Reduced oxygen packaging at retail FDA Food Code

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Reduced oxygen packaging at retail

Module 3.FDA Food Code

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Module 3Food Code PrefaceChapter 1. DefinitionsChapter 3. Food

3.502.12 ROP wwiitthhoouutt aa vvaarriiaannccee criteria(A) Hazards are Cb and LM(B) HACCP plan required (2 barrier VP)(C) FISH(D) Cook Chill & Sous Vide(E) Cheese(F) 48 hour rule

3.502.11 Variance Required

Chapter 8. HACCPPublic Health Reasons & Interpretations

Let’s walk the Food Code

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Let’s walk the Food Code

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The model Food Code provisions are consistent with, and where appropriate incorporate, federal performance standards for the same products and processes. Federal performance standards in effect define public food safety expectations for the product, usually in terms of lethality to a pathogenic microorganism of particular concern. UUssee ooff ppeerrffoorrmmaannccee ssttaannddaarrddss aass tthhee mmeeaassuurree ooff rreegguullaattoorryy ccoommpplliiaannccee mmeeaannss eessttaabblliisshhmmeennttss aarree ffrreeee ttoo uussee iinnnnoovvaattiivvee aapppprrooaacchheess iinn pprroodduucciinngg ssaaffee pprroodduuccttss,, iinn lliieeuu ooff aaddhheerreennccee ttoo ttrraaddiittiioonnaall pprroocceessssiinngg aapppprrooaacchheess,, ssuucchh aass ssppeecciiffiieedd ccooookkiinngg ttiimmeess aanndd tteemmppeerraattuurreess,, tthhaatt aacchhiieevvee tthhee ssaammee eenndd.. Federally inspected establishments demonstrate compliance with performance standards by showing that their process adheres to an aapppprroopprriiaatteellyy ddeessiiggnneedd,, vvaalliiddaatteedd HHAACCCCPP ppllaann.

PPRREEFFAACCEE

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Retail processors may be given the same opportunity as federally-regulated establishments to use innovative techniques in the production of safe foods. RReettaaiill eessttaabblliisshhmmeennttss mmaayy aappppllyy ttoo tthhee rreegguullaattoorryy aauutthhoorriittyy ffoorr aa vvaarriiaannccee ttoo uussee aa ssppeecciiffiicc ffeeddeerraall ffoooodd ssaaffeettyy ppeerrffoorrmmaannccee ssttaannddaarrdd ffoorr aa pprroodduucctt oorr aa pprroocceessss iinn lliieeuu ooff ccoommpplliiaannccee wwiitthh ootthheerrwwiissee aapppplliiccaabbllee ssppeecciiffiiccaattiioonnss iinn tthhee FFoooodd CCooddee. However, to show compliance with the federal performance standard, the retail processor must, like a federally inspected establishment, show that processing controls are in place to ensure that the standard is being met. Thus, a request for a variance based on a federal performance standard must be supported by a validated HACCP plan with record keeping and documented verification being made available to the regulatory authority.

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What is a performance standard?

99 CCFFRR’’ss

2211 CCFFRR’’ss

HHAACCCCPP bbaasseedd oonn aannootthheerr ffeeddeerraall rreegguullaattoorryy bbooddyy SSHHOOUULLDD bbee aacccceeppttaabbllee..

Seafood HACCPAcidified Foods

21 CFR 114

Meat & Poultry HACCP

Preventive Controls

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(ROP) Contents of Food

Code

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Chapter 1. DefinitionsHHAACCCCPP ppllaann means a written document that delineates the formal procedures for following the HAZARD Analysis and CRITICAL CONTROL POINT principles developed by The National Advisory Committee on Microbiological Criteria for Foods.PPaacckkaaggeedd.. (1) means bottled, canned, cartoned, bagged, or wrapped, whether PACKAGED in a FOOD ESTABLISHMENT or a FOOD PROCESSING PLANT. (2) does not include wrapped or placed in a carry-out container to protect the FOOD during service or delivery to the CONSUMER, by a FOOD EMPLOYEE, upon CONSUMER request.

