Part III
The HACCP System
INTRODUCTION
The Meaning of HACCP
Hazard x RisK
History of the HACCP System
Traditional Inspection x HACCP
System
The Seven Principles of HACCP
Meaning of HACCP
Hazard Analysis and
Critical Control Points
Why HACCP?
HA = Hazard Analysis
+
CCP = Critical Control Points
HACCP Application
Basic Agriculture
Food Processing
Distribution and Marketing
Catering Services
Street Foods
Use by consumers
HACCP Objectives
Eliminate or significantly reduce
hazards
Prevent or minimize microbial
growth and toxin production;
Control contamination.
HISTORY OF HACCP
– In the 1960s the Pillsbury Company
developed a program for the
production of safe foods for NASA
space program
– In 1971,Pillsbury presented HACCP
system to the public for the first time
– In 1973,it was applied to low-acid
canned foods
Recommendation of the
National Academy of Science
In 1985,NAS recommended that food
sanitary agencies,as well as food industry
in the US,should apply HACCP
Justification and
importance of HACCP
Why HACCP?
The Codex Alimentarius Commission
decided to adopt the acronym HACCP,
regardless the translation of Hazard
Analysis and Critical Control Points in
any of the official languages of the
United Nations
Uniform understanding
The CODEX ALIMENTARIUS
and HACCP
The Codex Alimentarius Commission,in its
twentieth session,held in Geneva,Switzerland
June 23 - 28,1997,adopted the revised
Recommended International Code of Practice
– General Principles of Food Hygiene
TRADITIONAL INSPECTION
X
HACCP
Traditional inspection:
based on sight,smell and tactile
sense to detect hazards (injuries,
contamination,etc.)
established when hazards were
macroscopic contamination and sick
animals
Microbial and chemical contaminants
are not detected by inspector
Analysis of samples of final product
(1/1,000) indicates the lot is very likely
(>94%) to be accepted,even if
contaminated
HACCP:
emphasizes process control
focus control on critical points related to food
safety
values communication between food
producer and inspection
HACCP
Preventive and not reactive (traditional
inspection)
Tool used to protect food from biological,
chemical and physical hazards
HACCP
A system to ensure food
safety
The HACCP system
is not 100% safe !
THE SEVEN PRINCIPLES
OF HACCP
THE SEVEN PRINCIPLES OF HACCP
1,Perform a Hazard Analysis (HA) and establish
the corresponding preventative measures
2,Determine the Critical Control Points (CCP)
3,Establish critical limits for each CCP
4,Establish monitoring systems
5,Establish corrective actions
6,Establish verification procedures
7,Establish record keeping and documentation
INTRODUCTION TO
HAZARDS
HAZARDS
Biological
Chemical
Physical
HAZARD
It is a biological,physical,or chemical
property that may cause food to become
unsafe for human consumption
In HACCP,“hazard” means
conditions or contaminants that may
cause illnesses or represent a threat
to the consumer’s health
It does not apply to the presence of other
types of contaminants,such as:
– insects or hair,
– decomposition,
– economic fraud and
– violation of quality requirements.
Factors that contribute to
the existence of hazards
INFECTIVE DOSE
It is the number of microorganisms
needed to cause illness,It depends on:
–consumers
–physiological factors
–immunological status of the individual
Important:
The presence of some microorganisms such as
Escherichia coli O157:H7,Clostridium
botulinum,in any amount,is enough to render
food potentially hazardous
VARIABLES OF THE PARASITE OR
MICROORGANISM
Variability of gene expression of multiple
pathogenic mechanisms
Potential for damage or stress of the
microorganism
Interaction of organism with food and
environment
pH susceptibility of organism
Immunological "uniqueness" of the organism
Interactions with other organisms
VARIABLES OF THE HOST
Age
General health
Pregnancy
Medications
Metabolic disorders
Alcoholism,cirrhosis,hemochromatosis
Amount of food consumed
Gastric acidity variation,antacids,natural
variation,achlorhydria
Genetic disturbances
Nutritional status
Immune competence
Surgical history
Occupation
FOODBORNE DISEASES
(FBD)
DEFINITION
two or more persons experience a
similar illness after ingestion of a
common food
epidemiological analysis implicates the
food as the source of the illness
FOODS MOST
FREQUENTLY INVOLVED
The foods most frequently
involved in outbreaks are foods of
animal origin.
TYPES OF FBD
FOODBORNE INFECTION
It results from ingesting food containing
living harmful microorganisms,
Examples,Salmonella,Shigella,hepatitis
A virus and Trichinella spiralis
FOODBORNE INTOXICATION
It results from ingestion of pre formed
toxins from bacteria or mold present in the
food.
Examples,botulinum toxin,
Staphylococcus enterotoxin,mycotoxins,
saxitoxin from dinoflagellates.
FOODBORNE TOXI-INFECTION
It results from consumption of food
containing a large amount of disease
causing microorganisms that are capable
of producing or releasing toxin once they
are ingested
Examples,Vibrio cholerae and
Clostridium perfringens.
CLASSIFICATION OF
HAZARDS
Biological hazard,bacteria,viruses and
parasites,natural toxins,microbial toxins,
metabolic toxins resulting from a bacterial
source.
Chemical hazard,pesticides,herbicides,
inorganic contaminants,antibiotics,
growth promoters,food additives,
lubricants,paints,disinfectants.
Physical hazard,glass,metal and wood
fragments or other objects that may cause
physical damage to the consumer
EVALUATION OF SEVERITY
HIGH
Severe health implications,including
death.
Biological,Clostridium botulinum toxin,
Salmonella Typhi,S,Paratyphi A and B,Shigella
dysenteriae,Vibrio cholerae O1,Vibrio vulnificus,
Brucella melitensis,Clostridium perfringens type C,
hepatitis A and E virus,Listeria monocytogenes (in
some patients),Escherichia coli O157:H7,
Trichinella sipralis,Taenia solium (in some cases).
Chemical,direct contamination of foodstuffs by
prohibited chemical substances or certain
metals like mercury,or chemical additives that
may cause severe intoxication or damage to
susceptible consumers,
Physical,foreign objects and undesirable
fragments that may cause damage or injury to
the consumer,such as stones,glass,needles,
metal and other objects representing a hazard
to consumer’s life
MODERATE,POTENTIALLY
WIDESPREAD
Less severe virulence,degree of
contamination and cross-contamination,
Medical attention can reverse the effects,
Hospitalization may be required.
Biological,other enteropathogenic Escherichia
coli,Salmonella spp.,Shigella spp.,
Streptococcus? hemolytic,Vibrio
parahaemolyticus,Listeria monocytogenes,
Streptococcus pyogenes,Rotavirus,Norwalk
virus,Entamoeba histolytica,Diphyllobothrium
latum,Cryptosporidium parvum.
MODERATE,LIMITED SPREAD (OR LOW)
Common cause of outbreaks; spread is
rare or limited; disease results from
ingestion of food containing very large
number of pathogens.
Biological,Bacillus cereus,Clostridium
perfringens type A,Campylobacter jejuni,
Yersinia enterocolitica,and Staphylococcus
aureus toxin,most of the parasites.
Chemical,approved chemicals may cause
moderate reactions like dizziness and allergies.
RISK EVALUATION
Risk is a function of the probability of an
adverse effect and the magnitude of that
effect,consequential to a hazard(s) in food.
It is the probability that a hazard will occur in
a given process thus affecting food safety.
The following data should be considered
when assessing risk:
Consumer complaints
Return of lots or shipments of the product
Adverse result of laboratory tests
Data from monitoring programs for FBS
agents
Information on the incidence of diseases in
animals and other facts that affect human
health
Two-dimensional health risk assessment
model
Severity of consequencesS a - S a ti s f a c to ry (n e gl i gi b l e )
M i - M i n o r
M a - M a j o r
C r - C ri ti c a l
H i gh
Sa Mi Ma Cr
M ed i um
Sa Mi Ma Ma
Low
Sa Mi Mi Mi
N eg l i gibl e
Sa Sa Sa Sa
Low M ed i um H i gh
BIOLOGICAL
HAZARDS
Foodborne biological hazards
include organisms such as:
Pathogenic bacteria
Parasites
Protozoa
Viruses
The microorganisms can be beneficial or
useful,However,some of them are
pathogenic,
Food industries and public health
authorities should be particularly
concerned about pathogenic
microorganisms
Deterioration that may result in food safety
threatening should be considered as a
biological hazard and prevented or
controlled by a HACCP plan
BACTERIA
GENERAL
CHARACTERISTICS
Presence of air:
– aerobic
– anaerobic
– facultative
Acidity of food,low
Temperature
– mesophilic
– psychrotrophilic
– psychrophilic
Water Activity,high
Spore-forming
FACTORS AFFECTING
BACTERIAL GROWTH
Intrinsic Factors
– Water Activity (Aw)
– Acidity (pH)
– Oxigen Reduction (Eh)
– Chemical Composition
– Presence of natural antimicrobial
substances
– Competitive Flora
Extrinsic Factors
– Temperature
– Relative humidity
– Atmosphere composition
Microorganisms reproduce through binary
division releasing by-products:
Yeast? production of beverages,bread,etc.
Lactic-acid-producing bacteria? production of
yogurt,cheese,sausage,etc.
Pathogenical bacteria - Staphylococcus aureus,
Clostridium botulinum and E,coli O157:H7 release
enterotoxin
INDICATOR ORGANISMS
Indicator organisms do not
present a direct health hazard
in a food product
It indicates:
The possible presence of pathogens or
toxin,or
The possibility that faulty practices
occurred during production,processing,
storage and/or distribution.
SOME FOODBORNE
PATHOGENIC BACTERIA
OF CONCERN
GRAM-NEGATIVE BACTERIA
Salmonella spp.
Salmonella is normally found in the
intestinal tract of humans and animals
(except for fish,mollusks and
crustaceans,which can become
contaminated after being harvested)
Salmonella Typhi,bacteremia and typhoid
fever
Salmonella Paratyphi A,B e C,enteric fever
Infective Dose,as low as 15-20 cells
Onset Time,12 to 36 hours
Symptoms,nausea,vomiting,
abdominal cramps,diarrhea,fever,and
headache,
Chronic consequences,arthritic
symptoms that may follow 3-4 weeks
after onset of acute symptoms.
Associated food,raw meat,poultry,
egg,milk and dairy products,fish,shrimp,
frog legs,yeast,coconut,sauces and
salad dressing,cake mixes,cream-filled
desserts and toppings,dried gelatin,
peanut butter,cocoa,and chocolate.
