21 CFR Part 110 - Current Good Manufacturing Practice In Manufacturing, Packing, or Holding Human Food

Current as of 1 April 2005 Subpart A - General Provisions

110.3 110.5 Current 110.10 110.1" #$!lusions. good anufa!turing Definitions. pra!ti!e. Personnel.

Subpart % - %uildings and &a!ilities

110.20 Plant 110.35 110.3( Sanitar' fa!ilities and !ontrols. and Sanitar' grounds. operations.

Subpart C - #)uip ent

110.*0 #)uip ent and utensils.

Subpart D +,eservedSubpart # - Produ!tion and Pro!ess Controls

110..0 Pro!esses 110."3 /are0ousing and distribution. and !ontrols.

Subpart & +,eservedSubpart G - Defe!t A!tion 1evels

110.110 2atural or unavoidable defe!ts in food for 0u an use t0at present no 0ealt0 0a3ard. A4567,859: 21 4.S.C. 3*2; 3(1; 3(*< *2 4.S.C. 2=*. S74,C#: 51 &, 2**(5; >une 1"; 1".=; unless ot0er?ise noted.

Sub art ! - General Pro"i#ion#

$110%& 'efinition#% 50e definitions and interpretations of ter s in se!tion 201 of t0e &ederal &ood; Drug; and Cos eti! A!t @t0e a!tA are appli!able to su!0 ter s ?0en used in t0is part. 50e follo?ing definitions s0all also appl': @aA Acid foods or acidified foods eans foods t0at 0ave an e)uilibriu p6 of *.= or belo?.

@bA Adequate eans t0at ?0i!0 is needed to a!!o plis0 t0e intended purpose in Beeping ?it0 good publi! 0ealt0 pra!ti!e. @!A Batter eans a se ifluid substan!e; usuall' !o posed of flour and ot0er ingredients; into ?0i!0 prin!ipal !o ponents of food are dipped or ?it0 ?0i!0 t0e' are !oated; or ?0i!0 a' be used dire!tl' to for baBer' foods. @dA Blanching; e$!ept for tree nuts and peanuts; eans a prepa!Baging 0eat treat ent of foodstuffs for a suffi!ient ti e and at a suffi!ient te perature to partiall' or !o pletel' ina!tivate t0e naturall' o!!urring en3' es and to effe!t ot0er p0'si!al or bio!0e i!al !0anges in t0e food. @eA Critical control point eans a point in a food pro!ess ?0ere t0ere is a 0ig0 probabilit' t0at i proper !ontrol a' !ause; allo?; or !ontribute to a 0a3ard or to filt0 in t0e final food or de!o position of t0e final food. @fA Food eans food as defined in se!tion 201@fA of t0e a!t and in!ludes ra? ingredients. aterials and

@gA Food-contact surfaces are t0ose surfa!es t0at !onta!t 0u an food and t0ose surfa!es fro ?0i!0 drainage onto t0e food or onto surfa!es t0at !onta!t t0e food ordinaril' o!!urs during t0e nor al !ourse of operations. C&ood-!onta!t surfa!esC in!ludes utensils and food-!onta!t surfa!es of e)uip ent. @0A Lot eans t0e food produ!ed during a period of ti e indi!ated b' a spe!ifi! !ode.

@iA Microorganisms eans 'easts olds; ba!teria; and viruses and in!ludes; but is not li ited to; spe!ies 0aving publi! 0ealt0 signifi!an!e. 50e ter Cundesirable i!roorganis sC in!ludes t0ose i!roorganis s t0at are of publi! 0ealt0 signifi!an!e; t0at subDe!t food to de!o position; t0at indi!ate t0at food is !onta inated ?it0 filt0; or t0at ot0er?ise a' !ause food to be adulterated ?it0in t0e eaning of t0e a!t. 7!!asionall' in t0ese regulations; &DA used t0e adDe!tive C i!robialC instead of using an adDe!tival p0rase !ontaining t0e ?ord i!roorganis . @DA Pest refers to an' obDe!tionable ani als or inse!ts in!luding; but not li ited to; birds; rodents; flies; and larvae. @BA Plant eans t0e building or fa!ilit' or parts t0ereof; used for or in !onne!tion ?it0 t0e anufa!turing; pa!Baging; labeling; or 0olding of 0u an food. @lA Quality control operation eans a planned and s'ste ati! pro!edure for taBing all a!tions ne!essar' to prevent food fro being adulterated ?it0in t0e eaning of t0e a!t.

@ A Rewor eans !lean; unadulterated food t0at 0as been re oved fro pro!essing for reasons ot0er t0an insanitar' !onditions or t0at 0as been su!!essfull' re!onditioned b' repro!essing and t0at is suitable for use as food. @nA !afe-moisture le"el is a level of oisture lo? enoug0 to prevent t0e gro?t0 of undesirable i!roorganis s in t0e finis0ed produ!t under t0e intended !onditions of anufa!turing; storage; and distribution. 50e a$i u safe oisture level for a food is based on its ?ater a!tivit' @a ?A. An a? ?ill be !onsidered safe for a food if ade)uate data are available t0at de onstrate t0at t0e food at or belo? t0e given a? ?ill not support t0e gro?t0 of undesirable i!roorganis s. @oA !aniti#e eans to ade)uatel' treat food-!onta!t surfa!es b' a pro!ess t0at is effe!tive in destro'ing vegetative !ells of i!roorganis s of publi! 0ealt0 signifi!an!e; and in substantiall' redu!ing nu bers of ot0er undesirable i!roorganis s; but ?it0out adversel' affe!ting t0e produ!t or its safet' for t0e !onsu er. @pA !hall is used to state andator' re)uire ents. ended or advisor' pro!edures or identif' re!o ended

@)A !hould is used to state re!o e)uip ent.