""RReedduucceedd ooxxyyggeenn ppaacckkaaggiinngg"" means: ddeessccrriibbeedd pprreevviioouussllyy""RReedduucceedd ooxxyyggeenn ppaacckkaaggiinngg"" includes: ddeessccrriibbeedd pprreevviioouussllyy

TTiimmee//TTeemmppeerraattuurree CCoonnttrrooll ffoorr SSaaffeettyy FFoooodd (formerly “potentially hazardous food” (PHF)) means a FOOD that requires time/temperature control for safety (TCS) to limit pathogenic microorganism growth or toxin formation. SSeeee TTaabbllee AA && BB..

""VVaarriiaannccee"" means a written document issued by the REGULATORY AUTHORITY that authorizes a modification or waiver of one or more requirements of this Code if, in the opinion of the REGULATORY AUTHORITY, a health HAZARD or nuisance will not result from the modification or waiver.

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(ROP) Contents of Food

Code

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Module 3AA.. HHaazzaarrddss aarree ppCCbb aanndd LLMMBB.. HHAACCCCPP ppllaann rreeqquuiirreedd

((22 bbaarrrriieerr VVPP))CC.. VVPP FFIISSHH DD.. CCooookk CChhiillll && SSoouuss VViiddeeEE.. VVPP CChheeeesseeFF.. 4488 hhoouurr RROOPP rruullee

3-502.12ROP w/ovariance

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33--550022..1122 RReedduucceedd OOxxyyggeenn PPaacckkaaggiinngg WWiitthhoouutt aa VVaarriiaannccee,, CCrriitteerriiaa..

(A) Except for a FOOD ESTABLISHMENT that obtains a VARIANCE as specified under § 3-502.11, a FOOD ESTABLISHMENT that PACKAGES TIME/ TEMPERATURE CONTROL FOR SAFETY FOOD using a REDUCED OXYGEN PACKAGING method shall control the growth and toxin formation of CClloossttrriiddiiuumm bboottuulliinnuumm and the growth of LLiisstteerriiaa mmoonnooccyyttooggeenneess. P

⚠⚠ NNoottee:: NNoonn--TTCCSS ffooooddss aarree eexxeemmpptt ffrroomm ccoonnttrroollss ((ii..ee.. HHAACCCCPP))..

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(B) Except as specified under ¶(F) of this section, a FOOD ESTABLISHMENT that PACKAGES TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a REDUCED OXYGEN PACKAGING method shall implement a HACCP PLAN that contains the information specified under ¶¶ 8-201.14 (C) and (D) and that: Pf

(1) Identifies the FOOD to be PACKAGED; Pf

(2) Except as specified under ¶¶ (C) -(E) of this section, requires that the PACKAGED FOOD shall be maintained at 5°C (41°F) or less and meet at least one of the following criteria: Pf

(a) Has an Aw of 0.91 or less, Pf

(b) Has a pH of 4.6 or less, Pf

(c) Is a MEAT or POULTRY product cured at a FOOD PROCESSING PLANT regulated by the USDA using substances specified in 9 CFR 424.21, Use of food ingredients and sources of radiation, and is received in an intact PACKAGE, Pf or

(d) Is a FOOD with a high level of competing organisms such as raw MEAT, raw POULTRY, or raw vegetables; Pf

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((aa)) HHaass aann AAww ooff 00..9911 oorr lleessss,, PPff