Control measures,
– heat food at a temperature sufficient to kill
bacteria,from 65 to 74°C (149 to 165°F) ;
– keep foods at temperatures below 5°C
(41°F) ;
– prevent cross contamination after cooking
– Prevent sick handlers or carriers of
Salmonella from handling food
Factors affecting the growth of Salmonella
spp.
Minimum temperature,0? 2,0° C (32?
35,5° F)
Maximum temperature,45,6° C (114° F)
Minimum pH,3,7
Maximum pH,9,5
Minimum Aw,0,945
Maximum % NaCl,8
Shigella spp.
The organism is frequently found in
water contaminated by human waste.
The bacilar dysentery or shigellosis
ranges from a non-symptomatic or
subclinical condition to a toxic and
severe form
Infective Dose,as low as 10 cells
Symptoms,abdominal pain,cramps,
diarrhea,fever,vomiting,blood,pus,mucus
in stools and constipation,Infections are
associated with ulceration of mucosa,rectal
bleeding and drastic dehydration,
Onset Time,1 to 7 days (12 to 50 hours)
Associated food,salads (potato,tuna,
shrimp,macaroni,and chicken),raw
vegetables,dairy products,and poultry,
Sewage-polluted water and unsanitary
habits by food handlers are the most
common causes of contamination.
Control measures:
– avoid contamination of the water supply
with human faeces
– personal hygiene
– good hygienic practices
– adequate cleaning and sanitizing in food
processing areas.
Factors affecting the growth of Shigella spp.
Minimum temperature,6,1°C (43°F)
Maximum temperature,47,1°C (117°F)
Minimum pH,4,8
Maximum pH,9,34
Minimum Aw,not available
Maximum % NaCl,6
Escherichia coli
Escherichia coli is a normal
inhabitant of the intestines of all
animals.
Enterohemorrhagic
Escherichia coli (EHEC)
Symptoms,severe cramping (abdominal pain)
and diarrhea that is initially watery but becomes
grossly bloody,Occasionally,vomiting occurs,
Fever is either low-grade or absent,
The disease can lead to a permanent loss of
kidney function.
Onset Time,3 to 9 days
infective dose,unknown.
Associated foods:Undercooked or raw
ground beef (hamburger),raw milk
Control measures:
– heating foods from 65 to 74°C (149 to
165°F);
– keeping foods in a temperature bellow 5°C
(41°F);
– avoiding cross contamination and
– not permitting infected persons to work
with food.
Factors affecting the growth of E,coli
Minimum temperature,2,5°C (36,5°F)
– For E,coli O157:H7,the minimum temp,is
7,3°C (45,14°F)
Maximum temperature,49,4°C (121°F)
Minimum pH,4,0
Maximum pH,9,0
Minimum Aw,0,95
Maximum % NaCl,not available
Enteroinvasive
Escherichia coli
Symptoms,abdominal cramps,
diarrhea,vomiting,fever,chills,and a
generalized malaise
Infective dose,it is thought to be as
low as 10 organisms
Onset Time,8 to 44 hours
Associated food,any food
contaminated with human feces from an
ill person,either directly or through
contaminated water,could cause
disease in others,Outbreaks have
been associated with hamburger meat
and unpasteurized milk.
Enteropathogenic
Escherichia coli
Symptoms,diarrhea in infants leading to
dehydration,electrolyte imbalance and death
Infective dose,similar to others (greater
than 106)
Onset Time,12 to 72 hours
Associated food,raw beef and chicken
Enterotoxigenic
Escherichia coli
Travelers' diarrhea
Infective dose,relatively large (100
million to 10 billion bacteria)
Associated food,infrequently isolated
from dairy products such as semi-soft
cheeses,
Yersinia enterocolitica
Have been isolated from such animals as
pigs,birds,beavers,cats,and dogs.
Environment (ponds and lakes) and food
sources such as meat,ice cream and
milk,
Symptoms,gastroenteritis with diarrhea
and/or vomiting; however,fever and
abdominal pain.
Infective dose,unknown
Onset Time,24 a 48 hours
Control measures:
– adequate cooking
– keeping ready-to-eat foods on
temperatures below 5°C (41°F),
– preventing cross contamination,
– eliminating Yersinia from swine,the mainly
reservoir of this bacteria.
Factors affecting the growth of Yersinia
Minimum temperature,-1,3°C (29,7°F)
Maximum temperature,44°C (111,2°F)
Minimum pH,3,0
Maximum pH,9,6
Minimum Aw,0,95
Maximum % NaCl,7
Campylobacter spp
It is often isolated from healthy cattle,chicken,
birds and even flies,It is sometimes present in
non-chlorinated water sources such as streams
and ponds.
Symptoms,diarrhea,which may be
watery or sticky and can contain blood
(usually occult) and fecal leukocytes
(white cells),Other symptoms often
present are fever,abdominal pain,
nausea,headache and muscle pain.
Infective dose,small (400-500 bacteria
may cause illness)
Onset Time,2 to 5 days
Associated foods,raw chicken,raw
milk
Control measures:
– complete cooking of the food,
– avoiding raw milk ingestion,
– eliminating or reducing C,jejuni from
chicken intestinal tract,
– preventing cross contamination,and
– adequate time/temperature values.
Factors affecting the growth of C,jejuni
Minimum temperature,30°C (86°F)
Maximum temperature,45°C (113°F)
Minimum pH,4,9
Maximum pH,9,5
Minimum Aw,0,97
Maximum % NaCl,2
Vibrio cholerae
Vibrio cholerae
serogroup O1
Symptoms,may vary from a mild,
watery diarrhea to an acute diarrhea,
with characteristic rice water stools,
abdominal cramps,nausea,vomiting,
dehydration,and shock; death may
occur after severe fluid and electrolyte
loss,
Infective dose,one million
organisms (105)
Onset Time,6 hours to 5 days
Associated food,water,
contaminated foods,raw seafood,
raw fruits and vegetables.
Vibrio cholerae
serogroup non-O1
Disease less severe than cholera
Symptoms,Diarrhea,abdominal
cramps,fever,vomiting and nausea
Onset Time,48 hours
Infective dose,It is suspected that
large numbers (> 106)
Factors affecting the growth of Vibrio
cholerae
Minimum temperature,not available
Maximum temperature,45°C (113°F)
Minimum pH,not available
Maximum pH,10
Minimum Aw,not available
Maximum % NaCl,6
Vibrio parahaemolyticus
Symptoms,diarrhea,abdominal
cramps,nausea,vomiting,headache,
fever,and chills
Infective dose,> 106 cfu/g
Onset Time,4 to 96 hours
Associated food,raw,improperly
cooked or cooked,fish,shellfish,crab,
oyster,shrimp,or lobster
Factors affecting the growth of
Vibrio parahaemolyticus
Minimum temperature,5°C (41°F)
Maximum temperature,44°C (111,2°F)
Minimum pH,4,5
Maximum pH,11
Minimum Aw,0,937
Maximum % NaCl,10
Vibrio vulnificus
Symptoms,gastroenteritis,or a syndrome
known as "primary septicemia."
Infective dose,unknown
Onset Time,7 hours to some days
Associated foods,raw seafood
Factors affecting the growth of
Vibrio vulnificus
Minimum temperature,10°C (50°F)
Maximum temperature,not available
Minimum pH,4,5
Maximum pH,not available
Minimum Aw,not available
Maximum % NaCl,8
Plesiomonas shigelloides
The reservoir includes fish,poultry,
crustacean,mammals,reptiles and
humans,
It can not yet be considered a definite
cause of human disease.
Symptoms,fever,chills,abdominal
pain,nausea,diarrhea,or vomiting
Infective dose,presumed high
Onset Time,1 to 2 days
Control measures:
– basic sanitation,
– cooking foods at adequate temperature,
– prevention of cross contamination,
– good hygiene practices and sanitization.
Aeromonas
Their pathogenicity is still on debate.
A,hydrophila and A,sobria cause two
kinds of diarrhea,one similar to cholera,
with watery diarrhea and moderate
fever and the other similar to the
dysentery caused by Shigella,
presenting mucous and blood in the
feces.
Associated food,drinking water,
shellfish,poultry,red meat,vegetables
and raw milk
GRAM-POSITIVE BACTERIA
Listeria monocytogenes
It can be isolated from soil,silage,and
other environmental sources,
L,monocytogenes is very resistant and
may survive freezing,drying,and heat
,
Symptoms,septicemia,meningitis,
meningoencephalitis,encephalitis,and
intrauterine or cervical infections in pregnant
women,which may result in spontaneous
abortion (2nd/3rd trimester) or stillbirth,
Some people may present cold-like
symptoms progressing to intestinal
symptoms.
Infective dose,unknown
Onset Time,greater than 12
hours (intestinal symptoms)
Associated food,raw milk,inadequately
pasteurized milk,cheese (particularly soft-
ripened varieties),ice cream,raw vegetables,
fermented sausages,raw and cooked poultry,
raw meats (all types),and raw and smoked
fish,
Control measures:
– cook food completely,
– Keep good hygiene practices during
processing
– avoid cross contamination.
Factors affecting growth of
Listeria monocytogenes
Minimum temperature,0°C (32°F)
Maximum temperature,45°C (113°F)
Minimum pH,4,3
Maximum pH,9,6
Minimum Aw,0,83
Maximum % NaCl,20
Bacillus cereus and other
Bacillus spp.
Spore-former.
Sources:soil,dust and intestinal tract of
animals and humans.
Symptoms of B,cereus diarrheal
type food poisoning,watery diarrhea,
abdominal cramps,and pain,Nausea
may accompany diarrhea,but vomiting
(emesis) rarely occurs,Symptoms are
similar to those of Clostridium
perfringens food poisoning.
Associated food,meats,milk,
vegetables,and fish.
Symptoms of food poisoning emetic type:
nausea and vomiting,abdominal cramps
and/or diarrhea may also occur.
Associated food,rice products,other
starchy foods such as potatoes,pasta and
cheese products,Food mixtures such as
sauces,puddings,soups,casseroles,
pastries,and salads.
Infective dose,greater than
106 cfu/g
Onset Time,6 to 15 hours
Control measures:
– adopt effective measures to destroy spores
– avoid spore germination in cooked foods
by keeping them refrigerated.
Factors affecting growth of Bacillus cereus
Minimum temperature,5°C (41°F)
Maximum temperature,50°C (122°F)
Minimum pH,4,3
Maximum pH,9,3
Minimum Aw,0,912
Maximum % NaCl,18
Clostridium botulinum
Spore-forming rod that produces a potent
neurotoxin
The organism and its spores are widely
distributed in nature.
Botulism types A,B,E e F,human
botulism
Botulism types C e D,botulism in
animals
Botulism type G:no outbreaks involving
it have been recognized
Wound botulism,is the rarest form of
botulism,The illness is similar to
tetanus.
