ASSIGNMENT

ON

FOOD SAFETY MANAGEMENT

SYSTEMS

SUBMITTED BY:
TEAM LEADER BAKUL DHAWAN
TEAM MEMBER SHREYA GOSWAMI
MANISH VATS
ABHIJEET SINGH
ARUN KUMAR

Hazard Analysis
One approach to hazard analysis divides it into two activitieshazard identification and
hazard evaluation. Hazard identification should result in a list of potential hazards at each
operations step (use a flow diagram) in the process from the receipt of raw materials to the
release of the finished product. During hazard identification, the team need not be confined
by the hazards likelihood of occurrence or its potential for causing disease. All potentially
significant hazards must be considered. To assist in this, the following list of hazards will be
valuable.

Hazard Identification
Biological hazards:
Pathogenic microorganisms (e.g., bacteria, protozoa,viruses)
A. Biological Hazards
Bacteria
1. Time/temp erature control (e.g., proper control of refrigeration and storage time minimizes
the growth of pathogens).
2. Thermal treatment (e.g., pasteurization).
3. Cooling and freezing (e.g., cooling and freezing retard the growth of pathogenic bacteria)
4. Fermentation and/or pH control (e.g., fermentation of apple cider by yeast pro duces
ethanol which is inhibitory to pathogenic bacteria).
5. Addition of salt or other preservatives (e.g., salt and other preservatives inhibit growth of
some pathogenic bacteria).
6. Drying or concentration (reduction of water activity, aw) may remove enough water from
the food to prevent pathogens from growing.
Parasites
1. Source control (e.g., preventing the parasite from having access to fruit by using GAPs).
2. Inactivation/removal
Chemical hazards:
Natural toxins
Chemicals

Allergens
Undeclared ingredients/cross-contaminants
Unlawful pesticide residues
Unapproved food and color additives
B. Chemical Hazards
1. Source control (e.g., vendor certification and raw material testing).
2. Production control (e.g., proper use and application of food additives).
3. Process control (e.g., proper application of the process such as washing, scrubbing and
culling to control patulin).
4. Labeling control (e.g., finished product properly labeled with ingredients and known
allergens).
5. Production scheduling (e.g. running products containing allergens last in the production
run).
Physical hazards:
Metal, glass, etc
After hazard identification, the team conducts a hazard evaluation. Hazard identification is
narrowed to those hazards that are significant to the product and process in question. The
steps in hazard evaluation are:
1. Assess severity of health consequences if potential hazard is not properly controlled,
2. Determine likelihood of occurrence of potential hazard if not properly controlled, and
3. Determine, using information from steps 1 and 2, if the potential hazard should be
addressed in the HACCP plan. HACCP focuses solely on hazards that are likely to occur and
likely to result in illness or injury to consumers if not controlled. Without this focus, it would
be tempting to try to control too much and thus lose sight of the truly relevant hazards. A
hazard must be controlled if it is:
(1) likely to occur, and
(2) if not properly controlled, is likely to result in illness or injury to consumers. In the case
of hazards for which regulatory action levels have been established for safety concerns (e.g.,
mycotoxins), the mere presence of the substance in the product does not constitute a hazard.
It is when the regulatory action level is exceeded that there may be an unacceptable health
risk to consumers. If violation of an action level in a particular food is reasonably likely to
occur, then the processors hazard analysis should identify that hazard as one to be controlled
through its HACCP system.

C. Physical Hazards
1. Source control (e.g., vendor certification and raw material testing).
2. Production control (e.g., use of magnets, metal detectors, sifter screens, destoners,
clarifiers, air tumblers and x-ray equipment).

