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Appendix 5 - Models 197 Appendix V: Models Examples For Illustrative Purposes Only (Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.)

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Appendix 5 - Models

197

Appendix V: Models

Examples For Illustrative Purposes Only(Models may not be fully consistent with guidance containedin FDA’s Fish and Fishery Products Hazards and Control Guide.)

Appendix 5 - Models

198

Notes:

Appendix 5 - Models

199

Continued

Raw Oysters: Description of the Process

Example: For Illustrative Purposes Only(Models may not be fully consistent with guidance contained in FDA’sFish and Fishery Products Hazards and Control Guide.)

Live Chesapeake Bay oysters are received from harvesters sacked andtagged. Shellstock are delivered to the processing facility within 20 hoursof harvesting.

Upon delivery to the processing facility, the shellstock is refrigerated at45 F until shucked. This is dry storage. Oysters may be kept several daysbefore shucking. Shellstock is placed on tables for hand shucking intobuckets. Buckets of shucked oyster meat are given to the packing roomfor washing, draining and placing into pint containers. Shucked meats arestored at 40 F.

Notes:

Shucked Oyster Process Flow Chart

Receiving Live Oysters

Dry Cooler Storage

Shucking

Washing/Draining

Packing

Shucked Oyster Storage

Appendix 5 - Models

200

Notes:

Shucked Oyster Process Flow ChartShaded step is critical control point

Receiving Live Oysters

Dry Cooler Storage

Shucking

Washing/Draining

Packing

Shucked Oyster Storage

Appendix 5 - Models

Receiving Live Oysters BIOLOGICAL Yes Oysters are assumed to be • Only accept shellstock from YesBacterial pathogen eaten raw. Oysters are waters open to harvest.contamination easily contaminated with • Require proper tagging.

pathogens from harvesting • Require proper harvesterwaters. license.

Baterial pathogen growth Yes Growth between harvest and • Limit time from harvest to Yesreceiving receiving is less than 20

hours

CHEMICAL Yes Industrial pollution • Only accept shellstock from YesChemical contamination frequently occurs in estuarine waters open to harvest.

waters. Oysters may become • Require proper tagging.contaminated with these • Require proper harvesterpollutants. license.

Natural toxins Yes Natural toxins and • Only accept shellstock from Yesorganisms that produce waters open to harvest.them can be filtered and • Require proper tagging.concentrated by oysters. • Require proper harvester

license.PHYSICALNone

Dry Cooler Storage BIOLOGICAL Yes Pathogens may increase in Maintain coolers at YesBacterial pathogen growth number if oysters are not temperatures below 45 F.

properly cooled duringstorage.

CHEMICALNone

PHYSICALNone

Shucking BIOLOGICAL Yes Excessive time in shucking Cumulative time of NoBacterial pathogen growth room can promote exposure is being controlled

pathogen growth. at shucked-oyster storage.CHEMICALNone

PHYSICAL No Hazard analysis indicates that• Bits of shell this inherent defect is not

“reasonably likely” to resultin the food being unsafe forconsumption.

• Metal fragments No Not reasonably likely to occur.

201

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measures can

be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

Firm Name: ABC Oyster Co. Product Description: Shucked oysters in plastic pint containers

Firm Address: Anywhere, USA

Method of Storage and Distribution: Shipped on ice and refrigerated;

stored at retail under refrigeration.

Signature: Intended Use and Consumer: Raw consumption

Date:

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled orenhanced at this step(1)

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decisions for

column 3.

(5)What control measures can

be applied to prevent thesignificant hazards?

(6)Is this step a

criticalcontrolpoint?

(Yes/No)

Washing/Draining BIOLOGICAL Yes Excessive time at washing/ Cumulative time of NoBacterial pathogen growth draining step can promote exposure is being controlled

pathogen growth. at shucked-oyster storage.CHEMICALNone

PHYSICALNone

Packing BIOLOGICAL Yes Excessive time at packing Cumulative time of NoBacterial pathogen growth step can promote pathogen exposure is being controlled

growth. at shucked-oyster storage.

CHEMICALNone

PHYSICALNone

Shucked Oyster Storage BIOLOGICAL Yes Pathogens may increase in Maintain cooler temperature. YesBacterial pathogen growth number if oysters are not Limit the cumulative

properly cooled during exposure time of oystersstorage. to ambient temperatures.

CHEMICALNone

PHYSICALNone

202

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

Firm

Nam

e:

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ter C

o.Pr

oduc

t Des

crip

tion:

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sters

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s

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ress

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hod

of S

tora

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etai

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n.

Sign

atur

e:In

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onsu

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aw c

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mpt

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Dat

e:

203

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(1)

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Plan

For

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*Mod

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uida

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aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

Appendix 5 - Models

Appendix 5 - Models

clos

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valu

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.

204

*Mod

els

may

not

be

fully

con

sist

ent w

ith g

uida

nce

cont

aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

(2)

Sign

ifica

nt H

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch C

ontr

olM

easu

res

(4)

(5)

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Mon

itori

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)C

orre

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(9)

Veri

ficat

ion

Wha

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owFr

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Exam

ple:

For

Illu

stra

tive

Purp

oses

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y* –

HA

CCP

Plan

For

m

(10)

Rec

ords

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

Appendix 5 - Models

Dried Shrimp: Description of the Process

205

Notes:

Continued

Example: For Illustrative Purposes Only(Models may not be fully consistent wiht guidance contained in FDA’sFish and Fishery Products Hazards and Control Guide.)

Shrimp received for drying are head-on, small and fresh. They aredelivered on ice by fishermen. The drying process is seasonal.

Head-on shrimp are kept on ice until processed. Shrimp are washed andweighed to remove ice and damaged shrimp. Shrimp are boiled in sea-soned (salt) water. The amount of salt used to season the shrimp mayvary and is determined by desired flavor of the end product.

After boiling each batch of shrimp, additional salt is added to the cookwater to maintain a constant concentration. Cooked shrimp are placedin forced-air drying units until the shrimp are properly dried, usually sixto seven hours.

The dried shrimp are rotated in a screen drum to remove shells and headsfrom the dried meat. Dried shrimp tails are sacked and stored. Sulfite isnot declared on the label because sulfited shrimp are not used. The shrimpmay be stored under refrigeration, although this is not necessary.

Appendix 5 - Models

206

Notes:Dried Shrimp Process Flow Chart

ReceivingSalt

Receiving Head-On Shrimp

Iced Shrimp Storage

Wash and Weigh Raw Shrimp

Cook Shrimp

Forced Air Drying

Screen Tumbling

Packaging or Sacking

Storage

Appendix 5 - Models

207

Dried Shrimp Process Flow ChartShaded step is critical control point

ReceivingSalt

Receiving Head-On Shrimp

Iced Shrimp Storage

Wash and Weigh Raw Shrimp

Cook Shrimp

Forced Air Drying

Screen Tumbling

Packaging or Sacking

Storage

Notes:

Appendix 5 - Models

208

Receiving Shrimp BIOLOGICAL Yes Raw seafood can be natural Cooking will destroy prior NoBacterial pathogen contamination reservoirs for pathogens. to consumption.

CHEMICAL Yes Potential for allergic-type Reject shrimp containing YesSulfiting agent reaction. sulfite residuals.

PHYSICALNone

Iced Shrimp Storage BIOLOGICAL Yes Pathogen growth if Cooking will destroy prior NoBacterial pathogen growth temperature abused. to consumption.

CHEMICALNone

PHYSICALNone

Receiving Salt BIOLOGICALNone

CHEMICALNone

PHYSICALNone

Wash Raw Shrimp BIOLOGICALNone

CHEMICALNone

PHYSICALNone

Cook Shrimp BIOLOGICAL Yes Improper cooking will allow Control time/temperature YesPathogen survival survival of pathogens. during cooking.

CHEMICALNone

PHYSICALNone

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

(1)Ingredient/processing step

(2)Identify potential hazardintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?Yes/No)

(4)Justify your decisions for

column 3.

(5)What control measures can

be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

Firm Name: ABC Shrimp Drying Co. Product Description: Dried shrimp in cloth sacks

Firm Address: Anywhere, USA

Method of Storage and Distribution: Dry storage, unrefrigerated

Signature: Intended Use and Consumer: Ready to eat without further processing

Date:

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

Drying BIOLOGICAL Yes Improperly dried shrimp Reduce water activity YesPathogen growth will have a wet spot, to acceptable levels.

allowing pathogen growth.CHEMICALNone

PHYSICALNone

Tumbling BIOLOGICAL No Controlled by SSOP.• Pathogen recontamination• Pathogen growth No Low water activity.

CHEMICALNone

PHYSICALNone

Packing BIOLOGICAL No Controlled by SSOP.Pathogen recontamination

Pathogen growth No Low water activity.

CHEMICALNone

PHYSICALNone

Storage BIOLOGICAL No Low water activity.Pathogen growth

CHEMICALNone

PHYSICALNone

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

(1)Ingredient/processing step

(2)Identify potential hazardintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?Yes/No)

(4)Justify your decisions for

column 3.

(5)What control measures can

be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

209

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

210

Rece

ivin

gSu

lfite

resid

uals

No

dete

ctab

le su

lfite

Pres

ence

of

Rapi

d su

lfite

Ever

y bo

atD

ockm

aste

rRe

ject

if p

rese

nt•

Dai

ly re

cord

Rece

ivin

ghe

ad-o

n sh

rimp

resid

uals

sulfi

te re

sidua

lste

stre

view

reco

rdin

any

3 g

rab

•La

b re

ports

sam

ples

with

offi

cial

AO

AC

tests

seas

onal

ly

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Surv

ival

of p

atho

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Boile

d at

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r thr

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ater

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ture

Visu

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.