Infant botulism,affects infants under 6
months of age,It is caused by the
ingestion of C,botulinum spores,which
colonize and produce toxin in the
intestinal tract of infants.
Honey is the one dietary reservoir of C,
botulinum spores thus far definitively
linked to infant botulism.
Foodborne botulism,is a severe type
of food poisoning caused by the
ingestion of foods containing the potent
neurotoxin formed during growth of
Clostridium botulinum,
The toxin is heat labile and can be
destroyed if heated at 80°C (176°F) for
10 minutes or longer,
The incidence of the disease is low,but
it is of considerable concern because of
its high mortality rate if not treated
immediately and properly.
Infective dose,a few nanograms
of toxin
Onset Time,18 to 36 hours
Symptoms,marked lassitude,
weakness and vertigo,usually followed
by double vision and progressive
difficulty in speaking and swallowing,
Paralysis.
Enteric symptoms can include
abdominal pain,diarrhea or constipation
The causes of death are respiratory
failure and obstruction of air in the
throat.
Associated food,any kind of food with
pH > 4.6,supports growth and toxin
production and,when processed,allows
spore survival if not heated before
consumption.
Ex.,hearts of palm,canned corn,sweet
peppers,green beans,soups,beets,
asparagus,mushrooms,ripe olives,spinach,
tuna fish,chicken,chicken livers,liver paste,
luncheon meat,ham,sausage,stuffed
eggplant,lobster,smoked and salted fish
Control measures:
– prevent spore germination; good hygiene
practices,
– perform adequate thermal processing of canned
foods and other processes like salting or drying,
fermentation or acidification
– good hygiene practices,
Factors affecting the growth of Clostridium
botulinum
PARAMETERS VALUES For C,botulinum E
Minimum temperature 10°C (50°F) 3.3°C (37.94°F)
Maximum temperature 50°C (122°F) 45°C (113°F)
Minimum pH 4.6
Maximum pH 9.0
MinimumAw 0.94 0.965
Maximum % NaCl 10
Clostridium perfringens type A
Spore-former,
Occurs widely throughout the
environment,the intestines of humans
and many domestic and wild animals,
Spores of the microorganism persist in
soil,sediments,and areas
contaminated by human or animal feces
Symptoms,intense abdominal
cramps and diarrhea
Infective dose,greater than 108
Onset Time,8 to 22 hours
Associated food,Catering services
where large amounts of food (meat,
meat products,gravy,etc) prepared
several hours before serving
Control measures:
– Controls in production and storage of foods
– Adequate cooling of foods below 10°C
(50°F) within 2 or 3 hours and maintaining
cooked foods above 60°C (140°F).
– Re-heating of cold or refrigerated foods
should achieve a minimal internal
temperature of 75°C (167°F).
Factors affecting the growth of Clostridium
perfringens type A
Minimum temperature,10°C (50°F)
Maximum temperature,52°C (125,6°F)
Minimum pH,5,0
Maximum pH,9,0
Minimum Aw,0,93
Maximum % NaCl,7
Staphylococcus aureus
The presence of this bacteria in
animals,especially the milk obtained
from animals with mastitis,results in
food contamination
Highly heat-stable protein toxin
Symptoms,nausea,vomiting,
abdominal cramps and prostration
Onset Time,rapid
Infective dose,less than 1.0
microgram of toxin (exceed 105 per
gram for S,aureus)
Associated food,meat and meat
products; poultry and egg products;
salads with egg,tuna,chicken,potato,
macaroni,bakery products such as
cream-filled pastries,cream pies,
chocolate eclairs,sandwich fillings,raw
milk and dairy products.
Control measures:
– time and temperature controls,especially
after cooking;
– prepair food close to the time it will be
served;
– appropriate personal hygiene and
adequate cooking foods to destroy
microorganisms.
Factors affecting growth of Staphylococcus
aureus
Minimum temperature,5,6°C (42°F)
Maximum temperature,50°C (122°F)
Minimum pH,4,3
Maximum pH,9,3
Minimum Aw,0,83
Maximum % NaCl,20
Parameters that limit production of
staphylococcal enterotoxin
Minimum temperature,10°C (50°F)
Maximum temperature,50°C (122°F)
Minimum pH,4,76
Maximum pH,9,02
Minimum Aw,0,86
Maximum % NaCl,12
FUNGI
Molds and yeast do not pose a
biological hazard to health but they are
responsible,in many cases,for food
deterioration.
Aflatoxins will be discussed as chemical
hazards.
VIRUS
Sources of foodborne viruses are feces
and urine of infected individuals and
contaminated water.
Foods involved are raw shellfish,raw
vegetables,salads,salads and water
contaminated with human feces.
Hepatitis A Virus
Hepatitis A is usually a mild disease
characterized by sudden onset of fever,
malaise,nausea,anorexia,and abdominal
discomfort,followed by several days of
jaundice
Onset Time,10 to 50 days
Associated food,cold cuts,sandwiches,
fruits,fruit juices,milk,dairy products,
vegetables,salads,shellfish,and iced drinks,
Water,shellfish,and salads are the most
frequent sources.
Hepatitis E Virus
Hepatitis caused by HEV is clinically
indistinguishable from hepatitis A,
Symptoms include malaise,anorexia,
abdominal pain,arthralgia and fever.
Infective dose,unknown
Onset Time,2 to 9 weeks
Associated food,water
The Norwalk virus family
Symptoms,nausea,vomiting,diarrhea,
and abdominal pain,Headache and
low-grade fever may occur,
Infective dose,unknown (presumed to
be low)
Onset Time,24 to 48 hours
Associated food,contaminated food or
water
Rotavirus
Symptoms,mild to severe disease
characterized by vomiting,watery
diarrhea,and low-grade fever.
Infective dose,10-100 infectious viral
particles
Onset Time,1 to 3 days
Associated foods,Infected food
handlers may contaminate ready-to-eat
foods
PARASITES
Trichinella spiralis
Life cycle of Trichinella spiralis
Toxoplasma gondii
Life cycle of Toxoplasma gondii
Cryptosporidium parvum
Life cycle of Cryptosporidium parvum
Giardia lamblia
Life cycle of Giardia lamblia
Ascaris lumbricoides
Life cycle of Ascaris lumbricoides
Trichuris trichiura
Life cycle of Trichuris trichiura
Diphyllobothrium spp,
Life cycle of Diphyllobothrium spp.
Entamoeba histolytica
Life cycle of Entamoeba histolytica
Taenia saginata
Life cycle of Taenia saginata
Taenia solium
Life cycle of Taenia solium
Fasciola hepatica
Life cycle of Fasciola hepatica
Cyclospora cayetanensis
Life cycle of Cyclospora cayetanensis
CHEMICAL
HAZARDS
Chemical hazards may be:
Chemical contaminants
naturally occurring in food
added during processing:
- intentionally
- accidentally
- criminally
Chemical contaminants naturally
occurring in food
Micotoxins (aflotoxin)
Scombrotoxin (histamine)
Ciguatoxin
Mushroom toxin
Toxins of molluscan shellfish
(PSP,DSP,NSP,ASP)
Polychlorinated biphenyl (PCB)
Chemical compounds
intentionally added to food
Food additives
- Food preservatives (nitrites,nitrates)
- Stabilizers (phosphates)
- Flavoring agents (monosodium
glutamate)
- Coloring agents
Chemical compouds
acccidentally added to food
insecticides
rodenticides
fungicides
herbicides
antibiotics
growth promoters
food additives
heavy metals
lubricants and paints
sanitizers
Chemical compouds criminally
added to food
Any compound commonly used by the
food industry,if added in amounts and
situation demonstrating criminal
purposes (e.g,sabotage)
PREVENTION
Use safe cleaning products
Adequate cleaning programs
Training of employees
Inspection after cleaning
Appropriate materials
Good Agricultural Practices
Avoid fishing in contaminated waters
Control on primary production of meat and milk
(Good Agricultural Practices - GAP)
Select suppliers
List all potentially allergenic on labels
Effective sanitation
Care during handling
Check raw material
Reject fish with temperature abuse
Strictly control addiction of products containing
nitrite,sodium metabisulfite and tartrazine
Control use of any compound and/or ingredient
that may cause poisoning
Calibrate and adjust equipment used to measure
additives
Train employees
PHYSICAL HAZARDS
Physical hazards include
Any foreign objects in food that can
result in disease:
– Glass
– Wood
– Stones
– Metal
– Insulation
– Bone
– Plastic
– Personal effects
PREVENTION
PLASTIC
Implement control of plastic
Visual inspection
Use bright colors (commonly blue) for
easier identification
BONES
Select appropriate suppliers
Inspect during reception,grinding and filling
Train employees
Separate through centrifugation or straining
GLASS
Avoid using glass containers
Keep glass out of production area
Strictly control breakage in final product
packed in glass
Avoid use of glass in production area
Remove glass protection from
manometers
Cover lamps with plastic protection
Control through X-ray
METAL
Adequate maintenance of equipment
Care in handling raw material packed in
metallic containers
Discard metal by inspection or use
flotation tanks,centrifuges,or strainer
STONE
Select appropriate suppliers
Discard chips by inspection or use of
flotation tanks,centrifuges,or strainer
WOOD
Avoid wooden boxes and pallets
Store wood away from food handling
areas
Prepare a plan to avoid use of wood or to
replace existing wood in the facilities
Inspect raw material to avoid introduction
of wood in the plant
PREREQUISITES FOR
HACCP IMPLEMENTATION
Prerequisite programs to implement
HACCP:
- Good Manufacturing Practices (GMP)
- Sanitation Standard Operating Procedures
(SSOP)
Preliminary steps need to be accomplished
before applying HACCP
Prerequisite programs
Preliminary steps needed to control conditions
related to safe food production
Examples:
Hygiene and sanitation of equipment
Training of employees
Preventive maintenance
Product identification
Good Manufacturing Practices - GMP
Prerequisite to implement HACCP
Some aspects involved:
– hygiene and personal health issues
– design and maintenance of buildings and
equipment
– calibration of equipment
– use of ingredients
– cleaning and sanitation
Sanitation Standard Operating
Procedures - SSOP
Developed by FSIS/USDA after an
inspection carried out in 1,014 meat
plants,demonstrated operational
problems in over 60% of them
Written procedures for sanitation
of facilities and equipment
Make daily evidence of
compliance
SSOP
PREVIOUS STEPS TO HACCP
IMPLEMENTATION
Assemble the HACCP team
Describe the food
Describe the intended use and identify
potential consumers
Develop a flow diagram of the process
Verify the flow diagram
Example of a Flow Diagram
Receiving
Cooking
Freezing
Boxing
Distributing
HACCP PRINCIPLES
PRINCIPLE 1,
HAZARD ANALYSIS
Conduct a hazard analysis
and identify the preventive
measures
Hazards can be:
Biological
Chemical
Physical
Hazard Analysis
A significant hazard must be controlled if:
it is likely to occur
there is a probability of consumers
being exposed to an unacceptable
hazard
Control measures
Biological hazards
Temperature/time control
Heating and cooking
Cooling and freezing
Fermentation and/or pH control
Addition of salt or other preservatives,
Drying
Control measures
Chemical hazards
Control of raw materials
Processing control
Proper segregation of non-food chemicals
during storage and handling
Control of incidental contamination from
chemicals
Labeling control
Control measures
Physical hazards
Control of raw material
Processing control,e.g,use of magnets,metal
detectors,sifter screens,de-stoners,clarifiers,air
tumblers
Control of processing environment
Preventive maintenance of equipment used in
food processing
PRINCIPLE 2,
CRITICAL CONTROL POINTS
Identify the Critical Control
Points (CCP) in the
process.