((bb)) HHaass aa ppHH ooff 44..66 oorr lleessss,, PPff

((cc)) IIss aa MMEEAATT oorr PPOOUULLTTRRYY pprroodduucctt ccuurreedd aatt aa FFOOOODD PPRROOCCEESSSSIINNGG PPLLAANNTT rreegguullaatteedd bbyy tthhee UUSSDDAA uussiinngg ssuubbssttaanncceess ssppeecciiffiieedd iinn 99 CCFFRR 442244..2211,, UUssee ooff ffoooodd iinnggrreeddiieennttss aanndd ssoouurrcceess ooff rraaddiiaattiioonn,, aanndd iiss rreecceeiivveedd iinn aann iinnttaacctt PPAACCKKAAGGEE,, PPff

oorr

((dd)) IIss aa FFOOOODD wwiitthh aa hhiigghh lleevveell ooff ccoommppeettiinngg oorrggaanniissmmss ssuucchh aass rraaww MMEEAATT,, rraaww PPOOUULLTTRRYY,, oorr rraaww vveeggeettaabblleess;; PPff

YY oorr NN -- ppeerrmmiibbeedd uunnddeerr 22 bbaarrrriieerr VVaaccuuuumm PPaacckkaaggiinngg

11.. PPeeppppeerroonnii sslliicceess22.. SSlliicceedd ddeellii ttuurrkkeeyy mmeeaattss 33.. SSlliicceedd rrooaasstt bbeeeeff44.. RRaaww sslliicceedd ccaarrrroottss aanndd cceelleerryy55.. FFrruuiitt lleeaatthheerr ((bbaannaannaa))66.. FFrruuiitt lleeaatthheerr ((pplluumm))77.. RRaaww mmeeaattss88.. GGrriillll mmaarrkkeedd rraaww mmeeaattss99.. RRaaww nnuutt cchheeeessee1100.. OOtthheerrss??

DDIISSCCUUSSSSIIOONN

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Two barrier vacuum packaging (no variance)BB ee ss tt PP rr aa cc tt ii cc ee ss

Store ≤ 5°C (41°F) Datalogger not required per food code..

AAww 0.89* - 0.91 Test via external lab annually (accuracy should be 0.005 – 0.01)

ppHH 4.2* - 4.6 Test via external lab or in-house.

CCuurreedd meat/poultry (USDA)Goal is to have nitrates or nitrites. If state inspected meats verifies that, it would be acceptable. If cured in-house HACCP required for that as well.

RRaaww with competing organisms

Grill marked meats would require mixing or re-exposure to remaining raw juices (containing competing microbes)

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(3) Describes how the PACKAGE shall be prominently and conspicuously labeled on the principal display panel in bold type on a contrasting background, with instructions to: Pf

(a) Maintain the FOOD at 5oC (41oF) or below, Pf

and(b) Discard the FOOD if within 30 calendar days of its PACKAGING if it is not served for on-PREMISESconsumption, or consumed if served or sold for off-PREMISES consumption; Pf

(4) Limits the refrigerated shelf life to no more than 30 calendar days from PACKAGING to consumption, except the time the product is maintained frozen, or the original manufacturer’s “sell by” or “use by” date, whichever occurs first;P

AADDeerr 3300 ddaayyss wwiillll 22 bbaarrrriieerr VVPP bbee hhaazzaarrddoouuss??

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F r e e z e r s t o p s t h e c l o c kWWhhaatt iiss tthhee rriisskk iiff aann ooppeerraattoorr eexxcceeeeddss tthhee 3300 ddaayyss bbyy oonnee ddaayy??

RR OO PP tt oo ff rree ee zzee rr ll aa bb ee llDate frozen ____________Date removed from freezer ______________________

New use by date _____________

OO rr ii gg ii nn aa ll RR OO PP LL aa bb ee ll

PPrroodduucctt nnaammee ____________________________________________________

DDaattee PPaacckkaaggeedd ____________________________________________________

UUssee bbyy ________________________________________________________________

KKeeeepp rreeffrriiggeerraatteedd aatt ≤≤ 4411ººFFDate placed in freezerrelabel as frozen

Date removed from freezermark day out of freezerhave balance of 30 days

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(5) Includes operational procedures that:

(a) Prohibit contacting READY-TO-EAT FOOD with bare hands as specified under ¶ 3-301.11(B), Pf

