Federal Register, Volume 72 Issue 49 (Wednesday, March 14, 2007)

[Federal Register Volume 72, Number 49 (Wednesday, March 14, 2007)]
[Proposed Rules]
[Pages 11990-12024]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 07-1172]

[[Page 11989]]

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Part III

Department of Health and Human Services

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Food and Drug Administration

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21 CFR Part 113

Temperature-Indicating Devices; Thermally Processed Low-Acid Foods
Packaged in Hermetically Sealed Containers; Proposed Rule

Federal Register / Vol. 72, No. 49 / Wednesday, March 14, 2007 /
Proposed Rules

[[Page 11990]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 113

[Docket No. 2007N-0026]

Temperature-Indicating Devices; Thermally Processed Low-Acid
Foods Packaged in Hermetically Sealed Containers

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to amend
its regulations for thermally processed low-acid foods packaged in
hermetically sealed containers to allow for use of other temperature-
indicating devices, in addition to mercury-in-glass thermometers,
during processing. FDA also is proposing to establish recordkeeping
requirements relating to temperature-indicating devices and to clarify
other aspects of low-acid canned food processing such as FDA's
interpretation of some requirements of the current regulations that
will, in part, allow the use of advanced technology for measuring and
recording temperatures during processing. Finally, FDA is proposing to
include metric equivalents of avoirdupois (U.S.) measurements where
appropriate.

DATES: Submit written or electronic comments on the proposed rule by
June 12, 2007. Submit comments regarding the information collection by
April 13, 2007, to the Office of Management and Budget (OMB) (see
ADDRESSES).

ADDRESSES: You may submit comments, identified by Docket No. 2007N-
0026, by any of the following methods:
Electronic Submissions
Submit electronic comments in the following ways:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Agency Web site: http://www.fda.gov/dockets/ecomments.
Follow the instructions for submitting comments on the agency Web site.
Written Submissions
Submit written submissions in the following ways:
FAX: 301-827-6870.
Mail/Hand delivery/Courier [For paper, disk, or CD-ROM
submissions]: Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
To ensure more timely processing of comments, FDA is no longer
accepting comments submitted to the agency by e-mail. FDA encourages
you to continue to submit electronic comments by using the Federal
eRulemaking Portal or the agency Web site, as described previously, in
the ADDRESSES portion of this document under Electronic Submissions.
Instructions: All submissions received must include the agency name
and docket number for this rulemaking. All comments received may be
posted without change to http://www.fda.gov/ohrms/dockets/default.htm,
including any personal information provided. For additional information
on submitting comments, see the ``Comments'' heading of the
SUPPLEMENTARY INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.fda.gov/ohrms/dockets/default.htm
and insert the docket number, found in brackets in the heading of this
document, into the ``Search'' box and follow the prompts and/or go to
the Division of Dockets Management, 5630 Fishers Lane, rm. 1061,
Rockville, MD 20852.
Information Collection Provisions: Submit written comments on the
information collection provisions to the Office of Information and
Regulatory Affairs, OMB. To ensure that comments on the information
collection are received, OMB recommends that written comments be faxed
to the Office of Information and Regulatory Affairs, OMB, Attn: FDA
Desk Officer, FAX: 202-395-6974.

FOR FURTHER INFORMATION CONTACT: Mischelle B. Ledet, Center for Food
Safety and Applied Nutrition (HFS-615), Food and Drug Administration,
5100 Paint Branch Pkwy., College Park, MD 20740, 301-436-2359.

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Background
II. Legal Authority
III. Proposed Rule
A. Equipment and Procedures (Sec. 113.40)
B. Containers (Sec. 113.60)
C. Establishing Scheduled Processes (Sec. 113.83)
D. Operations in the Thermal Processing Room (Sec. 113.87)
E. Processing and Production Records (Sec. 113.100)
F. Minor Revisions in Regulations
G. Immediate Implementation of Proposed Rule
IV. Analysis of Impacts
A. Preliminary Regulatory Impact Analysis: Flexibility in
Permitting Alternative Temperature-Indicating Devices
B. Regulatory Flexibility Analysis
C. Unfunded Mandate Analysis
V. Environmental Impact
VI. Paperwork Reduction Act
VII. Federalism
VIII. Comments
IX. References

I. Background

In the Federal Register of January 24, 1973 (38 FR 2398), FDA (we)
issued a final rule entitled ``Thermally Processed Low-Acid Food
Packaged in Hermetically Sealed Containers'' (low-acid canned foods)
(the 1973 final rule), part 113 (21 CFR part 113)\1\, which, among
other things, provides for the use of an ``indicating mercury-in-glass
thermometer'' for equipment and procedures for the following: (1)
Pressure processing in steam in still retorts (Sec. 113.40(a)), (2)
pressure processing in water in still retorts (Sec. 113.40(b)), (3)
pressure processing in steam in continuous agitating retorts (Sec.
113.40(c)), (4) pressure processing in steam in discontinuous agitating
retorts (Sec. 113.40(d)), (5) pressure processing in water in
discontinuous agitating retorts (Sec. 113.40(e)), (6) pressure
processing in steam in hydrostatic retorts (Sec. 113.40(f)), and (7)
aseptic processing and packaging systems (Sec. 113.40(g)). In
addition, aseptic processing systems (Sec. 113.40(g)) can be equipped
with a mercury-in-glass thermometer or an equivalent temperature-
indicating device, such as a thermocouple-recorder.
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\1\The low-acid canned food regulations (21 CFR part 128b) were
recodified as part 113 on March 15, 1977 (42 FR 14302). The
regulations were subsequently amended on March 16, 1979 (44 FR
16209) and June 11, 1997 (62 FR 31721).
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The 1973 final rule also established requirements for containers
(Sec. 113.60), requirements for establishing scheduled processes
(Sec. 113.83), and requirements for operations in the thermal
processing room (Sec. 113.87). The 1973 final rule also established
requirements for processing and production records, which include
requirements for maintaining records of mercury-in-glass thermometer
and recording thermometer readings (Sec. 113.100).
In the preamble to the 1973 final rule, FDA stated that two
comments on a tentative final order, published November 14, 1972 (37 FR
24117), ``recommended that provisions be made [in the final rule] for
the use of temperature[-]indicating devices other than mercury-in-glass
thermometers.''

[[Page 11991]]

FDA responded, ``The Commissioner [of Food and Drugs] has determined
that the mercury-in-glass thermometer is the recognized standard
against which all other temperature[-]indicating devices are checked
and calibrated. The regulation * * * retains the requirement that all
retorts be equipped with mercury-in-glass indicating thermometers.
However, because of the speed of the thermal process, alternate
temperature[-]indicating devices such as thermocouples will be allowed
in aseptic processing and packaging systems'' (38 FR 2398 at 2400).
Since publication of the 1973 final rule, FDA has received various
requests to permit use of alternative temperature-indicating devices or
to permit entry into the United States of low-acid canned foods that
were processed in countries that permit alternative temperature-
indicating devices to be used during processing. In responding to such
requests, FDA expressed concern about whether the devices were reliable
and maintained accuracy under actual plant operation conditions. FDA
also requested additional information relating to reliability and
accuracy, including evidence to show that, if the device does not
maintain its accuracy, this fact would become immediately known by the
operator and would not result in underprocessed food.
FDA is aware that technological advancements in thermometry have
been made since publication of the low-acid canned food regulations in
1973 and that temperature-indicating devices other than mercury-in-
glass thermometers are now available that may be appropriate for use in
thermal processing of low-acid foods. FDA also is aware, specifically
for low-acid canned food manufacturers, of traditional concerns about
ensuring that mercury from broken mercury-in-glass thermometers does
not contaminate the food or the processing environment. FDA recognizes
that the industry must proceed cautiously to transition from mercury-
in-glass thermometers to alternative technology to ensure that accuracy
and ability to function properly during processing are not compromised
by replacing mercury-in-glass thermometers with alternative
temperature-indicating devices. As with mercury-in-glass thermometers,
manufacturers who use alternative temperature-indicating devices must
conduct appropriate tests and implement procedures to ensure that the
device is accurate during processing and does not result in
underprocessed foods. Thus, although FDA supports elimination of
mercury from the processing environment and encourages industry to take
necessary and appropriate steps to transition from mercury-in-glass
thermometers to alternative temperature-indicating devices, the agency
also recognizes that it may not be practical for all manufacturers to
make this transition. Accordingly, FDA is proposing to revise
regulations in part 113 to permit industry use of temperature-
indicating devices, including mercury-in-glass thermometers, and to
require maintenance of records associated with ensuring that
temperature-indicating devices are accurate during processing.
FDA also is aware that the regulations from the 1973 final rule
include outdated terminology and that some of the provisions are
unclear. FDA is proposing to update and clarify these sections of the
regulations. FDA also is proposing to clarify and establish
recordkeeping requirements relating to ensuring the accuracy of
temperature-indicating devices.

II. Legal Authority

FDA is proposing these regulations under sections 402(a)(3) and
(a)(4) of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C.
342(a)(3) and (a)(4)). In addition, FDA is proposing these regulations
under section 361 of the Public Health Service Act (the PHS Act) (42
U.S.C. 264) that relates to communicable disease. Under section
402(a)(3) of the act, a food is deemed adulterated ``if it consists in
whole or in part of any filthy, putrid, or decomposed substance, or if
it is otherwise unfit for food.'' Under section 402(a)(4) of the act, a
food is adulterated ``if it has been prepared, packed, or held under
insanitary conditions whereby it may have become contaminated with
filth, or whereby it may have been rendered injurious to health.''
A commercial processor engaged in the thermal processing of low-
acid foods packaged in hermetically sealed containers must provide FDA
with information about its scheduled process that includes processing
method, type of retort or other thermal processing equipment employed,
minimum initial temperatures, times and temperatures of processing,
sterilizing value or other equivalent scientific evidence of processing
adequacy, critical control factors affecting heat penetration, and
source and date of the establishment of the process for each low-acid
food in each container size (21 CFR 108.35(c)(2)). The scheduled
process is designed to achieve commercial sterility. Commercial
sterility relates to conditions achieved through the application of
heat to render the food free of certain microorganisms capable of
reproducing under normal non-refrigerated conditions of storage and
distribution and viable microorganisms of public health significance
(Sec. 113.3(e)). Adhering to the scheduled process is important for
preventing growth in the food of microorganisms, such as Clostridium
botulinum. Clostridium botulinum produces a neurotoxin that causes
botulism, a communicable disease that can result in paralysis and death
(Ref. 1). The failure to use accurate temperature-indicating devices,
and other measures clarified in this proposed rule, to ensure that low-
acid foods are processed to achieve commercial sterility is an
insanitary condition and thus renders the food adulterated under
section 402(a)(4) of the act. In addition, such a food is unfit for
food under section 402(a)(3) of the act based on health risks from
insufficient processing.
Under section 701(a) of the act (21 U.S.C. 371(a)), FDA is
authorized to issue regulations for the act's efficient enforcement. A
regulation that requires measures to prevent human food from being
unfit for food and from being held under insanitary conditions allows
for the efficient enforcement of the act. This proposed rule requires
processors of thermally processed low-acid food to establish and
maintain records of the accuracy of the temperature-indicating device
and reference device. Other records relating to processing and
production are currently required in Sec. 113.100. The proposed rule
requires that all records under part 113, whether currently required or
proposed to be required in this proposed rule, be made available to FDA
for inspection and copying.
The proposed rule would require accuracy testing of temperature-
indicating devices against a calibrated 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. Documentation of accuracy of such devices is necessary to
determine, over time, whether each device complies with current
requirements to be accurate during processing and for verifying that
temperatures required by the scheduled process are met during
processing. Further, such documentation is necessary for evaluating the
performance of temperature-indicating devices that are technologically
and operationally different from mercury-in-glass thermometers
traditionally used in processing low-acid canned food. The records of
accuracy testing for each temperature-indicating device and reference
device will be linked to each

[[Page 11992]]

such device through the accuracy records so that the processor will be
able to ensure that temperature-indicating devices and reference
devices are tested as often as needed and will provide a means for the
processor to quickly identify and correct problems that may occur.
Without records documenting accuracy testing of temperature-indicating
devices and reference devices, processors would not know whether they
are adulterating their products. Therefore, a failure of processors to
establish and maintain these records results in thermally processed
low-acid canned food being prepared under insanitary conditions whereby
the food may have been rendered injurious to health.
Because FDA cannot continuously observe processors' operations, the
records for accuracy, and other records currently required for
processing and production, are essential for FDA to know whether
processors have complied with the current good manufacturing practice
requirements in part 113. FDA may consider it necessary to copy records
when, for example, our investigator may need assistance in reviewing a
certain record from relevant experts in headquarters. If we are unable
to copy the records, we would have to rely solely on our investigator's
notes and reports when drawing conclusions. In addition, copying
records will facilitate followup regulatory actions. We have
tentatively concluded that the ability to access and copy the records
is necessary to provide FDA with an enforceable regulation that will
ensure public health protection. Thus, the recordkeeping requirements
and access to such records would be necessary to the efficient
enforcement of the act. Under the proposed rule, the failure to comply
with the recordkeeping requirements would render the food adulterated
under section 402(a)(4) of the act.
In addition, FDA has authority under section 361 of the PHS Act to
make and enforce such regulations as ``are necessary to prevent the
introduction, transmission, or spread of communicable disease from
foreign countries into the States * * * or from one State * * * into
any other State'' (section 361(a) of the PHS Act). A low-acid canned
food that is not processed to achieve commercial sterility may become
contaminated with microorganisms such as Clostridium botulinum.
Clostridium botulinum produces a neurotoxin which, when ingested,
causes botulism. Botulism is a communicable disease that is
characterized by the rapid onset of paralysis. If untreated, this
paralysis can lead to death (Ref. 1). As explained previously in this
document, processing and production records required by part 113, and
those proposed in this rule related to accuracy testing, are necessary
to ensure that low-acid foods are prepared in a manner that will
prevent the spread of communicable disease. Section 361 of the PHS Act
provides FDA with the authority to institute recordkeeping
requirements, including access to such records to enable FDA to ensure
that low-acid foods are being processed in a manner to prevent the
spread of communicable disease. For these reasons, and for the reasons
stated previously in this document for access and copying of records to
provide for an enforceable regulation that will ensure public health
protection, we have tentatively concluded that the recordkeeping
requirements are necessary to prevent the spread of communicable
disease.