Critical Control Point (CCP)
"a step at which control can be applied
and where it is essential to prevent or
eliminate a food safety hazard or to
reduce it to an acceptable level.”
Points identified as CCP when hazards
can be avoided:
Introduction of pathogenic microorganisms or drug
residues can be avoided during the reception of raw
material
Chemical hazards can be avoided by controlling
formulation steps and addition of ingredients
Contamination of final product by pathogenic
microorganisms can be avoided by addition of
preservatives and/or pH adjustment.
Growth of pathogenic microorganisms can be
avoided by refrigeration.
Points identified as CCP when
hazards can be eliminated:
Thermal processing for adequate
time/temperature can eliminate pathogenic
microorganisms or reduce them to
acceptable levels
Metal pieces can be detected or removed
using metal detectors,sifter screens,de-
stoners,clarifiers,air tumblers
Freezing processes can kill parasites
(Trichinella spiralis,Cysticercus celullosae,
Anisakis spp.)
Points identified as CCP when
hazard can be reduced to
acceptable levels:
The presence of foreign matter can be
minimized by manual and/or automatic
collector
Some biological or chemical hazard can be
minimized by proper selection of suppliers of
raw material
Multiple CCP x Multiple Hazard
The same PCC may control more than one
hazard.
Example,immediate refrigeration of fresh
tuna avoid growth of pathogenic
microorganisms and production of histamine
Multiple CCP x Multiple Hazard
One hazard may request more than one CCP
for an effective control.
Example,hamburger thickness and internal
cooking temperature need to be controlled to
avoid survival of pathogens
CCP are specific to a product
and process
Many factors affect a CCP:
- Replacement of equipment
- Changes in product formulation
- Changes in operational flow
- Size of packaging
- Changes in GMP and SSOP
Decision Tree to
identify CCP
(Based on Codex Alimentarius)
Answer the questions in sequence.
1st Do preventive
measure (s) exist? No
No
Yes
Yes
Modify step,
process or
product
Is control at this
step necessary
for safety?
Not a CCP
Go to
question 2
2nd Is the step specifically designed to eliminate or
reduce the identified hazard
to an acceptable level?
No
Yes
Critical Control Point
Go to
question 3
3rd Could contamination with the identified hazard occur in
excess of acceptable levels
or increase to unacceptable
levels?
Yes
No
Not a CCP
Go to
question 4
4th Will a subsequent step eliminate the identified
hazard or reduce its likely
occurrence to an
acceptable level?
Yes
No
Not a CCP
Critical Control Point
Examples of CCP:
Pasteurizer
Dryer
Frying pans
Freezers (T,spiralis control)
PRINCIPLE 3
Establish critical limits for
each CCP
Critical Limit
Critical limit is a criterion which should be
met for each preventive measure associated
with a CCP,to ensure safety
Each CCP may have one or more critical
limits associated with each significant
hazard.
Examples of critical limits to destroy/
prevent pathogens
Time/ temperature requirements for thermal
processes such as pasteurization,cooking,
Sources of information on critical
limits include
Scientific publications/research data
Regulatory requirements and
guidelines
Experts
Experimental studies
Operating Limits
Are more restrictive than critical limits,
Established to prevent violation of
critical limits.
Process adjustment
Action to be taken to adjust the
process,bringing it back to control
PRINCIPLE 4
Establish monitoring systems
for each CCP
Monitoring
The act of conducting a planned
sequence of observations or
measurements of control to assess
whether a CCP is under control;
The record of this observation shall be
used on futures verifications
Purposes of monitoring
Measure the performance level of system's
operation at the CCP
Determine when the performance level of
the system results in loss of control at the
CCP,e.g,when there is deviation from a
critical limit
Establish records that reflect the
performance level of the system's operation
at the CCP to comply with the HACCP plan
Monitoring
What?,usually a measure or
observation to evaluate if the CCP is
operating within the critical limits
How?,usually physical or chemical
measures or observations,Should be
taken and recorded in real time
When (frequency)?,can be continuous
or non-continuous.
Who?,Someone trained for the activity
which will be monitored.
What will be monitored?
Measurement of the time and temperature of a
thermal process
Measurement of cold-storage temperature
Measurement of pH
Measurement of Aw
Speed of production line
Certificate of origin of raw material
Harvest area of molluscan shellfish
How will critical limits and preventive
measures be monitored?
Thermometers
Clocks
Scales
pH-meters
Water activity meters
Analytical equipment
Monitoring frequency
Continuous monitoring (if posible)
Thermographs
Metal detectors
Discontinuous monitoring
Internal temperature of cooked products
Evaluation of seam measures of canned food
Sensory evaluation
Responsibility for monitoring
Production personnel
Equipment operators
Supervisors
Maintenance personnel
Quality assurance personnel.
PRINCIPLE 5
Establish corrective actions
to be taken when monitoring
indicates deviation from
critical limits
Corrective Actions
Any action to be taken when the
results of monitoring at CCP indicates
loss of control.
Components of Corrective Actions
Correct and eliminate the cause of the
deviation and restore the control of process.
Identify product produced during process
failure and determine its use
Steps to determine the use of food
when critical limits are violated
1st Step,Determine if the product present a public
health risk,based on:
- experts evaluation
- results of chemical and/or microbiological analysis
2nd Step,If the evaluation above does not show any
risk,release the product to be consumed or to follow
the process
3rd Step,If the evaluation indicates that a
hazard occurred,determine if the product
should be:
- reworked/ reprocessed
- deviated to another use
4th Step,If it is not possible,the product
should be destroyed,It is the most expensive
option and will be used only as the last
alternative
PRINCIPLE 6,VERIFICATION
Establish procedures for
verification that HACCP is
working correctly
Verification
Application of methods,procedures,
tests and other types of evaluation,in
addition to monitoring,to determine
compliance with the HACCP plan.
Verification gives elements to ensure that
the HACCP plan is based on scientific
principles.
Verification activities
HACCP plan validation
CCP verification:
- Calibration of monitoring equipment
- Targeted sample collection and testing
- Review of monitoring records
HACCP plan verification:
- Audits
- Microbiological analysis of the final product
Validation
Validation is the act of assessing whether
the HACCP plan for a specific product and
process identifies and controls all significant
food safety hazards or reduces them to an
acceptable level.
It shall be performed before the HACCP plan
implementation.
Validation involves ensuring that the HACCP
plan is based on current good science and
current information and is appropriate for
the actual product and process
Who performs verification?
HACCP team
Persons qualified by training and experience
What kind of activities compose the
validation?
A scientific and technical review of each part
of HACCP plan,from hazard analysis to the
strategy for the verification of each CCP
(Re)Validation frequency
Initially (before implementation)
Every time it is necessary,
The following factors require revalidation of
a HACCP plan:
- replacement of raw materials
- changes in product and in process
- adverse audit findings
- frequent deviations on the CCP
- new information about hazards or control
measures
- routine monitoring activities; and
- new distribution practices or consumer handling.
Verification activities on CCP
Monitoring equipment calibration
Review of Calibration record
Targeted sample collection and testing
Review of monitoring records for all CCP
Calibration of monitoring
instruments
Calibration of appropriate equipment and
instruments used in the development and
implementation of the HACCP plan should be
performed:
At a frequency sufficient to assure
continuous accuracy
By checking accuracy against a recognized
standard
Targeted sample collection and
testing
Every time the reception of raw material is
considered a CCP,purchase specifications
should be issued to ensure the achievement of
the critical limits,A sample may be collected
and analysed to ensure that the specifications
were met
Microbiologic analysis of the
final product
The final product can be tested to ensure
compliance with the critical limits
The effectiveness of HACCP plan to
ensure that the identified microbiological
limits have not been exceeded
Microbiological analysis of the final product
should be used to verify if the process is
under control
Microbiological analysis are not a valuable
tool to monitor routinely a CCP
HACCP plan verification
Annually;
Always when there is a failure
in the system or an important
change of product or process.
Principle 7
Establish effective record
keeping procedures that
document the HACCP
System
Records
Records are essential source of information and
constitute a documental prove that CCP are
operating within critical limits and deviation are
treated appropriately
Information record
Information obtained during the monitoring
activities should be recorded at the moment
of the observation
False or incorrect records bring disbelief to
the HACCP plan
Record Review
Record reviews must be conducted
periodically by qualified staff members of
HACCP plan to ensure it’s working properly
Records that should be part of
HACCP system
HACCP plan and all background
documentation
CCP monitoring records
Corrective action records
Verification records (internal and
external)
Title and date of the record
Product identification (code,including time
and date)
Materials and equipment used
Operations performed
To assure product safety and to document
process and procedures,HACCP records must
contain the following information
Critical criteria and limits
Corrective action to be taken and by whom
Operator identification
Data (presented in a orderly format)
The reviewer’s initials and date of review
AUDIT
Audit activities include:
– Product description and flow chart review
– Monitoring required by the HACCP plan
at the CCP is performed
– Processes are operating within
established critical limits
– Records are filled out accurately and at
the time observations are made
Audit records include:
- Monitoring activities have been performed at
the locations and frequencies specified in the
HACCP plan
- Product has been controlled and corrective
actions have been taken whenever monitoring
has indicated the occurrence of a deviation
from critical limits
- Equipment has been calibrated at the
frequencies specified in the HACCP plan
Audit by official agency of inspection
and control
Review HACCP plan
Review changes to the HACCP plan and the
reasons for those changes
Review CCP monitoring records
Review corrective actions records
Review of verification records
Sample collection for laboratory analysis
The HACCP System
INTRODUCTION
The Meaning of HACCP
Hazard x RisK
History of the HACCP System
Traditional Inspection x HACCP
System
The Seven Principles of HACCP
Meaning of HACCP
Hazard Analysis and
Critical Control Points
Why HACCP?