(b) Identify a designated work area and the method by which: Pf

(i) Physical barriers or methods of separation of raw FOODS and READY-TO-EAT FOODS minimize cross contamination, Pf and(ii) Access to the processing EQUIPMENT is limited to responsible trained personnel familiar with the potential HAZARDS of the operation, Pf and

(c) Delineate cleaning and SANITIZATION procedures for FOOD CONTACT SURFACES; Pf and

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Two barrier vacuum packaging (no variance)BB ee ss tt PP rr aa cc ?? cc ee ss

RReeqquuiirreedd -- RROOPP SSttaannddaarrdd OOppeerraatt iinngg PPrroocceedduurreess

NNoo bbaarree hhaanndd ccoonnttaacctt ww-- RRTTEE Follow Food Code ¶ 3-301.11(B) e.g. latex gloves, utensils, etc.

PPhhyyssiiccaall bbaarrrriieerr ttoo sseeppaarraattee rraaww ffrroomm RRTTEE

Simply process in a physically different location (e.g. different table). USDA would refer to this as “separate by time or space”.

AAcccceessss lliimmiitteedd ttoo ttrraaiinneedd ssttaaffffStaff have to be trained in ROP and these standard operating procedures. If they don’t understand the hazards, they are less likely to apply controls. If they don’t know how to control hazards, they cannot control hazards.

DDeelliinneeaattee cclleeaanniinngg// ssaanniittaattiioonn If cleaning/sanitation is not same as all other facility equipment, the method(s) should be delineated (described).

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(6) Describes the ttrraaiinniinngg pprrooggrraamm that ensures that the individual responsible for the REDUCED OXYGEN PACKAGING operation understands the:Pf

(a) Concepts required for a safe operation,Pf

(b) EQUIPMENT and facilities,Pf and(c) Procedures specified under § (B)(5) of this section and ¶¶ 8-201.14 (C) and (D).Pf

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Two barrier vacuum packaging (no variance)BB ee ss tt PP rr aa cc tt ii cc ee ss

RReeqquuiirreedd -- RROOPP TTRRAAIINNIINNGGCCoonncceeppttss ffoorr ssaaffee ooppeerraattiioonn Hazards and controls for ROP (e.g. C. botulinum and L. monocytogenes). Two

barrier control explanation. Importance of expiration dates and labels.

EEqquuiippmmeenntt && FFaacciilliittyy What does the RROOPP equipment do? What hazards and controls are related to the equipment (e.g. cross contamination in a vacuum packaging machine).

PPrroocceedduurreess ssppeecciiffiieedd uunnddeerr §§ ((BB))((55)) ROP - Standard Operating Procedures (SOPs). Discussed previously.

¶¶¶¶ 88--220011..1144 ((CC)) aanndd ((DD))Understand the HACCP flow diagram (C) and understand the seven principles of (ROP) HACCP specifically documented in the facilities HACCP plan. CCPs, Critical limits, monitoring, corrective actions, records, and verifications.

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HHAACCCCPP PPllaann bbaasseedd oonn ¶¶¶¶ 88--220011..1144 ((CC)) aanndd ((DD))……..

(7) Is provided to the REGULATORY AUTHORITY prior to implementation as specified under ¶ 8-201.13(B).

⚠ Pre-approval NNOOTT required per US FDA model Food Code

== ““ WW II TT HH OO UU TT AA VV AA RR II AA NN CC EE ””

Some states are exemping this item from their Food Code adopion

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SUMMARY : Two barrier vacuum packaging (no variance)

Barrier 1 = SSttoorree ≤ 5°C (41°F)Barrier 2 Options (need one):• AAww 0.89 - 0.91,• ppHH 4.2 - 4.6, • CCuurreedd meat/poultry (USDA)• RRaaww with competing organismsPDP labeled (use by date)Freezer stops clock

30 days

NNoottee CCrriittiiccaall CCoonnttrrooll PPooiinnttss::