@rA $ater acti"ity @a?A is a easure of t0e free oisture in a food and is t0e )uotient of t0e ?ater vapor pressure of t0e substan!e divided b' t0e vapor pressure of pure ?ater at t0e sa e te perature. $110%( Current good manufacturing ractice% @aA 50e !riteria and definitions in t0is part s0all appl' in deter ining ?0et0er a food is adulterated @1A ?it0in t0e eaning of se!tion *02@aA@3A of t0e a!t in t0at t0e food 0as been anufa!tured under su!0 !onditions t0at it is unfit for food< or @ 2 A ?it0in t0e eaning of se!tion *02@aA@*A of t0e a!t in t0at t0e food 0as been prepared; pa!Bed; or 0eld under insanitar' !onditions ?0ereb' it a' 0ave be!o e !onta inated ?it0 filt0; or ?0ereb' it a' 0ave been rendered inDurious to 0ealt0. 50e !riteria and definitions in t0is part also appl' in deter ining ?0et0er a food is in violation of se!tion 3=1 of t0e Publi! 6ealt0 Servi!e A!t @*2 4.S.C. 2=*A. @bA &ood !overed b' spe!ifi! !urrent good t0e re)uire ents of t0ose regulations. $110%10 Per#onnel% 50e plant follo?ing: anage ent s0all taBe all reasonable easures and pre!autions to ensure t0e anufa!turing pra!ti!e regulations also is subDe!t to

@aA %isease control. An' person ?0o; b' edi!al e$a ination or supervisor' observation; is s0o?n to 0ave; or appears to 0ave; an illness; open lesion; in!luding boils; sores; or infe!ted ?ounds; or an' ot0er abnor al sour!e of i!robial !onta ination b' ?0i!0 t0ere is a reasonable possibilit' of food; food-!onta!t surfa!es; or food pa!Baging aterials be!o ing !onta inated; s0all be e$!luded fro an' operations ?0i!0 a' be e$pe!ted to result in su!0 !onta ination until t0e !ondition is !orre!ted. Personnel s0all be instru!ted to report su!0 0ealt0 !onditions to t0eir supervisors. @bA Cleanliness. All persons ?orBing in dire!t !onta!t ?it0 food; food-!onta!t surfa!es; and foodpa!Baging aterials s0all !onfor to 0'gieni! pra!ti!es ?0ile on dut' to t0e e$tent ne!essar' to

prote!t against !onta ination of food. 50e not li ited to:

et0ods for

aintaining !leanliness in!lude; but are

@lA /earing outer gar ents suitable to t0e operation in a anner t0at prote!ts against t0e !onta ination of food; food-!onta!t surfa!es; or food pa!Baging aterials. @2A Eaintaining ade)uate personal !leanliness. @3A /as0ing 0ands t0oroug0l' @and saniti3ing if ne!essar' to prote!t against !onta ination ?it0 undesirable i!roorganis sA in an ade)uate 0and-?as0ing fa!ilit' before starting ?orB; after ea!0 absen!e fro t0e ?orB station; and at an' ot0er ti e ?0en t0e 0ands a' 0ave be!o e soiled or !onta inated. @*A ,e oving all unse!ured De?elr' and ot0er obDe!ts t0at ig0t fall into food; e)uip ent; or !ontainers; and re oving 0and De?elr' t0at !annot be ade)uatel' saniti3ed during periods in ?0i!0 food is anipulated b' 0and. 8f su!0 0and De?elr' !annot be re oved; it a' be !overed b' aterial ?0i!0 !an be aintained in an inta!t; !lean; and sanitar' !ondition and ?0i!0 effe!tivel' prote!ts against t0e !onta ination b' t0ese obDe!ts of t0e food; food-!onta!t surfa!es; or food-pa!Baging aterials. @5A Eaintaining gloves; if t0e' are used in food 0andling; in an inta!t; !lean; and sanitar' !ondition. 50e gloves s0ould be of an i per eable aterial. @=A /earing; ?0ere appropriate; in an effe!tive !overs; or ot0er effe!tive 0air restraints. anner; 0air nets; 0eadbands; !aps; beard

@(A Storing !lot0ing or ot0er personal belongings in areas ot0er t0an ?0ere food is e$posed or ?0ere e)uip ent or utensils are ?as0ed. @.A Confining t0e follo?ing to areas ot0er t0an ?0ere food a' be e$posed or ?0ere e)uip ent or utensils are ?as0ed: eating food; !0e?ing gu ; drinBing beverages; or using toba!!o. @"A 5aBing an' ot0er ne!essar' pre!autions to prote!t against !onta ination of food; food-!onta!t surfa!es; or food-pa!Baging aterials ?it0 i!roorganis s or foreign substan!es in!luding; but not li ited to; perspiration; 0air; !os eti!s; toba!!o; !0e i!als; and edi!ines applied to t0e sBin. @!A &ducation and training. Personnel responsible for identif'ing sanitation failures or food !onta ination s0ould 0ave a ba!Bground of edu!ation or e$perien!e; or a !o bination t0ereof; to provide a level of !o peten!' ne!essar' for produ!tion of !lean and safe food. &ood 0andlers and supervisors s0ould re!eive appropriate training in proper food 0andling te!0ni)ues and foodprote!tion prin!iples and s0ould be infor ed of t0e danger of poor personal 0'giene and insanitar' pra!ti!es. @dA !uper"ision. ,esponsibilit' for assuring !o plian!e b' all personnel ?it0 all re)uire ents of t0is part s0all be !learl' assigned to !o petent supervisor' personnel. +51 &, 2**(5; >une 1"; 1".=; as a ended at 5* &, 2*."2; >une 12; 1"."$110%1) *+clu#ion#% @aA 50e follo?ing operations are not subDe!t to t0is part: #stablis0 ents engaged solel' in t0e 0arvesting; storage; or distribution of one or ore Cra? agri!ultural !o odities;C as defined in

se!tion 201@rA of t0e a!t; ?0i!0 are ordinaril' !leaned; prepared; treated; or ot0er?ise pro!essed before being arBeted to t0e !onsu ing publi!. @bA &DA; 0o?ever; ?ill issue spe!ial regulations if it is ne!essar' to !over t0ese e$!luded operations.