Firm

Nam

e:

ABC

Shrim

p D

ryin

g Co

.Pr

oduc

t Des

crip

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D

ried

shrim

p in

clo

th sa

cks

Firm

Add

ress

: A

nywh

ere,

USA

Met

hod

of S

tora

ge a

nd D

istrib

utio

n:

Dry

stor

age,

unr

efrig

erat

ed

Sign

atur

e:In

tend

ed U

se a

nd C

onsu

mer

: R

eady

to e

at w

ithou

t fur

ther

pro

cess

ing

Dat

e:

*Mod

els

may

not

be

fully

con

sist

ent w

ith g

uida

nce

cont

aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

Exam

ple:

For

Illu

stra

tive

Purp

oses

Onl

y* –

HA

CCP

Plan

For

m

(10)

Rec

ords

(2)

Sign

ifica

nt H

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch C

ontr

olM

easu

re

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Veri

ficat

ion

Wha

tH

owFr

eque

ncy

Who

Appendix 5 - Models

Pasteurized Blue Crabmeat: Description of Process Flow

211

Notes:

Continued

Example: For Illustrative Purposes Only(Models may not be fully consistent wiht guidance contained in FDA’sFish and Fishery Products Hazards and Control Guide.)

Blue crabs are caught and transported live to processing facilities byeither boat or truck. On arrival, the crabs are inspected for physicaldamage, chemical contamination and mortality. Those crabs that arenot immediately processed are placed in a cooler (55 F to 65 F) for amaximum of 24 hours.

The crabs are cooked in a retort for 10 minutes at 250 F (15 psig).Cooked crabs are placed in an air-cool room for a maximum oftwo hours or until steam is not visible from the crabs. The crabs arethen placed in a refrigerated room at 45 F until processed.

The cooled crabs are picked by hand into metal cans. In the packingrooms, cans are check-weighed and hermetically sealed on a one headseamer. The sealed containers are refrigerated. Within 48 hours ofpicking, meat is pasteurized. During the pasteurization process, the can ofpicked meat is heated in a water bath followed by cooling in ice slush.Finished product containers are stored under refrigeration.

Appendix 5 - Models

212

Notes:Pasturized Blue Crabmeat Processing Flow Chart

Boat Truck

Loading Area

Raw Crab Cooler

Retort

Air Cool Room

Cooked Crab Cooler

Picking Room

Packing/Sealing

Refrigerated Storage

Pasteurization Process

Packed ProductRefrigeration Room

Appendix 5 - Models

213

Notes:

Continued

Pasturized Blue Crabmeat Processing Flow ChartShaded step is Critical Control Point

Boat Truck

Loading Area

Raw Crab Cooler

Retort

Air Cool Room

Cooked Crab Cooler

Picking Room

Packing/Sealing

Refrigerated Storage

Pasteurization Process

Packed ProductRefrigeration Room

Appendix 5 - Models

Receipt BIOLOGICAL Yes Raw crabs can be a Pasteurization eliminates NoBacterial pathogen contamination reservoir for pathogens. pathogens.

CHEMICAL No No history of problems withEnvironmental contaminants crabs in area of harvest.

PHYSICALNone

Raw Crab Cooler BIOLOGICAL Yes Raw crabs contain human Pasteurization eliminates NoBacterial pathogen growth pathogens that can grow pathogens.

under refrigerated conditions.

CHEMICALNone

PHYSICALNone

Retort BIOLOGICAL Yes Improper cook will not kill Pasteurization eliminates NoPathogen survival or inactivate human pathogens.

pathogens.

CHEMICAL No SSOPBoiler chemicals

PHYSICAL NoNone

Air Cool Room BIOLOGICAL No • RecontaminationPathogens controlled by SSOP.

• Bacterial growth controlledby hot crab temperatureand short holding time.

CHEMICALNone

PHYSICALNone

214

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

If this product was sold as fresh crabmeat, then the retort process may be a critical control point.

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Firm Name: ABC Crab Co. Product Description: Pasteurized crabmeat in hermetically sealed steel cans

Firm Address: Anywhere, USA

Method of Storage and Distribution: Refrigerated

Signature: Intended Use and Consumer: Ready to eat without further processing

Date:

Appendix 5 - Models

Cooked Crab Cooler BIOLOGICAL Yes Time/temperature abuse Pasteurization eliminates NoBacterial pathogen growth could allow pathogen growth. the pathogens.

CHEMICALNone

PHYSICALNone

Picking Room BIOLOGICAL Yes Excessive time in processing Pasteurization will eliminate No• Bacterial pathogen growth room will promote pathogen the pathogens.

growth.

• Staphylococcus aureus No Although humans are naturalreservoirs, using USDA’spathogen modeling program,it was determined that thetemperature abuse conditionsnecessary for growth ofS. aureus to levels sufficientfor toxin production were notreasonably likely to occur.

• Bacterial pathogen No SSOPrecontamination

CHEMICALNone

PHYSICAL No Hazard analysis indicatesShell that this inherent defect is not

"reasonably likely" to resultin the food being unsafefor consumption.

Packing/Sealing BIOLOGICAL Yes Defective seams may allow Proper can seams. Yes• Bacterial pathogen entry of Clostridium

recontamination through can botulinum type E.seams

• Bacterial pathogen growth Yes Excessive time in processing Pasteurization will eliminate Noroom will promote pathogen the pathogens.growth.

• Staphylococcus aureus No Although humans are naturalreservoirs, using USDA’spathogen modeling program,it was determined that thetemperature abuse conditionsnecessary for growth ofS. aureus to levels sufficientfor toxin production were notreasonably likely to occur.

CHEMICALNone

PHYSICALNone

215

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

Refrigerated Storage BIOLOGICAL Yes Time/temperature abuse could Pasteurization eliminates the NoBacterial pathogen growth allow pathogen growth. pathogens.

CHEMICALNone

PHYSICALNone

Pasteurization BIOLOGICAL Yes Pathogens will survive Apply proper themal YesPathogen survival an improper thermal process. process.

CHEMICAL NoNone

PHYSICAL NoNone

Packed Product BIOLOGICAL Yes Human pathogens Proper refrigeration. YesRefrigeration Room Bacterial pathogens (Clostridium botulinum,

Type A) could grow ifproduct is temperatureabused.

CHEMICALNone

PHYSICALNone

216

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

Firm

Nam

e:

ABC

Crab

Co.

Prod

uct D

escr

iptio

n:

Paste

urize

d cr

abm

eat i

n he

rmet

ical

ly s

eale

d ste

el c

ans

Firm

Add

ress

: A

nywh

ere,

USA

Met

hod

of S

tora

ge a

nd D

istrib

utio

n:

Refri

gera

ted

Sign

atur

e:In

tend

ed U

se a

nd C

onsu

mer

: R

eady

to e

at w

ithou

t fur

ther

pro

cess

ing

Dat

e:

Pack

ing/

Seal

ing

Bact

eria

l pat

hoge

nCo

ntai

ner s

eam

s mee

tCa

n se

ams

•Ca

n-se

am te

ar-

•M

onito

r one

can

Qua

lity-

cont

rol

•Re

adju

st ca

nD

aily

reco

rdCa

n-se

amre

cont

amin

atio

n th

roug

hm

anuf

actu

rer’s

dow

n ev

alua

tion

at st

art-u

p w

hen

pers

onse

amin

g m

achi

ne.

revi

ewev

alua

tion

form

can

seam

ssp

ecifi

catio

nsan

adj

ustm

ent

•H

old

and

is m

ade

to se

alin

gev

alua

te p

rodu

ctm

achi

ne a

ndsin

ce p

revi

ous

ever

y fo

ur h

ours

chec

ks.

durin

g op

erat

ion

• Visu

al se

am•

One

can

eve

ryex

amin

atio

nha

lf ho

ur

Paste

uriz

a tio

nSu

rviv

a l o

f pa t

hoge

nsFo

r 401

x 3

01 c

a n,

Wa t

e r-b

a th

Rec o

rdin

gEa

c h b

a tc h

Qua

lity-

c ont

rol

Rec o

ok, r

e je c

t•

Da i

ly re

c ord

Reco

rder

cha

rtm

inim

um w

ater

bat

hte

mpe

ratu

re a

ndth

e rm

ome t

e rpe

rson

prod

uct o

r hol

dre

vie w

188

F, ti

me

120

min

utes

time

offo

r eva

luat

ion.

•Pr

oces

s vali

datio

nin

ba t

h. T

his c

ook

paste

uriz

a tio

n(o

n fil

e).

achi

eves

F=3

1,•

Calib

ratio

n of

ref.

185

F, z

=16

tem

pera

ture

re-

and

6Dco

rder

to M

IGki

ll pr

oces

sth

erm

omete

r dail

yan

d an

nual

calib

ratio

n of

MIG

the r

mom

e te r

Refri

gera

ted

Bact

eria

l pat

hoge

n,50

F m

axim

um fo

r coo

ler

Tem

pera

ture

of

Rec o

rdin

gCo

ntin

uous

with

Qua

lity-

c ont

rol

•H

old

a nd

• Da i

ly re

c ord

• Re c

orde

r cha

rtsSt

ora g

eC.

bot

ulim

um ty

pe A

c ool

e rth

e rm

ome t

e rvi

sua l

che

c ks

pers

onev

a lua

te b

a se d

revi

e w•

Cool

e rgr

owth

in p

acke

d pr

oduc

tan

d vi

sual

che

ckev

ery

four

hou

rson

tim

e an

d• C

alib

ratio

n of

tem

pera

ture

durin

g op

e ra t

ion

tem

pera

ture

tem

pera

ture

rec o

rdof

exp

osur

e.re

cord

er w

ith•

Adj

ust c

oole

r.M

IG th

erm

omete

rw

e ekl

y

217

*Mod

els

may

not

be

fully

con

sist

ent w

ith g

uida

nce

cont

aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

(2)

Sign

ifica

nt H

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r eac

h C

ontr

olM

easu

res

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

Wha

tH

owFr

eque

ncy

Who

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

(9)

Veri

ficat

ion

Exam

ple:

For

Illu

stra

tive

Purp

oses

Onl

y* –

HA

CCP

Plan

For

m

(10)

Rec

ords

Appendix 5 - Models

218

Notes:

Appendix 5 - Models

Vacuum Packed Hot Smoked Salmon,Cooked Ready-to-Eat Product: Description of Process Flow

219

Notes:

Continued

Example: For Illustrative Purposes Only(Models may not be fully consistent with guidance contained in FDA’sFish and Fishery Products Hazards and Control Guide.)