⚠ CCP 1a

⚠ CCP 1b

⚠93

Two barrier vacuum packaging (no variance)RR ii ss kk ss aa tt ≤≤ 44 11 ºº FF

LLmm

READY-TO-EAT READY-TO-COOK

LLmm CbCbNo growthpH ≤ 4.4

Aw ≤ 0.92

No growthpH ≤ 4.6

Aw ≤ 0.97

Keep VP risks in perspective

No growthpH ≤ 4.6

Aw ≤ 0.97

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When there is only one vacuum packager

VP Raw followed by VP RTE

Keep VP risks in perspec-ve

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(C) Except for FISH that is frozen before, during and a:er PACKAGING, a FOOD ESTABLISHMENT may not*PACKAGE FISH using a REDUCED OXYGEN PACKAGING method

Vacuum Packaging

**wwiitthhoouutt aa vvaarriiaannccee

WWhhyy?? Because fish is associated with psychrotrophic Clostridium botulinum, it is considered high risk. If fish is frozen, there is less chance of cross contamination during the ROP vacuum packaging process.

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3 - 5 0 2 . 1 2 ( C ) V P F I S H

FISH must be frozen (before, during, after) vacuum packaging. Operator may be the one to freeze the fish. E.g. IQF (individually quick frozen)

No ROP fish (CC or SV) without a varianceNo Unfrozen fish (VP) without a variance

No prohibiKon of ROP fish with a variance under 3-502.11

Seafood HACCP Guide has controls that can be applied to CC and SV of Fish.

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Note we are taking this out of order, but this is sill VP

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(1) Limit the cheeses PACKAGED to those that are commercially manufactured in a FOOD PROCESSING PLANT with no ingredients added in the FOOD ESTABLISHMENT and that meet the Standards of Identity as specified in 21 CFR 133.150 Hard cheeses, 21 CFR 133.169 Pasteurized process cheese or 21 CFR 133.187 Semisoft cheeses; P

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(E) Except as specified under ¶ (F) of this section, a FOOD ESTABLISHMENT that PACKAGES cheese using a REDUCED OXYGEN PACKAGING method shall:

(1) Limit the cheeses PACKAGED to those that are commercially manufactured in a FOOD PROCESSING PLANT with no ingredients added in the FOOD ESTABLISHMENT and that meet the Standards of Identity as specified in 21 CFR 133.150 Hard cheeses, 21 CFR 133.169 Pasteurized process cheese or 21 CFR 133.187 Semisoft cheeses; P

(2) Have a HACCP PLAN that contains the information specified under ¶¶ 8-201.14 (C) and (D) and as specified under ¶¶ (B)(1), (B)(3)(a), (B)(5) and (B)(6) of this section; Pf

(3) Labels the PACKAGE on the principal display panel with a “use by” date that does not exceed 30 days from its packaging or the original manufacturer’s “sell by” or “use by” date, whichever occurs first; Pf and

(4) Discards the REDUCED OYGEN PACKAGED cheese if it is not sold for off-PREMISES consumption or consumed within 30 calendar days of its PACKAGING. Pf

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Common interpretationsq Modified atmosphere packaging (MAP) and controlled atmosphere packaging (CAP) are

generally treated like vacuum packaging for the purposes of Food Code compliance.

q If its < 21% O2 it is reduced oxygen, but note the FDA definition says “PPAA CC KK AA GG EE DD ”

o Zip lock and "baggie" style bagged foods are NOT considered packaged

o Foil wrapped foods such as baked potatoes NOT considered packaged

q FFDDAA CCFFSSAANN hhaass rreecceennttllyy rreeccllaassssiiffiieedd hhiigghh ooxxyyggeenn ttrraannssffeerr rraattee ((OOTTRR)) bbaaggss aass RROOPP.. TThhiiss iinncclluuddeess ““ddrryy aaggee”” bbaaggss ((OOTTRR << 1100,,000000))

