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A. FDA's Most Likely Hazards/Control
Measures for Juice
FDA strongly recommends that the following hazards be considered in your
HACCP plan. This means that you should state them as significant
hazards in your Hazard Analysis and control them as CCP’s
unless you can demonstrate otherwise.
Table 1. Most Likely Hazards/Control
Measures for Juice
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Hazard Identity
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Hazard rationale
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Possible control measures
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Pathogens/biological
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Unless you produce one of the types of juice listed in footnote #12, or
a low acid juice not subject to the Low Acid Canned Foods regulations (21
CFR Part 113) one of the pathogens listed in footnote #13 is likely to be
the "pertinent microorganism" for your required 5-log pathogen
reduction treatment.
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- Pasteurization
- UV radiation
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Patulin/chemical
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Patulin is a mycotoxin
that can occur on rotten, moldy, bruised or damaged apples, and may occur
at hazardous levels if such apples are used to make juice
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- Supplier guarantee
for each shipment; only apples harvested to exclude fallen fruit were
supplied
- Cull or trim apples
after storage to remove rotten, moldy, bruised and damaged apples
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Milk residue (an undeclared allergen) in juice/chemical
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May occur in juice processed using equipment also used to process milk
or dairy products
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CCP or SSOP control for adequate cleaning of processing equipment
between a milk run and a juice run
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Fragments from glass containers/physical
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Glass fragments in juice can pose a risk of injury if ingested
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Check processing line for evidence of glass breakage (if containers are
mechanically handled)
Pass product through x-ray equipment or other defect rejection system
Pass product through separation device such as a screen
Check containers prior to filling for glass breakage (if containers are
manually handled)
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Metal Fragments
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Metal fragments in juice can pose a risk of injury if ingested
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Check equipment for evidence of broken or missing metal parts that may
enter the juice
Pass product through metal detection equipment
Pass product through separation device such as a screen or magnet (if
the metal is ferrous, e.g., a steel grinder blade)
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B. Recommended Control Measures for
Significant Hazards
FDA offers these suggestions for control measures for significant hazards.
Use them unless you can demonstrate that alternatives are equally effective.
1. Control Measures for Significant
Biological Hazards
1.1. Thermal systems
For apple juice at pH values of 4.0 or less, FDA recommends the following
thermal processes to achieve a 5-log reduction for oocysts of Cryptosporidium parvum based upon a conservative evaluation of
the available scientific data;
- 160 degrees F for 6
seconds (recommended treatment conditions in New York),
- 165 degrees F for 2.8
seconds,
- 170 degrees F for 1.3
seconds,
- 175 degrees F for 0.6
seconds, or
- 180 degrees F for 0.3
seconds
1.2. UV systems
If you are using a UV "pasteurizer", consult with the
manufacturer to determine proper settings to achieve an
microbial kill equivalent to the 5-log heat treatment
2. Control Measures for Significant
Chemical Hazards
2.1. 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:
- 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.
2.2. If culling or trimming apples after storage is
a CCP:
- 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.
2.3. If you are also pasteurizing milk in the same facility:
If you process juice on equipment that also has been used to process a
food that can cause allergic reactions, sucha as milk, FDA recommends that you implement
CCP or rigorous SSOP controls that will ensure that the equipment has been
cleaned properly before it is used to process juice.
For example, if you process milk on equipment also used to process juice,
we recommend that you clean the equipment to eliminate the milk residues
before using the equipment to process juice.
An appropriate SSOP might be to establish a procedure for cleaning your
equipment with a cleaning solution, e.g., a pre-rinse, followed by a caustic
wash, followed by a rinse. The procedure could include maintaining a log of
what foods, e.g., milk, eggnog, soy drinks, were processed on your equipment,
the sequence in which the foods were processed, and how/when the equipment
was cleaned. Your operator could check that log prior to starting any
production run for juice. Your control could provide that the equipment would
not be used for juice until the prescribed cleaning procedure was carried out,
and recorded in the log (See Example SSOP in section VII C). We recommend
that you initially validate the effectiveness of the cleaning procedure by
conducting tests for milk protein residue on the equipment after running the
cleaning. We also recommend that you establish a procedure to monitor the
efficacy of the cleaning process, e.g., swabbing the equipment surfaces and
testing the swabs for milk protein residue.
A CCP procedure could similarly be based upon a pre-rinse, caustic wash,
followed by rinse procedure. We do recommend that the parameters of the
procedure such as time, temperature, and percent caustic, initially be
validated for the effective removal of milk protein from the processing
equipment and monitoring of the parameters as critical limits be carried out
(See Example CCP in section VII C).
Whether an SSOP or a CCP is used, you should consider whether the
equipment's design makes cleaning difficult absent disassembly of the
equipment. If necessary to achieve effective cleaning, we recommend that you
disassemble the equipment as part of the cleaning process.
3. Control Measures for Significant
Physical Hazards
3.1 Glass Fragments
FDA recommends 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.
- 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
- 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.
- 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 re-run through a process that
includes a glass detection step.
3.2 Metal Fragments
- FDA recommends 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.
- 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.
- 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):
- 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.
- 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.
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