Salmon are caught in set nets, which are positioned near the shoreline.The fish are held on ice in the round (whole, uneviscerated) until deliveryto the processing plant, usually within a few hours of harvest. At theprocessing facility, the raw material is placed into totes, iced and placed ina cooler until needed for processing.

The totes are brought from the cooler into the processing area where theyare placed onto a tote dumper that lifts the tote and dumps the productinto a hopper. As needed, the hopper door is opened, and the fish flowonto a table. An employee aligns the fish toward an automatic header andeviscerator. After heading and eviscerating, the fish are transported via aconveyer belt to a table where employees fillet the fish. Employees at theend of the fillet line check for bones and inadequate evisceration, sort bysize and place the fillets into a brine solution. These fish are brined for 24hours under refrigeration to achieve the desired water-phase salt content.

After brining, the brine tanks are drained. The fillets are rinsed and placedonto racks for surface drying prior to smoking. Drying takes approxi-mately four hours and is performed under refrigeration. After drying, theracks are rolled into the smoking/cooling unit. The fish are hot smoked forapproximately six hours.

After smoking, the racks are removed from the unit and rolled into thecooler. Employees remove the smoked salmon from the racks and placethem into prelabeled packages. The packages are vacuum sealed and thenplaced into 25-pound boxes. The boxes are palletized and stored in acooler until distributed.

Appendix 5 - Models

220

Notes:

SaltReceiving

Vacuum Packaged Hot Smoked SalmonProcessing Flow Chart

Fish Delivery

Totes Iced

Cooler Storage

Tote Dumper

Hopper

Header/Eviscerator

Filleting

Brining

Rinsing

Drying

Smoking/Cooking

Cooling

Vacuum Packaging/Labeling

Boxing

Cooler Storage

Appendix 5 - Models

221

Notes:

SaltReceiving

Vacuum Packaged Hot Smoked SalmonProcessing Flow Chart

Shaded step is Critical Control Point

Fish Delivery

Totes Iced

Cooler Storage

Tote Dumper

Hopper

Header/Eviscerator

Filleting

Brining

Rinsing

Drying

Smoking/Cooking

Cooling

Vacuum Packaging/Labeling

Boxing

Cooler Storage

Appendix 5 - Models

Fish Delivery BIOLOGICAL• Bacterial pathogen Yes Raw seafood can be Hazard is controlled at the No

contamination natural sources for pathogens. smoking/cooking step.

• Parasites Yes Parasites occur in wild-caught Hazard is controlled at the Nofish. smoking/cooking

step.CHEMICALNone

PHYSICALNone

Totes Iced BIOLOGICAL No Period of time at this• Bacterial pathogen growth location is short.

• Bacterial pathogen No SSOPcontamination

CHEMICALNone

PHYSICALNone

Cooler Storage BIOLOGICAL Yes Temperature abuse can allow Hazard is controlled at the NoBacterial pathogen growth the growth of pathogenic smoking/cooking

microorganisms. step.CHEMICALNone

PHYSICALNone

Tote Dumper BIOLOGICAL No Period of time at this• Bacterial pathogen growth location is short.

• Bacterial pathogen No SSOPcontamination

CHEMICALNone

PHYSICALNone

222

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Firm Name: ABC Smoked Salmon Co. Product Description: Smoked salmon

Firm Address: Anywhere, USA

Method of Storage and Distribution: Refrigeration

Signature: Intended Use and Consumer: Ready to eat without further processing

Date:

Appendix 5 - Models

Hopper BIOLOGICAL• Bacterial pathogen growth No Period of time at this

location is short.

• Bacterial pathogen No SSOPcontamination

CHEMICALNone

PHYSICALNone

Header/Eviscerator BIOLOGICAL Yes Raw seafood can be a Hazard is controlled at the NoBacterial pathogens natural source of pathogens. cooking step, which is basedincluding C. botulinum on a high initial load of

C. botulinum.CHEMICALNone

PHYSICAL No Subsequently brining andMetal Fragments rinsing will remove any metal

fragments; little opportunityfor any metal to becomeembedded into the flesh offish. No historical problem.

Filleting BIOLOGICAL• Bacterial pathogen growth No Period of time at this

location is short.

• Bacterial pathogen No SSOPcontamination

CHEMICALNone

PHYSICALNone

Salt Receiving BIOLOGICALNone

CHEMICALNone

PHYSICALNone

Brining BIOLOGICAL Yes Salt content in the flesh in Proper brining. Yes• C. botulinum growth and combination with the smoke

toxin production in finished and heat treatment is necessaryproduct to control growth.

• Other bacterial pathogens Yes Salt content in the flesh is Hazard is controlled at the Noinsufficient to inhibit growth. smoking/cooking step.

CHEMICALNone

PHYSICALNone

223

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazard?

(6)Is this stepa criticalcontrolpoint ?(Yes/No)

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

224

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Rinsing BIOLOGICAL No Period of time at this• Bacterial pathogen location is short.

• Bacterial pathogen No SSOPcontamination

CHEMICALNone

PHYSICALNone

Drying BIOLOGICALBacterial pathogen Yes Salt content in the flesh is Hazard is controlled at the No

insufficient to inhibit growth. smoking/cooking step.CHEMICALNone

PHYSICAL NoNone

Smoking/cooking BIOLOGICAL Yes Adequate cook is necessary Proper smoking/cooking . YesBacterial pathogen survival to inactivate the bacterial path-

gens in the raw materials andintroduced during processing.

CHEMICALNone

PHYSICALNone

Cooling BIOLOGICAL No Controlled by SSOPs.• Pathogen recontamination

• C. bot. type E growth No Combination of salt andinhibitors from smoke.

• C. bot. type A growth No Length of time necessary togrow is not reasonably likelyto occur.

• Growth of other pathogens No Length of time necessary togrow is not reasonably likelyto occur.

CHEMICALNone

PHYSICALNone

Vacuum Packaging/Labeling BIOLOGICAL Controlled by SSOPs.• Bacterial pathogens introduced No

during packaging/labeling

• Growth of proteolytic C. bot. Yes Severe temperature abuse can Appropriate label statement Yesallow growth during subsequent regarding importance ofdistribution and storage. refrigeration. Include time

CHEMICAL temperature integrator labelNone or recorder

PHYSICALNone

Appendix 5 - Models

Boxing BIOLOGICAL No Period of time at thisBacterial pathogens location is short.

CHEMICALNone

PHYSICALNone

Cooler Storage BIOLOGICAL Yes C. botulinum can grow if not Proper refrigeration and YesProteolytic C. botulinum growth refrigerated. temperature integrator

labels or recordersCHEMICALNone

PHYSICALNone

225

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

Brin

ing

C. b

otul

inum

toxi

n•

Min

imum

24-

hour

•Ti

me

in b

rine

• Visu

al ti

me

•Ea

ch b

atch

bef

ore

• Pro

duct

ion

•Ho

ld lo

nger

in•

Daily

revi

ew•

Proc

essin

gpr

oduc

tion

in th

e fin

ished

soak

ing

time

chec

ksre

mov

ing

fish

empl

oyee

brin

e so

lutio

n.re

cord

reco

rdpr

oduc

t•

Min

imum

salt

cont

ent

•Sa

lt co

nten

t• S

alom

eter

•Ea

ch b

atch

at

•Qu

ality

-con

trol

•Ad

d sa

lt.•

Stud

y sh

owin

g•

Proc

essin

gof

60˚

salo

met

er a

tof

brin

esta

rt of

pro

cess

pers

onbr

inin

g m

etho

dre

cord

start

of p

roce

sspr

ovid

es a

t lea

st3.

5 pe

rcen

t wat

erph

ase

salt

•M

inim

um 2

:1 ra

tio o

f• W

eigh

t of f

ish•

Wei

ght o

f fish

•Ea

ch b

atch

•Pr

oduc

tion

•Ad

just

amou

nt•

Quar

terly

fini

shed

•Pr

oces

sing

brin

e to

fish

(wei

ght

and

brin

e (

scal

e)em

ploy

eeof

fish

or b

rine.

prod

uct a

naly

sisre

cord

to w

eigh

t)•

Wei

ght o

f brin

efo

r wat

er p

hase

(ca

libra

ted

salt

mar

k on

tank

)

*Mod

els

may

not

be

fully

con

sist

ent w

ith g

uida

nce

cont

aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

Firm

Nam

e:

ABC

Smok

ed S

alm

on C

o.Pr

oduc

t Des

crip

tion:

Sm

oked

sal

mon

Firm

Add

ress

: A

nywh

ere,

USA

Met

hod

of S

tora

ge a

nd D

istrib

utio

n:

Refri

gera

tion

Sign

atur

e:In

tend

ed U

se a

nd C

onsu

mer

: R

eady

to e

at w

ithou

t fur

ther

pro

cess

ing

Dat

e:

226

(2)

Sign

ifica

nt H

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch C

ontr

olM

easu

res

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Veri

ficat

ion

Wha

tH

owFr

eque

ncy

Who

Exam

ple:

For

Illu

stra

tive

Purp

oses

Onl

y* –

HA

CCP

Plan

For

m

(10)

Rec

ords

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

Expl

anat

ory

Note

: In

man

y ca

ses i

t will

be

nece

ssar

y to

con

trol t

he d

ryin

g st

ep to

ach

ieve

the

desi

r ed

wate

r-ph

ase

salt

cont

ent i

n fin

ishe

d pr

oduc

t.