q Foods packaged cold without a vacuum are not considered ROP (FDA interpretation)q Foods from manufacturers already in ROP packaging do not require HACCP

q If it comes from a manufacturer, the storage temperature and shelf life are as indicated on the product

q Non-TCS foods are safe from Cb and Lm; thus do NOT require HACCP

K A H O O T R O P F C P r e f a c e t o V P

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103

(2) Ensure the FOOD is: (a) Prepared and consumed on the PREMISES, or prepared and consumed off the PREMISES but within the samebusiness entity with no distribution or sale of the PACKAGED product to another business entity or the CONSUMER, Pf

(b) Cooked to heat all parts of the FOOD to a temperature and for a time as specified under ¶¶ 3-401.11 (A), (B), and (C), P

(c) Protected from contamination before and after cooking as specified under Parts 3-3 and 3-4, P

(d) Placed in a PACKAGE with an oxygen barrier and sealed before cooking, or placed in a PACKAGE and sealed immediately after cooking and before reaching a temperature below 57°C (135°F), P

(D) Cook-Chill & Sous Vide

145℉ Intact Meats | 155 ℉ 17sec Ground Meats | 165℉ PoultryCan also use roast cooking chart 3-401.11 (B)(1)

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(e) Cooled to 5°C (41°F) in the sealed PACKAGE or bag as specified under §3-501.14 and: P

(i) Cooled to 11°°CC ((3344°°FF)) within 48 hours of reaching 5°C (41°F) and held at that temperature unil consumed or discarded within 3300 ddaayyss arer the date of PACKAGING;P

(ii) Held at 55°°CC ((4411°°FF)) or less for no more than 77 ddaayyss, at which ime the FOOD must be consumed or discarded; P or

(iii) Held ffrroozzeenn wwiitthh nnoo sshheellff lliiffee rreessttrriicciioonn while frozen unil consumed or used. P

(f) HHeelldd iinn aa rreeffrriiggeerraaiioonn uunniitt tthhaatt iiss eeqquuiippppeedd wwiitthh aann eelleeccttrroonniicc ssyysstteemm tthhaatt ccoonniinnuuoouussllyy mmoonniittoorrss iimmee aanndd tteemmppeerraattuurree and is visually examined for proper operaion twice daily, Pf

(g) If transported off-site to a satellite locaion of the same business enity, eeqquuiippppeedd wwiitthh vveerriififiaabbllee eelleeccttrroonniicc mmoonniittoorriinngg ddeevviicceess ttoo eennssuurree tthhaatt iimmeess aanndd tteemmppeerraattuurreess aarree mmoonniittoorreedd dduurriinngg ttrraannssppoorrttaaiioonn, Pf and (h) Labeled with the product name and the date PACKAGED;Pf

Cook-chill & Sous Vide

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CHILLING to CONTROL PATHOGEN OUTGROWTH

135F

70F

41F

2h

6h

CHILL

3-501.14 Cooling.

(A) Cooked TIME/TEMPERATURE CONTROL FOR SAFETY FOOD shall be cooled:

(1) Within 2 hours from 57ºC (135ºF) to 21ºC (70°F); and

(2) Within a total of 6 hours from 57ºC (135ºF) to 5ºC (41°F) or less.

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135F

70F

41F

2h

6h

CHILL

41F↓ 34F48h

(i) Cooled to 1°C (34°F) within 48 hours of reaching 5°C (41°F) and held at that temperature until consumed or discarded within 30 days after the date of PACKAGING;P

Why? Prevent any growth of pCB and LM.

41-34F Risks? Very low. Simply placing ROP bags into ≤ 34ºF refrigeraFon will chill them from 41-34ºF usually in ≤ 6-8h.