HA = Hazard Analysis
+
CCP = Critical Control Points
HACCP Application
Basic Agriculture
Food Processing
Distribution and Marketing
Catering Services
Street Foods
Use by consumers
HACCP Objectives
Eliminate or significantly reduce
hazards
Prevent or minimize microbial
growth and toxin production;
Control contamination.
HISTORY OF HACCP
– In the 1960s the Pillsbury Company
developed a program for the
production of safe foods for NASA
space program
– In 1971,Pillsbury presented HACCP
system to the public for the first time
– In 1973,it was applied to low-acid
canned foods
Recommendation of the
National Academy of Science
In 1985,NAS recommended that food
sanitary agencies,as well as food industry
in the US,should apply HACCP
Justification and
importance of HACCP
Why HACCP?
The Codex Alimentarius Commission
decided to adopt the acronym HACCP,
regardless the translation of Hazard
Analysis and Critical Control Points in
any of the official languages of the
United Nations
Uniform understanding
The CODEX ALIMENTARIUS
and HACCP
The Codex Alimentarius Commission,in its
twentieth session,held in Geneva,Switzerland
June 23 - 28,1997,adopted the revised
Recommended International Code of Practice
– General Principles of Food Hygiene
TRADITIONAL INSPECTION
X
HACCP
Traditional inspection:
based on sight,smell and tactile
sense to detect hazards (injuries,
contamination,etc.)
established when hazards were
macroscopic contamination and sick
animals
Microbial and chemical contaminants
are not detected by inspector
Analysis of samples of final product
(1/1,000) indicates the lot is very likely
(>94%) to be accepted,even if
contaminated
HACCP:
emphasizes process control
focus control on critical points related to food
safety
values communication between food
producer and inspection
HACCP
Preventive and not reactive (traditional
inspection)
Tool used to protect food from biological,
chemical and physical hazards
HACCP
A system to ensure food
safety
The HACCP system
is not 100% safe !
THE SEVEN PRINCIPLES
OF HACCP
THE SEVEN PRINCIPLES OF HACCP
1,Perform a Hazard Analysis (HA) and establish
the corresponding preventative measures
2,Determine the Critical Control Points (CCP)
3,Establish critical limits for each CCP
4,Establish monitoring systems
5,Establish corrective actions
6,Establish verification procedures
7,Establish record keeping and documentation
INTRODUCTION TO
HAZARDS
HAZARDS
Biological
Chemical
Physical
HAZARD
It is a biological,physical,or chemical
property that may cause food to become
unsafe for human consumption
In HACCP,“hazard” means
conditions or contaminants that may
cause illnesses or represent a threat
to the consumer’s health
It does not apply to the presence of other
types of contaminants,such as:
– insects or hair,
– decomposition,
– economic fraud and
– violation of quality requirements.
Factors that contribute to
the existence of hazards
INFECTIVE DOSE
It is the number of microorganisms
needed to cause illness,It depends on:
–consumers
–physiological factors
–immunological status of the individual
Important:
The presence of some microorganisms such as
Escherichia coli O157:H7,Clostridium
botulinum,in any amount,is enough to render
food potentially hazardous
VARIABLES OF THE PARASITE OR
MICROORGANISM
Variability of gene expression of multiple
pathogenic mechanisms
Potential for damage or stress of the
microorganism
Interaction of organism with food and
environment
pH susceptibility of organism
Immunological "uniqueness" of the organism
Interactions with other organisms
VARIABLES OF THE HOST
Age
General health
Pregnancy
Medications
Metabolic disorders
Alcoholism,cirrhosis,hemochromatosis
Amount of food consumed
Gastric acidity variation,antacids,natural
variation,achlorhydria
Genetic disturbances
Nutritional status
Immune competence
Surgical history
Occupation
FOODBORNE DISEASES
(FBD)
DEFINITION
two or more persons experience a
similar illness after ingestion of a
common food
epidemiological analysis implicates the
food as the source of the illness
FOODS MOST
FREQUENTLY INVOLVED
The foods most frequently
involved in outbreaks are foods of
animal origin.
TYPES OF FBD
FOODBORNE INFECTION
It results from ingesting food containing
living harmful microorganisms,
Examples,Salmonella,Shigella,hepatitis
A virus and Trichinella spiralis
FOODBORNE INTOXICATION
It results from ingestion of pre formed
toxins from bacteria or mold present in the
food.
Examples,botulinum toxin,
Staphylococcus enterotoxin,mycotoxins,
saxitoxin from dinoflagellates.
FOODBORNE TOXI-INFECTION
It results from consumption of food
containing a large amount of disease
causing microorganisms that are capable
of producing or releasing toxin once they
are ingested
Examples,Vibrio cholerae and
Clostridium perfringens.
CLASSIFICATION OF
HAZARDS
Biological hazard,bacteria,viruses and
parasites,natural toxins,microbial toxins,
metabolic toxins resulting from a bacterial
source.
Chemical hazard,pesticides,herbicides,
inorganic contaminants,antibiotics,
growth promoters,food additives,
lubricants,paints,disinfectants.
Physical hazard,glass,metal and wood
fragments or other objects that may cause
physical damage to the consumer
EVALUATION OF SEVERITY
HIGH
Severe health implications,including
death.
Biological,Clostridium botulinum toxin,
Salmonella Typhi,S,Paratyphi A and B,Shigella
dysenteriae,Vibrio cholerae O1,Vibrio vulnificus,
Brucella melitensis,Clostridium perfringens type C,
hepatitis A and E virus,Listeria monocytogenes (in
some patients),Escherichia coli O157:H7,
Trichinella sipralis,Taenia solium (in some cases).
Chemical,direct contamination of foodstuffs by
prohibited chemical substances or certain
metals like mercury,or chemical additives that
may cause severe intoxication or damage to
susceptible consumers,
Physical,foreign objects and undesirable
fragments that may cause damage or injury to
the consumer,such as stones,glass,needles,
metal and other objects representing a hazard
to consumer’s life
MODERATE,POTENTIALLY
WIDESPREAD
Less severe virulence,degree of
contamination and cross-contamination,
Medical attention can reverse the effects,
Hospitalization may be required.
Biological,other enteropathogenic Escherichia
coli,Salmonella spp.,Shigella spp.,
Streptococcus? hemolytic,Vibrio
parahaemolyticus,Listeria monocytogenes,
Streptococcus pyogenes,Rotavirus,Norwalk
virus,Entamoeba histolytica,Diphyllobothrium
latum,Cryptosporidium parvum.
MODERATE,LIMITED SPREAD (OR LOW)
Common cause of outbreaks; spread is
rare or limited; disease results from
ingestion of food containing very large
number of pathogens.
Biological,Bacillus cereus,Clostridium
perfringens type A,Campylobacter jejuni,
Yersinia enterocolitica,and Staphylococcus
aureus toxin,most of the parasites.
Chemical,approved chemicals may cause
moderate reactions like dizziness and allergies.
RISK EVALUATION
Risk is a function of the probability of an
adverse effect and the magnitude of that
effect,consequential to a hazard(s) in food.
It is the probability that a hazard will occur in
a given process thus affecting food safety.
The following data should be considered
when assessing risk:
Consumer complaints
Return of lots or shipments of the product
Adverse result of laboratory tests
Data from monitoring programs for FBS
agents
Information on the incidence of diseases in
animals and other facts that affect human
health
Two-dimensional health risk assessment
model
Severity of consequencesS a - S a ti s f a c to ry (n e gl i gi b l e )
M i - M i n o r
M a - M a j o r
C r - C ri ti c a l
H i gh
Sa Mi Ma Cr
M ed i um
Sa Mi Ma Ma
Low
Sa Mi Mi Mi
N eg l i gibl e
Sa Sa Sa Sa
Low M ed i um H i gh
BIOLOGICAL
HAZARDS
Foodborne biological hazards
include organisms such as:
Pathogenic bacteria
Parasites
Protozoa
Viruses
The microorganisms can be beneficial or
useful,However,some of them are
pathogenic,
Food industries and public health
authorities should be particularly
concerned about pathogenic
microorganisms
Deterioration that may result in food safety
threatening should be considered as a
biological hazard and prevented or
controlled by a HACCP plan
BACTERIA
GENERAL
CHARACTERISTICS
Presence of air:
– aerobic
– anaerobic
– facultative
Acidity of food,low
Temperature
– mesophilic
– psychrotrophilic
– psychrophilic
Water Activity,high
Spore-forming
FACTORS AFFECTING
BACTERIAL GROWTH
Intrinsic Factors
– Water Activity (Aw)
– Acidity (pH)
– Oxigen Reduction (Eh)
– Chemical Composition
– Presence of natural antimicrobial
substances
– Competitive Flora
Extrinsic Factors
– Temperature
– Relative humidity
– Atmosphere composition
Microorganisms reproduce through binary
division releasing by-products:
Yeast? production of beverages,bread,etc.
Lactic-acid-producing bacteria? production of
yogurt,cheese,sausage,etc.
Pathogenical bacteria - Staphylococcus aureus,
Clostridium botulinum and E,coli O157:H7 release
enterotoxin
INDICATOR ORGANISMS
Indicator organisms do not
present a direct health hazard
in a food product
It indicates:
The possible presence of pathogens or
toxin,or
The possibility that faulty practices
occurred during production,processing,
storage and/or distribution.
SOME FOODBORNE
PATHOGENIC BACTERIA
OF CONCERN
GRAM-NEGATIVE BACTERIA
Salmonella spp.
Salmonella is normally found in the
intestinal tract of humans and animals
(except for fish,mollusks and
crustaceans,which can become
contaminated after being harvested)
Salmonella Typhi,bacteremia and typhoid
fever
Salmonella Paratyphi A,B e C,enteric fever
Infective Dose,as low as 15-20 cells
Onset Time,12 to 36 hours
Symptoms,nausea,vomiting,
abdominal cramps,diarrhea,fever,and
headache,
Chronic consequences,arthritic
symptoms that may follow 3-4 weeks
after onset of acute symptoms.
Associated food,raw meat,poultry,
egg,milk and dairy products,fish,shrimp,
frog legs,yeast,coconut,sauces and
salad dressing,cake mixes,cream-filled
desserts and toppings,dried gelatin,
peanut butter,cocoa,and chocolate.