Appendix 5 - Models

227

*Mod

els

may

not

be

fully

con

sist

ent w

ith g

uida

nce

cont

aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

Exam

ple:

For

Illu

stra

tive

Purp

oses

Onl

y* –

HA

CCP

Plan

For

m

Smok

ing/

Cook

ing

Bacte

rial p

athog

en su

rviv

al• M

inim

um in

terna

l• F

ish in

terna

l• T

herm

ocou

ple

• Con

tinuo

us w

ith• S

mok

er o

pera

tor

• Rec

ook,

des

troy,

•Da

ily re

cord

• The

rmoc

oupl

etem

pera

ture

of f

ish o

ftem

pera

ture

and

prob

es in

the t

hree

visu

al ch

eck

at th

eor

hol

d pr

oduc

t and

revi

ewre

cord

ing

char

t14

5 F

for 3

0 m

inut

estim

eth

ickes

t fish

in th

een

d of

each

batc

hev

aluate

.•

Stud

y id

entif

ying

cold

est p

art o

fco

ld sp

ot in

the

oven

smok

er•

Calib

ratio

n of

the

reco

rdin

g de

vice

at th

e beg

inni

ngan

d en

d of

each

day

•Qu

arter

ly te

sting

of w

ater p

hase

salt

cont

ent

• Vac

uum

/Pac

king

• Gro

wth

of p

roteo

lytic

• Pre

senc

e of a

ppro

priat

e• P

rodu

ct lab

el• V

isual

• Pre

-ope

ratio

nal

• Pac

king

supe

rviso

r• R

eject

pack

ages

• Wee

kly

reco

rd• P

ack

room

log

La

belin

gC.

botu

linum

in p

rolo

nged

la be l

statem

ent

c he c

kswi

thou

t la b

e l sta

te -re

vie w

prod

uct

men

t and

repl

ace

• Pre

senc

e of t

ime t

empe

ratu

re• T

TI’s

pres

ent a

nd• V

isual

• Eve

ry p

acka

ge• Q

ualit

y-co

ntro

lwi

th a

ppro

priat

e .• D

aily

reco

rd re

view

inte g

rato

r la b

e ls (T

TI’s)

a ctiv

a ted

perso

npa

c ka g

e s

• Hol

d an

d ev

aluate

pack

ages

with

out

TTI’s

; plac

e and

activ

ate p

rope

rTT

I’s

• Coo

ler st

orag

e•

Path

ogen

gro

wth

and

• Max

imum

cool

er t

empe

r-• C

ooler

tem

pera

ture

• Rec

orde

r• R

ecor

d co

ntin

uous

ly;

• Qua

lity-

cont

rol

•Re

adju

st co

oler

•Da

ily re

cord

• Coo

ler te

mpe

ratu

re p

oten

tial t

oxin

pro

ducti

onatu

re o

f 40º

F >

2 ho

urs

and

expo

sure

tim

e t

herm

omete

r

chec

k ch

art e

very

pe

rson

ther

mos

tat. H

old

revi

ew an

d we

ekly

char

t and

pac

kTT

I col

or a

nd T

TI v

isuals

12

hou

rs an

d TT

I’s.

and

evalu

ate,

cali

brati

onro

om re

cord

• TTI

colo

r cha

nges

dail

y b

ased

on

time

of r

ecor

ding

and

tempe

ratu

re th

erm

omete

r o

f exp

osur

e

(2)

Sign

ifica

nt H

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r eac

h C

ontr

olM

easu

res

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Veri

ficat

ion

Wha

tH

owFr

eque

ncy

Who

(10)

Rec

ords

Exp

lana

tory

not

e: T

TI’

s w

ould

acc

ompa

ny th

e pr

oduc

ts u

ntil

they

are

ope

ned

to a

tmos

pher

ic c

ondi

tion

s th

at p

reve

nt C

. bot

ulin

um g

row

th

Appendix 5 - Models

228

Notes:

Appendix 5 - Models

Example: For Illustrative Purposes Only(Models may not be fully consistent with guidance contained in FDA’sFish and Fishery Products Hazards and Control Guide.)

The fish sticks are not fully cooked. They are packed in a PET tray witha heat-sealed plastic film lid. There is no atmosphere modification. Eachpackage is labeled with a “use by” date, cooking instructions and thephrase, “keep frozen.” The product is intended for the general public.

Imported frozen minced fish (either pollock or haddock) is receivedin frozen blocks via freezer truck. The blocks are transferred to frozenstorage (-10 F).

Dry ingredients (batter, breading) and packaging materials are deliveredto the plant by truck. Dry goods are placed in dry, cold storage.

To be processed, the fish blocks are removed from the freezer, one palletat a time. Cases are opened and blocks unwrapped. Blocks are mechani-cally cut into preformed fish sticks. As sticks proceed on a conveyor belt,they are culled for uniformity and then battered and breaded, twice each.Recirculated batter is chilled to 45 F.

From the last breading application, the portions pass through a fryercontaining soy bean oil for less than one minute at 400 F. This fryersets the batter/breading but does not cook the fish.

The fish sticks exit the fryer and enter a nitrogen tunnel for individualquick freezing. The nitrogen tunnel freezer is set at -120 F; the exposuretime is 6 to 10 minutes.

As the fish sticks exit the freezer, they are culled for breading uniformityand packaged into either consumer packages (8 oz. or 22 oz.) or largefood-service cartons (10 pounds). Then they are labeled and passedthrough a metal detector. Packages are cased, palletized and stored inthe freezer at -10 F. Product is shipped on freezer trucks to retail or food-service distribution centers.

Frozen Breaded Fish Sticks: Description of Process Flow

229

Notes:

Continued

Appendix 5 - Models

230

Notes:Breaded Fish Sticks Process Flow Chart

Receive Frozen Receive DryFish Blocks Ingredients:

batter, breading, oil, packaging

Frozen Storage

Unwrap Dry Cold Storage

Cut/Saw Mix Batter

Cull Batter Pack/Weigh/Label

Bread Metal Detection

Fry Case

IQF Freeze Frozen Storage

Cull

Appendix 5 - Models

231

Notes:

Continued

Breaded Fish Sticks Process Flow ChartShaded step is Critical Control Point

Receive Frozen Receive DryFish Blocks Ingredients:

batter, breading,oil, packaging

Frozen Storage

Unwrap Dry Cold Storage

Cut/Saw Mix Batter

Cull Batter Pack/Weigh/Label

Bread Metal Detection

Fry Case

IQF Freeze Frozen Storage

Cull

Appendix 5 - Models

Receiving Frozen BIOLOGICAL No Product will be fully cookedFish Blocks • Pathogen contamination by the consumer.

• Parasites No Unlikely to be viable infrozen product.

CHEMICALNone

PHYSICAL No Hazard analysis indicatesBones that this inherent defect is

not "reasonably likely" toresult in the food beingunsafe for consumption.

Frozen Storage BIOLOGICAL No Product is frozen soPathogens opportunity for pathogen

growth is low.

CHEMICALNone

PHYSICALNone

Unwrap BIOLOGICAL No • Period of time at this• Pathogen growth step is short.

• Product is frozen.

• Pathogen contamination No SSOP

CHEMICALNone

PHYSICALNone

232

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justifiy your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Firm Name: ABC Breaded Fish Stick Co. Product Description: Partially cooked, battered and breaded fish sticks

Firm Address: Anywhere, USA

Method of Storage and Distribution: Frozen

Signature: Intended Use and Consumer: Cook and serve

Date:

Appendix 5 - Models

Cut/Saw BIOLOGICAL No • Period of time at this• Pathogen growth step is short.

• Product is frozen.

• Pathogen contamination No SSOP

CHEMICALNone

PHYSICAL Yes Risk of contaminating the Metal detector at later step NoMetal fragments product with broken saw

blades

Cull BIOLOGICAL No • Period of time at this• Pathogen growth step is short.

• Product is frozen.

• Pathogen contamination No SSOP

CHEMICALNone

PHYSICALNone

Receive Dry Ingredients BIOLOGICAL No Possibility of pathogenPathogen contamination contamination is remote

as documented by pastexperience.

CHEMICALNone

PHYSICALNone

Dry Cold Storage BIOLOGICALNone

CHEMICALNone

PHYSICALNone

Mix Batter BIOLOGICAL No Risk is low due to short• Pathogen growth mixing time.

• Pathogen contamination No Potable water is used (SSOP)

CHEMICALNone

PHYSICALNone

233

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step>

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant harzards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

Batter BIOLOGICAL Yes Pathogen growth (staph Keep temperature low. Yes• Pathogen growth toxin) if batter held too

long at elevated temperature.

• Pathogen contamination No SSOP

CHEMICALNone

PHYSICAL Yes Metal fragments from Metal detector at later step NoMetal fragments wire-mesh conveyers

Breading Operation BIOLOGICAL No Application of dry breading• Pathogen growth does not promote pathogen

growth.

• Pathogen contamination No SSOP

CHEMICALNone

PHYSICALMetal fragments Yes Metal fragments from wire- Metal detector at later step No

mesh conveyor

Fryer BIOLOGICALNone

CHEMICAL No Potential for toxicRancid cooking oil compounds from cooking

oil is remote.

PHYSICALNone

IQF Freeze BIOLOGICAL No Product is frozen withinPathogens minutes of frying, making

pathogen growth remote.

CHEMICALNone

PHYSICALNone

Cull BIOLOGICAL No • Period of time at this• Pathogen growth step is short.

• Product remains frozen.

• Pathogen contamination No SSOP

CHEMICALNone

PHYSICALNone

234

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

Pack/Weigh/Label BIOLOGICALNone

CHEMICALNone

PHYSICALNone

Metal Detection BIOLOGICALNone

CHEMICALNone

PHYSICAL Yes Metal fragments from saw Operable metal detector/Metal fragments and conveyer belts reject mechanism Yes

Case BIOLOGICAL No • Time at this step is shortPathogen growth so pathogens unlikely

to grow.• Product remains frozen.