Control Measures for Biological Hazards

1. 1.0 Minimum Requirement of 5-Log Pathogen Reduction
The 5-log pathogen reduction requirement in 21 CFR 120.24 describes the minimum
level of pathogen "kill" that your pathogen control measures must consistently
achieve. Processing experts evaluate treatments intended to destroy or inactivate
pathogens in food in terms of "logs" of kill, where the term "log" is a shorthand
expression of the mathematical term logarithm. A logarithm is "the exponent of the
power to which a base number must be raised to equal a given number." If the base
number is ten, it must be raised to the second power to equal 100, so the exponent is
2, i.e., 10 X 10 = 100. Again, if the base number is ten, it must be raised to the third
power to equal 1000, so the exponent is 3, i.e., 10 X 10 X 10 = 1000.
The HACCP regulation requires you to use treatments capable of consistently
achieving at least a 5-log reduction (using ten as the base number) in the level of the
pertinent microorganism in your juice. The important thing to understand is that each
log of kill is capable of causing a tenfold reduction in the number of organisms of the
pathogen that the treatment is designed to kill, i.e., the "pertinent microorganism." A
1-log process would be one that is capable of reducing the level of the pertinent
microorganism in the food by 10 fold, e.g., from 100 organisms (of the pathogen) per
gram of food to 10 organisms (of the pathogen) per gram of food. A 2-log process
further reduces the level of the target pathogen by another factor of 10, i.e., from 10
organisms (of the pathogen) per gram to 1 organism (of the pathogen) per gram of
food. Thus, the 5-log performance standard means that you must treat your juice using
a process capable of reducing levels of the pertinent pathogen in the juice by at least
100,000-fold (10 X 10 X 10 X 10 X 10 = 100,000).
This is illustrated in the following table:

Initial number of
pertinent
microorganism
bacteria per gram
of food

Log
reduction

Decrease in pertinent
microorganism bacteria
levels

Percent
of
change

Final
number of
bacteria
per gram
of food

100,000 (105)

10-fold

90 %

10,000
(104)

100,000 (105)

10x10 = 100 fold

99 %

1,000 (103)

100,000 (105)

10x10x10=1000 fold

99.9 %

100 (102)

100,000 (105)

10x10x10x10=10,000 fold

99.99 %

10 (101)

100,000 (105)

10x10x10x10x10=100,000
fold

99.999
%

1 (100)

1. The initial number of pathogens present in your untreated juice is likely to be far less
than 105 organisms per gram, i.e., only 101 or 102 organisms per gram. Applying a 5log treatment to juice that may contain such levels of pathogens achieves a tolerable
level of risk by ensuring that the process is adequate to destroy microorganisms of
public health significance or to prevent their growth.
Thus, if you use pasteurization as your pathogen control measure, that treatment must
be carried out to achieve consistently at least a 5-log reduction in the "pertinent
microorganism." Likewise, if you use UV radiation as your pathogen control measure,
that UV treatment must be carried out to achieve consistently at least a 5-log
reduction in the "pertinent microorganism."
If you are a citrus juice processor and rely on, as your pathogen control measure, a
series of surface sanitization treatments and an extraction process that limits juice/peel
contact as provided for under 21 CFR 120.24 (b), these treatments must consistently
achieve at least a 5-log reduction in the "pertinent microorganism."
Multiple processing steps, such as a series of surface sanitization treatments for citrus
fruit, may be used to achieve the 5-log reduction. However, under 21 CFR 120.24 (b)
and (c), all of the processing steps you perform to meet the 5-log pathogen reduction
requirement must be carried out in a single production facility.
We recommend that all juice processors consult with a process authority (see "Process
Validation" in section V.C.5) to establish their control measures for achieving the 5log pathogen reduction required under the HACCP regulation.
2. 1.1 What Does the "Pertinent Microorganism" Mean?
The "pertinent microorganism" is the most resistant microorganism of public health
significance that is likely to occur in the juice and is the pathogen that you must target
for the 5-log pathogen reduction treatment. By choosing the most resistant pathogen
as your target, you are also treating the product for all other pathogens that are less
resistant to the means of treatment.
One way to identify the pertinent microorganism for your juice is to consider whether
there have been any illness outbreaks associated with this type of juice, and what
microorganisms have caused the outbreaks. If certain pathogens have been
demonstrated, i.e., through outbreaks, to be potential contaminants in certain juices,
then the pertinent microorganism for your process typically should be one of these
pathogens.
For example, Salmonella species have been the cause of several illness outbreaks
related to orange juice and may be considered the "pertinent microorganism" for
orange juice products. E. coli O157:H7, a bacterial pathogen, and Cryptosporidium
parvum, a protozoan parasite, have both been the cause of outbreaks in untreated
apple juice, and both should be identified as potential hazards in a hazard analysis for
apple juice. Which of these two pathogens is determined to be the pertinent
microorganism will depend upon which of the two is most resistant to the means of
treatment, e.g., pasteurization, UV radiation, that you will use to achieve the 5-log