Sub art , - ,uilding# and Facilitie#

$110%20 Plant and ground#% @aA 'rounds. 50e grounds about a food plant under t0e !ontrol of t0e operator s0all be Bept in a !ondition t0at ?ill prote!t against t0e !onta ination of food. 50e et0ods for ade)uate aintenan!e of grounds in!lude; but are not li ited to: @1A Properl' storing e)uip ent; re oving litter and ?aste; and !utting ?eeds or grass ?it0in t0e i ediate vi!init' of t0e plant buildings or stru!tures t0at a' !onstitute an attra!tant; breeding pla!e; or 0arborage for pests. @2A Eaintaining roads; 'ards; and parBing lots so t0at t0e' do not !onstitute a sour!e of !onta ination in areas ?0ere food is e$posed. @3A Ade)uatel' draining areas t0at a' !ontribute !onta ination to food b' seepage; foot-borne filt0; or providing a breeding pla!e for pests. @*A 7perating s'ste s for ?aste treat ent and disposal in an ade)uate not !onstitute a sour!e of !onta ination in areas ?0ere food is e$posed. anner so t0at t0e' do

8f t0e plant grounds are bordered b' grounds not under t0e operatorFs !ontrol and not aintained in t0e anner des!ribed in paragrap0 @aA @1A t0roug0 @3A of t0is se!tion; !are s0all be e$er!ised in t0e plant b' inspe!tion; e$ter ination; or ot0er eans to e$!lude pests; dirt; and filt0 t0at a' be a sour!e of food !onta ination. @bA Plant construction and design . Plant buildings and stru!tures s0all be suitable in si3e; !onstru!tion; and design to fa!ilitate aintenan!e and sanitar' operations for food- anufa!turing purposes. 50e plant and fa!ilities s0all: @1A Provide suffi!ient spa!e for su!0 pla!e ent of e)uip ent and storage of aterials as is ne!essar' for t0e aintenan!e of sanitar' operations and t0e produ!tion of safe food. @2A Per it t0e taBing of proper pre!autions to redu!e t0e potential for !onta ination of food; food!onta!t surfa!es; or food-pa!Baging aterials ?it0 i!roorganis s; !0e i!als; filt0 or ot0er e$traneous aterial. 50e potential for !onta ination a' be redu!ed b' ade)uate food safet' !ontrols and operating pra!ti!es or effe!tive design; in!luding t0e separation of operations in ?0i!0 !onta ination is liBel' to o!!ur; b' one or ore of t0e follo?ing eans: lo!ation; ti e; partition; air flo?; en!losed s'ste s; or ot0er effe!tive eans. @3A Per it t0e taBing of proper pre!autions to prote!t food in outdoor bulB fer entation vessels b' an' effe!tive eans; in!luding: @iA 4sing prote!tive !overings. @iiA Controlling areas over and around t0e vessels to eli inate 0arborages for pests.

@iiiA C0e!Bing on a regular basis for pests and pest infestation. @ivA SBi ing t0e fer entation vessels; as ne!essar'.

@*A %e !onstru!ted in su!0 a anner t0at floors; ?alls; and !eilings a' be ade)uatel' !leaned and Bept !lean and Bept in good repair< t0at drip or !ondensate fro fi$tures; du!ts and pipes does not !onta inate food; food-!onta!t surfa!es; or food-pa!Baging aterials< and t0at aisles or ?orBing spa!es are provided bet?een e)uip ent and ?alls and are ade)uatel' unobstru!ted and of ade)uate ?idt0 to per it e plo'ees to perfor t0eir duties and to prote!t against !onta inating food or food-!onta!t surfa!es ?it0 !lot0ing or personal !onta!t. @5A Provide ade)uate lig0ting in 0and-?as0ing areas; dressing and lo!Ber roo s; and toilet roo s and in all areas ?0ere food is e$a ined; pro!essed; or stored and ?0ere e)uip ent or utensils are !leaned< and provide safet'-t'pe lig0t bulbs; fi$tures; sB'lig0ts; or ot0er glass suspended over e$posed food in an' step of preparation or ot0er?ise prote!t against food !onta ination in !ase of glass breaBage. @=A Provide ade)uate ventilation or !ontrol e)uip ent to ini i3e odors and vapors @in!luding stea and no$ious fu esA in areas ?0ere t0e' a' !onta inate food< and lo!ate and operate fans and ot0er air-blo?ing e)uip ent in a anner t0at ini i3es t0e potential for !onta inating food; food-pa!Baging aterials; and food-!onta!t surfa!es. @(A Provide; ?0ere ne!essar'; ade)uate s!reening or ot0er prote!tion against pests. $110%&( Sanitar- o eration#% @aA 'eneral maintenance. %uildings; fi$tures; and ot0er p0'si!al fa!ilities of t0e plant s0all be aintained in a sanitar' !ondition and s0all be Bept in repair suffi!ient to prevent food fro be!o ing adulterated ?it0in t0e eaning of t0e a!t. Cleaning and saniti3ing of utensils and e)uip ent s0all be !ondu!ted in a anner t0at prote!ts against !onta ination of food; food!onta!t surfa!es; or food-pa!Baging aterials. @bA !u(stances used in cleaning and saniti#ing) storage of to*ic materials+ @1A Cleaning !o pounds and saniti3ing agents used in !leaning and saniti3ing pro!edures s0all be free fro undesirable i!roorganis s and s0all be safe and ade)uate under t0e !onditions of use. Co plian!e ?it0 t0is re)uire ent a' be verified b' an' effe!tive eans in!luding pur!0ase of t0ese substan!es under a supplierFs guarantee or !ertifi!ation; or e$a ination of t0ese substan!es for !onta ination. 7nl' t0e follo?ing to$i! aterials a' be used or stored in a plant ?0ere food is pro!essed or e$posed: @iA 50ose re)uired to aintain !lean and sanitar' !onditions<