III. Proposed Rule

A. Equipment and Procedures (Sec. 113.40)

1. Temperature-Indicating Devices
Current Sec. 113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), and
(f)(1) require that retorts used for processing low-acid foods shall be
equipped with at least one mercury-in-glass thermometer. FDA is
proposing to revise the regulations to provide for use of temperature-
indicating devices that accurately indicate the temperature during
thermal processing. Accordingly, FDA is replacing the terms ``mercury-
in-glass thermometer'' and ``thermometer'' with ``temperature-
indicating device,'' as appropriate. Current Sec. 113.40(g)(1) already
allows for use of temperature-indicating devices for aseptic processing
of low-acid foods. However, FDA is proposing revisions in Sec.
113.40(g)(1) similar to proposed Sec. 113.40(a)(1), (b)(1), (c)(1),
(d)(1), (e)(1), and (f)(1) to ensure consistency in terminology,
interpretation, and application of all provisions of the regulation
that allow for use of temperature-indicating devices.
The term ``temperature-indicating device'' includes mercury-in-
glass thermometers. The proposed rule provides for use of temperature-
indicating devices for the following purposes: (1) Pressure processing
in steam in still retorts, (2) pressure processing in water in still
retorts, (3) pressure processing in steam in continuous agitating
retorts, (4) pressure processing in steam in discontinuous agitating
retorts, (5) pressure processing in water in discontinuous agitating
retorts, (6) pressure processing in steam in hydrostatic retorts, and
(7) aseptic processing and packaging. Processors are responsible for
ensuring that the temperature-indicating device is accurate during
processing.
FDA is proposing that temperature-indicating devices shall be
tested for accuracy against an ``accurate calibrated reference device''
upon installation and at least once a year thereafter, or more
frequently if necessary, to ensure accuracy during processing.
Currently, mercury-in-glass thermometers must be tested for accuracy
against a ``known accurate standard thermometer'' upon installation and
at least once a year thereafter, or more frequently if necessary. FDA
is proposing to require similar tests for accuracy for all temperature-
indicating devices. Traditionally, a ``known accurate standard
thermometer'' was a mercury-in-glass thermometer that had been
calibrated against an instrument that was traceable to a National
Institute of Standards and Technology (NIST) standard or according to
other standard calibration procedures that assured accuracy at the time
the thermometer was used as the ``standard.'' These thermometers are
often referred to as ``reference devices.'' (NIST is a non-regulatory
Federal agency that develops and promotes measurement, standards, and
technology to enhance productivity, facilitate trade, and improve the
quality of life.) FDA is proposing to replace the term ``known accurate
standard thermometer'' with the broader term ``accurate calibrated
reference device'' to recognize that reference or ``standard'' devices
other than mercury-in-glass thermometers are available and may be used
for determining accuracy.
FDA is proposing that the design of the temperature-indicating
device shall ensure that the accuracy of the device is not affected by
electromagnetic interference and environmental conditions. Although
electromagnetic energy does not affect the accuracy of mercury-in-glass
thermometers, temperature-indicating devices with electronic or
electromagnetic components are vulnerable and must be designed to
ensure that they are resistant to electromagnetic interference.
Environmental conditions, such as humidity, vibrations, and air
pressure, which may affect the accuracy or performance of the
temperature-indicating device, also must be identified and controlled,
to the extent necessary, to ensure that the temperature-indicating
device is accurate during processing. The current regulations
indirectly address control of the impact of environmental conditions on
mercury-in-glass thermometers by requiring calibration ``at least once
a

[[Page 11993]]

year * * * or more frequently if necessary, to ensure their accuracy''
(Sec. 113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), (f)(1), and
(g)(1)(i)(a)) and by requiring that a mercury-in-glass thermometer that
has a ``divided mercury column or that cannot be adjusted to the
standard shall be repaired or replaced before further use of the
retort'' (Sec. 113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), and
(f)(1); similar requirement in Sec. 113.40(g)(1)(i)(a)). The design of
the mercury-in-glass thermometer makes it relatively easy to detect a
malfunction, including those caused by environmental conditions,
because most are associated with a broken thermometer, separated
column, or scale slippage. However, malfunction of other temperature-
indicating devices may need to be detected by means other than
observation. For example, a temperature-indicating device could be
designed with a dual probe sensor that would enable detection of loss
of accuracy of one of the probes when the probe readings do not agree.
FDA recommends, but is not proposing to require, a dual probe design.
FDA recognizes that specific design specifications for temperature-
indicating devices may limit the flexibility of the regulation for
current and future technologies. Design specificity in the regulation
is not practical because of the diversity of technology associated with
temperature-indicating devices that have been or may be developed and
because, for each type of temperature-indicating device, different
factors or parameters may need to be addressed by design. Rather, the
proposed regulation would require that the design of the temperature-
indicating device ensure that the accuracy of the device is not
affected by electromagnetic interference and environmental conditions.
Thus, the processor is responsible for ensuring that the temperature-
indicating device is designed so that its accuracy during processing is
not compromised due to electromagnetic interference or environmental
conditions and that any malfunctions in the device that may affect
accuracy will be immediately detectable.
2. Documentation and Records
Current Sec. 113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), and
(f)(1) recommend, but do not specifically require, maintenance of
records of accuracy checks. These regulations indicate that the records
should specify the date, standard used, method used, and person
performing the test. The regulations also recommend, but do not
require, that each thermometer should have a tag, seal, or other means
of identity that includes the date on which it was last tested for
accuracy. Similar provisions in current Sec. 113.40(g)(1)(i)(a) apply
to maintenance of records of accuracy checks and to establishing a
means of identity for ``thermometers and temperature-indicating
devices.'' However, establishment and maintenance of records of the
accuracy of each temperature-indicating device are essential for
documenting accuracy of temperature-indicating devices throughout time,
for determining that each temperature-indicating device complies with
current requirements to be accurate during processing, and for
verifying that temperatures required by the scheduled process are met.
Further, such documentation is necessary for evaluating the performance
of temperature-indicating devices that are technologically and
operationally different from mercury-in-glass thermometers
traditionally used in processing low-acid canned food.
FDA is proposing to require that each temperature-indicating device
have a tag, seal, or other means of identity that will be used by the
processor to identify the temperature-indicating device and that each
reference device have a tag, seal, or other means of identity that will
be used by the processor to identify the reference device. FDA is
proposing to eliminate the current recommendation in Sec.
113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), (f)(1), and (g)(1)(i)(a)
to include on the tag or seal the date on which each thermometer was
last tested for accuracy. FDA does not object to recording the accuracy
test date on the tag or seal. However, as discussed later in this
document, FDA is proposing to require that the date of the last
accuracy test be included as part of the record of accuracy for the
temperature-indicating device. FDA believes this proposed change
clarifies the process for assuring that the written record of the
accuracy test can be linked to the appropriate temperature-indicating
device.
FDA is proposing that a written record of accuracy for each
temperature-indicating device shall be established and maintained.
Documentation of the accuracy of each temperature-indicating device
shall include the following information: (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
used for the accuracy test; (4) the identity of the equipment and
procedures used to adjust or calibrate the temperature-indicating
device; (5) the date and results of each accuracy test; (6) the name of
the person or facility that performed the accuracy test and adjusted or
calibrated the temperature-indicating device; and (7) the date of the
next scheduled accuracy test. Reference to the temperature-indicating
device identity in the record of accuracy provides an essential link
between each temperature-indicating device and the specific record
associated with that device. The name of the manufacturer enables the
processor to readily identify the source of the defective or deficient
device and to correct or replace the device, as appropriate.
Identification of the reference device used for the accuracy check and
of the equipment and procedures used to adjust or calibrate the
temperature-indicating device provides an essential reference for
additional followup in the event the reference device is subsequently
determined to be inaccurate. Documentation of the date and results of
accuracy tests provides evidence that scheduled tests were performed
and is essential for evaluating performance of the temperature-
indicating device over time. This information can be used to determine
whether more frequent accuracy tests are needed and whether a
temperature-indicating device needs to be replaced. Documentation of
the identification of the person or facility that performed the
accuracy test and adjusted or recalibrated the temperature-indicating
device is essential for appropriate followup in the event that the
temperature-indicating device subsequently is determined to be
inaccurate.
These records are necessary to ensure that appropriate accuracy
checks are performed for each temperature-indicating device, to
establish the appropriate frequency for accuracy checks, to identify
when there is a problem with a temperature-indicating device and, as
necessary, to repair or replace the device, and to determine and
initiate appropriate followup to ensure that low-acid canned foods are
appropriately processed. Because it is not possible for FDA to
continuously observe processors' operations, these records are
essential to ensure that the agency has the information needed to
identify noncompliance and to bring a non-compliant processor into
compliance. Thus, these records are essential for FDA to have an
enforceable regulation that will ensure public health protection.
Current Sec. 113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), and
(f)(1) require that thermometers (and temperature-indicating devices in
Sec. 113.40(g)(1)(i)(a)) shall be tested for accuracy against a

[[Page 11994]]

known accurate standard thermometer. This requirement implies, but does
not explicitly state, that the processor must be able to demonstrate,
by appropriate documentation, that the reference or standard device
used to determine the accuracy of the thermometers used to measure
temperature during processing also is accurate. Thus, although the
current regulations require documentation of the accuracy of the
standard thermometer, the specific documentation FDA expects processors
to maintain is not clear. FDA is proposing to clarify this requirement
by specifying that a written record of the accuracy of the reference
device shall be established and maintained. Documentation of the
accuracy of the reference device must include the following
information: (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 procedures used to test the accuracy and to adjust
or calibrate the reference device; (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 the accuracy test;
and (6) the traceability information. Traceability, as defined by the
International Vocabulary of Basic and General Terms in Metrology, means
a ``property of the result of a measurement or the value of a standard
whereby it can be related to stated references, usually national or
international standards, through an unbroken chain of comparisons all
having stated uncertainties'' (Ref. 2). Accordingly, records must be
maintained to document that the accuracy of the reference device can be
traced by comparison with a standard device, such as a NIST standard
temperature device. Documentation of the traceability information for
the reference device may be in the form of a guaranty of accuracy from
the manufacturer of the reference device or a certificate of
calibration from a laboratory. Information required in the record of
accuracy for a reference device is essential for assuring that
reference devices maintain their accuracy and ensures that the
processor can establish an unbroken chain to trace the accuracy of the
reference device to a standard device.
The requirements in proposed Sec. 113.40(a)(1), (b)(1), (c)(1),
(d)(1), (e)(1), (f)(1), and (g)(1)(i)(a) to establish and maintain
written records of accuracy of temperature-indicating devices and
reference devices, which include the identity of temperature-indicating
devices and reference devices, are subject to the recordkeeping
requirements of Sec. 113.100. See the discussion later in this
document relating to proposed revisions to Sec. 113.100.
FDA is proposing to revise Sec. 113.40(g)(1)(ii)(e) by removing
the requirement to observe and record the product temperature in the
temperature recorder-controller at the final heater outlet in aseptic
processing and packaging systems. The temperature in the final heater
outlet may not be a critical factor in the scheduled process and,
therefore, may not require maintenance of records. However, if the
final heater outlet temperature is identified as a critical factor in
the scheduled process, the temperature must be observed and recorded,
as required in Sec. 113.100(a).
3. Metric Equivalents
FDA is proposing to revise Sec. 113.40(a), (b), (c), (d), (e),
(f), and (g) to provide metric equivalents of avoirdupois (U.S.)
measurements. Currently, these regulations express temperature
measurements in Fahrenheit ([deg]F) units, length measurements in
inches and feet, and pressure measurements in pounds per square inch.
The proposed metric equivalents are provided in parenthesis in the text
of the proposed regulation, immediately following the avoirdupois
measurement. FDA is proposing to modify the current regulations to not
only provide the temperature measurements in Fahrenheit, but to follow
the Fahrenheit ([deg]F) measure with the units in Celsius ([deg]C). FDA
is proposing to provide measurements currently in inches also in
millimeters or centimeters, measurements currently in feet also in
centimeters or meters, and measurements in pounds per square inch of
pressure also in kilopascals.
4. Temperature-Recording Devices
Current Sec. 113.40(a)(2), (b)(2), (c)(2), (d)(2), (e)(2), (f)(2),
and (g)(1)(i)(b) states that, ``Graduations on the temperature-
recording devices shall not exceed 2 [deg]F within a range of 10 [deg]F
of the processing temperature. Each chart shall have a working scale of
not more than 55 [deg]F per inch within a range of 20 [deg]F of the
processing temperature. The temperature chart shall be adjusted to
agree as nearly as possible with, but to be in no event higher than,
the known accurate mercury-in-glass thermometer during the process
time.'' When the regulations were published in the 1973 final rule,
temperature-recording devices generally recorded temperatures to paper
charts and the paper charts served as the historical record of
temperatures during processing. At that time, the terms ``temperature-
recording device'' and ``recording chart'' were used interchangeably.
However, because of advancements in technology, temperatures may now be
recorded in a format other than the traditional chart that has a pre-
printed time and temperature scale and may be recorded and maintained
by mechanisms or devices other than recorders that use the traditional
recording charts. The permanent record of temperatures may be in the
form of an analog or graphical recording, such as a traditional chart
with pre-printed time and temperature scale. The permanent record also
may be an analog or graphical recording, for which the chart design,
continuous temperature recordings or tracings, and date and time
notations may be generated and printed by the temperature-recording
device onto a blank paper, chart, or other medium as they are generated
by the temperature-recording device. Processors also are using
temperature-recording devices, such as data loggers, that record
numbers or create other digital recordings at established intervals,
rather than providing continuous recordings on a chart. Therefore, FDA
recognizes that the term ``temperature-recording device'' does not
necessarily imply that temperatures are being recorded to a
``temperature-recording chart.'' Thus, the ``graduation'' and ``working
scale'' requirements in the current regulation do not apply to all
temperature-recording device records. The general term ``temperature-
recording device'' should be used when referring to the entire device
that records temperatures and the term ``temperature-recording chart''
should be used when referring to an actual chart that constitutes the
mechanism by which the temperature-recording device records processing
temperatures. The ``graduation'' and ``working scale'' requirements
specified in the current regulation are still applicable to the
``temperature-recording chart,'' when used as the mechanism for
recording processing temperatures.
FDA, therefore, is proposing to revise Sec. 113.40(a)(2), (b)(2),
(c)(2), (d)(2), (e)(2), (f)(2), and (g)(1)(i)(b) to provide flexibility
for processors to use temperature-recording device advanced technology,
to update terminology to reflect current and appropriate use of terms
such as ``temperature-recording device'' and ``temperature-recording
chart,'' to replace the terms ``mercury-in-glass thermometer'' and