Control measures,
– heat food at a temperature sufficient to kill
bacteria,from 65 to 74°C (149 to 165°F) ;
– keep foods at temperatures below 5°C
(41°F) ;
– prevent cross contamination after cooking
– Prevent sick handlers or carriers of
Salmonella from handling food
Factors affecting the growth of Salmonella
spp.
Minimum temperature,0? 2,0° C (32?
35,5° F)
Maximum temperature,45,6° C (114° F)
Minimum pH,3,7
Maximum pH,9,5
Minimum Aw,0,945
Maximum % NaCl,8
Shigella spp.
The organism is frequently found in
water contaminated by human waste.
The bacilar dysentery or shigellosis
ranges from a non-symptomatic or
subclinical condition to a toxic and
severe form
Infective Dose,as low as 10 cells
Symptoms,abdominal pain,cramps,
diarrhea,fever,vomiting,blood,pus,mucus
in stools and constipation,Infections are
associated with ulceration of mucosa,rectal
bleeding and drastic dehydration,
Onset Time,1 to 7 days (12 to 50 hours)
Associated food,salads (potato,tuna,
shrimp,macaroni,and chicken),raw
vegetables,dairy products,and poultry,
Sewage-polluted water and unsanitary
habits by food handlers are the most
common causes of contamination.
Control measures:
– avoid contamination of the water supply
with human faeces
– personal hygiene
– good hygienic practices
– adequate cleaning and sanitizing in food
processing areas.
Factors affecting the growth of Shigella spp.
Minimum temperature,6,1°C (43°F)
Maximum temperature,47,1°C (117°F)
Minimum pH,4,8
Maximum pH,9,34
Minimum Aw,not available
Maximum % NaCl,6
Escherichia coli
Escherichia coli is a normal
inhabitant of the intestines of all
animals.
Enterohemorrhagic
Escherichia coli (EHEC)
Symptoms,severe cramping (abdominal pain)
and diarrhea that is initially watery but becomes
grossly bloody,Occasionally,vomiting occurs,
Fever is either low-grade or absent,
The disease can lead to a permanent loss of
kidney function.
Onset Time,3 to 9 days
infective dose,unknown.
Associated foods:Undercooked or raw
ground beef (hamburger),raw milk
Control measures:
– heating foods from 65 to 74°C (149 to
165°F);
– keeping foods in a temperature bellow 5°C
(41°F);
– avoiding cross contamination and
– not permitting infected persons to work
with food.
Factors affecting the growth of E,coli
Minimum temperature,2,5°C (36,5°F)
– For E,coli O157:H7,the minimum temp,is
7,3°C (45,14°F)
Maximum temperature,49,4°C (121°F)
Minimum pH,4,0
Maximum pH,9,0
Minimum Aw,0,95
Maximum % NaCl,not available
Enteroinvasive
Escherichia coli
Symptoms,abdominal cramps,
diarrhea,vomiting,fever,chills,and a
generalized malaise
Infective dose,it is thought to be as
low as 10 organisms
Onset Time,8 to 44 hours
Associated food,any food
contaminated with human feces from an
ill person,either directly or through
contaminated water,could cause
disease in others,Outbreaks have
been associated with hamburger meat
and unpasteurized milk.
Enteropathogenic
Escherichia coli
Symptoms,diarrhea in infants leading to
dehydration,electrolyte imbalance and death
Infective dose,similar to others (greater
than 106)
Onset Time,12 to 72 hours
Associated food,raw beef and chicken
Enterotoxigenic
Escherichia coli
Travelers' diarrhea
Infective dose,relatively large (100
million to 10 billion bacteria)
Associated food,infrequently isolated
from dairy products such as semi-soft
cheeses,
Yersinia enterocolitica
Have been isolated from such animals as
pigs,birds,beavers,cats,and dogs.
Environment (ponds and lakes) and food
sources such as meat,ice cream and
milk,
Symptoms,gastroenteritis with diarrhea
and/or vomiting; however,fever and
abdominal pain.
Infective dose,unknown
Onset Time,24 a 48 hours
Control measures:
– adequate cooking
– keeping ready-to-eat foods on
temperatures below 5°C (41°F),
– preventing cross contamination,
– eliminating Yersinia from swine,the mainly
reservoir of this bacteria.
Factors affecting the growth of Yersinia
Minimum temperature,-1,3°C (29,7°F)
Maximum temperature,44°C (111,2°F)
Minimum pH,3,0
Maximum pH,9,6
Minimum Aw,0,95
Maximum % NaCl,7
Campylobacter spp
It is often isolated from healthy cattle,chicken,
birds and even flies,It is sometimes present in
non-chlorinated water sources such as streams
and ponds.
Symptoms,diarrhea,which may be
watery or sticky and can contain blood
(usually occult) and fecal leukocytes
(white cells),Other symptoms often
present are fever,abdominal pain,
nausea,headache and muscle pain.
Infective dose,small (400-500 bacteria
may cause illness)
Onset Time,2 to 5 days
Associated foods,raw chicken,raw
milk
Control measures:
– complete cooking of the food,
– avoiding raw milk ingestion,
– eliminating or reducing C,jejuni from
chicken intestinal tract,
– preventing cross contamination,and
– adequate time/temperature values.
Factors affecting the growth of C,jejuni
Minimum temperature,30°C (86°F)
Maximum temperature,45°C (113°F)
Minimum pH,4,9
Maximum pH,9,5
Minimum Aw,0,97
Maximum % NaCl,2
Vibrio cholerae
Vibrio cholerae
serogroup O1
Symptoms,may vary from a mild,
watery diarrhea to an acute diarrhea,
with characteristic rice water stools,
abdominal cramps,nausea,vomiting,
dehydration,and shock; death may
occur after severe fluid and electrolyte
loss,
Infective dose,one million
organisms (105)
Onset Time,6 hours to 5 days
Associated food,water,
contaminated foods,raw seafood,
raw fruits and vegetables.
Vibrio cholerae
serogroup non-O1
Disease less severe than cholera
Symptoms,Diarrhea,abdominal
cramps,fever,vomiting and nausea
Onset Time,48 hours
Infective dose,It is suspected that
large numbers (> 106)
Factors affecting the growth of Vibrio
cholerae
Minimum temperature,not available
Maximum temperature,45°C (113°F)
Minimum pH,not available
Maximum pH,10
Minimum Aw,not available
Maximum % NaCl,6
Vibrio parahaemolyticus
Symptoms,diarrhea,abdominal
cramps,nausea,vomiting,headache,
fever,and chills
Infective dose,> 106 cfu/g
Onset Time,4 to 96 hours
Associated food,raw,improperly
cooked or cooked,fish,shellfish,crab,
oyster,shrimp,or lobster
Factors affecting the growth of
Vibrio parahaemolyticus
Minimum temperature,5°C (41°F)
Maximum temperature,44°C (111,2°F)
Minimum pH,4,5
Maximum pH,11
Minimum Aw,0,937
Maximum % NaCl,10
Vibrio vulnificus
Symptoms,gastroenteritis,or a syndrome
known as "primary septicemia."
Infective dose,unknown
Onset Time,7 hours to some days
Associated foods,raw seafood
Factors affecting the growth of
Vibrio vulnificus
Minimum temperature,10°C (50°F)
Maximum temperature,not available
Minimum pH,4,5
Maximum pH,not available
Minimum Aw,not available
Maximum % NaCl,8
Plesiomonas shigelloides
The reservoir includes fish,poultry,
crustacean,mammals,reptiles and
humans,
It can not yet be considered a definite
cause of human disease.
Symptoms,fever,chills,abdominal
pain,nausea,diarrhea,or vomiting
Infective dose,presumed high
Onset Time,1 to 2 days
Control measures:
– basic sanitation,
– cooking foods at adequate temperature,
– prevention of cross contamination,
– good hygiene practices and sanitization.
Aeromonas
Their pathogenicity is still on debate.
A,hydrophila and A,sobria cause two
kinds of diarrhea,one similar to cholera,
with watery diarrhea and moderate
fever and the other similar to the
dysentery caused by Shigella,
presenting mucous and blood in the
feces.
Associated food,drinking water,
shellfish,poultry,red meat,vegetables
and raw milk
GRAM-POSITIVE BACTERIA
Listeria monocytogenes
It can be isolated from soil,silage,and
other environmental sources,
L,monocytogenes is very resistant and
may survive freezing,drying,and heat
,
Symptoms,septicemia,meningitis,
meningoencephalitis,encephalitis,and
intrauterine or cervical infections in pregnant
women,which may result in spontaneous
abortion (2nd/3rd trimester) or stillbirth,
Some people may present cold-like
symptoms progressing to intestinal
symptoms.
Infective dose,unknown
Onset Time,greater than 12
hours (intestinal symptoms)
Associated food,raw milk,inadequately
pasteurized milk,cheese (particularly soft-
ripened varieties),ice cream,raw vegetables,
fermented sausages,raw and cooked poultry,
raw meats (all types),and raw and smoked
fish,
Control measures:
– cook food completely,
– Keep good hygiene practices during
processing
– avoid cross contamination.
Factors affecting growth of
Listeria monocytogenes
Minimum temperature,0°C (32°F)
Maximum temperature,45°C (113°F)
Minimum pH,4,3
Maximum pH,9,6
Minimum Aw,0,83
Maximum % NaCl,20
Bacillus cereus and other
Bacillus spp.
Spore-former.
Sources:soil,dust and intestinal tract of
animals and humans.
Symptoms of B,cereus diarrheal
type food poisoning,watery diarrhea,
abdominal cramps,and pain,Nausea
may accompany diarrhea,but vomiting
(emesis) rarely occurs,Symptoms are
similar to those of Clostridium
perfringens food poisoning.
Associated food,meats,milk,
vegetables,and fish.
Symptoms of food poisoning emetic type:
nausea and vomiting,abdominal cramps
and/or diarrhea may also occur.
Associated food,rice products,other
starchy foods such as potatoes,pasta and
cheese products,Food mixtures such as
sauces,puddings,soups,casseroles,
pastries,and salads.
Infective dose,greater than
106 cfu/g
Onset Time,6 to 15 hours
Control measures:
– adopt effective measures to destroy spores
– avoid spore germination in cooked foods
by keeping them refrigerated.
Factors affecting growth of Bacillus cereus
Minimum temperature,5°C (41°F)
Maximum temperature,50°C (122°F)
Minimum pH,4,3
Maximum pH,9,3
Minimum Aw,0,912
Maximum % NaCl,18
Clostridium botulinum
Spore-forming rod that produces a potent
neurotoxin
The organism and its spores are widely
distributed in nature.
Botulism types A,B,E e F,human
botulism
Botulism types C e D,botulism in
animals
Botulism type G:no outbreaks involving
it have been recognized
Wound botulism,is the rarest form of
botulism,The illness is similar to
tetanus.