reduction of pathogens that is required under the juice HACCP regulation. The
pertinent microorganism for apple juice is discussed further in section
Although Listeria monocytogenes has not been linked specifically to an illness
outbreak from juice, it is ubiquitous in nature. For this reason, we recommend that
Listeria monocytogenes be considered as a possible "pertinent microorganism" for
juices that have not been associated with illness outbreaks caused by Salmonella
species, E. coli O157:H7, or Cryptosporidium parvum. Alternatively, for juices other
than apple juice, you may generically designate "vegetative bacterial pathogens" as
your pertinent microorganism if your juice is an acidic juice, i.e., pH of 4.6 or less, no
illness outbreaks believed to have been caused by non-bacterial pathogens have been
attributed to that juice type, and you are processing your juice using a process that has
been validated to achieve a 5-log reduction for Salmonella species, E. coli O157:H7,
and Listeria monocytogenes,
Low-acid juices, such as carrot juice, that are distributed under refrigeration, and are
not subject to the Low Acid Canned Foods regulation may pose hazards associated
with spore forming pathogens, specifically, toxins of non-proteolytic and proteolytic
strains of Clostridium botulinum. Control measures for such juices are likely to
involve multiple measures, e.g., a combination of a process step to destroy the nonproteolytic spores and measures to ensure that "Keep Refrigerated" labeling is used
for the juice if the juice does not receive a treatment sufficient to destroy the
proteolytic spores (Destruction of spores of the proteolytic strains requires a more
severe heat treatment but germination and growth of these spores may be prevented
by keeping the product under refrigeration during its lifecycle. Destruction of spores
of the non-proteolytic strains requires a less severe heat treatment, but these spores
can germinate and produce toxin even under refrigerated storage conditions).
3. 1.2 Shelf Life and Moderate Temperature Abuse Conditions
The 5-log pathogen reduction treatment must last through the normal shelf life of the
product when held under moderate temperature abuse conditions (21 CFR 120.24(a)).
This requirement is intended to ensure the effectiveness of the treatment if any
microorganisms that may be injured in processing, might be capable of surviving if
held under optimal growing conditions. Normal handling of juice includes the
movement of the juice from the plant to retail (e.g., transportation, warehouse storage)
and consumer handling after purchase (e.g., transport home, setting out on a counter
or table). Moderate abuse may occur when unusual circumstances occur during
customary handling. For example, unloading a truck on a hot day where the product
may sit on a loading dock for a short period of time could constitute moderate abuse.
In addition, moderate abuse could occur if consumers purchase a product on a warm
day, place it in their car, and run errands before refrigerating the product. Moderate
abuse does not include exposure to warm temperatures for extended periods of time.
Your "process authority" should be able to determine that the process you use, e.g.,
pasteurization, UV irradiation, will ensure that pathogens will not proliferate in your
juice should it undergo moderate temperature abuse.
4. 1.3 5-Log Treatment Performed on Juice after Extraction, with One Exception