[[Page 11995]]

``thermometer'' with ``temperature-indicating device,'' to replace the
term ``bulb'' with ``sensor'' (discussed later in this document), and
to clarify the requirements for temperature-recording devices and the
records created by the devices as follows:
Temperature-recording device. Each retort, or product sterilizer,
shall have an accurate temperature-recording device that records
temperatures to a permanent record, such as a temperature-recording
chart.
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.
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.
5. Sensors
FDA is proposing to revise Sec. 113.40(a), (b), (c), (d), (e),
(f), and (g)(1) by replacing the term ``bulb'' or ``bulb or sensor''
with the general term ``sensor'' when referring generally to the
sensing element of temperature-indicating devices, temperature-
recording devices, and temperature-controlling devices. The sensing
element of a mercury-in-glass thermometer is called a ``bulb'' in the
current regulations. The term ``sensor'' encompasses ``bulb'' as well
as other types of temperature-indicating device sensing elements, which
are not bulbs. In the proposed regulation, the inclusive term
``sensor'' is used when referring to the sensor portion of a
temperature-indicating device, which may be the bulb of a mercury-in
glass thermometer, or to the sensing element or probe of a temperature-
recording device or temperature-controlling device, which may include a
mercury-in-glass thermometer as a component of the device.
FDA is proposing to revise Sec. 113.40(b)(2) to clarify that, for
still retort systems that pressure process in water and are equipped
with combination recorder-controller sensors, 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. Current Sec. 113.40(b)(2) indicates
specific requirements for placement of sensors for recorder-
controllers, as follows: ``The recording-thermometer bulb should be
located adjacent to the bulb of the mercury-in-glass thermometer,
except in the case of a vertical retort equipped with a combination
recorder-controller. In such vertical retorts, the temperature
recorder-control bulb 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. In horizontal retorts, the temperature recorder-
control bulb 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 control bulb.''
These requirements for placement of combination recorder-controller
sensors were intended to ensure accurate measurement of the scheduled
process temperature and were helpful specific directives for sensor
placement when the regulations were published in 1973, based on retort
designs at that time. However, it may be technologically feasible to
comply with the specific requirements of the current regulation, but
place the sensor in a location that does not accurately measure the
scheduled process temperature. Thus, although the specific sensor
location requirements of current Sec. 113.40(b)(2) are still valid,
FDA believes further clarification is needed to ensure that combination
recorder-controller sensors are located where the recorded temperature
is an accurate measurement of the scheduled process temperature and is
not affected by the heating media. FDA is proposing to provide this
clarification in new Sec. 113.40(b)(2)(iv) as follows:
The temperature-recording device may be combined with the
steam controller and may be a combination recording-controlling
instrument. 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. Air-operated
temperature controllers should have adequate filter systems to ensure a
supply of clean, dry air.
FDA is proposing to clarify in Sec. 113.40(b)(9) that a sensor, in
addition to a gage, water glass, or petcock, may be used to determine
the water level in the retort during operation. For some water level
indictors, the term ``sensor'' may more appropriately describe the
mechanism that measures or detects the water level.
FDA is proposing to revise Sec. 113.40(e)(1) to clarify
requirements for placement of sensors of temperature-indicating devices
in discontinuous agitating retorts used for pressure processing in
water, i.e., a water immersion processing system. Current Sec.
113.40(e)(1) requires, ``Bulbs of indicating thermometers shall be
installed either within the retort shell or in external wells attached
to the retort.'' However, this basic, unqualified requirement to place
sensors in the retort shell or in external wells may not be sufficient
to ensure proper placement of temperature-indicating device sensors in
discontinuous agitating retorts used for pressure processing in water.
Current Sec. 113.40(b)(1), relating to pressure processing in water in
still retorts, also a water immersion process, clarifies that, ``Bulbs
of indicating thermometers shall be located in such a position that
they are beneath the surface of the water throughout the process * * *
this entry should be made in the side at the center, and the
thermometer bulb shall be inserted directly into the retort shell * * *
the thermometer bulbs shall extend directly into the water a minimum of
at least 2 inches without a separable well or sleeve.'' This type of
clarification relating to placement of temperature-indicating device
sensors in still retorts used for pressure processing in water also
applies to discontinuous retorts for pressure processing in water.
Thus, FDA is proposing to revise Sec. 113.40(e)(1) (proposed Sec.
113.40(e)(1)(v)) by adding clarifying language relating to temperature-
indicating device sensor

[[Page 11996]]

placement, similar to current Sec. 113.40(b)(1), as follows:
Each temperature-indicating device shall be installed
where it can be accurately and easily read. The sensor of the
temperature-indicating device shall be installed either within the
retort shell or in an external well attached to the retort. Sensors of
temperature-indicating devices shall be located in such a position that
they are beneath the surface of the water throughout the process. This
entry should be made in the side at the center, and the temperature-
indicating device sensor shall be inserted directly into the retort
shell. The temperature-indicating device sensor shall extend directly
into the water a minimum of at least 2 inches (5.1 centimeters) without
a separable well or sleeve. If a separate well or sleeve is used, there
must be adequate circulation to ensure accurate temperature
measurements. The temperature-indicating device--not the temperature-
recording device--shall be the reference instrument for indicating the
processing temperature.
6. Vents
FDA is proposing to revise Sec. 113.40(a)(12) to clarify that the
``installations and operating procedures'' in Sec. 113.40(a)(12)(i)(a)
through (a)(12)(i)(d) and (a)(12)(ii)(a) and (a)(12)(ii)(b) do not
apply to systems that use dividers between layers of containers.
Current Sec. 113.40(a)(12) states, in part, ``Some typical
installations and operating procedures reflecting the requirements of
this section for venting still retorts are given in paragraph
(a)(12)(i)(a) through (a)(12)(i)(d) and (a)(12)(ii)(a) and
(a)(12)(ii)(b) of this section.'' However, the placement of dividers
between layers of containers in a still retort system was not a
``typical installation or operating procedure'' at the time the
regulations were published in 1973. The venting procedures in current
Sec. 113.40(a)(12) were based on heat penetration studies in retort
systems without dividers and may be inadequate when dividers are placed
between layers of containers. The dividers may interfere with heat
distribution. Therefore, use of venting schedules developed for retorts
without dividers may not be appropriate for retorts with dividers
because such schedules may not be adequate to ensure that all areas of
the retort, and thus all containers in the retort, reach the required
processing temperature. FDA is proposing to add the phrase ``without
divider plates'' to the last sentence of Sec. 113.40(a)(12) as
follows:
Some typical installations and operating procedures
reflecting the requirements of this section for venting still retorts
without divider plates are given in paragraph (a)(12)(i)(a) through
(a)(12)(i)(d) and (a)(12)(ii)(a) and (a)(12)(ii)(b) of this section.
As required in current Sec. 113.40(a)(12)(iii), other
installations and operating procedures, such as still retorts with
divider plates, may be used if the processor has evidence, on file, in
the form of heat distribution data that its installations and operating
procedures accomplish adequate venting of air. Such documentation is
likely to include heat distribution studies conducted and documented by
the processor to show that the process temperature will be reached with
the dividers in place.
7. Screens
Current Sec. 113.40(b)(8) states, in part, ``Screens should be
installed over all drain openings.'' Current Sec. 113.40(b)(10)(ii)
states, in part, ``The suction outlets should be protected with
nonclogging screens to keep debris from entering the circulating
system.'' These provisions are intended to advise processors that they
are responsible for evaluating their water circulation systems and for
ensuring that drain openings and suction outlets do not become clogged
and prevent proper water circulation and proper heat distribution.
Although the current regulation is expressed as a recommendation,
rather than a requirement, processors are responsible for ensuring
proper heat distribution during processing and, therefore, must ensure
that heat distribution is not hampered by clogged drains or suction
outlets. FDA is proposing to revise Sec. 113.40(b)(8) and
113.40(b)(10)(ii) to clarify the requirement, as follows:
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.
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-section 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 equipped with a pilot light or
other signaling device to warn the operator when it is not running, and
with a bleeder to remove air when starting operations. 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. Air Supply and Controls and Water Circulation
FDA is proposing editorial changes to Sec. 113.40(e)(6). At the
beginning of the first complete sentence, the word ``Means'' is changed
to ``A means'' and the sentence was changed from a compound sentence to
two simple sentences. FDA also is proposing to renumber Sec.
113.40(e)(6) as Sec. 113.40(e)(6)(i), to read as follows:
Air supply and controls. 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.
FDA is proposing to revise Sec. 113.40(e)(6) to include
requirements for water circulation pressure processing in water in
discontinuous agitating water retorts, similar to the requirements in
current Sec. 113.40(b)(10)(ii) for pressure processing in water in
still retorts. Current Sec. 113.40(b) and (e) both establish equipment
and procedures for pressure processing in water. Section 113.40(b)
applies to still retorts and Sec. 113.40(e) applies to discontinuous
agitating retorts. The retort systems are operationally similar in that
they use water under pressure, which must be circulated to ensure
appropriate heat distribution. FDA considers the water circulation
requirements in Sec. 113.40(b) for still retorts also apply to
discontinuous agitating retorts. Because they are basic procedures for
assuring even heat distribution when pressure processing in water, FDA
currently considers these requirements when evaluating scheduled
processes for pressure processing in water in discontinuous agitating
retorts. FDA is proposing to clarify the water circulation procedures
for pressure processing in water in discontinuous agitating retorts by
adding new Sec. 113.40(e)(6)(ii) as follows:
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

[[Page 11997]]

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-section 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 equipped with a pilot light or
other signaling device to warn the operator when it is not running, and
with a bleeder to remove air when starting operations. Alternative
methods for circulation of water in the retort may be used when
established by a competent authority as adequate for even heat
distribution.
9. Drain Valve and Water Level Indicator
FDA is proposing to revise Sec. 113.40(e) to include requirements
for the drain valve and water level indicator in discontinuous
agitating water retorts, similar to the requirements in current Sec.
113.40(b)(8) and (b)(9), respectively, for pressure processing in water
in still retorts. As previously explained, the retort systems for which
equipment and procedures are established Sec. 113.40(b) and (e) are
operationally similar in that they use water under pressure. The basic
requirements for the drain valve and water level indicator in Sec.
113.40(b) for still retorts also should apply to discontinuous
agitating retorts. FDA is proposing to add new Sec. 113.40(e)(7) for
drain valve, consistent with proposed, revised Sec. 113.40(b)(8),
discussed previously in this document, and is proposing new Sec.
113.40(e)(8) for water level indicator, consistent with proposed,
revised Sec. 113.40(b)(9), as follows:
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.
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.
Because FDA is proposing new Sec. 113.40(e)(7) and (e)(8), as
discussed previously in this document, we also are proposing to
renumber current Sec. 113.40(e)(7), relating to critical factors, as
Sec. 113.40(e)(9).
10. Temperature-Recording Device Sensors
Current 113.40(g)(1)(i)(b) requires that a temperature-recording
device shall be installed in the product at the holding-tube outlet
between the holding tube and the inlet to the cooler. In addition, to
comply with current Sec. 113.40(g)(4), processors must identify where
temperature is a critical factor in the scheduled process and must
measure and record the temperatures that are critical factors. For
example, when processing a non-liquid product or a product that
contains solid particles, heat penetration of the solid and liquid
portions may vary and the temperature at locations other than the
holding-tube outlet may be critical to ensure effective heat
penetration throughout the product. Processors must determine each
point in the process where temperature is a critical factor for either
the solid or liquid portion of the product and must place temperature-
recording device sensors at those locations. Thus, processors must
determine where temperature measurements are critical, based on the
size and texture of particles in the food, and must locate sensors as
necessary to ensure that the process temperature is reached and
maintained throughout the process. FDA is proposing to clarify the
requirement for temperature-recording device sensors by adding the
following statement to Sec. 113.40(g)(1)(i)(b):
Additional temperature-recording device sensors shall be
located at each point where temperature is specified as a critical
factor in the scheduled process.
11. Flow Control
FDA is proposing to revise terminology in Sec. 113.40(g)(1)(i)(f)
by changing the title of the section from ``Metering pump'' to ``Flow
control'' by replacing the terms ``metering pump'' and ``speed
adjusting device'' with ``flow controlling device,'' and by replacing
the term ``speed changes'' with ``flow adjustments.'' The broad term
``flow controlling device'' encompasses ``metering pump'' and ``speed
adjusting device'' as well as other terms that may be used, such as
metering device or flow control meter, to describe or identify
equipment used to control product flow in the processing system.
Similarly, use of the term ``flow adjustments'' is consistent with and
broadly describes the function of flow controlling devices. The
proposed revision of the title of the section to ``Flow control'' is
consistent with the terminology changes within the text of proposed
Sec. 113.40(g)(1)(i)(f).

