e& to occur in our dair product.

    ;amp&es of $ACCP contro& measures used in t!e processing of dair products inc&ude measures carriedout at CCPNs specified in a $ACCP p&an suc! as pasteuri3ation of dair products for t!e e&imination or

    reduction to an accepta&e &e+e& of microio&ogica& pat!ogens.

    + Activities Not Conside!ed to e #ACC) Cont!ol easu!es1. *t!er %egu&ator %euirements t!at are not a part of t!e CI-S $ACCP Sstem

    a. %a -i&: Supp& Source

     . 'ae&ing Comp&iance

    c. Adu&teration

    d. 'icensing %euirements

    e. #rug %esidue and (race Bac: %euirements

    f. %egu&ator Samp&es in Comp&iance

    g. Appro+ed 'aorator ti&i3ed for t!e %egu&ator (ests and

    !. Pasteuri3ation uipment #esign and Insta&&ation

    2. G-Ps

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    -I )!epa!in fo! #ACC)

    A &ettin )eople Read(

    Successfu& imp&ementation of $ACCP reuires trained peop&e !o cooperate from t!e pre&iminar stagesto t!e imp&ementation and ongoing operation of t!e $ACCP sstem. Fe strong& recommend t!at ou

     egin it! Step 1 of AC-C"Ns ) pre&iminar steps of $ACCP, assem&ing a $ACCP team t!atinc&udes p&ant &e+e& and corporate &e+e& personne&.

    + #ACC) *!ainin and #ACC) Resou!ce ate!ials

    1. #air "oods $ACCP Core Curricu&um (raining

    2. S#A "#A $ACCP (raining Programs and %esources #ataase

    I #a$a!ds and Cont!ol &uide

    (!ese ta&es ma e used t!e mi&: p&ant $ACCP team as a guide to t!e identification of potentia&!a3ards t!at ma e associated it! t!e incoming ra materia&s

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    ). "#A Comp&iance Po&ic Guides

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    -N&R'-N* *>) OF )O*N*-A8 #A@AR' #A@AR' A''-*-ONA8

    OR )ROCSS #A@AR' #A@AR' RA*-ONA8  ANA&N* OR   RSO7RCS

    CON*RO8S

    t!e farm en+ironmentma ecome

    incorporated into t!e

    mi&:.

    )asteu!i$ed +ioloical +=13 +=13 +=13 I-S 'istmilE, eat Presence of $eat4treated mi&: $eat4treated mi&: or cream P-* Sec 5

    t!eated milE o! +egetati+e products ma not !a+e s!ou&d e treated as rac!eam, and Pat!ogens een !eated sufficient& mi&: and come fromcondensed to deacti+ate t!ese appro+ed sources.sEim milE organisms.

    +ioloical +=23 +=23 +=13 P-* Items 12p,Contamination Bu&: s!ipped Verif t!at tan: truc:s ere 15p, D 21p

      +egetati+e pasteuri3ed mi&: c&eaned and saniti3ed prior 74A SS 60) pat!ogens products ma !a+e een to pic:ing up t!e mi&: eing

    su>ect to un&oaded

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    *A+8 2 = -8B )8AN* )ROCSS-N& O)RA*-ONS 

    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    Receivin =ate!ials sipped( ulE tanEe!,

    e fluid milE andmilE p!oducts

    +ioloical +=13Contaminationit!

    +egetati+e pat!ogens.

    +=13(!e truc: un&oading area!as t!e potentia& to

    contaminate &iuid mi&:  products. (!ese products are

    norma&& transmittedt!roug! euipment t!at if unc&ean,

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    -N&R'-N*

    OR )ROCSS#A@AR' *>) OF

    #A@AR'#A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8

    RSO7RCSCemical C=13

    (o;ic

    C!emica&s

    C=13#e&i+er truc:s ma !a+e

     een used to transport to;icc!emica&s prior to food products or pac:aging

    materia&s.

    C=13Inspect +e!ic&es prior to un&oading for e+idence of unsanitar

    conditions, spi&&ed c!emica&s, off odors, of e+idence t!at mig!t

    indicate t!e de&i+ered product ma !a+e een contaminated.

    #PC E

    )(sical )=13;traneous-ateria&s

    )=13Ve!ic&es ma !a+e not eenmaintained in good repair or !a+e een used to carrmeta& or ood artic&es.

    12

    )=13Inspect +e!ic&es prior to un&oading for e+idence of foreignmateria&s t!at ma !a+e contaminated t!e product.