You must meet the 5-log pathogen reduction requirement by treating the juice
directly, i.e., after it has been extracted from the fruit, with one exception provided by.
However, for citrus juices, you may meet this requirement by applying pathogen
reduction treatments to the surface of the citrus fruit prior to extracting the juice. Such
treatments usually are carried out through a series of washing, brushing, and
sanitizing steps. Use of extraction methods that limit juice/peel contact may also be
counted towards the 5-log reduction.
5. 2.0 Location of Juice Extraction, Processing, and Packaging
You must carry out the 5-log pathogen reduction, whether it is via a one-step process
or a multi-step process, in a single facility, and that facility must be the same facility
in which the product is packaged in final form for sale. There are two potential
exceptions discussed in the following paragraphs. If you do treat your juice at a
different facility than the one in which the final packaging is carried out, the
treatments applied at the first facility cannot be counted towards meeting the 5-log
pathogen reduction requirement.
The first exception noted in the previous paragraph applies to producers and users of
high degree Brix juice concentrate. In a letter dated January 22, 2002 (and a January
25, 2002 letter of correction), FDA stated that it would consider the exercise of
enforcement discretion with respect to the "single facility" requirement as applied to
producers and users of high degree Brix concentrate where the following three
conditions are satisfied: (1) the producer and user establish appropriate prerequisite
programs and SSOPs for the transport of high Brix juice concentrate; (2) the producer
and user designate as a CCP in their respective HACCP plans the transport of high
Brix concentrate from the production facility to a second facility for formulation and
final packaging of concentrates; and (3) the producer and user establish control
measures to prevent, reduce, or eliminate the risk of recontamination of the
concentrate during
You may extract juice from the fruit in one location and ship the untreated juice to a
second location for processing (i.e., to achieve the 5-log pathogen reduction
requirement) and packaging. If you do this, we recommend that you obtain assurance,
e.g., a letter from the juice processor receiving the untreated juice, that the juice will
be given the required 5-log treatment at the second location, and you should cite this
assurance in your hazard analysis as the justification for not carrying out the 5-log
reduction in your facility. We also recommend that the label of the untreated juice, or
if transported in bulk, the invoice or other shipping documents, state that the juice has
not received a treatment sufficient to yield a 5 log pathogen reduction.

Control Measures for Chemical Hazards

There are no specific chemical hazards for which HACCP control measures are required
explicitly under the juice HACCP regulation. If you identify a chemical hazard that is
reasonably likely to occur in your juice, you will need to establish control measures for that
hazard in your HACCP plan. However, because FDA has recently established an action level
for patulin, a mycotoxin, which can occur in apple juice, we have included information on
control strategies for patulin. The information in this section includes examples of control
measures for incoming fruit based upon a supplier guarantee. These examples may be useful

for devising control measures for other chemical hazards, such as lead and tin, if such control
measures also are based upon a supplier guarantee.
We have also included information about appropriate controls to prevent cross contamination
of juice by other foods, e.g., milk, that may cause allergic reactions in sensitive individuals
when these other foods are produced on the same processing equipment.
1. 1.0 Control Strategies for Patulin for Apple Juice Processors
This section discusses factors you may wish to consider in your hazard analysis to
determine whether patulin is a hazard that is reasonably likely to occur in your juice.
It also discusses control measures and CCPs you may wish to consider for your
HACCP plan, should you determine that patulin is reasonably likely to occur in your
juice.
The potential for high levels of patulin to occur depends on several factors. There is
no single factor that will, in all cases, determine whether your apple juice may contain
high levels of patulin. The most significant factors are:
o