Infant botulism,affects infants under 6
months of age,It is caused by the
ingestion of C,botulinum spores,which
colonize and produce toxin in the
intestinal tract of infants.
Honey is the one dietary reservoir of C,
botulinum spores thus far definitively
linked to infant botulism.
Foodborne botulism,is a severe type
of food poisoning caused by the
ingestion of foods containing the potent
neurotoxin formed during growth of
Clostridium botulinum,
The toxin is heat labile and can be
destroyed if heated at 80°C (176°F) for
10 minutes or longer,
The incidence of the disease is low,but
it is of considerable concern because of
its high mortality rate if not treated
immediately and properly.
Infective dose,a few nanograms
of toxin
Onset Time,18 to 36 hours
Symptoms,marked lassitude,
weakness and vertigo,usually followed
by double vision and progressive
difficulty in speaking and swallowing,
Paralysis.
Enteric symptoms can include
abdominal pain,diarrhea or constipation
The causes of death are respiratory
failure and obstruction of air in the
throat.
Associated food,any kind of food with
pH > 4.6,supports growth and toxin
production and,when processed,allows
spore survival if not heated before
consumption.
Ex.,hearts of palm,canned corn,sweet
peppers,green beans,soups,beets,
asparagus,mushrooms,ripe olives,spinach,
tuna fish,chicken,chicken livers,liver paste,
luncheon meat,ham,sausage,stuffed
eggplant,lobster,smoked and salted fish
Control measures:
– prevent spore germination; good hygiene
practices,
– perform adequate thermal processing of canned
foods and other processes like salting or drying,
fermentation or acidification
– good hygiene practices,
Factors affecting the growth of Clostridium
botulinum
PARAMETERS VALUES For C,botulinum E
Minimum temperature 10°C (50°F) 3.3°C (37.94°F)
Maximum temperature 50°C (122°F) 45°C (113°F)
Minimum pH 4.6
Maximum pH 9.0
MinimumAw 0.94 0.965
Maximum % NaCl 10
Clostridium perfringens type A
Spore-former,
Occurs widely throughout the
environment,the intestines of humans
and many domestic and wild animals,
Spores of the microorganism persist in
soil,sediments,and areas
contaminated by human or animal feces
Symptoms,intense abdominal
cramps and diarrhea
Infective dose,greater than 108
Onset Time,8 to 22 hours
Associated food,Catering services
where large amounts of food (meat,
meat products,gravy,etc) prepared
several hours before serving
Control measures:
– Controls in production and storage of foods
– Adequate cooling of foods below 10°C
(50°F) within 2 or 3 hours and maintaining
cooked foods above 60°C (140°F).
– Re-heating of cold or refrigerated foods
should achieve a minimal internal
temperature of 75°C (167°F).
Factors affecting the growth of Clostridium
perfringens type A
Minimum temperature,10°C (50°F)
Maximum temperature,52°C (125,6°F)
Minimum pH,5,0
Maximum pH,9,0
Minimum Aw,0,93
Maximum % NaCl,7
Staphylococcus aureus
The presence of this bacteria in
animals,especially the milk obtained
from animals with mastitis,results in
food contamination
Highly heat-stable protein toxin
Symptoms,nausea,vomiting,
abdominal cramps and prostration
Onset Time,rapid
Infective dose,less than 1.0
microgram of toxin (exceed 105 per
gram for S,aureus)
Associated food,meat and meat
products; poultry and egg products;
salads with egg,tuna,chicken,potato,
macaroni,bakery products such as
cream-filled pastries,cream pies,
chocolate eclairs,sandwich fillings,raw
milk and dairy products.
Control measures:
– time and temperature controls,especially
after cooking;
– prepair food close to the time it will be
served;
– appropriate personal hygiene and
adequate cooking foods to destroy
microorganisms.
Factors affecting growth of Staphylococcus
aureus
Minimum temperature,5,6°C (42°F)
Maximum temperature,50°C (122°F)
Minimum pH,4,3
Maximum pH,9,3
Minimum Aw,0,83
Maximum % NaCl,20
Parameters that limit production of
staphylococcal enterotoxin
Minimum temperature,10°C (50°F)
Maximum temperature,50°C (122°F)
Minimum pH,4,76
Maximum pH,9,02
Minimum Aw,0,86
Maximum % NaCl,12
FUNGI
Molds and yeast do not pose a
biological hazard to health but they are
responsible,in many cases,for food
deterioration.
Aflatoxins will be discussed as chemical
hazards.
VIRUS
Sources of foodborne viruses are feces
and urine of infected individuals and
contaminated water.
Foods involved are raw shellfish,raw
vegetables,salads,salads and water
contaminated with human feces.
Hepatitis A Virus
Hepatitis A is usually a mild disease
characterized by sudden onset of fever,
malaise,nausea,anorexia,and abdominal
discomfort,followed by several days of
jaundice
Onset Time,10 to 50 days
Associated food,cold cuts,sandwiches,
fruits,fruit juices,milk,dairy products,
vegetables,salads,shellfish,and iced drinks,
Water,shellfish,and salads are the most
frequent sources.
Hepatitis E Virus
Hepatitis caused by HEV is clinically
indistinguishable from hepatitis A,
Symptoms include malaise,anorexia,
abdominal pain,arthralgia and fever.
Infective dose,unknown
Onset Time,2 to 9 weeks
Associated food,water
The Norwalk virus family
Symptoms,nausea,vomiting,diarrhea,
and abdominal pain,Headache and
low-grade fever may occur,
Infective dose,unknown (presumed to
be low)
Onset Time,24 to 48 hours
Associated food,contaminated food or
water
Rotavirus
Symptoms,mild to severe disease
characterized by vomiting,watery
diarrhea,and low-grade fever.
Infective dose,10-100 infectious viral
particles
Onset Time,1 to 3 days
Associated foods,Infected food
handlers may contaminate ready-to-eat
foods
PARASITES
Trichinella spiralis
Life cycle of Trichinella spiralis
Toxoplasma gondii
Life cycle of Toxoplasma gondii
Cryptosporidium parvum
Life cycle of Cryptosporidium parvum
Giardia lamblia
Life cycle of Giardia lamblia
Ascaris lumbricoides
Life cycle of Ascaris lumbricoides
Trichuris trichiura
Life cycle of Trichuris trichiura
Diphyllobothrium spp,
Life cycle of Diphyllobothrium spp.
Entamoeba histolytica
Life cycle of Entamoeba histolytica
Taenia saginata
Life cycle of Taenia saginata
Taenia solium
Life cycle of Taenia solium
Fasciola hepatica
Life cycle of Fasciola hepatica
Cyclospora cayetanensis
Life cycle of Cyclospora cayetanensis
CHEMICAL
HAZARDS
Chemical hazards may be:
Chemical contaminants
naturally occurring in food
added during processing:
- intentionally
- accidentally
- criminally
Chemical contaminants naturally
occurring in food
Micotoxins (aflotoxin)
Scombrotoxin (histamine)
Ciguatoxin
Mushroom toxin
Toxins of molluscan shellfish
(PSP,DSP,NSP,ASP)
Polychlorinated biphenyl (PCB)
Chemical compounds
intentionally added to food
Food additives
- Food preservatives (nitrites,nitrates)
- Stabilizers (phosphates)
- Flavoring agents (monosodium
glutamate)
- Coloring agents
Chemical compouds
acccidentally added to food
insecticides
rodenticides
fungicides
herbicides
antibiotics
growth promoters
food additives
heavy metals
lubricants and paints
sanitizers
Chemical compouds criminally
added to food
Any compound commonly used by the
food industry,if added in amounts and
situation demonstrating criminal
purposes (e.g,sabotage)
PREVENTION
Use safe cleaning products
Adequate cleaning programs
Training of employees
Inspection after cleaning
Appropriate materials
Good Agricultural Practices
Avoid fishing in contaminated waters
Control on primary production of meat and milk
(Good Agricultural Practices - GAP)
Select suppliers
List all potentially allergenic on labels
Effective sanitation
Care during handling
Check raw material
Reject fish with temperature abuse
Strictly control addiction of products containing
nitrite,sodium metabisulfite and tartrazine
Control use of any compound and/or ingredient
that may cause poisoning
Calibrate and adjust equipment used to measure
additives
Train employees
PHYSICAL HAZARDS
Physical hazards include
Any foreign objects in food that can
result in disease:
– Glass
– Wood
– Stones
– Metal
– Insulation
– Bone
– Plastic
– Personal effects
PREVENTION
PLASTIC
Implement control of plastic
Visual inspection
Use bright colors (commonly blue) for
easier identification
BONES
Select appropriate suppliers
Inspect during reception,grinding and filling
Train employees
Separate through centrifugation or straining
GLASS
Avoid using glass containers
Keep glass out of production area
Strictly control breakage in final product
packed in glass
Avoid use of glass in production area
Remove glass protection from
manometers
Cover lamps with plastic protection
Control through X-ray
METAL
Adequate maintenance of equipment
Care in handling raw material packed in
metallic containers
Discard metal by inspection or use
flotation tanks,centrifuges,or strainer
STONE
Select appropriate suppliers
Discard chips by inspection or use of
flotation tanks,centrifuges,or strainer
WOOD
Avoid wooden boxes and pallets
Store wood away from food handling
areas
Prepare a plan to avoid use of wood or to
replace existing wood in the facilities
Inspect raw material to avoid introduction
of wood in the plant
PREREQUISITES FOR
HACCP IMPLEMENTATION
Prerequisite programs to implement
HACCP:
- Good Manufacturing Practices (GMP)
- Sanitation Standard Operating Procedures
(SSOP)
Preliminary steps need to be accomplished
before applying HACCP
Prerequisite programs
Preliminary steps needed to control conditions
related to safe food production
Examples:
Hygiene and sanitation of equipment
Training of employees
Preventive maintenance
Product identification
Good Manufacturing Practices - GMP
Prerequisite to implement HACCP
Some aspects involved:
– hygiene and personal health issues
– design and maintenance of buildings and
equipment
– calibration of equipment
– use of ingredients
– cleaning and sanitation
Sanitation Standard Operating
Procedures - SSOP
Developed by FSIS/USDA after an
inspection carried out in 1,014 meat
plants,demonstrated operational
problems in over 60% of them
Written procedures for sanitation
of facilities and equipment
Make daily evidence of
compliance
SSOP
PREVIOUS STEPS TO HACCP
IMPLEMENTATION
Assemble the HACCP team
Describe the food
Describe the intended use and identify
potential consumers
Develop a flow diagram of the process
Verify the flow diagram
Example of a Flow Diagram
Receiving
Cooking
Freezing
Boxing
Distributing
HACCP PRINCIPLES
PRINCIPLE 1,
HAZARD ANALYSIS
Conduct a hazard analysis
and identify the preventive
measures
Hazards can be:
Biological
Chemical
Physical
Hazard Analysis
A significant hazard must be controlled if:
it is likely to occur
there is a probability of consumers
being exposed to an unacceptable
hazard
Control measures
Biological hazards
Temperature/time control
Heating and cooking
Cooling and freezing
Fermentation and/or pH control
Addition of salt or other preservatives,
Drying
Control measures
Chemical hazards
Control of raw materials
Processing control
Proper segregation of non-food chemicals
during storage and handling
Control of incidental contamination from
chemicals
Labeling control
Control measures
Physical hazards
Control of raw material
Processing control,e.g,use of magnets,metal
detectors,sifter screens,de-stoners,clarifiers,air
tumblers
Control of processing environment
Preventive maintenance of equipment used in
food processing
PRINCIPLE 2,
CRITICAL CONTROL POINTS
Identify the Critical Control
Points (CCP) in the
process.
Critical Control Point (CCP)
"a step at which control can be applied
and where it is essential to prevent or
eliminate a food safety hazard or to
reduce it to an acceptable level.”
Points identified as CCP when hazards
can be avoided:
Introduction of pathogenic microorganisms or drug
residues can be avoided during the reception of raw
material
Chemical hazards can be avoided by controlling
formulation steps and addition of ingredients
Contamination of final product by pathogenic
microorganisms can be avoided by addition of
preservatives and/or pH adjustment.
Growth of pathogenic microorganisms can be
avoided by refrigeration.
Points identified as CCP when
hazards can be eliminated:
Thermal processing for adequate
time/temperature can eliminate pathogenic
microorganisms or reduce them to
acceptable levels
Metal pieces can be detected or removed
using metal detectors,sifter screens,de-
stoners,clarifiers,air tumblers
Freezing processes can kill parasites
(Trichinella spiralis,Cysticercus celullosae,
Anisakis spp.)
Points identified as CCP when
hazard can be reduced to
acceptable levels:
The presence of foreign matter can be
minimized by manual and/or automatic
collector
Some biological or chemical hazard can be
minimized by proper selection of suppliers of
raw material
Multiple CCP x Multiple Hazard
The same PCC may control more than one
hazard.
Example,immediate refrigeration of fresh
tuna avoid growth of pathogenic
microorganisms and production of histamine
Multiple CCP x Multiple Hazard
One hazard may request more than one CCP
for an effective control.
Example,hamburger thickness and internal
cooking temperature need to be controlled to
avoid survival of pathogens
CCP are specific to a product
and process
Many factors affect a CCP:
- Replacement of equipment
- Changes in product formulation
- Changes in operational flow
- Size of packaging
- Changes in GMP and SSOP
Decision Tree to
identify CCP
(Based on Codex Alimentarius)
Answer the questions in sequence.
1st Do preventive
measure (s) exist? No
No
Yes
Yes
Modify step,
process or
product
Is control at this
step necessary
for safety?
Not a CCP
Go to
question 2
2nd Is the step specifically designed to eliminate or
reduce the identified hazard
to an acceptable level?
No
Yes
Critical Control Point
Go to
question 3
3rd Could contamination with the identified hazard occur in
excess of acceptable levels
or increase to unacceptable
levels?
Yes
No
Not a CCP
Go to
question 4
4th Will a subsequent step eliminate the identified
hazard or reduce its likely
occurrence to an
acceptable level?
Yes
No
Not a CCP
Critical Control Point
Examples of CCP:
Pasteurizer
Dryer
Frying pans
Freezers (T,spiralis control)
PRINCIPLE 3
Establish critical limits for
each CCP
Critical Limit
Critical limit is a criterion which should be
met for each preventive measure associated
with a CCP,to ensure safety
Each CCP may have one or more critical
limits associated with each significant
hazard.
Examples of critical limits to destroy/
prevent pathogens
Time/ temperature requirements for thermal
processes such as pasteurization,cooking,
Sources of information on critical
limits include
Scientific publications/research data
Regulatory requirements and
guidelines
Experts
Experimental studies
Operating Limits
Are more restrictive than critical limits,
Established to prevent violation of
critical limits.
Process adjustment
Action to be taken to adjust the
process,bringing it back to control
PRINCIPLE 4
Establish monitoring systems
for each CCP
Monitoring
The act of conducting a planned
sequence of observations or
measurements of control to assess
whether a CCP is under control;
The record of this observation shall be
used on futures verifications
Purposes of monitoring
Measure the performance level of system's
operation at the CCP
Determine when the performance level of
the system results in loss of control at the
CCP,e.g,when there is deviation from a
critical limit
Establish records that reflect the
performance level of the system's operation
at the CCP to comply with the HACCP plan
Monitoring
What?,usually a measure or
observation to evaluate if the CCP is
operating within the critical limits
How?,usually physical or chemical
measures or observations,Should be
taken and recorded in real time
When (frequency)?,can be continuous
or non-continuous.
Who?,Someone trained for the activity
which will be monitored.
What will be monitored?
Measurement of the time and temperature of a
thermal process
Measurement of cold-storage temperature
Measurement of pH
Measurement of Aw
Speed of production line
Certificate of origin of raw material
Harvest area of molluscan shellfish
How will critical limits and preventive
measures be monitored?
Thermometers
Clocks
Scales
pH-meters
Water activity meters
Analytical equipment
Monitoring frequency
Continuous monitoring (if posible)
Thermographs
Metal detectors
Discontinuous monitoring
Internal temperature of cooked products
Evaluation of seam measures of canned food
Sensory evaluation
Responsibility for monitoring
Production personnel
Equipment operators
Supervisors
Maintenance personnel
Quality assurance personnel.
PRINCIPLE 5
Establish corrective actions
to be taken when monitoring
indicates deviation from
critical limits
Corrective Actions
Any action to be taken when the
results of monitoring at CCP indicates
loss of control.
Components of Corrective Actions
Correct and eliminate the cause of the
deviation and restore the control of process.
Identify product produced during process
failure and determine its use
Steps to determine the use of food
when critical limits are violated
1st Step,Determine if the product present a public
health risk,based on:
- experts evaluation
- results of chemical and/or microbiological analysis
2nd Step,If the evaluation above does not show any
risk,release the product to be consumed or to follow
the process
3rd Step,If the evaluation indicates that a
hazard occurred,determine if the product
should be:
- reworked/ reprocessed
- deviated to another use
4th Step,If it is not possible,the product
should be destroyed,It is the most expensive
option and will be used only as the last
alternative
PRINCIPLE 6,VERIFICATION
Establish procedures for
verification that HACCP is
working correctly
Verification
Application of methods,procedures,
tests and other types of evaluation,in
addition to monitoring,to determine
compliance with the HACCP plan.
Verification gives elements to ensure that
the HACCP plan is based on scientific
principles.
Verification activities
HACCP plan validation
CCP verification:
- Calibration of monitoring equipment
- Targeted sample collection and testing
- Review of monitoring records
HACCP plan verification:
- Audits
- Microbiological analysis of the final product
Validation
Validation is the act of assessing whether
the HACCP plan for a specific product and
process identifies and controls all significant
food safety hazards or reduces them to an
acceptable level.
It shall be performed before the HACCP plan
implementation.
Validation involves ensuring that the HACCP
plan is based on current good science and
current information and is appropriate for
the actual product and process
Who performs verification?
HACCP team
Persons qualified by training and experience
What kind of activities compose the
validation?
A scientific and technical review of each part
of HACCP plan,from hazard analysis to the
strategy for the verification of each CCP
(Re)Validation frequency
Initially (before implementation)
Every time it is necessary,
The following factors require revalidation of
a HACCP plan:
- replacement of raw materials
- changes in product and in process
- adverse audit findings
- frequent deviations on the CCP
- new information about hazards or control
measures
- routine monitoring activities; and
- new distribution practices or consumer handling.
Verification activities on CCP
Monitoring equipment calibration
Review of Calibration record
Targeted sample collection and testing
Review of monitoring records for all CCP
Calibration of monitoring
instruments
Calibration of appropriate equipment and
instruments used in the development and
implementation of the HACCP plan should be
performed:
At a frequency sufficient to assure
continuous accuracy
By checking accuracy against a recognized
standard
Targeted sample collection and
testing
Every time the reception of raw material is
considered a CCP,purchase specifications
should be issued to ensure the achievement of
the critical limits,A sample may be collected
and analysed to ensure that the specifications
were met
Microbiologic analysis of the
final product
The final product can be tested to ensure
compliance with the critical limits
The effectiveness of HACCP plan to
ensure that the identified microbiological
limits have not been exceeded
Microbiological analysis of the final product
should be used to verify if the process is
under control
Microbiological analysis are not a valuable
tool to monitor routinely a CCP
HACCP plan verification
Annually;
Always when there is a failure
in the system or an important
change of product or process.
Principle 7
Establish effective record
keeping procedures that
document the HACCP
System
Records
Records are essential source of information and
constitute a documental prove that CCP are
operating within critical limits and deviation are
treated appropriately
Information record
Information obtained during the monitoring
activities should be recorded at the moment
of the observation
False or incorrect records bring disbelief to
the HACCP plan
Record Review
Record reviews must be conducted
periodically by qualified staff members of
HACCP plan to ensure it’s working properly
Records that should be part of
HACCP system
HACCP plan and all background
documentation
CCP monitoring records
Corrective action records
Verification records (internal and
external)
Title and date of the record
Product identification (code,including time
and date)
Materials and equipment used
Operations performed
To assure product safety and to document
process and procedures,HACCP records must
contain the following information
Critical criteria and limits
Corrective action to be taken and by whom
Operator identification
Data (presented in a orderly format)
The reviewer’s initials and date of review
AUDIT
Audit activities include:
– Product description and flow chart review
– Monitoring required by the HACCP plan
at the CCP is performed
– Processes are operating within
established critical limits
– Records are filled out accurately and at
the time observations are made
Audit records include:
- Monitoring activities have been performed at
the locations and frequencies specified in the
HACCP plan
- Product has been controlled and corrective
actions have been taken whenever monitoring
has indicated the occurrence of a deviation
from critical limits
- Equipment has been calibrated at the
frequencies specified in the HACCP plan
Audit by official agency of inspection
and control
Review HACCP plan
Review changes to the HACCP plan and the
reasons for those changes
Review CCP monitoring records
Review corrective actions records
Review of verification records
Sample collection for laboratory analysis