@iiA 50ose ne!essar' for use in laborator' testing pro!edures< @iiiA 50ose ne!essar' for plant and e)uip ent aintenan!e and operation< and

@ivA 50ose ne!essar' for use in t0e plantFs operations. @2A 5o$i! !leaning !o pounds; saniti3ing agents; and pesti!ide !0e i!als s0all be identified; 0eld; and stored in a anner t0at prote!ts against !onta ination of food; food-!onta!t surfa!es; or food-pa!Baging aterials. All relevant regulations pro ulgated b' ot0er &ederal; State; and

lo!al govern ent agen!ies for t0e appli!ation; use; or 0olding of t0ese produ!ts s0ould be follo?ed. @!A Pest control. 2o pests s0all be allo?ed in an' area of a food plant. Guard or guide dogs a' be allo?ed in so e areas of a plant if t0e presen!e of t0e dogs is unliBel' to result in !onta ination of food; food-!onta!t surfa!es; or food-pa!Baging aterials. #ffe!tive easures s0all be taBen to e$!lude pests fro t0e pro!essing areas and to prote!t against t0e !onta ination of food on t0e pre ises b' pests. 50e use of inse!ti!ides or rodenti!ides is per itted onl' under pre!autions and restri!tions t0at ?ill prote!t against t0e !onta ination of food food-!onta!t surfa!es; and food-pa!Baging aterials. @dA !anitation of food-contact surfaces. All food-!onta!t surfa!es; in!luding utensils and food!onta!t surfa!es of e)uip ent; s0all be !leaned as fre)uentl' as ne!essar' to prote!t against !onta ination of food. @1A &ood-!onta!t surfa!es used for anufa!turing or 0olding lo?- oisture food s0all be in a dr'; sanitar' !ondition at t0e ti e of use. /0en t0e surfa!es are ?et-!leaned; t0e' s0all; ?0en ne!essar'; be saniti3ed and t0oroug0l' dried before subse)uent use. @2A 8n ?et pro!essing; ?0en !leaning is ne!essar' to prote!t against t0e introdu!tion of i!roorganis s into food; all food-!onta!t surfa!es s0all be !leaned and saniti3ed before use and after an' interruption during ?0i!0 t0e food-!onta!t surfa!es a' 0ave be!o e !onta inated. /0ere e)uip ent and utensils are used in a !ontinuous produ!tion operation; t0e utensils and food-!onta!t surfa!es of t0e e)uip ent s0all be !leaned and saniti3ed as ne!essar'. @3A 2on-food-!onta!t surfa!es of e)uip ent used in t0e operation of food plants s0ould be !leaned as fre)uentl' as ne!essar' to prote!t against !onta ination of food. @*A Single-servi!e arti!les @su!0 as utensils intended for one-ti e use; paper !ups; and paper to?elsA s0ould be stored in appropriate !ontainers and s0all be 0andled; dispensed; used and disposed of in a anner t0at prote!ts against !onta ination of food or food-!onta!t surfa!es. @5A Saniti3ing agents s0all be ade)uate and safe under !onditions of use. An' fa!ilit'; pro!edure; or a!0ine is a!!eptable for !leaning and saniti3ing e)uip ent and utensils if it is establis0ed t0at t0e fa!ilit'; pro!edure; or a!0ine ?ill routinel' render e)uip ent and utensils !lean and provide ade)uate !leaning and saniti3ing treat ent. @eA !torage and handling of cleaned porta(le equipment and utensils . Cleaned and saniti3ed portable e)uip ent ?it0 food-!onta!t surfa!es and utensils s0ould be stored in a lo!ation and anner t0at prote!ts food-!onta!t surfa!es fro !onta ination. +51 &, 2**(5; >une 1"; 1".=; as a ended at 5* &, 2*."2; >une 12;1"."$110%&. Sanitar- facilitie# and control#% #a!0 plant s0all be e)uipped ?it0 ade)uate sanitar' fa!ilities and a!!o not li ited to: odations in!luding; but

@aA $ater supply. 50e ?ater suppl' s0all be suffi!ient for t0e operations intended and s0all be derived fro an ade)uate sour!e. An' ?ater t0at !onta!ts food or food-!onta!t surfa!es s0all be safe and of ade)uate sanitar' )ualit'. ,unning ?ater at a suitable te perature; and under pressure as needed; s0all be provided in all areas ?0ere re)uired for t0e pro!essing of food; for

t0e !leaning of e)uip ent; utensils; and food-pa!Baging fa!ilities.

aterials; or for e plo'ee sanitar'

@bA Plum(ing. Plu bing s0all be of ade)uate si3e and design and ade)uatel' installed and aintained to: @1A Carr' suffi!ient )uantities of ?ater to re)uired lo!ations t0roug0out t0e plant. @2A Properl' !onve' se?age and li)uid disposable ?aste fro t0e plant.