B. Containers (Sec. 113.60)

Current Sec. 113.60(a) requires processors to ensure proper
closure and to check for closure defects. This responsibility should
have extended to postprocess handling. However, current Sec. 113.60(a)
does not specifically address postprocess handling and current Sec.
113.60(d) relating to postprocess handling recommends, but does not
require, processors to design and operate automatic equipment used in
handling filled containers to preserve the can seam and container
closure integrity. Container handling equipment, including automated
and non-automated equipment, must be of appropriate equipment design
and construction, operated to ensure container closure integrity, and
replaced or repaired if defective to ensure proper container closure.
Otherwise, container handling equipment may be the source of damage to
the can seam and may prevent proper seam closure. Improper seam
closures may lead to contamination of the previously sterilized product
in the can. FDA is proposing to revise Sec. 113.60(d) to change the
term ``automatic equipment'' to ``container handling equipment,'' to
clarify that container handling equipment used in handling filled
containers shall be designed, constructed, and operated to preserve can
seam or other container closure integrity, and to clarify that
processors must check and, as necessary, repair or replace the
container handling equipment, including conveyors and non-automated
equipment, to ensure that they do not damage the containers and
container closures as follows:
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 at 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.

[[Page 11998]]

C. Establishing Scheduled Processes (Sec. 113.83)

Current Sec. 113.83 states, ``The type, range, and combination of
variations encountered in commercial production shall be adequately
provided for in establishing the scheduled process.'' Reprocessing of a
product and blending a previously processed product into a new
formulation are variations that may affect the adequacy of the
scheduled process and, therefore, must be carefully evaluated and
adequately addressed in the scheduled process. For example, because
starch, when heated, is gelatinized, a processed starchy food may have
a different viscosity than the same starchy food prior to processing.
When a previously processed starchy food is blended or reprocessed,
because of physical changes in the characteristics of the food, the
scheduled process used for the starchy food prior to processing may not
be adequate for the same food after processing. Thus, the scheduled
process must be established based on the specific food used as the
starting material for each specific process, i.e., when a reprocessed
or a previously processed product is blended into a new formulation,
the scheduled process must be specific for that situation. FDA is
proposing to clarify this requirement by revising Sec. 113.83 to
include the statement, ``When a product is reprocessed or a previously
processed product is blended into a new formulation, this condition
must be covered in the scheduled process.''

D. Operations in the Thermal Processing Room (Sec. 113.87)

FDA is proposing to revise Sec. 113.87(c) by inserting the term
``accurately'' in the first sentence to clarify that ``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.'' FDA is adding
this term to emphasize that initial temperature determinations must be
accurate, as determined by sufficiently frequent tests of the
temperature-indicating device for accuracy against an accurate
calibrated reference device. FDA also is proposing to add in Sec.
113.87(c), ``The temperature-indicating device used to determine the
initial temperature shall be tested for accuracy against an accurate
calibrated reference device at sufficient frequency to ensure that
initial temperature measurements are accurate. Records of the accuracy
tests shall be signed or initialed, dated, and maintained.'' Although
FDA believes it should be understood that initial temperature
measurements are expected to be accurate when taken and, therefore, the
temperature-indicating device used for initial temperatures must be
accurate, the proposed clarifications ensure consistency in
interpretation of the requirements of Sec. 113.87(c).
FDA is proposing to revise Sec. 113.87(e) to replace the term
``recording-temperature charts'' with ``temperature-recording device
records'' to ensure consistency with the changes in terminology
relating to the use of the term ``charts,'' discussed previously in
this document in changes to proposed revised Sec. 113.40. FDA also is
proposing to change the recommendation for clock times to reasonably
correspond to the time of the day to a requirement by changing the word
``should'' to ``shall.'' Correlation of records with the time the
records were created and with the time of the processing cycle is
essential for evaluating time and temperature correlations of the
scheduled process. This revision also is consistent with the
requirement of Sec. 113.100(a), ``Processing and production
information shall be entered at the time it is observed by the retort
or processing system operator * * *.'' Proposed revised Sec. 113.87(e)
would read as follows:
Clock times on temperature-recording device records shall
reasonably correspond to the time of day on the written processing
records to provide correlation of these records.

E. Processing and Production Records (Sec. 113.100)

Current Sec. 113.100 identifies requirements for processing and
production records. FDA is proposing in Sec. 113.100 to revise
terminology, consistent with terminology used in proposed Sec. 113.40.
FDA is proposing to replace the term ``mercury-in-glass thermometer''
with ``temperature-indicating device,'' to replace ``recording
thermometer'' with ``temperature-recording device,'' to replace
``metering pump'' with ``flow controlling device,'' and to replace
``recording thermometer charts'' with ``temperature-recording device
records.''
FDA is proposing to revise Sec. 113.100(a)(4) by removing the
requirement to maintain records of the product temperature in the final
heater outlet as indicted by the temperature recorder-controller in
aseptic processing and packaging systems. The temperature in the final
heater outlet may not be critical and, therefore, may not require
maintenance of records. However, if the final heater outlet temperature
is identified as a critical factor in the scheduled process, the
temperature must be observed and recorded, as required in Sec.
113.100(a).
FDA is proposing to revise Sec. 113.100(c) by adding the
statement, ``The records shall be signed or initialed and dated by the
reviewer.'' The current regulation requires that containers closure
records shall be signed or initialed by the container closure inspector
and reviewed by management, but it does not explicitly state that the
person in management who reviews the records must also sign or initial
and date the records. FDA is proposing to add this requirement because
such documentation is necessary to identify the manager who conducted
the review and thus avoid any misunderstandings about who reviewed the
record, to verify that the review was conducted by an individual
qualified by training and expertise relating to container closures who
can accept the records for the processor, to identify the person
responsible for ensuring following-up to correct container closure
defects, and to indicate that the records have been accepted by the
processor.
FDA is proposing to add a new Sec. 113.100(f) to provide for the
maintenance of computerized records, in accordance with part 11 (21 CFR
part 11). FDA regulations in part 11 set forth FDA criteria for
electronic records and signatures. Many low-acid canned food processors
currently maintain records on computers. The proposed addition of new
Sec. 113.100(f) clarifies and acknowledges that records relating to
processing low-acid canned foods may be maintained electronically,
provided they are in compliance with part 11.
FDA is proposing to add a new Sec. 113.100(g) to clarify that
records required under part 113, or copies of such records, must be
readily available during the retention period for inspection and
copying by FDA when requested. Proposed Sec. 113.100(g) provides that,
in part, ``if reduction techniques, such as microfilming, are used, a
suitable reader and photocopying equipment must be made readily
available to FDA.'' Access to such records during inspections is needed
by FDA field investigators to evaluate compliance with the requirements
of part 113. Copies of such records are needed for review by FDA
headquarters staff experts who evaluate complex scientific and
technical issues associated with processing low-acid canned foods and
with compliance with the requirements of part 113.

[[Page 11999]]

F. Minor Revisions in Regulations

FDA is proposing to correct typographical errors, revise sentence
structure, and make minor clarifying edits in the regulations, as
follows:
In proposed Sec. 113.40(a)(4), (a)(8), (b)(10)(i), (c)(5), and
(e)(6)(i), we changed compound sentences to simple sentences.
In the first sentence of proposed Sec. 113.40(b)(10)(ii), we
changed the word ``is'' to ``it.''
In the third sentence of proposed Sec. 113.40(d)(2)(iv), we
changed the phrase ``bleeder opening emitting steam'' to ``bleeder that
emits steam.''
In the second sentence of proposed Sec. 113.40(e)(1)(v), we
changed the phrase ``in external wells'' to ``in an external well.''
In the fifth sentence of proposed Sec. 113.40(e)(9), we corrected
the spelling of ``vacuum.''
In the first sentence of proposed Sec. 113.40(g)(1)(i)(G), we
corrected the spelling of ``continuous.''
In the third sentence of proposed Sec. 113.100(b), we changed the
word ``that'' to ``than.''

G. Immediate Implementation of Proposed Rule

FDA believes the proposed revisions to Sec. Sec. 113.40, 113.60,
113.83, 113.87, and 113.100 will provide industry with flexibility to
take advantage of technological advancements associated with
temperature-indicating devices and temperature-recording devices, will
clarify recordkeeping requirements for temperature-indicating devices
and other aspects of processing low-acid canned foods, and will clarify
provisions of the current regulations. FDA believes that the proposed
rule will ensure that temperature-indicating devices that replace
mercury-in-glass thermometers are accurate during processing. FDA also
believes the proposed rule allows industry to voluntarily transition
from mercury-in-glass thermometers to other temperature-indicating
devices and to reduce potential sources of mercury contamination in
food processing plants.
FDA believes that some processors are anxious to replace mercury-
in-glass thermometers with alternative temperature-indicating devices.
Therefore, pending issuance of a final rule, FDA intends to consider
the exercise of its enforcement discretion on a case-by-case basis when
processors of low-acid canned food elect to replace mercury-in-glass
thermometers with alternative temperature-indicating devices in a
manner that is consistent with the proposed rule. The act's enforcement
provisions commit complete discretion to the Secretary of Health and
Human Services (and by delegation to FDA) to decide how and when they
should be exercised (see Heckler v. Chaney, 470 U.S. 821 at 835 (1985);
see also Shering Corp. v. Heckler, 779 F.2d 683 at 685-86 (D.C. Cir.
1985) (stating that the provisions of the act ``authorize, but do not
compel the FDA to undertake enforcement activity'')). Until the agency
issues a final rule for temperature-indicating devices for thermally
processed low-acid foods packaged in hermetically sealed containers,
the agency believes that its exercise of enforcement discretion will
provide the needed flexibility to manufacturers who desire to
transition to alternative temperature-indicating devices. Processors
who choose to use alternative temperature-indicating devices must
comply with any revised requirements established in the final rule when
the final rule becomes effective.

IV. Analysis of Impacts

A. Preliminary Regulatory Impact Analysis: Flexibility in Permitting
Alternative Temperature-Indicating Devices

FDA has examined the impacts of the proposed rule under Executive
Order 12866, the Regulatory Flexibility Act (the RFA) (5 U.S.C. 601-
612), and the Unfunded Mandates Reform Act of 1995 (Public Law 104-4).
Executive Order 12866 directs agencies to assess all costs and benefits
of available regulatory alternatives and, when regulation is necessary,
to select regulatory approaches that maximize net benefits (including
potential economic, environmental, public health and safety, and other
advantages; distributive impacts; and equity). The agency believes that
this proposed rule is not a significant regulatory action as defined by
the Executive order.
1. Need for the Regulation
Current regulations for thermally processed low-acid foods in
hermetically sealed containers, except for aseptic packaging and
processing, require the exclusive use of mercury-in-glass thermometers
for indicating temperatures during food processing. The requirement for
exclusive use of mercury-in-glass thermometers reflects the absence of
alternatives on the market at the time current regulations became
effective in 1973. Because of technological advances in thermometry
since that time, alternatives to mercury-in-glass thermometers may now
be available for the low-acid food industry. Moreover, NIST has
developed standards for some alternative temperature-indicating devices
and there is little reason to assume that alternatives are any less
accurate than mercury-in-glass thermometers, given an appropriate
testing regime. We request comments on the possibility that alternative
temperature-indicating devices are at least as accurate as mercury-in-
glass thermometers, and also that there are appropriate and established
testing regimes to assure their accuracy.
Correspondence with industry representatives suggests that the
current regulation requiring mercury-in-glass thermometers may be a
barrier to innovation (Ref. 3). By allowing the low-acid food industry
flexibility to choose alternative temperature-indicating devices, the
proposed rule would allow processors to select temperature-indicating
devices based on gains to labor productivity and technical
considerations. Clarifying provisions in the current regulation would
facilitate the voluntary adoption and safe use of alternative
temperature-indicating technology, as well as replace outdated
terminology.
The potential to improve productivity may be one reason firms may
choose to adopt alternatives to mercury-in-glass thermometers.
Correspondence with the Food Products Association (FPA) (formerly,
National Food Processors Association) suggests that monitoring and
analysis capabilities from using alternative temperature-indicating
devices may be enhanced (Ref. 3). In addition, the potential to avoid
costly remediation of hazardous mercury spills, and growing concerns by
State and local governments about the health effects from the
accumulation of mercury in the environment, have led to legislation
that restricts the sale, manufacture, and distribution of mercury-in-
glass thermometers (Ref. 4). For these reasons, FPA correspondence
suggests that low-acid food processors are phasing out the use of
mercury-in-glass thermometers for all other purposes except those
necessary for regulatory compliance.
2. Regulatory Options Considered
Regulatory options considered include:
Option 1--No new regulation.
Option 2--Allow flexibility to use alternative temperature-
indicating devices, including mercury-in-glass thermometers, that can
be tested against an accurate calibrated reference device in processing
low-acid canned foods without an explicit record requirements.