CHEMICALNone

PHYSICALNone

Frozen Storage BIOLOGICAL No Product is frozen soPathogen growth pathogen growth unlikely.

CHEMICALNone

PHYSICALNone

235

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

236

Batte

rBa

cteria

l path

ogen

s and

Batte

r tem

pera

ture

not

toTe

mpe

ratu

re a

ndCh

eck

tempe

ratu

reEv

ery

hour

Quali

ty-c

ontro

l•

If ba

tter t

empe

r-•

Chec

k re

cord

sQu

ality

-con

trol

poten

tial p

athog

enex

ceed

50

F fo

r gre

ater t

han

expo

sure

tim

e for

in h

old

tank.

perso

natu

re is

ove

r 50

Fda

ily.

log

grow

thfo

ur h

ours

batte

rfo

r mor

e tha

n fo

ur•

Calib

rate

hour

s, du

mp

batte

rth

erm

omete

ran

d re

clean

hol

dwe

ekly.

tank.

Des

troy

orho

ld an

d ev

aluate

prod

uct m

ade

durin

g de

viati

on.

Meta

lM

etal

No d

etecta

ble m

etal

Meta

l fra

gmen

tsM

etal d

etecto

rCo

ntin

uous

Labe

ling

If de

tecto

r is

•Ru

n tes

t mate

rial

•Op

erato

r’s lo

gDe

tectio

nfra

gmen

ts in

fini

shed

oper

ator c

heck

sno

t on

or fa

ilswi

th m

etal o

fpr

oduc

tsho

urly

to e n

sure

sens

itivi

ty c

hec k

,a p

prop

riate

detec

tor i

s on.

then

all p

rodu

ctsiz

e to

chec

ksin

ce la

st ac

cept

able

sens

itivi

ty d

aily

chec

k is

held

and

rech

ecke

d fo

r meta

l.• S

uper

viso

rre

vie w

sop

erato

r log

sda

ily.

*Mod

els

may

not

be

fully

con

sist

ent w

ith g

uida

nce

cont

aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

Firm

Nam

e:

ABC

Brea

ded

Fish

Stic

k Co

.Pr

oduc

t Des

crip

tion:

Pa

rtial

ly c

ooke

d, b

atte

red

and

brea

ded

fish

stick

s

Firm

Add

ress

: A

nywh

ere,

USA

Met

hod

of S

tora

ge a

nd D

istrib

utio

n:

Froz

en

Sign

atur

e:In

tend

ed U

se a

nd C

onsu

mer

: C

ook

and

serv

e

Dat

e:

(2)

Sign

ifica

nt H

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch C

ontr

olM

easu

res

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Veri

ficat

ion

(10)

Rec

ords

Wha

tH

owFr

eque

ncy

Who

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

Exam

ple:

For

Illu

stra

tive

Purp

oses

Onl

y* –

HA

CCP

Plan

For

m

Exp

lana

tory

not

e: F

DA

’s H

ealth

Haz

ard

Eva

luat

ion

Boa

rd h

as s

uppo

rted

act

ion

agai

nst p

rodu

ct w

ith m

etal

fra

gmen

ts o

f 0.

3" (

7mm

) to

1.0

" (2

5mm

)

Appendix 5 - Models

Example: For Illustrative Purposes Only(Models may not be fully consistent with guidance contained in FDA’sFish and Fishery Products Hazards and Control Guide.)

Iced, whole wild-caught salmon are received directly from the fisher. Theprocessor sells directly to XYZ Sushi Bar for raw consumption.

Fish are rinsed with potable water and sorted to remove ice and damagedfish. The fish are re-iced and held less than 24 hours before processing.Fish are filleted and trimmed by hand. Fillets are blast frozen, glazed withpotable water, bagged and stored in the freezer. The finished product isdistributed frozen.

Frozen Salmon Fillets for Raw Consumption

237

Notes:

Continued

Fish Fillet Process Flow Chart

Receiving

Rinse

Sort

Iced Storage

Fillet, Skin and Trim

Blast Freeze

Glaze

Weigh/Pack/Label

Frozen Storage

Appendix 5 - Models

238

Notes:Fish Fillet Process Flow Chart

Shaded step is Critical Control Point

Receiving

Rinse

Sort

Iced Storage

Fillet, Skin and Trim

Blast Freeze

Glaze

Weigh/Pack/Label

Frozen Storage

Appendix 5 - Models

239

Receiving BIOLOGICAL Yes Parasites are present in the Freezing No• Parasites species being processed.

• Pathogens growth Yes Raw seafood can be natural Proper icing Yessource for pathogens. There-fore consumption of rawseafood carries some inherentrisks. Risk can be reducedwith thermal controls

CHEMICAL No Fish are harvested from watersChemical contamination where chemical contaminants

are not likely to occur.

PHYSICALNone

Rinse BIOLOGICAL No Period of time at this• Bacterial pathogen growth location is short.

• Bacterial pathogen No SSOPcontamination

CHEMICALNone

PHYSICALNone

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justifiy your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Firm Name: ABC Fish Co. Product Description: Salmon fillets, skinless

Firm Address: Anywhere, USA

Method of Storage and Distribution: Frozen

Signature: Intended Use and Consumer: To be consumed raw

Date:

If the processor has reasonable assurances that the product will be adequately frozen (as FDA Food Code) prior to consumption,the response in column 3 is “no” and the parasite hazard becomes a hazard to be controlled by the XYZ Sushi bar.

Appendix 5 - Models

Sort BIOLOGICAL No Period of time at this• Bacterial pathogen growth location is short

• Bacterial pathogen No SSOPcontamination

CHEMICALNone

PHYSICALNone

Iced storage BIOLOGICAL Yes Hazardous pathogen Proper icing YesBacterial pathogen growth

CHEMICALNone

PHYSICALNone

Fillet, skin and trim BIOLOGICAL No Period of time at this• Bacterial pathogen growth location is short.

• Bacterial pathogen No SSOPcontamination

CHEMICALNone

PHYSICAL No No history of occurrenceMetal inclusion with hand operation

Blast freeze BIOLOGICALNone

CHEMICALNone

PHYSICALNone

Glaze BIOLOGICAL No SSOPPathogen contamination

CHEMICALNone

PHYSICALNone

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step>

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant harzards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

240

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

241

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step>

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant harzards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Weigh/Pack/Label BIOLOGICALNone

CHEMICALNone

PHYSICALNone

Frozen storage BIOLOGICAL Yes Parasite survival if not Proper time and temperature YesParasite survival not properly frozen of freezing

CHEMICALNone

PHYSICALNone

If this product is sold fresh or not previously frozen, product labeling can be used for further assurance that the productwill be properly frozen prior to consumption.

Appendix 5 - Models

242

*Mod

els

may

not

be

fully

con

sist

ent w

ith g

uida

nce

cont

aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

Firm

Nam

e:

ABC

Fish

Co.

Prod

uct D

escr

iptio

n:

Salm

on fi

llets,

ski

nles

s

Firm

Add

ress

: A

nywh

ere,

USA

Met

hod

of S

tora

ge a

nd D

istrib

utio

n:

Froz

en

Sign

atur

e:In

tend

ed U

se a

nd C

onsu

mer

: T

o be

con

sum

ed ra

w

Dat

e:

Rece

ivin

g• P

athog

en g

rowt

h• P

rope

r icin

g• I

cing

• Visu

al•

Ever

y lo

t• P

roce

ss su

perv

isor

• Reje

ct if

not

• Wee

kly

reco

rd• R

eceiv

ing

log

prop

erly

iced

revi

ew

Iced

Sto

rage

• Path

ogen

gro

wth

• Pro

per i

cing

• Icin

g• V

isual

•Da

ily• P

roce

ss su

perv

isor

• If i

ce m

elted

or

• Wee

kly

reco

rd• R

efrig

erati

onin

adeq

uate,

revi

ewsto

rage

log

chec

k pr

oduc

ttem

pera

ture

, hol

dan

d ev

aluate

, or

cons

ider

div

ertin

gto

cook

use

or

rejec

t

Froz

en st

orag

e• P

aras

ite su

rviv

al• F

reez

e to

-4 F

(-20

C) f

or•

Fre e

z er t

empe

ratu

re•

Rec o

rdin

g•

Cont

inuo

us w

ith•

Proc

e ssin

g•

Adju

st fre

e ze r

•W

e ekl

y re

c ord

•Te

mpe

ratu

re c

hart

7

days

the r

mom

e ter

one v

isua l

c he c

ksu

perv

isor

revi

e wpe

r day

•Ti

me i

n fre

e ze r

•Vi

sua l

•Pr

oce s

sing

•Ex

te nd

stora

ge ti

me

•Ca

libra

te•

Froz

e n st

ora g

e log

•W

hen

rem

oved

supe

rviso

rth

e rm

ome te

r eve

ryfro

m fr

eeze

rsix

mon

ths

•Ev

ery

lot

(2)

Sign

ifica

nt H

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch C

ontr

olM

easu

res

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Veri

ficat

ion

(10)

Rec

ords

Wha

tH

owFr

eque

ncy

Who

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

Exam

ple:

For

Illu

stra

tive

Purp

oses

Onl

y* –

HA

CCP

Plan

For

m

Appendix 5 - Models

Example: For Illustrative Purposes Only(Models may not be fully consistent with guidance contained in FDA’sFish and Fishery Products Hazards and Control Guide.)

Domestic yellowfin tuna are caught by hook-and-line day boats returningon same day catch. The fish are headed and gutted before being held inice and packed in ice, including ice in gut cavity, on the vessel untildelivery to the plant.

Upon receipt at the processing plant, the unfrozen tuna is immediatelyindividually weighed, sorted (culled) and graded. They are iced andplaced in cooler storage at 40 F, followed by loining and trimming. Theloined product is regraded, sized, cello-wrapped and placed in 40- to 60-pound waxed or foam cartons with ice. It is labeled and placed in a coolerfor shipment to the fresh market. The cumulative process time is less thantwo hours.