@3A Avoid !onstituting a sour!e of !onta ination to food; ?ater supplies; e)uip ent; or utensils or !reating an unsanitar' !ondition. @*A Provide ade)uate floor drainage in all areas ?0ere floors are subDe!t to flooding-t'pe !leaning or ?0ere nor al operations release or dis!0arge ?ater or ot0er li)uid ?aste on t0e floor. @5A Provide t0at t0ere is not ba!Bflo? fro ; or !ross-!onne!tion bet?een; piping s'ste s t0at dis!0arge ?aste ?ater or se?age and piping s'ste s t0at !arr' ?ater for food or food anufa!turing. @!A !ewage disposal. Se?age disposal s0all be disposed of t0roug0 ot0er ade)uate eans. ade into an ade)uate se?erage s'ste or

@dA ,oilet facilities. #a!0 plant s0all provide its e plo'ees ?it0 ade)uate; readil' a!!essible toilet fa!ilities. Co plian!e ?it0 t0is re)uire ent a' be a!!o plis0ed b': @1A Eaintaining t0e fa!ilities in a sanitar' !ondition. @2A Geeping t0e fa!ilities in good repair at all ti es. @3A Providing self-!losing doors. @*A Providing doors t0at do not open into areas ?0ere food is e$posed to airborne !onta ination; e$!ept ?0ere alternate eans 0ave been taBen to prote!t against su!0 !onta ination @su!0 as double doors or positive airflo? s'ste sA. @eA -and-washing facilities. 6and?as0ing fa!ilities s0all be ade)uate and !onvenient and be furnis0ed ?it0 running ?ater at a suitable te perature. Co plian!e ?it0 t0is re)uire ent a' be a!!o plis0ed b' providing: @1A 6and-?as0ing and; ?0ere appropriate 0and-saniti3ing fa!ilities at ea!0 lo!ation in t0e plant ?0ere good sanitar' pra!ti!es re)uire e plo'ees to ?as0 andHor saniti3e t0eir 0ands. @2A #ffe!tive 0and-!leaning and saniti3ing preparations. @3A Sanitar' to?el servi!e or suitable dr'ing devi!es. @*A Devi!es or fi$tures; su!0 as ?ater !ontrol valves; so designed and !onstru!ted to prote!t against re!onta ination of !lean; saniti3ed 0ands. @5A ,eadil' understandable signs dire!ting e plo'ees 0andling unprote!ted food; unprote!ted food-pa!Baging aterials; of food-!onta!t surfa!es to ?as0 and; ?0ere appropriate; saniti3e t0eir

0ands before t0e' start ?orB; after ea!0 absen!e fro post of dut'; and ?0en t0eir 0ands a' 0ave be!o e soiled or !onta inated. 50ese signs a' be posted in t0e pro!essing roo @sA and in all ot0er areas ?0ere e plo'ees a' 0andle su!0 food; aterials; or surfa!es. @=A ,efuse re!epta!les t0at are !onstru!ted and !onta ination of food. aintained in a anner t0at prote!ts against

@fA Ru((ish and offal disposal. ,ubbis0 and an' offal s0all be so !onve'ed; stored; and disposed of as to ini i3e t0e develop ent of odor; ini i3e t0e potential for t0e ?aste be!o ing an attra!tant and 0arborage or breeding pla!e for pests; and prote!t against !onta ination of food; food-!onta!t surfa!es; ?ater supplies; and ground surfa!es.

Sub art C-*/ui ment

$110%00 */ui ment and uten#il# @aA All plant e)uip ent and utensils s0all be so designed and of su!0 aterial and ?orB ans0ip as to be ade)uatel' !leanable; and s0all be properl' aintained. 50e design; !onstru!tion; and use of e)uip ent and utensils s0all pre!lude t0e adulteration of food ?it0 lubri!ants; fuel; etal frag ents; !onta inated ?ater; or an' ot0er !onta inants. All e)uip ent s0ould be so installed and aintained as to fa!ilitate t0e !leaning of t0e e)uip ent and of all adDa!ent spa!es. &ood!onta!t surfa!es s0all be !orrosion-resistant ?0en in !onta!t ?it0 food. 50e' s0all be ade of nonto$i! aterials and designed to ?it0stand t0e environ ent of t0eir intended use and t0e a!tion of food; and; if appli!able; !leaning !o pounds and saniti3ing agents. &ood-!onta!t surfa!es s0all be aintained to prote!t food fro being !onta inated b' an' sour!e; in!luding unla?ful indire!t food additives.

@bA Sea s on food-!onta!t surfa!es s0all be s oot0l' bonded or aintained so as to

a!!u ulation of food parti!les; dirt; and organi! gro?t0 of i!roorganis s. atter and t0us

ini i3e ini i3e t0e opportunit' for

@!A #)uip ent t0at is in t0e anufa!turing or food-0andling area and t0at does not !o e into !onta!t ?it0 food s0all be so !onstru!ted t0at it !an be Bept in a !lean !ondition. @dA 6olding; !onve'ing; and anufa!turing s'ste s; in!luding gravi etri!; pneu ati!; !losed; and auto ated s'ste s; s0all be of a design and !onstru!tion t0at enables t0e to be aintained in an appropriate sanitar' !ondition. @eA #a!0 free3er and !old storage !o part ent used to store and 0old food !apable of supporting gro?t0 of i!roorganis s s0all be fitted ?it0 an indi!ating t0er o eter; te perature easuring devi!e; or te perature-re!ording devi!e so installed as to s0o? t0e te perature a!!uratel' ?it0in t0e !o part ent; and s0ould be fitted ?it0 an auto ati! !ontrol for regulating te perature or ?it0 an auto ati! alar s'ste to indi!ate a signifi!ant te perature !0ange in a anual operation. @fA 8nstru ents and !ontrols used for easuring; regulating; or re!ording te peratures; p6; a!idit'; ?ater a!tivit'; or ot0er !onditions t0at !ontrol or prevent t0e gro?t0 of undesirable i!roorganis s in food s0all be a!!urate and ade)uatel' aintained; and ade)uate in nu ber for t0eir designated uses. @gA Co pressed air or ot0er gases e!0ani!all' introdu!ed into food or used to !lean food!onta!t surfa!es or e)uip ent s0all be treated in su!0 a ?a' t0at food is not !onta inated ?it0 unla?ful indire!t food additives.