CHILLING to CONTROL PATHOGEN OUTGROWTH

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CC/SV bags are 1-3” thick

Large roasts have to be thinned

CC/SV bags have liOle inhibiPon to heat transfer

Chilling in Cook Chill/Sous Vide

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(f) Held in a refrigera3on unit that is equipped with an electronic system that con3nuously monitors 3me and temperature and is visually examined for proper opera4on twice daily, Pf

(g) If transported off-site to a satellite loca4on of the same business en4ty, equipped with verifiable electronic monitoring devices to ensure that 3mes and temperatures are monitored during transporta3on

Cold Holding in Cook Chill/Sous Vide

Is this required for vacuum packaging?

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Common interpreta6onsq Modified atmosphere packaging (MAP) and controlled atmosphere packaging (CAP) are

generally treated like vacuum packaging for the purposes of Food Code compliance.

q If its < 21% O2 it is reduced oxygen, but note the FDA definiwon says “PPAA CC KK AA GG EE DD ”

o Zip lock and "baggie" style bagged foods are NOT considered packaged

o Foil wrapped foods such as baked potatoes NOT considered packaged

q FFDDAA CCFFSSAANN hhaass rreecceennttllyy rreeccllaassssiififieedd hhiigghh ooxxyyggeenn ttrraannssffeerr rraattee ((OOTTRR)) bbaaggss aass RROOPP.. TThhiiss iinncclluuddeess ““ddrryy aaggee”” bbaaggss ((OOTTRR << 1100,,000000))

q Foods packaged cold without a vacuum are not considered ROP (FDA interpretawon)q Foods from manufacturers already in ROP packaging do not require HACCP

q If it comes from a manufacturer, the storage temperature and shelf life are as indicated on the product

q Non-TCS foods are safe from Cb and Lm; thus do NOT require HACCP

K A H O O T R O P C C / S V Q U I Z

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3-502.12 (F )

HRS

(F) A HACCP Plan is not required when a FOOD ESTABLISHMENT uses a REDUCED OXYGEN PACKAGING method to PACKAGE TIME/TEMPERATURE CONTROL FOR SAFETY FOOD that is always:

(1) Labeled with the production time and date,

(2) Held at 5°C (41°F) or less during refrigerated storage, and

(3) Removed from its PACKAGE in the FOOD ESTABLISHMENT within 48 hours after PACKAGING.

R O P

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D i s c u s s i o n

1. An operator places food in a bag, then cooks the food using the sousvide cooking method, then serves the food directly to consumers while still hot (called SV-Serve).

2. A caterer, places hot food leftovers into a bag and uses a synch tie to seal the bag. Bags are placed on ice until the caterer gets back to their kitchen. Bags are then refrigerated and opened the next day to use the leftovers.

3. An operator makes cook chill soups early in the morning. Soup iscooked, chilled, and stored at ≤ 41F. Throughout the day theoperator reheats the soup and keeps it under hot hold until consumed.

4. The above operator wishes to use leftovers the following day.

5. A chef makes lobster bisque using the cook chill method. The bisque is used or discarded within 48h.

ROP with HACCP or not?

Read 3-502.12 paragraphs (C) and (F).

Which applies?

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3-502.11Special Process

Variance-Waiver Always required

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3-502.11 A FOOD ESTABLISHMENT shall obtain a VARIANCE from the REGULATORY AUTHORITY as specified in § 8-103.10 and under § 8-103.11 before:

(D) Packaging TIME/TEMPERATURE CONTROL FOR SAFETY FOOD using a REDUCED OXYGEN PACKAGING method except where the growth of and toxin formation by Clostridium botulinum and the growth of Listeria monocytogenes are controlled as specified under § 3-502.12; Pf

IIff aann RROOPP pprroocceessss ddooeess nnoott mmaattcchh 33--550022..1122 eexxaaccttllyy,, tthhee ooppeerraattoorr mmuusstt ssuubbmmiitt tthheeiirr pprroocceessss aanndd HHAACCCCPP ppllaann iinn aa vvaarriiaannccee rreeqquueesstt uunnddeerr 33--550022..1111..