Fresh Tuna Loins:Description of Process

243

Notes:

Continued

Fresh Tuna Loins Processing Flow Chart

Receive/Weigh/Sort/Grade Unfrozen Tuna

Cooler Storage (Iced)

Loining/Trimming

Regrade/Sizing

Pack/Weigh/Label Fresh Loins

Finished ProductCooler Storage

Appendix 5 - Models

Fresh Tuna Loins Processing Flow ChartShaded step is Critical Control Point

Receive/Weigh/Sort/Grade Unfrozen Tuna

Cooler Storage (Iced)

Loining/Trimming

Regrade/Sizing

Pack/Weigh/Label Fresh Loins

Finished ProductCooler Storage

244

Notes:

Appendix 5 - Models

245

Receive/weigh/sort/ BIOLOGICAL No Product is to be cooked bygrade unfrozen tuna • Bacterial pathogen consumer.

contamination

• Parasites No Not likely in species

CHEMICAL Yes Tuna subjected to time- Ensure proper handling of YesScombrotoxin (histamine) temperature abuse can fish during harvest.

develop scombrotoxin(histamine).

PHYSICALNone

Cooler storage (iced) BIOLOGICAL No Product is to be cooked by• Bacterial pathogen growth consumers.

CHEMICAL Yes Tuna subjected to time- Maintain adequate YesScombrotoxin (histamine) temperature abuse can temperature control.

develop scombrotoxin(histamine).

PHYSICALNone

Loining/trimming BIOLOGICAL No Controlled by SSOPs• Bacterial pathogen

contamination

• Bacterial pathogen growth No Product is to be cooked byconsumer.

CHEMICAL No Hazard is not significantScombrotoxin (histamine) due to short process time.

PHYSICALNone

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justifiy your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Firm Name: ABC Tuna Co. Product Description: Fresh tuna loins

Firm Address: Anywhere, USA

Method of Storage and Distribution: Refrigerated

Signature: Intended Use and Consumer: General public will cook product before eating.

Date:

Note: If the cumulative processing time (from ice product cooler to final product cooler) approaches four hours,procedures should be in place at the intervening processing steps to ensure temperature control.

Appendix 5 - Models

Regrade/sizing BIOLOGICAL No Controlled by SSOPs• Bacterial pathogen

contamination

• Bacterial pathogen growth No Product is to be cooked byconsumer.

CHEMICAL No Hazard is not significantScombrotoxin (histamine) due to short process time.

PHYSICALNone

Pack/Weigh/label BIOLOGICAL No Controlled by SSOPs• Bacterial pathogen

contamination

• Bacterial pathogen growth No Product is to be cookedby consumer.

CHEMICAL No Hazard is not significantScombrotoxin (histamine) due to short process time.

PHYSICALNone

Finished product cooler BIOLOGICAL No Product is to be cooked bystorage Bacterial pathogen growth consumer.

CHEMICAL Yes Tuna subjected to Proper temperature control. YesScombrotoxin (histamine) temperature abuse can

develop scombrotoxin(histamine).

PHYSICALNone

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step>

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justify your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant harzards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

246

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Appendix 5 - Models

247

Rece

ive/w

eigh/

sort/

Scom

brot

oxin

form

ation

•In

terna

l fish

temp

eratu

re•

Inter

nal f

ish•

Ther

mome

ter•

Ever

y lo

t (en

tire

•Do

ckma

ster

•Re

je ct l

ot o

r tes

t•

Calib

rate

•Te

mper

ature

log

grad

e unf

roze

n tu

namu

st no

t be h

ighe

r tha

ntem

pera

ture

lot u

p to

12

fish)

for h

istam

ine;

ther

mome

ter(h

eade

d an

d gu

tted)

50 F

and

gut c

avite

yre

ject i

f exc

eeds

week

lypr

oper

ly ic

ed.

50 P

PM.

•Ha

rves

t rec

ord

must

show

•Ti

me-te

mper

ature

•Vi

sual

chec

k of

•Ev

ery

lot

•Do

ckma

ster

•Re

ject l

ot o

r tes

t•

Quar

terly

•Re

ceiv

er’s

log

fish

cool

ed to

50

F wi

thin

reco

rd o

f har

vest

reco

rdfo

r hist

amin

e;ve

rifica

tion

ofsix

hou

rs of

dea

th.

rejec

t if e

xcee

dshi

stami

ne te

st50

PPM

.me

thod

•No

mor

e tha

n 2.5

pe r

c ent

•Ha

rve s

t ve s

sel

•Se

nsor

y•

Eve r

y lo

t (e n

tire

•Qu

a lity

-con

trol

•Re

je ct l

ot o

r te s

t•

Daily

rec o

rd•

Sens

ory

log

of lo

t sho

uld

e xhi

bit

rec o

rds

e xam

ina ti

onlo

t up

to 1

2 fis

h)pe

rson

fish

e xhi

bitin

gre

vie w

dec o

mpos

ition

.de

comp

ositi

on fo

rhi

stami

ne; r

eject

if an

y ex

ceed

s50

PPM

.

*Mod

els

may

not

be

fully

con

sist

ent w

ith g

uida

nce

cont

aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

Firm

Nam

e:

ABC

Tuna

Co.

Prod

uct D

escr

iptio

n:

Fres

h tu

na lo

ins

Firm

Add

ress

: A

nywh

ere,

USA

Met

hod

of S

tora

ge a

nd D

istrib

utio

n:

Refri

gera

ted

Sign

atur

e:In

tend

ed U

se a

nd C

onsu

mer

: G

ener

al p

ublic

will

coo

k pr

oduc

t bef

ore

eatin

g.

Dat

e:

(2)

Sign

ifica

nt H

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r eac

h C

ontr

olM

easu

res

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Veri

ficat

ion

Wha

tH

owFr

eque

ncy

Who

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

Exam

ple:

For

Illu

stra

tive

Purp

oses

Onl

y* –

HA

CCP

Plan

For

m

(10)

Rec

ords

Appendix 5 - Models

248

Cool

er st

orag

e (ice

d)Sc

ombr

otox

in (h

istam

ine)

Prod

uct a

dequ

ately

iced

Pres

ence

of i

ceVi

sual

Ever

y six

hou

rs wh

ileOp

erati

ons m

anag

erAd

d ice

; che

ckCa

libra

te th

erm

o-Co

oler

log

plan

t is i

n op

erati

onpr

oduc

t int

erna

lm

eter w

eekl

y.tem

pera

ture

. If

inter

nal t

empe

ratu

reDa

ily re

cord

revi

ewex

ceed

s 45

F, or

abov

e 40º

F >

4 ho

urs,

rejec

t or c

ondu

cthi

stam

ine

test.

Fini

shed

pro

duct

Scom

brot

oxin

(hist

amin

e)Pr

oduc

t ade

quate

ly ic

edPr

esen

ce o

f ice

Visu

alEv

ery

six h

ours

while

Oper

ation

s man

ager

Add

ice; c

heck

Calib

rate

ther

mo-

Cool

er lo

gco

ole r

plan

t is i

n op

erati

onpr

oduc

t int

erna

lm

eter b

efor

e use

.tem

pera

ture

. If

inter

nal t

empe

ratu

reDa

ily re

cord

revi

ewex

ceed

s 45º

F, or

abov

e 40º

F >

4 ho

urs,

rejec

t or c

ondu

cthi

stam

ine

test.

*Mod

els

may

not

be

fully

con

sist

ent w

ith g

uida

nce

cont

aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

(2)

Sign

ifica

nt H

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch C

ontr

olM

easu

res

Exam

ple:

For

Illu

stra

tive

Purp

oses

Onl

y* –

HA

CCP

Plan

For

m

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Veri

ficat

ion

Wha

tH

owFr

eque

ncy

Who

(10)

Rec

ords

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

Appendix 5 - Models

Example: For Illustrative Purposes Only(Models may not be fully consistent with guidance contained in FDA’sFish and Fishery Products Hazards and Control Guide.)

A variety of different fish species in various product forms (whole, gutted,dressed, fillets, steaks, loin, etc.) are received from various suppliers by theMetro Fish Co. Fresh fish are not purchased directly from fishers or aquacul-ture farms except for some red hake and whiting that are occasionallypurchased directly from local fishers in the spring and fall. No shellfish arepurchased directly from fishers or aquaculture farms. All fish are fresh andare delivered by refrigerated truck or in containers in which the product isthoroughly iced. Clams and oysters are received and sold as live shellstockand stored in a cooler at 45 F. Minimal time is involved in repacking theseshellfish products. Shucked scallops are received in gallon containers andpacked in ice. With the exception of shellstock, products are immediatelymoved after receipt into a refrigerated storage cooler on ice. Customer ordersare packed and loaded on company-owned refrigerated trucks for delivery tocustomers.

Finfish species: flounder, cod, hake, pollock, monkfish, whiting, bluefish,striped bass (wild), hybrid striped bass (farm-raised), catfish (farm-raised),mackerel (northern), weakfish, tuna, mahi-mahi, swordfish and salmon (farm-raised)

Shellfish species: clams and oysters (live shellstock), shrimp (farm-raised) andsea scallops (wild) (meats)

Intended use: All products except clams and oysters are intended to bethoroughly cooked before being eaten. Live clams and oysters may be eatenraw or partially cooked. All products are intended for sale to the generalpublic.