Sub art ' 1Re#er"ed2 Sub art * - Production and Proce## Control#
$110%30 Proce##e# and control#% All operations in t0e re!eiving; inspe!ting; transporting; segregating; preparing; anufa!turing; pa!Baging; and storing of food s0all be !ondu!ted in a!!ordan!e ?it0 ade)uate sanitation prin!iples. Appropriate )ualit' !ontrol operations s0all be e plo'ed to ensure t0at food is suitable for 0u an !onsu ption and t0at food pa!Baging aterials are safe and suitable. 7verall sanitation of t0e plant s0all be under t0e supervision of one or ore !o petent individuals assigned responsibilit' for t0is fun!tion. All reasonable pre!autions s0all be taBen to ensure t0at produ!tion pro!edures do not !ontribute !onta ination fro an' sour!e. C0e i!al; i!robial; or e$traneous- aterial testing pro!edures s0all be used ?0ere ne!essar' to identif' sanitation failures or possible food !onta ination. All food t0at 0as be!o e !onta inated to t0e e$tent t0at it is adulterated ?it0in t0e eaning of t0e a!t s0all be reDe!ted; or if per issible; treated or pro!essed to eli inate t0e !onta ination. @aA Raw materials and other ingredients+ @1A ,a? aterials and ot0er ingredients s0all be inspe!ted and segregated or ot0er?ise 0andled as ne!essar' to as!ertain t0at t0e' are !lean and suitable for pro!essing into food and s0all be stored under !onditions t0at ?ill prote!t against !onta ination and ini i3e deterioration. ,a? aterials s0all be ?as0ed or !leaned as ne!essar' to re ove soil or ot0er !onta ination. /ater used for ?as0ing; rinsing; or !onve'ing food s0all be safe and of ade)uate sanitar' )ualit'. /ater a' be reused for ?as0ing; rinsing; or !onve'ing food if it does not in!rease t0e level of !onta ination of t0e food. Containers and !arriers of ra? aterials s0ould be inspe!ted on re!eipt to ensure t0at t0eir !ondition 0as not !ontributed to t0e !onta ination or deterioration of food. @2A ,a? aterials and ot0er ingredients s0all eit0er not !ontain levels of i!roorganis s t0at a' produ!e food poisoning or ot0er disease in 0u ans; or t0e' s0all be pasteuri3ed or ot0er?ise treated during anufa!turing operations so t0at t0e' no longer !ontain levels t0at ?ould !ause t0e produ!t to be adulterated ?it0in t0e eaning of t0e a!t. Co plian!e ?it0 t0is re)uire ent a' be verified b' an' effe!tive eans; in!luding pur!0asing ra? aterials and ot0er ingredients under a supplierFs guarantee or !ertifi!ation. @3A ,a? aterials and ot0er ingredients sus!eptible to !onta ination ?it0 aflato$in or ot0er natural to$ins s0all !o pl' ?it0 !urrent &ood and Drug Ad inistration regulations and a!tion levels for poisonous or deleterious substan!es before t0ese aterials or ingredients are in!orporated into finis0ed food. Co plian!e ?it0 t0is re)uire ent a' be a!!o plis0ed b' pur!0asing ra? aterials and ot0er ingredients under a supplierFs guarantee or !ertifi!ation; or a' be verified b' anal'3ing t0ese aterials and ingredients for aflato$ins and ot0er natural to$ins. @*A ,a? aterials; ot0er ingredients; and re?orB sus!eptible to !onta ination ?it0 pests; undesirable i!roorganis s; or e$traneous aterial s0all !o pl' ?it0 appli!able &ood and Drug Ad inistration regulations and defe!t a!tion levels for natural or unavoidable defe!ts if a anufa!turer ?is0es to use t0e aterials in anufa!turing food. Co plian!e ?it0 t0is re)uire ent a' be verified b' an' effe!tive eans; in!luding pur!0asing t0e aterials under a supplierFs guarantee or !ertifi!ation; or e$a ination of t0ese aterials for !onta ination.