(ROP) with Variance

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3-502.11 A FOOD ESTABLISHMENT shall obtain a VARIANCE from the REGULATORY AUTHORITY as specified in § 8-103.10 and under § 8-103.11

8-103.10 The REGULATORY AUTHORITY may grant a VARIANCE by modifying or waiving the requirements of this Code if in the opinion of the REGULATORY AUTHORITY a health HAZARD or nuisance will not result from the VARIANCE.

8-103.11 Before a VARIANCE from a requirement of this Code is APPROVED, the information that shall be provided …

• A statement of the proposed variance (cite code number).• Analysis of rationale why variance is safe (science support)• A complete HACCP plan

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Why 3-502.11?o aannyy aalltteerrnnaaXXvvee oorr ddeevviiaaXXoonn ttoo tthhee pprreessccrriippXXvvee 33--550022..1122 sseeccXXoonno acidificaXon to avoid the need for ROP HACCP (acidificaXon HACCP plan)o process involves fermentaXon, drying, curing, or another special processo cook chill with seafood ingredients (e.g. lobster bisque or clam chowder)o hybrid faciliXes (e.g. commissaries or grocery stores)o don’t have refrigerated shipping available and make acid(ified) foodso any undercooking, parXal cooking, disconXnuous cooking, or cooking to safe temperatures not in 3-402.11o vacuum package for storage, then sous vide cook at a later date (not covered in 3-502.12)o novel processes, novel tools, or novel equipment

MMaayy nneeeedd sscciieennwwfificc ssuuppppoorrtt iinncclluuddiinngg ssuuppppoorrtt ffrroomm aa ssuubbjjeecctt mmaabbeerr eexxppeerrtt..

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Fed. performance standardsSSeeaaffoooodd HHAACCCCPPo Permits ROP packaging of fish using many variationso Describes many different control factors incl. the “bot cook”UUSSDDAA FFSSIISS HHAACCCCPPo Doesn’t consider ROP of meat significant, just demonstrate control of hazardso USDA has different cooling parameters 130-80F in 90 minutes; 80-50F in 4.5 hours.

AAcciiddiiffiieedd FFooooddsso Following requirements in 21 CFR 114, operators can thermally process acid(ified) foods in hermetically sealed (ROP) bags or containers for aammbbiieennttstorage.

HHAACCCCPP bbaasseedd oonn aannootthheerr ffeeddeerraall rreegguullaattoorryy bbooddyy SSHHOOUULLDD bbee aacccceeppttaabbllee..

MMaayy nneeeedd sscciieenniifificc ssuuppppoorrtt iinncclluuddiinngg ssuuppppoorrtt ffrroomm aa ssuubbjjeecctt mmaauueerr eexxppeerrtt

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Module 3Food Code PrefaceChapter 1. DefiniXonsChapter 3. Food



Chapter 8. HACCPPublic Health Reasons & InterpretaXons

8-201.13When HACCP Required

8-201.14Contents of HACCP plan

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Submit only

Submit wait for approval

Specialized Processing

Methods

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e.g. Process authority letterApprovals from other jurisdictionsSafe harbor performance stds (e.g. USDA)

Letters of guarantee (e.g. food grade)

Equipment manuals

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33..55 LLiimmiittiinngg GGrroowwtthh ooff OOrrggaanniissmmss ooff ppuubblliicc HHeeaalltthh CCoonncceerrnn3.502.12 ROP wwiitthhoouutt aa vvaarriiaannccee criteria(A) Hazards are Cb and LM(B) HACCP plan required (2 barrier VP)(C) FISH(D) Cook Chill & Sous Vide(E) Cheese(F) 48 hour rule



Always read the Public Health reasons and be aware of FDA issued interpretations

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H A N D S O N

Using 8-201.14 as a guide create a checklist for required elements of a Food Code based HACCP plan. Cite the Food Code § §.

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General informa6on FC8-201.14 (A)

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Documents

Reduced oxygen packaging at retail FDA Food Code