Wholesale/Distribution/Warehouse Facilities:Description of Process Flow

249

Notes:

Continued

Appendix 5 - Models

250

Notes:

Wholesale/Distribution/Warehouse FacilitiesProcessing Flow Chart

(Frozen) Receive Product (Fresh)

Frozen Storage Refrigerated Storage

Pack or Repack

Frozen Storage Refrigerated Storage

Wholesale/Distribution/Sharehouse FacilitiesProcessing Flow Chart

Shaded step is Critical Control Point

(Frozen) Receive Product (Fresh)

Frozen Storage Refrigerated Storage

Pack or Repack

Frozen Storage Refrigerated Storage

Appendix 5 - Models

* Pr

oduc

t sou

rce-

rela

ted

haza

rds a

re g

ener

ally

con

trolle

d by

the

first

buye

r or p

roce

ssor

who

rece

ives

the

prod

uct d

irect

ly fr

om a

fish

er, a

ves

sel o

r an

aqua

cultu

re fa

rm.

** T

his t

able

can

be

deriv

ed b

y sta

rting

with

the

FDA

Haz

ards

and

Con

trol G

uide

and

usin

g an

y su

pple

men

tal i

nfor

mat

ion

or e

xper

ienc

e th

e pr

oces

sor m

ight

hav

e.

PRO

DU

CT

SOU

RC

E R

ELAT

ED H

AZA

RD

S*Pa

rasit

esH

istam

ine

Path

ogen

sTo

xins

Che

mic

al C

onta

min

ants

Aqu

acul

ture

Dru

gs

No

Haz

ards

Wor

kshe

et 1

— H

azar

d A

naly

sis

Prod

uct G

roup

ing

(HAC

CP W

hole

sale

Sea

food

Teac

hing

Exa

mpl

e)ce

rtian

Fin

fish

and

Shel

lfish

Spe

cies w

ith R

elat

ed H

azar

ds

251

Appendix 5 - Models

red

hake

clam

scl

ams

salm

on (f

)sa

lmon

(f)

salm

on (f

)m

acke

rel

wea

kfis

hoy

ster

soy

ster

sca

tfis

h (f

)ca

tfis

h (f

)m

acke

rel

tuna

whi

ting

blue

fish

hybr

id b

ass

(f)

cod

blue

fish

swor

dfis

hst

ripe

d ba

ss (w

)sh

rim

p (f

)po

llock

mah

i-m

ahi

flou

nder

(i)

flou

nder

shri

mp

(f)

mon

kfis

hcl

ams

oyst

ers

sea

scal

lops

(f)=

farm

-rai

sed;

(w

)= w

ild;

(i)=

insh

ore

* Pr

oduc

t so

urce

-rel

ated

haz

ards

are

gen

eral

ly c

ontro

lled

by th

e fir

st bu

yer o

r pro

cess

or w

ho re

ceiv

es th

e pr

oduc

t dire

ctly

from

a fi

sher

, a v

esse

l or a

n aq

uacu

lture

farm

.**

Thi

s tab

le c

an b

e de

rived

by

starti

ng w

ith th

e FD

A H

azar

ds a

nd C

ontro

l Gui

de a

nd u

sing

any

supp

lem

enta

l inf

orm

atio

n or

exp

erie

nce

the

proc

esso

r mig

ht h

ave.

PRO

DU

CT

SOU

RC

E R

ELAT

ED H

AZA

RD

S*Pa

rasit

esH

istam

ine

Path

ogen

sTo

xins

Che

mic

al C

onta

min

ants

Aqu

acul

ture

Dru

gs

No

Haz

ards

Wor

kshe

et 1

— H

azar

d A

naly

sis

Prod

uct G

roup

ing

(HAC

CP W

hole

sale

Sea

food

Teac

hing

Exa

mpl

e)ce

rtian

Fin

fish

and

Shel

lfish

Spe

cies w

ith R

elat

ed H

azar

ds

252

Appendix 5 - Models

Path

ogen

s fr

omH

arve

st A

rea

Nat

ural

Toxi

ns

Che

mic

alC

onta

min

ants

& P

estic

ides

Aqu

acul

ture

Dru

gs

His

tam

ine

Para

site

s

** T

his t

able

can

be

deriv

ed b

y sta

rting

with

the

FDA

Haz

ards

and

Con

trol G

uide

and

usin

g an

y su

pple

men

tal i

nfor

mat

ion

or e

xper

ienc

e th

e pr

oces

sor m

ight

hav

e.

Iden

tify

cont

rol m

easu

reFi

sh a

nd S

hellf

ish S

peci

es(fr

om P

rodu

ct G

roup

ing

Wor

kshe

et)

Is th

is ha

zard

signi

fican

t?Ye

s/No

Just

ify y

our

deci

sion

(from

col

umn

3)H

azar

d en

hanc

ed,

intr

oduc

ed o

r co

ntro

lled

at th

is st

ep

Wor

kshe

et 2

— S

peci

es-R

elat

ed H

azar

d A

naly

sis

Proc

essin

g St

ep =

Rec

eivi

ng

Is th

is C

CP?

Yes/N

o

253

Appendix 5 - Models

Path

ogen

s fr

omG

roup

1 —

Cla

ms

and

oyst

ers

Yes

Raw

she

llfis

h is

a k

now

n so

urce

Che

ck ta

gs to

ens

ure

that

all

prod

uct

Yes

Har

vest

Are

aof

pat

hoge

nic

orga

nism

s;is

tagg

ed, f

rom

cer

tifie

d sh

ippe

rste

mpe

ratu

re a

buse

dur

ing

tran

sit

and

tem

pera

ture

-con

trol

led

duri

ngco

uld

lead

to b

acte

rial

gro

wth

.tr

ansi

t.

Nat

ural

Tox

ins

Gro

up 1

— C

lam

s an

d oy

ster

sYe

sPr

oduc

ts f

rom

una

ppro

ved

wat

ers,

Che

ck ta

gs to

ens

ure

that

all

prod

uct

Yes

(e.g

. PSP

)ha

rves

ters

or

ship

pers

cou

ld c

onta

inis

tagg

ed a

nd fr

om c

ertif

ied

ship

pers

.na

tura

l tox

ins.

Che

mic

alG

roup

1 —

Cla

ms

and

oyst

ers

Yes

Prod

ucts

fro

m u

napp

rove

d w

ater

s,C

heck

tags

to e

nsur

e th

at a

ll pr

oduc

tY

esC

onta

min

ants

harv

este

rs o

r sh

ippe

rs c

ould

hav

eis

tagg

ed a

nd fr

om c

ertif

ied

ship

pers

.&

Pes

ticid

esch

emic

al c

onta

min

ants

.

salm

on, c

atfi

sh, h

ybri

d st

ripe

d ba

ss,

No

Not

pur

chas

ed d

irec

tly f

rom

fis

hers

Tem

pera

ture

con

trol

led

duri

ngN

ow

ild s

trip

ed b

ass,

flo

unde

r, bl

uefi

sh,

or fi

sh fa

rms.

Haz

ard

is c

ontr

olle

dtr

ansi

t.sh

rim

p, s

ea s

callo

psby

fir

st p

roce

ssor

.

Aqu

acul

ture

salm

on, c

atfi

sh, h

ybri

d st

ripe

d ba

ss,

No

Not

pur

chas

ed d

irec

tly f

rom

fis

hers

No

Dru

gssh

rim

por

fish

farm

s. H

azar

d is

con

trol

led

by f

irst

pro

cess

or.

His

tam

ine

Gro

up 2

— m

acke

rel,

tuna

, blu

efis

hYe

sC

ould

dev

elop

a h

ista

min

e ha

zard

Tem

pera

ture

con

trol

led

duri

ngY

esm

ahi-

mah

if ti

me-

tem

pera

ture

abu

se o

ccur

s.tr

ansi

t. N

ot p

urch

ased

dir

ectly

fro

mfi

sher

s or

fish

farm

s.

Para

site

ssa

lmon

, mac

kere

l, co

d, p

ollo

ck,

No

Sold

to re

tail

stor

es o

r res

taur

ants

No

flou

nder

, mon

kfis

hfo

r sal

e to

gen

eral

pub

lic w

ho w

illco

ok th

em b

efor

e th

ey a

re e

aten

.

254

** T

his t

able

can

be

deriv

ed b

y sta

rting

with

the

FDA

Haz

ards

and

Con

trol G

uide

and

usin

g an

y su

pple

men

tal i

nfor

mat

ion

or e

xper

ienc

e th

e pr

oces

sor m

ight

hav

e.

Iden

tify

cont

rol m

easu

reFi

sh a

nd S

hellf

ish S

peci

es(fr

om P

rodu

ct G

roup

ing

Wor

kshe

et)

Is th

is ha

zard

signi

fican

t?Ye

s/No

Just

ify y

our

deci

sion

(from

col

umn

3)H

azar

d en

hanc

ed,

intr

oduc

ed o

r co

ntro

lled

at th

is st

ep

Wor

kshe

et 2

— S

peci

es-R

elat

ed H

azar

d A

naly

sis

Proc

essin

g St

ep =

Rec

eivi

ng

Is th

is C

CP?

Yes/N

o

Appendix 5 - Models

255

Receiving BIOLOGICAL Yes Pathogen could be present Check all incoming product Yes• Pathogens from harvest in product. May be eaten to ensure that it is properly

area raw. tagged and from a certifieddealer.

• Pathogen growth during Yes Potential thermal abuse Temperature control Yestransit could elevate pathogen levels

CHEMICAL Yes Chemical contaminants Check incoming product to Yes• Chemical contaminants may be present. ensure that it is properly

tagged and from a certifieddealer.

• Natural toxins Yes Toxins may be present. Check incoming product to Yesensure that it is properlytagged and from a certifieddealer.

PHYSICALNone

Refrigerated storage BIOLOGICAL Yes Pathogens could grow if Temperature control YesPathogen growth product is not stored properly

and temperature abuse occurs.

CHEMICAL No No additives used in storageFood and color additives

PHYSICAL No Not likely to occur in storageMetal or glass

Pack/Repack BIOLOGICAL No Time and temperature abuse• Pathogen growth is not likely to occur because

of short duration of processstep.