[[Page 12000]]

Option 3 (the Proposed Rule)--All of the provisions in option 2 and
include explicit recordkeeping requirements for test results and
explicit records access requirements for required records.
3. Costs and Benefits of Option 1 (No New Regulation)
There are neither costs nor benefits from the option of no new
regulation.
4. Costs and Benefits of Option 2 (Allow the Use of Alternative
Temperature-Indicating Devices Without a Record Requirement for
Accuracy Tests)
The costs and benefits are estimated separately for the proposed
voluntary and mandatory provisions of the rule. The voluntary provision
allows low-acid canned food manufacturers to use alternatives to
mercury-in-glass thermometers as temperature-indicating devices. In
option 2, the mandatory provisions are considered to be clarifications
of the current regulation and are primarily intended to facilitate the
voluntary adoption and safe use of alternative temperature-indicating
technologies. Option 2 does not consider requirements for low-acid
canned food manufacturers to establish and maintain records on accuracy
tests necessary to ensure that each temperature-indicating device,
including each mercury-in-glass thermometer, and each reference device
is accurate during processing. Nor does option 2 consider requirements
for FDA access to such records upon inspection.
There are no compliance costs from allowing alternative
temperature-indicating devices. The benefits from allowing alternative
temperature-indicating devices are from any reduction of the risk of
foodborne illness that results from the use of alternative temperature-
indicating devices, the avoided cleanup and disposal costs resulting
from breaking mercury-in-glass thermometers during non-production
times, and the increase in labor productivity at low-acid canned food
manufacturers.
a. Costs from permitting the use of alternative temperature-
indicating devices. The proposed regulation permits, but does not
require, low-acid food manufacturers to adopt alternatives to mercury-
in-glass thermometers. Thus, costs associated with choosing an
alternative to mercury-in-glass thermometers are voluntarily incurred.
These costs would be incurred only if the expected private benefits
from doing so are higher than the costs. To show our estimation method
and solicit comments, we specify the determinants of the costs of
alternative temperature-indicating devices.
Higher purchase prices and maintenance costs may influence a firm's
decision to use alternative temperature-indicating devices.
Correspondence with FPA suggests that most digital alternatives are
slightly more expensive than mercury-in-glass thermometers (Ref. 3).
According to FPA, after installation, there are no significant
differences in maintenance costs during normal operations between
mercury-in-glass thermometers and alternative temperature-indicating
devices (Ref. 3). Thus, the higher cost would be a one-time capital
cost. FPA also suggests that many firms are using alternative
temperature-indicating device technology for purposes that are beyond
the scope of the low-acid food regulations (Ref. 3). This implies that
the productivity gains from their adoption are greater than the higher
purchase prices.
Temperature-indicating devices must be tested against an accurate
calibrated reference device, including tests relating to relevant
factors such as electromagnetic interference and environmental
conditions. Environmental conditions may affect the accuracy of
mercury-in-glass thermometers. Thus, low-acid food manufacturers have
experience with understanding and controlling these factors to ensure
that mercury-in-glass thermometers are accurate and function properly
during processing. Tests to ensure that alternative temperature-
indicating devices are not susceptible to electromagnetic interference
may result in higher costs for testing and maintaining the devices.
FPA suggests that many companies already use alternative
temperature-indicating devices for unregulated purposes, and that the
use of mercury-in-glass thermometers in these establishments is
restricted to regulatory compliance purposes (Ref. 3). In the event
that alternative temperature-indicating devices currently used by
industry for unregulated purposes are tested against an accurate
calibrated reference device, the experience of their use for the
unregulated purpose would likely mitigate any additional learning, or
adjustment costs for their testing. Nevertheless, one-time adjustment
costs are likely to be incurred by all low-acid canned food
manufacturers that adopt alternative temperature-indicating device
technology--especially early adopters of such technology--as they
adjust to new testing protocols and appropriate testing frequencies.
FDA assumes that, after testing protocols and frequencies are
established, the testing costs will be comparable to those required for
testing mercury-in-glass thermometers. FDA requests comments on the
magnitude of the costs (if any) associated with learning about and
adjusting to testing requirements for alternative temperature-
indicating devices, as well as our assumption that testing costs for
alternative temperature-indicating devices, subsequent to the initial
establishment of testing protocols, are comparable to those for
mercury-in-glass thermometers.
Finally, we assume that firms able to achieve gains in labor
productivity and reduce remediation costs will phase in alternative
temperature-indicating devices. One firm predicted that alternative
temperature-indicating devices will be chosen for all new purchases
immediately following issuance of the final rule, and that the total
period for transition from mercury-in-glass thermometers to alternative
temperature-indicating devices will be 5 years (Ref. 3). FDA assumes
that all mid-sized and large low-acid canned food manufacturers will
adopt alternative temperature-indicating device technology within 5
years after issuance of the final rule. We request comments on this
assumption.
b. Benefits from permitting the use of alternative temperature-
indicating devices.
Changes in the Risk of Foodborne Illness
The Centers for Disease Control and Prevention (CDC) report that
there were 20 cases of foodborne botulism and 76 cases of infant
botulism in the United States in 2003 (Ref. 5). There have been no
reported cases of foodborne botulism associated with commercially
canned low-acid food in recent years. CDC reported one case of botulism
from food eaten at a restaurant and one case from food eaten at an
unknown location in 1994, but home-canned food and Alaska Native foods
consisting of fermented seafood are currently the principal sources of
foodborne botulism (Ref. 5). The risk factors for infant botulism,
including from food and non-food sources, remain largely unknown.
Although cases of botulism are mostly associated with food prepared
or canned at home, a change to inaccurate or improperly functioning
temperature-indicating devices by low-acid canned food manufacturers
could potentially increase the risk of foodborne botulism. Increased
risk of botulism associated with new technology could result from
increased risk of device errors for indicating and recording
temperatures, or an increased risk of human errors in reading
alternative temperature-indicating devices. An increased risk of
illness could accompany an increased risk of such errors that lead to
food

[[Page 12001]]

being processed at unsafe low temperatures.
To acknowledge the potential for increased risk associated with the
adoption of alternative technologies mentioned previously in this
document, this proposed rule requires alternative temperature-
indicating devices to be tested for accuracy against an accurate
calibrated reference device. The proposed rule also requires tests
relating to relevant factors such as electromagnetic interference and
environmental conditions. Alternatives to the mercury-in-glass
thermometer that meet NIST requirements are currently available to the
industry and we assume that such technology is at least as accurate as
mercury-in-glass thermometers given an appropriate testing regime.
There may be a period of learning and adjustment to the new
temperature-indicating technology for a short period immediately
following its adoption, during which the risk of inaccurate measurement
may be temporarily elevated. We assume that the frequency of testing
for accuracy during this adjustment period may increase for a short
time to compensate for any increased risk of inaccurate measurement
from the new technology. Consequently, we assume that any increases in
risk during the adjustment period will be fully mitigated through
appropriate or increased testing. We request comments on this
assumption.
An increase in risk of illness could arise from an increase in
human error in reading the alternative temperature-indicating device.
However, we assume that the alternatives to the mercury-in-glass
thermometer are likely to be no more difficult to read than mercury-in-
glass thermometers. Thus, we expect no increase in the number of
reading errors. Some alternative temperature-indicating devices may
have a digital display of the temperature and may be easier to read
than mercury-in-glass thermometers. However, there is also the
possibility that certain digital displays with poor resolution may
facilitate reading errors. In addition, the magnitude of a reading
error from a digital display may be different than that from a mercury-
in-glass thermometer. The relative risk of misreading a digit displayed
in the ``tens'' and ``ones'' columns may be different for digital
displays compared to the conventional mercury-in-glass thermometers.
Although we assume no increase in the risk of reading errors for
digital devices, we request comments on this assumption.
Avoided Cleanup Costs
The principal benefit from allowing flexibility in the use of
temperature-indicating device technology by low-acid canned food
manufacturers is the reduced risk of cleanup and disposal costs
resulting from breaking mercury-in-glass thermometers during non-
production times (e.g., calibration, equipment maintenance, storage).
Disposal and cleanup costs for mercury spills and damaged mercury-in-
glass thermometers can be high. FPA estimates the cost of environmental
disposal of mercury-in-glass thermometers to be about $500 (Ref. 3).
Examples of cleanup costs provided by the Northeast Waste Management
Officials' Association include the $6,000 cleanup costs paid by a
school following the breakage of 12 thermometers (Ref. 6), or
approximately $500 per thermometer. According to Harvard University
Operations Services, mercury spills involving thermometer breakage are
one of the most common accidents involving laboratory equipment, with
cleanup costs of approximately $110 per thermometer (Ref. 7).
Mercury-in-glass thermometer breakage can occur within the
processing plant during calibration, equipment maintenance, storage,
and other non-production times. Because we do not have accident data
from processors, we estimate mercury-in-glass thermometer breakage
rates using information on accident rates involving laboratory
equipment. According to a 2004 bulletin published by the Lawrence
Berkeley Laboratory, the annual number of laboratory accident rates for
2002, 2003, and 2004 was 2.17, 2.51, and 1.25 per 100 employees
(respectively), for an annual average of approximately 2 per 100
employees (Ref. 8).
Using 2002 U.S. Economic Census data on the number of employees in
the low-acid canned food industry, we extrapolated the laboratory
accident rates reported previously in this document. There were
reported to be 78,016 employees in the canned food industry (North
American Industry Classification System (NAICS) codes 311421, 311422,
and 311514 for fruits and vegetables canning, specialty canning, and
seafood canning) in 2002 (Ref. 9). We assume that half of all employees
of canning manufacturers are involved in the manufacturing process. We
further assume that half of the employees involved in the manufacturing
process will come into direct contact with mercury-in-glass
thermometers at some point during the performance of their jobs. This
yields an estimate of 19,504 employees of low-acid canned food
manufacturers that come into direct contact with temperature-indicating
devices.
Based on the laboratory accident rates reported previously, we
estimate that there are approximately 390 manufacturing process related
accidents per year (i.e., (19,504 / 100) x an accident rate of 2) in
the low-acid canned food industry. We assume that half of these
accidents involve equipment that comes directly in contact with
mercury-in-glass thermometers, and half of those, or approximately 100,
involve mercury-in-glass thermometer breakage and require remediation
in the form of cleanup and disposal.
We estimate that all large and mid-sized low-acid canned food
manufacturers will adopt alternative temperature-indicating device
technology because of the potential savings in cleanup costs as well as
the potential for increased productivity made possible from alternative
temperature-indicating devices. There currently are approximately 1,100
domestic and 5,600 foreign-based low-acid canned food manufacturers
registered with FDA that supply the domestic market (Ref. 10). Because
that data does not include firm size information, we estimate the
proportion of large and mid-sized domestic low-acid canned food
manufacturers using U.S. Economic Census data, and assume the same
proportions of large and mid-sized foreign firms as well.
Based on the 2002 U.S. Economic Census there were a total of 1,051
fruit and vegetable, specialty canning, and dry, condensed, and
evaporated dairy product manufacturing establishments reported for
NAICS codes 311421, 311422, and 311514, and that large and mid-sized
establishments (i.e., establishments with more than 19 employees)
comprise approximately half of the total. Consequently, we estimate
that if half of the low-acid food manufacturers were to discontinue use
of mercury-in-glass thermometers as provided in the proposed rule,
approximately 50 domestic accidents per year involving mercury-in-glass
thermometers would be avoided (i.e., 100 accidents divided by 2 for
large and mid-sized establishments) and 255 foreign-based accidents per
year involving mercury-in-glass thermometers would be avoided (i.e.,
100 accidents, scaled by the ratio of foreign to domestic firms, 5,600
/ 1,100, and divided by 2 for large and mid-sized firms) that would
otherwise incur cleanup and disposal costs during non-production times.
Implicit in this estimate is the assumption that the accident rates for
domestic and foreign-based manufacturers are the same. We request
comments on this assumption.

[[Page 12002]]

We assume that each accident involves one mercury-in-glass
thermometer. In addition, we assume that cleanup and remediation costs
per accident are the same for foreign-based and domestic low-acid
canned food manufacturers. Consequently, we estimate that after half of
the low-acid canned foods manufactures adopt alternative temperature-
indicating device technology, between $5,500 and $25,000 in remediation
costs (i.e., 50 accidents x $110, and 50 accidents x $500) would be
averted by domestic manufacturers, and between $25,000 and $127,000 in
remediation costs (i.e., 255 accidents x $110, and 255 accidents x
$500, rounded to the nearest thousand) would be averted by foreign-
based manufacturers. Total remediation costs averted would be between
$30,500 and $152,000.
Increased Productivity from Allowing Alternative Technologies
We use U.S. Department of Labor estimates of changes in labor
productivity from 1995 to 2004 to estimate the savings to large, mid-
sized, and small firms from improved temperature monitoring and
recordkeeping productivity that may result from using alternative
temperature-indicating devices. We assume that cost savings and
increases in labor productivity from adopting alternative temperature-
indicating technology would be the same for domestic and foreign-based
firms of similar size.
We computed the average of the U.S. Department of Labor quarterly
estimates of the percent change in quarterly output per hour (expressed
in annual terms) in the non-farm business sector over the 10-year
period from 1996 through 2005 to be 2.8 percent (Ref. 11). We estimated
that productivity gains to labor engaged in monitoring temperature
sensitive processes by low-acid canned food manufacturers that adopt
alternative temperature-indicating technology would be 2.8 percent as
well.
We assume that monitoring temperature sensitive processes requires
the equivalent of one full time job at large establishments, half a
full time job at mid-sized establishments, and one quarter of a full
time job at small establishments. We doubled the mean hourly wage of
$13.55 for production labor in 2002, obtained from the Bureau of Labor
Statistics (Ref. 12), to account for overhead costs and estimated that
adopting new temperature-indicating technology could increase labor
productivity by as much as $0.76 per hour (i.e., 2.8 percent x $27.10)
at large establishments, $0.38 per hour at mid-sized establishments
(i.e., 2.8 percent divided by 2 x $27.10), and $0.19 per hour at small
establishments (i.e., 2.8 percent divided by 4 x $27.10).
5. Costs and Benefits of Option 3, the Proposed Rule (Option 2 With
Added Recordkeeping and Records Access Requirements)
a. Costs of the recordkeeping and records access requirements. The
current low-acid food regulations recommend, but do not require, that
records of thermometer accuracy checks that specify date, standard
used, method used, and person performing the test be maintained. The
proposed rule requires, rather than recommends, maintenance of written
documentation of the accuracy of the temperature-indicating device, and
also written documentation of the accuracy of the reference device. The
proposed rule also requires that each temperature-indicating device and
reference device have a tag, seal, or other means of identity that can
be referenced in the required records as the identity of the device.
These proposed recordkeeping requirements apply to mercury-in-glass
thermometers as well as alternative temperature-indicating devices and
reference devices. Additional costs associated with the proposed
revised recordkeeping requirements may be incurred for all temperature-
indicating devices and reference devices.
The costs of the requirement to establish and maintain records are
the setup costs required to design and establish a form for recording
the required information, and the additional labor requirements needed
to record the information. In addition, there will be one-time costs
for training employees to comply with the requirement. We assume that
one to two accuracy tests will be performed per year per device and
that only a small number of forms would need to be designed. Thus, the
setup costs for the recordkeeping requirement would be minimal.
Moreover, we assume that the current recordkeeping practice is to
maintain most, if not all, of these records and that the additional
one-time training costs would be minimal as well.
We assume that additional labor costs to record the required
information will be small because the current regulations recommend
maintaining similar records. Thus, we assume that the current practice
is to keep track of most, if not all, of the information required by
the proposed rule. However, we request comments on this assumption.
Current incentives to track accuracy and performance of mercury-in-
glass thermometers may vary across the industry, and information that
is currently generated during accuracy tests may not be permanently
recorded, as required under this proposed rule. Thus, we assume there
will be labor costs incurred from this proposed rule to record
information that is currently generated, but not recorded. We assume
that half of the industry currently does not have sufficient incentive
to track the performance of the temperature-indicating devices
necessary to permanently record all of the required information. We
further assume that current practice by these firms is to leave
unrecorded one to four separate pieces of information required under
the proposed rule, and that each piece of information takes between 10
and 15 seconds to permanently record. Consequently, we estimated that
half of all low-acid canned food manufacturers would spend between 10
seconds and 1 minute (i.e., 1 x 10 seconds and 4 x 15 seconds) per
device, recording information required in the proposed rule that is
currently unrecorded.
We estimated the number of temperature-indicating devices that
would be subject to recordkeeping requirements using the results of a
survey of the low-acid canned food industry conducted by FDA and
published in 1994 (Ref. 13). Findings from that survey indicate that
the number of mercury-in-glass thermometers found at establishments
ranged from 1 to 65, with only 4 percent of establishments having more
than 30 thermometers, and 67 percent having fewer than 10. Assuming the
number of thermometers is uniformly distributed between 1 and 10 for 67
percent of establishments, between 11 and 30 for 29 percent of
establishments, and between 31 and 65 for 4 percent of establishments,
we estimated a weighted average of about 10 thermometers per
establishment (i.e., 67 percent x 5.5 + 29 percent x 15.5 + 4 percent x
48 rounded to the nearest integer).
Based on the findings from this study, we estimated that low-acid
canned food establishments use an average of 10 devices annually, for a
total number of 33,500 thermometers with accuracy test results that are
currently not fully recorded (i.e., 1/2 x 6,700 establishments x 10
thermometers) as required in the proposed rule. We assume that each
device requires one to two tests per year (for a mean of 1.5), and
estimated the total burden for the industry for recording the required
test result information to be between 140 hours and 838 hours per year
(i.e., 33,500 thermometers x 10 seconds x 1.5 tests / 3,600 seconds per
hour, and

[[Page 12003]]

33,500 thermometers x 60 seconds x 1.5 tests / 3,600 seconds per hour).
Doubling the $13.55 mean hourly wage for production labor for 2002 from
the Bureau of Labor Statistics (Ref. 11) to account for overhead costs,
we computed the labor cost of recording accuracy test information
required in this proposal to be between $3,800 and $22,700, rounded to
the nearest hundred.
The costs of the requirement to allow FDA access to records
documenting the accuracy of both temperature-indicating devices and
reference devices include the costs of document retrieval and
reproduction, as well as time spent with FDA investigators prior to,
and immediately following, these activities. We assume these costs
would be incurred once per year with a regular facility inspection, as
well as irregularly during outbreak investigations. We assume the costs
from the records access requirements would be incurred by a small
number of firms that currently fail to permit FDA access to records
under the current regulation.
b. Benefits of the recordkeeping and records access requirements.
The benefits from the proposed recordkeeping and records access
requirements are derived from the enhanced ability by manufacturers to
track critical accuracy and performance data for temperature-indicating
devices which may improve safety, as well as the ability by FDA to
determine compliance with the recordkeeping requirements. Although we
believe that maintenance of these records is the current industry
practice, the explicit requirement in this proposed rule may increase
the incentive for industry compliance with records requirements,
including those related to the testing of temperature-indicating
devices and reference devices, and may increase the frequency with
which testing occurs. The benefits from requiring maintenance of
accuracy testing records may be particularly high during the transition
period following the adoption of alternative temperature-indicating
devices if they are useful for learning about the performance
characteristics and required testing protocols.
FDA's experience is that most manufacturers currently permit access
to temperature-indicating device test results and other records under
the current regulation, and we expect the benefits of the records
access requirement from improving regular inspections to be small.
However, the records access requirement may provide benefits from any
accompanying increase in incentives to test alternative temperature-
indicating devices for accuracy that might result due to concern by a
manufacturer with being in compliance with the testing requirement.
Additional incentives for testing for accuracy may be particularly
important during a transition period when knowledge about alternative
temperature-indicating device performance characteristics may be
uncertain.
In addition, there may be benefits from any increase in the degree
of certainty that a manufacturer will comply with a records access
request, particularly during an outbreak investigation when records of
test results may be essential to determine the cause of the outbreak.
However, any increase in the incentives to test alternative
temperature-indicating devices for accuracy, and also in the degree of
certainty that a manufacturer will comply with a records access
request, may be smaller for foreign-based manufacturers compared with
domestic manufacturers. This may be true if foreign-based manufacturers
export their products to buyers based not only in the United States,
but also in countries that do not require the maintenance and access to
records documenting the accuracy of temperature-indicating device
technology. Under such circumstances foreign-based low-acid canned food
manufacturers may choose to sell their products in other countries
rather than comply with FDA records requirements. We request comments
on the possibility that the incentives for maintaining records by
foreign-based low-acid canned food manufacturers that export to the
United States are smaller than those for domestic manufacturers.
6. Summary
In summary, the proposed rule provides flexibility by permitting
alternative temperature-indicating devices without increasing public
health risks from low-acid foods. In addition, the proposed rule may
result in additional or more frequent testing of alternative
temperature-indicating devices, which may be particularly useful for
evaluating device performance. The setup costs for designing new forms
for recording the required accuracy test information and the one-time
training costs are assumed to be minimal. The recurring additional
labor costs are estimated to be between $3,800 and $22,700.
The avoided mercury cleanup costs from broken mercury-in-glass
thermometers, and also the potential for enhanced labor productivity
from adopting alternative temperature-indicating device technology, may
be substantial. We estimate that avoided cleanup costs from broken
mercury-in-glass thermometers will be between $30,500 and $152,000 if
all large and medium sized low-acid food firms adopt alternative
temperature-indicating devices. Table 1 of this document summarizes the
costs and benefits of the proposed rule, rounded to the nearest
thousand.

Table 1.--A Summary of the Costs and Benefits of the Proposed Rule
------------------------------------------------------------------------
Description Impact
------------------------------------------------------------------------
One-time Costs
------------------------------------------------------------------------
Design of new recordkeeping forms minimal
------------------------------------------------------------------------
Recordkeeping training minimal
------------------------------------------------------------------------
Recurring Costs
------------------------------------------------------------------------
Recordkeeping $5,000-$23,000
------------------------------------------------------------------------
Records access (incurred by a small minimal
number of firms that currently fail to
permit FDA access)
------------------------------------------------------------------------
Purchase and additional testing of voluntarily incurred
alternative devices
------------------------------------------------------------------------
Benefits
------------------------------------------------------------------------
Change in risk from low-acid canned foods no change
------------------------------------------------------------------------
Avoided mercury cleanup costs $31,000-$152,000
------------------------------------------------------------------------
Enhanced labor productivity not quantified, but may be
substantial
------------------------------------------------------------------------

B. Regulatory Flexibility Analysis

The RFA requires agencies to analyze regulatory options that would
minimize any significant impact of a rule on small entities. The agency
certifies that the proposed rule will not have a significant economic
impact on a substantial number of small entities.
FDA has examined the economic implications of this proposed rule as
required by the RFA. If a rule has a significant economic impact on a
substantial number of small entities, the RFA requires agencies to
analyze regulatory options that would lessen the economic effect of the
rule on small entities. The voluntary provisions of this proposed rule
would not generate any compliance costs for any small entities because
they do not require small entities to undertake any new activity. A
small business will not

[[Page 12004]]

choose alternative temperature-indicating device technology unless it
believes that doing so will increase private benefits by more than it
increases private costs.
The per-firm costs of the mandatory recordkeeping requirement of
this proposed rule will be small. The additional labor costs from the
recordkeeping requirements are estimated to be between $3,800 and
$22,700 or between approximately $1.00 and $4.00 per firm (i.e., $3,800
/ 6,700 firms and $22,700 / 6,700 firms, rounded up). Moreover, costs
for small firms will be at the lower end of this range since they will
have fewer temperature-indicating devices and reference devices to
test. We assume the costs from the records access requirement would be
small and incurred by a small number of firms that currently fail to
grant FDA access to records under the current regulation. Accordingly,
FDA certifies that this proposed rule will not have a significant
impact on a substantial number of small entities. Under the RFA, no
further analysis is required.

C. Unfunded Mandate Analysis

Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $122 million, using the most current (2005) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
proposed rule, if finalized, to result in any 1-year expenditures that
would meet or exceed this amount and has determined that this proposed
rule does not constitute a significant rule under the Unfunded Mandates
Reform Act of 1995.

V. Environmental Impact

The agency has determined under 21 CFR 25.30(j) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.

VI. Paperwork Reduction Act

This proposed rule contains information collection provisions that
are subject to review by OMB under the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520). A description of these provisions is
given in the following paragraphs with an estimate of the annual
recordkeeping burden. Included in the estimate is the time for
reviewing instructions, searching existing data sources, gathering and
maintaining the data needed, and completing and reviewing each
collection of information.
FDA invites comments on the following topics: (1) Whether the
proposed collection of information is necessary for the proper
performance of FDA's functions, including whether the information will
have practical utility; (2) the accuracy of FDA's estimate of the
burden of the proposed collection of information, including the
validity of the methodology and assumptions used; (3) ways to enhance
the quality, utility, and clarity of the information to be collected;
and (4) ways to minimize the burden of the collection of information on
respondents, including through the use of automated collection
techniques, when appropriate, and other forms of information
technology.

Title: Recordkeeping Requirements for Temperature-Indicating Devices

Description: The information proposed to be collected contains the
results of tests of the accuracy of temperature-indicating devices used
by low-acid food firms. Much of this information is currently generated
from the accuracy ``checks'' recommended under current regulations, and
some of it may not be permanently recorded as required under this
proposed rule.
Current low-acid food regulations recommend that records of
thermometer accuracy checks that specify date, reference device used,
method used, and person performing the test be maintained. The proposed
rule requires maintenance of written documentation of the accuracy of
the temperature-indicating device and also written documentation of the
accuracy of the reference device. The required documentation of
accuracy is necessary to track the performance of devices, and may be
particularly important for new temperature-indicating device technology
during the transition period following its adoption. By requiring
permanent records of the accuracy test results, manufacturers may have
incentive to test temperature-indicating devices for accuracy more
frequently than they would under the current regulations.
Description of Respondents: All commercial low-acid canned food
processors. Based on FDA low-acid canned food manufacturers'
registration data, we estimate that there are approximately 6,700 low-
acid canned food processing establishments.
Burden: The costs of the recordkeeping requirement are the setup
costs required to design and establish a form for recording the
required information, and the additional labor requirements needed to
record the information. The initial setup costs for designing a new
record form are assumed to be minimal since only one to two accuracy
tests will be performed on an average of 10 devices per firm.
We assume that labor costs to record the required information will
be small because current practice is to keep track of most, if not all,
of this information. Because current incentives to track accuracy of
mercury-in-glass thermometers may vary across the industry, information
that is currently generated during accuracy tests may not be
permanently recorded as required under the proposed rule. Thus, we
assume there will be labor costs incurred from this proposed rule to
record information that is currently generated, but not recorded.
We assume that half of the industry currently does not have
sufficient incentive to track the performance of the temperature-
indicating devices and reference devices necessary to permanently
record all of the required information. We further assume that current
practice by these firms is to leave unrecorded one to four separate
pieces of information required under the proposed rule, and that each
piece of information takes between 10 and 15 seconds to permanently
record. Consequently, we estimate that half of all low-acid canned food
manufacturers would spend between 10 seconds and 1 minute (i.e., 1 x 10
seconds and 4 x 15 seconds) per device, recording information required
in the proposed rule.
Based on a survey conducted by FDA between 1992 and 1993, we
estimate that low-acid food firms use an average of 10 devices,
including reference devices. We estimate that 3,350 low-acid canned
food manufacturers currently do not fully record the accuracy test
results required by the proposed rule. We assume that each device
requires one to two tests per year (midpoint of 1.5 tests per year). We
estimate the annual frequency per recordkeeping to be 15 (i.e., 10
devices x 1.5 tests per year). We estimate the burden for recording the
additional information to be between 10 and 60 seconds per device
(midpoint of 35 seconds or 0.0097 hours per device). Table 2 of this
document reports the

[[Page 12005]]

average annual burden described previously in this document.

Table 2.--Estimated Annual Recordkeeping Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
No. of Annual Frequency Total Annual
21 CFR Section Recordkeepers per Recordkeeping Records Hours per Record Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
113.40(a)(1), (b)(1), (c)(1), (d)(1), (e)(1), and 3,350 15 50,250 0.0097 487
(f)(1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\There are no capital costs or operating and maintenance costs associated with this collection of information.

In compliance with the PRA (44 U.S.C. 3507(d)), the agency has
submitted the information collection provisions of this proposed rule
to OMB for review. Interested persons are requested to send comments
regarding information collection to OMB (see DATES and ADDRESSES).

VII. Federalism

We have analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. We have determined that
the proposed rule does not contain policies that have substantial
direct effects on States, on the relationship between the National
Government and the States, or on the distribution of power and
responsibilities among the various levels of government. Accordingly,
we have tentatively concluded that the proposed rule does not contain
policies that have federalism implications as defined in the Executive
order and, consequently, a federalism summary impact statement is not
required.

VIII. Comments

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) written or electronic comments regarding this document.
Submit a single copy of electronic comments or two paper copies of any
mailed comments, except that individuals may submit one paper copy.
Comments are to be identified 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.

IX. References

The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES) and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
FDA has verified the Web site addresses, but is not responsible for
subsequent changes to the Web sites after this document publishes in
the Federal Register.
1. Heymann, David L., ``Control of Communicable Diseases,'' 18th
ed., 2004, An Official Report of the American Public Health
Association, American Public Health Association, Washington, DC, p.
612, 2001.
2. International Vocabulary of Basic and General Terms in
Metrology (VIM), BIPM, IEC, IFCC, ISO, IUPAC, IUPAP, OIML, 2d ed.,
p. 47, definition 6.10, 1993.
3. Letter from Sia Economides, FPA, to Mischelle Ledet, FDA,
August 23, 2004.
4. Smith, Brandie, King County Passes Mercury Thermometer Sales
Ban, Washington Free Press, 63, May/June 2003, accessed
online January 25, 2007, at http://www.washingtonfreepress.org/63/kingCountyPassesMercury.htm.
5. CDC, ``Summary of Notifiable Diseases--United States, 2003,''
Morbidity and Mortality Weekly Report, April 22, 2005, accessed
online January 25, 2007, at http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5254a1.htm.
6. Great Lakes Regional Pollution Prevention Roundtable,
``Mercury-Thermometers: Spills,'' Mercury-Thermometer Topic Hub,
Northeast Waste Management Officials' Association, accessed online
January 25, 2007, at http://www.glrppr.org/hubs/subsection.cfm?hub=
101&subsec=17&nav=17, last updated July 13, 2006.
7. University Operations Services, Harvard University Web site,
accessed online January 25, 2007, at http://www.uos.harvard.edu/ehs/onl_fac_env_mer.shtml.
8. ``Accident Prevention Urged for Final Weeks of Fiscal Year
`04,'' Today at Berkeley Lab--Friday, August 27, 2004, accessed
online January 25, 2007, at http://www.lbl.gov/today/2004/Aug/27-Fri/safety_page.html.
9. U.S. Census Bureau, ``2002 Economic Census'', accessed online
January 25, 2007, at http://factfinder.census.gov/servlet/IBQTable?_bm=y&-geo_id=&-ds_name=EC0231I3&-_lang=en.
10. FDA/Center for Food Safety and Applied Nutrition,
``Acidified and Low-Acid Canned Food Registration Data,'' December
2005.
11. U.S. Department of Labor, Bureau of Labor Statistics, Output
Per Hour--Non-farm Business Productivity--PRS85006092, accessed
online January 25, 2007, at http://data.bls.gov/cgi-bin/surveymost?bls.
12. U.S. Department of Labor, Bureau of Labor Statistics,
accessed online January 25, 2007, at ftp://ftp.bls.gov/pub/news.release/History/ocwage.11192003.news.
13. Stringer, L.W., Proceedings of Advances in Instrumentation
and Control, Vol. 49, part 2, pp. 715-723, 1994.

List of Subjects in 21 CFR Part 113

Food packaging, Foods, Reporting and recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 113 be amended as follows:

PART 113--THERMALLY PROCESSED LOW-ACID FOODS PACKAGED IN
HERMETICALLY SEALED CONTAINERS

1. The authority citation for 21 CFR part 113 continues to read as
follows:

Authority: 21 U.S.C. 342, 371, 374; 42 U.S.C. 264.
2. Revise Sec. 113.40 to read as follows:

Sec. 113.40 Equipment and procedures.

(a) Equipment and procedures for pressure processing in steam in
still retorts--(1) Temperature-indicating device. Each retort shall be
equipped with at least one temperature-indicating device that
accurately indicates the temperature during processing. Temperature-
indicating devices shall be tested for accuracy against an accurate
calibrated 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 reference device 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) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and
maintained.
(A) Documentation of the accuracy of the temperature-indicating
device shall include a reference to the tag, seal, or other means of
identity used by the processor to identify the temperature-indicating
device, the name of the manufacturer of the temperature-indicating
device, the identity of the reference device used for the accuracy test
and of equipment and procedures

[[Page 12006]]

used to adjust or calibrate the temperature-indicating device, the date
and results of each accuracy test, the name of the person or facility
that performed the accuracy test and adjusted or calibrated the
temperature-indicating device, and the date of the next scheduled
accuracy test.
(B) Documentation of the accuracy of the reference device shall
include a reference to the tag, seal, or other means of identity used
by the processor to identify the reference device, the name of the
manufacturer of the reference device, the identity of the equipment and
procedures used to test the accuracy and to adjust or calibrate the
reference device, the identity of the person or facility that performed
the accuracy test and adjusted or calibrated the reference device, the
date and results of the accuracy test, and the traceability
information. Documentation of the traceability information for the
reference device may be in the form of a guaranty of accuracy from the
manufacturer of the reference device or a certificate of calibration
from a laboratory.
(iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired or replaced before further use.
(iv) A temperature-indicating device shall be easily readable 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 sensor of the temperature-
indicating device 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 that records temperatures to a
permanent record, such as a temperature-recording chart.
(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 to agree as nearly as possible with, but to be in no event
higher than, the temperature-indicating device during the process time.
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 recording-
controlling instrument. 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 which emits steam
continuously during the processing period. 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 should be graduated in divisions of 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 recording-controlling instrument when combined with a temperature-
recording device. The steam controller may be air-operated and actuated
by a temperature sensor positioned near the temperature-indicating
device in the retort. A steam controller activated by the steam
pressure of the retort is acceptable if it is carefully maintained
mechanically so that it operates satisfactorily.
(5) Steam inlet. The steam inlet to each still retort shall be
large enough to provide sufficient steam for proper operation of the
retort. Steam may enter either the top portion or the bottom portion of
the retort but, in any case, shall enter the portion of the retort
opposite the vent; for example, steam inlet in bottom portion and vent
in top portion.
(6) Crate supports. A bottom crate support shall be used in
vertical still retorts. Baffle plates shall not be used in the bottom
of still retorts.
(7) Steam spreaders. Steam spreaders are continuations of the steam
inlet line inside the retort. Horizontal still retorts shall be
equipped with steam spreaders that extend the length of the retort. For
steam spreaders along the bottom of the retort, the perforations should
be along the top 90[deg] of this pipe, that is, within 45[deg] on
either side of the top center. Horizontal still retorts over 30 feet
(9.1 meters) long should have two steam inlets connected to the
spreader. In vertical still retorts, the steam spreaders, if used,
should be perforated along the center line of the pipe facing the
interior of the retort or along the sides of the pipe. The number of
perforations should be such that the total cross-sectional area of the
perforations is equal to 1.5 to 2 times the cross-sectional area of the
smallest restriction in the steam inlet line.
(8) 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. For
horizontal still retorts, bleeders shall be located within
approximately 1 foot (30.5 centimeters) of the outermost locations 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 steam within the retort. Vertical retorts shall have at
least one bleeder opening located in that portion of the retort
opposite the steam inlet. 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 so that the operator
can

[[Page 12007]]

observe that they are functioning properly.
(9) 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 dividers 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.
(10) Air valves. Retorts using air for pressure cooling shall be
equipped with a suitable valve to prevent air leakage into the retort
during processing.
(11) Water valves. Retorts using water for cooling shall be
equipped with a suitable valve to prevent leakage of water into the
retort during processing.
(12) Vents. Vents shall be installed in such a way that air is
removed from the retort before timing of the process is started. Vents
shall be controlled by gate, plug cock, or other adequate type valves
which shall be fully open to permit rapid discharge of air from the
retort during the venting period. Vents shall not be connected directly
to a closed drain system. If the overflow is used as a vent, there
shall be an atmospheric break in the line before it connects to a
closed drain. The vent shall be located in that portion of the retort
opposite the steam inlet; for example, steam inlet in bottom portion
and vent in top portion. Where a retort manifold connects several vent
pipes from a single still retort, it shall be controlled by a gate,
plug cock, or other adequate type valve. The retort manifold shall be
of a size that the cross-sectional area of the pipe is larger than the
total cross-sectional area of all connecting vents. The discharge shall
not be directly connected to a closed drain without an atmospheric
break in the line. A manifold header connecting vents or manifolds from
several still retorts shall lead to the atmosphere. The manifold header
shall not be controlled by a valve and shall be of a size that the
cross-sectional area is at least equal to the total cross-sectional
area of all connecting retort manifold pipes from all retorts venting
simultaneously. Timing of the process shall not begin until the retort
has been properly vented and the processing temperature has been
reached. Some typical installations and operating procedures reflecting
the requirements of this section for venting still retorts without
divider plates are given in paragraph (a)(12)(i)(A) through
(a)(12)(i)(D) and (a)(12)(ii)(A) and (a)(12)(ii)(B) of this section.
(i) Venting horizontal retorts. (A) Venting through multiple 1-inch
(2.5 centimeters) vents discharging directly to atmosphere.
[GRAPHIC] [TIFF OMITTED] TP14MR07.007

Specifications. One 1-inch (2.5 centimeters) vent for every 5 feet
(1.5 meters) of retort length equipped with a gate or plug cock valve
and discharging to atmosphere; end vents not more than 2.5 feet (76
centimeters) from ends of retort.
Venting method. Vent valves should be wide open for at least 5
minutes and to at least 225 [deg]F (107.2 [deg]C), or at least 7
minutes and to at least 220 [deg]F (104.4 [deg]C).
(B) Venting through multiple 1-inch (2.5 centimeters) vents
discharging through a manifold to atmosphere.

[[Page 12008]]

[GRAPHIC] [TIFF OMITTED] TP14MR07.008

Specifications. One 1-inch (2.5 centimeters) vent for every 5 feet
(1.5 meters) of retort length; and vents not over 2.5 feet (76
centimeters) from ends of retort: Size of manifold--for retorts less
than 15 feet (4.6 meters) in length, 2.5 inches (6.4 centimeters); for
retorts 15 feet (4.6 meters) and over in length, 3 inches (7.6
centimeters).
Venting method. Manifold vent gate or plug cock valve should be
wide open for at least 6 minutes and to at least 225 [deg]F (107.2
[deg]C), or for at least 8 minutes and to at least 220 [deg]F (104.4
[deg]C).
(C) Venting through water spreaders.
[GRAPHIC] [TIFF OMITTED] TP14MR07.009

Size of vent and vent valve. For retorts less than 15 feet (4.6
meters) in length, 2 inches (5.1 centimeters); for retorts 15 feet (4.6
meters) and over in length, 2.5 inches (3.8 centimeters).
Size of water spreader. For retorts less than 15 feet (4.6 meters)
in length, 1.5 inches (3.8 centimeters); for retorts 15 feet (4.6
meters) and over in length, 2 inches (5.1 centimeters). The number of
holes should be such that their total cross-sectional area is
approximately equal to the cross-sectional area of the vent pipe inlet.
Venting method. Water spreader vent gate or plug cock valve should
be wide open for at least 5 minutes and to at least 225 [deg]F (107.2
[deg]C), or for at least 7 minutes and to at least 220 [deg]F (104.4
[deg]C).

[[Page 12009]]

(D) Venting through a single 2.5-inch (6.4 centimeters) top vent
(for retorts not exceeding 15 feet (4.6 meters) in length).
[GRAPHIC] [TIFF OMITTED] TP14MR07.010

Specifications: A 2.5-inch (6.4 centimeters) vent equipped with a
2.5-inch (6.4 centimeters) gate or plug cock valve and located within 2
feet (61 centimeters) of the center of the retort.
Venting method: Vent gate or plug cock valve should be wide open
for at least 4 minutes and to at least 220 [deg]F (104.4 [deg]C).
(ii) Venting vertical retorts. (A) Venting through a 1.5-inch (3.8
centimeters) overflow.

[[Page 12010]]

[GRAPHIC] [TIFF OMITTED] TP14MR07.011

Specifications. A 1.5-inch (3.8 centimeters) overflow pipe equipped
with a 1.5-inch (3.8 centimeters) gate or plug cock valve and with not
more than 6 feet (1.8 meters) of 1.5-inch (3.8 centimeters) pipe beyond
the valve before break to the atmosphere or to a manifold header.
Venting method. Vent gate or plug cock valve should be wide open
for at least 4 minutes and to at least 218 [deg]F (103.3 [deg]C), or
for at least 5 minutes and to at least 215 [deg]F (101.7 [deg]C).
(B) Venting through a single 1-inch (2.5 centimeters) side or top
vent.

[[Page 12011]]

[GRAPHIC] [TIFF OMITTED] TP14MR07.012

Specifications. A 1-inch (2.5 centimeters) vent in lid or top side,
equipped with a 1-inch (2.5 centimeters) gate or plug cock valve and
discharging directly into the atmosphere or to a manifold header.
Venting method. Vent gate or plug cock valve should be wide open
for at least 5 minutes and to at least 230 [deg]F (110.0 [deg]C), or
for at least 7 minutes and to at least 220 [deg]F (104.4 [deg]C).
(iii) Other procedures. Other installations and operating
procedures that deviate from the above specifications may be used if
there is evidence in the form of heat distribution data, which shall be
kept on file, that they accomplish adequate venting of air.
(13) 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.
(b) Equipment and procedures for pressure processing in water in
still retorts--(1) Temperature-indicating device. Each retort shall be
equipped with at least one temperature-indicating device that
accurately indicates the temperature during processing. Temperature-
indicating devices shall be tested for accuracy against an accurate
calibrated 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 reference device 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) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and
maintained.

[[Page 12012]]

(A) Documentation of the accuracy of the temperature-indicating
device shall include a reference to the tag, seal, or other means of
identity used by the processor to identify the temperature-indicating
device, the name of the manufacturer of the temperature-indicating
device, the identity of the reference device used for the accuracy test
and of equipment and procedures used to adjust or calibrate the
temperature-indicating device, the date and results of each accuracy
test, the name of the person or facility that performed the accuracy
test and adjusted or calibrated the temperature-indicating device, and
the date of the next scheduled accuracy test.
(B) Documentation of the accuracy of the reference device shall
include a reference to the tag, seal, or other means of identity used
by the processor to identify the reference device, the name of the
manufacturer of the reference device, the identity of the equipment and
procedures used to test the accuracy and to adjust or calibrate the
reference device, the identity of the person or facility that performed
the accuracy test and adjusted or calibrated the reference device, the
date and results of the accuracy test, and the traceability
information. Documentation for the reference device may be in the form
of a guaranty of accuracy from the manufacturer or a certificate of
calibration from a laboratory.
(iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired or replaced before further use.
(iv) A temperature-indicating device shall be easily readable 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. Sensors of temperature-indicating
devices shall be located in such a position that they are beneath the
surface of the water throughout the process. On horizontal retorts,
this entry should be made in the side at the center, and the
temperature-indicating device sensor shall be inserted directly into
the retort shell. In both vertical and horizontal retorts, the
temperature-indicating device sensor shall extend directly into the
water a minimum of at least 2 inches (5.1 centimeters) without a
separable well or sleeve. If a separate well or sleeve is used, there
must be adequate circulation to ensure accurate temperature
measurements. 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 that records temperatures to a
permanent record, such as a temperature-recording chart.
(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 to agree as nearly as possible with, but to be in no event
higher than, the temperature-indicating device during the process time.
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
recording-controlling instrument. 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. Air-operated temperature controllers should have adequate filter
systems to ensure a supply of clean, dry air.
(3) Pressure gages. (i) Each retort should be equipped with a
pressure gage that should be graduated in divisions of 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.
(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

[[Page 12013]]

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) 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.
(10)(i) 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.
(ii) 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-section 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 equipped with a pilot light or other
signaling device to warn the operator when it is not running, and with
a bleeder to remove air when starting operations. Alternative methods
for circulation of water in the retort may be used when established by
a competent authority as adequate for even heat distribution.
(11) 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.
(12) Retort headspace. The headspace necessary to control the air
pressure should be maintained between the water level and the top of
the retort shell.
(13) Vertical and horizontal still retorts. Vertical and horizontal
still retorts should follow the arrangements in the diagrams below 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-S

[[Page 12014]]

[GRAPHIC] [TIFF OMITTED] TP14MR07.013

BILLING CODE 4160-01-C

[[Page 12015]]

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.
(14) 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.
Temperature-indicating devices shall be tested for accuracy against an
accurate calibrated 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 reference device 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) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and
maintained.
(A) Documentation of the accuracy of the temperature-indicating
device shall include a reference to the tag, seal, or other means of
identity used by the processor to identify the temperature-indicating
device, the name of the manufacturer of the temperature-indicating
device, the identity of the reference device used for the accuracy test
and of equipment and procedures used to adjust or calibrate the
temperature-indicating device, the date and results of each accuracy
test, the name of the person or facility that performed the accuracy
test and adjusted or calibrated the temperature-indicating device, and
the date of the next scheduled accuracy test.
(B) Documentation of the accuracy of the reference device shall
include a reference to the tag, seal, or other means of identity used
by the processor to identify the reference device, the name of the
manufacturer of the reference device, the identity of the equipment and
procedures used to test the accuracy and to adjust or calibrate the
reference device, the identity of the person or facility that performed
the accuracy test and adjusted or calibrated the reference device, the
date and results of the accuracy test, and the traceability
information. Documentation for the reference device may be in the form
of a guaranty of accuracy from the manufacturer or a certificate of
calibration from a laboratory.
(iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired or replaced before further use.
(iv) A temperature-indicating device shall be easily readable 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 sensor of the temperature-
indicating device 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 that records temperatures to a
permanent record, such as a temperature-recording chart.
(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 to agree as nearly as possible with, but to be in no event
higher than, the temperature-indicating device during the process time.
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

[[Page 12016]]

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 recording-
controlling instrument. 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 opening emitting steam
continuously during the processing period. 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, which should be graduated in divisions of 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 recording-controlling instrument 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.
(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 marked
on the recording chart 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 marked 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

[[Page 12017]]

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.
Temperature-indicating devices shall be tested for accuracy against an
accurate calibrated 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 reference device 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) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and
maintained.
(A) Documentation of the accuracy of the temperature-indicating
device shall include a reference to the tag, seal, or other means of
identity used by the processor to identify the temperature-indicating
device, the name of the manufacturer of the temperature-indicating
device, the identity of the reference device used for the accuracy test
and of equipment and procedures used to adjust or calibrate the
temperature-indicating device, the date and results of each accuracy
test, the name of the person or facility that performed the accuracy
test and adjusted or calibrated the temperature-indicating device, and
the date of the next scheduled accuracy test.
(B) Documentation of the accuracy of the reference device shall
include a reference to the tag, seal, or other means of identity used
by the processor to identify the reference device, the name of the
manufacturer of the reference device, the identity of the equipment and
procedures used to test the accuracy and to adjust or calibrate the
reference device, the identity of the person or facility that performed
the accuracy test and adjusted or calibrated the reference device, the
date and results of the accuracy test, and the traceability
information. Documentation for the reference device may be in the form
of a guaranty of accuracy from the manufacturer or a certificate of
calibration from a laboratory.
(iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired or replaced before further use.
(iv) A temperature-indicating device shall be easily readable 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 sensor of the temperature-
indicating device 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 that records temperatures to a
permanent record, such as a temperature-recording chart.
(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 to agree as nearly as possible with, but to be in no event
higher than, the temperature-indicating device during the process time.
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 recording-
controlling instrument. 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. 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 should be graduated in divisions of 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 recording-controlling instrument 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.
(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

[[Page 12018]]

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 containing drainage of condensate
during the retort operation.
(7) Retort speed timing. The rotational speed of the retort shall
be specified in the schedules 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 schedules
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.
Temperature-indicating devices shall be tested for accuracy against an
accurate calibrated 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 reference device 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) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and
maintained.
(A) Documentation of the accuracy of the temperature-indicating
device shall include a reference to the tag, seal, or other means of
identity used by the processor to identify the temperature-indicating
device, the name of the manufacturer of the temperature-indicating
device, the identity of the reference device used for the accuracy test
and of equipment and procedures used to adjust or calibrate the
temperature-indicating device, the date and results of each accuracy
test, the name of the person or facility that performed the accuracy
test and adjusted or calibrated the temperature-indicating device, and
the date of the next scheduled accuracy test.
(B) Documentation of the accuracy of the reference device shall
include a reference to the tag, seal, or other means of identity used
by the processor to identify the reference device, the name of the
manufacturer of the reference device, the identity of the equipment and
procedures used to test the accuracy and to adjust or calibrate the
reference device, the identity of the person or facility that performed
the accuracy test and adjusted or calibrated the reference device, the
date and results of the accuracy test, and the traceability
information. Documentation for the reference device may be in the form
of a guaranty of accuracy from the manufacturer or a certificate of
calibration from a laboratory.
(iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired or replaced before further use.
(iv) A temperature-indicating device shall be easily readable 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 sensor of the temperature-
indicating device shall be installed either within the retort shell or
in an external well attached to the retort. Sensors of temperature-
indicating devices shall be located in such a position that they are
beneath the surface of the water throughout the process. This entry
should be made in the side at the center, and the temperature-
indicating device sensor shall be inserted directly into the retort
shell. The temperature-indicating device sensor shall extend directly
into the water a minimum of at least 2 inches (5.1 centimeters) without
a separable well or sleeve. If a separate well or sleeve is used, there
must be adequate circulation to ensure accurate temperature
measurements. 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 that records temperatures to a
permanent record, such as a temperature-recording chart.
(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

[[Page 12019]]

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 to agree as nearly as possible with, but to be in no event
higher than, the temperature-indicating device during the process time.
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 recording-
controlling instrument. The temperature-recording device sensor shall
be installed either within the retort shell or in a well attached to
the shell. 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 should be graduated in divisions of 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 recording-controlling instrument when combined with a temperature-
recording device.
(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)(i) Air supply and controls. 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) 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-section 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 equipped with a pilot light or other
signaling device to warn the operator when it is not running, and with
a bleeder to remove air when starting operations. Alternative methods
for circulation of water in the retort may be used when established by
a competent authority as adequate for even heat distribution.
(7) 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.
(8) 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.
(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. Temperature-
indicating devices shall be tested for accuracy against an accurate
calibrated 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 reference device 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) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and
maintained.
(A) Documentation of the accuracy of the temperature-indicating
device shall include a reference to the tag, seal, or other means of
identity used by the processor to identify the temperature-indicating
device, the name of the manufacturer of the temperature-indicating
device, the identity of the reference device used for the accuracy test
and of equipment and procedures used to adjust or calibrate the
temperature-indicating device, the date and results of each accuracy
test, the name of the person or facility that performed the accuracy
test and adjusted or calibrated the temperature-indicating device, and
the date of the next scheduled accuracy test.
(B) Documentation of the accuracy of the reference device shall
include a reference to the tag, seal, or other means of identity used
by the processor to identify the reference device, the name of the
manufacturer of the reference device, the identity of the equipment and
procedures used to test the accuracy and to adjust or calibrate the
reference device, the identity of the person or

[[Page 12020]]

facility that performed the accuracy test and adjusted or calibrated
the reference device, the date and results of the accuracy test, and
the traceability information. Documentation for the reference device
may be in the form of a guaranty of accuracy from the manufacturer or a
certificate of calibration from a laboratory.
(iii) A temperature-indicating device that is defective or cannot
be adjusted to the accurate calibrated reference device shall be
repaired or replaced before further use.
(iv) A temperature-indicating device shall be easily readable 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
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 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 that records temperatures to a
permanent record, such as a temperature-recording chart.
(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 to agree as nearly as possible with, but to be in no event
higher than, the temperature-indicating device during the process time.
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 recording-
controlling instrument. 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 which emits steam continuously
during the processing period. Additional temperature-recording device
sensors shall be installed in the hydrostatic water legs if the
scheduled process specified maintenance of particular temperatures in
the hydrostatic water legs. 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 should be graduated in divisions of 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 recording-controlling instrument 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.
(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. Temperature-indicating devices shall be tested for

[[Page 12021]]

accuracy against an accurate calibrated 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 reference device
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) Written documentation of the accuracy of the temperature-
indicating device and the reference device shall be established and
maintained.
(i) Documentation of the accuracy of the temperature-indicating
device shall include a reference to the tag, seal, or other means of
identity used by the processor to identify the temperature-indicating
device, the name of the manufacturer of the temperature-indicating
device, the identity of the reference device used for the accuracy test
and of equipment and procedures used to adjust or calibrate the
temperature-indicating device, the date and results of each accuracy
test, the name of the person or facility that performed the accuracy
test and adjusted or calibrated the temperature-indicating device, and
the date of the next scheduled accuracy test.
(ii) Documentation of the accuracy of the reference device shall
include a reference to the tag, seal, or other means of identity used
by the processor to identify the reference device, the name of the
manufacturer of the reference device, the identity of the equipment and
procedures used to test the accuracy and to adjust or calibrate the
reference device, the identity of the person or facility that performed
the accuracy test and adjusted or calibrated the reference device, the
date and results of the accuracy test, and the traceability
information. Documentation for the reference device may be in the form
of a guaranty of accuracy from the manufacturer or a certificate of
calibration from a laboratory.
(3) A temperature-indicating device that is defective or cannot be
adjusted to the accurate calibrated reference device shall be repaired
or replaced before further use.
(4) A temperature-indicating device shall be easily readable 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 that records temperatures
to a permanent record, such as a temperature-recording chart. A
temperature-recording device 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
to agree as nearly as possible with, but to be in no event higher than,
the temperature-indicating device during the process time. 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, there shall be an accurate differential
pressure recorder-controller installed on the regenerator. The scale
divisions shall not exceed 2 pounds per square inch (13.8 kilopascals)
on the working scale of not more than 20 pounds per square inch per
inch of scale (55 kilopascals per centimeter). The controller shall be
tested for accuracy against a known accurate standard pressure
indicator upon installation and at least once every 3 months of
operation thereafter, or more frequently if necessary, to ensure its
accuracy. 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.
(F) Flow control. A flow controlling 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

[[Page 12022]]

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 and shall be reprocessed or destroyed. 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 metering
pump 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
instrumented 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 and 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, recording tachometer may be used to provide a continuous
record

[[Page 12023]]

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.
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 at 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.
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. When a product is reprocessed or a previously
processed product is blended into a new formulation, this condition
must be covered in the scheduled process. 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, 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.
5. Amend Sec. 113.87 by revising paragraphs (c) and (e) to read as
follows:

Sec. 113.87 Operations in the thermal processing room.

* * * * *
(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 an
accurate calibrated reference device at sufficient frequency to ensure
that initial temperature measurements are accurate. Records of the
accuracy tests shall be signed or initialed, dated, and maintained.
* * * * *
(e) Clock times on temperature-recording device records shall
reasonably correspond to the time of day on the written processing
records to provide correlation of these records.
* * * * *
6. Amend Sec. 113.100 by revising paragraphs (a) introductory
text, (a)(4), (b), and (c) and by adding paragraphs (f) and (g) to read
as follows:

Sec. 113.100 Processing and production records.

(a) Processing and production information shall be entered at the
time

[[Page 12024]]

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 written 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) Written 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.
* * * * *
(f) Records of this part may be maintained electronically, provided
they are in compliance with part 11 of this chapter.
(g) All records required under this part, or copies of such
records, must be readily available during the retention period for
inspection and copying by FDA when requested. If reduction techniques,
such as microfilming, are used, a suitable reader and photocopying
equipment must be made readily available to FDA.

Dated: March 4, 2007.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 07-1172 Filed 3-13-07; 8:45 am]
BILLING CODE 4160-01-S