    #PC E

    Ra. ilE Sto!ae +ioloical +=13Contaminationit!+egetati+e

     pat!ogens

    +=13(!ese products are norma&&stored in +esse&s t!at, if unc&ean

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    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    Sto!ae, +lendin% Addition of 

    -n!edients

    +ioloical +=13Contamination

    it!

    +egetati+e

     pat!ogens

    +=13Pat!ogens can e present in

    t!e en+ironment in t!e dr &ending area. Product isusua&& e;posed during

     &ending. Ingredients ma ecome contaminated euipment t!at is unc&ean or

    unc&eana&e.

    +=13Verif t!at &ending euipment and associated &ines and +a&+es

    simi&ar appurtenances are constructed in suc! a a t!at t!e

    can e c&eaned. -aintain records t!at t!e are c&eaned as needed

     ut at &east eac! da used. -aintain t!e addition &ending

    en+ironment c&ean and re&ati+e& free of dust or soi& t!at cou&dcontaminate product during addition &ending. uipment used

    for addition &ending is constructed to minimi3e product or

    ingredient e;posure.

    #PC E74A SS 724, 674,

    D 57

    21C"% 110.7)

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    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    )(sical )=13;traneous

    -ateria&s

    )=13Inad+ertent addition of 

     pac:aging materia& and

    ot!er o>ects !ic! are

     present in t!e &ending area.

    )=13*pening of ingredients is conducted in a manner t!at i&&

    minimi3e t!e opportunit for its of pac:aging, cutting too&s,etc. from entering t!e product. Verification t!at, at some point int!e process ingredient or t!e mi&: product to !ic! t!e

    ingredient is added, i&& pass t!roug! a fi&ter, screen, sma&&orifice

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    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    +ioloical +=23Contamination

    it!

    +egetati+e

     pat!ogens

    +=23Pasteuri3er regenerator 

    sections !a+e een

    documented to occasiona&&

    &ea:. %a and pasteuri3ed

    mi&: are on opposite sidesof a meta& arrier

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    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    )asteu!i$ed ilE % ilE )!oductSto!ae 5:ceptd!( p!oducts

    +ioloical +=13Contamination

    it!

    +egetati+e

     pat!ogens

    +=13$uman i&&ness outrea:s

    !a+e een &in:ed to post4 pasteuri3ationcontamination of mi&: and

    mi&: products.11, 1), 16, 15

    +=13*penings and out&et +a&+es are capped !en not in use, ot!er 

    openings are c&osed it! tig!t fitting co+ers. Associated

     pipe&ines and simi&ar appurtenances are simi&ar& protected.

    Verif t!at storage +esse&s and associated &ines and +a&+es and

    simi&ar appurtenances are constructed in suc! a a t!e can ec&eaned. -aintain records storage +esse&s are c&eaned after eac!

    use. -aintain records t!at associated &ines and +a&+es and

    simi&ar appurtenances are c&eaned as needed ut at &east eac!

    da used.

    74A AP 60)74A SS 224 D

    674

    +ioloical +=23Grot! of 

    Vegetati+ePat!ogens

    +=23$uman i&&ness outrea:s!a+e een &in:ed to post4 pasteuri3ationcontamination of mi&: andmi&: products.

    11, 1), 16, 15

    +=23-aintain t!e temperature sufficient& &o to minimi3e t!egrot! of pat!ogens. C&ean t!e storage +esse&s and associated&ines and +a&+es and simi&ar appurtenances at freuencies t!at do

    not a&&o for acteria& grot! of pat!ogens in t!e product at t!e

     product temperature used. oteH If times or temperatures &ess

    stringent t!an specified in t!e P-* are to e used, t!e must e

    re+ieed and found accepta&e to t!e State and "#A.

    74A AP 60)

    Cemical C=13C&eaning DSaniti3ingSo&ution

    %esidues

    C=13Fit!out proper separation eteen c&eaning D

    saniti3ing so&utions and product t!ere cou&d e

     product contamination.

    C=13-aintain proper separation or p!sica& rea: eteen circuitscontaining c&eaning so&ution and +esse&s and &ines used tocontain product.

    P-* Item

    1)p

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    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    Cemical C=13C&eaning D

    Saniti3ing

    So&ution

    %esidues

    C=13Fit!out proper separation

     eteen c&eaning Dsaniti3ing so&utions and product t!ere cou&d e

     product contamination.