• Pathogen contamination No SSOPs

CHEMICALNone

PHYSICALNone

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

Group 1 — Clams and Oysters

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justifiy your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Firm Name: Metro Fish Co. Product Description: Group 1 — Live Clams and Oysters

Firm Address: One Metropolitan Ave.

Metropolis, USA Method of Storage and Distribution: Stored and distributed under refrigeration

Signature: Intended Use and Consumer: May be eaten raw or partially cooked.

Date: Sold to the general public.

Appendix 5 - Models

256

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

Group 2 — Mackerel, Tuna, Bluefish, and Mahi-Mahi

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justifiy your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Firm Name: Metro Fish Co. Product Description: Group 2 — Mackerel, tuna, bluefish and mahi-mahi

Firm Address: One Metropolitan Ave.

Metropolis, USA Method of Storage and Distribution: Stored and distributed fresh on ice.

Signature: Intended Use and Consumer: Product will be fully cooked by consumer.

Date: Sold to the general public.

Receiving BIOLOGICAL No Product intended to be• Parasites fully cooked before being

eaten.

• Pathogen contamination No Product intended to befully cooked before beingeaten.

CHEMICAL Yes Temperature abuse could Proper temperature control Yes• Histamine lead to histamine formation. during transit

• Chemical contaminants No Hazard controlled by firstreceiver from fishers.

PHYSICALNone

Refrigerated storage BIOLOGICAL No Product to be fully cookedPathogen growth

CHEMICAL Yes Time and temperature abuse Proper icing during YesHistamine could lead to histamine storage

formation.

PHYSICALNone

Pack/Repack BIOLOGICAL No Product to be fully cookedPathogen growth

CHEMICAL No Minimal time out ofHistamine refrigeration

PHYSICALNone

Appendix 5 - Models

257

Receiving BIOLOGICAL No Product to be fully cooked• Parasites (salmon, pollockcod, flounder, monkfish)

• Pathogen growth during No Product to be fully cookedtransit

CHEMICAL No Hazard controlled by first• Aquaculture drugs (salmon, receiver from aquaculturecatfish, hybrid striped bass, farm.shrimp)

• Chemical contamination No Hazard controlled by first(salmon, catfish, hybrid receiver from fishers.striped bass, wild striped bass,flounder, shrimp, sea scallops)

PHYSICALNone

Refrigerated storage BIOLOGICAL No Product to be fully cookedPathogen growth

CHEMICALNone

PHYSICALNone

Pack/Repack BIOLOGICAL No Minimal time lapsePathogen growth at this end step. Product is to

be fully cooked.

CHEMICALNone

PHYSICALNone

Example: For Illustrative Purposes Only*Hazard-Analysis Worksheet

Group 3 — Salmon, Catfish, Hybird, Striped Bass, Wild Striped Bass, Flounder, Bluefish, Cod,Pollock, Monkfish, Shrimp, and Sea Scallops

(1)Ingredient/processing step

(2)Identify potential hazardsintroduced, controlled or

enhanced at this step.

(3)Are anypotential

food-safetyhazards

significant?(Yes/No)

(4)Justifiy your decision for

column 3.

(5)What control measure(s)

can be applied to prevent thesignificant hazards?

(6)Is this stepa criticalcontrolpoint?

(Yes/No)

*Models may not be fully consistent with guidance contained in FDA’s Fish and Fishery Products Hazards and Control Guide.

Firm Name: Metro Fish Co. Product Description: Group 3 — Salmon, catfish, hybrid striped bass,

Firm Address: One Metropolitan Ave. wild striped bass, flounder, cod, pollock, monkfish, red hake, whiting, weakfish,

Metropolis, USA swordfish, shrimp, sea scallops.

Method of Storage and Distribution: Stored and distrributed fresh on ice.

Signature: Intended Use and Consumer: Product to be fully cooked before it is eaten.

Date: Sold to the general public.

Appendix 5 - Models

258

*Mod

els

may

not

be

fully

con

sist

ent w

ith g

uida

nce

cont

aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

Firm

Nam

e:

Met

ro F

ish C

o.Pr

oduc

t Des

crip

tion:

G

roup

1 —

Liv

e Cl

ams a

nd O

yste

rs

Firm

Add

ress

: O

ne M

etro

polit

an A

ve.

M

etro

polis

, USA

Met

hod

of S

tora

ge a

nd D

istrib

utio

n:

Stor

ed a

nd d

istrib

uted

und

er re

frige

ratio

n

Sign

atur

e:In

tend

ed U

se a

nd C

onsu

mer

: M

ay b

e ea

ten

raw

or p

artia

lly c

ooke

d. S

old

to th

e ge

nera

l pub

lic.

Dat

e:

Rece

ivin

gPa

thog

ens a

nd ch

emica

lAl

l she

llfish

are p

rope

rlyVi

sual

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k of

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al ch

eck

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ch sh

ipme

ntRe

ceiv

ing

mana

ger

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t al l

prod

uct

Revi

ew al

l rec

ords

Shell

fish

purc

hase

cont

amin

ants,

and

natu

ral

tagge

d an

d re

ceiv

ed fr

omsh

ellsto

ck ta

gs an

dde

liver

y of

tags

not p

rope

rly ta

gged

at lea

st on

ce a

week

.lo

gto

xins

from

har

vest

area

.ce

rtifie

d de

alers

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ippe

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rtific

ation

num

ber a

tor

from

certi

fied

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ery.

deale

r.

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ogen

gro

wth

All p

rodu

ct is

kept

less

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ping

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eratu

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sual

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k of

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ment

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ivin

g ma

nage

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uct g

reate

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r cer

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eject.

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oler

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cord

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omete

rCo

ntin

uous

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t man

ager

If co

oler

temp

eratu

reRe

view

all r

ecor

dsCo

ntin

uous

reco

rder

exce

ed 4

5 F

for m

ore t

han

and

visu

al tem

pera

ture

tempe

ratu

re re

cord

er.is

grea

ter th

an 4

5 F

at lea

st on

ce a

week

and

cool

er lo

gfo

ur h

ours

chec

ks.

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al ch

eck

ever

yfo

r fou

r hou

rs, ch

eck

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k an

d ca

libra

tefo

ur h

ours

durin

gme

at tem

pera

ture

.th

ermo

meter

s onc

eop

e ra ti

on.

per w

e ek.

If me

at tem

pera

ture

is >

45 F,

hold

and

cont

act s

tate a

utho

rity

or d

estro

y pr

oduc

t.

(2)

Sign

ifica

nt H

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r ea

ch C

ontr

olM

easu

res

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Veri

ficat

ion

Wha

tH

owFr

eque

ncy

Who

Exam

ple:

For

Illu

stra

tive

Purp

oses

Onl

y* –

HA

CCP

Plan

For

mG

roup

1 —

Cla

ms

and

Oys

ters

(10)

Rec

ords

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

Appendix 5 - Models

Rece

ivin

gHi

stami

neAl

l fish

are a

dequ

ately

iced

.Ch

eck

for i

ceVi

sual

chec

kEa

ch d

elive

ryRe

ceiv

ing

mana

ger

Re-ic

e. If

ice is

not

Daily

reco

rd re

view

Rece

ivin

g lo

gad

equa

te, ch

eck

Calib

rate

therm

omete

r.in

terna

l pro

duct

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ratu

re. I

ftem

pera

ture

is g

reate

rth

an 4

5 F

rejec

t lot

or te

st 60

fish

oren

tire l

ot. R

eject

ifan

y tes

t is g

reate

r tha

n50

ppm

hist

amin

e.

Stor

a ge

Hista

mine

Prod

ucts

a re a

dequ

a tely

ice d

Pres

ence

of i

ceVi

sual

chec

kEv

ery

four

hou

rsPl

ant

mana

ger

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e. if

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not

Daily

reco

rd re

view

.Co

oler

log

and

store

d in

the c

ooler

durin

g pl

ant o

pera

ting

pres

ent,

chec

kCa

librat

e the

rmom

eter.

hour

s.in

te rna

l pro

duc t

tempe

ratu

re. I

fgr

eater

than

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F fo

rmo

re th

an fo

ur h

ours,

re-ic

e and

test

for

hista

mine

. Des

troy

lot i

f any

samp

leex

ceed

s 50

ppm

hista

mine

.

*Mod

els

may

not

be

fully

con

sist

ent w

ith g

uida

nce

cont

aine

d in

FD

A ’s

Fis

h an

d F

ishe

ry P

rodu

cts

Haz

ards

and

Con

trol

Gui

de.

Firm

Nam

e:

Met

ro F

ish C

o.Pr

oduc

t Des

crip

tion:

G

roup

2 —

Mac

kera

l, tu

na, b

luef

ish a

nd m

ahi-m

ahi

Firm

Add

ress

: O

ne M

etro

polit

an A

ve.

M

etro

polis

, USA

Met

hod

of S

tora

ge a

nd D

istrib

utio

n:

Stor

ed a

nd d

istrib

uted

fres

h on

ice.

Sign

atur

e:In

tend

ed U

se a

nd C

onsu

mer

: P

rodu

ct w

ill b

e fu

lly c

ooke

d by

con

sum

er. S

old

to th

e ge

nera

l pub

lic.

Dat

e:

259

(2)

Sign

ifica

nt H

azar

d(s)

(3)

Cri

tical

Lim

itsfo

r eac

h C

ontr

olM

easu

res

(4)

(5)

(6)

(7)

Mon

itori

ng(8

)C

orre

ctiv

eA

ctio

n(s)

(9)

Veri

ficat

ion

Wha

tH

owFr

eque

ncy

Who

Exam

ple:

For

Illu

stra

tive

Purp

oses

Onl

y* –

HA

CCP

Plan

Form

Gro

up 2

— M

acke

rel,

Tuna

, Blu

efish

, and

Mah

i-Mah

i

(1)

Cri

tical

Con

trol

Poin

t (C

CP)

(10)

Rec

ords

Appendix 5 - Models

260

Notes: