not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C)
of the process temperature. Temperature-recording devices that create
multipoint plottings of temperature readings shall record the
temperature at intervals that will assure that the parameters of the
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as
data loggers, that record numbers or create other digital records may
be used. Such a device shall record the temperature at intervals that
will assure that the parameters of the process time and process
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be
adjusted with sufficient frequency to ensure agreement as nearly as
possible with, but to be in no event higher than, the temperature-
indicating device during processing. A means of preventing unauthorized
changes in adjustment shall be provided. A lock or a notice from
management posted at or near the temperature-recording device that
provides a warning that only authorized persons are permitted to make
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may
be combined with the steam controller and may be a combination
recorder-controller. For a vertical retort equipped with a combination
recorder-controller, the temperature recorder-controller sensor shall
be located at the bottom of the retort below the lowest crate rest in
such a position that the steam does not strike it directly. For a
horizontal retort equipped with a combination recorder-controller, the
temperature recorder-controller sensor shall be located between the
water surface and the horizontal plane passing through the center of
the retort so that there is no opportunity for direct steam impingement
on the sensor. For all still retort systems that pressure process in
water and are equipped with combination recorder-controllers, the
temperature recorder-controller sensors shall be located where the
recorded temperature is an accurate measurement of the scheduled
process temperature and is not affected by the heating media.
    (3) Pressure gages. (i) Each retort should be equipped with a
pressure gage that is accurate to 2 pounds per square inch (13.8
kilopascals) or less.
    (ii) Each retort should have an adjustable pressure relief or
control valve of a capacity sufficient to prevent an undesired increase
in retort pressure when the water valve is wide open and should be
installed in the overflow line.
    (4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. The
steam controller may be combined with a temperature-recording device
and, thus, may be a combination recorder-controller. Air-operated
temperature controllers should have adequate filter systems to ensure a
supply of clean, dry air.
    (5) Steam introduction. Steam shall be distributed in the bottom of
the retort in a manner adequate to provide uniform heat distribution
throughout the retort. In vertical retorts, uniform steam distribution
can be achieved by any of several methods. In horizontal retorts, the
steam distributor shall run the length of the bottom of the retort with
perforations distributed uniformly along the upper part of the pipe.
    (6) Crate supports. A bottom crate support shall be used in
vertical still retorts. Baffle plates shall not be used in the bottom
of the retort. Centering guides should be installed so as to ensure
that there is about a 1.5-inch (3.8 centimeters) clearance between the
side wall of the crate and the retort wall.
    (7) Stacking equipment and position of containers. Crates, trays,
gondolas, etc., for holding containers shall be made of strap iron,
adequately perforated sheet metal, or other suitable material. When
perforated sheet metal is used for the bottoms, the perforations should
be approximately the equivalent of 1-inch (2.5 centimeters) holes on 2-
inch (5.1 centimeters) centers. If divider plates are used between the
layers of containers, they should be perforated as stated in this
paragraph. The positioning of containers in the retort, when specified
in the scheduled process, shall be in accordance with that process.
Dividers, racks, trays, or other means of positioning of flexible
containers shall be designed and employed to ensure even circulation of
heating medium around all containers in the retort.
    (8) Drain valve. A nonclogging, water-tight valve shall be used. A
screen shall be installed or other suitable means shall be used on all
drain openings to prevent clogging.
    (9) Air supply and controls. In both horizontal and vertical still
retorts for pressure processing in water, a means shall be provided for
introducing compressed air at the proper pressure and rate. The proper
pressure shall be controlled by an automatic pressure control unit. A
check valve shall be provided in the air supply line to prevent water
from entering the system. Air or water circulation shall be maintained
continuously during the come-up time and during processing and cooling
periods. The adequacy of the air or water circulation for uniform heat
distribution within the retort shall be established in accordance with
procedures recognized by a competent processing authority and records
shall be kept on file. If air is used to promote circulation, it shall
be introduced into the steam line at a point between the retort and the
steam control valve at the bottom of the retort.
    (10) Water level indicator. There shall be a means of determining
the water level in the retort during operation, e.g., by using a
sensor, gage, water glass, or petcock(s). Water shall cover the top

layer of containers during the entire come-up time and processing
periods and should cover the top layer of containers during the cooling
periods. The operator shall check and record the water level at
intervals sufficient to ensure its adequacy.
    (11) Water circulation. When a water circulating system is used for
heat distribution, it shall be installed in such a manner that water
will be drawn from the bottom of the retort through a suction manifold
and discharged through a spreader which extends the length of the top
of the retort. The holes in the water spreader shall be uniformly
distributed and should have an aggregate area not greater than the
cross-sectional area of the outlet line from the pump. The suction
outlets shall be protected with nonclogging screens or other suitable
means shall be used to keep debris from entering the circulating
system. The pump shall be designed to provide proper flow on startup
and during operation, such as with a bleeder or other suitable means to
remove air during startup and with an appropriate device or design to
prevent pump cavitation during operation. The pump shall be equipped
with a signaling device to warn the operator when it is not running.
Alternative methods for circulation of water in the retort may be used
when established by a competent authority as adequate for even heat
distribution.
    (12) Cooling water supply. In vertical retorts, the cooling water
should be introduced at the top of the retort between the water and
container levels. In horizontal retorts the cooling water should be
introduced into the suction side of the pump. A check valve should be
included in the cooling water line.
    (13) Retort headspace. The headspace necessary to control the air
pressure should be maintained between the water level and the top of
the retort shell.
    (14) Vertical and horizontal still retorts. Vertical and horizontal
still retorts should follow the arrangements in the diagrams in this
paragraph. Other installation and operating procedures that deviate
from these arrangements may be used, as long as there is evidence in
the form of heat distribution data or other suitable information, which
shall be kept on file, which demonstrates that the heat distribution is
adequate.
BILLING CODE 4160-01-P

[GRAPHIC] [TIFF OMITTED] TR03MR11.006

BILLING CODE 4160-01-C

Legend for Vertical and Horizontal Still Retorts

A--Water line.
B--Steam line.
C--Temperature control.
D--Overflow line.
E1--Drain line.
E2--Screens.
F--Check valves.
G--Line from hot water storage.
H--Suction line and manifold.
I--Circulating pump.
J--Petcocks.

K--Recirculating line.
L--Steam distributor.
M--Temperature-controller sensor.
N--Temperature-indicating device sensor.
O--Water spreader.
P--Safety valve.
Q--Vent valve for steam processing.
R--Pressure gage.
S--Inlet air control.
T--Pressure control.
U--Air line.
V--To pressure control instrument.
W--To temperature control instrument.
X--Wing nuts.
Y1--Crate support.
Y2--Crate guides.
Z--Constant flow orifice valve.
Z1--Constant flow orifice valve used during come-up.
Z2--Constant flow orifice valve used during cook.

    (15) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process.
    (i) When maximum fill-in or drained weight is specified in the
scheduled process, it shall be measured and recorded at intervals of
sufficient frequency to ensure that the weight of the product does not
exceed the maximum for the given container size specified in the
scheduled process.
    (ii) Closing machine vacuum in vacuum-packed products shall be
observed and recorded at intervals of sufficient frequency to ensure
that the vacuum is as specified in the scheduled process.
    (iii) Such measurements and recordings should be made at intervals
not to exceed 15 minutes.
    (iv) When the product style results in stratification or layering
of the primary product in the containers, the positioning of containers
in the retort shall be according to the scheduled process.
    (c) Equipment and procedures for pressure processing in steam in
continuous agitating retorts--(1) Temperature-indicating device. Each
retort shall be equipped with at least one temperature-indicating
device that accurately indicates the temperature during processing.
Each temperature-indicating device shall have a sensor and a display.
Each temperature-indicating device and each reference device that is
maintained by the processor shall be tested for accuracy against a
reference device for which the accuracy is traceable to a National
Institute of Standards and Technology (NIST), or other national
metrology institute, standard reference device by appropriate standard
procedures, upon installation and at least once a year thereafter, or
more frequently if necessary, to ensure accuracy during processing.
Each temperature-indicating device and each reference device that is
maintained by the processor shall have a tag, seal, or other means of
identity.
    (i) The design of the temperature-indicating device shall ensure
that the accuracy of the device is not affected by electromagnetic
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device
and of a reference device that is maintained by the processor shall be
established and maintained in accordance with Sec.  113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of
graduated scale. A mercury-in-glass thermometer that has a divided
mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it
can be accurately and easily read. The temperature-indicating device
sensor shall be installed either within the retort shell or in external
wells attached to the retort. External wells or pipes shall be
connected to the retort through at least a \3/4\-inch (2 centimeters)
diameter opening and equipped with a \1/16\-inch (1.5 millimeters) or
larger bleeder opening so located as to provide a full flow of steam
past the length of the temperature-indicating device sensor. The
bleeders for external wells shall emit steam continuously during the
entire processing period. The temperature-indicating device--not the
temperature-recording device--shall be the reference instrument for
indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an
accurate temperature-recording device. Each temperature-recording
device shall have a sensor and a mechanism for recording temperatures
to a permanent record, such as a temperature-recording chart. The
temperature-recording device sensor shall be installed either within
the retort shell or in a well attached to the shell. Each temperature-
recording device sensor well shall have a \1/16\-inch (1.5 millimeters)
or larger bleeder that emits steam continuously during the processing
period.
    (i) Analog or graphical recordings. Temperature-recording devices
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the
appropriate chart. Each chart shall have a working scale of not more
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C)
of the process temperature. Temperature-recording devices that create
multipoint plottings of temperature readings shall record the
temperature at intervals that will assure that the parameters of the
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as
data loggers, that record numbers or create other digital records may
be used. Such a device shall record the temperature at intervals that
will assure that the parameters of the process time and process
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be
adjusted with sufficient frequency to ensure agreement as nearly as
possible with, but to be in no event higher than, the temperature-
indicating device during processing. A means of preventing unauthorized
changes in adjustment shall be provided. A lock or a notice from
management posted at or near the temperature-recording device that
provides a warning that only authorized persons are permitted to make
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may
be combined with the steam controller and may be a recorder-controller.
    (3) Pressure gages. Each retort should be equipped with a pressure
gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or
less.
    (4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recorder-controller when combined with a temperature-recording
device. A steam controller activated by the steam pressure of the
retort is acceptable if it is carefully maintained mechanically so that
it operates satisfactorily. Air-operated temperature controllers should
have adequate filter systems to ensure a supply of clean, dry air.
    (5) Bleeders. Bleeders, except those for temperature-indicating
device wells, shall be \1/8\-inch (3 millimeters) or larger and shall
be wide open during the entire process, including the come-up time.
Bleeders shall be located within approximately 1 foot (30.5
centimeters) of the outermost location of containers

at each end along the top of the retort. Additional bleeders shall be
located not more than 8 feet (2.4 meters) apart along the top of the
retort. All bleeders shall be arranged so that the operator can observe
that they are functioning properly. The condensate bleeder shall be
checked with sufficient frequency to ensure adequate removal of
condensate or shall be equipped with an automatic alarm system(s) that
would serve as a continuous monitor of condensate-bleeder functioning.
Visual checks should be done at intervals of not more than 15 minutes.
A record of such checks should be kept to show that the bleeder is
functioning properly.
    (6) Venting and condensate removal. Vents shall be located in that
portion of the retort opposite the steam inlet. Air shall be removed
before processing is started. Heat distribution data or documentary
proof from the manufacturer or from a competent processing authority,
demonstrating that adequate venting is achieved, shall be kept on file.
At the time steam is turned on, the drain should be opened for a time
sufficient to remove steam condensate from the retort, and provision
shall be made for continuing drainage of condensate during the retort
operation. The condensate bleeder in the bottom of the shell serves as
an indicator of continuous condensate removal.
    (7) Retort speed timing. The rotational speed of the retort shall
be specified in the scheduled process. The speed shall be adjusted and
recorded when the retort is started, at any time a speed change is
made, and at intervals of sufficient frequency to ensure that the
retort speed is maintained as specified in the scheduled process. These
adjustments and recordings should be made every 4 hours or less.
Alternatively, a recording tachometer may be used to provide a
continuous record of the speed. A means of preventing unauthorized
speed changes on retorts shall be provided. A lock or a notice from
management posted at or near the speed adjustment device that provides
a warning that only authorized persons are permitted to make
adjustments is a satisfactory means of preventing unauthorized changes.
    (8) Emergency stops. If a retort jams or breaks down during
processing operations, necessitating cooling the retort for repairs,
the retort shall be operated in such a way that ensures that the
product is commercially sterile, or the retort is to be cooled promptly
and all containers either reprocessed, repacked and reprocessed, or
discarded. When operated as a still retort, all containers shall be
given a full still retort process before the retort is cooled. If, in
such an emergency, a scheduled still process or another process
established to ensure commercial sterility is to be used, it shall be
made readily available to the retort operator.
    (i) Any containers in the retort intake valve or in transfer valves
between cooker shells of a continuous retort at the time of breakdown
shall either be reprocessed, repacked and reprocessed, or discarded.
    (ii) Both the time at which the reel stopped and the time the
retort was used for a still retort process, if so used, shall be
indicated on the temperature-recording device record and entered on the
other production records required in this chapter. If the alternative
procedure of prompt cooling is followed, the subsequent handling
methods used for the containers in the retort at the time of stopping
and cooling shall be entered on the production records.
    (9) Temperature drop. If the temperature of the continuous retort
drops below the temperature specified in the scheduled process while
containers are in the retort, the retort reel shall be stopped
promptly. An automatic device should be used to stop the reel when the
temperature drops below the specified process temperature. Before the
reel is restarted, all containers in the retort shall be given a
complete scheduled still retort process if the temperature drop was 10
[deg]F (5 [deg]C) or more below the specified temperature, or
alternatively, container entry to the retort shall be stopped and the
reel restarted to empty the retort. The discharged containers shall be
either reprocessed, repacked and reprocessed, or discarded. Both the
time at which the reel stopped and the time the retort was used for a
still retort process, if so used, shall be indicated on the
temperature-recording device record and entered on the other production
records required in this chapter. If the alternative procedure of
emptying the retort is followed, the subsequent handling methods used
for the containers in the retort at the time of the temperature drop
shall be entered on the production records. If the temperature drop was
less than 10 [deg]F (5 [deg]C), a scheduled authorized emergency still
process approved by a qualified person(s) having expert knowledge of
thermal processing requirements may be used before restarting the
retort reel. Alternatively, container entry to the retort shall be
stopped and an authorized emergency agitating process may be used
before container entry to the retort is restarted. When emergency
procedures are used, no containers may enter the retort and the process
and procedures used shall be noted on the production records.
    (10) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process. The minimum headspace of
containers, if specified in the scheduled process, shall be measured
and recorded at intervals of sufficient frequency to ensure that the
headspace is as specified in the scheduled process. The headspace of
solder-tipped, lapseam (vent hole) cans may be measured by net weight
determinations. The headspace of double seamed cans may also be
measured by net weight determinations for homogenous liquids, taking
into account the specific can end profile and other factors which
affect the headspace, if proof of the accuracy of such measurements is
maintained and the procedure and resultant headspace is in accordance
with the scheduled process. When the product consistency is specified
in the scheduled process, the consistency of the product shall be
determined by objective measurements on the product taken from the
filler before processing and recorded at intervals of sufficient
frequency to ensure that the consistency is as specified in the
scheduled process. Minimum closing machine vacuum in vacuum-packed
products, maximum fill-in or drained weight, minimum net weight, and
percent solids shall be as specified in the scheduled process for all
products when deviations from such specifications may affect the
scheduled process. All measurements and recordings of critical factors
should be made at intervals not to exceed 15 minutes.
    (d) Equipment and procedures for pressure processing in steam in
discontinuous agitating retorts--(1) Temperature-indicating device.
Each retort shall be equipped with at least one temperature-indicating
device that accurately indicates the temperature during processing.
Each temperature-indicating device shall have a sensor and a display.
Each temperature-indicating device and each reference device that is
maintained by the processor shall be tested for accuracy against a
reference device for which the accuracy is traceable to a National
Institute of Standards and Technology (NIST), or other national
metrology institute, standard reference device by appropriate standard
procedures, upon installation and at least once a year thereafter, or
more frequently if necessary, to ensure accuracy during

processing. Each temperature-indicating device and each reference
device that is maintained by the processor shall have a tag, seal, or
other means of identity.
    (i) The design of the temperature-indicating device shall ensure
that the accuracy of the device is not affected by electromagnetic
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device
and of a reference device that is maintained by the processor shall be
established and maintained in accordance with Sec.  113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of
graduated scale. A mercury-in-glass thermometer that has a divided
mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it
can be accurately and easily read. The temperature-indicating device
sensor shall be installed either within the retort shell or in external
wells attached to the retort. External wells or pipes shall be
connected to the retort through at least a \3/4\-inch (2 centimeters)
diameter opening and equipped with a \1/16\-inch (1.5 millimeters) or
larger bleeder opening so located as to provide a full flow of steam
past the length of the temperature-indicating device sensor. The
bleeders for external wells shall emit steam continuously during the
entire processing period. The temperature-indicating device--not the
temperature-recording device--shall be the reference instrument for
indicating the processing temperature.
    (2) Temperature-recording device. Each retort shall have an
accurate temperature-recording device. Each temperature-recording
device shall have a sensor and a mechanism for recording temperatures
to a permanent record, such as a temperature-recording chart. The
temperature-recording device sensor shall be installed either within
the retort shell or in a well attached to the shell. Each temperature-
recording device sensor well shall have a \1/16\-inch (1.5 millimeters)
or larger bleeder that emits steam continuously during the processing
period.
    (i) Analog or graphical recordings. Temperature-recording devices
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the
appropriate chart. Each chart shall have a working scale of not more
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C)
of the process temperature. Temperature-recording devices that create
multipoint plottings of temperature readings shall record the
temperature at intervals that will assure that the parameters of the
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as
data loggers, that record numbers or create other digital records may
be used. Such a device shall record the temperature at intervals that
will assure that the parameters of the process time and process
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be
adjusted with sufficient frequency to ensure agreement as nearly as
possible with, but to be in no event higher than, the temperature-
indicating device during processing. A means of preventing unauthorized
changes in adjustment shall be provided. A lock or a notice from
management posted at or near the temperature-recording device that
provides a warning that only authorized persons are permitted to make
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may
be combined with the steam controller and may be a recorder-controller.
    (3) Pressure gages. Each retort should be equipped with a pressure
gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or
less.
    (4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recorder-controller when combined with a temperature-recording
device. A steam controller activated by the steam pressure of the
retort is acceptable if it is mechanically maintained so that it
operates satisfactorily. Air-operated temperature controllers should
have adequate filter systems to ensure a supply of clean, dry air.
    (5) Bleeders. Bleeders, except those for temperature-indicating
device wells, shall be \1/8\-inch (3 millimeters) or larger and shall
be wide open during the entire process, including the come-up time.
Bleeders shall be located within approximately 1 foot (30.5
centimeters) of the outermost location of containers, at each end along
the top of the retort; additional bleeders shall be located not more
than 8 feet (2.4 meters) apart along the top. Bleeders may be installed
at positions other than those specified in this paragraph, as long as
there is evidence in the form of heat distribution data that they
accomplish adequate removal of air and circulation of heat within the
retort. In retorts having top steam inlet and bottom venting, a bleeder
shall be installed in the bottom of the retort to remove condensate.
All bleeders shall be arranged in a way that enables the operator to
observe that they are functioning properly.
    (6) Venting and condensate removal. The air in each retort shall be
removed before processing is started. Heat distribution data or
documentary proof from the manufacturer or from a competent processing
authority, demonstrating that adequate venting is achieved, shall be
kept on file. At the time steam is turned on, the drain should be
opened for a time sufficient to remove steam condensate from the retort
and provision should be made for continuing drainage of condensate
during the retort operation.
    (7) Retort speed timing. The rotational speed of the retort shall
be specified in the scheduled process. The speed shall be adjusted, as
necessary, to ensure that the speed is as specified in the scheduled
process. The rotational speed as well as the process time shall be
recorded for each retort load processed. Alternatively, a recording
tachometer may be used to provide a continuous record of the speed. A
means of preventing unauthorized speed changes on retorts shall be
provided. A lock or a notice from management posted at or near the
speed-adjustment device that provides a warning that only authorized
persons are permitted to make adjustments is a satisfactory means of
preventing unauthorized changes.
    (8) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process. The minimum headspace of
containers in each retort load to be processed, if specified in the
scheduled process, shall be measured and recorded at intervals of
sufficient frequency to ensure that the headspace is as specified in
the scheduled process. The headspace of solder-tipped, lap seam (vent
hole) cans may be measured by net weight determinations. When the
product consistency is specified in the scheduled process, the
consistency of the product shall be determined by objective
measurements on the product taken from the filler before processing and
recorded at intervals of sufficient frequency to ensure that the
consistency

is as specified in the scheduled process. Minimum closing machine
vacuum in vacuum-packed products, maximum fill-in or drained weight,
minimum net weight, and percent solids shall be as specified in the
scheduled process for all products for which deviations from such
specifications may affect the scheduled process. All measurements and
recordings of critical factors should be made at intervals not to
exceed 15 minutes.
    (e) Equipment and procedures for pressure processing in water in
discontinuous agitating retorts--(1) Temperature-indicating device.
Each retort shall be equipped with at least one temperature-indicating
device that accurately indicates the temperature during processing.
Each temperature-indicating device shall have a sensor and a display.
Each temperature-indicating device and each reference device that is
maintained by the processor shall be tested for accuracy against a
reference device for which the accuracy is traceable to a National
Institute of Standards and Technology (NIST), or other national
metrology institute, standard reference device by appropriate standard
procedures, upon installation and at least once a year thereafter, or
more frequently if necessary, to ensure accuracy during processing.
Each temperature-indicating device and each reference device that is
maintained by the processor shall have a tag, seal, or other means of
identity.
    (i) The design of the temperature-indicating device shall ensure
that the accuracy of the device is not affected by electromagnetic
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device
and of a reference device that is maintained by the processor shall be
established and maintained in accordance with Sec.  113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of
graduated scale. A mercury-in-glass thermometer that has a divided
mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it
can be accurately and easily read. In both horizontal and vertical
retorts, the temperature-indicating device sensor shall be inserted
directly into the retort shell or in a separate well or sleeve attached
to the retort. The temperature-indicating device sensor shall be
located so that it is beneath the surface of the water throughout the
process and where there is adequate circulation to ensure accurate
temperature measurement. On horizontal retorts, the temperature-
indicating device sensor should be located in the side at the center of
the retort. The temperature-indicating device--not the temperature-
recording device--shall be the reference instrument for indicating the
processing temperature.
    (2) Temperature-recording device. Each retort shall have an
accurate temperature-recording device. Each temperature-recording
device shall have a sensor and a mechanism for recording temperatures
to a permanent record, such as a temperature-recording chart. The
temperature-recording device sensor shall be installed either within
the retort shell or in a well attached to the shell.
    (i) Analog or graphical recordings. Temperature-recording devices
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the
appropriate chart. Each chart shall have a working scale of not more
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C)
of the process temperature. Temperature-recording devices that create
multipoint plottings of temperature readings shall record the
temperature at intervals that will assure that the parameters of the
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as
data loggers, that record numbers or create other digital records may
be used. Such a device shall record the temperature at intervals that
will assure that the parameters of the process time and process
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be
adjusted with sufficient frequency to ensure agreement as nearly as
possible with, but to be in no event higher than, the temperature-
indicating device during processing. A means of preventing unauthorized
changes in adjustment shall be provided. A lock or a notice from
management posted at or near the temperature-recording device that
provides a warning that only authorized persons are permitted to make
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may
be combined with the steam controller and may be a recorder-controller.
Air-operated temperature controllers should have adequate filter
systems to ensure a supply of clean, dry air.
    (3) Pressure gages. Each retort should be equipped with a pressure
gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or
less.
    (4) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recorder-controller when combined with a temperature-recording
device. Air-operated temperature controllers should have adequate
filter systems to ensure a supply of clean, dry air.
    (5) Retort speed timing. The rotational speed of the retort shall
be specified in the scheduled process. The speed shall be adjusted, as
necessary, to ensure that the speed is as specified in the scheduled
process. The rotational speed as well as the process time shall be
recorded for each retort load processed. Alternatively, a recording
tachometer may be used to provide a continuous record of the speed. A
means of preventing unauthorized speed changes shall be provided. A
lock or a notice from management posted at or near the speed adjustment
device that provides a warning that only authorized persons are
permitted to make adjustment is a satisfactory means of preventing
unauthorized changes.
    (6) Air supply and controls. When air is used to provide
overpressure:
    (i) A means shall be provided for introducing compressed air at the
proper pressure and rate. The proper pressure shall be controlled by an
automatic pressure control unit. A check valve shall be provided in the
air supply line to prevent water from entering the system.
    (ii) A water level indicator, e.g., sensor, gage, water glass, or
petcock(s), shall be used for determining the water level in the retort
during operation. Water shall cover the top layer of containers during
the entire come-up time and processing periods and should also cover
the top layer of containers during the cooling periods. The operator
shall check and record the water level at intervals sufficient to
ensure its adequacy.
    (7) Water circulation. When a water circulating system is used for
heat distribution, it shall be installed in such a manner that water
will be drawn from the bottom of the retort through a suction manifold
and discharged through a spreader which extends the length of the top
of the retort. The holes in the water spreader shall be uniformly
distributed and should have an

aggregate area not greater than the cross-sectional area of the outlet
line from the pump. The suction outlets shall be protected with
nonclogging screens or other suitable means shall be used to keep
debris from entering the circulating system. The pump shall be designed
to provide proper flow on startup and during operation, such as with a
bleeder or other suitable means to remove air during startup and with
an appropriate device or design to prevent pump cavitation during
operation. The pump shall be equipped with a signaling device to warn
the operator when it is not running. Alternative methods for
circulation of water in the retort may be used when established by a
competent authority as adequate for even heat distribution.
    (8) Drain valve. A nonclogging, water-tight valve shall be used. A
screen shall be installed or other suitable means shall be used on all
drain openings to prevent clogging.
    (9) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process. The minimum headspace of
containers, if specified in the scheduled process, shall be measured
and recorded at intervals of sufficient frequency to ensure that the
headspace is as specified in the scheduled process. The headspace of
solder-tipped, lap seam (vent hole) cans may be measured by net weight
determinations. When the product consistency is specified in the
scheduled process, the consistency of the product shall be determined
by objective measurements on the product taken from the filler before
processing and recorded at intervals of sufficient frequency to ensure
that the consistency is as specified in the scheduled process. Minimum
closing machine vacuum in vacuum-packed products, maximum fill-in or
drained weight, minimum net weight, and percent solids shall be as
specified in the scheduled process for all products when deviations
from such specifications may affect the scheduled process. All
measurements and recordings of critical factors should be made at
intervals not to exceed 15 minutes.
    (f) Equipment and procedures for pressure processing in steam in
hydrostatic retorts--(1) Temperature-indicating device. Each retort
shall be equipped with at least one temperature-indicating device that
accurately indicates the temperature during processing. Each
temperature-indicating device shall have a sensor and a display. Each
temperature-indicating device and each reference device that is
maintained by the processor shall be tested for accuracy against a
reference device for which the accuracy is traceable to a National
Institute of Standards and Technology (NIST), or other national
metrology institute, standard reference device by appropriate standard
procedures, upon installation and at least once a year thereafter, or
more frequently if necessary, to ensure accuracy during processing.
Each temperature-indicating device and each reference device that is
maintained by the processor shall have a tag, seal, or other means of
identity.
    (i) The design of the temperature-indicating device shall ensure
that the accuracy of the device is not affected by electromagnetic
interference and environmental conditions.
    (ii) Records of the accuracy of the temperature-indicating device
and of a reference device that is maintained by the processor shall be
established and maintained in accordance with Sec.  113.100(c) and (d).
    (iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired before further use or replaced.
    (iv) A temperature-indicating device shall be accurate to 1 [deg]F
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of
graduated scale. A mercury-in-glass thermometer that has a divided
mercury column shall be considered defective.
    (v) Each temperature-indicating device shall be installed where it
can be accurately and easily read. The temperature-indicating device
sensor shall be located in the steam dome near the steam-water
interface. When the scheduled process specifies maintenance of
particular temperatures in the hydrostatic water legs, a temperature-
indicating device sensor shall be located in each hydrostatic water leg
in a position near the bottom temperature-recording device sensor. The
temperature-indicating device--not the temperature-recording device--
shall be the reference instrument for indicating the processing
temperature.
    (2) Temperature-recording device. Each retort shall have an
accurate temperature-recording device. Each temperature-recording
device shall have a sensor and a mechanism for recording temperatures
to a permanent record, such as a temperature-recording chart. The
temperature-recording device sensor shall be installed either within
the steam dome or in a well attached to the dome. Each temperature-
recording device sensor well shall have a \1/16\-inch (1.5 millimeters)
or larger bleeder that emits steam continuously during the processing
period. Additional temperature-recording device sensors shall be
installed in the hydrostatic water legs in situations where the
scheduled process specifies maintenance of particular temperatures in
the hydrostatic water legs.
    (i) Analog or graphical recordings. Temperature-recording devices
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the
appropriate chart. Each chart shall have a working scale of not more
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20
[deg]F (10 [deg]C) of the process temperature. Chart graduations shall
not exceed 2 [deg]F (1 [deg]C) within a range of 10 [deg]F (5 [deg]C)
of the process temperature. Temperature-recording devices that create
multipoint plottings of temperature readings shall record the
temperature at intervals that will assure that the parameters of the
process time and process temperature have been met.
    (ii) Digital recordings. Temperature-recording devices, such as
data loggers, that record numbers or create other digital recordings
may be used. Such a device shall record the temperature at intervals
that will assure that the parameters of the process time and process
temperature have been met.
    (iii) Adjustments. The temperature-recording device shall be
adjusted with sufficient frequency to ensure agreement as nearly as
possible with, but to be in no event higher than, the temperature-
indicating device during processing. A means of preventing unauthorized
changes in adjustment shall be provided. A lock or a notice from
management posted at or near the temperature-recording device that
provides a warning that only authorized persons are permitted to make
adjustments is a satisfactory means of preventing unauthorized changes.
    (iv) Temperature controller. The temperature-recording device may
be combined with the steam controller and may be a recorder-controller.
    (3) Pressure gages. Each retort should be equipped with a pressure
gage that is accurate to 2 pounds per square inch (13.8 kilopascals) or
less.
    (4) Recording of temperatures. Temperatures indicated by the
temperature-indicating device or devices shall be entered on a suitable
form during processing operations. Temperatures shall be recorded by an
accurate temperature-recording device or devices at the following
points:

    (i) In the steam chamber between the steam-water interface and the
lowest container position.
    (ii) Near the top and the bottom of each hydrostatic water leg if
the scheduled process specifies maintenance of particular temperatures
in the legs.
    (5) Steam controller. Each retort shall be equipped with an
automatic steam controller to maintain the retort temperature. This may
be a recorder-controller when combined with a temperature-recording
device. A steam controller activated by the steam pressure of the
retort is acceptable if it is carefully mechanically maintained so that
it operates satisfactorily. Air-operated temperature controllers should
have adequate filter systems to ensure a supply of clean, dry air.
    (6) Venting. Before the start of processing operations, the retort
steam chamber or chambers shall be vented to ensure removal of air.
    (7) Bleeders. Bleeder openings \1/4\-inch (6 millimeters) or larger
shall be located at the top of the steam chamber or chambers opposite
the point of steam entry. Bleeders shall be wide open and shall emit
steam continuously during the entire process, including the come-up
time. All bleeders shall be arranged in such a way that the operator
can observe that they are functioning properly.
    (8) Retort speed. The speed of the container-conveyor chain shall
be specified in the scheduled process and shall be determined and
recorded at the start of processing and at intervals of sufficient
frequency to ensure that the retort speed is maintained as specified.
The speed should be determined and recorded every 4 hours. An automatic
device should be used to stop the chain when the temperature drops
below that specified in the scheduled process. A means of preventing
unauthorized speed changes shall be provided. A lock or a notice from
management posted at or near the speed-adjusting device that provides a
warning that only authorized persons are permitted to make adjustments
is a satisfactory means of preventing unauthorized changes.
    (9) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process.
    (i) When maximum fill-in or drained weight is specified in the
scheduled process, it shall be measured and recorded at intervals of
sufficient frequency to ensure that the weight of the product does not
exceed the maximum for the given container size specified in the
scheduled process.
    (ii) Closing machine vacuum in vacuum-packed products shall be
observed and recorded at intervals of sufficient frequency to ensure
that the vacuum is as specified in the scheduled process.
    (iii) Such measurements and recordings should be made at intervals
not to exceed 15 minutes.
    (g) Aseptic processing and packaging systems--(1) Product
sterilizer--(i) Equipment--(A) Temperature-indicating device. Each
product sterilizer shall be equipped with at least one temperature-
indicating device that accurately indicates the temperature during
processing. Each temperature-indicating device shall have a sensor and
a display. Each temperature-indicating device and each reference device
that is maintained by the processor shall be tested for accuracy
against a reference device for which the accuracy is traceable to a
National Institute of Standards and Technology (NIST), or other
national metrology institute, standard reference device by appropriate
standard procedures, upon installation and at least once a year
thereafter, or more frequently if necessary, to ensure accuracy during
processing. Each temperature-indicating device and each reference
device that is maintained by the processor shall have a tag, seal, or
other means of identity.
    (1) The design of the temperature-indicating device shall ensure
that the accuracy of the device is not affected by electromagnetic
interference and environmental conditions.
    (2) Records of the accuracy of the temperature-indicating device
and of a reference device that is maintained by the processor shall be
established and maintained in accordance with Sec.  113.100(c) and (d).
    (3) A temperature-indicating device that is defective or cannot be
adjusted to the accurate calibrated reference device shall be repaired
before further use or replaced.
    (4) A temperature-indicating device shall be accurate to 1 [deg]F
(0.5 [deg]C). The temperature range of a mercury-in-glass thermometer
shall not exceed 17 [deg]F per inch (4 [deg]C per centimeter) of
graduated scale. A mercury-in-glass thermometer that has a divided
mercury column shall be considered defective.
    (5) Each temperature-indicating device shall be installed where it
can be accurately and easily read. The temperature-indicating device--
not the temperature-recording device--shall be the reference instrument
for indicating the processing temperature.
    (B) Temperature-recording device. Each product sterilizer shall
have an accurate temperature-recording device. Each temperature-
recording device shall have a sensor and a mechanism for recording
temperatures to a permanent record, such as a temperature-recording
chart. A temperature-recording device sensor shall be installed in the
product at the holding-tube outlet between the holding tube and the
inlet to the cooler. Additional temperature-recording device sensors
shall be located at each point where temperature is specified as a
critical factor in the scheduled process.
    (1) Analog or graphical recordings. Temperature-recording devices
that create analog or graphical recordings may be used. Temperature-
recording devices that record to charts shall be used only with the
appropriate chart. Each chart shall have a working scale of not more
than 55 [deg]F per inch (12 [deg]C per centimeter) within a range of 20
[deg]F (10 [deg]C) of the desired product sterilization temperature.
Chart graduations shall not exceed 2 [deg]F (1 [deg]C) within a range
of 10 [deg]F (5 [deg]C) of the process temperature. Temperature-
recording devices that create multipoint plottings of temperature
readings shall record the temperature at intervals that will assure
that the parameters of the process time and process temperature have
been met.
    (2) Digital recordings. Temperature-recording devices, such as data
loggers, that record numbers or create other digital recordings may be
used. Such a device shall record the temperature at intervals that will
assure that the parameters of the process time and process temperature
have been met.
    (3) Adjustments. The temperature-recording device shall be adjusted
with sufficient frequency to ensure agreement as nearly as possible
with, but to be in no event higher than, the temperature-indicating
device during processing. A means of preventing unauthorized changes in
adjustment shall be provided. A lock or a notice from management posted
at or near the temperature-recording device that provides a warning
that only authorized persons are permitted to make adjustments is a
satisfactory means of preventing unauthorized changes.
    (C) Temperature controller. An accurate temperature controller
shall be installed and capable of ensuring that the desired product
sterilization temperature is maintained. Air-operated temperature
controllers should have adequate filter systems to ensure a supply of
clean, dry air.
    (D) Product-to-product regenerators. When a product-to-product
regenerator

is used to heat the cold unsterilized product entering the sterilizer
by means of a heat exchange system, it shall be designed, operated, and
controlled so that the pressure of the sterilized product in the
regenerator is greater than the pressure of any unsterilized product in
the regenerator to ensure that any leakage in the regenerator is from
the sterilized product into the unsterilized product.
    (E) Differential pressure recorder-controller. When a product-to-
product regenerator is used, it shall be equipped with an accurate
differential pressure recorder-controller. The differential pressure
recorder-controller shall be accurate to within 2 pounds per square
inch (13.8 kilopascals). One pressure sensor shall be installed at the
sterilized product regenerator outlet and the other pressure sensor
shall be installed at the unsterilized product regenerator inlet. The
sensor and recorder of the differential pressure recorder-controller
shall be tested for accuracy against an accurate reference device upon
installation and at least once every 3 months of operation thereafter,
or more frequently if necessary, to ensure its accuracy.
    (1) Analog or graphical recordings. Differential pressure recorder-
controllers that create analog or graphical recordings may be used.
Differential pressure recorder-controllers that record to charts shall
be used only with the appropriate chart. The scale divisions of the
chart shall not exceed 2 pounds per square inch (13.8 kilopascals) on a
working scale of not more than 20 pounds per square inch per inch of
scale (55 kilopascals per centimeter).
    (2) Digital recordings. Differential pressure recorder-controllers,
such as data loggers, that record numbers or create other digital
recordings may be used. Such differential pressure recorder-controllers
shall record the differential pressure at intervals that will assure
that the minimum differential pressure is maintained.
    (F) Flow control. A flow control device shall be located upstream
from the holding tube and shall be operated to maintain the required
rate of product flow. A means of preventing unauthorized flow
adjustments shall be provided. A lock or a notice from management
posted at or near the flow controlling device that provides a warning
that only authorized persons are permitted to make adjustments is a
satisfactory means of preventing unauthorized changes.
    (G) Product holding tube. The product-sterilizing holding tube
shall be designed to give continuous holding of every particle of food
for at least the minimum holding time specified in the scheduled
process. The holding tube shall be designed so that no portion of the
tube between the product inlet and the product outlet can be heated,
and it must be sloped upward at least \1/4\-inch per foot (2.1
centimeters per meter).
    (H) Flow-diversion systems. If a processor elects to install a
flow-diversion system, it should be installed in the product piping
located between the product cooler and the product filler or aseptic
surge tank and should be designed to divert flow away from the filler
or aseptic surge tank automatically. Controls and/or warning systems
should be designed and installed with necessary sensors and actuators
to operate whenever the sterilizing temperature in the holding tube or
pressure differential in the product regenerator drops below specified
limits. Flow-diversion systems should be designed and operated in
accordance with recommendations of an aseptic processing and packaging
authority.
    (I) Equipment downstream from the holding tube. Product coolers,
aseptic surge tanks, or any other equipment downstream from the holding
tube, with rotating or reciprocating shafts, valve stems, instrument
connections, or other such points, are subject to potential entry of
microorganisms into the product. Such locations in the system should be
equipped with steam seals or other effective barriers at the potential
access points. Appropriate means should be provided to permit the
operator to monitor the performance of the seals or barriers during
operations.
    (ii) Operation--(A) Startup. Before the start of aseptic processing
operations the product sterilizer and all product-contact surfaces
downstream shall be brought to a condition of commercial sterility.
    (B) Temperature drop in product-sterilizing holding tube. When
product temperature in the holding tube drops below the temperature
specified in the scheduled process, product flow should be diverted
away from the filler or aseptic surge tank by means of a flow-diversion
system. If for any reason product subjected to a temperature drop below
the scheduled process is filled into containers, the product shall be
segregated from product that received the scheduled process. The
processing deviation shall be handled in accordance with Sec.  113.89.
The product holding tube and any further system portions affected shall
be returned to a condition of commercial sterility before product flow
is resumed to the filler or to the aseptic surge tank.
    (C) Loss of proper pressures in the regenerator. When a regenerator
is used, the product may lose sterility whenever the pressure of
sterilized product in the regenerator is less than 1 pound per square
inch (6.9 kilopascals) greater than the pressure of unsterilized
product in the regenerator. In this case, product flow should be
diverted away from the filler or aseptic surge tank by means of the
flow-diversion system. If for any reason the product is filled into
containers, the product shall be segregated from product that received
the scheduled process. The processing deviation shall be handled in
accordance with Sec.  113.89. Product flow to the filler or to the
aseptic surge tank shall not be resumed until the cause of the improper
pressure relationships in the regenerator has been corrected and the
affected system(s) has been returned to a condition of commercial
sterility.
    (D) Loss of sterile air pressure or other protection level in the
aseptic surge tank. When an aseptic surge tank is used, conditions of
commercial sterility may be lost when the sterile air overpressure or
other means of protection drops below the scheduled process value.
Product flow to and/or from the aseptic surge tank shall not be resumed
until the potentially contaminated product in the tank is removed, and
the aseptic surge tank has been returned to a condition of commercial
sterility.
    (E) Records. Readings at the following points shall be observed and
recorded at the start of aseptic packaging operations and at intervals
of sufficient frequency to ensure that these values are as specified in
the scheduled process: Temperature-indicating device in holding tube
outlet; temperature-recording device in holding tube outlet;
differential pressure recorder-controller, if a product-to-product
regenerator is used; product flow rate as established by the flow
control device or as determined by filling and closing rates and, if an
aseptic surge tank is used, sterile air pressure or other protection
means; and proper performance of steam seals or other similar devices.
The measurements and recordings should be made at intervals not to
exceed 1 hour.
    (2) Container sterilizing, filling, and closing operation--(i)
Equipment--(A) Recording device. The container and closure
sterilization system and product filling and closing system shall be
implemented to demonstrate that the required sterilization is being
accomplished continuously. Recording devices shall be used to record,
when applicable, the sterilization media flow rates, temperature,
concentration, or other factors. When a batch system is

used for container sterilization, the sterilization conditions shall be
recorded.
    (B) Timing method(s). A method(s) shall be used either to give the
retention time of containers, and closures if applicable, in the
sterilizing environment specified in the scheduled process, or to
control the sterilization cycle at the rate specified in the scheduled
process. A means of preventing unauthorized speed changes must be
provided. A lock or a notice from management posted at or near the
speed adjusting device that provides a warning that only authorized
persons are permitted to make adjustments is a satisfactory means of
preventing unauthorized changes.
    (ii) Operation--(A) Startup. Before the start of packaging
operations, both the container and closure sterilizing system and the
product filling and closing system shall be brought to a condition of
commercial sterility.
    (B) Loss of sterility. A system shall be provided to stop packaging
operations, or alternatively to ensure segregation of any product
packaged when the packaging conditions fall below scheduled processes.
Compliance with this requirement may be accomplished by diverting
product away from the filler, by preventing containers from entering
the filler, or by other suitable means. In the event product is
packaged under conditions below those specified in the scheduled
process, all such product shall be segregated from product that
received the scheduled process. The processing deviation shall be
handled in accordance with Sec.  113.89. In the event of loss of
sterility, the system(s) shall be returned to a condition of commercial
sterility before resuming packaging operations.
    (C) Records. Observations and measurements of operating conditions
shall be made and recorded at intervals of sufficient frequency to
ensure that commercial sterility of the food product is being achieved;
such measurements shall include the sterilization media flow rates,
temperatures, the container and closure rates (if applicable) through
the sterilizing system, and the sterilization conditions if a batch
system is used for container sterilization. The measurements and
recordings should be made at intervals not to exceed 1 hour.
    (3) Incubation. Incubation tests should be conducted on a
representative sample of containers of product from each code; records
of the test results should be maintained.
    (4) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process. Such measurements and
recordings should be done at intervals not to exceed 15 minutes.
    (h) Equipment and procedures for flame sterilizers. The container
conveyor speed shall be specified in the scheduled process. The
container conveyor speed shall be measured and recorded at the start of
operations and at intervals of sufficient frequency to ensure that the
conveyor speed is as specified in the scheduled process. Such
measurements and recordings should be done at 1-hour intervals.
Alternatively, a recording tachometer may be used to provide a
continuous record of the speed. A means of preventing changes in flame
intensity and unauthorized speed changes on the conveyor shall be
provided. A lock or a notice from management posted at or near the
speed adjusting device that provides a warning that only authorized
persons are permitted to make adjustments is a satisfactory means of
preventing unauthorized changes. The surface temperature of at least
one container from each conveyor channel shall be measured and recorded
at the entry and at the end of the holding period at intervals of
sufficient frequency to ensure that the temperatures specified in the
scheduled process are maintained. Such measurements and recordings
should be done at intervals not to exceed 15 minutes.
    (1) Process interruption. In the event of process interruption
wherein the temperature of the product may have dropped, an authorized,
scheduled emergency plan approved by a qualified person having expert
knowledge of the process requirements may be used.
    (2) Critical factors. Critical factors specified in the scheduled
process shall be measured and recorded on the processing record at
intervals of sufficient frequency to ensure that the factors are within
the limits specified in the scheduled process.
    (i) Equipment and procedures for thermal processing of foods
wherein critical factors such as water activity are used in conjunction
with thermal processing. The methods and controls used for the
manufacture, processing, and packing of such foods shall be as
established in the scheduled process and shall be operated or
administered in a manner adequate to ensure that the product is safe.
The time and temperature of processing and other critical factors
specified in the scheduled process shall be measured with instruments
having the accuracy and dependability adequate to ensure that the
requirements of the scheduled process are met. All measurements shall
be made and recorded at intervals of sufficient frequency to ensure
that the critical factors are within the limits specified in the
scheduled process.
    (j) Other systems. All systems, whether or not specifically
mentioned in this part, for the thermal processing of low-acid foods in
hermetically sealed containers shall conform to the applicable
requirements of this part and the methods and controls used for the
manufacture, processing, and packing of these foods shall be as
established in the scheduled process. These systems shall be operated
or administered in a manner adequate to ensure that commercial
sterility is achieved. Critical factors specified in the scheduled
process shall be measured and recorded at intervals of sufficient
frequency to ensure that the critical factors are within the limits
specified in the scheduled process.

0
3. Amend Sec.  113.60 by revising paragraph (d) to read as follows:

Sec.  113.60  Containers.

* * * * *
    (d) Postprocess handling. Container handling equipment used in
handling filled containers shall be designed, constructed, and operated
to preserve the can seam or other container closure integrity.
Container handling equipment, including automated and non-automated
equipment, shall be checked with sufficient frequency and repaired or
replaced as necessary to prevent damage to containers and container
closures. When cans are handled on belt conveyors, the conveyors should
be constructed to minimize contact by the belt with the double seam,
i.e., cans should not be rolled on the double seam. All worn and frayed
belting, can retarders, cushions, etc. should be replaced with new
nonporous material. All tracks and belts that come into contact with
the can seams should be thoroughly scrubbed and sanitized at intervals
of sufficient frequency to avoid product contamination.

0
4. Revise Sec.  113.83 to read as follows:

Sec.  113.83  Establishing scheduled processes.

    Scheduled processes for low-acid foods shall be established by
qualified persons having expert knowledge of thermal processing
requirements for low-acid foods in hermetically sealed containers and
having adequate facilities for making such determinations. The type,
range, and combination of variations encountered in commercial
production shall be

adequately provided for in establishing the scheduled process.
Variations include those that occur due to seasonal or growing
fluctuations, variety differences, supplier processes, reprocessing,
and mixing a batch of processed product with the same unprocessed
product before it is processed. Critical factors, e.g., minimum
headspace, consistency, maximum fill-in or drained weight,
aw, etc., that may affect the scheduled process, shall be
specified in the scheduled process. Acceptable scientific methods of
establishing heat sterilization processes shall include, when
necessary, but shall not be limited to, the use of microbial thermal
death time data, process calculations based on product heat penetration
data, and inoculated packs. Calculation shall be performed according to
procedures recognized by competent processing authorities. If
incubation tests are necessary for process confirmation, they shall
include containers from test trials and from actual commercial
production runs during the period of instituting the process. The
incubation tests for confirmation of the scheduled processes should
include the containers from the test trials and a number of containers
from each of four or more actual commercial production runs. The number
of containers from actual commercial production runs should be
determined on the basis of recognized scientific methods to be of a
size sufficient to ensure the adequacy of the process. Complete records
covering all aspects of the establishment of the process and associated
incubation tests shall be prepared and shall be permanently retained by
the person or organization making the determination.

0
5. Amend Sec.  113.87 by revising paragraphs (b), (c), and (e) to read
as follows:

Sec.  113.87  Operations in the thermal processing room.

* * * * *
    (b) A system for product traffic control in the retort room shall
be established to prevent unretorted product from bypassing the retort
process. Each retort basket, truck, car, or crate used to hold
containers in a retort, or one or more containers therein, shall, if it
contains any retorted food product, be plainly and conspicuously marked
with a heat-sensitive indicator, or by other effective means that will
indicate visually, to thermal processing personnel, those units that
have been retorted. A visual check shall be performed to determine
whether or not the appropriate change has occurred in the heat-
sensitive indicator as a result of retorting for all retort baskets,
trucks, cars, or crates, to ensure that each unit of product has been
retorted. A record of these checks should be made.
    (c) The initial temperature of the contents of the containers to be
processed shall be accurately determined and recorded with sufficient
frequency to ensure that the temperature of the product is no lower
than the minimum initial temperature specified in the scheduled
process. For those operations that use water during the filling of the
retort or during processing, provision shall be made to ensure that the
water will not, before the start of each thermal process, lower the
initial temperature of the product below that specified in the
scheduled process. The temperature-indicating device used to determine
the initial temperature shall be tested for accuracy against a
reference device for which the accuracy is traceable to a National
Institute of Standards and Technology (NIST), or other national
metrology institute, standard reference device, by appropriate standard
procedures, with sufficient frequency to ensure that initial
temperature measurements are accurate. Records of the accuracy of the
temperature-indicating device and of a reference device that is
maintained by the processor shall be established and maintained in
accordance with Sec.  113.100(c) and (d).
* * * * *
    (e) Clock times on temperature-recording device records shall
reasonably correspond to the time of day on the processing records to
provide correlation of these records.
* * * * *

0
6. Section 113.100 is amended by:
0
a. Revising paragraphs (a) introductory text, (a)(4), (b);
0
b. Redesignating paragraphs (c), (d), and (e), as paragraphs (e), (f),
and (g), respectively;
0
c. Adding new paragraphs (c), (d), and (h); and
0
d. Revising newly redesignated paragraph (e).
    The revisions and additions read as follows:

Sec.  113.100  Processing and production records.

    (a) Processing and production information shall be entered at the
time it is observed by the retort or processing system operator, or
other designated person, on forms that include the product, the code
number, the date, the retort or processing system number, the size of
container, the approximate number of containers per coding interval,
the initial temperature, the actual processing time, the temperature-
indicating device and temperature-recording device readings, and other
appropriate processing data. Closing machine vacuum in vacuum-packed
products, maximum fill-in or drained weight, or other critical factors
specified in the scheduled process shall also be recorded. In addition,
the following records shall be maintained:
* * * * *
    (4) Aseptic processing and packaging systems. Product temperature
in the holding tube outlet as indicated by the temperature-indicating
device and the temperature-recording device; differential pressure as
indicated by the differential pressure recorder-controller, if a
product-to-product regenerator is used; product flow rate, as
determined by the flow controlling device or by filling and closing
rates; sterilization media flow rate or temperature or both; retention
time of containers, and closures when applicable, in the sterilizing
environment; and, when a batch system is used for container and/or
closure sterilization, sterilization cycle times and temperatures.
* * * * *
    (b) Temperature-recording device records shall be identified by
date, retort number, and other data as necessary, so they can be
correlated with the record of lots processed. Each entry on the
processing and production records shall be made by the retort or
processing system operator, or other designated person, at the time the
specific retort or processing system condition or operation occurs, and
this retort or processing system operator or other designated person
shall sign or initial each record form. Not later than 1 working day
after the actual process, and before shipment or release for
distribution, a representative of plant management who is qualified by
suitable training or experience shall review all processing and
production records for completeness and to ensure that the product
received the scheduled process. The records, including temperature-
recording device records, shall be signed or initialed and dated by the
reviewer.
    (c) Records of the accuracy of a temperature-indicating device
shall include:
    (1) A reference to the tag, seal, or other means of identity used
by the processor to identify the temperature-indicating device;
    (2) The name of the manufacturer of the temperature-indicating
device;
    (3) The identity of the reference device, equipment, and procedures
used for the accuracy test and to adjust the