Whether the apples used include fallen fruit - Apple juice made from apples
that include fallen fruit is more likely to contain high levels of patulin than
juice made from apples harvested to exclude fallen fruit.
The condition of apples at the time of harvest - Juice made from apples with
visible damage (e.g., from birds or insects, mold, or rot), is more likely to
contain high levels of patulin than juice made from apples without such visible
defects. Proper agricultural control practices by the grower, e.g., insect
control, anti-fungal applications when needed, can assist in minimizing mold
growth and rot on apples.
How apples are handled prior to storage - Patulin production can occur during
the storage of apples, particularly in apples that are bruised in handling prior to
and during storage.
Storage conditions for apples - Apples stored without proper temperature and
atmospheric control of the storage environment are more likely to contain high
levels of patulin than apples stored under controlled conditions.
Monitoring apples during storage for core rot - Patulin production in stored
apples can be caused by core rot that is not visible by observation of the
exterior of the apple. Lots of apples that are experiencing core rot may be
identified by cutting and cross-sectional examination. Eliminating lots of
apples with high levels of core rot from the juice production stream will
reduce patulin levels in the juice.
Culling or trimming apples prior to juice production - Growth of patulin
producing molds is evidenced frequently by the appearance of visible mycelia
or rot on the apple. Culling or trimming apples just prior to juice production to
eliminate damaged, bruised, moldy, and rotting apples will reduce patulin
levels in the juice.

2. 1.1 Hazard Analysis

You may be able to gather a substantial amount of data pertinent to your juice and
process and perform a comprehensive hazard analysis, considering all of the factors in
the previous section, and determine that no controls (in rare instances), or relatively
limited measures, are necessary to control patulin for your apple juice process.
For instance, you may determine, based upon data for the type of apples you use, that
the use of apples that include fallen fruit would likely lead to excessive levels of
patulin in your juice. You may opt to control for patulin via a CCP at the receiving
step for apples based upon a supplier guarantee specifying that no fallen fruit is
included among the apples supplied in the shipment. However, you also may
determine that because you produce juice from apples that are stored only for very
brief periods, during which data indicate that significant patulin production will not
occur in the varieties of apple you use, the culling or trimming of apples prior to juice
production is not necessary for the control of it, provided that you establish a control
to ensure that apples are stored for a maximum period of time before juice production.
However, because patulin levels in juice can be affected by many factors as noted
previously, not all processors may be able to acquire data or other information to
perform a comprehensive hazard analysis considering all of the factors noted in the
previous section. In such cases, it may be prudent for you to assume that patulin is a
hazard that is reasonably likely to occur and to control for patulin by requiring a
supplier guarantee for each shipment specifying that no fallen fruit is included among
the apples supplied, and also by establishing a culling or trimming step in your
process after the storage step, at which rotten, moldy, bruised, and damaged apples
are removed from the production stream.
Thus, you might elect to have two CCPs for the control of patulin, the receipt of
apples and the culling (or trimming) step prior to juice production. If you store apples
for extended periods of time, we recommend a third control measure, inspecting
apples taken from stored lots by cutting the apples and visually checking for core rot
at various times during the storage period. Lots of apples showing significant levels of
core rot may not be acceptable for juice production. These checks for core rot would
constitute a third CCP. By establishing the three aforementioned controls, i.e.,
exclusion of fallen fruit, culling or trimming of rotten, moldy, bruised and damaged
apples from production stream, and eliminating stored apples with high levels of core
rot, it is likely that you will be able to adequately control patulin levels in your juice.
We suggest that you test some of your juice to show that your control measures will
effectively control patulin. A commercial laboratory can do this testing for you. We
suggest that an appropriate basis for determining that your control measures are
effective is, if upon analysis of at least 3 samples of your juice for patulin taken
during one year (each analyzed in duplicate and sampled under conditions where the
occurrence of patulin is most likely, e.g., after apples are stored for the longest
potential storage time), you find that all patulin levels are below FDA's action level
and that the value achieved by adding 2 standard deviations to the mean is below
FDA's action level of 50 parts per billion. This is illustrated in the following examples
for hypothetical juices A, B and C:

Juice

Patulin level, Mean (std dev)

(derived from 6 data points; 3
analyses during the year, each in
duplicate)

Patulin level at
mean plus 2x std
deviations.

Is patulin being
effectively
controlled?

40.2 (7.2)

54.6

No

0.97 (1.67)

4.31

Yes

3.43 (31.9)

67.23

No

Processors in the same geographic region that use common varieties of apples and
common production techniques may wish to consider pooling resources to test
representative samples of their juices to develop baseline data on patulin for use in
their hazard analyses.
If there are significant changes in your process or in factors that may affect patulin
levels, e.g., a change in the variety of apples you use to make juice, a change in your
storage practices, a new supplier, or abnormal weather conditions, we also
recommend that you re-validate your hazard analysis by testing juice made under the
new conditions.
3. 1.2 Control Measures
If the receiving of apples is a CCP:
A supplier guarantee specifying that only apples harvested to exclude fallen fruit were
supplied in the shipment is likely to be an effective control measure for patulin. Under
such an approach:
o

o
o
o

The existence of the supplier guarantee for each shipment of incoming fruit
specifying that only apples harvested to exclude fallen fruit were supplied in
the shipment would be the critical limit. For a small processor who harvests
apples from his own orchard, we recommend, in lieu of a supplier guarantee,
that the processor's apple pickers be instructed not to harvest fallen fruit and
the processor confirm that the workers are adhering to the instructions.
A monitoring procedure would be to confirm visually the existence of the
guarantee for each incoming shipment of apples.
The corrective action procedure would be to reject any shipment of fruit not
accompanied by a guarantee from the supplier.
The verification procedure could consist of periodic auditing of the supplier to
ensure that the supplier is following the provisions of the guarantee, or testing
the juice periodically to confirm that it does not contain high levels of patulin.
We recommend that processor's who rely on guarantees or certificates from
suppliers to control a hazard couple these types of controls with a strong
verification procedure, such as visiting the farm periodically or periodically
testing the juice.

If culling or trimming apples after storage is a CCP:

o
o
o

The culling or trimming of the fruit during the sorting step after storage to
eliminate moldy, rotten, bruised, and damaged (e.g., from birds or insects)
fruit is likely to be an effective control measure.
The use of only apples or apple portions free of mold, rot, bruising, and other
damage would be the critical limit.
A monitoring procedure would be to inspect apples at the sorting step to
ensure that the apples are free of rot, mold, bruising, and other damage.
The corrective action procedure would be to cull or trim any apples that show
mold, rot, bruising, or other damage. In practice, we recommend that you
establish visual or other criteria for what constitutes a damaged apple that
should be culled. We further recommend that criteria be established based
upon validation data showing that juice made from apples culled using the
criteria do not contain unacceptable levels of patulin.
The verification procedure could consist of periodically testing the juice to
confirm that the juice does not contain high levels of patulin and reviewing
records of monitoring, corrective action, and verification.

Control Measures for Physical Hazards

1. 1.0 Physical Hazards
There are no specific physical hazards, e.g., glass or metal fragments, for which
control measures are explicitly required under the juice HACCP regulation. The
necessity for control measures for any potential physical hazard is dependent upon a
finding in your hazard analysis that the specific hazard is reasonably likely to occur in
your juice. FDA has issued a Compliance Policy Guide describing when hard or sharp
foreign objects in food, such as glass or metal fragments, could pose a health hazard.
If it is reasonably likely that your juice may become contaminated with hard or sharp
foreign objects that meet the criteria in this CPG, we recommend that you regard the
object as a potential hazard in your juice.
2. 1.1 Glass Fragments
We can recommend several ways to establish control measures for glass fragments in
juice.
One way is the use of on-line glass detection equipment such as x-ray detection. In
this method, the product itself is continuously monitored after the last step at which
glass inclusion is reasonably likely to occur (e.g. after bottling and sealing of the
juice). This could be, for example, at a process step designated for x-ray examination.
The critical limit might be designated as "no glass fragments in the finished product."
The following illustrates the elements that might be entered into your HACCP plan.
o

What is the critical limit? No glass fragments in finished product (Note: FDA's
Health Hazard Evaluation Board has supported regulatory action against
product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. See
also FDA Compliance Policy Guide 555.425).
What will be monitored? The presence of glass fragments in containers
passing the CCP

o
o

How is monitoring done? Use of x-ray equipment or other defect rejection

system
How often? Continuous; each container is subjected to detection. For x-ray
equipment and other defect rejection systems, we recommend that you
confirm that the device is operating correctly, at least at the start of each
production day
Who will perform the monitoring? For x-ray detection and other defect
rejection systems, the equipment itself performs monitoring. We recommend
that you check at least once per day to ensure that the device is operating.

Another way to control glass fragments, applicable in operations where the containers
are manually (not mechanically) handled and sealed, involves inspecting glass
containers visually before they are filled to ensure that glass fragments are not present
in the containers. An appropriately trained individual at a container inspection step in
the process may do this. We recommend that there be a check at the start of
production to ensure that the appropriate personnel are assigned to the processing step
where the inspection will occur. The critical limit might be designated as "no glass
fragments in empty glass containers at the container inspection step."
A third way to control glass fragments is visual inspection at steps in the process
where glass breakage can result in glass entering the juice, such as the glass container
receiving, glass container storage, mechanical conveying, mechanical filling, and
mechanical capping. The inspection looks for any evidence of glass breakage in those
areas. CCPs might be identified as the glass receiving and storage steps and the
mechanical conveying, filling and capping steps. The critical limit might be
designated as "no broken glass at the CCPs for glass inclusion." If broken glass is
observed, the line is stopped, the glass is removed, and the product that has moved
through that area since the last inspection is placed on hold for further action as
appropriate, e.g. to be run through off-line glass detection equipment, to be destroyed,
to be diverted to non-food use, or to be re-run through a process that includes a glass
detection step.
o
o
o
o

What is the critical limit? No broken glass at the CCPs for glass inclusion
What will be monitored? The presence of broken glass on or near equipment
at the CCPs
How is monitoring done? Visual check of the glass handling areas for broken
glass
How often? We recommend that you check before starting operations each
day, check at least every four hours during operation, check at the end of
operations each day, and check whenever there is an equipment or other
malfunction that could increase the likelihood that glass containers could be
damaged
Who should perform the monitoring? Any person who has a thorough
understanding of the proper condition of the glass handling equipment and
surrounding area may perform monitoring. In assigning the responsibility for
this monitoring function, we recommend that you consider the complexity of
the equipment and the level of understanding necessary to evaluate its
condition.

If broken glass is observed at a CCP, we recommend that the corrective action

procedure be to stop the line, remove the broken glass, and then place on hold any
product that has moved through the area where the glass breakage was observed since
the last inspection, for further action as appropriate, e.g., to be run through off-line
glass detection equipment, to be destroyed, to be diverted to non-food use, or to be rerun through a process that includes a glass detection step.
3. 1.2 Metal Fragments
We can recommend several possible ways to establish control measures for metal
fragments in juice.
One way involves the use of on-line metal detection equipment. With this method, the
equipment continuously monitors the product after the last step at which metal
inclusion is reasonably likely to occur (e.g., after bottling and sealing of the juice) at a
process step designated for metal detection. The critical limit might be designated as
"no metal fragments in the finished product." The following illustrates some of the
elements that might be entered into your HACCP plan.
o

o
o
o

What is the critical limit? No metal fragments in finished product (Note:

FDA's Health Hazard Evaluation Board has supported regulatory action
against product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length.
See also FDA Compliance Policy Guide 555.425).
What will be monitored? The presence of metal fragments in containers
passing the CCP.
How is monitoring done? By the use of metal detection equipment.
How often? Continuously. Each container is subjected to detection. We
recommend that you confirm that the device is operating correctly at least at
the start of each production day.
Who should perform the monitoring? Monitoring is performed by the
equipment itself. We recommend that a check be made at least once per day to
ensure that the device is operating correctly.