@5A ,a? aterials; ot0er ingredients; and re?orB s0all be 0eld in bulB; or in !ontainers designed and !onstru!ted so as to prote!t against !onta ination and s0all be 0eld at su!0 te perature and relative 0u idit' and in su!0 a anner as to prevent t0e food fro be!o ing adulterated ?it0in t0e eaning of t0e a!t. Eaterial s!0eduled for re?orB s0all be identified as su!0. @=A &ro3en ra? aterials and ot0er ingredients s0all be Bept fro3en. 8f t0a?ing is re)uired prior to use; it s0all be done in a anner t0at prevents t0e ra? aterials and ot0er ingredients fro be!o ing adulterated ?it0in t0e eaning of t0e a!t. @(A 1i)uid or dr' ra? aterials and ot0er ingredients re!eived and stored in bulB for 0eld in a anner t0at prote!ts against !onta ination. @bA Manufacturing operations+ @1A #)uip ent and utensils and finis0ed food !ontainers s0all be aintained in an a!!eptable !ondition t0roug0 appropriate !leaning and saniti3ing as ne!essar'. 8nsofar as ne!essar'; e)uip ent s0all be taBen apart for t0oroug0 !leaning. @2A All food anufa!turing; in!luding pa!Baging and storage; s0all be !ondu!ted under su!0 !onditions and !ontrols as are ne!essar' to ini i3e t0e potential for t0e gro?t0 of i!roorganis s; or for t0e !onta ination of food. 7ne ?a' to !o pl' ?it0 t0is re)uire ent is !areful onitoring of p0'si!al fa!tors su!0 as ti e; te perature; 0u idit'; a ?; p6; pressure; flo? rate; and anufa!turing operations su!0 as free3ing; de0'dration; 0eat pro!essing; a!idifi!ation; and refrigeration to ensure t0at e!0ani!al breaBdo?ns; ti e dela's; te perature flu!tuations; and ot0er fa!tors do not !ontribute to t0e de!o position or !onta ination of food. @3A &ood t0at !an support t0e rapid gro?t0 of undesirable i!roorganis s; parti!ularl' t0ose of publi! 0ealt0 signifi!an!e; s0all be 0eld in a anner t0at prevents t0e food fro be!o ing adulterated ?it0in t0e eaning of t0e a!t. Co plian!e ?it0 t0is re)uire ent a' be a!!o plis0ed b' an' effe!tive eans; in!luding: @iA Eaintaining refrigerated foods at *5 & @(.2CA or belo? as appropriate for t0e parti!ular food involved. @iiA Eaintaining fro3en foods in a fro3en state. @iiiA Eaintaining 0ot foods at 1*0 & @=0CA or above. @ivA 6eat treating a!id or a!idified foods to destro' esop0ili! i!roorganis s ?0en t0ose foods are to be 0eld in 0er eti!all' sealed !ontainers at a bient te peratures. @*A Eeasures su!0 as sterili3ing; irradiating; pasteuri3ing; free3ing; refrigerating; !ontrolling p6 or !ontrolling a? t0at are taBen to destro' or prevent t0e gro?t0 of undesirable i!roorganis s; parti!ularl' t0ose of publi! 0ealt0 signifi!an!e; s0all be ade)uate under t0e !onditions of anufa!ture; 0andling; and distribution to prevent food fro being adulterated ?it0in t0e eaning of t0e a!t. @5A /orB-in-pro!ess s0all be 0andled in a anner t0at prote!ts against !onta ination. s0all be

@=A #ffe!tive easures s0all be taBen to prote!t finis0ed food fro !onta ination b' ra? aterials; ot0er ingredients; or refuse. /0en ra? aterials; ot0er ingredients; or refuse are unprote!ted; t0e' s0all not be 0andled si ultaneousl' in a re!eiving; loading; or s0ipping area if

t0at 0andling !ould result in !onta inated food. &ood transported b' !onve'or s0all be prote!ted against !onta ination as ne!essar'. @(A #)uip ent; !ontainers; and utensils used to !onve'; 0old; or store ra? aterials; ?orB-inpro!ess; re?orB; or food s0all be !onstru!ted; 0andled; and aintained during anufa!turing or storage in a anner t0at prote!ts against !onta ination. @.A #ffe!tive easures s0all be taBen to prote!t against t0e in!lusion of etal or ot0er e$traneous aterial in food. Co plian!e ?it0 t0is re)uire ent a' be a!!o plis0ed b' using sieves; traps; agnets; ele!troni! etal dete!tors; or ot0er suitable effe!tive eans. @"A &ood; ra? aterials; and ot0er ingredients t0at are adulterated ?it0in t0e eaning of t0e a!t s0all be disposed of in a anner t0at prote!ts against t0e !onta ination of ot0er food. 8f t0e adulterated food is !apable of being re!onditioned; it s0all be re!onditioned using a et0od t0at 0as been proven to be effe!tive or it s0all be ree$a ined and found not to be adulterated ?it0in t0e eaning of t0e a!t before being in!orporated into ot0er food. @10A Ee!0ani!al anufa!turing steps su!0 as ?as0ing; peeling; tri ing; !utting; sorting and inspe!ting; as0ing; de?atering; !ooling; s0redding; e$truding; dr'ing; ?0ipping; defatting; and for ing s0all be perfor ed so as to prote!t food against !onta ination. Co plian!e ?it0 t0is re)uire ent a' be a!!o plis0ed b' providing ade)uate p0'si!al prote!tion of food fro !onta inants t0at a' drip; drain; or be dra?n into t0e food. Prote!tion a' be provided b' ade)uate !leaning and saniti3ing of all food-!onta!t surfa!es; and b' using ti e and te perature !ontrols at and bet?een ea!0 anufa!turing step. @11A 6eat blan!0ing; ?0en re)uired in t0e preparation of food; s0ould be effe!ted b' 0eating t0e food to t0e re)uired te perature; 0olding it at t0is te perature for t0e re)uired ti e; and t0en eit0er rapidl' !ooling t0e food or passing it to subse)uent anufa!turing ?it0out dela'. 50er op0ili! gro?t0 and !onta ination in blan!0ers s0ould be ini i3ed b' t0e use of ade)uate operating te peratures and b' periodi! !leaning. /0ere t0e blan!0ed food is ?as0ed prior to filling; ?ater used s0all be safe and of ade)uate sanitar' )ualit'. @12A %atters; breading; sau!es; gravies; dressings; and ot0er si ilar preparations s0all be treated or aintained in su!0 a anner t0at t0e' are prote!ted against !onta ination. Co plian!e ?it0 t0is re)uire ent a' be a!!o plis0ed b' an' effe!tive eans; in!luding one or ore of t0e follo?ing: @iA 4sing ingredients free of !onta ination. @iiA # plo'ing ade)uate 0eat pro!esses ?0ere appli!able. @iiiA 4sing ade)uate ti e and te perature !ontrols. @ivA Providing ade)uate p0'si!al prote!tion of !o ponents fro drain; or be dra?n into t0e . @vA Cooling to an ade)uate te perature during anufa!turing. i!roorganis s. !onta inants t0at a' drip;

@viA Disposing of batters at appropriate intervals to prote!t against t0e gro?t0 of

@13A &illing; asse bling; pa!Baging; and ot0er operations s0all be perfor ed in su!0 a ?a' t0at t0e food is prote!ted against !onta ination. Co plian!e ?it0 t0is re)uire ent a' be a!!o plis0ed b' an' effe!tive eans; in!luding:

@iA 4se of a )ualit' !ontrol operation in ?0i!0 t0e !riti!al !ontrol points are identified and !ontrolled during anufa!turing. @iiA Ade)uate !leaning and saniti3ing of all food-!onta!t surfa!es and food !ontainers. @iiiA 4sing aterials for food !ontainers and food- pa!Baging as defined in 130.3@dA of t0is !0apter. @ivA Providing p0'si!al prote!tion fro aterials t0at are safe and suitable;

!onta ination; parti!ularl' airborne !onta ination.