    C=13-aintain proper separation or p!sica& rea: eteen circuits

    containing c&eaning so&ution and +esse&s and &ines used to

    contain product.

    P-* Item1)p

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    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    +ulE )asteu!i$ed)!oduct = 8oad

    Out 5:cept '!()!oducts

    +ioloical +=13Contamination

    it!

    +egetati+e

     pat!ogens

    +=13Pat!ogens !a+e een found

    in u&: pasteuri3ed producteit!er from t!e &oad out process or from &oading into

    tan:ers !ic! !a+e not eenc&eaned and saniti3ed.

    , 11

    +=13'oad out product ?fitting to fitting? it! t!e truc: openings

    c&osed or ot!erise adeuate& protected. se and proper&

    maintain a sstem of &ies and +a&+es for &oad out t!at is separate

    from t!at used to recei+e products for pasteuri3ation or

    repasteuri3ation. (an: truc:s must not e used to !au&contaminating sustances suc! as unpasteuri3ed &iuid eggs

    it!out a t!roug! c&eaning and a detai&ed inspection. Verif t!at

    t!e truc:s ere c&ean and saniti3ed prior to &oading

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    -N&R'-N*OR )ROCSS

    #A@AR'*>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    +ioloical +=3#e+e&opment

    of (o;ins

    +=3#air products are cu&tured

    under conditions t!at ma

    a&&o to;in4producing

     acteria to gro and

     produce to;ins in t!e case of starter cu&ture fai&ure or

     partia& fai&ure.

    +=3(!e p&ant needs a procedure to !and&e ?S&o? +ats t!at i&&

    e&iminate t!e possii&it t!at cu&tured products containing to;ins

    so&d or distriuted as food.

    Cemical C=13

    C&eaning D

    Saniti3ing

    So&ution

    %esidues

    C=13Fit!out proper separation eteen c&eaning D

    saniti3ing so&utions and product t!ere cou&d e

     product contamination.

    C=13-aintain proper separation or p!sica& rea: eteen circuitscontaining c&eaning so&ution and +esse&s and &ines used tocontain product. If curd as! ater is treated it! adisinfectant, t!e &e+e&s s!a&& e contro&&ed to pre+entadu&teration.

    P-* Item

    1)p

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    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    a !ig! acid content product or roasted nuts, or f&a+oring e;tracts!a+ing !ig! a&co!o& content as part of a p&ant ua&it assurance programs to assure t!at t!ese ingredients do not contaminate t!edair product.

    Cemical C=13

    Contaminatesin t!e

    Ingredient

    C=13

    Ingredients ma containunintended contaminates.

    C=13

    Supp&ier guarantees otained for a&& post pasteuri3ation addedingredients.

    Cemical C=23

    A&&ergens

     eing mi;ed

    it! products

    t!at are not

    &ae&ed as

    containing

    a&&ergens.

    C=23"oods t!at contain

    undec&ared a&&ergens ma

    cause &ife t!reatening

    reactions in sensiti+e

    indi+idua&s.

    C=23Ingredient addition euipment suc! as !oppers and feeders and

    associated piping and +a&+es t!at are used for mi&: and mi&:

     products t!at contain a&&ergens

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    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    Cemical C=13C&eaning D

    Saniti3ing

    So&ution

    %esidues

    C=13Fit!out proper separation

     eteen c&eaning Dsaniti3ing so&utions and product t!ere cou&d e

     product contamination.

    C=13-aintain proper separation or p!sica& rea: eteen circuits

    containing c&eaning so&ution and +esse&s and &ines used to

    contain product.

    P-* Item1)p

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    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    Cemical C=13C&eaning D

    Saniti3ing

    So&ution

    %esidues

    C=13Fit!out proper separation

     eteen c&eaning Dsaniti3ing so&utions and product t!ere cou&d e

     product contamination.

    C=13-aintain proper separation or p!sica& rea: eteen circuits

    containing c&eaning so&ution and +esse&s and &ines used to

    contain product.