A second way to control metal fragments involves the use of a separation device such
as a screen after the last step at which metal inclusion is reasonably likely to occur, at
a process step designated for screening. For this approach (see example HACCP plans
for Pasteurized Refrigerated Apple Juice and Not-from-concentrate Orange Juice in
section VII):
o
o
o

The critical limit might be designated as "screen is functional."

Monitoring may be done by a daily visual check for screen integrity.
We recommend that verification include periodic calibration testing to ensure
that the screen retains its separation capability for metal particles of a specific
size. In establishing this size, we recommend that you consider that FDA's
Health Hazard Evaluation Board has supported regulatory action against
product with glass fragments of 0.3" (7 mm) to 1.0" (25 mm) in length. (See
also FDA Compliance Policy Guide 555.425).

A third way to control metal fragments involves visually inspecting equipment for
damage or missing parts at process steps such as extraction and grinding, where such

damage or loss of parts could lead to metal fragments in your juice. This approach
may only be feasible for relatively simple equipment that can be fully inspected
visually in a reasonable time period. Under this approach, CCPs might be identified as
the fruit grinding and extraction steps in a process. The critical limit might be
designated as "no broken or missing metal parts from equipment at the CCPs for
metal inclusion." If broken or missing metal parts are observed, the line is stopped,
the equipment is repaired and, if necessary, adjusted or modified, and the product that
has moved through that area since the last inspection is placed on hold for further
action as appropriate, e.g., to be run through off-line metal detection equipment, to be
destroyed, to be diverted to non-food use, or to be re-run through a process that
includes a metal detection step. The following illustrates the elements that might be
entered into your HACCP plan.
o
o
o
o

What is the critical limit? No broken or missing metal parts from grinding (or
extraction) equipment
What will be monitored? The presence of broken or missing metal parts on or
near the grinder
How is monitoring done? By visual check of the grinder and immediate
vicinity for broken or missing metal parts
How often? Check before starting operations each day, check at least every
four hours during operation, check at the end of operations each day, and
check whenever there is an equipment or other malfunction that could increase
the likelihood that metal inclusion could occur.
Who will perform the monitoring? Any person who has a thorough
understanding of the proper condition of the equipment and surrounding area
may perform monitoring.
If broken or missing metal parts are observed at a CCP, the corrective action
procedure would be to stop the line, repair, adjust, and modify the equipment
as necessary; the product that has moved through that area since the last
inspection is placed on hold for further action as appropriate, e.g., to be run
through off-line metal detection equipment, to be destroyed, to be diverted to
non-food use, or to be re-run through a process that includes a metal detection
step.

FLOW CHART DESCRIPTION FOR MANGO JUICE PRODUCTION

FRUIT SELECTION

WASHING

BLANCHING

PEELING AND CUTTING

PULPING

THERMAL TREATMENT

MIXING
(mango pulp, water, sugar, citric acid, vitamin C, calcium, beta carotene, iron,
stabilizer and ascorbic acid)

FILLING HOT INTO CANS

SEALING

COOLING

READY TO SERVE

RISK CALCULATION
Risk = Occurrence * Severity
Vegetative Pathogens
RISK = 5 * 3 = 15

Coliforms
RISK = 5 * 5 = 25

E. coli O157:H7
RISK = 6 * 2 = 12

Salmonella species (spp.)

RISK = 3 * 4 = 12

Cryptosporidium
RISK = 3 * 3 = 9

Listeria monocytogenes
RISK = 2 * 6 = 12

Cryptosporidium parvum
RISK = 3 * 3 = 9

Protozoan Pathogens
RISK = 5 * 3 = 15