temperature-indicating device or, if an outside facility is used to
conduct the accuracy test for the temperature-indicating device, a
guarantee, certificate of accuracy, certificate of calibration, or
other document from the facility that includes a statement or other
documentation regarding the traceability of the accuracy to a National
Institute of Standards and Technology (NIST) or other national
metrology institute standard;
    (4) The identity of the person or facility that performed the
accuracy test and adjusted or calibrated the temperature-indicating
device;
    (5) The date and results of each accuracy test, including the
amount of calibration adjustment; and
    (6) The date on or before which the next accuracy test must be
performed.
    (d) Records of the accuracy of a reference device maintained by the
processor shall include:
    (1) A reference to the tag, seal, or other means of identity used
by the processor to identify the reference device;
    (2) The name of the manufacturer of the reference device;
    (3) The identity of the equipment and reference to procedures used
for the accuracy test and to adjust or calibrate the reference device
or, if an outside facility is used to conduct the accuracy test for the
reference device, a guarantee, certificate of accuracy, certificate of
calibration, or other document from the facility that includes a
statement or other documentation regarding the traceability of the
accuracy to a NIST or other national metrology institute standard;
    (4) The identity of the person or facility that performed the
accuracy test and adjusted or calibrated the reference device;
    (5) The date and results of each accuracy test, including the
amount of calibration adjustment; and
    (6) The date on or before which the next accuracy test must be
performed.
    (e) Records of all container closure examinations shall specify the
product code, the date and time of container closure inspections, the
measurements obtained, and all corrective actions taken. Records shall
be signed or initialed by the container closure inspector and reviewed
by management with sufficient frequency to ensure that the containers
are hermetically sealed. The records shall be signed or initialed and
dated by the reviewer.
* * * * *
    (h) Records of this part may be maintained electronically, provided
they are in compliance with part 11 of this chapter.

    Dated: February 23, 2011.
David Dorsey,
Acting Deputy Commissioner for Policy, Planning and Budget.
[FR Doc. 2011-4475 Filed 3-2-11; 8:45 am]
BILLING CODE 4160-01-P


[Federal Register Volume 80, Number 92 (Wednesday, May 13, 2015)]
[Notices]
[Pages 27322-27323]
[FR Doc No: 2015-11527]

-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2000-D-0598 (Formerly 2000D-1631)]

International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products (VICH
GL23(R)); Studies To Evaluate the Safety of Residues of Veterinary
Drugs in Human Food: Genotoxicity Testing; Revised Guidance for
Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a revised guidance for industry (GFI) #116 entitled
``Studies to Evaluate the Safety of Residues of Veterinary Drugs in
Human Food: Genotoxicity Testing'' (VICH GL23(R)). This revised
guidance has been developed for veterinary use by the International
Cooperation on Harmonisation of Technical Requirements for Registration
of Veterinary Medicinal Products (VICH). In this VICH guidance, the
recommendation for a second test to evaluate the potential of a
chemical to produce chromosomal effects is revised. The revised
guidance indicates that the potential of a chemical to produce
chromosomal effects can be evaluated using one of the following three
tests: (1) An in vitro chromosomal aberrations test using metaphase
analysis, which detects both clastogenicity and aneugenicity; (2) an in
vitro mammalian cell micronucleus test, which detects the activity of
clastogenicity and aneugenicity; or (3) a mouse lymphoma test, which,
with modification, can detect both gene mutation and chromosomal
damage. This revised VICH guidance document is intended to facilitate
the mutual acceptance of safety data necessary for the establishment of
acceptable daily intakes for veterinary drug residues in human food by
the relevant regulatory authorities.

DATES: Submit either electronic or written comments on Agency guidance
at any time.

ADDRESSES: Submit written requests for single copies of the revised
guidance to the Policy and Regulations Staff (HFV-6), Center for
Veterinary Medicine, Food and Drug Administration, 7519 Standish Pl.,
Rockville, MD 20855. Send one self-addressed adhesive label to assist
that office in processing your request. See the SUPPLEMENTARY
INFORMATION section for electronic access to the revised guidance
document.
    Submit electronic comments on the revised guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Tong Zhou, Center for Veterinary
Medicine (HFV-153), Food and Drug Administration, 7500 Standish Place,
Rockville, MD 20855,<PHONE_NUMBER><EMAIL_ADDRESS>
SUPPLEMENTARY INFORMATION:

I. Background

    In recent years, many important initiatives have been undertaken by
regulatory authorities and industry associations to promote the

international harmonization of regulatory requirements. FDA has
participated in efforts to enhance harmonization and has expressed its
commitment to seek scientifically based, harmonized technical
procedures for the development of pharmaceutical products. One of the
goals of harmonization is to identify, and then reduce, differences in
technical requirements for drug development among regulatory agencies
in different countries.
    FDA has actively participated in the International Conference on
Harmonisation of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) for several years to develop
harmonized technical requirements for the approval of human
pharmaceutical and biological products among the European Union, Japan,
and the United States. The VICH is a parallel initiative for veterinary
medicinal products. The VICH is concerned with developing harmonized
technical requirements for the approval of veterinary medicinal
products in the European Union, Japan, and the United States, and
includes input from both regulatory and industry representatives.
    The VICH Steering Committee is composed of member representatives
from the European Commission, European Medicines Evaluation Agency,
European Federation of Animal Health, Committee on Veterinary Medicinal
Products, FDA, the U.S. Department of Agriculture, the Animal Health
Institute, the Japanese Veterinary Pharmaceutical Association, the
Japanese Association of Veterinary Biologics, and the Japanese Ministry
of Agriculture, Forestry, and Fisheries.
    Six observers are eligible to participate in the VICH Steering
Committee: One representative from the government of Australia/New
Zealand, one representative from the industry in Australia/New Zealand,
one representative from the government of Canada, one representative
from the industry of Canada, one representative from the government of
South Africa, and one representative from the industry of South Africa.
The VICH Secretariat, which coordinates the preparation of
documentation, is provided by the International Federation for Animal
Health (IFAH). An IFAH representative also participates in the VICH
Steering Committee meetings.
    In the Federal Register of March 5, 2013 (78 FR 14306), FDA
published a notice of availability for a draft revised guidance
document entitled ``Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food: Genotoxicity Testing'' (VICH GL23(R))
giving interested persons until May 6, 2013, to comment on the draft
revised guidance. FDA received one comment on the draft revised
guidance, and that comment, as well as those received by other VICH
member regulatory agencies, were considered as the guidance was
finalized. The guidance announced in this document finalizes the draft
revised guidance dated March 5, 2013. The revised guidance is a product
of the Safety Expert Working Group of the VICH.
    This revised VICH guidance document recommends a second test to
evaluate the potential of a chemical to produce chromosomal effects.
The revised VICH guidance indicates that the potential of a chemical to
produce chromosomal effects can be evaluated using one of the following
three tests: (1) An in vitro chromosomal aberrations test using
metaphase analysis, which detects both clastogenicity and aneugenicity;
(2) an in vitro mammalian cell micronucleus test, which detects the
activity of clastogenicity and aneugenicity; or (3) a mouse lymphoma
test, which, with modification, can detect both gene mutation and
chromosomal damage. This revised VICH guidance is intended to
facilitate the mutual acceptance of safety data necessary for the
establishment of acceptable daily intakes for veterinary drug residues
in human food by the relevant regulatory authorities. The objective of
this revised VICH guidance is to ensure international harmonization of
genotoxicity testing.

II. Significance of Guidance

    This guidance, developed under the VICH process, is being issued
consistent with FDA's good guidance practices regulation (21 CFR
10.115). This guidance represents the current thinking of FDA on this
topic. It does not establish any rights for any person and is not
binding on FDA or the public. You can use an alternative approach if it
satisfies the requirements of the applicable statutes and regulations.

III. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR part 514 have been approved under
OMB control number 0910-0032.

IV. Comments

    Interested persons may submit either electronic comments regarding
this document to http://www.regulations.gov or written comments to the
Division of Dockets Management (see ADDRESSES). It is only necessary to
send one set of comments. Identify comments with the docket number
found in brackets in the heading of this document. Received comments
may be seen in the Division of Dockets Management between 9 a.m. and 4
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

VI. Electronic Access

    Persons with access to the Internet may obtain the revised guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

    Dated: May 7, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-11527 Filed 5-12-15; 8:45 am]
 BILLING CODE 4164-01-P