@vA 4sing sanitar' 0andling pro!edures. @1*A &ood su!0 as; but not li ited to; dr' i$es; nuts; inter ediate oisture food; and de0'drated food; t0at relies on t0e !ontrol of a ? for preventing t0e gro?t0 of undesirable i!roorganis s s0all be pro!essed to and aintained at a safe oisture level. Co plian!e ?it0 t0is re)uire ent a' be a!!o plis0ed b' an' effe!tive eans; in!luding e plo' ent of one or ore of t0e follo?ing pra!ti!es: @iA Eonitoring t0e a? of food. @iiA Controlling t0e soluble solids-?ater ratio in finis0ed food. @iiiA Prote!ting finis0ed food fro oisture pi!Bup; b' use of a oisture barrier or b' ot0er so t0at t0e a? of t0e food does not in!rease to an unsafe level. eans;

@15A &ood su!0 as; but not li ited to; a!id and a!idified food; t0at relies prin!ipall' on t0e !ontrol of p6 for preventing t0e gro?t0 of undesirable i!roorganis s s0all be onitored and aintained at a p6 of *.= or belo?. Co plian!e ?it0 t0is re)uire ent a' be a!!o plis0ed b' an' effe!tive eans; in!luding e plo' ent of one or ore of t0e follo?ing pra!ti!es: @iA Eonitoring t0e p6 of ra? aterials; food in pro!ess; and finis0ed food.

@iiA Controlling t0e a ount of a!id or a!idified food added to lo?-a!id food. @1=A /0en i!e is used in !onta!t ?it0 food; it s0all be ade fro ?ater t0at is safe and of ade)uate sanitar' )ualit'; and s0all be used onl' if it 0as been anufa!tured in a!!ordan!e ?it0 !urrent good anufa!turing pra!ti!e as outlined in t0is part. @1(A &ood- anufa!turing areas and e)uip ent used for anufa!turing 0u an food s0ould not be used to anufa!ture non0u an food-grade ani al feed or inedible produ!ts; unless t0ere is no reasonable possibilit' for t0e !onta ination of t0e 0u an food. +51 &, 2**(5; >une 1"; 1".=; as a ended at =5 &, 5=*("; Sept. 1"; 2000$110%)& 4are5ou#ing and di#tribution% Storage and transportation of finis0ed food s0all be under !onditions t0at ?ill prote!t food against p0'si!al; !0e i!al; and i!robial !onta ination as ?ell as against deterioration of t0e food and t0e !ontainer.

Sub art F 1Re#er"ed2

Sub art G - 'efect !ction 6e"el#

$110%110 5a8ard% 7atural or una"oidable defect# in food for 5uman u#e t5at re#ent no 5ealt5

@aA So e foods; even ?0en produ!ed under !urrent good anufa!turing pra!ti!e; !ontain natural or unavoidable defe!ts t0at at lo? levels are not 0a3ardous to 0ealt0. 50e &ood and Drug Ad inistration establis0es a$i u levels for t0ese defe!ts in foods produ!ed under !urrent good anufa!turing pra!ti!e and uses t0ese levels in de!iding ?0et0er to re!o end regulator' a!tion. @bA Defe!t a!tion levels are establis0ed for foods ?0enever it is ne!essar' and feasible to do so. 50ese levels are subDe!t to !0ange upon t0e develop ent of ne? te!0nolog' or t0e availabilit' of ne? infor ation. @!A Co plian!e ?it0 defe!t a!tion levels does not e$!use violation of t0e re)uire ent in se!tion *02@aA@*A of t0e a!t t0at food not be prepared; pa!Bed; or 0eld under unsanitar' !onditions or t0e re)uire ents in t0is part t0at food anufa!turers; distributors; and 0olders s0all observe !urrent good anufa!turing pra!ti!e. #viden!e indi!ating t0at su!0 a violation e$ists !auses t0e food to be adulterated ?it0in t0e eaning of t0e a!t; even t0oug0 t0e a ounts of natural or unavoidable defe!ts are lo?er t0an t0e !urrentl' establis0ed defe!t a!tion levels. 50e anufa!turer; distributor; and 0older of food s0all at all ti es utili3e )ualit' !ontrol operations t0at redu!e natural or unavoidable defe!ts to t0e lo?est level !urrentl' feasible. @dA 50e i$ing of a food !ontaining defe!ts above t0e !urrent defe!t a!tion level ?it0 anot0er lot of food is not per itted and renders t0e final food adulterated ?it0in t0e eaning of t0e a!t; regardless of t0e defe!t level of t0e final food. @eA A !o pilation of t0e !urrent defe!t a!tion levels for natural or unavoidable defe!ts in food for 0u an use t0at present no 0ealt0 0a3ard a' be obtained upon re)uest fro t0e Center for &ood Safet' and Applied 2utrition @6&S-5=5A; &ood and Drug Ad inistration; 5100 Paint %ran!0 PB?'.; College ParB; ED 20(*0. +51 &, 2**(5; >une 1"; 1".=; as a ended at =1 &, 1**.0; Apr. 2; 1""=< == &, 5=035; 2ov. =; 2001-