    P-* Item1)p

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    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8

    #A@AR' ANA&N* OR CON*RO8SA''-*-ONA8RSO7RCS

    Cemical  one

    )(sical  one

    Aseptic )!oduct =)!ocessin

    +ioloical +=13Contamination

      pat!ogens,

    suc! as C.)otuliniu%

    +=13Botu&ism to;in is one of t!emost to;ic sustances t!at

    can e found in food.1), 20, 21

    +=13nder t!e CI-S #air $ACCP program, aseptic processing

    and t!e design, construction and operation and testing of aseptic

     processing euipment must conform to a&& of t!e reuirementsof t!e Grade ?A? Pasteuri3ed -i&: *rdinance, 21C"% 10E and

    117, and t!e fi&ed process for t!e products eing produced.

     oteH If c&eaning freuencies are to e performed at freuencies

    &ess t!an t!ose specified in t!e P-* Item 12p, t!e are to e

    re+ieed and found accepta&e to t!e State and "#A.

    P-* Section )21 C"% 10E D

    117

    P-* Items 12p,1)p

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    -N&R'-N*OR )ROCSS #A@AR'

    *>) OF#A@AR' #A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8RSO7RCS

    Cemical C=23(o;ic or 

    carcinogenic

    sustances in

    t!e pac:aging

    C=23Pac:aging materia&, !ic!

    does not meet C"%reuirements, ma containto;ic or carcinogenic

    sustances.

    1E

    C=23Pac:aging materia& comes from a source t!at !as een +erified

    to e free of to;ic or carcinogenic sustances. *ne a to do

    t!is is to use pac:aging from I-S &isted sources.

    I-S 'ist21C"% 110.E0

    )(sical  one

    )!oduct lines and

    uipment

    5&ene!al

    Conce!ns

    +ioloical +=13Contamination  Vegetati+ePat!ogens

    +=13-a introduce pat!ogens if unc&ean or unc&eana&e.

    +=13Verif t!at product &ines and euipment are constructed in suc!a a t!at t!e can e c&eaned. -aintain records t!at storage+esse&s are c&eaned after eac! use. -aintain records t!at t!e product &ines and euipment c&eaned as needed nut at &east eac!da un&ess a &onger inter+a& !as een re+ieed and foundaccepta&e to t!e State and "#A.

    74A AP 60)

    P-* Item 10p,11p, D12p

    Cemical C=13

    A&&ergens

     eing mi;ed

    it! productst!at are not

    &ae&ed as

    containing

    a&&ergens

    C=13"oods ma contain

    undec&ared a&&ergens ma

    cause &ife t!reateningreactions in sensiti+e

    indi+idua&s.

    C=13Ingredient addition euipment suc! as !oppers and feeders and

    associated piping and +a&+es t!at are used for mi&: and mi&:

     products t!at contain a&&ergens

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    -N&R'-N*

    OR )ROCSS#A@AR'

    *>) OF

    #A@AR'#A@AR' RA*-ONA8 #A@AR' ANA&N* OR CON*RO8S

    A''-*-ONA8

    RSO7RCS

    )(sical  one

    Ai! 7nde!)!essu!e

    5-nco!po!ated intop!oduct o!

    di!ected at a foodcontact su!face

    +ioloical +=13

    Contamination

      Pat!ogens

    +=13Pat!ogens ma e

    introduced in t!e air supp&.

    +=13Air is dran from a c&ean area, is fi&tered at t!e inta:e as

    needed, and is pro+ided to t!e point of use oi& free and it! free

    of e;cess moisture. A fina& fi&ter is pro+ided as near as possi&e

    to t!e point of use to +erif t!ese aspects.

    P-* Appendi;$

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    92

    I- Refe!ences

    A )ulised *e:t

      A&3amora, S. -., -. S. (apia, and A. 'pe34-a&o 3ini%ally Processed 0ruits and Ve'eta)les Aspen Pu&is!ers, Inc.

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    •  Vander3ant, C. D #. ". Sp&ittstoesser 1 7H in /luid %il:  J #air Sci 1EE #ec51

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    •  "&eming et a& Pasteurized %il: as a eicle o/ in/ection in an out)rea: o/ listeriosis ng& J -ed 1E) "e712

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    •  -ac:e, Boogard, $aes and Barani ecoery o/ eat-in*ured &isteria %onocyto'en e s Int J "ood -icroio&, 19 Jun2217H 0olloin' Heat $oc:  J "ood Protection, 112E41171, Vo&. 60, o.

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    ndnotes

    1.1

    I"(, 2001. +a&uation and #efinition of Potentia&& $a3ardous "oods. %eport for I"("#A Contract o. 2274E42777, (as: *rder o. 9. C!apter 6,

    -icroio&ogica& C!a&&enge (esting.

    2.2

    C&i+er, #. *. Virus (ransmission +ia "ood Institute of "ood (ec!no&ogistsN